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People, Places, Processes & Products that Influence the Supply Chain

 

hpnonline Daily Update

2013
April 2007
   

 

April 30, 2007

Amerinet leadership changes hands as Ebert takes the helm

SterilMed and The Scope Exchange merge

Ray Taurasi joins Healthmark Industries

CMS proposes payment changes for Medicare home health services  

CMS issues guidance on hospital emergency services requirements

Joint update: FDA/USDA update on tainted animal feed

 

Alzheimer’s memory loss may one day be reversible

Major manufacturer of unapproved and adulterated drugs agrees to stop illegal practices

 


Amerinet leadership changes hands as Ebert takes the helm

Todd Ebert, president and chief operating officer of Amerinet Inc., saw his leadership role within the national group purchasing organization expanded even more following the announced resignation today of CEO Victor Samolovitch. Though Ebert takes the chief executive reins of Amerinet, responsible for overall leadership of the organization, his professional elevation does not include the CEO title, which has been shelved. As president, Ebert “will focus on continued implementation of the Amerinet strategic business plan adopted in June 2006,” he told Healthcare Purchasing News in a prepared statement. “The plan calls for continued organizational growth, investment into program development and differentiating Amerinet in the marketplace. Key areas include programs and services such as clinical consulting, clinical preference products and data analysis and management tools.” For now the CEO position will not exist, according to Lisa DiMuccio-Conway, Amerinet’s vice president of marketing, and “there is not to be a CEO search at this time.”  

Samolovitch was promoted to Amerinet CEO last June as the GPO celebrated its 20th anniversary and was embarking on a new business model that unified its three shareholder organizations under a single national platform. He succeeded the retiring Robert P. “Bud” Bowen. Samolovitch was president of Warrendale, PA-based Amerinet Central, one of the GPO’s key shareholder companies. Samolovitch also had been part of Amerinet since 1986. When Bowen retired, Amerinet tapped Samolovitch to be CEO and created a new position for Ebert, who had served as president. As president and newly named chief operating officer, Ebert would oversee “customer-facing operations,” such as contracting, marketing and sales. He originally hailed from Salt Lake City-based Intermountain Health Care, another key Amerinet shareholder.

Bert Zimmerli, Amerinet’s chairman of the board, praised Samolovitch for his leadership role in the GPO’s move to a single organization from the shareholder-based structure it operated under since its inception in 1986. “Over the past year, Vic has been instrumental in leading Amerinet through its organizational transition to one national group purchasing organization,” Zimmerli stated in a press release distributed to the media this morning. “Thanks to Vic’s vision and perseverance, Amerinet developed a restructuring plan that solidly positions the organization for future success and growth.”

AmeriNet, (its original designation in 1986), comprised four multi-state regional purchasing groups during its debut: Haricomp (which became Vector Healthsystem), Health Services Corporation of America (which left the GPO four years later and now is part of MedAssets), Hospital Shared Services of Western Pennsylvania (which became Amerinet Central) and Intermountain Health Care. Based in St. Louis, with offices in Salt Lake City, Providence, RI, and Warrendale, PA, Amerinet serves more than 22,000 acute and non-acute healthcare providers nationwide.

 

SterilMed and The Scope Exchange merge

SterilMed and The Scope Exchange have reached an agreement to merge. The merger is part of SterilMed and The Scope Exchange’s strategy to help healthcare providers conserve their resources by extending the life of medical devices, instruments, and equipment. Combining the two companies’ expertise in the repair and reprocessing of medical devices will provide customers with a comprehensive single-source supplier. The merged expertise combined with SterilMed’s broad market presence will further strengthen the breadth of services provided, including industry leading technical capabilities and showcase repair facilities. The newly formed company can now offer the benefits of an integrated reprocessing and repair service approach.

 

Ray Taurasi joins Healthmark Industries

Healthmark Industries Company, Inc. (St. Clair Shores, MI) is pleased to announce the appointment of Ray Taurasi as the new Director Clinical Sales & Services - Eastern Region. “Ray is an excellent addition to our Sales and Marketing team. His long time experience both in managing of and in marketing to sterile processing departments means he has unique insight into our customers and their needs,” explained Steven Basile, Vice President Sales. “Ray will be responsible for working with our Eastern Region sales representatives, providing them with training, direction and sales support. He will also be a vital asset to our customers as they seek clinical support and education.”
Stephen Kovach, Healthmark’s Director of Clinical Education, said “I have worked with Ray for years, as a counterpart managing CS Departments, as a colleague on various ASHCSP and IAHCSMM boards and activities and most recently on various AAMI Sterilization Standards committees. I look forward to drawing upon Ray’s vast experience as we continue to expand our efforts in customer education and support.” 

Taurasi’s healthcare career spans over three decades as an administrator, educator, technologist and consultant. Taurasi has been a member of ASHCSP since 1969 and holds advanced membership status. He is also a past president of IAHCSMM. For 19 years, he was the Director of CPD at Boston’s Beth Israel Deaconess Medical Center and prior to that he was the Director of SPD and Faulkner Hospital. He has been a faculty member of numerous colleges teaching in the divisions of business administration and health sciences. For the past five years he has authored a monthly column in Healthcare Purchasing News entitled “CS Solutions”. In addition to professional credentials in the field of Central Service Technology and Education, he holds a BS degree in management and counseling and an MBA. His dedication to the healthcare field and community service has won him international recognition and several prestigious awards, including IAHCSMM Presidential Citation Subject Matter Expert. 

Healthmark Industries Company provides solutions for the sterile processing profession including products designed to address the needs and challenges related to the sterilization, decontamination, storage and distribution of medical equipment and supplies. For more information see THIS LINK.

 

CMS proposes payment changes for Medicare home health services  

The Centers for Medicare & Medicaid Services (CMS) proposed a rule designed to ensure more appropriate payment for services provided by Medicare home health agencies, while establishing incentives for more efficient care for Medicare beneficiaries. This proposed rule contains the first refinements to the Medicare home health prospective payment system (HH PPS) since 2000 and also contains the annual update to the Medicare HH PPS payment rates. The net impact of all of the proposed refinements and updates in the HH PPS proposed rule is an estimated additional $140 million in payments to home health agencies in CY 2008. 

The proposed home health market basket increase for CY 2008 is 2.9%. Home health agencies (HHAs) collect and report Outcome and Assessment Information Set (OASIS) data. For CY 2008, CMS proposes to evaluate home health care quality by continuing to rely on the submission of OASIS assessments. Continuing to use the current OASIS instrument ensures that providers would avoid any additional burden of reporting through a separate mechanism and any related costs associated with the development and testing of a new reporting mechanism. The proposed rule includes a provision to continue to adjust payment for reporting of quality data. HHAs that submit the required quality data would receive payments based on the proposed full home health market basket update of 2.9 percent for CY 2008. If a HHA does not submit quality data, the home health market basket percentage increase would be reduced by 2 percentage points to 0.9 percent for CY 2008. The proposed rule adds two National Quality Forum-endorsed measures to the 10 that are currently reported: emergent care for wound infections - deteriorating wound status; and improvement in status of surgical wound.

CMS analysis of the latest available home health claims data indicates a significant increase in the observed case-mix since 2000 and that the case-mix increase is due to changes in coding practices and documentation rather than to treatment of more resource-intensive patients. To account for the changes in case-mix that are not related to a home health patient’s actual clinical condition, this rule proposes to reduce the national standardized 60-day episode payment rate by 2.75 percent per year for three years beginning in CY 2008. This rule proposes ways to improve the comprehensiveness of the case-mix model and thus improve the accuracy of Medicare’s payments. The proposed case-mix model includes a proposal to replace the current therapy threshold at 10 visits per episode with three new therapy thresholds at six, 14, and 20 therapy visits. The new levels would have graduated payment levels between the proposed therapy thresholds to reduce incentives to inappropriately target higher thresholds.  

This rule also proposes to modify the low utilization payment adjustment (LUPA) and to eliminate the significant change in condition payment adjustment. The rule proposes to increase payment for LUPA episodes that occur as the only episode or the first episode during a series of home health episodes to account for the initial greater costs in such episodes. CMS is also proposing to revise the way to account for non-routine medical supplies (NRS) in the standardized 60-day episode payment rate. This rule proposes to pay for NRS based on 5 severity groups, similar to the proposed clinical case-mix model, to more accurately reflect home health agency costs for NRS. The comment period closes on Tuesday, June 26.The proposed rule is available at THIS LINK.
For a fact sheet summary see THIS LINK.

 

CMS issues guidance on hospital emergency services requirements

The Centers for Medicare & Medicaid Services (CMS) issued guidance clarifying the responsibility of hospitals provide emergency services if they participate in the Medicare program. The guidance makes it clear that nearly all hospitals, including specialty hospitals and others without emergency departments, must be able to evaluate persons with emergencies, provide initial treatment, and refer or transfer these individuals when appropriate. The guidance does not apply to critical access hospitals (CAHs), which are small, rural hospitals that are subject to separate regulation.

Today’s letter reiterates Medicare’s long-standing requirement that hospitals have appropriate policies and procedures in place to address individuals’ emergency care needs 24 hours per day, 7 days per week. “Any hospital participating in Medicare, regardless of the type of hospital and apart from whether the hospital has an emergency department must have the capability to provide basic emergency care interventions.” said Leslie V. Norwalk, Esq., Acting Administrator of the Centers for Medicare & Medicaid Services. “The guidance we are issuing today is part of an overall strategy to ensure quality care by assuring the rapid response to emergencies for all people with Medicare.”

Three key requirements are (a) the capability to appraise the emergency situation, (b) providing initial treatment, and (c) referral when appropriate. The letter clarifies that the Medicare Conditions of Participation (CoPs) do not permit a hospital to rely upon 9-1-1 services as a substitute for the hospital’s own ability to provide these services. In a separate development, CMS issued a proposed rule on April 13, 2007 that would increase transparency and public disclosure concerning emergency services. The FY 2008 acute care hospital inpatient prospective payment system (IPPS) proposed rule would require a hospital to notify all patients in writing if a doctor of medicine or doctor of osteopathy is not present in the hospital 24 hours a day, seven days per week. The hospital would be required to disclose how it would meet the medical needs of a patient who develops an emergency condition while no doctor is on site. 

CMS also invited comments on whether current requirements for emergency service capabilities in hospitals with and without emergency departments should be strengthened in certain areas, such as the types of clinical personnel that should be present at all times and their competencies; the type of emergency response equipment that should be available; and whether hospital emergency departments should be required to operate 24 hours per day, 7 days per week. Although the survey guidance issued today applies to all hospitals, it also implements one element of the Strategic and Implementing Plan for Specialty Hospitals that CMS reported to Congress in August of 2006, in accordance with the provisions of section 5006 of the Deficit Reduction Act of 2005. For more information see THIS LINK.



Joint update: FDA/USDA update on tainted animal feed

The U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) continue their investigation of imported rice protein concentrate which has been found to contain melamine and melamine-related compounds. Based on information currently available, FDA and USDA believe the likelihood of illness after eating pork from swine fed the contaminated product would be very low. The agencies are taking certain actions out of an abundance of caution. As announced on April 26, swine known to have been fed adulterated (contaminated) product will not be approved to enter the food supply. (Because the animal feed in question was adulterated, USDA cannot rule out the possibility that food produced from animals fed this product could also be adulterated.)

As reported on April 22 by FDA, the Agency determined that rice protein concentrate imported from China was contaminated with melamine and melamine-related compounds. The product was imported by Wilbur-Ellis, an importer and distributor of agricultural products. Although the company began importing product from China in August 2006, the company did not become aware of the contamination until April 2007. As part of the ongoing investigation, FDA has determined the rice protein was used in the production of pet food and a portion of the pet food was used to produce animal feed. The ongoing investigation is tracing products distributed since August 2006 by Wilbur-Ellis throughout the distribution chain.


At this time, the agencies have no evidence of harm to humans associated with the processed pork product, and therefore no recall of meat products processed from these animals is being issued. If any evidence surfaces to indicate there is harm to humans, the appropriate action will be taken. The assessment that, if there were to be harm to human health, it would be very low, is based on a number of factors, including the dilution of the contaminating melamine and melamine-related compounds from the original rice protein concentrate as it moves through the food system. First it is a partial ingredient in the pet food; second, it is only part of the total feed given to the hogs; third, it is not known to accumulate in the hogs and the hogs excrete melamine in their urine; fourth, even if present in pork, pork is only a small part of the average American diet. Neither FDA nor USDA has uncovered any evidence of harm to the swine from the contaminated feed.

 

In addition, the agencies are not aware of any human illness that has occurred from exposure to melamine or its by-products. To further evaluate any potential harm to humans, the FDA is developing and implementing further tests and risk assessments based on the toxicity of the compounds and how much of the compounds consumers could be expected to actually consume. The ongoing investigation and product reconciliation and testing have led to certain farms. The agencies expect the investigation will continue to find more places where product may have been distributed. As of April 26, sites in the following states are believed to have received and used contaminated product: California, Kansas, New York, North Carolina, South Carolina and Utah.

 



Alzheimer’s memory loss may one day be reversible

A new US study suggests it may one day be possible to reverse the memory loss associated with Alzheimer’s and similar degenerative brain diseases. The study is published in Nature. Scientists at MIT’s Picower Institute for Learning and Memory in Cambridge, MA, put mice with induced brain atrophy in an enriched environment; a “playground” where they had the company of other mice, were given new colorful toys to play with every day, and were able to exercise on wheels. The enriched environment mice recovered long term memories while mice kept in a bare cage on their own did not. Li-Huei Tsai, Picower Professor of Neuroscience in the Department of Brain and Cognitive Sciences and her colleagues got the same results when they gave the brain atrophied mice a new type of experimental drug called histone deacetylase (HDAC) inhibitors.  

Neurodegenerative diseases of the central nervous system are frequently accompanied by impaired learning and memory, and eventually dementia. Scientists have been trying to find ways to reverse the process and re-establish the ability to learn and remember. In this study, Prof Tsai showed it was possible to “re-established access to long-term memories after significant brain atrophy and neuronal loss had already occurred”. The stimulated mice’s brain cells had sprouted new dendrites and produced new synapses, in effect reversing the degeneration. Prof Tsai, who is also a Howard Hughes Medical Institute investigator, said: “This is exciting because our results show that learning ability can be improved and ‘lost’ long-term memories can be recovered even after a significant number of neurons have already been lost in the brain.” “This hints at the possibility that cognitive function can be improved even in advanced stages of dementia,” she added.

HDACs help genes that have been too tightly packed in the nucleus of cells to express themselves and make proteins. HDACs have been increasingly used by researchers in other fields, for instance in clinical trials with Huntington’s disease patients. Some HDACs are already available to help chemotherapy drugs target DNA by opening up the chromatin structure. However, as Prof Tsai said: “To our knowledge, HDACs have not been used to treat Alzheimer’s disease or dementia. Future research should address whether HDAC inhibitors will be effective for treating neurodegenerative diseases.” Speculating on their findings, Prof Tsai and her colleagues suggested that perhaps degenerative brain diseases like Alzheimer’s do not wipe out memories, but make them inaccessible in some way. Many treatments for Alzheimer’s and other brain degenerative diseases target the early stages, while this study suggests memory and learning may be restorable even when the brain is already quite damaged. A new report from the Alzheimer’s Association says there are now more than 5 million Americans living with the disease. At present one American develops Alzheimer’s every 72 seconds. This is estimated to become every 33 seconds by 2050 as 78 million baby boomers began turning 60 last year. (Medical News Today) For the abstract, see THIS LINK.

 

 

Major manufacturer of unapproved and adulterated drugs agrees to stop illegal practices

The U.S. Food and Drug Administration (FDA) announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, Mark Tengler, PharmaFab’s president, and Russ McMahen, PFab’s vice president of scientific affairs, to stop the illegal manufacture and distribution of prescription and over-the-counter drug products. The products are illegal because they are not produced according to the required current good manufacturing practice (CGMP) and many also lack required FDA approval. The case was filed in the United States District Court for the Northern District of Texas. PharmaFab is a major contract manufacturer and distributor of more than 100 different prescription and over-the-counter drug products, including cough and cold products, ulcer treatments, and postpartum hemorrhage products. Consumers who have products manufactured by PharmaFab should consult with their physician.

 

The unapproved drugs manufactured by PharmaFab include, but are not limited to: De-Congestine Sustained Release Capsules; GFN 1200/DM 60/PSE 60 Extended-Release Tablets; Rhinacon A Tablets; Sudal 12 Chewable Tablets; Histex PD 12 Suspension; Atuss HX CIII; Ergotrate Tablets; and Hyoscyamine Sulfate Time-Release Capsules. Because these drugs have not undergone FDA approval, their safety and effectiveness have not been established, and FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling. According to the complaint filed with the court, PharmaFab did not comply with CGMP by not investigating manufacturing failures and not recording and justifying why it deviated from written manufacturing procedures. Further, the company lacked an effective quality control unit and failed to establish reliable expiration dates for products. Compliance with CGMP is necessary to ensure that drugs have the requisite safety, identity, strength, quality, and purity.


The consent decree requires the defendants to destroy certain illegal drugs, and bars them from distributing all drugs until they obtain required FDA approval and fully comply with CGMP. If they resume distributing drugs, the defendants are required to retain an auditor to conduct inspections of their facilities for a period of five years and to provide reports to FDA analyzing compliance with CGMP and labeling requirements. The decree also allows FDA to require recall or shutdown in the event of future violations and provides for damages of $5,000 per day and $1,000 per violation, up to a maximum of $5 million per year, if the defendants fail to comply with its terms.
   

 


April 27, 2007

AmerisourceBergen receives DEA order to temporarily halt distribution
of controlled substances from Orlando facility

 

Landmark study shows at least 10 genetic variants
are associated with adult onset diabetes

 

Over time, more women are developing MS than men

New prostate cancer test may detect more tumors

New Clorox Anywhere hand sanitizing spray helps
industry professionals prevent spread of infection

DuPont introduces engineered elastic nonwoven technology
to
offer stretch capability in a nonwoven fabric

Novation introduces first product catalog for private label brand, NOVAPLUS

 


AmerisourceBergen receives DEA order to temporarily halt distribution
of controlled substances from Orlando facility

AmerisourceBergen Corporation announced that the U.S. Drug Enforcement Administration (DEA) has temporarily suspended the Orlando, FL Distribution Center’s (DC), license to distribute DEA controlled substances and listed chemicals. The temporary suspension affects only the Orlando DC and only DEA controlled items. The action may impact approximately 1,400 pharmacy customers in Florida. In the event this temporary suspension is not quickly resolved, alternative arrangements will be made for customers served by the Orlando Distribution Center, so they will not be inconvenienced. The DEA asserts that AmerisourceBergen did not maintain effective controls against diversion of controlled substances, specifically hydrocodone, to four internet pharmacies from January 1, 2006 through January 31, 2007. Historically, AmerisourceBergen has proactively cooperated with the DEA in preventing diversion of hydrocodone and other controlled substances, and will fully cooperate with the agency in resolving the temporary suspension. The Company has a diversion program and a DEA-approved suspicious-order monitoring program in place to identify customers who are suspected of inappropriately selling products sold to them by AmerisourceBergen. All of the Orlando Distribution Center’s DEA audits, the most recent within the last year, were passed with no deficiencies found. AmerisourceBergen is not doing business with any of the four customers cited by the DEA, and all of the pharmacies mentioned by the agency held active DEA licenses to sell controlled substances at the time AmerisourceBergen sold product to them.

 

Landmark study shows at least 10 genetic variants are associated
with adult onset diabetes


In the most comprehensive look at genetic risk factors for type 2 diabetes to date, a U.S.-Finnish team, working in close collaboration with two other groups, has identified at least four new genetic variants associated with increased risk of diabetes and confirmed existence of another six. The findings of the three groups, published simultaneously today in the online edition of the journal Science, boost to at least 10 the number of genetic variants confidently associated with increased susceptibility to type 2 diabetes, a disease that affects more than 200 million people worldwide. “This achievement represents a major milestone in our battle against diabetes. It will accelerate efforts to understand the genetic risk factors for this disease, as well as explore how these genetic factors interact with each other and with lifestyle factors,” said National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D. “Such research is opening the door to the era of personalized medicine. Our current one-size-fits-all approach will soon give way to more individualized strategies based on each person's unique genetic make-up.”


To make their discoveries, researchers used a relatively new, comprehensive strategy known as a genome-wide association study. “Genome-wide association studies offer a powerful way to uncover the genetic variations that contribute to diabetes, as well as other common conditions, such as asthma, arthritis, heart disease, cancer and mental illnesses,” said lead study author, Michael Boehnke, Ph.D., of the University of Michigan's School of Public Health, Ann Arbor. “Once susceptibility genes are identified, researchers then can use this information to develop better approaches to detecting, treating and preventing disease.” To conduct a genome-wide association study, researchers use two groups of participants: a large group of people with the disease being studied and a large group of otherwise similar people without the disease. Utilizing DNA purified from blood or cells, researchers quickly survey each participant’s complete set of DNA, or genome, for strategically selected markers of genetic variation. If certain genetic variations are found more frequently in people with the disease compared to healthy people, the variations are said to be associated with the disease. The associated genetic variations can serve as a strong pointer to the region of the genome where the genetic risk factor resides. However, the first variants detected may not themselves directly influence disease susceptibility, and the actual causative variant may lie nearby. This means researchers often need to take additional steps, such as sequencing every DNA base pair in that particular region of the genome, to identify the exact genetic variant that affects disease risk.


In the latest work, researchers began by scanning the genomes of more than 2,300 Finnish people who took part in the Finland-United States Investigation Of NIDDM Genetics (FUSION) and Finrisk 2002 studies. About half of the participants had type 2 diabetes and the other half had normal blood glucose levels. To validate their findings, the researchers compared their initial results with results from genome scans of 3,000 Swedish and Finnish participants in the Diabetes Genetics Initiative and 5,000 British participants in the Wellcome Trust Case Control Consortium, led by Peter Donnelly, D.Phil., Oxford University. After identifying promising leads through this approach, the three research teams jointly replicated their findings using smaller, more focused sets of genetic markers in additional groups totaling more than 22,000 people from Finland, Poland, Sweden, the United Kingdom and the United States. All told, the genomes of 32,554 people were tested for the study, making it one of the largest genome-wide association efforts conducted to date. Ultimately, the researchers identified four new diabetes-associated variations, as well as confirmed previous findings that associated six other genetic variants with increased diabetes risk.


When the genomes of the Finnish participants were scanned for all 10 diabetes-associated genetic variants, researchers could identify individuals whose genetic profiles placed them at increased risk for type 2 diabetes, including one subset of people who faced a risk four times higher than those at the lowest genetic risk. This “could potentially have value in a personalized preventive medicine program,” the researchers wrote. However, the researchers emphasized that their predictions of disease risk need to be interpreted with caution because the diabetes group in their sample was “enriched” with people who had affected siblings and because the healthy group excluded people who had impaired glucose tolerance or impaired fasting glucose. For more information about genome-wide association studies, see THIS LINK.

 

 


Over time, more women are developing MS than men


Over time, more women are developing multiple sclerosis (MS) than men, according to research that will be presented at the American Academy of Neurology’s 59th Annual Meeting in Boston, April 28 – May 5, 2007. In 1940, the ratio of women to men with MS in the United States was approximately two to one. By 2000, that ratio had grown to approximately four to one. “That’s an increase in the ratio of women to men of nearly 50 percent per decade,” said study author Gary Cutter, PhD, of the University of Alabama at Birmingham School of Public Health. “We don’t yet know why more women are developing MS than men, and more research is needed.”

 

Cutter said researchers will need to explore multiple changes that have occurred for women over the last several decades, including the use of oral contraceptives, earlier menstruation, obesity rates, changes in smoking rates, and later age of first births. “We also need to ask the general questions about what women do differently than men, such as use of hair dye and use of cosmetics that may block vitamin D absorption,” he said. “At this point we’re just speculating on avenues of research that could be pursued.” Cutter said the largest increase in the ratio has been for those whose MS started at younger ages. For the study, researchers examined a database (the North American Research Committee On Multiple Sclerosis, or NARCOMS, hosted at Barrow Neurological Institute in Phoenix, Ariz.) of 30,336 people with MS and determined the male/female ratio according to the year the disease was diagnosed and the age of the person when the disease started.

 


New prostate cancer test may detect more tumors

An experimental blood test for prostate cancer may help eliminate tens of thousands of unnecessary biopsies at the same time that it detects many tumors that are now missed by the test commonly used, its developers said. PSA, the current test, measures a protein normally produced by the prostate, while the experimental one, called EPCA-2, detects a chemical made principally in cancerous tissue. Prostate cancer, the most common malignancy in men, is one of the more perplexing areas of medicine. Physicians are unsure how to find it and when to treat it. Today, about 80 percent of prostate biopsies find no tumor, a percentage that is rising as physicians become more aggressive in searching for the disease. “We hope this will minimize the number of unnecessary biopsies,” said Robert H. Getzenberg, a molecular biologist at Johns Hopkins Hospital who developed the new test, which is still under study and not yet commercially available. A description of it appears in the journal Urology.

”It’s an exciting new marker,” said Martin G. Sanda, a urologist at Harvard Medical School. “There certainly is a need for a better test than PSA. Everyone accepts that.” His view was echoed by Gerald L. Andriole Jr., chief of urologic surgery at Washington University School of Medicine, who said that “if the data hold up, this marker will be a substantial improvement over PSA.” The PSA test casts a net that is too big and too full of holes. Finding a replacement that catches fewer healthy men, but more of those who do have cancer, would help settle at least one of the clinical conundrums concerning prostate cancer. The new test is being developed by researchers at Johns Hopkins Hospital and Onconome Inc., a Seattle-based biomedical company. It could become commercially available in 2008.  

EPCA-2 is a protein that is part of the “nuclear matrix,” the scaffolding inside a cell’s nucleus that helps it copy its genes. The Hopkins researchers measured it in different groups of men whose cancer status was known. They tried the new test on 30 men with PSA readings above 2.5 and in whom biopsies found no cancer. All had normal EPCA-2 readings (below 30 ng per ml.). This suggested that the test may eliminate many of the “false-positive” PSA results, readings that are abnormal but apparently do not denote cancer. On the other hand, the EPCA-2 test appears able to detect cancer even when the tumor is small. It identified 36 out of 40 men who had cancer confined to the prostate gland, and 39 out of 40 men in whom the tumor had spread. It also identified many men, 14 out of 18, who had cancer but whose PSAs were normal. This last group is especially worrisome to physicians. A study published three years ago found that about 12 percent of men with normal PSA readings have cancer.  

The new test is not perfect, though. Getzenberg and his colleagues tried it on 35 men with severe “benign prostatic hypertrophy”, enlargement of the prostate that sometimes makes the PSA go up but is not cancer. In eight of them, the EPCA-2 was high, suggesting that the EPCA-2 test would flag some men who turn out not to have cancer, although probably not as many as the PSA test does. The new test will not help solve the other major clinical uncertainty in prostate cancer. It is unclear who will clearly benefit from aggressive treatment and who are likely to be able to live a normal life if the tumors are simply followed and removed only if they begin to cause symptoms. (Washington Post)

 

New Clorox Anywhere hand sanitizing spray helps
industry professionals prevent spread of infection

Clorox’s Professional Products Division extends the Clorox brand’s health and wellness efforts beyond surfaces to hand hygiene with the launch of Clorox Anywhere Hand Sanitizing Spray, representing the company’s first entry into the personal care category. The new bleach-free, alcohol-based spray is formulated to kill 99.999 percent of germs on contact and does not dry out hands or leave a sticky, greasy residue. Available in an easy-to-use spray, this delivery mechanism also helps target places in the hand that can often be missed by traditional sanitizers, such as fingernails, knuckles and spaces between fingers. Clorox Anywhere Hand Sanitizing Spray is formulated to help kill microorganisms that can cause illnesses including adenovirus; Hepatitis A, B and C; MRSA; norovirus and rotavirus. The hand sanitizing spray contains glycerin, a naturally-occurring moisturizer, to help professionals who wash and sanitize their hands frequently. For more information see THIS LINK.

 

DuPont introduces engineered elastic nonwoven technology
to
offer stretch capability in a nonwoven fabric
 

DuPont announces the introduction of Engineered Elastic Nonwoven Technology, a new offering that enables designers to provide unique elastic functionality and deliver soft-stretch comfort. Available now, this innovative technology is latex-free and contains no elastomeric polymers or chemical additives, resulting in a versatile fabric that can meet a variety of industry needs. “DuPont Engineered Elastic Nonwoven Technology is a breakthrough development that enhances our traditional nonwoven media portfolio and provides a cost-effective substrate for high-power elastic sheeting applications,” said Matt Trerotola, vice president and general manager, DuPont Nonwovens. Fabrics produced from DuPont Engineered Elastic Nonwoven Technology can be high stretch or high stretch with varying degrees of elastic recovery power, depending on end user needs.  

Potential applications and benefits include: wound dressings that are soft and have comfortable stretch; knit-like stretchable gown sleeves and cuffs for use in protective and clean room apparel; hygiene side panels for diapers and adult incontinence garments that are less irritating and fit better; elastic bandages and low power wound care sleeves that may be less irritating than conventional materials; elastic protective covers that fit better, reducing the number of sizes needed; elastic interlinings that are resistant to deformation; and elastic composites that are versatile and stretchable. Those interested in fabric samples or additional information may contact DuPont by calling 1‑888-476-6827 or by e-mail to zelasticnonwovens@dupont.com



Novation introduces first product catalog for private label brand, NOVAPLUS

Novation, the health care contracting services company of VHA Inc. and the University HealthSystem Consortium (UHC), recently introduced the first product catalog for its private label brand, NOVAPLUS. The catalog offers information on more than 1,300 products from the industry’s leading manufacturers and features an easy-to-use format with a quick reference glossary. Products are organized by category and include color images, information about product features and benefits.

NOVAPLUS products are identical to their brand-name equivalents and offer hospitals quality products for the best price and the benefits of standardization. NOVAPLUS products include a wide range of products, including anesthesia, medical, pharmaceutical, radiology, respiratory and surgical products. NOVAPLUS was first introduced in 1985 and provides alliance members with a unique competitive advantage in the supply chain marketplace. In 2006, NOVAPLUS’ portfolio of products helped members realize substantial supply cost savings through NOVAPLUS purchases. The NOVAPLUS catalog will be produced annually. Alliance members can request catalogs through their Novation portfolio executive or access an electronic copy of the catalog through the member portal on Marketplace@Novation.
  

 


 

April 26, 2007

 

NEJM: Physician ties to drug industry stronger than ever


IOM report: The future of disability in America

 

Prognosis: Predicting heart disease among the 20-somethings

 

Cheaper, easier virtual colonoscopy could boost detection

Emergency medicine to benefit from the HL7’s
first registered clinical profile

MedAssets Supply Chain Systems and M Cubed Medical join forces
to help decrease costs for physician practices

Amerinet announces agreements
 



NEJM: Physician ties to drug industry stronger than ever

Despite the potential for conflict of interest, virtually all practicing physicians in the U.S. have some form of relationship with pharmaceutical manufacturers but the nature and extent of those relationships vary, depending on the kind of practice, medical specialty, patient mix, and professional activities, reports a study in the April 26 issue of the New England Journal of Medicine. In the first national survey to gauge the predictors and depth of relationships between industry and practicing physicians, 94 percent of doctors report that they have at least one type of relationship with the drug industry, mostly in the form of receiving food in the workplace or prescription samples. However, more than one third are reimbursed for costs associated with professional meetings or continuing medical education (CME), and more than a quarter receive honoraria for consulting, lecturing or enrolling patients in clinical trials, say researchers.

The findings, from a survey of 1,662 practicing physicians conducted in late 2003 and 2004, also show that drug and device manufacturers pick and choose which doctors to form the strongest ties with. For example, cardiologists are more than twice as likely as family practitioners to receive direct payments from drug companies for consulting and other services and are also significantly more likely to be paid honoraria than pediatricians, anesthesiologists, or surgeons. “Cardiology is a highly influential specialty within the medical profession. If the drug and device industry can influence cardiologists, they can likely influence the prescribing practices of other doctors,” said lead researcher and co-author Eric Campbell, Ph.D., an associate professor of medicine at the Institute for Health Policy at Massachusetts General Hospital and Harvard Medical School.  

Campbell and his co-authors, including Institute for Health Policy Director David Blumenthal, MD, report that the idea that companies target opinion leaders for marketing is further suggested by the higher frequency of industry payments to physicians who have developed clinical guidelines and who serve as mentors for doctors in training. Researchers surveyed physicians in six specialties (anesthesiology, cardiology, family practice, general surgery, internal medicine, and pediatrics) to measure the extent of their financial associations with industry and the factors that predict those ties. The study found striking differences in the nature of physician-industry relationships depending on the primary practice location of the physician. Compared to physicians practicing in hospitals, those in group practices were three times as likely to receive gifts and nearly four times more likely to be paid for professional services. Group practice physicians along with solo or two-person practices also met more frequently with industry representatives such as drug detailers than did physicians practicing in hospitals or clinics or staff model HMOs. The authors suggest that the primary reason for these differences is that hospitals may be more likely to have policies and practices in place that limit physician contact with industry representatives. It may also be that hospitals are more likely to provide physician education through grand rounds and CME events, rendering physicians in these facilities less dependent on industry representatives as the source of medical education and information.

The survey also found that: Pediatricians and anesthesiologists were significantly less likely than family practitioners to receive samples, reimbursements and payments for professional services. Family practitioners reported the highest average number of meetings with industry representatives (16 meetings a month), followed by internists and cardiologists (9-10 per month, respectively). Anesthesiologists had only 2 meetings a month. All specialties except anesthesiology appear to be meeting more frequently with industry today as compared to 2000, when the average was about 4.4 meetings per month. Women physicians are less likely to receive payment than their male counterparts. Physicians were more likely to receive payments if less than 25 percent of their patients were uninsured or covered by Medicaid.



IOM report: The future of disability in America

Today more than 40 million Americans live with a disability. If we consider people who now have disabilities, people who are likely to develop disabilities, and people who are or will be affected by the disabilities of family members and others close to them, then disability will affect the lives of most Americans. Members of the baby boom generation, people born between 1946 and 1964, face an especially uncertain future as they grow older, as their risk of disability increases, and as programs such as Social Security and Medicare face serious funding challenges. Disability in the form of limited activities and restricted participation in social life is not an unavoidable result of injury and chronic disease. It results, in part, from choices society makes about working conditions, health care, transportation, housing, and other aspects of our environment. The United States faces important decisions that could reduce, or increase, the extent to which people can live independently and be involved in their communities. Inaction may lead to diminished quality of life, increased stress on individuals and families, and lost productivity.

 

The Institute of Medicine (IOM) was asked to assess the current situation and provide recommendations for improvement, which culminated in the report “The Future of Disability in America”. The committee reviewed developments since two previous IOM reports on disability (1991, “Disability in America” and 1997, “Enabling America”), analyzed a number of shortcomings in the nation’s disability policies and programs, and raised serious questions about how individuals and society will cope with the challenges of disability. Some progress has been made since the release of the two previous reports: The growth of assistive and “mainstream” electronic technologies allows many people to interact more easily with their environments; and advances in public health and medicine have contributed to reduced incidences of certain injuries, developmental disorders, and other potentially disabling health conditions. However, too little progress has been made in adopting the major public policy and practice recommendations made in the 1991 and 1997 IOM reports. Due in part to inadequate implementation and enforcement, the 1991 Americans with Disability Act (ADA) has not lived up to its promise. Physical and other barriers still exist in many places, even hospitals and medical offices. Research spending on disability is inadequate. Medicare, Medicaid, and private health plans employ outdated policies for covering assistive technologies and services.

 

The new report encourages agencies involved in disability monitoring to adopt the World Health Organization’s International Classification of Functioning, Disability and Health (ICF) as their conceptual framework. Using the ICF would help standardize how agencies describe and measure different aspects of disability, which would improve the clarity and comparability of research findings and strengthen the base of scientific knowledge that guides public policies and health practices. This report reiterates the absence of a comprehensive disability monitoring system and recommends creating one. The current report recommends increasing public funding to support a program for research. Federal funding agencies should invest more in the development, testing, and dissemination of promising interventions that will help people maintain their independence and ability to function in community life. The report recommends that policymakers eliminate or modify the “in-home-use” requirement in the Medicare statute and regulations. This provision keeps many from obtaining scooters and wheelchairs that would allow them to navigate reliably and safely outside the home. For more information see THIS LINK.

 


Prognosis: Predicting heart disease among the 20-somethings

It’s never too soon to think about the risk of cardiac disease. A study published today has found that mildly elevated levels of cholesterol or slightly above normal blood pressure from ages 18 to 30 are strong predictors of having coronary artery calcium at ages 30 to 35. Coronary artery calcium, a form of arterial plaque, is a predictor of later heart disease. Researchers recruited 5,115 people from 18 to 30 in 1985 and 1986 and followed them with physical examinations 2, 5, 7, 10 and 15 years later. The scientists tested blood pressure, cholesterol and serum glucose levels and recorded body mass index. The study appears in The Journal of the American College of Cardiology. At the year-15 examination, 10 percent had coronary artery calcium detectable on a CT scan. Compared with young adults who had below-optimal levels of the risk factors at the start of the study, those with above-optimal levels were one and a half to three times as likely to have coronary artery calcium 15 years later. Catherine Loria, the lead author and an epidemiologist at the National Heart, Lung and Blood Institute, said even young people should be screened. “If they do have above-optimal levels, even slightly,” she added, “they might want to make lifestyle changes to reduce their risk.” At the start of the study, 20 percent had high levels of LDL, the so-called bad cholesterol, and a third were overweight. Twenty-five percent smoked cigarettes. By the 15th year, fewer smoked, but 30 percent had above-normal LDL, 35 percent had elevated blood pressure, and more than two-thirds were overweight or obese. (The New York Times)

 

 

Cheaper, easier virtual colonoscopy could boost detection

A cutting-edge technology called “virtual colonoscopy” promises fewer complications and better cost-effectiveness than traditional colonoscopy, researchers report. These technologies have been compared before, but the current analysis relies on the notion that identifying and removing polyps smaller than 6 millimeters won’t do much to reduce colorectal cancer cases. “Because there’s virtually no risk associated with having such small polyps, 90 percent of folks don’t need an invasive and expensive colonoscopy to screen for colon cancer,” explained lead researcher Dr. Perry J. Pickhardt, an associate professor in the school of medicine and public health and radiologist at the University of Wisconsin in Madison. “So, here it was easy to show that virtual colonoscopy is a very effective way to filter out these people and hone in on those who really need the more invasive procedure,” he said. Pickhardt is not suggesting that virtual colonoscopies replace traditional optical screening. But non-invasive screening might up the number of people who decide to undergo screening, he said. “We need to encourage more folks to get screened, period,” he said. “We’re not trying to take away from the screening already in place. It’s a personal choice. Some people prefer the colonoscopy route compared to virtual colonoscopy, and that’s fine.”  

Pickhardt and his colleagues discussed their findings in the June 1 issue of the journal Cancer. Virtual colonoscopy involves a combination of sophisticated X-rays and CT scans of the abdomen after it has been pumped with air. A two- and three-dimensional computer model of the gastrointestinal tract is then generated, potentially revealing cancerous and precancerous lesions. If dangerous lesions are spotted, a second, more invasive procedure is required. Unlike traditional colonoscopy, the virtual method is faster, involves no sedation, no post-procedure recovery, and no risk of invasive complications such as abdominal bleeding or life-threatening bowel perforation. However, the American Cancer Society (ACS) has not yet backed this option as a proven screening method, citing the need for further research. Instead, the group suggests other screening methods, including blood stool tests; a barium enema combined with X-rays; a flexible sigmoidoscopy and traditional optical colonoscopy. All people over 50 are encouraged to undergo a regular colonoscopy once every 10 years, or either a barium enema or a flexible sigmoidoscopy (with or without a yearly blood test) once every five years. The ACS does not deem a digital rectal exam to be a sufficient means of screening. 

To compare some of these options, Pickhardt and his colleagues developed a mathematical model involving 100,000 patients with an average risk for colorectal cancer. In the computer simulation, all of these “patients” (over the age of 50) were screened for colon cancer once every decade for three decades, using either a standard colonoscopy, a flexible sigmoidoscopy, a virtual colonoscopy, or a combination thereof. Polyp searches were based on one of two thresholds: those measuring 6 millimeters in diameter and up, and lesions of any size. The model indicated that 2,940 patients would ultimately go on to develop colorectal cancer. The simulation also revealed that flexible sigmoidoscopy screenings reduced the rate of cancer by just over 31 percent, while traditional colonoscopy reduced the rate by just over 40 percent. Virtual colonoscopies were only slightly less efficient than the traditional method, achieving an almost 38 percent reduction when polyps of all sizes were considered. The prevention rate dropped slightly, to 36.5 percent, when screenings focused only on polyps 6 millimeters and up. Virtual colonoscopy also had the added benefit of dramatically reducing the need for unnecessary polyp removal. Nearly 78 percent fewer patients went on to have an invasive polyp removal after a virtual screening compared with patients who underwent a regular colonoscopy. And when virtual screenings focused solely on lesions 6 millimeters and up nearly 12,900 additional unwarranted polyp removals were avoided.  

In terms of both preventing cancer and minimizing cost, the use of any screening method was better than no screening at all, the study found. However, virtual colonoscopy with a 6-millimeter polyp diameter threshold was by far the most cost-effective approach: Costs were less than half that of traditional colonoscopy when broken down by year of life saved. Even with no polyp size threshold, virtual colonoscopy still came in at more than 20 percent cheaper. However, Pickhardt noted that the high-tech procedure is not yet widely available. (HealthDay News)

 

Emergency medicine to benefit from the HL7’s
first registered clinical profile

Health Level Seven (HL7), a healthcare IT standards development organization, announced the Emergency Care Functional Profile (EC FM) as the first registered profile based upon HL7’s EHR System Functional Model (EHR-S FM) standard. In late February, the EHR System Functional Model standard became the healthcare industry’s first ANSI-approved standard to specify the functional requirements for an electronic health record system. HL7’s Emergency Care Special Interest Group (SIG) developed the Emergency Care Functional Profile for Emergency Department Information Systems to develop an open and objective standard for the development, refinement, and evaluation of information systems employed in the ED. As a registered profile, it becomes a standard that may be referenced by the Certification Commission for Health Information Technology (CCHIT) as a foundation for certification of EHR systems in the emergency department setting.  

Adopting registered profiles is one way that CCHIT ensures a consistent methodology for assessing EHR systems across all healthcare domains. Registering profiles that conform to the EHR System Functional Model is an important step in the widespread adoption of this standard because technically EHR systems conform to profiles rather than the model itself. The Functional Model is structured to allow vendors to implement a specific profile for real-world settings, such as the Emergency Department, and users to purchase a system that conforms to the profile. Registering a profile with HL7 gives the profile credibility and approval that it has met a minimum set of guidelines of what a profile should contain.  

The Emergency Care Functional Profile is not only critical for the integration of Emergency Departments (ED) into the developing national health information network, but is also needed for handling regional disasters such as Hurricane Katrina. The EHR-S Functional Model and the Emergency Care Function Profile will facilitate solutions to underlying ED operational problems such as overcrowding, ambulance diversion and shortage of services. Systems conforming to the EC FP will facilitate vital care to the over 110 million patients seen each year in US emergency departments. The EHR System Functional Model is versatile, adaptable, and applicable across the continuum of care. There are several profiles under development in addition to Emergency Care. For more information see THIS LINK.

 

MedAssets Supply Chain Systems and M Cubed Medical join forces
to help decrease costs for physician practices  
 

MedAssets Supply Chain Systems announced an exclusive affiliate agreement with M Cubed Medical, a newly formed specialty group purchasing organization headquartered in Webster City, IA. M Cubed Medical serves the non-acute care market including physician practices, clinics and ambulatory surgery centers. The multi-year agreement was effective April 1, 2007. M Cubed Medical has developed a strategy that congregates the collective economic power of physicians across the country to bring the same improved cost and efficiencies already seen in physician-owned ambulatory surgery centers to the supply side of the business while maintaining a fair profit margin for manufacturers. The affiliation with MedAssets will provide additional savings opportunities and access to MedAssets’ CDQuick, a best-of-breed contract catalog. “By utilizing MedAssets’ group purchasing contracts and technology, physicians and other non-acute care providers will save money on purchases for common medical supplies, office supplies, business services, pharmaceuticals, and capital equipment,” said Gary Green, senior vice president, MedAssets Supply Chain Systems.

 

Amerinet announces agreements  

Amerinet Inc. announces its agreement for baby products with Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies. Effective May 1, 2007, through April 30, 2010, this agreement provides cost-saving opportunities to Amerinet members on infant hygiene products that include baby wash, powders, lotions, oils and shampoos.

Amerinet Inc. announces its agreement with Vendormate for vendor credentialing and compliance monitoring services. Effective April 1, 2007, through February 28, 2010, this agreement includes patent-pending Vendormate VISION service which delivers supplier registration, automated policy acceptance, screening, rating, cataloging and physical access control. Vendormate’s services are uniquely suited to satisfy both internal policies and government mandates including HIPAA, Stark Law and Deficit Reduction Act.   

 


April 25, 2007


FDA causes unnecessary scare about common painkillers


U.S. wonders if drug data was accurate

FDA to test imported additives for melamine

New virus discovered; 3 organ transplant recipients
in Australia succumb to infection

 

Study links faulty DNA repair to Huntington’s disease onset

Medicare Trustees release annual report

Only 1 week left to take advantage of special AAMI membership offering

Hospitals to utilize Diagnostix’s industry-driven pharmacy technology


FDA causes unnecessary scare about common painkillers

 

The U.S. Food and Drug Administration (FDA) has caused an unnecessary scare about some pain relievers by adding a warning to drugs that are safe, said Curt Furberg, M.D., Ph.D., from Wake Forest University School of Medicine. At the same time, he says the agency has failed to recognize the harm of a pain reliever that should be taken off the market. “The FDA is adding ‘black box’ warnings to all prescription and over-the-counter pain relievers, even to naproxen, which the evidence shows is safe,” said Furberg, who serves on the FDA Drug Safety and Risk Management Advisory Committee. “This is based on the false assumption that all nonsteroidal anti-inflammatory drugs increase the risk of heart attacks. In fact, there are major differences between these agents.”


In a commentary published by Trials, an online journal of BioMed Central, Furberg says the FDA has failed to recognize current scientific evidence when it made decisions on the safety of nonsteroidal anti-inflammatory drugs (NSAIDs) that are often used to treat the pain or inflammation from arthritis. The most commonly used NSAIDs are ibuprofen (Advil), naproxen (Aleve), and diclofenac (Voltaren). There are more than a dozen others, including drugs such as celecoxib (Celebrex) that are in a special class known as selective COX-2 inhibitors because of the hormone they target. The other NSAIDs are known as “non-selective.” Furberg said while the evidence for the non-selective NSAIDs is somewhat limited, an analysis combining several small studies found that high doses (500 mg twice daily) of Aleve were not associated with an increased risk of heart attacks compared to a placebo, or an inactive pill. On the other hand, high doses of Advil (800 mg three times a day) and Voltaren (75 mg twice daily) were associated with rates of heart attack that were 51 percent and 63 percent higher, respectively, than placebo.


An analysis of a large number of trials comparing COX-2 inhibitors to other NSAIDs found similar results, that Voltaren was estimated to increase vascular risk by about 70 percent over Aleve. “Naproxen does not increase the risk of heart attacks and ought to be a painkiller of choice,” said Furberg. “On the other hand, Voltaren carries the same risk as the harmful COX-2 inhibitors Bextra and Vioxx, which have been taken off the market. The FDA has failed to recognize the evidence that the risk of heart attack varies substantially among this group of drugs and that Voltaren has the highest risk of all. Since it is the most commonly used NSAID, the unrecognized harm it has caused worldwide could be enormous.”


The European Regulatory Agency has reviewed the same evidence that the FDA considered and reached entirely different conclusions, said Furberg. He said this suggests that the decisions are not based on scientific evidence. With Celebrex, the FDA didn’t follow the recommendations of its Advisory Committee to substantially restrict the drug’s use. Instead, it required only a “vaguely worded” black box warning, said Furberg. European countries require clear warnings for patients at high risk of heart attacks and have said COX-2 inhibitors should not be taken by patients with heart disease. With the non-selective NSAIDs, Europe has given a “clean bill of health” to the agents and the FDA has judged them to have similar risks to Celebrex and is adding “black box” warnings. “Decisions by regulatory agencies are expected to follow explicit regulations and should be evidence-based,” said Furberg. “Scientific studies point to clinically important differences among the non-selective NSAIDs, which the FDA has not recognized. It’s time for the FDA to set the record straight.” For more information see THIS LINK.

 

 


U.S. wonders if drug data was accurate


The Food and Drug Administration is examining whether Eli Lilly & Company provided it with accurate data about the side effects of the antipsychotic drug Zyprexa, a potent medicine that has been linked to weight gain and diabetes. The F.D.A. has questions about a Lilly document from February 2000 in which the company found that patients taking Zyprexa in clinical trials were three and a half times as likely to develop high blood sugar as those who did not take the drug. That document was not submitted to the agency. But a few months later, Lilly provided data to the F.D.A. that showed almost no difference in blood sugar between patients who took Zyprexa and those who did not. The F.D.A. confirmed its inquiry in response to questions from The New York Times. The agency said it had not yet decided whether to take any action against Lilly. “The F.D.A. continues to explore the concerns raised recently regarding information provided to the F.D.A. on Zyprexa’s safety,” Dr. Mitchell Mathis, a deputy director in the psychiatry division of the agency’s center for drug evaluation and research, said. A Lilly spokesman, Phil Belt, said the company had rechecked its database and found errors in the original statistics. The data submitted later was accurate, Belt said. But the 2000 document said that its figures had already been checked for error. The Times disclosed the existence of the document in an article last December.

The discrepancy between Lilly’s initial data and what it later submitted came at a time when Zyprexa’s sales were soaring, even as some doctors and foreign regulatory agencies were questioning the drug’s safety. The F.D.A. has never concluded that Zyprexa causes diabetes more than other widely used psychiatric drugs, although the American Diabetes Association has. Zyprexa remains Lilly’s top-selling drug, with $4 billion in worldwide annual sales. But prescriptions in the United States have fallen nearly 50 percent since 2003 amid the safety concerns. Besides the F.D.A. inquiry, Lilly is facing federal and state investigations into the way it marketed and promoted Zyprexa. The company has already agreed to pay $1.2 billion to settle 28,500 lawsuits from people who contend that they developed diabetes or other diseases after taking the drug. At least 1,200 more lawsuits are pending. Belt, the Lilly spokesman, said in a statement that the company properly marketed Zyprexa and disclosed its side effects to the F.D.A. and doctors. “Lilly always cooperates fully with requests for information from the F.D.A.,” he said, “and that includes any requests regarding information on Zyprexa. Lilly is forthcoming with all relevant clinical data on all of our products.”


Lawyers who represent drug companies said the F.D.A. largely depended on the companies to be honest about the side effects of their drugs. With a staff of fewer than 3,000, including support personnel, the agency’s drug division oversees more than 12,000 prescription medicines and 400 nonprescription drugs. In most cases, said William W. Vodra, senior counsel at the law firm of Arnold & Porter and a former F.D.A. associate chief counsel, it does not perform detailed audits of clinical trials or independently check the integrity of the data that companies send to it. “There’s no way they could police the system with the resources they have,” Vodra said. Robert A. Dormer, a partner in the law firm of Hyman, Phelps & McNamara, who represents drug companies, said that the companies did not have to provide every analysis they performed to the F.D.A. (The New York Times) To read the original article see THIS LINK.

 

FDA to test imported additives for melamine

Concerned that a wide variety of Chinese vegetable protein products may be contaminated with the harmful compound melamine, the Food and Drug Administration said yesterday that it will begin testing batches of six imported ingredients used in pet foods and livestock feed, as well as additives to human food. Officials have not found the substance in food products for people but detected it in two imported ingredients widely used in pet food: wheat gluten and rice protein. The agency said that imported corn gluten, corn meal, soy protein and rice bran will also be tested. The vegetable proteins are used in bread, pizza, baby food and many vegetarian dishes. “This is a proactive step,” said David Acheson, chief medical officer of the FDA Center for Food Safety and Applied Nutrition. “We will test a variety of foods and feeds because we need to know all there is to know” about the melamine contamination.

Melamine, a nitrogen-based compound used in products such as countertops, glues and fertilizers, was identified this month as the cause of fatal kidney failure in an unknown number of dogs and cats, leading to the recall of more than 100 brands of pet food. Officials traced the melamine to two Chinese plants, which have been supplying American distributors since last summer. Agency officials said that some contaminated products, sold by pet food manufacturers as scraps, were fed to hogs in the Carolinas, New York, California and Utah, and that some of those animals tested positive for melamine. They said that a contaminated shipment of feed had been sent to a Missouri chicken farm as well. Stephen Sundlof, director of the FDA’s Center for Veterinary Medicine, said a second chemical called cyanuric acid, which is related to melamine, has also been found in samples of rice protein concentrate. FDA officials said that they are in discussions with Chinese officials about inspecting the plants where the contaminated pet food originated, but that no agreement has been reached. Julia Ho, of the agency’s Office of International Programs, said Chinese authorities also are investigating.

Steve Miller, chief executive of ChemNutra, a Las Vegas-based importer of nutritional and pharmaceutical chemicals, said he suspects that the contamination was intentional. “We are concerned that we may have been the victim of deliberate and mercenary contamination for the purpose of making the wheat gluten we purchased appear to have a higher protein content than it did, because melamine causes a false high result on protein tests,” Miller wrote in an open letter posted on ChemNutra’s Web site. Michael Payne, outreach coordinator for the Western Institute of Food Safety at the University of California at Davis's School of Veterinary Medicine, said he thinks that there is little risk of people becoming ill by eating pork from pigs that ate melamine-laced feed. Toxicology studies on laboratory rodents have long suggested that it takes high
doses of the chemical to cause health problems, typically in the bladder and kidneys, Payne said. And the modest doses found in pet food would be diluted even further in the body of a pig that ate it. (Washington Post) To read the original article see THIS LINK.
 


New virus discovered; 3 organ transplant recipients in Australia succumb to infection


The unfortunate deaths of three organ transplant recipients in Australia this past January has led to the discovery of a new virus. All three had received organs from the same deceased donor in December, and their closely spaced deaths suggested their transplants might have exposed them to a deadly infectious agent. When investigators at the Victorian Infectious Diseases Reference Laboratory in Melbourne applied all the standard tests, however, they could not identify any known pathogen. So the Australian team turned to scientists at the Greene Infectious Disease Laboratory of the Mailman School of Public Health of Columbia University, who have been developing new techniques for diagnosing infectious diseases with funds from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.


Partnering with the company 454 Life Sciences, the Columbia University team applied a high-throughput technology that can sequence hundreds of thousands of bits of DNA simultaneously. Then, using bioinformatics algorithms they had created, the team sorted through the data and identified a new infectious agent, a virus that was sufficiently different from any known virus that it could not have been detected using existing diagnostic methods. By assembling additional genetic sequences, the researchers determined that the new virus is related to, but distinct from, known strains of lymphocytic choreomeningitis virus (LCMV), which has been implicated in a small number of cases of disease transmission by organ transplantation. The knowledge of the genetic sequence of this new virus will enable improvements in screening that may enhance the future safety of organ transplantation. For more information, see THIS LINK or THIS LINK.

 

 


Study links faulty DNA repair to Huntington’s disease onset


Huntington’s disease, an inherited neurodegenerative disorder that affects roughly 30,000 Americans, is incurable and fatal. But a new discovery about how cells repair their DNA points to a possible way to stop or slow the onset of the disease. The research was funded by the National Institutes of Health (NIH). “As so often happens, basic research on a fundamental biological process, in this case, enzymes involved in DNA repair, leads to new insights about how diseases arise and new approaches for treating or preventing them,” said NIH Director Elias A. Zerhouni, M.D. The study was published April 22 as an Advanced Online Publication in Nature and led by Cynthia T. McMurray, Ph.D., a professor of pharmacology at the Mayo Clinic in Rochester, MN.

Unlike most inherited diseases, Huntington’s disease symptoms usually don’t appear until middle age, leading scientists to wonder what triggers the disease onset and whether it can be halted, or at least slowed down. People with the disease have a version of a gene called huntingtin that carries an extra segment with a particular sequence of repeated subunits. If the segment is too large, the gene produces a faulty protein that has a destructive effect in the brain. “Huntington’s disease is a progressive disease, but nobody knows exactly why,” said McMurray. “Our work supports the idea that the disease progresses when the extra segment expands over time in non-dividing cells such as nerve cells.”

 

McMurray’s study shows that the inserted segment grows when cells try to remove oxidative lesions, which are caused by byproducts of the oxygen we breathe. DNA repair enzymes initially keep oxidative lesions in check, but over time, increasing numbers of lesions overwhelm the repair systems. Oxidative lesions also accumulate in people who do not have Huntington’s disease, but because their huntingtin gene lacks the extra segment it is not prone to expansion. While scientists have long suspected that oxidative lesions play a role in Huntington’s disease, the specific role of the lesions has remained elusive until now.


To show that the extra segment enlarges with age, the researchers engineered mice to carry a version of the human huntingtin gene with an inserted segment, one large enough to cause Huntington’s disease in humans. After a few months, when the mice had aged, the scientists analyzed the gene and found that the segment had expanded. They also observed an increase in oxidative lesions in the mouse DNA. To see if the oxidative lesions played a role in expansion of the extra DNA segment, the researchers next deleted OGG1, a key enzyme in oxidative lesion repair. Without OGG1, the bulk of the DNA’s oxidative lesions remained untouched, and the inserted segment did not grow at all or it grew far less than in mice carrying a working version of OGG1.


These findings show that while doing its part in removing oxidative lesions, OGG1 triggers a far more damaging effect, the DNA expansion associated with Huntington’s disease. “The effect is much like what might happen if a technician came to repair a minor defect in your computer but was called away by a more urgent problem midway through the process. Now your computer is lying in pieces and you’re unable to use it,” said McMurray. The study suggests that OGG1 might offer a target for the development of new Huntington’s disease treatments. McMurray’s team is already pursuing this path and is screening for small molecules that block OGG1 function. This work may also be relevant to research on other diseases, such as Alzheimer’s and Parkinson’s, in which oxidative lesions are believed to play a role.

 



Medicare Trustees release annual report   

The new Medicare Trustees Report shows that while Medicare’s financial outlook remains troubling, the program’s outlook has improved slightly compared to last year’s estimate. The Trustees note that Medicare expenditures were $408 billion in 2006, or 3.1 percent of gross domestic product (GDP), and are projected to increase to over 11 percent of GDP in 75 years. HHS Secretary Mike Leavitt said the report points to the need to act quickly and efficiently to strengthen and improve Medicare, including enactment of the steps proposed in the President’s budget to address Medicare’s fiscal health.

“We are already beginning to implement steps to protect Medicare for future generations,” said Centers for Medicare & Medicaid Services Acting Administrator Leslie V. Norwalk. “Medicare is now providing up-to-date preventive benefits and comprehensive drug coverage and is developing better information on quality and costs of healthcare to ensure that we pay appropriately for the healthcare of our beneficiaries. A critical element of this process is the movement we have underway for Medicare to change from being a passive payer of services to becoming an active purchaser of high-quality, efficient care. Until those steps are fully implemented, today’s report starkly demonstrates the need to act to change Medicare’s current growth trajectory.”

In the estimate, Medicare’s Hospital Insurance Trust Fund is projected to be exhausted in 2019, one year later than estimated in last year's report. This change results from slightly higher projected income and slightly lower projected expenditures than shown in last year’s report. HI expenditure growth is estimated to average 7.2 percent per year over the next 10 years. Because of continued rapid growth in expenditures for the program as a whole, program costs financed by general revenues, rather than by “dedicated revenues,” are projected to exceed 45 percent in 2013. Because this result falls within the first seven years of the projection period (2007-2013), the Trustees have issued a determination of “excess general revenue Medicare funding.” This determination has now been made in two consecutive years, triggering a “Medicare funding warning.”  

An element of good news in this year’s Trustees Report involves the new prescription drug benefit under Medicare Part D. The latest cost projections for Part D through 2015 are 13 percent lower than estimated in last year’s report (and substantially lower than the original estimates from 2003). Plan bids for 2007 were 10 percent lower than in 2006, as a result of intense competition among plans to attract and retain enrollees and plans’ expectations to further increase use of inexpensive generic drugs, rather than more costly brand-name equivalents. In addition, overall prescription drug costs have increased much more slowly during 2004-2006 than in prior years. 

 

Only 1 week left to take advantage of special AAMI membership offering

Until April 30, hospitals that join AAMI will receive a complimentary registration to attend AAMI’s Annual Conference & Expo in Boston, MA from June 16-18 (a $750 value.) Your facility can become an institutional member for as low as $540 per year, which would provide you and your colleagues with: A subscription to AAMI’s award-winning journal, BI&T, which includes practical articles of interest for CEs, BMETs, and other medical technology professionals; A subscription to the monthly newsletter, AAMI News, to stay on top of breaking industry news; Full access to AAMI's new online journal, a comprehensive library of searchable and archived articles; Significant discounts on all educational program registration, AAMI standards and other publications, which is available to all members of your facility; Access to salary benchmarking information, Joint Commission guidance, career resources, networking opportunities, and much more. To become an institutional member, simply submit this online form, www.aami.org/advertising/membership/institution.html, and AAMI will contact you. Make sure to select the dues level that best fits your department or facility’s needs. If you have questions, contact Susan DeCourcey, Vice President of IT and Membership Services, AAMI, at sdecourcey@aami.org or 703-525-4890, ext. 232.  

 

Hospitals to utilize Diagnostix’s industry-driven pharmacy technology

Diagnostix, a subsidiary of Amerinet Inc., announced that 10 healthcare providers, representing a unique range of healthcare services from across the county, have chosen AccuPrice, to monitor and resolve pricing discrepancies in their pharmacy programs. AccuPrice, a pharmacy-auditing tool, takes unique provider contract price files and audits the distribution invoice file to identify price variances. The provider receives a daily e-mail report outlining discrepancies between wholesaler and contract prices. Amerinet applies the resources necessary to resolve variances and works with the distributor to issue the necessary credits. 

The latest members to sign up to utilize AccuPrice include: Columbia Memorial Hospital, Astoria, OR; Highlands Hospital, Connellsville, PA; Medina General Hospital, Medina, OH; Moses, Ludington Hospital, Ticonderoga, NY; North Philadelphia Health System, Philadelphia, PA; Platte Valley Medical Center, Brighton, CO; Samaritan Health Services, Corvallis, OR; St. Barnabas Hospital, Bronx, NY; St. Joseph’s Community Health, Hillsboro, WI; and Virginia Mason Medical Center, Seattle, WA.       

 


April 24, 2007


Human bird flu deaths reported in Egypt, Cambodia;
China, Indonesia still not sharing virus samples with WHO

 

Overcrowded hospitals may risk adverse events on busiest days


Drug company sales visits influenced doctors, study finds

 

Neither abortion nor miscarriage associated with breast cancer risk

One in four hospital patients is admitted with a mental health
or substance abuse disorder

Scrushy settles SEC civil claims

GHX develops collaborative contract commitment tool
for the healthcare supply chain


Human bird flu deaths reported in Egypt, Cambodia;
China, Indonesia still not sharing virus samples with WHO


The World Health Organization (WHO) has confirmed two new human cases of the highly pathogenic H5N1 strain of avian influenza in Egypt and another case in Cambodia, the first to be confirmed in that country in 2007. The Cambodian Ministry of Health said the 13-year-old girl, from Ponhea Kreak district in Kampong Cham province, developed symptoms April 2, was hospitalized the next day and died April 5. Samples from the girl tested positive for H5N1 at the Pasteur Institute in Phnom Penh. Sick and dead poultry were reported in the village in recent weeks, according to WHO, and the girl reportedly had eaten part of a sick chicken before she became ill. A team from the Ministry of Health, WHO and the Pasteur Institute there are following up with the girl’s contacts and conducting awareness-raising activities in the area. Of seven cases confirmed in Cambodia, all have been fatal. In Egypt, the Ministry of Health and Population announced two new human H5N1 cases that were confirmed by the Egyptian Central Public Health Laboratory and U.S. Naval Medical Research Unit No.3 in Cairo. A 2-year-old female from Menia Governorate developed symptoms April 3 and the next day was admitted to a hospital where she is in stable condition. Investigations show that she had contact with backyard poultry. Another girl, a 15-year-old female from Cairo Governorate, developed symptoms March 30, was admitted to the hospital April 5 and died April 10. Of 34 cases confirmed in Egypt, 13 have been fatal.


The announcement brings to 291 the total number of human cases confirmed by WHO since 2003, with 172 deaths. These totals include all countries except Indonesia, which since January has not shared virus samples from infected people with WHO collaborating centers and does not have a public health laboratory that WHO has certified to confirm human cases of the H5N1 strain of avian flu. On March 27, after a two-day meeting in Jakarta, Indonesia, among officials from WHO and 20 nations that have had animal and human H5N1 outbreaks, WHO agreed not to share virus samples with vaccine makers without approval from the virus-collecting country, and the government of Indonesia agreed to resume sharing H5N1 virus samples. The meeting endorsed WHO’s efforts to link vaccine manufacturers in developed and developing countries to speed the transfer of technology to manufacture influenza vaccine. Individual countries will negotiate how vaccine is made available to them. So far, WHO has not yet received samples from Indonesia.

WHO can confirm that Indonesia has had 81 avian flu cases since 2003 and 63 deaths, but news reports put the total at 94, with 74 deaths. China also has been withholding virus samples from infected people since April 2006 for unknown reasons, but its H5N1 case count is up to date at WHO. “We have confirmed China’s cases,” said WHO spokesman Gregory Hartl, “because if the national laboratory has been certified as being able to do H5N1 testing and it undergoes periodic review, then we will accept their national certification or report.” On April 25, WHO is scheduled to hold another meeting in Geneva to focus on ways to increase developing-country access to potential pandemic vaccines. The gathering will bring together representatives from WHO, countries affected by H5N1, vaccine manufacturers and donors to discuss strategies for vaccine production and access. According to WHO, potential outcomes include an agreement on ways to increase access to vaccines, including options for stockpiling vaccines. (USINFO) For WHO’s timeline of events for avian influenza see THIS LINK.

For a summary of a WHO consultation on clinical aspects of human infection with avian influenza see THIS LINK.

 

Overcrowded hospitals may risk adverse events on busiest days


Hospitals that operate at or over their capacity may be at increased risk of adverse events that injure patients, according to a study led by investigators from Massachusetts General Hospital (MGH) and Brigham and Woman’s Hospital (BWH). The report in the May issue of the journal Medical Care suggests that efforts to meet two primary challenges facing hospitals today, reducing costs and improving patient safety, may work against each other. “While financial and political pressures to make health care more efficient are leading to increased hospital occupancy and greater patient turnover, patients and policymakers are quite rightly demanding that health delivery systems be made safer,” said Joel Weissman, PhD, of the MGH Institute of Health Policy, the report’s lead author. “Our study suggests that pushing efficiency efforts to their limits could be a double-edged sword that may jeopardize patient safety.”

 

In order to examine their hypothesis that increased workload could raise the likelihood of adverse events, the investigators examined data from four hospitals in two states, two large urban teaching hospitals and two suburban teaching hospitals, over the 12 months from October 2000 through September 2001. To compile patient care information they reviewed patient charts and billing records on almost 25,000 patients, selecting 6,841 for comprehensive review, and analyzed that data against information on hospital workloads and staffing patterns, with a focus on variations within each hospital. From the nearly 7,000 records receiving detailed review, 1,530 adverse events, defined as preventable injuries not resulting from patients’ underlying medical condition, were identified. The most common such events were wound infections and adverse drug events. At three of the four hospitals, the rate of adverse events did not appear to increase at times of peak workload. But at the fourth, a major urban teaching hospital with consistently high occupancy rates, exceeding 100 percent for more than three months, workload increases and higher patient-to-nurse ratios were associated with more adverse events.

 

“While we looked at only four hospitals, which limits the ability to generalize these findings, the hospital where we found a relationship between working conditions and adverse events was disproportionately crowded for much of the study period,” said  study co-author Eran Bendavid, MD. “That suggests hospitals operating at the high end of their capacity may need to examine safety systems with an eye towards coping with periods of high stress.” Formerly with the MGH Institute of Health Policy, Bendavid is now at the Center for Health Policy at Stanford University. “This study helps quantify the impression that many clinicians have and confirms that systems perform poorly when they are overloaded,” said study co-author David Bates, MD, MSc, of the BWH Division of General Medicine and Primary Care. “Future research should address approaches for distributing workload and examine the effectiveness of strategies to improve safety in high-workload situations.”

 

 


Drug company sales visits influenced doctors, study finds


Almost half of sales visits by pharmaceutical company representatives advocating the use of the drug gabapentin led to doctors stating that they intended to increase their prescription of the drug or recommend it to colleagues, according to an analysis of a survey completed by the doctors shortly after the visits. Nearly 40 percent of the visits involved discussion of so-called “off-label” uses of the drug not approved by the Food and Drug Administration, say the authors of the study. At the time of the visits, gabapentin was approved only for secondary treatment of a certain form of epilepsy. Off-label uses included treatment of pain, migraine, and psychiatric conditions.

 

“The increased intention to prescribe after these sales visits is remarkable, and is in fact greater than has been observed in other studies,” said lead author Michael A. Steinman, MD, a staff physician at the San Francisco VA Medical Center (SFVAMC). The senior author is Lisa Bero, PhD, professor of clinical pharmacy and health policy studies at the University of California, San Francisco (UCSF) and an expert on pharmaceutical industry marketing practices. The study appears in the April 24, 2007 issue of PLoS Medicine. The authors analyzed a survey form that chronicled 116 visits to 97 physicians by pharmaceutical sales representatives from 1995 to 1999. The forms were collected by a market research firm and became available to the researchers as the result of a lawsuit against Parke-Davis, the maker of gabapentin. The lawsuit was brought by a former employee who alleged that the company promoted gabapentin, which it sold under the name Neurontin, for uses not officially approved by the FDA.

 

“To me, the remarkable thing is how effective a very brief visit by a drug representative, most often less than five minutes, can be in influencing physicians’ choices to use a drug for an unapproved indication,” Bero said. After 46 percent of the visits, the doctors expressed the intention to increase either their prescribing of gabapentin or their recommendations that their colleagues prescribe the drug. During 39 percent of visits, the sales representative either gave or promised free drug samples to the doctor, said Steinman, who is also an assistant professor of medicine at UCSF.  During 38 percent of the visits, the “main message” involved discussion of at least one use of gabapentin that was not approved by the FDA at the time, he says. “We can’t say for sure whether these off-label uses were brought up by the sales representatives or the physicians,” cautions Steinman, “but it’s clear there was extensive discussion of uses that were not approved by the FDA, which, in general, sales representatives are prohibited from discussing in an unsolicited manner.”

 

Steinman notes that physicians were just as likely to say they intended to increase prescription of gabapentin whether or not visits included mention of off-label use. Neither the duration of visit nor the visit’s perceived educational value made any detectable difference in intention to prescribe, he said. There was no indication of whether the physicians followed up on their stated intention to prescribe more gabapentin, he said. Steinman speculates that the real effectiveness of pharmaceutical sales visits lies primarily in the “relationship-building” that occurs during those visits. “Aside from free drug samples, the representative will often bring a gift, lunch for the doctor and his or her staff, new pens and coffee mugs, offers to attend an educational conference. As a result, the doctor feels subtly, even subconsciously, indebted to the representative. This can lead to higher prescribing.” 

 

 


Neither abortion nor miscarriage associated with breast cancer risk

Neither induced abortion nor spontaneous abortion (miscarriage) appears to be associated with breast cancer risk in premenopausal women, according to a report in the April 23 issue of Archives of Internal Medicine. Women younger than age 35 who carry a pregnancy to term appear to have a reduced lifetime risk of breast cancer, according to background information in the article. Pregnancy may accelerate breast cell differentiation, the process by which cells take on specialized roles. “An incomplete pregnancy may not result in sufficient differentiation to counter the high levels of pregnancy hormones that may foster proliferation,” the rapid growth and division typical of cancer cells, the authors write. “However, these biological mechanisms are uncertain, and a prematurely terminated pregnancy may not affect breast cancer risk at all.”

Karin B. Michels, Sc.D., Ph.D., and colleagues at Brigham and Women’s Hospital, Harvard Medical School and Harvard School of Public Health, Boston, examined the association between abortion and breast cancer in 105,716 women who were part of the Nurses’ Health Study II (NHSII). A total of 16,118 participants (15 percent) reported having a history of induced abortion and 21,753 (21 percent) had a history of spontaneous abortion. Between 1993 and 2003, 1,458 new cases of breast cancer occurred among the women. “In this cohort study of young women, we found no association between induced abortion and breast cancer incidence and a suggestion of an inverse association between spontaneous abortion and breast cancer incidence during 10 years of follow-up,” the authors write. “We observed associations in two subgroups, an association between induced abortion and progesterone receptor–negative breast cancer [cancer that does not respond to the hormone progesterone] and an inverse association between spontaneous abortion before the age of 20 years and breast cancer incidence,” they continue.

However, they caution that these secondary analyses are based on small numbers of women. “No obvious mechanisms can be provided for these subgroup findings; thus, chance has to be considered as a possible explanation.” A 2003 international expert panel convened by the National Cancer Institute reviewed and assessed research regarding reproductive events and the risk of breast cancer, and concluded that based on existing evidence, induced abortion is not associated with an increased risk of breast cancer. “The data from the NHSII provide further evidence of a lack of an important overall association between induced or spontaneous abortions and risk of breast cancer,” the authors conclude. “Among this predominantly pre-menopausal population, neither induced nor spontaneous abortion was associated with the incidence of breast cancer.”

 

One in four hospital patients is admitted with a mental health or substance abuse disorder

Almost one-fourth of all stays in U.S. community hospitals for patients age 18 and older, 7.6 million of nearly 32 million stays, involved depressive, bipolar, schizophrenia and other mental health disorders or substance use related disorders in 2004, according to a new report by HHS’ Agency for Healthcare Research and Quality. This study presents the first documentation of the full impact of mental health and substance abuse disorders on U.S. community hospitals. According to the report, about 1.9 million of the 7.6 million stays were for patients who were hospitalized primarily because of a mental health or substance abuse problem. In the other 5.7 million stays, patients were admitted for another condition but they also were diagnosed as having a mental health or substance abuse disorder. Nearly two-thirds of costs were billed to the government: Medicare covered nearly half of the stays, and 18 percent were billed to Medicaid. Roughly 8 percent of the patients were uninsured. Private insurers were billed for the balance. The study also found that one of every three stays of uninsured patients was related to a mental health or substance abuse disorder.

“Community hospitals play an important role in the treatment of people with mental health and substance abuse disorders,” said AHRQ Director Carolyn M. Clancy, M.D.  “This report gives healthcare policymakers an in-depth look at the impact of mental health and substance abuse care on the healthcare system.” Substance Abuse and Mental Health Services Administration Administrator Terry Cline, Ph.D., said, “The significant number of hospital stays related to mental health and substance use disorders signals the need for an increased national effort to identify and intervene early before the conditions require a hospital stay. Too often because of social stigma or lack of understanding, individuals and health care providers don't recognize the signs or treat mental health or substance use disorders with the same urgency as other medical conditions.”

AHRQ found that most patients with mental health and substance abuse disorders were older. For example, although people age 80 and older comprised only 5 percent of the U.S. population in 2004, they accounted for nearly 21 percent of all hospital stays for these conditions, principally for dementia. There were also gender differences. The most frequent admitting diagnosis for women was mood disorders, while that for men was substance abuse. AHRQ also found that patients who have been diagnosed with both a mental health condition and a substance abuse disorder, those with “dual diagnoses”, accounted for 1 million of the nearly 8 million stays. Nearly half of these cases with dual diagnoses involved drug abuse, a third involved alcohol abuse, and one in five involved both drug and alcohol abuse.

In addition, 240,000 women hospitalized for childbirth or pregnancy also had mental health or substance abuse problems. Four of every 10 of these patients were between 18 and 24 years of age. Suicide attempts accounted for nearly 179,000 hospital stays. Of these, 93 percent involved a mental health condition, most commonly mood disorders, and/or substance abuse. Nearly three-quarters of these patients were between ages 18 and 44 and more than half were women. Poisoning, by overdosing prescription medicines or ingesting a toxic substance was the most common way patients attempted suicide. The report is based on 2004 data, the latest currently available, from AHRQ’s Healthcare Cost and Utilization Project Nationwide Inpatient Sample, a database of hospital inpatient stays that is nationally representative of all short-term, non-federal hospitals. The data are drawn from hospitals that comprise 90 percent of all discharges in the United States and include all patients, regardless of insurance type, as well as the uninsured. For more information see THIS LINK.

 

Scrushy settles SEC civil claims

HealthSouth Corp. founder Richard M. Scrushy reached an $81 million deal with the Securities and Exchange Commission to settle claims against him related to the massive accounting fraud at the healthcare rehabilitation company, according to The Wall Street Journal. Under terms of the agreement, filed in U.S. District Court in Birmingham, AL, Scrushy agreed to give up $77.5 million in gains and pay a $3.5 million penalty. Scrushy neither admitted or denied the SEC’s allegations, and will receive credit for $71.5 million he has already paid or forfeited in related cases, cutting the remaining bill to $9.5 million. Scrushy was charged by the Justice Department and the SEC in 2003 with accounting fraud and insider trading. At the time, the SEC sought more than $200 million in penalties, and Scrushy faced the possibility of years in prison. (The Wall Street Journal)

 

GHX develops collaborative contract commitment tool for  the healthcare supply chain  

GHX has extended the functionality of its Contract Center to include a collaborative contract commitment module that can be utilized by all providers, manufacturers, distributors, and group purchasing organizations (GPOs) in the healthcare supply chain.  More than sixty hospitals have already successfully used the tool to activate hundreds of contracts negotiated by HealthTrust Purchasing Group with Medtronic, Boston Scientific Corporation, and St. Jude Medical. Johnson and Johnson Healthcare Systems Inc. will begin utilizing the contract commitment module later this year. Cardinal Health has also expressed support for a single industry solution for contract commitment.

Effective contract management requires that all authorized parties to a contract share accurate information related to factors such as tier pricing and commitments, customer eligibility, and effective contract dates in a timely manner. When that information is inconsistent or delayed, errors can occur that not only create rework and higher labor costs but also may result in financial losses for the various parties as the result of inaccurate pricing, rebates and chargebacks. The GHX Contract Commitment Module addresses these issues by automating what has traditionally been a highly manual process and by enabling manufacturers, distributors, GPOs, and healthcare providers to agree on key contract terms and conditions up front.  

These process improvements help ensure greater accuracy in both transactions and reporting related to contract purchases, whether they are through a GPO or direct with a manufacturer. GPOs can provide manufacturers with data on contract terms and conditions, including tier pricing, definitions, and requirements, as well as which customers are eligible for various contracts. Hospitals and other healthcare providers can then utilize the tool to activate contracts, with manufacturer approval and agreement on effective dates occurring in a collaborative online environment. For more information, see THIS LINK.  

 


 

April 23, 2007


Medicaid programs ‘severely challenged,’ report says

 

In turnabout, infant deaths climb in South

 

FDA was aware of dangers to food;
outbreaks were not preventable, officials say

 

FDA to consider approval of first CCR5 antagonist against HIV/AIDS

MedAssets’ 2007 Healthcare Business Summit celebrates successes
in healthcare

Physicians should be able to review performance rates before release

 

Antibiotics not necessary to treat most abscesses,
even in the presence of MRSA

 


Medicaid programs ‘severely challenged,’ report says


State Medicaid programs vary wildly in their eligibility criteria, the scope and quality of their care, and the amount they reimburse physicians providing it, according to an independent assessment published last week. Overall, the programs are “severely challenged,” with the best scoring the equivalent of a low D and the worst way below an F. “This evaluation demonstrates a bleak picture for millions of people in many states,” wrote the authors of the 143-page evaluation, produced by Public Citizen’s Health Research Group. The top five programs, in order of rank, were in Massachusetts, Nebraska, Vermont, Alaska and Wisconsin. The bottom five, with lowest-ranked last, were in South Dakota, Oklahoma, Texas, Idaho and Mississippi. Maryland ranked 15, the District 27, and Virginia 37. Beyond the minimum specified services that the federal government mandates state Medicaid programs to provide, states may choose to expand coverage for other services. For example, all states and the District also choose to cover uninsured poor women needing care for breast or cervical cancer. Thirteen states and the District also cover uninsured people with tuberculosis.
 

The anecdotal differences between states can be dramatic. For example, a pregnant woman in a family of three must have a household income of less than $22,128 to qualify for Medicaid in Wyoming. In Minnesota, she could qualify with an income of $45,650, according to the report. “We know that the differences between programs reflect both differences in priorities and resources, but nobody knows the extent of them. The programs haven’t been subjected to a uniform scoring scheme,” said Annette B. Ramirez de Arellano, a health-policy expert who headed the project. The authors used published data to measure Medicaid performance in 55 areas. In calculating a final score out of a possible 1,000 points, they weighted issues of eligibility and reimbursement more heavily than breadth of services and quality of care. The highest- and lowest-ranked states differed in their scores by a factor of two, 646 for Massachusetts vs. 318 for Mississippi. There was even more variation in the components that went into the total scores. For example, the top-ranked state for the breadth of its eligibility criteria (Rhode Island) scored 3.3 times higher than the lowest-ranked state (Indiana) in that category. In the reimbursement component of the score, there was a 20-fold difference between Alaska, which had the most generous reimbursement, and New Jersey, which had the least. “Most of the states are failing in one or more areas, and some of them are failing in most areas,” Ramirez de Arellano said.

 

Public Citizen’s Health Research Group did a similar analysis and ranking 20 years ago. Four states in the top 10 now were in the top 10 then. Five states in the bottom 10 now were in the bottom 10 then. The authors admitted they were operating off incomplete information on many subjects, which made their task difficult. For example, the quality assessment was largely based on nursing home performance and the success of childhood immunizations, although Medicaid pays for the entire range of medical care. The reimbursement comparisons were based only on Medicaid programs using a fee-for-service payment scheme. However, 60 percent of Medicaid patients are in managed-care schemes in which physicians or clinics get a flat fee to provide all medical services to a client. Alan Weil, executive director of the National Academy for State Health Policy, said the report fails to capture Medicaid’s cutting edge, experimental coverage programs, managed-care reimbursement schemes and home-based care, because there are no data collected in all states that can serve as grounds for comparing those components. (Washington Post)

 

 


In turnabout, infant deaths climb in South


For decades, Mississippi and neighboring states with large black populations and expanses of enduring poverty made steady progress in reducing infant death. But, in what health experts call an ominous portent, progress has stalled and in recent years the death rate has risen in Mississippi and several other states. The setbacks have raised questions about the impact of cuts in welfare and Medicaid and of poor access to doctors, and, many doctors say, the growing epidemics of obesity, diabetes and hypertension among potential mothers, some of whom tip the scales here at 300 to 400 pounds. “I don’t think the rise is a fluke, and it’s a disturbing trend, not only in Mississippi but throughout the Southeast,” said Dr. Christina Glick, a neonatologist in Jackson, MI, and past president of the National Perinatal Association. To the shock of Mississippi officials, who in 2004 had seen the infant mortality rate, defined as deaths by the age of 1 year per thousand live births, fall to 9.7, the rate jumped sharply in 2005, to 11.4. The national average in 2003, the last year for which data have been compiled, was 6.9.

 

Smaller rises also occurred in 2005 in Alabama, North Carolina and Tennessee. Louisiana and South Carolina saw rises in 2004 and have not yet reported on 2005. Whether the rises continue or not, federal officials say, rates have stagnated in the Deep South at levels well above the national average. Most striking, here and throughout the country, is the large racial disparity. In Mississippi, infant deaths among blacks rose to 17 per thousand births in 2005 from 14.2 per thousand in 2004, while those among whites rose to 6.6 per thousand from 6.1. (The national average in 2003 was 5.7 for whites and 14.0 for blacks.) The overall jump in Mississippi meant that 65 more babies died in 2005 than in the previous year, for a total of 481. The main causes of infant death in poor Southern regions included premature and low-weight births; Sudden Infant Death Syndrome, which is linked to parental smoking and unsafe sleeping positions as well as unknown causes; congenital defects; and, among poor black teenage mothers in particular, deaths from accidents and disease. Dr. William Langston, an obstetrician at the Mississippi Department of Health, said that officials could not yet explain the sudden increase and were investigating. Dr. Langston said the state was working to extend prenatal care and was experimenting with new outreach programs. But, he added, “programs take money, and Mississippi is the poorest state in the nation.”

 

In the past 10 years, the infant mortality rate for blacks in most of the Delta has averaged about 14 per thousand in some counties and more than 20 per thousand in others. But Sharkey County, one of the poorest, has had a startlingly different record. From 1991 through 2005, the rate for blacks hovered at around 5 per thousand. State officials say the county’s population is too small, it registers only 100 births a year, to be statistically significant. But many experts feel it is no coincidence that a steep drop in infant deaths followed the start of an intensive home-visiting system run by the Cary Christian Center, using local mothers as counselors. The program, which is paid for with private money, buses nearly all pregnant blacks in Sharkey and a small neighboring county to pre- and postnatal classes. (The New York Times)

 


FDA was aware of dangers to food;
outbreaks were not preventable, officials say

The Food and Drug Administration has known for years about contamination problems at a Georgia peanut butter plant and on California spinach farms that led to disease outbreaks that killed three people, sickened hundreds, and forced one of the biggest product recalls in U.S. history, documents and interviews show. Overwhelmed by huge growth in the number of food processors and imports, however, the agency took only limited steps to address the problems and relied on producers to police themselves, according to agency documents. Congressional critics and consumer advocates said both episodes show that the agency is incapable of adequately protecting the safety of the food supply. FDA officials conceded that the agency’s system needs to be overhauled to meet today’s demands, but contended that the agency could not have done anything to prevent either contamination episode.

Last week, the FDA notified California state health officials that hogs on a farm in the state had likely eaten feed laced with melamine, an industrial chemical blamed for the deaths of dozens of pets in recent weeks. Officials are trying to determine whether the chemical’s presence in the hogs represents a threat to humans. Pork from animals raised on the farm has been recalled. The FDA has said its inspectors probably would not have found the contaminated food before problems arose. The tainted additive caused a recall of more than 100 different brands of pet food. The outbreaks point to a need to change the way the agency does business, said Robert E. Brackett, director of the FDA’s food-safety arm, which is responsible for safeguarding 80 percent of the nation’s food supply. “We have 60,000 to 80,000 facilities that we’re responsible for in any given year,” Brackett said. Explosive growth in the number of processors and the amount of imported foods means that manufacturers “have to build safety into their products rather than us chasing after them,” Brackett said.  

Tomorrow, a House Energy and Commerce subcommittee will hold a hearing on the unprecedented spate of recalls. Rep. John D. Dingell (D-MI), chairman of the full House committee is considering introducing legislation to boost the agency’s accountability, regulatory authority and budget. According to Caroline Smith DeWaal, who heads the Center for Science in the Public Interest, a consumer-advocacy group, “When budgets are tight... the food program at FDA gets hit the hardest.” In next year’s budget, passed amid discovery of contamination problems in spinach, tomatoes and lettuce, Congress has voted the FDA a $10 million increase to improve food safety, DeWaal said. The Agriculture Department, which monitors meat, poultry and eggs and keeps inspectors in every processing plant, got an increase 10 times that amount to help pay for its inspection programs. The FDA visits problem food plants about once a year and the rest far less frequently, Brackett said. (Washington Post) To read the original article see THIS LINK.

 

FDA to consider approval of first CCR5 antagonist against HIV/AIDS

An advisory panel of the U.S. Food and Drug Administration (FDA) is meeting this week to decide whether to recommend approval of Pfizer’s HIV/AIDS drug Maraviroc for patients already taking other drugs. If approved, it will be the first drug available in the class called CCR5 antagonists. Many HIV drugs fight the virus from inside infected white blood cells. CCR5 antagonists stop the virus from getting into cells by blocking the main entry point common to most people who have the infection. CCR5 stands for chemokine (C-C motif) receptor 5. HIV uses it as a co-receptor to get into target cells: the CD4 T-cells or helper cells, the main coordinators of the immune system. When the co-receptor “sees” the HIV virus it signals to the main CD4 cell receptor to allow the HIV antigen into the target T-cell.

By blocking the CCR5 co-receptor, CCR5 antagonists stop strains of HIV known as “R5-tropic”, an HIV variant that is common in earlier infection. However, as the disease progresses, the virus adapts to use an alternative entry point, the CXR4 receptor. In February, Pfizer announced that marketing authorization applications for Maraviroc were receiving accelerated review in both the US and Europe. The marketing applications for Maraviroc are supported by efficacy and safety data from two phase 3 trials. Named MOTIVATE-1 and 2 (Maraviroc plus Optimized Therapy In Viremic Antiretroviral Treatment-Experienced patients), the trials show 24 weeks of data comparing Optimized Background Therapy, with or without Maraviroc, in over 1,000 highly treatment-experienced patients with CCR5-tropic HIV-1. The HIV virus was suppressed in 45 percent of the patients, compared with 23 percent who took a placebo. Maraviroc and the placebos were taken in combination with other drugs. According to Pfizer, these trial results have been accepted for presentation at a forthcoming HIV conference.

CCR5 antagonists have raised safety concerns in the past. Earlier drugs under development were linked to lymphoma and liver damage. These risks did not appear to be significant in the Pfizer studies, but according to media reports, the FDA reviewers are concerned about modest increases in liver damage. Other drug companies are also working on CCR5 antagonists. Nobody knows what the long term effect of using CCR5 antagonists will be. Some have speculated that it will accelerate the development of new strains of HIV that use other entry points. Early trials have suggested not, but it highlights the importance of keeping an eye on the impact of the drug over the coming years should it pass the FDA and European approval. According to researchers on the Pfizer trials, the priority now is to get the drug to the people who are running out of options. The longer term effects will not be known until the drug has been used for 5 to 10 years. (Medical News Today)


 

MedAssets’ 2007 Healthcare Business Summit celebrates successes
in healthcare
 

At its Healthcare Business Summit in Las Vegas, April 9-13, MedAssets announced its commitment to further expand its technologies and services to help healthcare providers improve their overall financial and operational performance. In his address to the more than 2,700 healthcare professionals attending the MedAssets Healthcare Business Summit, MedAssets’ Chairman, President and CEO John Bardis shared the company’s plans to expand its revenue cycle management suite through acquisition of Xactimed and emphasized that the company’s diligent and deliberate growth is driven by the need to solve the challenges healthcare providers are facing as they work to improve the quality of care and efficiency in our nation’s healthcare system.   

During the event, MedAssets recognized customers who had achieved substantial financial and operational success through the use of the company’s technologies and services. MedAssets Supply Chain Systems also presented awards to GPO suppliers who work with healthcare providers to help them realize greater cost efficiency. This year marked the initial presentation of The Lifetime Financial Improvement Award as well as awards recognizing high-performing customers of MedAssets’ subsidiaries Avega Health Systems, MedAssets Net Revenue Systems and MedAssets Analytical Systems. The Lifetime Financial Improvement Award, which recognizes the healthcare provider that has documented and signed off on the greatest financial savings over a multi-year relationship with MedAssets, was presented to St. Joseph Health System for saving $98 million. Norton Healthcare received MedAssets Net Revenue Systems Customer of the Year Award, and Maricopa Integrated Health System was recognized as MedAssets Net Revenue Systems Best Practice Leader.  

A total of 16 customers received the MedAssets Net Revenue Systems Best Practice Award. The Avega Best Practice Leader Award was presented to three customers: Legacy Health System, Vanguard Health System and Mercy Hospital in Iowa. Four MedAssets Analytical Systems customers received Utilization Excellence Awards: Erlanger Health System, MedCath, Wellmont Health System and Atlantic Health System. The 2007 Outstanding Humanitarian Award went to Chris Van Gorder, chief executive officer of Scripps Health in San Diego, CA. The MedAssets President’s Award was presented to Trae Roby of OfficeMax for his strong leadership and delivery of superior value to MedAssets’ customers. OfficeMax was also recognized as this year’s Strategic Sponsor of the Healthcare Business Summit. The second annual Enterprise President’s Award was presented to Atlantic Health for its improved financial performance achieved through the complete MedAssets enterprise solution platform including supply chain innovation and other technology solutions. Other award presentations included 260 supplier awards, as well as The Supply Chain Savings Award, which was presented to OfficeMax and ICU Medical. For more information see THIS LINK.

 

 

Physicians should be able to review performance rates before release


A policy paper and principles assuring that physicians are given the opportunity to comment on performance ratings that they believe are inaccurate were adopted this week by the American College of Physicians (ACP) at its annual meeting April 19-21 in San Diego. The principles, part of the paper “Developing a Fair Process Through Which Physicians Participating in Performance Measurement Programs Can Request a Reconsideration of Their Ratings”, also address performance ratings that do not take into account the characteristics of the practice or patient population being treated prior to the release of ratings to the public.


Accurate reports of physician performance will allow physicians to effectively assess and improve their performance, and enable consumers and purchasers to make informed decisions concerning treatments, coverage and the quality of care. The principles, ACP says, should be considered in tandem with other organizational principles on developing measures; sharing, aggregating, and reporting data; and the ethics of physician performance measurement. Performance data should be used for public reporting or to determine physician payment only after data are fully adjusted for case-mix composition, including age, severity of illness, co-morbidities, and other features of a physician’s practice and patient population that may influence the results. “A fair and accurate reconsideration process is yet another way to minimize unintended consequences that may compromise the care of the patient,” said ACP President Lynne M. Kirk, MD, FACP. “These principles reflect the importance of balancing stakeholders’ urgent need for useful information with the need for due diligence to ensure that the information provided is valid, reliable, and useful.”

 

 

 

Antibiotics not necessary to treat most abscesses,
even in the presence of MRSA


A 30-year review of the medical literature concerning a common skin infection reveals that abscesses treated by simple incision and drainage heal just as well as those treated with incision, drainage and antibiotics. An article appearing online in the Annals of Emergency Medicine finds that, except in cases where cellulitis is present, abscesses can be treated successfully without antibiotics, even in an environment heavily contaminated with methicillin-resistant Staphylococcus aureus (MRSA) (“Are Antibiotics Necessary After Incision and Drainage of a Cutaneous Abscess?”). “The typical treatment for an emergency patient with a skin abscess is incision, drainage and antibiotics, but it looks like incision and drainage alone are enough,” said study author Worth W. Everett, MD, of the University of Pennsylvania Department of Emergency Medicine. “Given widespread concerns about antibiotic misuse and antibiotic resistance, this could change how we treat this very common emergency department complaint for both adults and children.”

 

MRSA, a powerful Staph infection sometimes referred to as a “superbug,” has proliferated recently in many public settings, including hospitals and healthcare facilities. MRSA’s resistance to many antibiotics and potential to cause harm to people with both normal and compromised immune systems have raised alarm among many healthcare workers. “Patients tend to clamor for antibiotics, even in situations where the evidence is clear that they are ineffective, such as with the common cold or the flu,” said Dr. Everett. “The body has a tremendous ability to heal itself over time, and we can now see that this includes skin abscesses, at least those that do not include cellulitis. The current research simply does not support the routine practice of prescribing antibiotics following incision and drainage of simple abscesses.”


The National Institutes of Health (NIH) has solicited proposals to study on a broader scale how to treat skin and soft tissue infections, including abscesses, and whether antibiotics are necessary. “Every study we looked at came to the same conclusion: abscesses treated with incision and drainage alone healed at the same rate as abscesses treated with incision, drainage and antibiotics,” said Dr. Everett. “If the anticipated NIH study supports the findings of the last 30 years, this may help stem the tide of antibiotic overuse. The next step, of course, will be to reinforce to the public the message that they don't need antibiotics to treat every ailment.”
 

 

 

 

 


 

 

April 20, 2007

 

 

‘Bird Flu’ genome study shows new strains, Western spread

 

Baby boomers appear to be less healthy than parents

 

John Hopkins begins aggressive screening for ‘superbugs’ in children

 

OSHA, NIOSH publish bulletin to help protect surgical personnel
from needle stick injuries

 

VHA Rapid Response Team network saves lives in Central Atlantic Region
 

Premier, Cardinal Health team up to help hospitals identify safer products
through use of standardized terminology

 

Misusing vitamin to foil drug test may be toxic

 

CDC launches new home page and other Web site improvements
 


‘Bird Flu’ genome study shows new strains, Western spread

In a paper in the May issue of Emerging Infectious Diseases, an international team of researchers report the first ever large-scale sequencing of western genomes of the deadly avian influenza virus, H5N1. Their study of 36 genomes of the virus collected from wild birds in Europe, the Middle East and Africa (EMA), and Vietnam confirms not only that the virus has very recently spread west from Asia, but that two of the new western strains have already independently combined, or reassorted, to create a new strain. Several samples also contained the mutation associated with the form of the “bird flu” that caused several human deaths in 2006. It is the virus’s ability to rapidly mutate into a pathogen that may eventually be passed between humans that concerns health officials about a worldwide pandemic of H5N1 influenza. The study also produced some evidence that strengthens the case that humans have had an impact on the movement of the flu out of Asia. “This is the first time anyone’s looked at all of the H5N1 genomes in the west,” said Steven Salzberg, the study’s lead author and director of the University of Maryland Center for Bioinformatics and Computational Biology. “Until now, the studies have been primarily on samples from the Far East. Our study shows that the virus is spreading west, and that there have been three separate introductions of H5N1 in Europe, the Middle East and Africa.”


The study shows that the new Euro-African lineage, which was the cause of fatal human infections in Egypt and Iraq in 2006, has been introduced at least three times into the EMA region and has split into three distinct, independently evolving lineages. Two of those sublineages have recently reassorted. The broad dispersal of the different forms of the virus throughout the different countries over a relatively short period of time points to the possibility of human movement, rather than wild birds as the reason for the quick spread of the H5N1. “The migratory pathways of wild birds don’t correspond with the movement of the genomes that we sequenced,” said Salzberg. “Humans carry chickens between many of the countries in our study, often transporting them across great distances. That and the weak biosecurity standards in most rural areas point to human-related movement of live poultry as the source of the introduction of H5N1 in some countries.” While the study “dramatically increased the number of genomes that have been sequenced, we have to do more surveys,” Salzberg said. “It’s surprising that we found what we did with such a small sample.” To read the paper see THIS LINK.

 


Baby boomers appear to be less healthy than parents

As the first wave of baby boomers edges toward retirement, a growing body of evidence suggests that they may be the first generation to enter their golden years in worse health than their parents. While not definitive, the data sketch a startlingly different picture than the popular image of health-obsessed workout fanatics who know their antioxidants from their trans fats and look 10 years younger than their age. Boomers are healthier in some important ways, they are much less likely to smoke, for example, but large surveys are consistently finding that they tend to describe themselves as less hale and hearty than their forebears did at the same age. They are more likely to report difficulty climbing stairs, getting up from a chair and doing other routine activities, as well as more chronic problems such as high cholesterol, blood pressure and diabetes. “We’re seeing some very powerful evidence all pointing to parallel findings,” said Mark D. Hayward, a sociologist at the University of Texas at Austin. “The trend seems to be that people are not as healthy as they approach retirement as they were in older generations. It’s very disturbing.”  

While cautioning that the data are just starting to emerge, researchers say the findings track with several unhealthy trends, notably the obesity epidemic. Two-thirds of Americans are overweight, and those extra pounds make joints wear out more quickly, boost cholesterol and blood pressure, and raise the risk of a host of debilitating health problems. And despite all those gym memberships, baby boomers tend to be less physically active than their parents and grandparents, their daily routines often dominated by desk jobs and the drive to and from work. Boomers tend to report more stress than earlier generations, from their jobs, their commutes, taking care of their parents and their kids, all of which can take a physical toll, which is compounded by having less support from extended families and communities, experts say.  

When researchers examined the first wave of baby boomers (5,030 adults born between 1948 and 1953)to enter a federally funded Health and Retirement Study which is tracking more than 20,000 U.S. adults as they move through middle age toward retirement, they were shocked to discover that they appeared to report poorer health than groups born between 1936 and 1941, and between 1942 and 1947. The baby boomers were much less likely than their predecessors to describe their health as “excellent” or “very good,” and were more likely to report having difficulty with routine activities, such as walking several blocks or lifting 10 pounds. They were also more likely to report pain, drinking and psychiatric problems, and chronic problems such as high blood pressure, high cholesterol and diabetes. It is unclear whether boomers are really sicker or are simply more health-conscious by dint of being better educated and having better access to information. They may also have higher expectations, making them more likely to notice and complain about aches and pains that earlier generations would have accepted as just part of getting older.  

The findings are consistent with a number of studies, including one last year that found American adults have poorer health than their British counterparts, and a preliminary analysis of data collected between 1972 and 2003 for the National Health Interview Survey, a nationally representative survey of more than 100,000 Americans. If the findings are confirmed by further analysis, the trend could force policymakers to rethink a host of expectations and projections about the nation’s overall medical bill and the future of Social Security and other retirement programs. (Washington Post)
To read the original article see THIS LINK.



John Hopkins begins aggressive screening for ‘superbugs’ in children

Infection control and critical care experts at The Johns Hopkins Hospital have ordered testing for the two most common hospital superbugs for every child admitted to its pediatric intensive care unit. The more stringent admission screening methods for methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE) go well beyond standard hospital practices, where tests are only ordered after symptoms or early signs of infection appear. The new hospital practice was introduced March 1 after a study conducted at Hopkins last year showed that more frequent screening detected many more carriers of the germs before their presence led to infection or the germs spread to others. Admission screening is already standard at Hopkins for adults admitted to intensive care units. Health experts fear spread of these particular bacteria because they have developed resistance to the antibiotic drugs most commonly used to combat them. Though infections caused by these bacteria are rarely fatal, carriers of either bug are at greater risk for more dangerous infections.  

Results from the study, presented April 16 at the annual meeting of the Society of Health Care Epidemiology of America (SHEA) in Baltimore, are believed among the first to make a case for better screening in efforts to slow spread of the germs in hospitalized children. The study compared the effectiveness of weekly screening to current practices for ordering tests and found the weekly model to be many times more effective than standard risk monitoring, in which the highly contagious bacteria are looked for after patients develop skin rash, fever or pain. Weekly swab testing and bacterial growth cultures were done on nearly 330 patients in the hospital’s pediatric intensive care unit for four months. Results were compared to findings of cultures obtained from patients showing possible signs or symptoms of infection. All patients were under age 18. The weekly testing for MRSA, the most common superbug, detected more than half of young patients who were carrying the germ (54 percent, or one and a half times as many)  than were detected through routine testing, which missed 35 percent of those with MRSA. Results for detecting VRE, a lesser known but still common superbug, were six times higher with weekly testing than with routine testing, which missed 82 percent of those with VRE.  

Like most bacteria, hospital superbugs are picked up through direct contact, by touching someone or a surface with it. “The results were quite clear to us: Aggressive patient safety programs should consider testing on admission as standard practice,” said study senior author and hospital epidemiologist Trish Perl, M.D.  Perl and her team, however, will wait for evidence of improved patient safety before making any national recommendations to government agencies and other hospitals. Perl is past president of SHEA. “We need to find patients who have these bacteria on them and who, as such, are not only at risk of personal infection, but also pose a serious threat of infection to other patients and hospital staff,” she said. According to Perl, a professor of medicine and pathology at The Johns Hopkins University School of Medicine, patients found to be infected or to be a carrier before infection has set in are placed in isolation for the remainder of their stay. Wound care is done only in designated, confined treatment spaces or separate rooms, and hospital staff must take special precautions between treatments, such as cleaning equipment and furniture with strong disinfectants and wearing disposable gloves, masks and gowns. 

 

“Children are more vulnerable to the problem of antibiotic resistance because their bodies are not fully developed to fight off illness and because fewer drugs are FDA approved for use in children,” said Aaron Milstone, M.D., a pediatric infectious diseases research fellow at Hopkins who led the tudy. Vancomycin (Vancocin) is currently the only FDA-approved drug for MRSA in children, and only one drug, linezolid (Zyvox), is approved in pediatrics for VRE. Milstone says children admitted to Hopkins are increasingly identified as harboring MRSA or VRE, with recent reports from the intensive care unit showing four times as many children with MRSA and twice as many with VRE than five years ago. 

 

 

OSHA, NIOSH publish bulletin to help protect surgical personnel from needle stick injuries

The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) in the U.S. Centers for Disease Control and Prevention have jointly published a Safety and Health Information Bulletin (SHIB) designed to help protect surgical personnel from needle stick injuries while using suture needles. “Surgical personnel are at risk of occupational exposure to bloodborne pathogens from injuries caused by sharp surgical instruments,” said Assistant Secretary of Labor for OSHA Edwin G. Foulke, Jr. “We strongly encourage the use of blunt-tip suture needles when feasible and appropriate to reduce this risk.” “The effectiveness of blunt-tip suture needles for preventing needle stick injuries has been widely reported,” said NIOSH Director John Howard, M.D.

The SHIB, available on the OSHA Web site at
http://www.osha.gov/dts/shib/shib032307.html and on the NIOSH Web site at http://www.cdc.gov/niosh/docs/2007-132/, describes the hazards of sharp-tip suture needles and presents evidence of the effectiveness of blunt-tip needles in decreasing injuries. It also emphasizes OSHA’s requirement to use appropriate, available and effective safer medical devices. Sharp-tip suture needles are the leading source of penetrating injuries to surgical personnel, causing 51-to-71 percent of these incidents. These injuries potentially expose staff and patients to bloodborne pathogens. The American College of Surgeons (ACS) issued a statement in 2005 supporting the use of blunt-tip suture needles where clinically appropriate. This statement has been endorsed by the six organizations that, along with the ACS, make up the Council on Surgical and Perioperative Safety.


 

VHA Rapid Response Team network saves lives in Central Atlantic Region

In May 2005, VHA Inc., a national health care alliance, launched a national effort to help its members implement Rapid Response Teams, hospital teams that can be called upon to help when it looks like patients in medical-surgical units are slowly spiraling toward a crisis such as cardiac arrest or shock, with the purpose of preventing that event. Thirty-one hospitals from Maryland, North Carolina, South Carolina, Tennessee, Virginia, West Virginia and Washington D.C., joined the VHA initiative through its Central Atlantic office. By learning as a network through VHA and participating in VHA-sponsored educational meetings, using standard data collection tools and sharing their results, 68 percent of the hospitals decreased their mortality rates and experienced 256 fewer code blue episodes (incidents when the patient stops breathing) outside of the intensive care unit (ICU). “Rapid response teams help nurses provide better patient care, reduce costs and improve hospital culture,” said Crystal Mullis, RN, BSN, MBA, MHA, director of performance improvement at VHA. “More than half of the organizations that participated in the VHA rapid response team network in the region saw improvements in mortalities, percent of codes outside of the ICU and percent of patients that coded and survived.”

 

Moses Cone Health System in Greensboro, NC, was so impressed with the results of their program that the system hired a dedicated team that is not assigned from ICU staff. Convincing administration about hiring the team was relatively easy as both the finance committee and chief financial officer understood the value of the rapid response team concept. Rapid response team composition varies by hospital, but all teams contain a nurse trained in critical care. Teams can include a variety of other hospital staff members, physicians, residents, respiratory therapists and pharmacists. When patients show signs of clinical deterioration, distress or changes in vital signs, the team is called within minutes to the bedside for rapid assessment and treatment. Their response is crucial because patient survival rates are directly impacted by how quickly the patient is assessed and treated; swift clinical intervention decreases patient mortality rates significantly. The rapid response team is especially helpful when new staff needs help, hospital resources are limited or physicians are unavailable. VHA members participating in the rapid response team network have seen dramatic results from their adoption of the concept.
 

Mary Washington Hospital in Fredericksburg, VA, calls its team the Medical-Surgical Emergency Team (MSET). Prior to launch, they experienced up to 25 codes a month. Within the first three months, their code calls dropped by 10 to13 calls. NorthEast Medical Center in Concord, N.C., launched its program, called the Stabilization Teaching Administration and Transport (STAT) team, in March 2004. The program’s success spurred the launch of a secondary group called the Code Care team in June 2006. By dialing a special number, patients and family members can activate the Code Care team to evaluate a patient's condition. The STAT team is called if the patient’s condition is serious or potentially life-threatening, and it has helped the hospital achieve a 65 percent decrease in cardiac arrests outside of the critical care unit and emergency department. Parkwest Medical Center in Knoxville, TN, launched its program in January 2006. In one year, the hospital achieved a 40 percent reduction for in-patient non-critical care codes. In addition, the hospital has reduced the number of days that patients spend in the critical care unit and estimates it has avoided $520,000 in costs. For more information see THIS LINK.

 

 


Premier, Cardinal Health team up to help hospitals identify safer products
through use of standardized terminology


Hospitals will have an easier time selecting safer products through an “industry first” effort by the Premier healthcare alliance and Cardinal Health to standardize medical product terminology in online catalogs. Historically, industry information describing the contents of a specific medical product has been inconsistent or non-existent, posing possible safety concerns. Through Premier’s Supply Chain Advisor electronic product catalog and Cardinal Health SupplyLine, a large product comparison and purchasing database, Premier members will have a standard set of nomenclature for product attributes to make it easier to search for products that won’t cause allergic reactions or those that are potentially toxic. For example, products that are made without latex, mercury, PVC and DEHP will have the new standardized nomenclature to include attributes such as: LATEX-FREE for products without latex; DEHP-FREE for products without the plasticizer, DEHP (Di(2–ethylhexyl) phthalate); MERCURY-FREE for products without mercury; and PVC-FREE for products without polyvinyl chloride.


Unlike pharmaceuticals, medical and surgical products do not have a standard coding system, and functionally equivalent healthcare products are often difficult and time consuming to identify for cost saving opportunities. SupplyLine is a core component in Cardinal Health’s rapidly growing Supply Technologies business that enables healthcare providers and companies to evaluate more than 800,000 healthcare products and research alternatives from thousands of manufacturers. In addition to cost savings, the benefits of SupplyLine include reduced waste and excess, improved inventory controls, improved utilization management and outcome analysis.

The Premier Safety Institute Web site has extensive resources on latex allergies and environmentally preferable purchasing at www.premierinc.com/safety. Premier Data Management Services has already processed several million new and updated product descriptions received in the past few months from SupplyLine. As the Supply Chain Advisor (SCA) database becomes populated by these new attributes, SCA users will be trained so they can begin to use the new search capabilities.

 

Misusing vitamin to foil drug test may be toxic

Taking excessive doses of a common vitamin in an attempt to defeat drug screening tests may send the user to the hospital, or worse. Researchers from The Children’s Hospital of Philadelphia and The University of Pennsylvania reported on two adults and two adolescents who suffered toxic side effects from taking large amounts of niacin, also known as vitamin B3, in mistaken attempts to foil urine drug tests. Both adult patients suffered skin irritation, while both adolescents had potentially life-threatening reactions, including liver toxicity and hypoglycemia (low blood sugar), as well as nausea, vomiting and dizziness. One of the teens also had disrupted heart rhythms. All four patients recovered after treatment in hospital emergency rooms for the adverse effects. The report appeared online in the Annals of Emergency Medicine.  

“Because niacin is known to affect metabolic processes, there is a completely unfounded claim that it can rapidly clear the body of drugs such as cannabis and cocaine. However, niacin is toxic when taken in large amounts.” said study leader Manoj K. Mittal, M.D., a fellow in Emergency Medicine at The Children’s Hospital of Philadelphia. Niacin is easily available as an over-the-counter vitamin supplement. As a vitamin, the daily recommended intake is 15 milligrams, but niacin is used in much larger doses to treat vitamin deficiencies and other conditions. “People often assume niacin is completely safe,” said Dr. Mittal. “As a water-soluble vitamin, it is easily excreted from the body. However, the body has its limits, and some of these patients took 300 times the daily recommended dose of niacin.” Dr. Mittal added that there is a report in the medical literature of a patient who suffered liver failure, requiring a liver transplant, after taking excessive doses of niacin. “We hope that our study will alert emergency medicine physicians and other healthcare providers to this hazardous practice,” said Dr. Mittal.

 

CDC launches new home page and other Web site improvements

The Centers for Disease Control and Prevention (CDC) unveiled a new look for the home page and major topic pages of its Web site. The changes are designed to make it easier for people to find health information and resources quickly. The CDC Web site address is www.cdc.gov. The redesigned site has an improved layout, a more powerful search engine, and other features to help people locate needed health and science information more efficiently. Among new features on the home page: Health and safety information is now grouped in broad, easy-to-browse topic areas. Additional new features provide better access to data and statistics, recent news, tools and resources, and new publications. A new Google-based search engine provides more relevant search results. An interactive features area at the top of the new home page highlights a number of current issues, events and health topics with relevant photographs or videos. This feature enables CDC to better display health recommendations, guidelines and upcoming events. A “Top 20 at CDC.gov” section allows visitors to quickly view a list of the most popular health topics, and access each directly from the home page. For a virtual tour see THIS LINK.  

 

 

 

 


 

April 19, 2007

 

Consorta Inc. finalizes agreement to become sixth equity owner
of HealthTrust Purchasing Group

 

Decrease in breast cancer incidence linked to drop in hormone replacement


1,000 extra ovarian cancer deaths due to HRT in UK since 1991

Republicans block Medicare drug price bill

WSJ: Pediatric ICUs make headway against infection

US critical care delivery system in critical condition

 

Women weighed down by health care costs, new study finds

Difficult births in obese women due to uterus failure
 


Consorta Inc. finalizes agreement to become sixth equity owner
of HealthTrust Purchasing Group
 

Consorta Inc. and HealthTrust Purchasing Group LP, two of the nation’s leading healthcare group purchasing organizations, today finalized the agreement that establishes Consorta as the sixth equity owner in HealthTrust. The combination of the two companies creates the nation’s fourth largest group purchasing organization (GPO), with more than $13 billion in combined volume. According to John W. Strong, Consorta’s president and chief executive officer, during the first five years of the partnership, Consorta forecasts that the combination will provide shareholders and members with $535 million in cost savings, via price reductions and broader coverage afforded by HealthTrust’s portfolio. All 12 Consorta shareholders are participating in the combination, along with Consorta affiliates. 

“We are very pleased to have these outstanding Consorta shareholders and affiliates as new members of HealthTrust,” said Jim Fitzgerald, president of HealthTrust. “While it validates our unique model and value-proposition, I'm even more excited about the potential to strengthen our competitive position. We’ll refresh all of our contracts over the next 18 months, delivering added value to all HealthTrust members.” HealthTrust will be responsible for all GPO Operations, including contracting. Consorta will remain an independent organization, serving as its shareholders’ voice on the HealthTrust Board of Advisors, and on HealthTrust clinical advisory boards to guide product selection. Consorta will also provide educational and analytical programs and manage member compliance for its shareholders.

 

Decrease in breast cancer incidence linked to drop in hormone replacement


A special report in the April 19, 2007 edition of The New England Journal of Medicine concludes that the sharp decline in breast-cancer incidence in 2003, followed by a relative stabilization at a lower rater in 2004, is most likely related to the first report of the Women’s Health Initiative (WHI) (JAMA 2002; 288:321-333. Risks and benefits of estrogen plus progestin in healthy postmenopausal women…) and the ensuing drop in hormone-replacement therapy among postmenopausal women. The report shows that the age adjusted incidence rate of breast cancer in women in the United States fell sharply by 6.7% in 2003, as compared with the rate in 2002. Data from 2004 showed a leveling-off relative to the 2003 rate with little additional decrease. The decrease was evident only in women who were 50 years of age or older and was more evident in cancers that were estrogen-receptor (ER)-positive than in those that were ER-negative. The reports’ lead author is Peter Ravdin, M.D., of the Anderson Cancer Center, and included investigators from the National Cancer Institute and the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed). Rowan Chlebowski, MD, PhD, a principal investigator/oncologist at LA BioMed, and the only researcher to participate in the 2002 reports of the trial evaluating estrogen plus progestin (which led to the decrease in menopausal hormone therapy use in 2003) and the 2006-07 studies outlining the subsequent decrease in breast cancer, states: “While the cause of the reduction is not definitive, the sustained decrease in new breast cancer diagnosed in the U.S. is a remarkable event. We estimate 44,000 fewer breast cancers over those two years (2003-04) and thousands more in the coming decades.”


Researchers looked at several variables that could be responsible for such a decline. They looked for flaws in the data itself, changes in reproductive factors, changes in mammographic screening, changes in environmental exposures, changes in diet, and changes in use of hormone-replacement therapy. Only the use of hormone-replacement therapy changed substantially, with the total number of prescriptions for the two most commonly prescribed forms of hormone-replacement therapy in the U.S., Premarin and Prempro, having their steepest declines starting in 2002 and particularly in 2003 (62 million scripts in 2000, 61 million in 2001, 47 million in 2002, 24 million in 2003, 21 million in 2004, and 18 million in 2005). The reduction of hormone-replacement therapy could have caused a decreased incidence of breast cancer by direct hormonal effects on the growth of occult breast cancers, a change that would have affected predominantly ER-positive tumors. The rapidity of the change suggests that clinically occult breast cancers stopped progressing or even regressed soon after the discontinuation of the therapy. The hypotheses is that hormone withdrawal can rapidly influence the growth of breast cancer is supported by anecdotal reports of regression of breast cancer after discontinuation of hormone replacement therapy.

 

 


1,000 extra ovarian cancer deaths due to HRT in UK since 1991


A suspected 1,000 extra women in the UK have died from ovarian cancer between 1991 and 2005 because they were using Hormone Replacement Therapy (HRT), according to an article published online and in an upcoming edition of The Lancet. There were also around 1,300 extra cases of ovarian cancer diagnosed in the same period. The figures are reported in the “Million Women Study” by Professor Valerie Beral and colleagues, of the Cancer Research UK Epidemiology Unit, Oxford, UK. Ovarian cancer is the fourth most common cancer in UK women, with about 6,700 developing the condition and 4,600 dying from it every year. The researchers assessed data from 948,576 postmenopausal women who did not have previous cancer or bilateral oophorectomy (removal of the ovaries) for five years. Around 30% were current HRT users and 20% had previously received HRT. 2,273 women developed ovarian cancer and 1,591 died from it. They found that current HRT users were on average 20% more likely to develop and die from ovarian cancer than those who had never received HRT. For every 1,000 women using HRT, 2.6 developed ovarian cancer over five years, compared to 2.2 per 1,000 in women who did not use HRT, one extra ovarian cancer diagnosed in every 2,500 HRT users, and one extra death from ovarian cancer in every 3,300 users. But risk did not differ significantly by type of HRT preparation used, its constituents, or mode of administration.

The women’s socioeconomic status, reproductive history, previous use of oral contraceptives, body-mass index, alcohol and tobacco consumption did not appreciably alter the effect of HRT on their risk of developing ovarian cancer. The researchers also reported that after women stop taking HRT, their risk of ovarian cancer returns to that found in never-users of HRT. In total, ovarian, endometrial and breast cancer account for around 40% of all cancers diagnosed in UK women. The authors conclude: “The effect of HRT on ovarian cancer should not be viewed in isolation, especially since use of HRT also affects the risk of breast and endometrial cancer.” They add: “The total incidence of these three cancers in the study population is 63% higher in current users of HRT than never users. Thus when ovarian, endometrial and breast cancer are taken together, use of HRT results in a material increase in these common cancers.” In an accompanying comment, Dr. Steven Narod, of the Women’s College Research Institute, University of Toronto, Canada, said: “Use of hormone replacement has declined dramatically in the UK and elsewhere since the report of the Women’s Health Initiative, and is thought to be responsible for a recent reduction in breast cancer rates recorded in the US. “With these new data on ovarian cancer, we expect the use of HRT to fall further. We hope that the number of women dying of ovarian cancer will decline as well.”

 

Republicans block Medicare drug price bill

Senate Republicans blocked legislation yesterday that would have allowed the federal government to negotiate Medicare drug prices, denying Democrats a victory on their 2006 election vow to lower prescription costs for senior citizens. “We’ll have plenty of additional chances,” said Sen. Ron Wyden (D-OR), a supporter of the bill. “This is not the end of the debate.” Democrats needed a 60-vote majority to start debate on the measure, but lost 55 to 42. Democratic leaders had low expectations for victory. For one, they faced formidable opposition from the pharmaceutical and health insurance industries, two of the most powerful lobbying forces on Capitol Hill. But the benefit also has gained wide popularity, costing consumers and the government far less than initially projected. Republicans in particular who had been skeptical about the benefit now acknowledge its success and are reluctant to tamper with it. Currently, more than 22 million seniors and disabled people receive drug coverage under Medicare. The Senate legislation would have allowed the government to directly negotiate with drug companies to secure lower prices for medications. But an independent Congressional Budget Office analysis found that the proposal would not result in cheaper drugs unless Congress modified the program, possibly restricting access and choice for beneficiaries. (Washington Post)

 

WSJ: Pediatric ICUs make headway against infection

For the sickest infants and children, pediatric intensive-care units provide the highest level of medical care, treating children after complicated surgeries, severe illness or accidents. But the very catheters, intravenous lines and invasive medical procedures used to keep children alive are also putting them at higher risk of bacterial infection. Now, with mounting alarm about the high rate of hospital-acquired infections, critical-care specialists are taking new steps to protect the smallest and most vulnerable patients, challenging the prevailing wisdom that infections are simply inevitable in a busy and stressful intensive-care environment. The nonprofit National Association of Children’s Hospitals and Related Institutions, with 208 member hospitals in the U.S. and overseas, is leading an ambitious effort to eradicate bloodstream infections, the most severe infectious threat in pediatric ICUs. In the first six months of the three-year project, 29 participating hospital units have slashed infection rates by close to 70% by adhering to a rigid set of measures shown to prevent infection in children, including far more rigorous care of catheters, higher sterile precautions, and constant assessment of the need for keeping catheters in place. Pediatric intensive-care units also are adopting new programs to sharply reduce or eliminate urinary-tract infections for children with bladder catheters, and pneumonia for children on ventilators, the two most prevalent complications after bloodstream infections.  

While infections have always been a risk for hospital patients of every age, experts say that children may be at even higher risk than adults. Until now, though, prevention efforts have focused largely on adults, and measures that are known to prevent infection in children aren’t always consistently used, experts say. Over the past few years, hospital bugs have become increasingly resistant to common antibiotics, striking two million patients and claiming 100,000 lives annually. There are no precise statistics on how many of those deaths are infants and children. But a review of published literature last month in the journal Pediatric Critical Care by Jana Stockwell, a pediatric critical-care physician at hospital operator Children’s Healthcare of Atlanta, concluded that infections can strike as many as 16% of children in pediatric units, a higher rate than in many adult ICUs, and increase the risk of death by up to 20%. Studies also show that treating an infection can add nearly $40,000 in additional hospital costs. “These kids are at incredible risk for infection, with thin skins that provide a poor barrier to infection and immature or severely compromised immune systems,” said Paul Sharek, chief clinical patient-safety officer for Lucille Packard Children’s Hospital at Stanford University, which has made reducing catheter-related infections its No. 1 goal for the past two years. Even though the steps for preventing infections are fairly routine, he adds, “it’s easier said than done, and involves massive cultural shifts” for medical staff who are used to handling medical procedures their own way.

Catheters are a big focus of such efforts because they require an invasive procedure that could allow bacteria to enter the body. Nachri’s bloodstream-infection prevention effort is relying on so-called “bundles” of catheter insertion and maintenance protocols that have already been shown to save lives and costs. Children’s Healthcare Corp. of America, a supply-purchasing cooperative of 42 children’s hospitals, pilot-tested the bundles in 2005. The goal was to cut bloodstream infections by 50%, to 1.5 infections per 1,000 catheter days. About two-thirds of the 28 participating hospitals were able to reduce infections by an average of 57%, which Barbara Spreadbury, a vice president at CHCA, estimates saved 112 children’s lives, and nearly $1 million in potential treatment costs. The aim now is to test a more comprehensive set of measures over a longer period and get them adopted as standard procedure, according to Mary Gorman, a vice president overseeing the project at Nachri. (Source: The Wall Street Journal) To read the original article see THIS LINK.

 

US critical care delivery system in critical condition


The demand for critical care services in the United States will soon outpace the supply of specialists trained in intensive care, a situation that, if not remedied, may prove fatal for critically ill patients. The solution to this problem lies not in recruiting and training more personnel, but in reorganizing the critical care system nationwide, according to a report from a group of critical care stakeholders, led by University of Pittsburgh School of Medicine researchers and published in the April issue of the journal Critical Care Medicine. “The number of Americans over the age of 65 is expected to double by 2030. In addition to non-elective medical admissions for critical illness among chronically ill elders, the growth rate in elective surgical procedures requiring intensive care unit admission, such as bypass surgery, is growing fastest among this age group,” said Amber E. Barnato, M.D., M.P.H., M.Sc., assistant professor, department of medicine, University of Pittsburgh School of Medicine. “All of this means more and more people will demand already strained intensive care services. This anticipated mismatch between supply and demand is perhaps no different for critical care services than for other medical care disproportionately serving elders, ranging from emergency services to long-term care services, but the opportunities for improving the efficiency of the existing system to meet demand are probably greater.”


The report, developed following a meeting of critical care stakeholders called the Prioritizing the Organization and Management of Intensive care Services (PrOMIS) Conference held in September 2005, calls for creation of a tiered, regionalized system for critical care services in an effort to centralize expertise, equipment and facilities. This would make the necessary critical care services readily available to the patients who are most in need. “Prior conferences aimed at addressing this problem sought input only from critical care professionals, who are a fraction of all the stakeholders,” said Dr. Barnato, lead author of the report. “These groups often stated the need for more trained providers. Surveying a wider group of interested parties, we found that this isn’t necessarily the best or only solution.”


For the PrOMIS Conference, organizers attempted to identify problems in the current U.S. critical care system as seen by all stakeholders, including those from professional organizations, critical care and non-critical care physicians, federal and private health insurers, federal and private funding organizations, and the general public. In the paper, researchers say the primary concern voiced by participants was that the “utilization, organization and management of intensive care services in the United States was not optimal.” They broadly agreed that there was a need to regionalize and tier the critical care system, similar to what previously had been done by the U.S. trauma system. Such a system would require the most critically ill patients to be seen in top-level critical care centers. Lower-level centers would not provide ongoing critical care services, but would need to transfer critically ill patients to higher-level centers. Participants also cited the need to acknowledge that some critical care services should be provided by physicians, such as hospitalists and emergency physicians, who currently are not certified by the existing critical care boards. Conference organizers hope that critical care societies will support a second stakeholder meeting, PrOMIS II, charged with developing concrete accreditation criteria for the proposed regionalized tiered system, defining explicit triage and quality surveillance criteria for each tier, developing a comprehensive set of core competencies for critical care providers and endorsing a method to train and certify critical care providers in these competencies.

 

 

Women weighed down by health care costs, new study finds

As Cover the Uninsured Week approaches, a new Commonwealth Fund report by researchers at the National Women’s Law Center finds that even women with health insurance coverage are more likely than insured men to go without needed healthcare because of costs. Also, a higher percentage of women than men struggle with medical bills. The report, “Women and Health Coverage: The Affordability Gap,” by Elizabeth M. Patchias and Judith G. Waxman of the National Women’s Law Center finds that women are at a disadvantage because they have greater healthcare needs and lower incomes than men. More specifically, the report finds that 38% of women are struggling with medical bills compared with 29% of men. And, the high cost of healthcare services and premiums is forcing many women, even women with health insurance, to go without needed care. In fact, 33% of insured women and 68% of uninsured women don’t get the healthcare they need because they can’t afford it. In contrast, 23% of insured and 49% of uninsured men are avoiding care because of cost. Further, 16% of women are underinsured, meaning they have high out-of-pocket costs compared to their income, while only 9% of men are underinsured.

“Women are more likely than men to go without needed healthcare services because of costs, yet they still have higher out-of-pocket expenses. This disparity exists for both insured and uninsured women,” said Waxman, vice president for Health and Reproductive Rights at the National Women’s Law Center. “As policymakers and advocates explore how to expand and improve health coverage, they should ensure that any proposal provides comprehensive benefits and low cost-sharing.” Other factors contribute to this gender gap in healthcare coverage and access: women are slightly more likely than men to purchase coverage in the individual insurance market which is often more expensive and less comprehensive than employer coverage. Women are also more likely than men to take prescription drugs. “These findings show that comprehensive healthcare coverage that doesn’t require high out-of-pocket costs is vital to ensuring that women get the care they need to be healthy,” said Sara Collins, assistant vice president for the Program on the Future of Health Insurance at The Commonwealth Fund.
To view the report see THIS LINK.

 

Difficult births in obese women due to uterus failure

In a study of 4,000 pregnant women, researchers found that almost 1 in 5 overweight women had to undergo an emergency Caesarean Section birth because the muscles in their uterus failed. The research suggests obesity impairs the ability of the uterus to contract sufficiently in order to dilate the cervix and deliver the baby. The team from the University of Liverpool’s Physiology department found that obese women were 3.5 times more likely to require a Caesarean for slow labor than normal weight women. Obese women who gave birth vaginally were also found to encounter other problems in child birth, more than twice as many (6%) experienced excessive bleeding following delivery compared with normal weight women (3%). This blood loss was also attributed to poor uterine activity in the obese group.


Professor Sue Wray, said, “Our research shows overweight women are at considerably higher risk of having to undergo an emergency Caesarean Section birth and find labor a more difficult experience than normal weight women. Interestingly, when we took uterus muscle samples from the overweight women and studied them in the lab they also performed poorly and contracted less well than matched samples from normal weight women.” The research team found that less calcium was able to enter the uterine cells of the obese women to support uterus muscles in contracting during labor. Professor Wray explained: “We suspect one reason preventing sufficient levels of calcium entering the uterus muscles is the high levels of cholesterol in an obese woman’s bloodstream. This could disrupt cell membranes and signaling pathways, including calcium entry. We will be investigating this further in future studies.” Dr. Siobhan Quenby from the University of Liverpool’s Obstetrics department commented: “In the meantime it is vital pre-pregnancy advice and counseling is available to women about the implications of weight on childbirth. Pregnancies among overweight women must be classified as high risk pregnancies and appropriate antenatal care should be provided so they receive the optimum care during maternity.”
   

 


April 18, 2007

FDA seizes all medical products from NJ device manufacturer
for significant manufacturing violations

FDA approves first U.S. vaccine for humans against
the avian influenza virus H5N1

UGA study suggests that lowering blood pressure following stroke
may reduce damage

New research shows that flu is a trigger of heart attacks

For-profit dialysis centres may be over-treating anemia

Long Island Chapter for Central Service honors Parseghian
as “Kathi O’Shaughnessy Tech of the Year”

HHS issues report to Congress on e-prescribing
 


FDA seizes all medical products from NJ device manufacturer
for significant manufacturing violations

U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals today seized all implantable medical devices from Shelhigh Inc., Union, NJ, after finding significant deficiencies in the company’s manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility. The products include pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.

Shelhigh’s violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates. Physicians should consider using alternative devices. Physicians should also monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information. FDA will issue a Preliminary Public Health Notification to physicians and other health care professionals and a Preliminary Advice for Patients shortly with more information; those documents will be posted to FDA’s Web site. The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as meetings with the company at which FDA warned Shelhigh that failure to correct its violations could result in an enforcement action. FDA also alerted the company to its manufacturing deficiencies and other violations in two warning letters.

Medical devices manufactured by Shelhigh include: Shelhigh Pericardial Patch; Shelhigh No-React Pericardial Patch; Shelhigh No-React PneumoPledgets; Shelhigh No-React VascuPatch; Shelhigh No-React Tissue Repair Patch/UroPatch; Shelhigh Pulmonic Valve Conduit No-React Treated; Shelhigh No-React Dura Shield; Shelhigh BioRing (annuloplasty ring); Shelhigh No-React EnCuff Patch; Shelhigh No-React Stentless Valve Conduit; Shelhigh Internal Mammary Artery; Shelhigh Gold perforated patches; Shelhigh Pre Curved Aortic Patch (Open); Shelhigh NR2000 SemiStented aortic tricuspid valve; Shelhigh BioConduit stentless valve; Shelhigh NR900A tricuspid valve; Shelhigh MitroFast Mitral Valve Repair System; Shelhigh BioMitral tricuspid valve; and Shelhigh Injectable Pulmonic Valve System. 


 

FDA approves first U.S. vaccine for humans against the avian influenza virus H5N1

The U.S. Food and Drug Administration (FDA) announced the first approval in the United States of a vaccine for humans against the H5N1 influenza virus, commonly known as avian or bird flu. The vaccine could be used in the event the current H5N1 avian virus were to develop the capability to efficiently spread from human to human, resulting in the rapid spread of the disease across the globe. Should such an influenza pandemic emerge, the vaccine may provide early limited protection in the months before a vaccine tailored to the pandemic strain of the virus could be developed and produced.

The vaccine was obtained from a human strain and is intended for immunizing people 18 through 64 years of age who could be at increased risk of exposure to the H5N1 influenza virus contained in the vaccine. H5N1 influenza vaccine immunization consists of two intramuscular injections, given approximately one month apart. The manufacturer, sanofi pasteur Inc., will not sell the vaccine commercially. Instead, the vaccine has been purchased by the federal government for inclusion within the U.S. Strategic National Stockpile for distribution by public health officials if needed. The vaccine will be manufactured at sanofi pasteur's Swiftwater, PA, facility.

A clinical study was conducted to collect safety information and information on recipient’s immune responses and to determine the appropriate vaccine dose. The vaccine was generally well tolerated, with the most common side effects reported as pain at the injection site, headache, general ill feeling and muscle pain. The study showed that 45 percent of individuals who received a 90 microgram, two-dose regimen developed antibodies at a level that is expected to reduce the risk of getting influenza. Although the level of antibodies seen in the remaining individuals did not reach that level, current scientific information on other influenza vaccines suggests that less than optimal antibody levels may still have the potential to help reduce disease severity and influenza-related hospitalizations and deaths.

With the support of FDA, the U.S. National Institutes of Health and other government agencies, sanofi pasteur and other manufacturers are working to develop a next generation of influenza vaccines for enhanced immune responses at lower doses, using technologies intended to boost the immune response. Meanwhile, the approval and availability of this vaccine will enhance national readiness and the nation’s ability to protect those at increased risk of exposure. For more information see www.pandemicflu.gov.


 

UGA study suggests that lowering blood pressure following stroke
may reduce damage

A new University of Georgia study suggests that commonly prescribed drugs used to lower blood pressure may help reduce brain damage when given within 24 hours of a stroke. The finding, based on a study using rats and published in the April issue of the Journal of Hypertension, may ultimately revolutionize emergency stroke care by putting blood pressure-lowering medications alongside clot-busting drugs and blood thinners as front-line medications. “There is a long-standing controversy about whether you should even treat elevated blood pressure in stroke victims,” said lead author Susan Fagan, professor of clinical and administrative pharmacy at the UGA College of Pharmacy and the Medical College of Georgia. “We were able to show that lowering blood pressure in the 24 hours following a stroke can reduce brain damage.”

Fagan and her team induced strokes in rats by occluding a major artery in the brain. After three hours, the suture was removed to simulate the effect of thrombolytic, or clot-busting, drugs. The rats were then given one of two common blood pressure lowering drugs or, for the control group, a saline solution. When the researchers measured the amount of brain damage, they found that the rats that had received the blood pressure lowering drugs fared significantly better. While the control group showed damage in 50 percent of the brain, those receiving the drugs hydralazine and enalapril showed 30 percent damage.

The finding complements a study Fagan and her colleagues published last year in the same journal that found similar reductions in brain damage using the common blood pressure drug, candesartan, a popular drug in the class known as angiotensin receptor blockers (ARBs). The rats given candesartan, however, showed the additional benefit of improved function while the rats receiving the other blood pressure medications had less benefit. Fagan said that in addition to protecting the brain and blood vessels through lowering blood pressure, ARBs appear to provide additional benefits by blocking the damaging effects of angiotensin II, a molecule released from the brain and probably other tissues following stroke.

Many physicians believe that elevated blood pressure following a stroke is necessary to keep oxygenated blood at the site of the blockage. Now that there is convincing evidence that lowering blood pressure can be beneficial after stroke, Fagan is working on a protocol for a human clinical trial that would identify what patient characteristics predict a good response to blood pressure lowering. “There are probably some patients that can benefit a great deal by having their blood pressure lowered within that first 24 hours after a stroke,” Fagan said. “Our challenge now is identifying those patients.”

 
 

New research shows that flu is a trigger of heart attacks

Doctors need to take concerted action to ensure that people who are at risk of heart disease receive the influenza vaccine every autumn, according to the authors of a new report published in the European Heart Journal. Their research shows that influenza epidemics are associated with a rise in deaths from heart disease and that flu can actually trigger the heart attacks that result in death. However, only about 60% of people in the US who ought to have a flu shot actually have one and this percentage is even smaller in Europe, said Professor Mohammad Madjid, the lead author of the report. “Our research has shown that influenza epidemics are associated with a rise in coronary deaths. This calls for more intensive efforts to increase the vaccination rate in people at risk of coronary heart disease. This may be especially important in an influenza pandemic when we would expect to see high mortality amongst the elderly and those suffering from heart problems or who have multiple coronary risk factors,” he said. “Between 10 and 20% of people catch flu every year, and I have estimated that we can prevent up to 90,000 coronary deaths a year in the US if every high risk patient received an annual flu vaccination.”

Madjid, who is assistant professor of medicine at the University of Texas-Houston, and a senior research scientist at the Texas Heart Institute in Houston, worked with colleagues in the US and in St. Petersburg in the Russian Federation to investigate deaths between 1993 and 2000 in St. Petersburg that had been shown by autopsy reports to be due to coronary heart disease. “This was a population where only a small minority were receiving flu vaccines or statin drugs, so this enabled us to see what happened naturally in the absence of these medicines,” said Madjid. “Relying on autopsy reports rather than death certificates enabled us to be much more accurate about the cause of death, because doctors often neglect to list flu on a death certificate if their patients have died from a heart attack and, conversely, heart attack symptoms can be missed in patients suffering from flu and pneumonia.”

They found that 11,892 people died from acute myocardial infarction (AMI) (47.8% men and 52.2% women), and 23,000 died from chronic ischaemic heart disease (IHD) (40.1% men and 59.9% women). The peaks in deaths from both AMI and IHD coincided with the times when influenza epidemics and acute respiratory disease (ARD), which often accompanies flu, were at their height. They found that the chances of dying from AMI increased by a third in epidemic weeks, compared to non-epidemic weeks, and the chances of dying from IHD increased by a tenth. This was the same for both men and women and in different age groups. Researchers believe that flu causes an acute and severe inflammation in the body, which, in some patients, can destabilize atherosclerotic plaques in coronary arteries and cause heart attacks.

Madjid said: “Most people develop atherosclerotic lesions in their coronary arteries in early childhood and these lesions grow over time. Inflammation plays a pivotal role in development and growth of these lesions. Most people in Western countries live with different stages of atherosclerosis and many will never show any clinical manifestations of the atherosclerosis. However, in some patients the quiescent, stable atherosclerotic plaques undergo sudden changes, mainly due to exaggerated inflammation, leading to rupture of these vulnerable plaques and subsequent formation of clots resulting in heart attacks. This study shows that flu is an important trigger of heart attacks because flu is a severe infection, with high incidence rates and is readily preventable.” Madjid pointed out that the implications of the research were even more important with a looming flu pandemic when a much higher percentage of the population could be expected to catch the illness.

 


For-profit dialysis centres may be over-treating anemia

In a new US study, scientists suggest that large for-profit kidney dialysis chains in the US give patients more anti-anemia drugs and aim for higher hemoglobin levels than nonprofit centres. Giving patients too much anti-anemia drugs can put their lives at risk. The study is published in the Journal of the American Medical Association (JAMA). Epoetin (marketed as Epogen and Procrit) is prescribed to kidney patients as part of their dialysis treatment, depending on how anemic they are and the level of hemoglobin their doctor is aiming to get them to. In the US as well as hospital-based dialysis facilities there are independently owned profit based facilities that claim back expenses for patient treatment, including anti-anemia epoetin, from Medicare. Epoetin therapy is the single largest Medicare drug expenditure for dialysis-related anemia, accounting for 1.8 billion dollars of expenditure in 2004, said the study authors. The researchers used data from the US Renal Data System and found 159,522 adult Medicare-eligible, end-stage renal disease patients who were receiving hemodialysis at various centres during November and December 2004. They analyzed the data using statistical regression models to examine the mean epoetin dose and dose adjustment by profit, chain, and affiliation status of the centres that patients attended.

The researchers found that: Dosing of epoetin varied significantly depending on organizational status and ownership of the kidney dialysis centre. The 106,116 patients who attended large for-profit dialysis centres were consistently administered the highest doses of epoetin compared with 28,199 patients who attended nonprofit centres, regardless of how anemic they were. A typical hospital-based centre administered an average dose of 16,188 units per week of epoetin, while for-profit chain centres administered an average dose of 20,838 units a week. On average, for-profit centres gave patients an average dose of 3,306 units a week more than non-profit dialysis centres. The greatest difference in dosing practice patterns between centres was found among patients with hematocrit levels of less than 33 percent. On average, compared with nonprofit centres, for-profit centres increased epoetin doses 3-fold for patients with hematocrit levels of less than 33 percent. Among the 6 large chain facilities with a similar patient case-mix, the average dose of epoetin ranged from 17,832 units per week at chain 5 (nonprofit facilities with a mean hematocrit level of 34.6 percent) to 24,986 units per week at chain 2 (for-profit facilities with a mean hematocrit level of 36.5 percent).

The researchers concluded that: “Dialysis facility organizational status and ownership are associated with variation in epoetin dosing in the United States. Different epoetin dosing patterns suggest that large for-profit chain facilities used larger dose adjustments and targeted higher hematocrit levels.” The authors expressed concern that overprescription of epoetin was taking place in the for-profit centres. In an accompanying editorial (Use of Epoetin in Chronic Renal Failure), Dr Daniel Coyne, professor of medicine at Washington University School of Medicine, in St. Louis, said that the authorities disagree on what the optimal level of hemoglobin in the blood should be. For example, the US Food and Drug Administration (FDA), recommend the maximum level of blood hemoglobin should be under 12 grams per decilitre (12 g/dl). But, this compares with 13 g/dl, the maximum level recommended by the National Kidney Foundation, which Dr. Coyne says is about to revise its guidelines. In his view, because of recent clinical trials, Dr. Coyne thinks the 12 g/dl limit is safer.

Experts reacting to this study suggest that changing the way for-profit dialysis centres are reimbursed by Medicare (currently they are paid for doing dialysis and giving the anemia drugs separately) to a composite system would be a better way to do it and would remove the incentive that is tied to the drug on its own. Administrators of for-profit dialysis centres say that the decision on which dose and guideline to follow is under the control of the patient’s doctor. The FDA has recently issued warnings for epoetin and another similar drug darbepoetin which is used to treat cancer patients with anemia. Too much hemoglobin is dangerous because it increases the risk of heart attacks, strokes and blood clots. (Medical News Today)


 

 

Long Island Chapter for Central Service honors Parseghian as “Kathi O’Shaughnessy Tech of the Year”

The Long Island Chapter for Central Service is honored to recognize Charles Parseghian as the recipient of the prestigious “Kathi O’Shaughnessy Tech of the Year Award”, sponsored by Healthmark Industries Company Inc. O’Shaughnessy was one of the leaders of this Chapter for many years and held most all positions on the Board of Directors. Her commitment to education in the field of Central Service was paramount. She knew that our profession was getting more technical with all the advancements in Medicine and that we would as technicians have to step up to the plate or be left out. She traveled all over the country with this mission. O’Shaughnessy lost her battle to cancer last October but never gave up her fight. It’s with this spirit that The Long Island Chapter for Central Service recognizes and applauds Parseghian on his career goals.


 

HHS issues report to Congress on e-prescribing

In a report to Congress, HHS Secretary Michael Leavitt announced the results of an electronic prescribing pilot project that support the adoption of new electronic prescribing standards. These standards, required by the Medicare Modernization Act of 2003, would help cut both medication errors and health care costs. “Electronic prescribing improves efficiencies while helping to eliminate potentially harmful drug interactions and other medication problems,” Secretary Leavitt said. “It also solves the problem of hard-to-read handwritten prescriptions. Additionally, such health information technologies promote affordability by allowing physicians to know which medications are covered by their patients’ Part D plans.”

The pilot project demonstrated that three initial standards are already capable of supporting e-prescribing transactions in Medicare Part D. These are standard transactions that provide physicians with patients’ formulary and benefit information, medication history, and the fill status of their medications. The report also found that, with some adjustments, e-prescribing can work successfully in long-term care settings. Some of the initial e-prescribing standards tested by the pilot project were found to have potential but still need further development if they are to be adopted as e-prescribing standards. These include standards used to convey structured patient instructions, a terminology to describe clinical drugs, and messages that convey prior authorization information. Five pilot sites operating in eight states tested initial standards to determine if they were ready for widespread adoption. Those pilot sites were Achieve Healthcare Information Technologies, LLP, Eden Prairie, MN; Brigham and Women’s Hospital, Boston, MA; Rand Corporation, Santa Monica, CA; SureScripts, LLC, Alexandria, VA; and University Hospitals Health System, Cleveland, OH. For more information see THIS LINK.


April 17, 2007


Rampage strains area hospitals

MedAssets to expand revenue cycle suite offering
with agreement to acquire XactiMed

FDA announces recommendations to reauthorize medical device
user fee program

Geisinger launches extensive study on obesity and related liver problem

Study shows hope for early diagnosis of Alzheimer's

‘Live’ Web Cast Opportunity to see computer-assisted
knee replacement surgery

FDA urgently warns consumers about health risks
of potentially contaminated olives

SPSmedical introduces new catalog


Rampage strains area hospitals

BLACKSBURG, VA, April 17 -- Four hospitals in this rural area of southwestern Virginia were swamped Monday after the Virginia Tech shooting rampage sent more than two dozen victims to emergency rooms, with the first arriving here at a regional medical center about 7:30 a.m. “I don’t know if you can ever be prepared for this type of violence,” Scott Hill, chief executive officer of Montgomery Regional Hospital, said Monday night. Hill said that extra nurses and an additional surgeon were called in to help treat more than a dozen patients sent to the 146-bed hospital. “We certainly had a lot of patients and extra help to deal with the situation,” Hill said. “We were in constant communication with police, so we knew what was coming.”

Hospital officials kept friends and family members sequestered away from the news media. William Brady, an emergency medicine professor at the University of Virginia, said that the total number of gunshot wounds would swamp any hospital, especially those in rural areas with limited resources. “If it’s a single hospital or two hospitals, it could certainly paralyze the hospital,” he said. “It can really slow a hospital down.” He said gunshot wounds pose special challenges. (Washington Post)

 


MedAssets to expand revenue cycle suite offering with agreement to acquire XactiMed

MedAssets Inc. and XactiMed Inc. announced today, they entered into an agreement whereby MedAssets will acquire XactiMed, a provider of web-based revenue cycle technologies and services to the healthcare industry. The agreement, which is expected to be finalized in May, will expand the offering of MedAssets Net Revenue Services to include claims management, remittance management, denial management solutions, and an array of revenue cycle services and consulting. 

Based in Richardson, TX, XactiMed is ranked number one in KLAS for Claims Management in 2006. The company also offers Medicare direct claims processing, accounts receivable collections and denials management with more than 350 hospitals and provider organizations as clients. The addition of XactiMed’s solutions with the MedAssets Net Revenue Systems’ portfolio will offer healthcare providers an integrated suite of technologies and services to improve accuracy in their revenue cycle processes, improve accounts receivable days outstanding, increase charge capture, speed collections and improve compliance. MedAssets’ current revenue cycle offerings include chargemaster management, charge capture auditing, defensible pricing, denials management, as well as supply item file and chargemaster linkage.

“This agreement will provide us with more resources to solve our customer’s revenue cycle issues,” said Neil Hunn, president of MedAssets Net Revenue Systems. “XactiMed’s solutions and services will complement as well as expand MedAssets’ revenue cycle suite, allowing us to provide an integrated, comprehensive offering to help healthcare providers improve their net revenue by improving business processes around billing and collections. MedAssets continues to remain fully committed to the development of an integrated, end-to-end revenue cycle solution”.

 


FDA announces recommendations to reauthorize medical device user fee program

The U.S. Food and Drug Administration (FDA) proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II), which, if adopted, would help to ensure that safe and effective medical devices get to patients in a timely manner. FDA is accepting public comments on the proposal for the next 30 days and is holding a public meeting on April 30. Under the medical device user fee program, industry covers a portion of the costs of FDA’s pre-market review program through a variety of fees. The fees are used in concert with the agency’s annual appropriations to help FDA meet its review performance goals, which would speed more promising products to market than before. The industry user fees represent less than a quarter of the overall device budget for MDUFMA II. MDUFMA II would provide industry with predictable and more stable fees because the amount for each type of fee for each year of the program would be prescribed in the statute. Manufacturers would continue to pay fees when they submit applications for some types of medical device applications, but at a lower rate than under the current program. The proposal would also provide for additional fees. A fee would be assessed on facilities that register with FDA as a medical device manufacturer. In addition, annual report filing fees would be collected for pre-market approvals.


Small businesses, a significant portion of device manufacturers, would see additional benefits under the proposal. The fees currently paid by businesses with $100 million or less in annual sales or receipts would be reduced from 80 percent of the full fee in the first device user fee program to 50 percent for 510(k) applications, and from 38 percent to 25 percent for pre-market approvals and related supplement fees. FDA would continue to waive the fee for all first-time pre-market approval applications for businesses with $30 million or less in annual sales or receipts. In addition, the proposal would allow a mechanism for foreign businesses to qualify as small businesses.


To achieve greater transparency, FDA would continue to foster interactive review by encouraging informal communication with companies; facilitate the timely scheduling of informal and formal meetings; expand the kinds of performance information FDA makes available to the public; enhance opportunities for stakeholders to provide input into guidance document development; facilitate the development of guidance to streamline the processes and to clarify the data requirements for the approval or clearance of imaging devices that use contrast agents or radiopharmaceuticals. The proposal would streamline the third party inspection program, which allows for the use of accredited private sector auditors for routine inspections, by making it easier for manufacturers to participate in the program. MDUFMA II would foster the development of innovative in vitro diagnostic tests by issuing new industry guidance on important emerging issues and reviewing some low-risk devices to determine whether any of them could be exempted from the need for product review. In addition, FDA would conduct a pilot program under which the agency would review simultaneously a company's 510(k) and waiver applications under the Clinical Laboratory Improvement Amendments, the law that governs quality standards for all laboratory testing.

To view the notice CLICK HERE. To submit electronic comments on the proposal, visit www.regulations.gov or www.fda.gov/dockets/ecomments. For more information see THIS LINK.

 


Geisinger launches extensive study on obesity and related liver problem


Relying on one of the largest collections of liver tissue samples ever acquired by a single organization, Geisinger Health System researchers have embarked on a massive study of one of the fastest growing liver problems. Nonalcoholic fatty liver disease starts with the accumulation of fat on the liver, which leads to inflammation and scarring. It can progress to the point of permanent liver damage and lead to the potentially fatal cirrhosis. If the damage becomes too great, a liver transplant may be needed. Linked to America’s increasing obesity problem, doctors have predicted a steep increase in the coming years. The disease is asymptomatic in its early stages and many people don’t know they have it initially.

Geisinger Health System is leveraging several key system resources in an effort to develop a simple blood test to diagnose the disease. Early detection would likely help patients better manage the disease and could even save lives. Yet a major obstacle needs to be cleared first. Right now, the only way to definitely diagnose the disease is through a liver biopsy. However, biopsies can pose health risks because of the potential for bleeding from the liver or for infection. The goal is to develop a noninvasive blood test for the disease and then bring it to market so other physicians can use it, said Geisinger staff scientist Glenn S. Gerhard, MD. To that end, Geisinger is uniquely positioned to develop such a test because of the array of resources the system has at its disposal. Geisinger has collected more than 600 liver tissue and blood samples donated from patients who have undergone bariatric weight loss surgery. “Nonalcoholic fatty liver disease hasn’t really been studied, in part, because investigators can’t get access to samples,” Gerhard said.

The federal government estimates that the disease affects 2 to 5 percent of Americans, while another 10 to 20 percent of the population has fat in their liver, but no inflammation or liver damage. As part of the project, investigators from the Weis Center for Research, the Center for Health Research, the Center for Nutrition and Weight Management, and the Department of Surgery are combing through Geisinger’s $80 million Electronic Health Record to learn why some obese and overweight people develop nonalcoholic fatty liver disease and similar problems.

“We need to look at what causes this disease and how we can treat it,” Gerhard said. A liver transplant costs about $370,000 on average, while bariatric surgery costs $40,000 in Pennsylvania, depending on the negotiated rate with the person’s health plan. (These costs are not what the patient pays, but the average costs for the provider.)

 


Study shows hope for early diagnosis of Alzheimer's

Research by faculty and staff at Rowan University, Glassboro, NJ; the University of Pennsylvania School of Medicine; and Drexel University may lead to better diagnosis of early-stage Alzheimer’s disease. In a $1.1-million National Institutes of Health’s National Institute on Aging study that team members conducted during the last three years, they determined early Alzheimer’s could be diagnosed with a high rate of accuracy evaluating electroencephalogram (EEG) signals. The study may lead to an earlier diagnosis, and therefore earlier treatment and improved quality of life, for people at the earliest stages of the disease. Rowan University electrical and computer engineering associate professor Dr. Robi Polikar conducted the research with Dr. Christopher Clark, associate professor of neurology, associate director of the NIH-sponsored Alzheimer's Disease Center at Penn and director of the Penn Memory Center, and with Dr. John Kounios, a Drexel psychology professor. “Individuals in the earliest stage of Alzheimer’s disease are often not aware of their progressing memory loss, and family members often believe the changes are simply due to aging,” Clark said. “Even the patient’s personal physician may be reluctant to initiate an evaluation until a considerable degree of brain failure has occurred. The advantage of using a modified EEG to detect these early changes is that it is non-invasive, simple to do, can be repeated when necessary and can be done in a physician’s office. This makes it an ideal method to screen elderly individuals for the earliest indication of this common scourge of late life.”

The teams conducted several experiments, ultimately evaluating the parietal and occipital regions of the brains of 71 patients, some already diagnosed with Alzheimer’s and some without Alzheimer’s. Their diagnostic accuracy rate was 82 to 85 percent using the EEGs (e.g., it matched evaluations conducted at Penn 82 to 85 percent of the time). Alzheimer’s disease cannot be confirmed until a patient has died and his or her brain has been examined. Gold standard tests administered at world-class research facilities, such as Penn, have a 90-percent accuracy rate. However, most people are evaluated at community hospitals and clinics, where the diagnostic accuracy is estimated to be around 75 percent. Though the study’s accuracy rate is under that 90-percent figure, it still means the test potentially could have great value to physicians and patients and their families, and the results are particularly significant for patients who have limited access to teaching hospitals, where they may undergo six to 12 months of evaluation for a diagnosis. The team members hope that eventually they or other researchers will develop a hand-held device that can be used to conduct similar evaluations as those done by the Rowan/Penn//Drexel group. “We don’t envision this replacing a neurologist,” Polikar said. “We hope it can serve as a first test for those folks who don’t have access to research facilities.” If the initial test indicates a possible problem, physicians could refer the patient to a research hospital for further evaluation.  

 

‘Live’ Web Cast Opportunity to see computer-assisted knee replacement surgery

On Wednesday, April 18 at 4:00 PM EDT (20:00 UTC/GMT) web viewers will have a unique opportunity to witness a “live” total knee replacement surgical procedure that employs a state-of-the-art Computer-Assisted Surgery (CAS) system from ORTHOsoft Inc. ORTHOsoft is an international company that develops and markets software applications, instruments and computerized medical systems that help improve the accuracy of knee, hip and spine procedures. The “live” Web cast will originate from Tampa General Hospital (Tampa, FL). Kenneth Gustke, M.D., founding member of the American Association of Hip and Knee Surgeons, will perform the total knee replacement surgery. The procedure will be narrated by Steven Lyons, M.D., surgeon at the Florida Orthopaedic Institute. CAS, such as with ORTHOsoft Navitrack(R) Navigation Systems, provides surgeons immediate instrument alignment and implant placement feedback. With CAS, hip, knee, and ankle replacement adjustments surgeons can have a perfect alignment rate up to 98 percent. The prime benefit for patients when surgeons use CAS is shorter post-surgery recovery time. To see the “live” procedure on the Internet visit http://www.gettingbackontrack.com and click on the Web cast link on the right side of the home page. For more information about ORTHOsoft's Navitrack Navigation System see THIS LINK.
 

 

FDA urgently warns consumers about health risks
of potentially contaminated olives


The U.S. Food and Drug Administration (FDA) is alerting consumers to possible serious health risks from eating olives that may be contaminated with a deadly bacterium, Clostridium botulinum. C. botulinum can cause botulism, a potentially fatal illness. The olives are made by Charlie Brown di Rutigliano & Figli S.r.l, of Bari, Italy and are being recalled by the manufacturer. No illnesses have been reported to date in connection with this recall. The olives should not be eaten alone or in other foods, even if they do not appear to be spoiled. Consumers should discard these products or return them to the point of purchase. If in doubt, consumers should contact the retailer and inquire whether its olives are part of the recall.


The olives are sold under the following brands: Borrelli, Bonta di Puglia, Cento, Corrado's, Dal Raccolto, Flora, Roland and Vantia, and have codes that start with the letter “G” and are followed by 3 or 4 digits. All sizes of cans, glass jars and pouches of Cerignola, Nocerella and Castelvetrano type olives are affected. Symptoms of botulism include general weakness, dizziness, double vision, trouble with speaking or swallowing, difficulty in breathing, weakness of other muscles, abdominal distension and constipation. People experiencing these symptoms should seek immediate medical attention. Consumers may also report illnesses associated with consumption of these olives to the nearest FDA district offices. Charlie Brown di Rutigliano & Figli S.r.l, initiated a recall of these olives on March 27, 2007. The recalled olives had been distributed to wholesalers, who have marketed them nationally to restaurants and retail stores. FDA concluded that additional warnings are needed because, to date, the company has not contacted importers with specific instructions on the recall. Consumers with questions may contact Charlie Brown Company at 011-039-080-7839073 or charliebrownbari@yahoo.com.

 

 
 

SPSmedical introduces new catalog

SPSmedical introduces a redesigned 2007 catalog featuring sterilization products, services and educational programs. This new catalog segments sterilization products & services by sterilization process (Steam, EO Gas, Gas Plasma, Peracetic Acid, Dry Heat and Chemical Vapor). SPSmedical is the largest sterilizer testing laboratory in N. America and sells a comprehensive line of sterility assurance products including biological indicators, chemical indicators, integrators, bowie-dick test packs, packaging and recordkeeping products. GPO’s and the Federal Government have contracted for SPSmedical products, which are available through authorized distributors worldwide. Contact SPSmedical at 1-800-722-1529 or info@spsmedical.com for a FREE catalog and more information.


April 16, 2007


CMS proposes payment reforms for inpatient hospital services in 2008

Staph aureus infection rates on the rise in U.S. hospitals

Rhode Island Hospital study identifies high-risk patient populations for MRSA carriage

Rare case of dental patient-to-patient hepatitis B virus transmission recorded

 

Premier healthcare alliance launches ‘green’ best-practices Web site

Jani-King approves healthcare cleaning system

Independent healthcare research leader announces new name:
ECRI Institute

Healthcare providers to benefit from Amerinet’s agreement with Med1Online


CMS proposes payment reforms for inpatient hospital services in 2008

The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that takes steps to improve the accuracy of Medicare’s payment under the acute care hospital inpatient prospective payment system (IPPS), while providing additional incentives for hospitals to engage in quality improvement efforts. The payment reforms include a proposal to restructure the inpatient diagnosis related groups (DRGs) to account more fully for the severity of the patient’s condition. In addition, the proposed rule includes provisions to ensure that Medicare no longer pays hospitals for their additional costs of hospital-acquired conditions (including infections), and includes an expanded list of publicly reported quality measures. The proposed rule would also reduce payment for a DRG involving the implantation of a device, when a hospital replaces a device and the replacement is supplied to the hospital at no or reduced cost. Medicare’s inpatient rates for operating expenses will increase by 3.3 percent in FY 2008 for those hospitals that report quality data to CMS. Overall, the proposed rule is estimated to increase payments to more than 3,500 acute care hospitals by $3.3 billion.

The proposed rule would create 745 new severity-adjusted diagnosis related groups (DRGs) (Medicare Severity DRGs or MS-DRGs) to replace the current 538 DRGs. Projected aggregate spending from the reforms will not change. However, payments would increase for hospitals serving more severely ill patients and decrease for serving patients who are less severely ill. CMS is proposing to revise the current DRGs so that the system will continue to be based upon a non-proprietary case mix system making it available to the public. By more accurately recognizing the costs of caring for a patient, the new MS-DRGs will further reduce incentives for hospitals to “cherry pick,” the practice of treating only the healthiest and most profitable patients. They also address concerns that specialty hospitals may selectively provide such profitable services.

For FY 2008, CMS is proposing to adopt a high cost outlier threshold of $23,015, down from $24,475 in FY 2007. By better recognizing severity of illness in the DRGs, fewer cases would be paid as outliers. However, CMS proposed to lower the outlier threshold to meet the legal requirement to continue paying between 5 and 6 percent of payments as outliers. The proposed rule recommends changes to the way Medicare pays for hospital capital-related costs based on an analysis that showed substantial positive margins experienced by some hospitals. 

The proposed rule would add five new quality measures, which would bring to 32 the number of measures hospitals would need to report in FY 2008 in order to qualify for the full market basket update in FY 2009. 

The proposed rule would require physician-owned hospitals to disclose such ownership to patients and provide the names of the physician owners upon request. The proposed rule would also require physician-owned hospitals to require physician owners who are members of the hospital’s medical staff to disclose their ownership to the patients they refer to the hospital. Disclosure would be required at the time of referral. The proposed rule would require a hospital to notify all patients in writing if a doctor of medicine or doctor of osteopathy is not present in the hospital 24 hours a day, seven days per week, and describe how the hospital will meet the medical needs of a patient who develops an emergency condition while no doctor is on site. 

Under the proposed rule, hospitals would be paid during 2008 based on a blend of one-third list charge-based weights and two-thirds hospital cost-based weights for the DRGs. In 2009, hospitals would be paid 100 percent based on cost-based DRG weights. Comments on the proposed rule will be accepted until June 12, 2007 and a final rule, to be effective for discharges on or after October 1, 2007, will be published later in the summer. To read the press release see THIS LINK. For fact sheets on the proposed rule see THIS LINK or THIS LINK

 


Staph aureus infection rates on the rise in U.S. hospitals

Findings presented at the Society of Healthcare Epidemiology of America annual meeting further demonstrate that there has been a significant increase in Staphylococcus aureus (commonly referred to as Staph aureus) infection rates among patients in U.S. hospitals, resulting in longer hospitalizations and millions of dollars of excess healthcare costs. Researchers analyzed more than 45 million hospital discharge records and found that from 1998 to 2003 the prevalence of Staph aureus infection among all patients increased at an annual rate of 7.1 percent. The problem grew even faster among surgical patients; the rate of Staph aureus infection rose 7.9 percent each year for all surgical stays and 9.3 percent each year for orthopedic patients.

The studies, which were funded by 3M Health Care, were conducted by lead investigator Dr. Gary Noskin, Associate Professor of Medicine at the Feinberg School of Medicine, Northwestern University and Associate Chief Medical Officer at Northwestern Memorial Hospital. “Staph aureus causes a wide range of infections, from mild skin infections to life-threatening blood stream infections,” said Angela Dillow, PhD, Global Business Manager, 3M Medical Diagnostics. “Identifying the bacteria and reducing its spread in hospitals is crucial to improving patient outcomes, and these findings underscore the need to control these infections.” Prior to surgery, about one-third of patients carry Staph aureus in the nose, but do not have an infection. It is only if the bacteria enter other parts of the body, through a surgical incision, for example, that they can result in a serious infection.

The researchers also presented findings on the economic impact of Staph aureus infections in hospitals and found that from 1998 to 2003 the economic burden among all Staph aureus-related inpatient stays increased from $8.7 billion to $14.5 billion, an annual increase of 11.9 percent. The costs of Staph aureus for invasive cardiovascular stays and invasive neurological stays rose at 12.4 percent a year and 13.5 percent a year, respectively. “These findings clearly demonstrate the considerable economic implications of Staph aureus infections for hospitals nationwide,” said Dr. Gary Noskin. “It suggests that there could be large cost savings associated with aggressive efforts to prevent patients from becoming infected with these bacteria.”

Another abstract submitted by Dr. Noskin and colleagues at the meeting examined the economic benefit of screening for Staph aureus from nasal samples. The study showed rapid pre-admission testing for nasal Staph aureus and subsequent colonization suppression of carriers resulted in an average annual cost savings of approximately $519 million for U.S. hospitals. Researchers analyzed data from the 2003 Nationwide Inpatient Sample and published literature. Primary input variables included the marginal effect of Staph aureus infection on expenditures, prevalence of nasal Staph aureus carriage, sensitivity and specificity of the rapid Staph aureus screening device, efficacy of nasal Staph aureus colonization suppression and cost data. “Rapid, pre-admission testing of patients could help hospitals better identify patients that are colonized with Staph aureus and in the appropriate setting attempt to decolonize them to help reduce the risk of infection and control costs,” said Dillow.


 

 

Rhode Island Hospital study identifies high-risk patient populations for MRSA carriage

A study presented Saturday at the Society for Healthcare Epidemiology of America (SHEA) annual meeting found that patients in long-term elder care and HIV-infected outpatients appear to be high-risk groups for carriage of methicillin-resistant Staphylococcus aureus (MRSA), a common cause for healthcare associated infections. “MRSA can be spread in the healthcare environment and community and can cause serious infections,” said lead investigator Leonard Mermel, MD, medical director, department of epidemiology & infection control, Rhode Island Hospital. “Identifying patient populations that have a high risk of MRSA carriage is important in our efforts to control the spread of this microbe among patients.”

In the prospective, multi-center trial, which was funded by 3M Health Care, clinical nasal swabs were collected from various patient groups at 11 U.S. sites, including inpatients screened for MRSA through active surveillance, inpatients and outpatients requiring hemodialysis, inpatients and outpatients with HIV-infection, pre-op cardiac surgery patients and patients admitted from long-term elder care. Among patients at facilities that did not regularly screen for MRSA, prevalence of MRSA was highest in patients admitted from long-term care (18 percent) and HIV-infected outpatients (17 percent), suggesting these patient populations are at especially high risk of MRSA carriage. In addition, this trial is the first to look at the quantity of MRSA in the nares of different patient populations. Currently, the standard method to detect carriage of MRSA is by routine culture whereby results can take several days.
Delayed results can lead to MRSA transmission since potential MRSA carriers are often not isolated from patients without MRSA until these results are available.


Rare case of dental patient-to-patient hepatitis B virus transmission recorded

Researchers have documented a case of hepatitis B virus (HBV) transmission between two patients at a dentist’s office in the United States. While this kind of infection is exceedingly rare, universal vaccination against the virus would likely have prevented both cases, according to the authors of the report and an accompanying commentary. Both appear in the May 1 issue of The Journal of Infectious Diseases, now available online. The case report, by John T. Redd, MD, MPH, and colleagues from the Centers for Disease Control and Prevention (CDC) and the New Mexico Department of Health, describes the index patient as a sexually inactive 60-year-old woman with no history of intravenous drug use or other potential exposures to HBV who had undergone multiple tooth extractions on a single office visit. A cross-match of the state’s Hepatitis B Registry identified the source patient: a 36-year-old woman who had had teeth extracted hours earlier on the same day in the same office by the same surgeon and assistants, and receiving the same medications as the index patient. No evidence of HBV infection was found in any member of the office staff. Blood tests indicated that the source patient had had chronic HBV infection with a high viral load at the time of oral surgery.

 

Genetic analysis showed that virus of the same genotype and subtype was isolated from both patients, and that the isolates had identical DNA sequences in a sampled region. Medical records and blood tests of 25 patients operated on after the source patient showed that 16 (64 percent) were vaccinated and immune to HBV. “I was pleasantly surprised by the high prevalence of immunity,” commented Dr. Redd. “It may have helped to limit spread of the virus.” When investigators visited the office and monitored its operation they found all staff members followed standard infection control practices. The investigators could only speculate that there might have been a lapse in clean-up procedures after the source patient, leaving an area contaminated with her blood. HBV infection has long been a concern in dental infection control. The blood-borne pathogen is hardy, persisting in dried blood on surfaces for a week or more. It can be present even in the absence of visible blood. With routine vaccination against the virus in U.S. dental healthcare personnel over the last two decades, the incidence of HBV infection in this high-risk group has dramatically fallen, and no cases of dentist-to-patient HBV transmission have been reported in the U.S. since 1987. This is the only known case of patient-to-patient transmission in a dental setting.

The authors concluded that the case underscored the need for meticulous maintenance of blood-borne pathogen infection control for all patients in dental settings. They also said that it reinforced the value of universal childhood HBV vaccination, which has been recommended in the U.S. since 1991. In an accompanying editorial, Ban Mishu Allos, MD, and William Schaffner, MD, of Vanderbilt University School of Medicine, noted that adults account for most new cases of HBV infection in the United States, and that current recommendations based on such risk factors as sexual activity and intravenous drug use have resulted in meager vaccination rates. “Fewer than 10 percent of young adults with high-risk behaviors have received HBV vaccine,” they said. In contrast, the incidence of HBV infection in children has been dramatically reduced by universal vaccination policies, and surgeon- and dentist-to-patient transmissions of the infection were essentially eliminated with routine vaccination of healthcare workers.

 


Premier healthcare alliance launches ‘green’ best-practices Web site

To help more hospitals share best practices for developing “green”, or environmentally sound, programs, the Premier Safety Institute recently launched a new public Web site, “Green Corner.” Located at www.premierinc.com/greencorner, the site showcases hospital and supplier success stories about “green” initiatives that contribute to a safer, healthier community environment. Stories are categorized under major topics, such as energy savings and waste reduction, making it easy for hospitals to find specific information on programs of interest. “Going green” not only is a smart way for hospitals to protect the environment, it also allows them to reduce operational costs, gain a competitive advantage and keep staff and patients satisfied.


“‘Green Corner’ provides a valuable resource for healthcare professionals seeking anecdotes about how their peers in the hospital industry are tackling important community environmental issues, both simple and complex,” said Gina Pugliese, RN, vice president of the Premier Safety Institute. Pugliese noted that such information can provide an important starting point for projects whose ultimate goal is to reduce waste, save money and protect a community's quality of life both now and for future generations.

 

The new site also complements the Safety Institute’s free, electronic newsletter, “Green Link,” that highlights the latest news on “green” healthcare practices and purchasing. In addition, “Green Corner” expands the Premier Environmentally Preferable Purchasing (EPP) program’s public suite of offerings, which currently includes electronic tools to support critical environmental efforts such as mercury pollution prevention and computer recycling. Premier’s EPP program, a collaboration of the Safety Institute and Premier's group purchasing program, supports the efforts of members and the industry-at-large to enhance the safety and health of patients, healthcare workers and the environment. For example, on behalf of hundreds of hospitals and the communities they serve, the EPP program recently secured purchasing agreements with Dell and Gateway for computers and electronic devices that address significant environmental concerns regarding the manufacturing, use and end-of-life disposal and/or recycling of electronics.

 

 



Jani-King approves healthcare cleaning system

After more than one year of research and testing, Jani-King International has partnered with Rubbermaid to officially implement a color-coded microfiber cleaning and disinfecting system into its standard environmental services program. Jani-King, a commercial cleaning franchise company, worked with Rubbermaid, a provider of high efficiency environmental services equipment, in order to adapt best practices, procedures and techniques for cleaning and disinfecting in a healthcare environment.

“For patients with weakened or susceptible immune systems, there is nothing more dangerous than increased bio load on healthcare surfaces,” said Mark Regna, Director of Healthcare at Jani-King International. “We labored for over a year testing and analyzing the Rubbermaid equipment and recommended procedures. What we have proven is that microfiber technology is highly effective in disinfecting surfaces while the use of a color-coded cleaning system greatly reduces the risk of cross transmission.” Jani-King has already implemented this new cleaning and disinfecting standard into its healthcare certificate program. According to Regna, every Jani-King franchise owner and all environmental service staff must receive a healthcare certificate of completion by Jani-King prior to servicing a healthcare account. For more information see THIS LINK
 


 

 

Independent healthcare research leader announces new name: ECRI Institute

Renewing its mission to research best approaches to improve patient care, nonprofit healthcare research organization today announces its new name: ECRI Institute. The independent organization, formerly known as ECRI, unveils its new logo, with the tagline “The Discipline of Science. The Integrity of Independence.” The organization’s redesigned public Web site offers improved navigation and enhanced content. This rebranding process is the first for the independent nonprofit founded in 1968. For more information see THIS LINK


 

Healthcare providers to benefit from Amerinet’s agreement with Med1Online

Amerinet Inc. announces its agreement with Med1Online for customized medical equipment management services. Effective April 1, 2007, through March 30, 2010, this contract provides cost-saving opportunities to Amerinet members on asset recovery, new and used equipment sales, repair/service/extended warranties, internal exchange program (through a customized Extra-Net system), inventory and appraisal services, and equipment planning. Med1Online, LLC (Med1Online), is a re-seller of capital medical equipment. Incorporated in 2002, Med1Online has become a worldwide distributor of both new and used medical equipment. For more information, see THIS LINK  


April 13, 2007

Hire Heroes program launched to place veterans with disabilities
in healthcare jobs

CDC report highlights growing foodborne illness challenges;
E. coli O157, Salmonella, Vibrio cause concern

CDC changes recommendations for gonorrhea treatment due to
drug resistance; Few treatment options remain

Major genetic study identifies clearest link yet to obesity risk

 

F.D.A. rejects Merck’s new pain medication

Materials managers invited to attend Healthcare Supplier & Provider
Institute meeting for free; New Provider Only session

Needle guidance now available for Siemens’ new high-density transducer

RF Technologies offers free Sensatec bed and chair alarms
as part of trade-in program


Hire Heroes program launched to place veterans with disabilities
in healthcare jobs

Hire Heroes, a program designed to help veterans with disabilities find careers in the healthcare industry, was launched today by Health Careers Foundation, a non-profit healthcare education organization. The announcement was made during the general session of the MedAssets’ Healthcare Business Summit in Las Vegas, NV. MedAssets is one of a number of healthcare companies providing funding to Health Careers Foundation. As part of the Health Careers Foundation, Hire Heroes will help veterans returning from Operation Iraqi Freedom and Operation Enduring Freedom with any level of disability as determined by the United States Department of Veterans Affairs. “Through Health Careers Foundations’ connections within the healthcare industry, the Hire Heroes program will help thousands of our veterans with disabilities throughout our nation,” said Clayton Shepherd, chief executive officer, Health Careers Foundation. “By adding these honorable veterans to the healthcare industry, they will be able to continue to serve and to make a difference.”

Hire Heroes will identify veterans with disabilities who are seeking career placement services by working with transition centers and VA rehabilitation centers. Each applicant will be qualified and screened to determine career interests, job skills and location preferences. Additionally, Hire Heroes will work with potential employers by contacting interested healthcare companies to identify suitable positions for the veterans. Companies hiring veterans are eligible for a tax credit of $4,800 per hired

hero and are entitled to a tax deduction for donations made to the program. The cost of ongoing operations will be covered by employer donations of $6,000 for each hired hero. Hire Heroes’ goal is to place more than 8,000 heroes in jobs within the healthcare industry in the first three years of operation. The program start date is June 1. Efforts are underway to raise the necessary operating funds to make this program a success.

“Our mission is to be the bridge to the right healthcare career fit for our returning heroes,” said Bayne Tippins, director, Hire Heroes. “Currently, there is a shortage of employees in the healthcare field. Hire Heroes will help to ease this shortage as well as ease the transition from military to civilian life.” The Hire Heroes program was inspired by the experiences of Justin Callahan, who served as a Sergeant in the U.S. Army during Operation Iraqi Freedom and is now a corporate event planner for MedAssets. While undergoing treatment at Walter Reed Army Medical Center, Callahan met John Bardis, chairman, president and CEO of MedAssets, by chance in a hotel lobby. Bardis extended a job offer to Callahan that day, and Justin has been a MedAssets’ employee since he officially retired from the military three years ago. Callahan’s experiences raised awareness and understanding of the challenges veterans with disabilities may face when re-entering and adjusting to the workplace, which led to the creation of Hire Heroes. “This program gives guys a chance to start a new life and really opens paths for them,” Callahan said. “It is more than helping them out with a job. It’s about helping them grow stronger mentally and emotionally to have a more normal life.” To learn more about the Hire Heroes organization, please visit www.hireheroesusa.org, or contact Bayne Tippins, Director, Hire Heroes, 1-866-915-HERO.

 


CDC report highlights growing foodborne illness challenges; E. coli O157, Salmonella, Vibrio cause concern


A report released Thursday by the Centers for Disease Control and Prevention (CDC) shows a leveling of cases for some foodborne infections after a period of decline. For others, incidences of infection which had declined appear to be returning to earlier levels. The findings are from 2006 data reported to the CDC as part of the agency’s Foodborne Diseases Active Surveillance Network (also known as FoodNet). FoodNet monitors foodborne disease and related epidemiologic studies to help health officials better understand the epidemiology of foodborne diseases in the United States.

Camplylobacter, Listeria, Shigella and Yersinia show a sustained decline in incidence compared to baseline data from 1996-1998, but most of the decrease occurred between 1999 and 2002. The FoodNet data showed there continues to be little change in the incidence of Salmonella cases, and progress made in 2003 and 2004 in reducing the number of cases of with E. coli O157 infections has been lost. Vibrio infections, which are often related to the consumption of raw shellfish like oysters, have increased to the highest level since FoodNet began conducting surveillance. The 2006 FoodNet data indicated that the incidence of infections caused by E. coli O157 and Salmonella was similar to 1996-1998 baseline years.

 

The reasons for the lack of decrease in the incidence of infections caused by E. coli O157 and Salmonella are not fully understood. One possible explanation is the development of cases of disease in foods that previously were not associated with these diseases, such as spinach and peanut butter. Previous efforts to decrease the incidence of E. coli O157 in ground beef and Salmonella in eggs have been successful, but contamination of other foods may be the problem now, according to Dr. Robert Tauxe, deputy director of CDC’s Division of Foodborne, Bacterial and Mycotic Diseases.


Consumers can reduce their risk for foodborne illness by following safe food-handling recommendations and by avoiding the consumption of unpasteurized milk, raw or undercooked oysters, raw or undercooked eggs, raw or undercooked ground beef, and undercooked poultry. The risk for foodborne illness can also be decreased by choosing in-shell pasteurized eggs, irradiated ground meat, and high pressure-treated oysters. The report appears in the April 13 Morbidity and Mortality Weekly Report at THIS LINK http://www.cdc.gov/mmwr/. To learn more about FoodNet, see THIS LINK http://www.cdc.gov/foodnet/.

 

 

 


CDC changes recommendations for gonorrhea treatment due to drug resistance; Few treatment options remain


The Centers for Disease Control and Prevention (CDC) no longer recommends antibiotics known as fluoroquinolones (ciprofloxacin, ofloxacin, and levofloxacin) as a treatment for gonorrhea in the United States. This limits the options available to treat gonorrhea, one of the most common sexually transmitted diseases in the U.S. The recommendation was prompted by new data released today in CDC’s Morbidity and Mortality Weekly Report (MMWR) showing that fluoroquinolone-resistant gonorrhea is now widespread in the United States among heterosexuals and men who have sex with men (MSM). The data showed the proportion of drug-resistant cases among heterosexuals rising above the recognized threshold of 5 percent for changing treatment recommendations. CDC had recommended fluoroquinolones no longer be used to treat gonorrhea in MSM when this threshold was crossed in earlier years.


The new data, from CDC’s Gonococcal Isolate Surveillance Project (GISP) in 26 U.S. cities, showed that among heterosexual men, the proportion of gonorrhea cases that were fluoroquinolone-resistant Neisseria gonorrhoeae (QRNG) reached 6.7 percent in the first half of 2006, an 11-fold increase from 0.6 percent in 2001. Recommended options for treating gonorrhea are now limited to a single class of antibiotics known as cephalosporins. Public health officials believe the lack of treatment options underscores the need for accelerated research into new drugs, as well as increased efforts to monitor for emerging drug resistance, especially to cephalosporins. While significant resistance to cephalosporins has not been observed to date, CDC is working with state and local health departments to monitor emerging cephalosporin resistance. CDC is urging health departments to maintain or develop capacity to perform cultures for Neisseria gonorrhoeae and to assess any gonorrhea treatment failures for possible resistance. In addition, CDC is working with the World Health Organization to strengthen international efforts to monitor for the emergence of cephalosporin resistance and with government and industry partners to identify and evaluate promising new drug regimens.


The new CDC analysis shows an increase in the past five years in the overall proportion of gonorrhea cases that are fluoroquinolone-resistant, from less than 1 percent in 2001 to 13.3 percent in the first half of 2006. The analysis also indicated that fluoroquinolone resistance is widespread geographically. Resistant cases were seen across the U.S. in the first half of 2006 (in 25 of the 26 cities in the analysis), and sharp increases occurred from 2004 to 2006 in several cities, including Philadelphia (from 1.2 percent to 26.6 percent of gonorrhea cases) and Miami (from 2.1 percent to 15.3 percent). The analysis showed QRNG continued to rise among MSM; 38 percent of MSM gonorrhea cases were QRNG in the first half of 2006, compared to 1.6 percent in 2001. Within the class of cephalosporins, CDC now recommends ceftriaxone, available as an injection, the preferred treatment for all types of gonorrhea infection. For more information CLICK HERE http://www.cdc.gov/std/gonorrhea/arg/

 


Major genetic study identifies clearest link yet to obesity risk

Scientists have identified the most clear genetic link yet to obesity in the general population as part of a major study of diseases funded by the Wellcome Trust, the UK’s largest medical research charity. People with two copies of a particular gene variant have a 70% higher risk of being obese than those with no copies. Scientists from the Peninsula Medical School, Exeter, and the University of Oxford first identified a genetic link to obesity through a genome-wide study of 2,000 people with type 2 diabetes and 3,000 controls. This study was part of the Wellcome Trust Case Control Consortium, one of the biggest projects ever undertaken to identify the genetic variations that may predispose people to or protect them from major diseases. Through this genome-wide study, the researchers identified a strong association between an increase in BMI and a variation, or “allele”, of the gene FTO. Their findings are published online in the journal Science. The researchers then tested a further 37,000 samples for this gene from Bristol, Dundee and Exeter as well as a number of other regions in the UK and Finland. The study found that people carrying one copy of the FTO allele have a 30% increased risk of being obese compared to a person with no copies. However, a person carrying two copies of the allele has a 70% increased risk of being obese, being on average 3kg heavier than a similar person with no copies. Amongst white Europeans, approximately one in six people carry both copies of the allele.

“As a nation, we are eating more but doing less exercise, and so the average weight is increasing, but within the population some people seem to put on more weight than others,” explains Professor Andrew Hattersley from the Peninsula Medical School. “Our findings suggest a possible answer to someone who might ask ‘I eat the same and do as much exercise as my friend next door, so why am I fatter?’ There is clearly a component to obesity that is genetic.” The researchers currently do not know why people with copies of the FTO allele have an increased BMI and rates of obesity. “Even though we have yet to fully understand the role played by the FTO gene in obesity, our findings are a source of great excitement,” said Professor Mark McCarthy from the University of Oxford. “By identifying this genetic link, it should be possible to improve our understanding of why some people are more obese, with all the associated implications such as increased risk of diabetes and heart disease. New scientific insights will hopefully pave the way for us to explore novel ways of treating this condition.”

“This is an exciting piece of work that illustrates why it was so important to sequence the human genome,” said Dr. Mark Walport, Director of the Wellcome Trust. “Obesity is one of the most challenging problems for public health in the UK. The discovery of a gene that influences the development of obesity in the general population provides a new tool for understanding how some people appear to gain weight more easily than others. This discovery, along with further results expected from the Wellcome Trust Case Control Consortium later this year, will open up a wealth of new avenues to understand and treat common diseases.”  

 


F.D.A. rejects Merck’s new pain medication


A panel of federal drug advisers voted 20 to 1 Thursday to reject an application by Merck to sell its pain pill Arcoxia because of concerns that the drug could cause as many as 30,000 heart attacks annually if widely used. Food and Drug Administration officials were unusually harsh in their criticism of the medicine. “What you’re talking about is a potential public health disaster” if Arcoxia is approved for sale, Dr. David Graham, an F.D.A. safety officer, told the panel. Arcoxia is a sister to Vioxx, which Merck withdrew in 2004 after a study showed that it also increased the risks of heart attacks and strokes. Merck sells Arcoxia in 63 countries, and the company underwrote an extensive safety testing program that involved 34,000 arthritis patients. The studies showed that Arcoxia caused nearly three times as many heart attacks, strokes and deaths as naproxen, a popular pain pill sold as Aleve, but was no more effective in curing pain. Patients taking Arcoxia suffered worrisome increases in blood pressure. A Merck spokeswoman, Kyra Lindemann, said the company was “disappointed in today’s outcome.” “We continue to believe that Arcoxia has the potential to become a valuable treatment option,” Lindemann said, adding that Merck would continue to sell the drug outside the United States. (The New York Times)


 

 

Materials managers invited to attend Healthcare Supplier & Provider Institute meeting for free; New Provider Only session

Materials managers are invited to attend the Third Annual Healthcare Supplier & Provider Institute meeting, to be held April 23-24 in Dallas, TX, at the Gaylord Texan Resort and Hotel. The meeting is free to all providers. New this year is the “Healthcare Provider Only” meeting taking place on the first day, April 23 at 1:00 p.m. This professionally moderated session, with material managers only, will address current strategies, results and lessons learned from each of the participants. Nationally recognized Dr. Gene Schneller, Professor and Director of the Health Sector Supply Chain Initiatives at the W. P. Carey School of Business at Arizona State University, will also participate, presenting and accepting questions regarding his current research. There is limited space available for this free provider only offering, so those interested in participating should contact Harla Adams at 817-842-2331 or hadams@nihcl.com.

By attending the meeting you will have the opportunity to hear from provider executives from Baylor Healthcare System, Community Health Network, Excela Health, Sentara Healthcare, St. David’s, Iowa Health System, North Mississippi Health Services, Northwestern Memorial Hospital and Universal Health Services Inc. You will also hear from executives from Ascent Healthcare Solutions, KCI, GE Healthcare, Owens & Minor, Consorta, MedAssets, Novation and Premier. For more information CLICK HERE http://www.healthcaresupplierinstitute.com/.To register CLICK HERE http://www.healthcaresupplierinstitute.com/html/registration.html.

 

 

Needle guidance now available for Siemens’ new high-density transducer


CIVCO Medical Solutions announces the release of its newest needle guidance system for Siemens, the 17L5 HD. The ergonomic 17L5 HD multi-angle needle guidance system is designed to work in conjunction with biopsy software on Siemens ACUSON Sequoia ultrasound platform to provide detailed imaging of small parts, breast, and subtle pathologies. CIVCO’s needle guidance systems utilize a two-part system consisting of a custom reusable biopsy bracket and a disposable snap-on needle guide. Together, these tools offer physicians reduced technique variability, providing a shorter learning curve and reduced procedure time. This needle guidance system is designed to increase the productivity of ultrasound-guided procedures including tissue biopsy, fluid aspirations and catheter placement. In addition, the single-use design of the Ultra-Pro II needle guide reduces the risk of cross-contamination and increases patient throughput.

The Ultra-Pro II needle guide now incorporates more flexibility and advanced features to increase productivity during ultrasound-guided procedures. The needle guide directs instruments according to on-screen software guidelines and features a larger tab for improved quick-release function, allowing easy detachment of the needle from the transducer. Easy-to-read gauge sizes on the inserts make it simple to identify and alter gauge sizes in a darkened ultrasound suite. The guide now features a larger funnel for instrument insertion and will accept a full range of needle sizes including: 8.5FR, 14-23GA. Multi-angle brackets offer professionals different angles for needle placement. Once the desired angle has been selected, a stainless steel pin locks the angle securely into position. For more information see THIS LINK http://www.civco.com/index.

 


RF Technologies offers free Sensatec bed and chair alarms as part of trade-in program

Healthcare facilities can trade in outdated, unreliable bed and chair alarms and receive a free upgrade to RF Technologies’ Sensatec Fall Management alarms. The offer allows facilities to trade in competitors’ systems for the latest technology in bed and chair alarms. There is no limit to the number of alarm units that may be traded. Whether a facility wants to upgrade one alarm unit for a single bed or 300 new alarm units for an entire facility, the RF Technologies trade-in program can be tailored to meet specific needs. Sensatec Fall Management Solution features: Free Bed & Chair Alarms; Convenient & Flexible Program; Easy-to-Operate Alarms; Simple “Plug & Play” Setup; Volume/Delay Control; Auto-On/Auto-Reset Feature; Low Battery Indication; Nurse Call Integration; and Protective Silicon Enclosure. To receive Sensatec control units at no charge, facilities simply send their current alarms to RF Technologies. The facility will receive new control units at no cost by agreeing to purchase a minimum number of sensor pads over the next 24-month or 36-month period. Facilities interested in the trade-in program should call Dan Mueller, Sensatec Representative, at toll free 1-800-669-9946 ext. 5174 for a no-obligation quote. For more information see THIS LINK http://www.rft.com/


April 12, 2007


More states adopt apology shield to protect doctors

Rheumatoid arthritis drug may help treat type 2 diabetes

Massachusetts offers details on health coverage

 

Medicare provides funding for health insurance counseling in all 50 states

 

Scientists stop genes that help breast cancer to spread

Centers for Medicare and Medicaid Services launches DOQ-IT University

MaineGeneral Health automates business processes with Oracle


More states adopt apology shield to protect doctors

Lawmakers in Rhode Island and eight other states are now considering bills that would allow physicians to apologize and tell their patients, “I’m sorry” when things go wrong without having to fear that their words will be used against them in court. At least 27 other states have already passed similar laws, nearly all of them in the past four years, according to the American Medical Association. The wave of “I’m sorry” laws is part of a movement in the medical industry to encourage doctors to promptly and fully inform patients of errors and, when warranted, to apologize.

Some hospitals say apologies help defuse patient anger and stave off lawsuits. At the same time, many doctors are trained or warned never to admit errors in case a patient sues. Apology laws vary by state. In Arizona, Connecticut, Idaho, Maine and 11 other states, doctors can safely apologize to or commiserate with patients or their families about an undesirable or unexpected outcome, according to the AMA. A law in Vermont exempts only oral statements of regret or apology, not written ones. Illinois gives doctors a 72-hour window to safely apologize after they learn about the cause of a medical mishap. Providence lawyer

Steven Minicucci, who handles malpractice suits, said displays of compassion are rarely useful in building such cases. But an apology and an admission of error could be key evidence. He opposes the Rhode Island legislation. “I like to call it the ‘I’m-sorry-I-killed-your-mother’ bill,” Minicucci said. “If a doctor comes out and says something like that, he shouldn’t be able to immunize himself against statements like that by couching it in an apology.” Boston-based ProMutual Group, which insures 18,000 healthcare clients in the Northeast, warns against apologies that admit guilt. “We encourage physicians to apologize about the outcome, not necessarily for any error that may have occurred,” ProMutual spokeswoman Nina Akerley said. “Apology is not about confession.” (The Associated Press)

 

Rheumatoid arthritis drug may help treat type 2 diabetes

A drug designed to treat juvenile rheumatoid arthritis may also be helpful for managing type 2 diabetes, new research suggests. The study found that daily injections of anakinra led to a drop in long-term levels of glucose in the blood, while they increased in people given a placebo. “We (showed) that a 13-week treatment with anakinra improves glucose regulation and insulin production in people with type 2 diabetes,” said one of the study’s authors, Dr. Marc Donath, an attending physician and a professor of endocrinology and diabetes at University Hospital Zurich in Switzerland. The study is published in the April 12 issue of the New England Journal of Medicine.

Sometimes, beta cells, insulin-producing cells, in the pancreas are destroyed in type 2 diabetes as they are in type 1 diabetes. Through previous research, Donath and his colleagues learned that a substance called interleukin-1 beta was a factor in the demise of these cells in people with type 2 diabetes. The drug anakinra is an interleukin-1-receptor antagonist, which means it can block the action of interleukin-1 beta. To assess whether or not this could have an effect on people with type 2 diabetes, the researchers randomly assigned 36 people to receive a once-daily placebo injection and 34 people to receive once-daily injections of 100 milligrams of anakinra for 13 weeks. After 13 weeks, the glycated hemoglobin levels were 0.46 percent lower in the group that received anakinra. Glycated hemoglobin, also referred to as glycosylated hemoglobin or A1C, is a test that measures the average amount of glucose in the blood for about three months. People without diabetes generally have levels around 5 percent. The higher the level, the greater the risk of diabetes complications, which can include heart disease, nerve damage, kidney failure and loss of vision. “Our study is proof of concept for a mechanism underlying the disease and (may possibly) block its progression,” said Donath, who added, “Interleukin-1 beta may be involved in other complications of the disease, such as arteriosclerosis. Therefore, this therapy may also prevent cardiovascular events. However, this remains to be shown.”

Anakinra was well tolerated by the study participants, and Donath and his colleagues plan on conducting larger, follow-up studies of the medication. “This study points to inflammation as definitely having a role in the (diabetes) story,” said Dr. Stuart Weiss, an endocrinologist at New York University Medical Center, and a clinical assistant professor of medicine at the New York University School of Medicine. But, Weiss said that while this avenue of research is “worth pursuing, I wouldn’t get my hopes up for a clinical application, especially since the drug appears to lose its effectiveness over time.” Additionally, Weiss pointed out that it appeared the drug was more effective in thinner people. “The authors don’t really discuss this, but it’s an interesting finding; it’s not what we’d expect.” (HealthDay News)

 

Massachusetts offers details on health coverage


Massachusetts is poised to become the first state to make it possible for 99 percent of its adults to be covered by health insurance, with an ambitious plan that sets limits for the premiums people would be expected to pay. State officials said that under the plan, they expected that all but about 65,000 of the 328,000 adults who are currently uninsured would be able to get affordable coverage. The proposal sets a sliding scale of affordability standards in which, for example, a single person earning $40,001 a year would be expected to pay no more than 9 percent of income, or about $300 a month, for health insurance; a single person earning $25,000 a year would be expected to pay a much smaller percentage, about 3.3 percent of income, or $70 a month.

 

The plan is expected to be approved by the Commonwealth Health Insurance Connector Authority on Thursday. Jon Kingsdale, the executive director of the authority, the agency set up to administer the plan, said setting the affordability standards “was always the most difficult and innovative element” of the state’s groundbreaking healthcare law, passed a year ago. The law required all residents to get health insurance or face a fine or tax penalty. But from the beginning, there was concern that available health plans might be too expensive for some people, or, that some affordable plans might provide skimpy coverage. Last month, the authority voted to require all plans to have substantial coverage, including prescription drug benefits, which raised further questions about how expensive the insurance would be. “To do this right means we’re walking a tight rope,” Kingsdale said. “We don’t want to be too punitive, we don’t want to put too high a standard of affordability, but we don’t want to let too many people out of a universal requirement. We’ve been putting a lot of stakes in the ground, but this is the center pole that will allow us to put up the tent and get everybody covered.”

 

The plan, if approved Thursday, would still need to be presented at public hearings across the state and face a final vote in June. The proposal would cost the state $13 million more than the $200 million it was planning to spend. This proposal changes premiums and subsidy rates that were established earlier. It would allow about 52,000 more low-income people to qualify for free or cheaper coverage. A person earning up to $15,315, one and half times the federal poverty level, would not have to pay anything under this proposal. Individuals earning $30,630 to $50,001 would not be eligible for state subsidies, but they would not be penalized if they could not find health insurance priced at $150 to $300 a month. People who earn more than $50,001 would not be given a cap on insurance costs. People who claim they cannot afford coverage under the new system could apply for a waiver.

 

The proposal represents a carefully hammered-out compromise. Business groups wanted to make sure that premiums for state-sponsored insurance would not be too much less than the employee contributions to an employer’s plan because they fear that people would flock to the government-sponsored plans, driving up the cost to the state. Advocates for poor people had wanted lower costs for more residents. “It doesn’t go the whole way, but it’s good enough for today,” said John McDonough, executive director of Health Care for All, an advocacy group. Leslie A. Kirwan, the Massachusetts secretary of administration and finance, who is chairwoman of the authority’s board, said the support of advocates like McDonough was earned in part by action by Gov. Deval L. Patrick, who agreed to waive fees that more than 10,000 poor families were paying for their children to be covered by Medicaid. (The New York Times)

 


Medicare provides funding for health insurance counseling in all 50 states  

Medicare will provide funding for health insurance counseling in every state to help beneficiaries get the most from the health program for elderly and disabled persons, the Centers for Medicare & Medicaid Services (CMS) announced. Each state will receive a share of $30 million in grant funds so state agencies can bring personalized assistance to people with Medicare at the local level. Under the State Health Insurance Assistance Programs (SHIPs), CMS provides funding to 54 SHIPs, including all  50 states, and the District of Columbia, Puerto Rico, Guam and the Virgin Islands. SHIPs are a key part of Medicare’s education and outreach efforts to educate beneficiaries about health insurance coverage, including Medigap, Medicare Advantage options, Medicare prescription drug coverage, and long-term care financing. In recent months, they assisted millions of beneficiaries with finding drug plans suited to their individual needs.  

SHIP counselors will continue to provide enrollment assistance to Medicare beneficiaries and offer personalized counseling regarding all of their Medicare benefits, including new preventive health screenings and services. Through counseling, education and outreach, networks of local programs are helping beneficiaries understand and utilize their Medicare benefits. SHIPs are intended to serve beneficiaries who want information, counseling, and assistance beyond what is available through other CMS channels, including 1-800-MEDICARE and www.medicare.gov

To help them succeed, CMS will continue to provide training for SHIP counselors and full access to computer programs and other support tools, such as the Plan Finder tool and Tip Sheets, developed by CMS to help SHIPs with outreach and other functions. SHIP grants are calculated in two parts. The initial grant is distributed as a fixed award of $75,000 ($25,000 to Guam and the Virgin Islands) to each of the applicants. The second portion is a variable sum based on the percentage of nationwide Medicare beneficiaries who live in the state, the proportion of the state’s Medicare beneficiaries to the total state population, and the proportion of the state’s Medicare beneficiary population who live in rural areas. For a complete list of state health insurance counseling programs, see THIS LINK.

 

 

Scientists stop genes that help breast cancer to spread

U.S. scientists have demonstrated a way to stop breast cancer spreading to other parts of the body by either switching off the genes involved or blocking them with drugs. The study is published in the journal Nature. Tumours formed from cancer that has spread or metastased from the primary site to other parts of the body cause 90 percent of cancer deaths. The process of metastasis or cancer spread is still much of a mystery to scientists. They can’t tell the difference between a tumour that won't spread and one that will. And why, when hundreds of tumour cells get into the bloodstream every day, do only a small number of them take up residence in a new site and start multiplying?

Dr. Joan Massagué from the Memorial Sloan-Kettering Cancer Center in New York, has been working in this field for some time. He and his team have been looking at cell regulation and how it helps cancer cells to spread to specific tissues. In 2005, they found a number of genes that help breast cancer to metastase to the lungs. In this new study, they have identified four genes in particular that work together to help cells from the primary site to settle at a new site and grow. The four genes are: EREG, MMP1, MMP2 and COX2. Dr Massagué and his team performed two types of experiments. In one they switched off the genes, and in another they targeted them with drugs. In the first experiment they took human breast cancer cells and switched off all four genes before inserting them into mice. The tumours did not grow, and metastasis to the lungs was greatly reduced. However, when they only silenced the genes individually, the effect was nowhere near as dramatic. 

In the second experiment they used a combination of three drugs to inhibit the action of the genes. Two of the drugs have already been approved for clinical use: cetuximab and celecoxib, while the third, GM6001, is still experimental. The drugs had a similar effect to switching the genes off. And the two approved drugs without the experimental one also stopped the cancer from spreading. In speculating on the results, the team suggested the four genes have to work together to help both tumour growth and spread. They said the genes probably hijack blood vessels and make them feed the tumour instead of healthy cells. Then they help tumour cells get into the bloodstream, penetrate capillary walls in the lungs, become established, and start multiplying. So far Dr. Massagué and his team have been working with mice; they hope to set up trials with humans very soon. Since two of the drugs are already approved for clinical use, this should speed things up. However, other scientists would prefer to wait for the results of human trials before getting too excited. The next stage, said Dr. Massagué, is to find women whose breast cancer relies on these four genes. Then they can test whether the drugs they used with the mice will stop the metastasis to the lungs in humans.  

Many scientists believe that cancer spread starts after the primary tumour has reached maturity. But this research challenges that and suggests that cancer cells start migrating to other sites from the start. And the same genes that drive the growth of the primary tumour also help the cells to move and settle somewhere else. Another potential contribution this study makes is the possibility that these same genes are involved in fuelling metastasis of other cancers, or at least that similar rules are involved. That is the hope expressed by Christoph Klein, who studies metastasis at the University of Regensburg in Germany. While this study sheds valuable light on the mystery of metastasis, there are still areas that puzzle experts. For instance, some patients are diagnosed with metastased tumours without the primary tumour every being found. And nobody knows why different cancers spread to particular tissues, such as why breast cancer travels to lung and bone in particular. (Medical News Today)

 

Centers for Medicare and Medicaid Services launches DOQ-IT University

The Centers for Medicare & Medicaid Services (CMS) announced the national launch of DOQ-IT (Doctor’s Office Quality Information Technology) University, or DOQ-IT U, to support health information technology (HIT) in physicians’ offices. DOQ-IT U is an interactive, Web-based tool designed to provide solo and small-to-medium sized physician practices with the education for successful HIT adoption, including lessons on culture change, vendor selection and operational redesign, along with clinical processes. The nationally available e-learning system is available at no charge.  

DOQ-IT U will provide lessons in assessment, planning and implementation methodologies that will be disease and population specific, incorporating clinical decision support and evidence-based medicine guidelines. This e-learning platform will be utilized to provide physicians with a self-paced curriculum and associated tools, based on adult learning principles, available at their convenience. Additional features, such as surveys, utilization tracking, and Continuing Medical Education/Continuing Education Unit (CME/CEU) offering/issuing capabilities will also be included in the near future. 

The first learning sessions (modules), available now, focus on physician office workflow redesign, culture change, and communication necessary for successful Electronic Health Record (EHR) adoption, implementation of care management, and the incorporation of a strong patient self-management component to clinical care. Disease specific modules, starting with diabetes, will include a patient self-management component, which is critical to successfully managing patients with chronic disease. For more information, see THIS LINK.

 

MaineGeneral Health automates business processes with Oracle

Oracle announced that MaineGeneral Health, the parent corporation of a network of an acute care hospital, physician practices, long-term nursing care, homecare, behavioral health, and assisted living and retirement communities, has recently deployed Oracle’s PeopleSoft Enterprise Financial Management 8.9 to automate and manage business processes, as well as enhance operational efficiency. MaineGeneral Health wanted to automate and consolidate key financial management functions across its three hospitals and eight business units, seeking a stable platform that would expand visibility of critical enterprise data, automate approval workflow, improve reporting functionality and enable e-commerce. The organization selected and implemented PeopleSoft applications for financial management, accounts payable, asset management, project costing, purchasing, inventory management and eprocurement. The system will help the organization improve financial positioning visibility; reduce administrative costs, including payment-processing costs; and improve employee productivity by providing an integrated solution with broad functionality.  

Leveraging PeopleSoft’s cross-module validation capabilities, MaineGeneral Health can integrate and validate data from its materials and accounts payable systems and general ledger and asset systems to improve process efficiency and ensure data accuracy. Further, the solution allows the organization to automate inter-company purchases and allocate expenses to each business, as appropriate. Oracle’s PeopleSoft applications provide MaineGeneral Health with enterprise-wide visibility into financial data and expanded reporting capabilities that will help the organization close financial books much faster. MaineGeneral Health expects to decrease the time needed to close its books from 21 days to 10 days. In addition, by accelerating the payment process, the institution can take advantage of rapid pay discounts, which were difficult to take advantage of with the organization’s legacy system.     

 

 


 

April 11, 2007


Egyptian girl dies of bird flu

 

Medicare proposes revised clinical trial policy

Diabetes may be associated with increased risk of mild cognitive impairment

Diabetes can lead to host of consequences

ACS Report: Progress against cancer at risk; early detection, prevention need more attention  

VHA introduces a new tool to improve capital budgeting efficiency for hospitals

Amerinet signs exclusive agreement with St. Theresa Medical Complex


Egyptian girl dies of bird flu

A 15-year-old Egyptian girl who tested positive for the H5N1 bird flu virus has died in hospital, bringing the number of deaths from the disease in Egypt to 14, the health ministry said on Wednesday. A ministry statement said Marianna Kameel Mikhail, who was admitted to hospital in Cairo on Thursday, died of respiratory failure on Tuesday evening despite being treated with the antiviral Tamiflu and being placed on a respirator. None of her family was found to have bird flu, it added. “This case is the 14th death from 34 cases of bird flu infection since the disease appeared in Egypt in February 2006,” the statement said. Egypt has the highest number of confirmed human bird flu cases outside Asia. (Reuters)

 

 

Medicare proposes revised clinical trial policy

 

The Centers for Medicare & Medicaid Services (CMS) announced its proposed revisions to the Clinical Trial Policy national coverage determination (NCD). Under the Clinical Trial Policy, first developed in September 2000, Medicare pays for certain items and services for Medicare beneficiaries involved in clinical trials. “This new decision will signal our continued support to provide access to services for beneficiaries by facilitating participation in the full range of qualified, scientifically sound research projects,” said CMS Acting Administrator Leslie V. Norwalk, Esq. In developing the revised clinical trial policy, CMS convened the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) on December 13, 2006. The MedCAC proposed several recommendations, subsequently reviewed by a federal panel led by the Agency for Healthcare Research and Quality (AHRQ). In addition to AHRQ, the federal panel included representatives from CMS, FDA, CDC, HRSA and the NIH. Based on the recommendations from the MedCAC and the federal panel, CMS is proposing to revise its Clinical Trial Policy.

 

Highlights of the proposed changes include: Renaming the policy as the Clinical Research Policy; Adding FDA post-approval studies and coverage with evidence development (CED) to studies that would qualify under this policy; Requiring all studies to be registered on the NIH ClinicalTrials.gov website before enrollment begins; Requiring studies to publish their results; Paying for investigational clinical services if they are covered by Medicare outside the trial or required under an CED through the NCD process; and Expanding the “deeming” agencies to all DHHS Agencies, the Veterans Administration, or the Department of Defense.  Deeming agencies are agencies that can “deem” whether a trial has met the general standards outlined in the policy.

The proposed NCD opens a 30-day comment period. CMS will review all the public comments and suggestions received and incorporate them into a final NCD. CMS will publish the final NCD no later than sixty days after the end of the comment period. The revised policy will be effective with the publication of the final NCD. For details see THIS LINK.

 

 

Diabetes may be associated with increased risk of mild cognitive impairment

Individuals with diabetes may have a higher risk of developing mild cognitive impairment, a condition that involves difficulties with thinking and learning and may be an intermediate step toward Alzheimer’s disease, according to a report in the April issue of Archives of Neurology, one of the JAMA/Archives journals. “Among cardiovascular risk factors, type 2 diabetes mellitus has been consistently related to a higher risk of Alzheimer’s disease,” the authors write. Mild cognitive impairment-particularly a type known as amnestic mild cognitive impairment, which affects memory more significantly than non-amnestic mild cognitive impairment-is increasingly recognized as a transitional state between normal functioning and Alzheimer's disease. José A. Luchsinger, M.D., and colleagues at Columbia University Medical Center, NY, studied 918 individuals older than 65 years (average age 75.9) who did not have mild cognitive disorder or dementia when they enrolled between 1992 and 1994.  

At the beginning of the study and again every 18 months through 2003, each participant underwent an in-person interview and standard assessment, which included a medical history, physical and neurological examination, and a battery of neurological tests that measured learning, memory, reason and language skills, among others. Of the participants, 23.9 percent had diabetes, 68.2 percent had hypertension, 33.9 percent had heart disease and 15 percent had had a stroke. During an average of 6.1 years of follow-up, 334 individuals developed mild cognitive impairment, including 160 amnestic cases and 174 non-amnestic cases. Diabetes was related to a significantly higher risk of mild cognitive impairment overall and of amnestic mild cognitive impairment specifically after controlling for other factors that may affect risk, including age, ethnic group, years of education and heart and blood vessel disease. 

“The risk of mild cognitive impairment attributable to diabetes was 8.8 percent for the whole sample, 8.4 percent for African-American persons, 11 percent for Hispanic persons and 4.6 percent for non-Hispanic white persons, reflecting the differences in diabetes prevalence by ethnic group,” the authors write. Diabetes could be related to a higher risk for amnestic mild cognitive impairment by directly affecting the build-up of plaques in the brain, a hallmark characteristic of Alzheimer's disease, the authors note. In addition, cerebrovascular disease-diseases such as stroke that affect the vessels supplying blood to the brain-is related to both diabetes and Alzheimer's disease. “Our results provide further support to the potentially important independent role of diabetes in the pathogenesis of Alzheimer’s disease,” the authors conclude. “Diabetes may also be a risk factor for non-amnestic forms of mild cognitive impairment and cognitive impairment, but our analyses need to be repeated in a larger sample.” 

 

Diabetes can lead to host of consequences

The rate of complications from diabetes is high, says a report, The State of Diabetes Complications in America, being released today by the American Association of Clinical Endocrinologists. It shows that nearly 60% of people with diabetes have at least one of the complications caused by long-term failure to control the high blood-sugar levels tied to the disease. Most of the complications could have been avoided with early diagnosis and aggressive treatment, said Daniel Einhorn of La Jolla, CA, an endocrinologists association board member. High levels of sugar in the blood can damage veins, causing vision loss, kidney disease and loss of circulation to the legs and feet that can result in amputation. Diabetes contributes to stroke and heart disease. Einhorn says studies show that intense, early treatment with improved diet, daily exercise and medications when needed can lower blood-sugar levels and prevent or at least delay complications. But “the report shows we are failing in the primary mission of preventing complications,” he said. “The problem is that people don’t recognize diabetes early enough, so by the time of diagnosis, about half of people with diabetes already have a complication that took years to develop.”  

Based on data from national surveys, the report is the first to combine economic and health data on type 2 diabetes complications, says the endocrinologists association, which prepared it with the Amputee Coalition of America, Mended Hearts, the National Federation of the Blind and the National Kidney Foundation. It estimates the cost of treating complications at $22.9 billion in 2006, said University of Chicago health economist Willard Manning, who contributed to the analysis. He says people with diabetic complications face health costs three times those of non-diabetics and can expect to spend an average $1,600 per year in out-of-pocket expenses for care that averages nearly $10,000 a year, most of it paid by insurance. The report, which was paid for by drug manufacturer GlaxoSmithKline, notes that the prevalence of complications is greater in blacks (about 59%) than whites (about 55%), and highest in Hispanics (about 68%). Einhorn says diabetes, like high blood pressure or high cholesterol, is painless and easy to ignore until it has already caused damage. “There is a huge cost to denial of this disease,” he said. (USA Today)

 

ACS Report: Progress against cancer at risk; early detection, prevention need more attention  

The United States has made great strides against cancer recently, with overall deaths from the disease declining for 2 years in a row. But a new report from the American Cancer Society warns that this progress is threatened by disturbing trends in cancer prevention and early detection efforts. Tobacco control and cancer screening are of particular concern, according to Cancer Prevention and Early Detection Facts & Figures 2007 (CPED), the annual ACS report examining the factors that influence cancer cases and deaths. The ever-expanding waistlines of both adults and children in America are also a serious problem. “Much of the suffering and death from cancer could be prevented by more systematic efforts to reduce tobacco use, improve diet, increase activity levels, and expand the use of established screening tests,” said John R. Seffrin, PhD, national chief executive officer of the American Cancer Society. “But this report shows we may be losing momentum in some key areas that have been critical to our success.” 

Tobacco use is expected to cause some 168,000 cancer deaths this year alone, and overall it’s the single largest preventable cause of disease and death in the US. Smoking causes cancers of the lung, larynx, mouth and throat, esophagus, and bladder, and contributes to several other types of cancer. About 40% of the recent decline in cancer deaths among men is due to declines in their smoking rates over the past 50 years, the report says. Although smoking rates among both youth and adults began dropping in 1997, that decline appears to have stalled. Smoking rates among high school students did not change significantly between 2003 and 2005, the report says. Likewise, adult smoking rates were also basically unchanged from 2004 to 2005. Higher tobacco taxes, restrictions on smoking in public places, counter-advertising, and coverage for quit-smoking programs and services are all effective means of curbing tobacco use. Funding for such programs falls far short of what is needed, the report says. For every $1 spent on tobacco control in the US in 2003, the tobacco industry spent $23 promoting products.  

More money is also needed for cancer screening programs that help people with low incomes or no insurance. Cancer screening tests can find the disease at its earliest stage, when treatments are more likely to be successful. ACS is pressing Congress to boost funding for the National Breast and Cervical Cancer Early Detection Program, run by the US Centers for Disease Control and Prevention. Although this program helps more than 400,000 women get the mammograms and Pap tests they need every year, that’s just 13% of the uninsured and low income women eligible for this lifesaving program. Even women with health insurance are falling behind in their mammograms. The American Cancer Society recommends annual tests for women 40 and older. Yet in 2003, just 55% of women in this group said they’d had a mammogram in the previous year. 

Only around 42% of adults 50 and older have been screened for colorectal cancer in the appropriate time frame. Insurance coverage is a major issue: only 17% of uninsured people have been tested, compared to 44% of those with health insurance. Low colorectal cancer screening rates are a concern because unlike screening for many other cancers, colorectal cancer screening can find colon growths called polyps before they ever become cancerous, preventing the disease entirely.  

About two-thirds of Americans are overweight or obese, and only a fraction get the exercise needed to help stave off weight gain or lose weight. About one-third of US cancer deaths are related to excess weight, poor nutrition, and lack of physical activity, the report notes. Being too heavy is clearly linked with many cancers, including cancer of the breast, colon, endometrium, esophagus, and kidney. The CPED report says community efforts are needed to make our environment more conducive to good food and exercise choices. It calls for limits on junk food marketing in schools, encouraging more nutrition information in restaurants, stronger physical education requirements in schools, and more investment in parks, bike lanes, and sidewalks.  

The report also calls for greater efforts to educate the public about sun safety, staying out of the sun during peak hours, using sunscreen and protective clothing, and keeping to the shade. Getting sunburned can increase the risk of both melanoma and non-melanoma skin cancers.

 

VHA introduces a new tool to improve capital budgeting efficiency for hospitals

The hospital capital budgeting process is often a time-consuming venture that requires department managers to conduct their own research, estimate costs and manually place data into Excel spreadsheets to submit to the hospital’s chief financial officer. To solve this problem, VHA Inc., the national health care alliance, and Attainia Inc., a provider of capital equipment planning systems in healthcare, have co-developed a new Web-based software product to simplify and streamline the capital budgeting process. Budget BuilderSM, developed exclusively for VHA members, automates the budgeting process and helps hospitals identify cost-saving opportunities that previously may have gone unnoticed. “The annual capital budgeting effort is painful for hospitals, which have been forced to develop budgets with inaccurate or out-of-date information using labor-intensive processes,” said Nik Fincher, senior director of capital asset services for VHA. “With Budget Builder, hospitals have fast access to real cost information that will ensure that budgets are more accurate. For example, a hospital with a $10 million overall capital budget can save between $3 million and $3.5 million by using the cost-cutting information contained in Budget Builder.”

Budget Builder provides members with list pricing information for more than 17,000 equipment items and over 1,500 suppliers. It also includes up-to-date pricing that factor in the contract discounts and tiered pricing structures offered through Novation, VHA’s contracting services company. It also links seamlessly with other Attainia’s software products that VHA members may have purchased. VHA member Carolinas Healthcare System, Charlotte, NC, helped pilot the Budget Builder software tool. Michael Rush, director of materials resource management for Carolinas, said the health system wanted to improve the capital budgeting process and fix the current flawed process. “The problem we were facing was buying equipment sporadically and not knowing who and where and when they were being bought. We saw the need to purchase capital equipment in bulk. This is where the reports generated by Budget Builder come into play,” said Rush. Because Budget Builder is Web-based, hospitals do not need to purchase new hardware or install new software.

 

Amerinet signs exclusive agreement with St. Theresa Medical Complex

Amerinet Inc., a national healthcare purchasing organization, announced that St. Theresa Medical Complex, Kenner, LA has chosen Amerinet to serve as its sole-source purchasing organization. Amerinet will negotiate contracts on behalf of St. Theresa Medical Complex, and make available an array of competitively priced, quality products and services provided by industry leaders. This new three-year agreement creates a partnership of shared responsibility to control costs and discover new revenue streams.

The new partnership will focus on total supply spend management and margin enhancement services, including cost reduction, contract evaluation, contract implementation and program coordination at all of the St. Theresa facilities. St. Theresa is a “new” locally owned and operated medical facility currently under construction. When complete, the medical complex will consist of a 42-bed, long-term acute care hospital, a 55-bed rehab hospital, an ambulatory surgery center and a diagnostic radiology center. The care to be delivered is designed specifically for patients who need functional restoration/rehabilitation and medical management services.    

 



April 10, 2007


Women under-treated for ovarian cancer

 

VA takes the lead in paperless care

Statin drugs lower respiratory death risk

Proportion of Americans who are severely obese
rising faster than those who are moderately obese

New Canadian guidelines to address growing obesity epidemic

 

The Council of Supply Chain Executives announces new member
 


Women under-treated for ovarian cancer

Ovarian cancer is one of the most lethal cancers women can get, yet one out of three U.S. patients diagnosed with the disease doesn’t get the full, recommended surgical treatment, a new study finds. “It’s very concerning that we see such a large proportion of women with ovarian cancer not being treated up to what we would consider a minimal standard for surgery,” said the study’s lead author, Dr. Barbara A. Goff, director of the division of gynecologic oncology at the University of Washington, Seattle. Her team published the findings online April 9 in the journal Cancer. According to the American Cancer Society, ovarian cancer is diagnosed in about 24,000 women in the United States each year, and 14,300 die annually from the disease. The cancer typically shows few symptoms until it is diagnosed in its advanced stages. The new study builds on previous research, Goff said. “People [in previous studies] have looked at this on a state-by-state basis. What this study really did was look across a broad geographic area of the U.S. It gave us a good sense of what is happening in our country,” she said. “Minorities, women who live in low-income areas, elderly women [over 70] and those who live in rural areas are significantly less likely to get comprehensive care compared to those women who don’t meet those [criteria],” according to Goff.  

The Seattle team analyzed hospital data from up to nine states for the period between 1999 to 2002, looking at factors associated with comprehensive surgical care. Only 67 percent of the 10,432 women whose cases were reviewed got the recommended comprehensive surgical procedures. A third of women were treated at a hospital that performed fewer than 10 ovarian cancer surgeries a year, not at the high-volume facilities that are considered superior. Almost half received treatment from a surgeon who performed fewer than 10 such procedures a year, not the best scenario for a good outcome. One-fourth got care from a doctor who did only one ovarian cancer surgery annually. Much previous research has found that women who are treated by specialists, in this case gynecologic oncologists, have better survival, and that those who have complete removal of the tumor (which is more often done by a specialist) have better survival.  

An opinion issued by the American College of Obstetricians and Gynecologists in 2002 stressed the importance of referral to a gynecologic oncologist if ovarian cancer is suspected. A U.S. National Institutes of Health consensus panel issued similar recommendations on comprehensive surgery for ovarian cancer more than a decade ago. Another expert said the study confirms the importance of seeing a gynecologic oncologist, as the ACOG opinion recommends. “It matters who does the surgery,” said Dr. Ilana Cass, director of the gynecologic oncology fellowship program at Cedars-Sinai Medical Center, Los Angeles, and a gynecologic oncologist. The new study, she added, has more complete numbers than previous research. The experts’ prime advice for women diagnosed with ovarian cancer or suspected ovarian cancer: Seek out a specialist. The problem, Goff said, is that the diagnosis is usually made at the time of surgery. If ovarian cancer is even suspected, she said, women should seek a referral to a center with a high volume of ovarian cancer surgeries, performed by a specialist. She defines “high volume” as 10 or more such surgeries per year. If a woman cannot find a center that does 10-plus procedures, finding a center and a physician that does at least more than one a year is next-best option. “Those doctors who did 2 to 10 ovarian cancer surgeries were significantly better than those who did only one,” Goff noted. Cass agreed that asking to be referred to a high-volume center and to be seen by a physician who is a gynecologic oncologist are both good steps. (HealthDay News)

 

VA takes the lead in paperless care

Since 1999, the Department of Veterans Affairs’ 155 hospitals, 881 clinics, 135 nursing homes and 45 rehabilitation centers have been linked by a universal medical records network. It allows any authorized person to look at 5.3 million patients’ records, everything from a nurse’s note written during a hospital stay, to the result of a blood test drawn at a clinic visit, to the moving-picture film of a coronary angiogram done in a cardiology lab. The Department of Veterans Affairs is today one of the few health systems, and by far the largest, that is virtually paperless. A study commissioned by the Department of Health and Human Services last fall reported that one-quarter of American physicians use some sort of electronic record-keeping in their practices. But less than 10 percent have systems that store all necessary data, allow electronic ordering of tests and provide clinical reminders. Only 5 percent of the country’s 6,000 hospitals have computerized ordering of drugs and tests, and even fewer have a fully integrated system like the VA’s. Although some people believe making medical records widely available to many practitioners is a threat to privacy, VA officials believe strongly that patient privacy is more secure now than in the era of paper charts. In the past 2 1/2 years, the VA has investigated 20 complaints of security breaches. Seventeen were for patient records accessed by unauthorized people, and three were for release of medical data to third parties without patient consent, VA spokeswoman Jo Schuda said.

In the popular mind, the chief deficit in medical records is legible handwriting. But that doesn’t begin to describe the problem. Many hospitals have multiple paper charts for each patient, one for hospital stays, another for clinic visits and others for specialty services such as physical therapy. Information is passed via carbons, faxes and letters. (Before the VA got its electronic system, only 60 percent of patients’ charts could be found on any given visit.) Looking at X-rays and imaging scans is equally inconvenient and unpredictable, requiring trips to a film library and luck that the right folder can be retrieved. Electronic medical records eliminate those headaches. Searchable computerized databases also allow physicians to examine information collected across time and space. (In the case of the VA, a doctor in Washington can easily find a blood test from a patient treated five years ago at the San Francisco veterans hospital.)  

The ability to detect trends in physiological variables such as serum chemistry, cell counts, blood pressure and even weight is important to good decision-making. But it is often hard to do. Electronic medical records make it easier.  Electronic record systems also bridge one of the more perilous chasms in medicine: the transfer of care when patients leave the hospital. Two years ago, a study of 2,600 patients discharged from university hospitals found that 41 percent had test results pending when they left. One in 10 of those tests eventually proved abnormal enough to warrant action, more testing, a new diagnosis or a change in treatment. However, other research has shown that up to 85 percent of patients visit their primary care doctors, who these days are likely to have had little if any role in their hospital care, before a summary of their last hospitalization arrives. A 2003 study showed that 49 percent of patients suffered at least one medical error in the two months after leaving the hospital, often because the outside doctors didn’t know what was done in the hospital, or what was left to do.
Electronic records are especially helpful in managing prescription drugs. The VA software flags questionable doses and potential interactions. Hospitalized patients have bar codes on their wristbands that are scanned for an identity check each time a pill is dispensed or an injection given. The computer system tells practitioners not only what a patient has been prescribed but what he has actually picked up from the pharmacy.

The VA is now rolling out “My Health e Vet,” a feature that allows patients to create a portal to their own charts, where they can record measurements they take at home; list over-the-counter medicines they use; and offer comments about their health. Electronic records can also improve physician performance. They can warn of things that shouldn’t be done, provide reminders of what should be done and monitor what is done. A study published in 2004 compared the care of VA and non-VA patients in 12 communities, using 348 quality indicators as the yardstick. VA patients scored higher on overall quality, chronic disease care and preventive care. 

Electronic records appear to be money-saving devices, at least in some hands. By one estimate, they could save American medical care $162 billion a year. Many hospital systems, however, balk at the upfront investment, which can range from “a few million to 50 to 60 million dollars,” said Pat Wise, an executive with Healthcare Information and Management Systems Society. The cost of the VA’s electronic medical record, called VistA (for Veterans Information Systems and Technology Architecture), is hard to measure. It was developed over many years by many people, including hundreds of clinicians. However, the software is now free to anyone who wants to get it through the Freedom of Information Act. (Washington Post) To read the original article see THIS LINK.

 

Statin drugs lower respiratory death risk


People who use statin drugs are less likely to die of influenza and chronic bronchitis, according to a study that shows yet another unexpected benefit of the cholesterol-lowering medications. Their study of more than 76,000 people showed that those who had taken statins for at least 90 days had a much lower risk of dying from chronic obstructive pulmonary disease or COPD, the technical name for emphysema and chronic bronchitis. Patients on statins also had a lower risk of dying from influenza or pneumonia, the researchers reported Monday. Statins, which include Pfizer Inc.’s $10 billion-a-year Lipitor, Bristol-Myers Squibb Co.’s Pravachol and Merck and Co. Inc.’s Zocor, are the world’s best-selling drugs, taken by millions to reduce the risk of heart attack.

 

The new study supports a theory proposed last year that statin drugs might help patients with H5N1 avian influenza, which some studies suggest kills by causing an immune system overreaction called a cytokine storm. Floyd Frost of the Lovelace Respiratory Research Institute in Albuquerque, New Mexico, and colleagues analyzed their institute’s database of medical records from several health maintenance organizations. They looked at incidence of influenza and pneumonia and of COPD, and then cross-checked to see which patients were also taking statins. “This study found a dramatically reduced risk of death from COPD among statin users and a significantly reduced risk of death from influenza/pneumonia,” the researchers wrote in their report, published in the journal Chest.

 

“These findings suggest that moderate-dose statin use reduces the risk of influenza/pneumonia death and strongly suggest that statins reduce the risk of COPD death.” In 2006, researchers in Canada reported that statins act against sepsis, a dangerous blood infection, and a 2005 study found the death rate was 64 percent lower in pneumonia patients who had been taking statins. “Even if statins are not able to significantly reduce the risk of death from avian influenza, their use could significantly extend the time between disease onset and death,” they wrote. “This additional survival time could increase the effectiveness of anti-influenza drugs, providing a longer time to reduce mortality risks.” (Reuters)

 

 

Proportion of Americans who are severely obese
rising faster than those who are moderately obese

The proportion of Americans who are severely obese, about 100 pounds or more overweight, increased by 50 percent from 2000 to 2005, twice as fast as the growth seen in moderate obesity, according to a RAND Corporation study issued today. “The proportion of people at the high end of the weight scale continues to increase at a brisk rate despite increased public attention on the risks of obesity and the increased use of drastic weight loss strategies such as bariatric surgery,” said Roland Sturm, author of the report and an economist at RAND, a nonprofit research organization. The findings will be published later this year in the journal Public Health. To be classified as severely obese, a person must have a body mass index of 40 or higher, roughly 100 pounds or more overweight for an average adult man. People with a BMI of 25 to 29 are considered overweight, while a BMI of 30 or more classifies a person as being obese. Sturm found that from 2000 to 2005, the proportion of Americans with a BMI of 30 or more increased by 24 percent, the proportion of people with a BMI of 40 or more increased by 50 percent and the proportion of Americans with a BMI of 50 or more increased by 75 percent. The heaviest groups have been increasing at the fastest rates for the past 20 years.

The RAND Health study found that based on self-reported height and weight, which tends to understate actual BMI, 3 percent of Americans are already severely obese. Since that is the fastest growing group of obese Americans, widely published trends for obesity underestimate the consequences of the obesity epidemic because illness and service use are much higher among severely obese individuals. Among middle-aged adults, people with a BMI over 40 are expected to have health costs that are double those experienced by normal weight peers, while moderate obesity (a BMI of 30-35) is associated with only a 25 percent increase.

The prevalence of severe obesity continues to surge despite a rapid increase in the use of bariatric procedures. The number of bariatric surgeries increased from an estimated 13,000 in 1998 to more than 100,000 in 2003. Experts estimate that as many as 200,000 of the procedures were performed in 2006. “The explosion in the use of bariatric surgery has made no noticeable dent in the trend of morbid obesity,” Sturm said. Sturm said the latest findings challenge a common belief held by physicians that people who are obese are a fixed proportion of the population and are not affected by changes in eating and physical activity patterns in the general population. The study suggests that clinically severe obesity, instead of being a rare pathological condition among genetically vulnerable individuals, is an integral part of the population’s weight distribution. As the whole population becomes heavier, the extreme category, the severely obese, increases the fastest.  

 


New Canadian guidelines to address growing obesity epidemic

The first-ever Canadian Clinical Practice Guidelines (CPG) on the Management and Prevention of Obesity in Adults and Children, published April 10, 2007 in the Canadian Medical Association Journal (CMAJ), recommend that waist circumference be measured in all Canadian adults, and that a national surveillance system be developed that incorporates this measurement along with height and weight. Canada is the first country in the world to produce comprehensive evidence-based guidelines to address the management and prevention of overweight and obesity in adults and children. These are also important guidelines for health professionals and policy-makers to help them address Canada’s increasing prevalence rates. The guidelines were developed by a panel of experts from across Canada, who identified a need for a comprehensive set of clinical guidelines to provide healthcare practitioners with a toolkit to manage and treat overweight and obese patients, as well as those who have a high waist circumference. Furthermore, the panel identified gaps in existing knowledge, and new research requirements needed to help develop a greater understanding of weight and body shape and their link to chronic diseases such as cardiovascular disease and diabetes.

The recommendation for measuring the waist circumference of all adults is the result of the latest research indicating that fat in the abdominal area is linked to an increased risk of cardiovascular disease and diabetes. The guidelines reference the International Diabetes Federation (IDF) cut-off points for waist circumference, given that these measures better reflect the ethnic diversity of Canada. Using IDF criteria, over 50% of Canadians are considered abdominally obese. The guidelines also recommend that: First-line treatment for overweight and obese adults should consist of diet changes and regular exercise, supported by behavior change; if unsuccessful, treatment with medications or bariatric surgery should be considered; Starting at 10 years of age, overweight or obese Canadians should undergo screening that would include tests measuring levels of fasting glucose, HDL (the good) and LDL (the bad) cholesterol, and triglycerides (a form of fat in the blood) levels. Furthermore, they should be monitored at regular intervals; Patients participating in weight management programs should be provided with education and support in behavior modification techniques as an add-on to other lifestyle modifications; Programs to promote healthy, active living and to prevent overweight and obesity should be implemented in schools to reduce the risk of childhood obesity; these include interventions to increase daily physical activity through physical education class-time and opportunities for active recreation; “Screen time” (e.g. television watching, and video or computer games) should be limited to less than two hours per day to encourage increased activity and less food consumption, and to limit exposure to food advertising.

 

The Council of Supply Chain Executives announces new member

The Council of Supply Chain Executives is pleased to announce the participation of Bill Mosser. Mosser serves the Temple University Health System, as Managing Director Supply Chain Services. In this role Mosser serves as the senior executive responsible for the health system’s supply chain strategies and operations. He is the primary architect of the strategies for strategic sourcing, product formulary management, technology assessment and demand pull inventory, all programs being implemented at TUHS. In addition, Mosser oversees the management teams responsible for procurement services, contracting and supplier management, product management, technology management and planning, inventory management and supply distribution services at all health system campuses. Prior to joining Temple, Mosser was President and Lead Consultant for KTM Consulting, LLC a Supply Chain and Information Systems Project Management consulting firm in Bethlehem, PA.
To learn more about the Council’s members see THIS LINK.

The third annual meeting of The Council will be held on November 7-8, 2007 in Nashville, TN. Limited slots are available for suppliers to participate. For more information please contact Hays Waldrop, President and CEO, via email at hays@ihesllc.com or call (615) 794-2501. For more information see THIS LINK.  

  

 



April 9, 2007


FDA provides Web access to information on post-approval device studies


Cairo’s first human bird flu infection confirmed

 

Small steps lead to healthier hearts for women

 

China alters organ transplant laws

 

FDA announces that companies must stop marketing suppository products containing trimethobenzamide

 

FDA licenses first biologic product to prevent Hepatitis B reinfection in liver transplant patients

 

Lehigh Valley Hospital and Health Network selects Patient Care Technology Systems’ automatic OR tracking software

 


FDA provides Web access to information on post-approval device studies

The U.S. Food and Drug Administration (FDA) unveiled a new Web page that will keep the public informed about the status of post-approval patient studies for certain recently approved medical devices. “Electronic access will give the public an opportunity to see progress being made on a company’s post-market commitments,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. Modern devices provide significant health benefits, but experience has shown that the full magnitude of some potential risks doesn’t always emerge during the mandatory clinical trials that are required for approval. FDA sometimes orders post-approval studies to address remaining issues such as the product's performance once it becomes more widely available or is used over a longer period of time. Generally, companies must submit interim post-approval study status reports every six months for the first two years of the study and annually thereafter until the final report has been submitted.

 

FDA’s new Web page includes information on all post-approval device studies ordered by FDA since Jan. 1, 2005. Each listing includes the company’s name, the product’s name, the approval number and date, and describes the study and whether it is meeting its reporting deadlines. No information on clinical data is available because the studies may be ongoing and include personal and confidential information. There are currently more than 40 listings on the Web page. The Institute of Medicine called for public reporting of post-market studies in a 2005 study on pediatric devices. That same year, FDA initiated an internal review of its ability to monitor post-approval studies. As a result, the agency shifted responsibility for tracking these studies from its pre-market staff to its post-market staff and set up a new electronic system for them to do so.

 

FDA is currently implementing an ambitious action plan drawn up last year by a Post-market Device Transformation Leadership Team, a group of experts drawn from both inside and outside of FDA. Their action items included: pursuing the development of a unique identifier system to identify a device and the information associated with that device throughout its lifetime, mandatory use of electronic reporting for required adverse event reports and revising the Center for Devices and Radiological Health's current system of adverse event reporting. The new Web page is available at THIS LINK. For more information on FDA’s post-market action plan consult see THIS LINK.

 


Cairo’s first human bird flu infection confirmed

Authorities in Egypt have confirmed that a girl, 15, is the first human to become infected with the bird flu virus in the capital, Cairo, the 34th human to become infected in the country so far. The patient, Marianna Kameel Mikhail, is from the Shubra district, Cairo. She was hospitalized on April 5th. Doctors say she is in a ‘stable’ condition. According to the Egyptian news agency, MENA, she is being treated with the antiviral medication, Tamiflu. Authorities say she had been in contact with sick birds prior to becoming ill. 13 people have so far died of bird flu in Egypt. (Medical News Today)



Small steps lead to healthier hearts for women

For years, doctors have been fighting the perception that heart disease is a mainly male affliction. But, in fact, cardiovascular disease is the number one killer of both men and women in the United States, according to the National Institutes of Health. Two of every five women who die are taken by heart disease or stroke, more than from all forms of cancer combined. Now, health officials are broadening their push to educate more women about their heart risks. The renewed campaign follows an American Heart Association study, initially done in 1997, that found that only 30 percent of women were aware that heart disease and stroke were their greatest health threats. A follow-up survey released last year found that number had climbed to 55 percent. “The problem I see is that, yes, women are much more knowledgeable, but they aren’t translating that knowledge into action,” said Dr. Jennifer Mieres, director of nuclear cardiology and associate professor of clinical medicine at New York University School of Medicine, and a national spokeswoman for the American Heart Association.

The heart association continues to push its “Go Red for Women” campaign, which includes an online self-survey to evaluate an individual woman’s specific risk factors. “That way, women can increase their thought process about their risk factors,” said Dr. Nieca Goldberg, a cardiologist and associate professor of medicine at New York University, and medical director of the university’s Women's Heart Program. A big part of the problem is that women often don’t experience a heart attack the same way men do. “Women’s symptoms can be more subtle,” Goldberg said. “It can be shortness of breath without any chest pain. Some suddenly feel very exhausted with minimal activity. Pain often is felt lower in the chest and mistaken for a stomach problem.” Because the symptoms are less obvious, women often wait too long to get treatment. “If you look at statistics of women who’ve died suddenly of heart attack, two-thirds died before they could reach the hospital,” Goldberg said.

Heart disease also often takes place in women differently than it does in men, Goldberg added. In men, plaque forms on the walls of blood vessels in specific places, eventually causing a “kink” in the vessel that stops blood flow. To treat it, doctors implant a stent at the point of blockage, which reopens the blood vessel. But as many as 30 percent of women suffer from micro-vascular coronary disease, Goldberg said. The plaque distributes more evenly throughout the blood vessels, slowing blood flow without creating a flow-stopping kink. In those cases, arteries have difficulty dilating during exercise or exertion, causing extreme fatigue in women. “When women go to have an angiogram, there have been situations where doctors don’t see any blockages, even though the patient has symptoms and a bad stress test,” she said. Since there’s no specific blockage, treating micro-vascular coronary disease is much harder. “When doctors go in to look, there are no kinks, so they can’t be stented,” Goldberg said. “Women are given drugs to thin the blood and take care of symptoms, as well as reduce cholesterol levels.”

Since heart disease is often harder to detect and harder to treat in women, prevention is the key to saving most women's lives. Women need to take a hard look at their risk factors, Mieres and Goldberg said. “If they can’t recite their cholesterol levels or blood pressure, they need to schedule a visit with their doctor because that shows those probably haven’t been checked in a while,” Goldberg said. Women also should consider whether or not a relative has had heart disease. There is a genetic risk involved, and family members often share the same lifestyle risks, such as drinking, smoking or eating unhealthy foods. Once that risk is known, women can take steps to improve their health, Mieres said. Mieres recommends taking small steps that lead to big ones, walking 10 minutes a day and increasing that to 30 minutes, or eating an apple for a snack instead of a candy bar. “Doctors want women to realize that simple steps can make a world of difference in terms of your heart health,” said Mieres. (HealthDay News) For more information on the “Go Red for Women” campaign, see THIS LINK.



China alters organ transplant laws

China published new rules governing human organ transplants in its latest effort to clean up a business critics say has little regard for medical ethics. But the regulations were packed with shortcomings, a human rights group said Saturday, including a failure to address what it called the “crucial issue” of the procurement of organs from executed prisoners. The rules issued Friday by China’s State Council, or Cabinet, include a ban on the sale of human organs for profit and on donations by people under 18, according to the text of the regulations published by the Communist Party newspaper People’s Daily. The regulations, which take effect May 1, are also meant to standardize transplant procedures at the limited number of hospitals licensed to perform them.

 

Little information about China’s lucrative transplant business is publicly available. Human rights groups have said many organs, including those transplanted into wealthy foreigners, come from executed prisoners who may not have given their permission. Human Rights Watch urged Beijing for full transparency on the removal of body organs from executed prisoners. Health officials say China faces a severe shortage of human organs, estimating that out of 1.5 million people who need transplants in China each year, only about 10,000 operations are carried out. Voluntary donations remain far below demand in China, partly due to cultural biases against organ removal before burial. (The Associated Press)

 

 


FDA announces that companies must stop marketing suppository products containing trimethobenzamide


As part of the Food and Drug Administration’s (FDA) on-going initiative to ensure that all marketed U.S. drugs have required marketing approval, the agency announced that companies must stop manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride. These products are used to treat nausea and vomiting in adults and children. Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness. These products have been marketed under various names, including Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz. FDA urges consumers who are using suppositories containing trimethobenzamide, and who have questions or concerns, to contact their healthcare provider. There are many alternative products approved to effectively treat nausea and vomiting, and that are available in a variety of forms, including tablets, capsules, solutions, injectables and suppositories. Several oral capsules and injectable products containing trimethobenzamide have been approved by FDA and are not affected by today’s action.


The Federal Register notice which outlines the agency’s order to manufacturers and distributors, also concludes all outstanding issues for drugs containing trimethobenzamide, under the Drug Efficacy Study Implementation program (DESI). Under DESI, FDA evaluated the evidence of effectiveness for thousands of drug products previously approved for safety only, including those products marketed under the name of Tigan containing trimethobenzamide. Because DESI findings apply to any unapproved products that are identical, related, or similar to DESI-reviewed drugs, today’s notice makes the marketing of any unapproved trimethobenzamide hydrochloride suppository products unlawful. Companies manufacturing or marketing trimethobenzamide hydrochloride suppository products must cease shipping them in interstate commerce by May 9, 2007. Any company wishing to market a product containing trimethobenzamide in suppository form must now obtain an approved new drug application prior to marketing. For more information see THIS LINK.

 

 


FDA licenses first biologic product to prevent Hepatitis B reinfection in liver transplant patients


The U.S. Food and Drug Administration (FDA) announced the approval of HepaGam B for the prevention of hepatitis B reinfection in certain liver transplant patients. HepaGam B is the first product of its kind (an immune globulin product) approved for this purpose. Hepatitis B is a serious disease caused by a virus that attacks the liver and can cause lifelong infection, liver cancer, liver failure and death. Liver transplant patients who have already been exposed to the hepatitis B virus (HBV) are at an increased risk of reinfection because they have weakened immune systems. “This approval provides a new treatment option for the reduction of hepatitis B recurrence in liver transplant patients with a prior history of this serious disease,” said Jesse Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research. “It is the first immune globulin product, one of several classes of proteins derived from human plasma, approved for this use.”


HepaGam B works by providing an immediate immune response to the virus. This immunity protects patients previously exposed to HBV. Patients must receive injections at the time of their liver transplant and throughout their lives. This product is manufactured from human plasma collected at U.S. licensed plasma centers from healthy donors. FDA based its approval on the company's clinical data in a study of HBV-infected persons undergoing full liver transplants, which showed a reduction in the virus recurrence rate from 86 percent to about 13 percent. Adverse reactions were similar to other immune globulin products for other indications and included headache and hypertension. In January 2006, FDA licensed HepaGam B to prevent infection with HBV for the following other purposes: after acute exposure to blood or certain body fluids containing HBV; perinatal exposure of infants to mothers previously exposed to HBV; sexual exposure to persons previously exposed to HBV; and household exposure to persons with acute HBV infection. HepaGam B is manufactured by Cangene Corp. of Winnipeg, Canada.

 

 


Lehigh Valley Hospital and Health Network selects Patient Care Technology Systems’ automatic OR tracking software


Patient Care Technology Systems (PCTS) announced that Lehigh Valley Hospital and Health Network (LVHHN) has selected Amelior ORTracker automatic tracking software to improve the efficiency of surgical care throughout its perioperative departments in all three hospitals within LVHHN. The tracking system will encompass patient flow throughout the Surgical Staging Units, the Operating Rooms and Post Anesthesia Care Units. The automatic tracking software provides real-time tracking of patients and mobile medical devices using wireless ultra-wideband badges worn by patients and attached to equipment.
 

In addition to locating and tracking Operating Room resources, the software translates interactions between patients, medical staff and equipment into time-stamped stages of a patient’s course of treatment. This information is continuously updated on an electronic tracking map to inform caregivers of anticipated demand as patients are prepared for surgery and later for recovery. The software organizes and enhances communications between caregivers regarding the status of patients, rooms, and the availability of clinical staff. As a result, phone calls and other manual interventions to manage care progression are reduced resulting in more timely care and a quieter patient environment. Extensive data on patient flow and resource utilization is generated through the software’s reporting engine to assist perioperative departments to further analyze department utilization.    

 

 


 

April 6, 2007


Bird flu kills Indonesian teen, toll at 73 


New urgency in debating healthcare

Statins linked to lower risk of infection; Markedly lower frequency of sepsis in dialysis patients observed

Touro Infirmary selects Broadlane for supply chain services

Criteria for depression are too broad, researchers say

 

Total shoulder replacements as safe as swapping out hips and knees


Research shows Masimo Acoustic Respiratory Monitoring technology provides “significantly more reliable monitoring of respiration rate”

 

Bird flu kills Indonesian teen, toll at 73 

An Indonesian teenager died of bird flu in the bustling capital of Jakarta, bringing the toll in the country hardest hit by the virus to 73, a health ministry official and doctor said Friday. The 15-year-old girl was admitted to the Sulianti Saroso Hospital for Infectious Diseases on Monday and died late Thursday, said Sandakan Giriputro, a doctor at the facility. “By the time she arrived, it was too late,” he said. “She died after experiencing multi-organ failure.” Health Ministry official Muhammad Nadirin confirmed that the girl’s lab tests showed she had contracted the H5N1 virus, apparently after coming into contact with infected pet birds at her home in central Jakarta. Bird flu has killed at least 170 people since it began ravaging Asian poultry stocks in 2003, hitting Indonesia the hardest, according to the World Health Organization. (The Associated Press)

 

 

New urgency in debating healthcare


Since Hillary Rodham Clinton’s effort to overhaul the nation’s medical system was rejected in 1994, most big employers have stayed out of the debate on healthcare reform. But with their medical costs ballooning, top executives of large companies are starting to speak up again, and many are calling for a national approach to fixing healthcare. Few advocate a wholesale shift to government-directed medicine, but most are seeking broad changes in the employer-subsidized health system, which they regard as unsustainable in its current form. Business executives are motivated in large part by health insurance premiums that are rising much faster than inflation, adding to their costs at a time when many are facing more intense competition from abroad, where companies rely on government-supported healthcare systems largely financed by taxes.

 

A 2006 study by the Kaiser Family Foundation and Hewitt Associates found that premiums in the United States had risen about 87 percent since 2000. “Five years from now this problem will have to be cured, or the competitiveness of the United States will be dramatically affected,” said J. Randall MacDonald, senior vice president for human resources at I.B.M. But companies are by no means speaking with one voice. Everybody’s problem, the growing cost of health coverage, can be felt differently depending on the size of a company and whether it has promised health benefits to retirees. Older companies, for example, are more likely to welcome government help on coverage for workers who leave before they are eligible for Medicare and may find they cannot afford insurance. But Silicon Valley technology companies that do not have or need retiree coverage are wary of new taxpayer-financed subsidies.

 

The healthcare debate is heating up as candidates polish their positions for next year’s presidential primaries, and as Democrats in Congress assert their newfound power. In general, employers “are more interested in reform today than at any time since the Clinton effort” in the early 1990s, said Robert S. Galvin, global healthcare and policy director at General Electric, which provides health benefits for 460,000 employees and dependents and 240,000 retirees and dependents. The surge of interest, Galvin said, “is driven by compounding health cost increases at three times the general inflation rate, plus the entrance of Wal-Mart and other retailers” that are beginning to feel the pain of out-of-control increases in costs. Many retailers, with large staffs of low-paid, temporary and part-time workers, would welcome a larger government role. (The New York Times) To read the full article see THIS LINK.  

 

Statins linked to lower risk of infection; Markedly lower frequency of sepsis in dialysis patients observed

Researchers at Johns Hopkins may have discovered an unintended benefit in the drugs millions of Americans take to lower their cholesterol: The medications, all statins, seem to lower the risk of a potentially lethal blood infection known as sepsis in patients on kidney dialysis. The study is published in the current issue of the Journal of the American Medical Association (JAMA). Sepsis is the leading cause of death in non-coronary intensive care units in the United States, according to the U.S. Centers for Disease Control. It also poses serious risk for kidney patients undergoing regular dialysis treatments. The Hopkins researchers cautioned that kidney dialysis patients should not necessarily ask their doctors to put them on statins until more studies are done to verify their findings.

 

Building on earlier, limited studies that suggested risk reduction in animals and some people, Professor of Medicine, Director of the Welch Center and senior author Neil R. Powe, M.D., and his Johns Hopkins team followed 1041 dialysis patients for 10 years, dividing the subjects into those taking statins and those not. “Those taking statins had a 41 in a 1,000 chance of being hospitalized for sepsis, while the other group not taking statins had a 110 out of 1,000 risk. Although the overall absolute risk is relatively small, the statin group’s risk is dramatically lower,” says Rajesh Gupta M.D., the study’s lead author, who was a senior medical resident at Hopkins when the study was conducted.

 

Gupta says it remains unclear why or how statins work this way, “but the consistency of the findings with laboratory studies adds a lot of credence to the idea that statins are doing something substantial to reduce risk.” “Statins are known to have an effect on the body’s immune system, but what that is exactly, and how many statin users it affects, is still not widely understood.”  Statins may regulate the immune response to infection or fight microbes directly, Powe suspects. The study’s authors also suppose that statins may work like penicillin, since the first statin was originally derived from a fungus which, it is theorized, secretes a statin as a way to starve other competing microorganisms that require cholesterol to survive. The study included patients from 81 dialysis clinics across 19 states. Only those enrollees who were admitted to the hospital with sepsis were counted, in order to rule out any subjects who became septic during an unrelated hospital stay. Only 14 percent of those initially enrolled in the study were on statins. Out of the 1,041 patients, there were a total of 303 hospitalizations for sepsis.

 


Touro Infirmary selects Broadlane for supply chain services

Broadlane announced that Touro Infirmary, New Orleans’ only community based, not-for-profit, faith-based hospital, has selected Broadlane to provide an array of supply chain services under an exclusive agreement. Financial terms were not announced. Under the agreement, Broadlane will provide Touro Infirmary with national and local strategic supply chain services for consumable supplies and equipment, pharmaceuticals and purchased services. Touro Infirmary will gain access to Broadlane’s existing portfolio of contracts and, in addition, Broadlane will assist Touro Infirmary in developing custom contracts and in managing various high physician preference item standardization and utilization efforts. Touro Infirmary subsidiaries include Woldenberg Village, Crescent City Physicians, Touro at Home and Metro Lab and the combined annual supply spend is in excess of $50 million. Additionally, Touro Infirmary will fully integrate into Broadlane's technology and e-commerce exchange, BroadLink. BroadLink is for Broadlane clients only and is not owned by suppliers.

 

Criteria for depression are too broad, researchers say

Up to 25 percent of people in whom psychiatrists would currently diagnose depression may only be reacting normally to stressful events such as a divorce or losing a job, according to a new analysis that reexamined how the standard diagnostic criteria are used. The finding could have far-reaching consequences for the diagnosis of depression, the growing use of symptom checklists to identify those who may be depressed, and the $12 billion-a-year U.S. market for antidepressant drugs. Diagnoses are currently made on the basis of a constellation of symptoms that include sadness, fatigue, insomnia and suicidal thoughts. The diagnostic manual used by doctors says that anyone who has at least five such symptoms for as little as two weeks may be clinically depressed. Only in the case of someone grieving over the death of a loved one is it normal for symptoms to last as long as two months, the manual says. The new study, however, found that extended periods of depression-like symptoms are common in people who have been through other life stresses such as a divorce or a natural disaster and that they do not necessarily constitute illness.

The study also suggested that drug treatment may often be inappropriate for people who are experiencing painful, but normal, responses to life’s stresses. Supportive therapy, on the other hand, may be useful, and may keep someone who has been through a divorce or has lost a job from going on to develop full-blown depression. The researchers, including Michael B. First of Columbia University, the editor of the authoritative diagnostic manual, based their findings on a national survey of 8,098 people. They found that those who had experienced a variety of stressful events frequently had prolonged periods in which they reported many symptoms of depression. Only a fraction, however, had severe symptoms that could be classified as clinical depression, the researchers said. An estimated one in six Americans suffer depression at some point in their lives. Under the more limited criteria the researchers urged, that number would be 25 percent lower. “The cost of not looking at context is you think anyone who comes under this diagnosis has a biological disorder, so should more or less automatically get antidepressant medication, and everything else is superfluous,” said lead author Jerome Wakefield, a New York University researcher. (Washington Post)

 

Total shoulder replacements as safe as swapping out hips and knees


Contrary to widespread belief, total surgical replacement of arthritic shoulder joints carries no greater risk of complications than replacement of other major joints, a Johns Hopkins study suggests. In fact, the Johns Hopkins researchers say, their study shows that patients who undergo shoulder arthroplasty to relieve chronic and significant pain can expect significantly fewer complications, much shorter hospital stays and less costs than patients undergoing hip or knee replacement.

 

The Hopkins research team, led by Edward McFarland, M.D., director of the Division of Adult Orthopedics at The Johns Hopkins Hospital, analyzed anonymous patient information provided by the Maryland Health Services Cost Review Commission, the state’s hospital rate-regulator. They looked at all arthroplasties performed in Maryland to alleviate osteoarthritis pain between 1994 and 2001, including details of 15, 414 hip surgeries, 34, 471 knee operations and 625 shoulder procedures. “After looking at how all these patients fared, we concluded that, comparatively, total shoulder surgery is just as safe and effective as other types of arthroplasties,” said McFarland. “Lower numbers of shoulder procedures done both regionally and nationally may indicate that many people live with shoulder pain because they fear that the corrective surgery is too risky or costs more than similar procedures. But we have found that this is just not true.” The findings appeared in an online version of the journal Clinical Orthopedics. According to nationwide 2003 Medicare figures, 6,700 people had shoulder joints replaced that year, compared to 106,887 hip replacements and 199,195 total knee replacements.

 

Patients in the study who had shoulder surgery had far less in-hospital post-surgical complications (7.5 percent) compared with those patients who had their hips and knees replaced (15.5 percent and 14.7 percent, respectively). McFarland's team also determined that the average time a person remained hospitalized after the surgery was lowest for those recovering from shoulder procedures (just 2.42 days for shoulder patients, versus more than four days for both the hip and knee equivalents). Shoulder arthroplasty is also less expensive, according to McFarland. A shoulder replacement's total costs, on average, are $10, 351; whereas hip replacement surgery averages $15, 442, and knee arthroplasty, $14, 674. McFarland says most patients who are candidates for total shoulder replacement surgery are “at the end of their rope” trying to manage chronic pain and disability with drugs. “Ninety-nine percent of the people who have a shoulder replacement for arthritis get pain relief and say that they wish they had done it sooner,” said McFarland. “This study indicates there may be little reason to wait.”

 

 

Research shows Masimo Acoustic Respiratory Monitoring technology provides “significantly more reliable monitoring of respiration rate”

Masimo reported that three new independent studies, including one presented the recent International Anesthesiology Research Society (IARS) Clinical & Scientific Congress in Orlando, concluded that Masimo Acoustic Respiratory Monitoring technology (ARM) is “at least as accurate as capnometry” and “significantly more reliable” for monitoring respiration in spontaneously breathing patients. Respiration is one of the five vital signs, but clinicians have long looked for a continuous and noninvasive method of monitoring respiration that is both clinically accurate, easy to use, and well tolerated by patients. Current methods of respiration monitoring, including impedance pneumography with ECG and end-tidal CO2 with capnometry, each have limitations that make them unreliable in certain clinical situations.

In the study released at the recent IARS, conducted by M. R. Macknet, MD and a team of researchers at Loma Linda University's Department of Anesthesiology, fifteen pediatric PACU patients were monitored with Masimo's ARM technology consisting of an adhesive bioacoustic sensor applied to the patient’s neck and connected to a breathing frequency monitor prototype. In addition, a nasal cannula was placed, secured with tape, and connected to a capnometer. The study showed that “premature cannula dislodgement occurred in 14 patients” in less that 20 minutes, while “in no patient was the bioacoustic sensor dislodged before the end of the stay in the PACU.” “This data shows the relative ease and high incidence of capnometer cannula dislodgement compared to the new bioacoustic sensor,” the researchers commented. “In clinical settings where continuous and reliable monitoring of spontaneous respiration is important, the new bioacoustic sensor provides significantly greater patient connection time, which should lead to significantly more reliable monitoring of respiration rate.”

In two studies released in January at the 2007 Society for Technology in Anesthesiology annual meeting, researchers monitored ten postoperative adult ICU and six pediatric PACU patients in separate studies with Masimo’s ARM technology as well as a nasal cannula connected to a capnometer. They concluded that Masimo’s new bioacoustic respiratory sensor “demonstrates accuracy for respiratory rate monitoring as good as capnometry” and that the device “offers multiple benefits over existing devices and has a potential to improve monitoring in a general care setting.”

Masimo expects to combine its Masimo Rainbow SET Read-Through Motion and Low Perfusion pulse oximetry with Masimo ARM technology as part of a general floor monitoring solution designed to increase patient safety and heed the growing call to find ways reduce unnecessary deaths on general care floors. The combination of these two technologies will give hospitals a continuous and noninvasive way to accurately monitor a patient’s oxygenation and ventilation during patient-controlled analgesia, consistent with the new recommendations from the Anesthesia Patient Safety Foundation (APSF). In addition, the combination of Masimo Rainbow SET pulse oximetry and Masimo ARM should assist hospitals in being compliant with new American Society of Anesthesia (ASA) guidelines for management of patients at risk of obstructive sleep apnea (OSA) by providing an accurate and reliable combination of oxygen saturation and respiration rate monitoring. The technology is currently undergoing additional clinical and engineering testing and is expected to be introduced at Alpha Sites in late 2007.   

 


April 5, 2007


Health system to receive a license from state of Florida to operate a pharmaceutical repackaging facility

 

Study questions exam to detect breast cancer

 

Ibuprofen may boost chance of heart problems in high risk patients with osteoarthritis

Scientists spot mutation linked to birth defects

Effect of hormone therapy on risk of heart disease may vary by age and years since menopause

Medicare announces measure specifications for the Physician Quality Reporting Initiative

Vaccine helps prevent ear infections

 

 

Health system to receive a license from state of Florida to operate a pharmaceutical repackaging facility

Four numbers on a piece of paper may not mean much to you, but for LeeSar the Supply Chain Company for Lee Memorial Health System and Sarasota Memorial Health System (FL) it means a lot. For the past two years LeeSar has been trying to receive a license from the State of Florida Department of Public Health to operate a pharmaceutical repackaging facility. Although the health system would save money repackaging this product from direct bulk shipments, that was not the total reason this license was so important. So when LeeSar received notice that its new repackaging facility had passed inspection and then received its license with its four figured license number the excitement was that we could now free up our pharmacists to work on the patient floors with the doctors and nurses on medication management and by doing so insure the highest quality of patient care to our community. The repackaging operation is now moving into its operational phase and registering all medications it will repackage with the state. For further information you can contact; Bob Simpson, President of LeeSar @ 239-303-3402.

 

Study questions exam to detect breast cancer


A highly promoted and widely used computerized system for examining mammograms is leading to less accuracy, not more, a new study finds. The system, known as computer-aided detection, or CAD, did not find more breast cancer, researchers are reporting today. But it did lead to many more false alarms that resulted in additional testing and biopsies for spots on mammograms that turned out to be harmless. Such detection systems, approved by the Food and Drug Administration in 1998, are sold by several companies, including Hologic of Bedford, MA; iCAD of Nashua, NH; and Kodak. According to the National Cancer Institute, the systems are now being used in about 30 percent of mammography centers. The equipment is expensive, costing $50,000 to $175,000, but Medicare, assuming it would improve the outcome, pays an extra $20 for each mammogram read with it. That made it profitable for large centers to use it. Doctors also worried about lawsuits if they were not using it and missed a cancer. But all along, as more and more mammography centers bought the software, the assumption was that the computer would find cancers that radiologists would miss, saving women’s lives.

The new findings are likely to surprise radiologists, said Dr. Ferris M. Hall, a radiology professor at Harvard Medical School. Dr. Hall wrote an editorial accompanying the paper, which was published today in The New England Journal of Medicine. But executives at the company whose equipment was used in the study, Hologic, said they interpreted the results differently. If there is a suspicious spot on a mammogram, women will want to have a biopsy to rule out invasive cancer, said Robert A. Cascella, the company’s president and chief operating officer. And the study showed that computer-aided detection was finding proportionately more very early precancerous growths. “That’s a valuable finding,” he said. The company has improved its software since the study was conducted, Cascella added.  

The study’s lead author, Dr. Joshua J. Fenton of the University of California, Davis, emphasized that women should continue to have mammograms. But, Dr. Fenton said, they may want to ask if their mammography center uses computer-aided detection. His study, he said, “does raise concerns that technology is causing harm without clear benefit.” New technology, like computer-aided detection, digital mammography, magnetic resonance imaging and ultrasound, can be so sensitive that doctors have trouble deciding which findings are worrisome. The only screening method that has been rigorously evaluated is old-fashioned X-ray film mammograms, but it is likely to be replaced by something, or some combination of things, whose benefits and risks are largely unknown. “We are getting ourselves out on thinner and thinner ice,” said Dr. Suzanne W. Fletcher, an emerita professor of ambulatory care and prevention at Harvard Medical School. “With mammography, we have multiple studies showing what happens to mortality rates if you get this versus if you don’t,” Dr. Fletcher said. “With these newer technologies, we don’t.”  

The new study of computer-aided detection was an analysis of 429,345 mammograms obtained from 1998 to 2002 at 43 mammography centers. During that time, seven of the centers switched to computer-aided detection. That enabled the investigators to compare results with and without computer software to help radiologists find suspicious spots. Computer-aided detection, the researchers wrote, “was associated with significantly higher false positive rates, recall rates, and biopsy rates and with significantly lower overall accuracy.” With computer-aided detection, 31 percent more women were called in for additional tests and 20 percent more had biopsies. (The New York Times) To read the full article see THIS LINK.

 

Ibuprofen may boost chance of heart problems in high risk patients with osteoarthritis

The common painkiller, ibuprofen, may boost the likelihood of heart problems in high risk patients who have osteoarthritis, suggests research published ahead of print in the Annals of the Rheumatic Diseases. Previous studies have suggested that ibuprofen interferes with the effects of aspirin. The research team compared the cardiovascular health over one year of more than 18,000 patients aged over 50 with osteoarthritis. The patients were taking part in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET). They were taking either high dose (400 mg a day) lumiracoxib, a type of drug known as a cyclo-oxygenase (COX-2) inhibitor, or ibuprofen (800 mg three times a day), or naproxen (500 mg twice daily), both of which are traditional non-steroidal anti-inflammatory drugs (NSAIDs). One in 10 were considered to be at high risk of a heart attack or stroke, some of whom also took low dose aspirin (70 to 100 mg a day). Some 623 patients were taking ibuprofen, just over half of whom (57%) were also taking low dose aspirin.

The results showed that there was no difference in the total number of heart attacks and strokes among participants at low risk of cardiovascular disease, irrespective of their drug treatment. But this was not true of those at high risk. High risk patients taking aspirin and ibuprofen were around nine times as likely to have heart attacks and strokes over one year as those on lumiracoxib. This is the first analysis of trial data to show an increased risk for ibuprofen, say the authors.  Among high risk patients not taking aspirin, the rate of heart attacks or strokes was higher for those on the COX -2 inhibitor than it was for those on naproxen, but no higher than for those on ibuprofen. Participants taking ibuprofen also developed congestive heart failure more often than those on the COX inhibitor. Most patients given COX-2 inhibitors and NSAIDs are elderly, and evidence to date suggests that both drug types boost the chances of heart attack and stroke. But the authors say that their findings suggest that ibuprofen interferes with the blood thinning properties of aspirin in patients at high risk of cardiovascular disease.

 

Scientists spot mutation linked to birth defects

Canadian researchers say they have found the first genetic mutation clearly linked to neural tube birth defects such as spina bifida in humans. “We have identified the mutations in a few patients with neural tube defects,” said Philippe Gros, professor of biochemistry at McGill University in Montreal. “There are a total of 10 patients where we found the mutations. It is a very small number, but this is the first time that it has been pinned down.” The gene, designated VANGL1, codes for a protein that enables cells to orient themselves properly during development, Gros explained. A mutation causes cells to lose their orientation, so the tissue in which it is expressed fails to develop properly, causing gaps that leave nerve tissue exposed. Gros’s group first identified the mutation in mice. Now, reporting in the April 5 issue of the New England Journal of Medicine, they say they have found three VANGL1 mutations linked to neural tube defects in children treated at birth defect centers in Italy and France.

”There have been many association studies, some risk factors identified in certain genes, alterations in some genes associated with neural tube defects, but there hasn’t been any clearly causative mutation,” Gros said. “There hasn’t been any situation like this, where you knock out the gene and find a neural defect in the mouse and then find the same thing in humans.” Yet VANGL1 is just one part of a large picture of neural tube defect causation, he said. “It is clearly a multigene situation, where alterations in more than one gene are responsible for the effect,” Gros said. “This is a very important finding that associates defects in this gene with neural tube defects in these specific families,” said Marcy C. Speer, director of the Duke University Center for Human Genetics in Durham, NC.  

As far as medical practice is concerned, “for therapy, we are not sure that it will have a great impact at this time,” Gros said. Scientifically, the discovery is fascinating, because the gene is found throughout the animal world, conserved all the way from flies to humans,” he said. The next step in the McGill research will be to investigate other proteins in which VANGL1 plays a role, to further pin down its mode of action, Gros said. (HealthDay News)

 

Effect of hormone therapy on risk of heart disease may vary by age and years since menopause

Secondary analyses of findings from the Women’s Health Initiative (WHI) suggest that women who begin hormone therapy within 10 years of menopause may have less risk of coronary heart disease (CHD) due to hormone therapy than women farther from menopause. Overall, hormone therapy did not reduce the risk of CHD. However, the farther a woman was from the onset of menopause when she began hormone therapy, the greater her risk of CHD due to hormone therapy appeared to be. Although these findings did not meet statistical significance, they suggest that the health consequences of hormone therapy may vary by time from menopause.

These findings are consistent with the primary publications from the WHI trials of estrogen plus progestin and estrogen-alone (total of 27,347 participants) in showing no overall benefit for CHD, and in suggesting that risk due to hormones may differ depending on age or years since menopause. “Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause,” will be published in the April 4 issue of the Journal of the American Medical Association. In a secondary analysis, scientists reanalyze previously collected data and findings in an effort to clarify or ask new questions. In the case of this latest WHI analysis, the authors combined the data from the two trials to explore in more detail the previously observed trends in hormone effects by distance from the menopause. Differences in hormone therapy effects were examined in three age categories (50 to 59, 60 to 69, and 70 to 79) or in years since the onset of menopause (less than 10, 10 to 19, and 20 or more). The Women’s Health Initiative and the newly published analyses are funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health.

The analyses also suggest that the increased risk in heart disease due to hormone therapy in older women is primarily in those who also have hot flashes and night sweats. Study participants who had these symptoms were more likely to have risk factors for CHD such as high blood pressure or high blood cholesterol, but it was not clear whether this explained their higher risk on hormone therapy. Other results from the analyses of the combined trials include: Confirmation that hormone therapy increases the risk of stroke and this risk does not appear to be influenced by age or time since menopause; Even in women within 10 years of menopause, there appears to be an increased risk of breast cancer in women taking estrogen with a progestin; There was a trend (not statistically significant) towards reduced risk for death associated with hormone use in younger compared to older women.

 

Medicare announces measure specifications for the Physician Quality Reporting Initiative  

The Centers for Medicare and Medicaid Services (CMS) announced the posting of detailed specifications for the 74 measures included in the 2007 Physician Quality Reporting Initiative (PQRI). PQRI establishes a financial incentive for physicians and other health practitioners to participate in a voluntary quality reporting program. Eligible professionals who successfully report data for a designated set of quality measures may earn a bonus payment, subject to a cap, of 1.5 percent of total allowed charges for covered Medicare physician fee schedule services provided during the reporting period of July 1, 2007 to December 31, 2007.  

The 2007 PQRI quality measures relate to important processes of care that are linked to improved healthcare quality outcomes. They are evidence- and consensus-based measures that reflect the work of national organizations involved in quality measure development, consensus endorsement, and adoption. The specifications have been posted well in advance of the statutory deadline of July 1, 2007. This is to help eligible professionals to identify measures applicable to their practices and to prepare for submission of quality data in advance of the July 1, 2007 start date of the program. CMS anticipates a small number of additional specification changes, which may expand the applicability of the measures to additional eligible professionals. The PQRI measures apply to services that eligible professionals provide to Medicare beneficiaries in their offices and other settings. CMS is implementing an extensive outreach and education plan to assist eligible professionals to understand the program and the measures and to implement processes to efficiently capture the quality data that is to be reported under the PQRI program. The measure specifications document and other programmatic information are available at THIS LINK

 

Vaccine helps prevent ear infections     

 

A new study found that the pneumococcal conjugate vaccine (PCV7) moderately lowered the incidence of middle ear infections and reduced the need for pressure-equalizing ear tubes, a common surgical treatment for recurrent infections. “Children prone to recurrent ear infections benefit from the vaccine,” said lead study author Katherine A. Poehling, an assistant professor of pediatrics at Monroe Carrell Jr. Children’s Hospital at Vanderbilt University in Nashville, TN. But do not expect this scourge of childhood, which affects more than 80 percent of children under age three and costs $5 billion to treat each year, to go the way of whooping cough anytime soon. The reason: PCV7 prevents only a fraction of the infections that cause it.

According to the Centers for Disease Control and Prevention (CDC), the vaccine combats the seven most common strains of pneumococcal bacteria behind otitis media (middle ear infection). But pneumococcal bacteria cause only 30 to 55 percent of such infections; other classes of bacteria cause the rest. The PCV7 vaccine has been part of the routine immunization schedule for infants in the U.S. since 2000. It was developed to prevent meningitis, invasive pneumonia and other potentially deadly diseases. It is given to infants in four doses: at two, four, six and 12 to 15 months. The findings, published in the April issue of Pediatrics are the first to document the long-term effects of the vaccine on middle ear infections. Study co-author J. Pekka Nuorti, a medical epidemiologist at the CDC’s National Center for Immunization and Respiratory Diseases, estimates that the PCV7 vaccine prevents two million cases of otitis media in children under two years of age in the U.S. annually.

”Studies show that the number of middle ear infections caused by the pneumococcus serotypes in the vaccine have declined dramatically, but others have increased by 30 percent,” Nuorti said. Bacteria on the rise may be filling the ecological void left by the decline in the vaccine’s seven pneumococcus strains. But, he adds, two vaccines in the pipeline would cover more pneumococcal strains, including those whose rates of occurrence are escalating. “Parents shouldn’t think that just because their kids are getting vaccinated that they won’t get otitis media,” said Richard Rosenfeld, director of otolaryngology at Long Island College Hospital in New York City. “Seventy percent to 80 percent of the tendency to get otitis media is genetic. Beyond that are a host of factors, including smoking in the household, attending day care and breast-feeding for the first three months of life…. The vaccine alters that equation, but the effect isn’t dramatic.” (Scientific American)
 

 


April 4, 2007

WHO proposes global agenda on transplantation

States revising organ-donation law; critics fear measure may not go far enough to protect donors

$500 million pledged to fight childhood obesity

RFID Resource Center launched; Service provides knowledgebase for healthcare supply chain

HIBCC & Partners HealthCare collaborate on patient safety standard

10 charged in $5 million Medicare fraud

Study suggests some drug resistance to influenza B medications

Amerinet announces agreement with Skytron for medical supplies


WHO proposes global agenda on transplantation

This week, at the second Global Consultation on Transplantation the World Health Organization (WHO) presented countries and other stakeholders with a blueprint for updated global guiding principles on cell, tissue and organ donation and transplantation. Those principles aim to address a number of problems: the global shortage of human materials, particularly organs, for transplantation; the growing phenomenon of ‘transplant tourism’ partly caused by that shortage; quality, safety and efficacy issues related to transplantation procedures; traceability and accountability of human materials crossing borders. Stakeholders agreed to the creation of a Global Forum on Transplantation to be spearheaded by WHO, to assist and support developing countries initiating transplantation programs and to work towards a unified global coding system for cells, tissues and organs.

A central theme of the discussions was WHO’s concern over increasing cases of commercial exploitation of human materials. “Non-existent or lax laws on organ donation and transplantation encourage commercialism and transplant tourism,” said Dr. Luc Noel, in charge of transplantation at WHO. “If all countries agree on a common approach, and stop commercial exploitation, then access will be more equitable and we will have fewer health tragedies.” Recent estimates communicated to WHO by 98 countries show that the most sought after organ is the kidney. Sixty-six thousand kidneys were transplanted in 2005 representing a mere 10% of the estimated need. In the same year, 21,000 livers and 6,000 hearts were transplanted. Both kidney and liver transplants are on the rise but demand is also increasing and remains unmatched. Reports on ‘transplant tourism’ show that it makes up an estimated 10% of global transplantation practices. The phenomenon has been increasing since the mid-1990's, coinciding with greater acceptance of the therapeutic benefits of transplantation and with progress in the efficacy of the medicines, immuno-suppressants, used to prevent the body’s rejection of a transplanted organ.

The principles put forward by WHO underscore that the person, whether recipient of an organ or a donor, must be the main concern both as patient and as human being; that commercial exploitation of organs denies equitable access and can be harmful to both donors and recipients; that organ donation from live donors poses numerous health risks which can be avoided by promoting donation from deceased donors; and that quality, safety, efficacy and transparency are essential if society is to reap the benefits transplantation can offer as a therapy. “Live donations are not without risk, whether the organ is paid for or not. The donor must receive proper medical follow-up but this is often lacking when he or she is seen as a means to making a profit,” added Dr. Noel. “Donations from deceased persons eliminate the problem of donor safety and can help reduce organ trafficking.” WHO action on transplantation will be aided by a global observatory set up in Madrid under the auspices of the Government of Spain. The observatory, which is linked to the WHO Global Knowledge Base, will provide an interface for health authorities and the general public to access data on donation and transplantation practices, legal frameworks and obstacles to equitable access.

 

States revising organ-donation law; critics fear measure may not go far enough to protect donors

State legislatures are rewriting legislation governing organ donations in one of the most ambitious initiatives in at least 20 years to alleviate the chronic shortage of kidneys, livers and other body parts, an effort that some doctors and ethicists fear tilts too far toward allowing organs to be taken. Virginia, Idaho, Utah and South Dakota have already adopted a model law designed to make organ donation easier by clarifying a host of sensitive questions. An especially tricky one is how to handle unconscious patients who signed donor cards but also specified that they did not want to kept alive on life-support. Another one is what doctors should do when the family of a dying person who agreed to be a donor objects to surgeons taking their loved one’s organs. 

The measure awaits the signatures of the governors of Arkansas, Indiana, Iowa and New Mexico. At least 17 other states, plus the District and the U.S. Virgin Islands, are considering the legislation. Supporters hope it is adopted nationwide. While praised by transplant advocates, the model law has stirred concern among some doctors and bioethicists. Critics say it could result in people becoming donors or kept on life support against their or their family’s wishes. And some worry that the measure could make doctors more hesitant about administering morphine and other drugs to make dying patients comfortable, for fear of rendering their organs useless for transplantation. The revised model law is the latest in a series of initiatives by transplant advocates to boost the number of organs available for the more than 95,000 Americans on waiting lists. Organ banks have also been aggressively promoting a controversial practice that allows surgeons to take organs from patients who are not brain dead, more than doubling the number of such donations in the past three years. “There are lots of efforts to bridge the growing gap between demand and supply,” said Arthur L. Caplan, a University of Pennsylvania bioethicist. “We have to be very careful that we don’t make people think that we don’t have their best interests in mind and are just going to use them to get their body parts.”  

The model law, the Revised Uniform Anatomical Gift Act, updates 1968 legislation adopted by every state to make organ donation procedures uniform nationwide. Among many changes, the measure expands the list of people who can consent to an unconscious patient becoming a donor, and makes it clear that a person’s decision to be an organ donor cannot be revoked by anyone else. The most controversial section deals with unconscious patients who have signed donor cards but also “living wills” or other documents that state that they do not want a ventilator or other medical care to keep them alive, which is sometimes necessary to maintain organ viability until a transplant can take place. Under the act, the donor card trumps the living will, which triggered objections from some bioethicists and doctors who care for critically ill patients. In response, the commission sent states substitute language that calls for family members or others to be consulted in such situations to try to determine what the donor would have wanted. Those states that have approved the law already, however, will have to wait until next year to amend it.  

The measure aims to establish more computerized registries of people who have agreed to be donors but makes no similar provision for those who do not want to be donors. It also gives organ procurement organizations the power to keep potential donors on life-support while they evaluate their organs’ suitability for transplantation. “If there’s a patient requiring palliative or comfort care, you treat them first. That’s clear. This doesn’t change that balance,” said Christina W. Strong, who represented the Association of Organ Procurement Organizations. “What it does is make sure that to free up an ICU bed a hospital doesn’t forget the patient may have wanted to be a donor or their family may want them to be a donor.” (Washington Post)



$500 million pledged to fight childhood obesity

The Robert Wood Johnson Foundation plans to spend more than $500 million over the next five years to reverse the increase in childhood obesity. It is one of the largest public health initiatives ever tried by a private philanthropy. “This is an epidemic that is going to cost the country in terms of morbidity and mortality and economically,” said Dr. Risa Lavizzo-Mourey, the foundation’s president and chief executive. “The younger generation is going to live sicker and die younger than their parents because of obesity.” The foundation estimates that roughly 25 million children 17 and under are obese or overweight, nearly a third of the 74 million in that age group, according to Census Bureau data and a 2006 study published in The Journal of the American Medical Association. Many of those children are poor and live in neighborhoods where outdoor play is unsafe and access to fresh fruits and vegetables is limited. “In many cases, the environment makes it almost impossible for them to choose healthy lifestyles,” Dr. Lavizzo-Mourey said. “We’re going to try to change that.”
 

The foundation plans to invest in programs to improve access to healthy food, encourage the development of safe play spaces, increase research to enhance understanding of obesity and prod governments into adopting policies to address the problem, among other things. Experts on childhood obesity welcomed the foundation’s plans. “Government grants for biomedical research in general, including obesity research, are being funded at the lowest levels I’ve seen in my career,” said Dr. David Ludwig, director of the Optimal Weight for Life Clinic at Children’s Hospital Boston and author of a new book, “Ending the Food Fight.” “So we are especially dependent on philanthropic support.” Philanthropy has long fueled improvements in health, from John D. Rockefeller, whose money produced a yellow fever vaccine, to Bill and Melinda Gates, who are underwriting new health technologies and vaccines to address a variety of global problems.  

Robert Wood Johnson, who built Johnson & Johnson into one of the world’s largest health and medical care products companies, established his foundation at his death in 1968 with 10,204,377 shares of the company’s stock. He committed it to improving the health of Americans. Over the last few years, the foundation has pledged $80 million to childhood obesity programs, like grants to the Food Trust to persuade supermarket operators to return to poor neighborhoods. Its new effort intends to capitalize on and enhance efforts by the food industry and school districts and governments to address the problem, Dr. Lavizzo-Mourey said. Several snack food producers are making changes in their packaging and ingredients, and three soft-drink companies said they would no longer supply sweetened drinks to school cafeterias and vending machines. Several states have mandated changes in school menus, increased physical education requirements and begun reporting students’ body mass index scores to parents. (The New York Times)

 

RFID Resource Center launched; Service provides knowledgebase for healthcare supply chain


The Health Industry Business Communications Council (HIBCC) has announced the launch of its new RFID Resource Center. The Center provides information for the healthcare industry as it considers the emerging role of radio frequency identification technology, and is accessible to the public from the organization’s web site. Included in the RFID Resource Center: “RFID & HIBC: A Guideline to Implementation,” detailing the requirements for utilizing the HIBC Supplier Labeling Standard with RFID technology; “Understanding RFID in Healthcare: Benefits, Limitations and Recommendations”, a comprehensive and practical guide to RFID technology, its potential in healthcare and the cost implications of implementation; articles and announcements from other industries regarding trends in RFID. The RFID Resource Center can be accessed from the home page of the HIBCC Web site at THIS LINK.

 

HIBCC & Partners HealthCare collaborate on patient safety standard

The Health Industry Business Communications Council (HIBCC) and Partners HealthCare System have announced their joint development of a data standard to enhance providers’ patient safety systems. The standard, entitled, “Positive Identification for Patient Safety; Part 1: Medication Delivery” defines the processes and technologies involved with safe medication administration and management. The new standard is being developed from work initiated by Massachusetts General Hospital (MGH), a hospital within the Partners HealthCare System. In 2004 MGH embarked on a project to define and develop a safer system for the administration of medication to its patients. The success of their efforts led the organization to seek formal standardization of their processes, in order that they could be easily and uniformly implemented by other providers. HIBCC, an ANSI-accredited standards development organization (SDO), will administer the process to formally develop an approved data standard.

 

10 charged in $5 million Medicare fraud

Ten persons were indicted in federal court Tuesday, accused of bilking Medicare out of more than $5 million for fraudulent claims for durable medical equipment and treatments in expensive infusion therapies intended for AIDS and HIV patients. Raul Rodriguez and Armando Arias were accused of committing fraud using Coral Way Professional Services and Sunshine Health Center of Miami, as well as R&J Medical Services and N.R. Medical Services, both located in Miami-Dade County. The infusion therapy schemes have been widespread. According to a governor’s office report, Florida has far fewer AIDS/HIV cases than California or New York, but Florida providers submitted claims for AIDS/HIV cases that were more than three times the claims from California and five times more than from New York, according to the report. The clinics and their operators have been difficult for investigators to track down because they often switch names, owners and locations, closing quickly as investigators approach.

Tuesday’s indictment showed what investigators call a typical pattern, in which Medicare patients were given kickbacks to indicate they were given treatment at the clinics. Besides Rodriguez and Arias, those indicted were Carlos Enrique Monteagudo, Alain Rhaf Vega, Marisol Gonzalez Torres, Edith Balog, Leonel Galdos Jr., William Balladares, Yulen Arderi and Jannette Morales. Balog was accused of being the owner of record of R&J from November 2002 to August 2004. Torres was office manager and patient recruiter at Coral Way from October 2004 through March 2005, when the clinic closed. The indictment charges that the accused received about $2.5 million in fraudulent durable medical equipment claims and $3.2 million for false billing of infusion therapies. Prosecutors alleged that a medical assistant was told to tamper with blood samples to justify the HIV/AIDS therapies and to inject patients with a salt solution rather than medications. Rodriguez, Arias, Monteagudo, Vega, Galdos and Balladares were also accused of money laundering in alleged attempts to hide the money from federal authorities. Rodriguez and Arias were also charged with witness tampering in alleged attempts to bribe persons to get them to lie to investigators and a grand jury. (Miami Herald)

 

Study suggests some drug resistance to influenza B medications

Use of certain common antiviral drugs during a recent influenza B epidemic in Japan showed the development of viruses with partial resistance to the drugs, according to a study in the April 4 issue of JAMA. Two antiviral drugs, zanamivir and oseltamivir, which are a type of drugs known as neuraminidase inhibitors, have been effective against influenza and are used extensively. There has been documented evidence of the emergence of oseltamivir-resistant type A viruses, but similar information on influenza B viruses has been limited. Influenza B viruses are associated with annual outbreaks of illness and increased death rates worldwide, according to the article.

Shuji Hatakeyama, M.D., Ph.D., of the University of Tokyo, Japan, and colleagues examined the prevalence and transmissibility of influenza B viruses with reduced sensitivity to neuraminidase inhibitors in Japan, where zanamivir and oseltamivir are now used more extensively than anywhere else in the world. In the winter of 2004-2005, an influenza B virus caused a widespread epidemic in Japan, creating an opportunity to assess the effectiveness of neuraminidase inhibitors. The researchers identified a variant with reduced drug sensitivity in one (1.4 percent) of the 74 children who had received oseltamivir, and seven (1.7 percent) of the 422 influenza B viruses isolated from untreated patients were found to have reduced sensitivity to zanamivir, oseltamivir, or both. Review of the clinical and viral genetic information available on these seven patients indicated that four were likely infected in a community setting, while the remaining three were probably infected through contact with siblings shedding the mutant viruses. “Continued surveillance for the emergence or spread of neuraminidase inhibitor–resistant influenza viruses is critically important,” the authors write. “Further evaluation of the biological properties of neuraminidase inhibitor–resistant influenza viruses is needed to fully assess their pathogenicity in humans.”

In an accompanying editorial, Anne Moscona, M.D., of Weill Medical College of Cornell University, New York, and Jennifer McKimm-Breschkin, Ph.D., of Molecular and Health Technologies, Parkville, South Victoria, Australia, comment, “The report by Hatakeyama et al raises more questions than it answers, including questions about viral evolution, biological fitness, and transmissibility. But some facts are strikingly clear. Influenza B mutants with reduced sensitivity to neuraminidase inhibitors are circulating, and these viruses can cause infections with no difference in duration of symptoms, level of viral shedding, or clinical outcome. Contrary to what had been hoped until now, some resistant variants are vigorous pathogens. Whether these viruses arise by spontaneous mutation or through drug selection, or whether they are transmitted within families or acquired from the community, the resistant variants may be here to stay. In light of the recent observation that oseltamivir may be less effective against influenza B than against influenza A, an important concern is whether suboptimal dosing for these viruses will lead to increased selection of viruses with high-level resistance.”

“Influenza viruses evolve rapidly and nimbly, which compels ongoing investigation of antiviral therapies that use alternative mechanisms of action and target different points in the viral life cycle. The emergence of drug-resistant influenza B should draw attention to the importance of continual monitoring of strains over time and to the need for frequent rethinking of policies for use of antiviral drugs. While the news about resistance is not good and certainly calls into question some of the current assumptions about drug-resistant viruses, an effective response to this news can help contend with the new challenges of influenza.”

 

Amerinet announces agreement with Skytron for medical supplies

Amerinet announces its agreement with Skytron, Division of the KMW Group for medical supplies. Effective through March 31, 2010, this agreement includes Skytron’s patient examination and procedure lighting. Skytron products include: portable, fixed and recessed lighting that is ideal for any size and type of health care facility. This contract was a result of a competitive bidding process. For more information see THIS LINK

 

 


 

April 3, 2007


HealthGrades patient-safety study shows hospital errors rise 3 percent

 

Mammograms for women in their 40s should be based on individual

 

AHRMM & Arizona State University Partner on Healthcare Supply Chain Benchmarking Initiative

 

Is it the flu? Get the fast flu test

 

Medicare announces competitive acquisition program for certain DME, prosthetics, orthotics, and supplies

NIAID expands capability for influenza research and surveillance

Family members most often source of whooping cough in young infants

 


HealthGrades patient-safety study shows hospital errors rise 3 percent


Patient safety incidents at the nation’s hospitals rose three percent over the years 2003 to 2005, but the nation’s top-performing hospitals had a 40 percent lower rate of medical errors when compared with the poorest-performing hospitals, according to the largest annual study of patient-safety issued by HealthGrades, the leading independent healthcare ratings company.
 

The HealthGrades study of 40.56 million Medicare hospitalization records over the years 2003 to 2005 found: Patient-safety incidents continue to rise in American hospitals, with 1.16 million preventable patient-safety incidents occurring over the three years studied among Medicare patients in the nation’s hospitals, an incidence rate of 2.86 percent; 247,662 deaths were potentially preventable over the three years, and Medicare patients who had one or more patient-safety incidents had a one-in-four chance of dying; The excess cost to hospitals was $8.6 billion over three years, with some of the most common incidents proving to be the most costly; Ten of the 16 patient-safety incidents tracked worsened from 2003 to 2005, by an average of almost 12 percent, while seven incidents improved, on average, by six percent. Patient-safety incidents with the greatest increase in incident rates were post operative sepsis (34.28 percent), post-operative respiratory failure (18.70 percent) and selected infections due to medical care (12.23 percent); and Patient-safety incidents with the highest incidence rates were decubitus ulcer, failure to rescue and post-operative respiratory failure.

Of the nearly 5,000 hospitals studied, the HealthGrades study identified 242 hospitals, those in the top five percent of all hospitals, to serve as a benchmark against which other hospitals can be evaluated, naming them Distinguished Hospitals for Patient Safety. On average, these hospitals had a 40 percent lower rate of patient-safety incidents when compared with the poorest-performing hospitals. If all hospitals performed at the level of the Distinguished Hospitals for Patient Safety, the study found: Approximately 206,286 patient-safety incidents and 34,393 Medicare deaths could have been avoided; and $1.74 billion could have been saved.

To be ranked in overall patient-safety performance, hospitals had to be rated in at least 19 of the 28 procedures and diagnoses rated by HealthGrades and have a current overall HealthGrades star rating of at least 2.5 out of 5.0. The final ranking set included 752 teaching hospitals and 857 non-teaching hospitals. The top 15 percent, or 242 hospitals, were identified as Distinguished Hospitals for Patient Safety, and represent less than five percent of all U.S. hospitals examined in the study. The study says, “Despite the flurry of research, publications and process improvement activity that has occurred since the IOM report there is a growing consensus that not much progress has been made leading to a visible national impact. Our findings support this consensus. However, our findings also support that progress continues to be made at the top. Distinguished Hospitals for Patient Safety continue to lead the nation in providing safer care…resulting in much lower costs to society. We believe that Distinguished Hospitals have deliberately chosen and maintained patient safety as a top priority.” For more information CLICK HERE.

 



Mammograms for women in their 40s should be based on individual


Should all women in their 40s be routinely screened for breast cancer? Not necessarily, according to the American College of Physicians. In a new set of guidelines for clinicians of 40-something patients, the group recommends that mammography screening decisions be made on a case-by-case basis. It advises clinicians to discuss the benefits and harms of screening with the patient, as well as each woman’s individual cancer risk and preference about screening. The organization based its recommendations, which will be published in the April 3 issue of Annals of Internal Medicine, on a rigorous review of evidence showing there is variation in the benefits and harms associated with mammography among women in their 40s. The American College of Physicians is the leading professional organization for internal medicine specialists, with a membership of 120,000.

“There are important benefits to screening mammography, but we believe the decision to be screened should be based on an informed conversation between a patient and her physician,” said health policy expert Douglas K. Owens, MD, MS, a researcher with the Veterans Affairs Palo Alto Health Care System and a professor of medicine at the Stanford University School of Medicine, who chaired the committee that developed the guidelines. “In our view, the evidence doesn’t support a blanket recommendation for women in this age group.”

Breast cancer is the second-leading cause of cancer related death among women in the United States; according to the American Cancer Society, 25 percent of all diagnosed cases are among women younger than age 50. Among these younger women, the risk of breast cancer varies greatly, from less than 1 percent for a 40-year-old woman with no risk factors to 6 percent for a 49-year-old woman with multiple risk factors, which include family history of breast cancer, older age at the birth of her first child and younger age at the onset of menstruation. While it is well-established that mammography reduces mortality from breast cancer in 50- to 70-year-old women, and that women in this age-group should be routinely screened, the evidence isn’t as clear-cut for younger women.

Because of the ongoing controversy, the American College of Physicians’ Clinical Efficacy Assessment Subcommittee decided to take its own look at the evidence related to screening in women in their 40s. After their review, the group concluded that screening mammography for women in this age group likely provides a modest reduction in breast cancer mortality, but, as with any screening intervention, it also comes with the risk of potential harms. Based on this, it recommended that clinicians: Periodically perform individualized assessment of risk for breast cancer to help guide decisions about screening mammography; Inform women ages 40 to 49 of the potential benefits and harms of screening mammography; Base screening mammography decisions on benefits and harms of screening as well as a woman's preferences and breast cancer risk profile. In the new guidelines, the organization emphasizes the importance of using a woman’s concerns about breast cancer and screening to help guide decision-making about mammography. Women’s thoughts about mammography or their risks of developing breast cancer will likely vary greatly, the group notes, but it expects the potential reduction in breast cancer mortality associated with screening to outweigh other considerations for many women. “We still think many women will choose to get mammography, and we're supportive of that,” said Owens. “The most important thing is that women be well-informed about the decision they're making.”

 

AHRMM & Arizona State University Partner on Healthcare Supply Chain Benchmarking Initiative

The Association for Healthcare Resource & Materials Management (AHRMM) has partnered with the W. P. Carey School of Business at Arizona State University (ASU) to establish the Healthcare Supply Chain Benchmarking and Performance Improvements Metrics, an initiative that aims to advance and improve healthcare supply chain performance analysis over the next two years. Through the partnership, AHRMM and ASU will develop an online benchmarking and performance improvement tool using well established research method techniques that have been successfully applied to improving supply chain performance in other industries. This tool will allow hospitals and providers to compare their performance with organizations of similar size and operation. The Healthcare Supply Chain Benchmarking and Performance Improvements Metrics is in the first phase of development.  

“Despite past success with benchmarking, healthcare organizations still need a consistent, actionable, and credible measure to ensure accurate comparisons and reporting of financial and other supply chain measures,” said Deborah Sprindzunas, AHRMM’s executive director. “By identifying and developing effective indicators of supply chain performance as well as metrics for evaluating partner performance, AHRMM and ASU’s new tool will lead the way toward consistent, transferable performance analysis.”  

During the first phase the research team plans to engage industry experts in the identification, evaluation, and selection of target metrics for the healthcare field. The second phase involves development of a data capture and online benchmarking tool for use by practicing supply chain managers. The third phase moves this project to initial data collection and model validation activities where a sample of targeted organizations will provide data for validating the metric definitions and testing the use of the benchmarking and analysis tool. During the final phase, full scale data collection commences.  

“The Healthcare Supply Chain Benchmarking and Performance Improvements Metrics will not only enable organizations to determine the best performer, it will also determine best known practices and capabilities that have yet to be adopted by the majority of the industry,” explained Vicki Smith-Daniels, Professor of Supply Chain Management, W.P. Carey School of Business, Arizona State University. Associations representing various healthcare professions will be invited to participate in benchmarking and performance improvement analysis on a frequent basis, allowing for longitudinal analysis of supply chain performance improvement in the field of healthcare.
For more information CLICK HERE.

 


Is it the flu? Get the fast flu test


Fast flu tests, which drastically cut the time to diagnose a patient with influenza or not, are helping doctors better treat the illness, according to a recent study and medical experts. Timing is key in treating the flu, said Dr. Greg Poland of the Mayo Clinic in Rochester, MN. If diagnosed early enough, from 24 to 48 hours after a patient first shows symptoms, a treatment of antiviral drugs can alleviate the severity of symptoms, cut down on the number of days sick and decrease potential complications, Poland said. “I think all through my career, what the medical system tried to teach people is that when you have a virus or influenza, don’t come in because there is nothing we can do,” Poland said. “Now, what we are saying is that medical science has advanced.”

 

The rapid diagnostic tests can take anywhere from five to 30 minutes to come up with a diagnosis. In contrast, results for a traditional viral culture test can take several days to a week. The rapid tests generally involve a nasal or throat swab and can be examined in the doctor’s office. A viral culture also usually collects a fluid sample that is sent to a laboratory. The use of these rapid tests has been growing during the past few years and more than 10 variations of the tests have been approved by the Food and Drug Administration, the CDC said. Depending on the test used and if conducted properly, they register about a 70 percent accuracy rate in diagnosing whether a patient has the flu and are about 90 percent specific in figuring out what type of flu it is, the CDC said. “Done improperly, and I think a lot get done improperly, the sensitivity falls dramatically,” Poland said. The traditional culture tests are more consistently accurate and they can distinguish between flu subtypes with more specificity. “The gold standard is still a culture, but the gold standard is not timely, hence its usefulness in diagnosis and treatment is limited,” Poland said.

 

Research shows the tests are having an effect on treatment. Rapid testing has led to a decreased use of antibiotics in the treatment of children with the flu, according to a recent study conducted by Rochester General Hospital and the University of Rochester School of Medicine and Dentistry. The tests also have helped lead to shorter hospital stays for kids and lessened the amount of extra laboratory testing, the study said. The diagnostic tests also could be a benefit for the public health sector because they make it easier to keep track of test results. In some cases, especially with longer laboratory testing periods, different doctors and nurses may handle the testing process and reporting the results to public health agencies gets lost in the shuffle, Poland said. However, with a rapid test, where results are in-house and the process is shorter, the reporting is more accurate. Consequently, surveillance of possible outbreaks across the country is enhanced, doctors said.

 

Context plays an important role in deciding when to use the test, said Dr. Henry Bernstein of the Children’s Hospital at Dartmouth in New Hampshire and also a member of the American Academy of Pediatrics’ committee on infectious diseases. For example, early in the season, the U.S. flu season can last from late December through March, the rapid tests are useful because many patients mistake symptoms of other illnesses for the flu, he said. However, in the midst of the flu season when a specific community might be overrun by the illness, the tests might be impractical or a waste of money. The reasons for being judicious in using the tests, especially if done improperly, increasing the chances of an inaccurate diagnosis, are twofold, doctors say. Antiviral doses are limited each flu season and prescribing them indiscriminately could build a resistance to the drugs in the community, doctors say. The rapid diagnostic tests have been around for several years and are widely used, with some insurance plans covering them. Yet only now are people growing more aware of them, said Poland. (CNN)
 


Medicare announces competitive acquisition program for certain DME, prosthetics, orthotics, and supplies 

The Centers for Medicare & Medicaid Services (CMS) issued a final rule that will reduce beneficiary out-of-pocket costs, improve the accuracy of Medicare’s payments for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), help combat supplier fraud, and ensure beneficiary access to high quality DMEPOS items and services through a new competitive bidding program. In 2008, the competitive bidding program will operate in competitive bidding areas (CBAs) within 10 of the largest Metropolitan Statistical Areas (MSAs), excluding the New York, Los Angeles, and Chicago MSAs and will apply to 10 of the top DMEPOS product categories based on criteria outlined in the final rule. The program will be expanded into 70 additional MSAs in 2009. After 2009, CMS will expand the program to additional areas and items.  

The new competitive bidding program, which is required by the Medicare Prescription Drug, Improvement & Modernization Act of 2003, will replace the current payment amounts, for the items being bid, under Medicare’s DMEPOS fee schedule with payment rates derived from the bidding process. Suppliers that wish to furnish competitively bid items in a CBA will be required to submit bids to furnish those items. Contracts will be awarded to a sufficient number of winning bidders in each CBA to ensure access and service to high quality DMEPOS items. The winning bids will be used to establish a single Medicare payment amount for each item. For beneficiaries in the selected CBAs, this program will reduce out-of-pocket expenses while ensuring that they receive high quality items and services. This is because the rule requires all contracting suppliers to be accredited by an approved accreditation organization as meeting CMS’ quality standards. CMS has designated 10 entities as qualified to accredit DME suppliers, based on quality standards that were posted on the CMS website in August 2006. 

The single payment amounts established through competitive bidding will be lower than the current fee schedule amounts for the items. In addition, contract suppliers must accept the single payment amount established through competitive bidding as payment in full. The beneficiary’s liability is limited to 20 percent of the payment amount and any unmet Part B deductible. For taxpayers, the competitive bidding program means potentially significant savings for Medicare. When fully implemented in 2010, it is projected that these savings will amount to $1 billion annually.  

CMS is creating a limited exception to the competitive bidding requirement that will allow certain treating professionals to furnish items on the competitive bidding list to their own patients without having to participate in bidding and without becoming a contract supplier. This exception would apply to certain specified items furnished by physicians, physician assistants, clinical nurse specialists, nurse practitioners, occupational therapists in private practice, and physical therapists in private practice. The item must be furnished as part of their professional services.  

CMS has included in the final rule a number of provisions that will modify the rule’s impact on small suppliers. CMS worked closely with the Small Business Administration to establish a new definition of small suppliers that is reflective of this area of the health care industry. The use of this new definition, in conjunction with policies established in the final regulation, will enhance the ability of small suppliers to participate in the competitive bidding program. The final rule will be published in the Federal Register on April 10. For more information CLICK HERE.

 

NIAID expands capability for influenza research and surveillance

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced it is awarding $23 million per year for seven years to establish six Centers of Excellence for Influenza Research and Surveillance. Collectively, the centers will expand NIAID’s influenza surveillance program internationally and in the United States, and will bolster influenza research in key areas, including understanding how the virus causes disease and how the human immune system responds to infection with the virus. The goal of the newly created centers is to provide the federal government with important information to inform public health strategies for controlling and lessening the impact of seasonal influenza as well as an influenza pandemic.

The new awards build upon an ongoing program led by St. Jude Children’s Research Hospital in Memphis, TN, initiated by NIAID after the 1997 Hong Kong outbreak of highly pathogenic avian influenza in humans. NIAID is expanding the surveillance and research program to now include six Centers of Excellence for Influenza Research and Surveillance, residing at St. Jude Children’s Research Hospital, Memphis, University of California at Los Angeles, University of Minnesota, Minneapolis, Emory University, Atlanta, Mount Sinai School of Medicine, New York City and University of Rochester, Rochester, NY.

Their work will include determining the prevalence of avian influenza in animals that routinely come into close contact with people; understanding how flu viruses evolve, adapt and transmit infection; and identifying immunological factors that can determine whether a flu virus causes only mild illness or death. Additionally, some centers will monitor for international and domestic cases of animal and human influenza to rapidly detect and characterize viruses that may have pandemic potential and to create vaccine candidates targeted to those viruses. Ultimately, these studies will lay the groundwork for developing new and improved control measures for emerging and reemerging flu viruses. For more information CLICK HERE or CLICK HERE.

 

Family members most often source of whooping cough in young infants


Infants with whooping cough were most likely infected by the people they live with, according to a multi-country study led by researchers from the University of North Carolina at Chapel Hill School of Public Health. The study found that parents were the source of pertussis, commonly known as whooping cough, in 55 percent of infants. In all, household members including siblings, aunts and uncles, cousins and grandparents were responsible for 75 percent of pertussis cases among infants for whom a source could be identified. The results appear in the April 2007 issue of the Pediatric Infectious Disease Journal.

 

Although pertussis vaccination has reduced the number of reported cases in industrialized countries by more than 95 percent from what it was in the 1950s, the number of reported pertussis cases in the United States has tripled in the past two decades. “It is important to understand how the disease is spread, particularly to infants who are too young to be vaccinated themselves, so that steps can be taken to prevent infections in these vulnerable infants and potentially save lives,” said Dr. Annelies Van Rie, assistant professor of epidemiology in the UNC School of Public Health and the study’s senior author. “It is troubling to learn that infants are often infected with pertussis by their own family members, who are often unaware of having pertussis themselves, and in whom pertussis could have been prevented if they had received a pertussis booster vaccination,” she said.

 

The study, funded by grants from the Institut Pasteur Foundation, Sanofi Pasteur and Sanofi Pasteur-MSD, was conducted over a 20-month period in four countries, Canada, France, Germany and the United States. The researchers found that among infants with pertussis for whom the source case could be identified, parents were the primary source of pertussis in infants, followed by siblings (16 percent), aunts/uncles (10 percent), friends/cousins (10 percent), grandparents (6 percent) and part-time caregivers (2 percent). “Ongoing research, such as this study, demonstrates that adolescents and adults can transmit pertussis to infants,” Van Rie said. “Pertussis immunization of adolescents and adults, especially those in contact with young infants would not only protect themselves form pertussis, but would also protect young infants from pertussis and could save lives.”

 

Newborns who are too young to be fully vaccinated against the disease are more vulnerable to severe pertussis and face the possibility of serious complications and even death. Infants account for more than 90 percent of pertussis deaths in the U.S. The disease is spread though airborne droplets that are transmitted when an infected person coughs or sneezes. The infected person may look and feel healthy between episodes of coughing. If left untreated, people infected with pertussis can spread the disease for several weeks.

Reports of pertussis have increased most dramatically among adolescents and adults. This is partly because pertussis immunity from early childhood vaccinations wears off, leaving adults and adolescents susceptible to the disease. Most adolescents and adults are not diagnosed with pertussis because they frequently have milder cases of the disease and physicians still perceive pertussis as a childhood disease. The U.S. Centers for Disease Control and Prevention now recommends that adults and adolescents be given a tetanus-diphtheria-pertussis booster (Tdap) in place of the tetanus-diphtheria (Td) booster to reduce the burden of pertussis in the United States.

 


April 2, 2007


Premier acquires CareScience, strengthening ability of hospitals to improve quality while safely reducing cost

 

New York Times: Some hospitals call 911 to save their patients

Dengue surging in Mexico, Latin America 

Severe dengue infections may go unrecognized in international travelers

Universal red blood cells could relieve blood bank shortages

Conflict-of-interest inquiry may be reopening at NIH

Russia sees ill effects of ‘General Winter’s’ retreat

CHeS Webinar series focuses on benefits of synchronized product data across the health care industry

Amerinet signs exclusive agreement with Ohio Valley Hospital Consortium


 

Premier acquires CareScience, strengthening ability of hospitals to improve quality while safely reducing cost

On Friday, March 30, 2007, Quovadx, Inc. and Premier Inc. simultaneously signed a definitive agreement and closed the related transaction wherein Premier purchased all outstanding shares of CareScience stock for $34.9 million, or a multiple of approximately 2.3 times CareScience's 2006 revenue. The transaction was approved by the Boards of Directors of both Quovadx and Premier. The final purchase price is subject to certain post-closing adjustments, including the final calculation of working capital for CareScience as of March 31, 2007. The sale is not expected to result in any income taxes due from Quovadx.

"CareScience's robust clinical analytics, research capabilities and dedicated employees enhance Premier's industry-leading capabilities for improving healthcare quality while safely reducing the cost of care," said Stephanie Alexander, Premier senior vice president. "We look forward to creating new and enhanced solutions that will provide hospitals and health systems greater access to the expertise, clinical research and knowledge-sharing they need to meet the critical challenges facing healthcare today."

Together, Premier and CareScience serve more than 900 hospitals. CareScience's physician-accepted, clinical expertise complements Premier's process improvement focus and unparalleled database of hospital comparative data. Premier’s Performance Suite is a single source for integrating quality and safety, labor management, and supply chain efficiency. It provides Web-based performance measurement and benchmarking, real-time surveillance and best practices to help improve quality and reduce costs. CareScience works with hospitals to use comparative data as the basis for implementing clinical quality improvement plans that optimize patient outcomes and operational performance, increase staff efficiency and reduce costs.

“The acquisition of CareScience further demonstrates Premier’s commitment to its long-term goal of reshaping American healthcare in ways that make it the safest, most effective and efficient system in the world,” said Susan DeVore, Premier’s chief operating officer. “The greatest challenge for hospitals today is improving quality of care while safely reducing costs. Today’s agreement will help hospitals across the nation meet that challenge.”

In a second transaction Sunday, April 1, 2007, Quovadx Inc. and Battery Ventures entered into an agreement wherein Battery Ventures will acquire 100 percent of the outstanding shares of the common stock of Quovadx, Inc. for $136.7 million payable to Quovadx stockholders. Stockholders are therefore expected to receive $3.15 per share, subject to certain post-closing adjustments. The estimated per share price includes the net proceeds from the March 30, 2007 sale of the Company's CareScience division.

 

New York Times: Some hospitals call 911 to save their patients

Should a hospital be able to handle a medical emergency? Patients at some hospitals may find the staff resorting to what someone might do at home in a crisis: call 911 for an ambulance. That happened recently in Texas, where a 44-year-old man named Steve Spivey developed breathing problems after spine surgery. No physician was working there when the staff first recognized he was in trouble. They phoned 911, and he was taken to a nearby full-service hospital, where he was pronounced dead a short time later. The episode occurred at a small hospital that is owned and run by doctors, one of roughly 140 such hospitals around the country, with nearly two dozen more under development, that are set up to specialize in certain types of procedures like heart surgery, back operations and hip replacements. These hospitals have been assailed for cherry-picking the most profitable procedures from the nation’s 4,500 or so full-service hospitals. Critics have argued that the doctors have a financial incentive in sending patients to their own facilities, even when those patients might be better off having their surgery in regular hospitals. But the Texas case, and others like it, have invited new scrutiny from regulators and members of Congress about these hospitals’ ability to care for patients who suffer complications after their operations.

While some of these hospitals are large sophisticated operations, like those hospitals specializing in cardiac care, others are much more modest. Small surgical hospitals may not have separate emergency facilities or, as in the Texas case, a doctor on site at all times during a patient’s recovery. As the number of doctor-owned surgical hospitals grows, federal and state officials now acknowledge that the government rules may be too vague about the emergency abilities a hospital must have in place. Regulators are particularly concerned about the very small hospitals that focus on only a few kinds of surgery but perform operations that frequently require an overnight stay. While Medicare’s rules currently say a hospital must “meet the emergency needs of patients in accordance with acceptable standards of practice,” the details are left largely to the hospital’s discretion. Federal and state officials say they are now reviewing the guidelines to toughen the rules and make them more specific. Medicare recently terminated its agreement with the facility involved in the Texas case, West Texas Hospital, a 14-bed hospital in Abilene that performed procedures ranging from plastic surgery to complex spine operations.
Although the chief executive of West Texas Hospital defended its practices, he said it would not appeal the government’s decision. The hospital has since closed.

The doctors who set up the specialized hospitals defend them by saying that by running the centers themselves and concentrating only on certain procedures, they can provide the best results for patients. Proponents of the specialty hospitals say the Abilene and such cases are aberrations that critics are exploiting to defend the turf of full-service hospitals. They say they are able to handle their patients’ medical emergencies, whether or not they have emergency departments. But some members of Congress are now pushing Medicare to take a closer look at how such hospitals are regulated. “The problem with physician-owned specialty hospitals is that decision-making is more likely to be driven by financial interest rather than patient interest,” said Senator Charles E. Grassley, (R-IA). “You see it in the cherry-picking of patients, and with policies that instruct hospital staff to call 911 for the local community hospital if emergency care is needed,” said Grassley, a ranking member of the Senate Committee on Finance, which oversees Medicare. Congress has asked for various reports on the issue, including a comprehensive analysis last year by the federal Department of Health and Human Services. (The New York Times) To read the full article CLICK HERE.


 

Dengue surging in Mexico, Latin America 

The deadly hemorrhagic form of dengue fever is increasing dramatically in Mexico, and experts predict a surge throughout Latin America fueled by climate change, migration and faltering mosquito eradication efforts. Overall dengue cases have increased by more than 600 percent in Mexico since 2001, and worried officials are sending special teams to tourist resorts to spray pesticides and remove garbage and standing water where mosquitoes breed ahead of the peak Easter Week vacation season. Even classic dengue, known as “bonebreak fever”, can cause severe flu-like symptoms, excruciating joint pain, high fever, nausea and rashes. More alarming is that a deadly hemorrhagic form of the disease, which adds internal and external bleeding to the symptoms, is becoming more common. It accounts for one in four cases in Mexico, compared with one in 50 seven years ago, according to Mexico’s Public Health Department.

While hemorrhagic dengue is increasing around the developing world, the problem is most dramatic in the Americas, according to the Centers for Disease Control and Prevention. Dengue is driven by longer rainy seasons some blame on climate change, as well as disposable plastic packaging and other trash that collects water. Migrants and tourists, including the many thousands of Americans expected for spring break this year, carry new strains of the virus across national borders, where mosquitoes can spread the disease. The CDC says there’s no drug to treat hemorrhagic dengue, but proper treatment, including rest, fluids and pain relief, can reduce death rates to about 1 percent. Latin America’s hospitals are ill-equipped to handle major outbreaks, and officials say the virus is likely to grow deadlier, in part because tourism and migration are circulating four different strains across the region. A person exposed to one strain may develop immunity to that strain, but subsequent exposure to another strain makes it more likely the person will develop the hemorrhagic form. This dengue spread “is one of the primordial public health problems the country faces,” said Mexico’s Public Health Department, which has sent hundreds of workers to the resorts of Puerto Vallarta, Cancun and Acapulco to try to avert outbreaks ahead of the Easter week vacation. “We are working intensively, both the federal and state governments, on (these) three sites that we want to keep under control, so that it doesn’t become a risk for tourists,” said Pablo Kuri, head of Mexico’s National Center for Epidemiology and Disease Control.  

The Canadian Embassy in Mexico City issued an alert about dengue after five Canadians were sickened in Puerto Vallarta earlier this year. Acapulco, a city of 700,000, has documented 549 cases of classic and hemorrhagic dengue in the first two months of 2007, up from just 86 for the same period last year. In January and February, Mexico’s dry season, there were 1,589 cases of both types of dengue nationwide, up 380 percent from the same period in 2006, Kuri said. And last year was also bad for dengue: Mexico documented 27,000 infections overall, including 4,477 hemorrhagic cases and 20 deaths, compared with 1,781 cases overall in 2001. Dengue has been found along the U.S.-Mexico border, where 151 classic and 46 hemorrhagic cases were recorded last year in the Gulf state of Tamaulipas, south of Texas. The Intergovernmental Panel on Climate Change, made up of the world’s leading climate scientists, predicted in March that global warming and climate change would cause an upsurge in dengue. The global solution to dengue outbreaks is mosquito control, and faltering eradication efforts, together with climate change, probably share blame for dengue’s rise in the Americas, Kuri said. (Associated Press)

 

Severe dengue infections may go unrecognized in international travelers


Severe cases of a common travelers’ infection may not be recognized if doctors rely on the World Health Organization’s (WHO) guidelines for identifying it, according to a new study published in the April 15 issue of The Journal of Infectious Diseases, now available online. Dengue is the most important emerging disease among international travelers, with a 30-fold increase in incidence over the past 50 years worldwide. Like malaria, dengue is transmitted to humans by mosquitoes.  Most cases are mild. Symptoms include fever, rash, headache, pain behind the eyes, and muscle and joint pain.

 

According to the WHO, dengue hemorrhagic fever (DHF) is characterized by fever, low platelet count, clinical evidence of leaking capillaries, and spontaneous bleeding or fragile blood vessels. The most serious cases can lead to shock and death. There is no cure for dengue infection, but management of the disease’s effects can prevent the worst outcomes. The study, conducted by Ole Wichmann, MD, MCTM, DTM&H, at the Robert Koch Institute in Berlin, Germany, and colleagues throughout Europe, collected data through the European Network on Surveillance of Imported Diseases at 14 sites in 8 European countries.

 

Out of more than 200 patients treated for dengue infection at these sites over two years, less than 1 percent fit all four criteria necessary to meet the WHO definition of DHF. However, 11 percent had at least one manifestation of severe dengue disease, and a total of 23 percent required hospitalization due to dengue-related symptoms. “Dengue exists more as a continuous spectrum,” Dr. Wichmann said. “Severe disease can be present in patients who do not fulfill all four DHF criteria.” “The term ‘dengue hemorrhagic fever’ puts undue emphasis on bleeding,” he added, noting that plasma leakage and shock can occur without it. “Clinicians who mainly focus on bleeding...may miss the most important conditions that require hospitalization and treatment.”

 

Their findings also showed that travelers who acquire a second dengue infection are more at risk for severe cases of dengue, although some patients had severe symptoms when infected during their first trip to a dengue-endemic country. It is becoming more and more crucial that health care providers understand the clinical spectrum of dengue and its diagnosis. “Given the increase in business travel and other travel, and the global spread of dengue fever, these findings have important implications for the future burden of severe imported dengue infections,” Wichmann said. As a next step to their study Wichmann highlighted the need for more inquiry into a clinical definition of dengue. “In order to perform more uniform surveillance and research, including vaccine trials, studies are urgently needed to establish new and more robust definitions for severe dengue.”

 

Universal red blood cells could relieve blood bank shortages

An international team of academic and industry scientists has come up with a feasible way of making universal red blood cells that are stripped of their blood type. The hope is that it can be developed into a viable way of relieving blood bank shortages. The study is published in the early online edition of the journal Nature Biotechnology. The idea of “universal red blood cells” has been around for some time and its feasibility has been demonstrated in clinical trials. For example, scientists in the US about 25 years ago managed to use a coffee bean glycosidase enzyme to strip the B antigen from red blood cells. But the process proved to be impractical.

In the new study, a team of scientists led by Professor Henrik Clausen from the University of Copenhagen in Denmark, found a more abundant source of glycosidase enzymes in bacteria. They found two bacterial glycosidase gene families with enzymes that efficiently remove A and B antigens from red blood cells (RBCs). Prof Clausen and colleagues conclude that “The enzymatic conversion processes we describe hold promise for achieving the goal of producing universal RBCs, which would improve the blood supply while enhancing the safety of clinical transfusions”. The university scientists worked with US industry scientists from ZymeQuest in Beverly, MA. The next step is to start clinical trials to test the method’s treatment safety and efficiency. (Medical News Today)



Conflict-of-interest inquiry may be reopening at NIH

Federal investigators are reviewing the activities of 103 scientists who may have had improper links to pharmaceutical companies while they were employed at the National Institutes of Health, apparently resurrecting a conflict-of-interest inquiry that many in the agency thought was closed. In a letter sent to several members of Congress on March 23, Daniel R. Levinson, inspector general for the Department of Health and Human Services, said his office is looking into the cases “to determine whether investigation is warranted.” Levinson also wrote that his office is reviewing whether NIH is adequately monitoring potential conflicts of interest among its thousands of grant recipients, typically university researchers. Members of Congress and watchdog groups have long called for such a review, noting that conflict-of-interest policies at universities are generally more lenient than those at NIH. The concern, critics say, is that federal grant money not go to scientists who may be predisposed to get results that favor their drug company sponsors.  

Scientific and academic organizations counter that adequate safeguards are already in place and fear that many of the nation’s best scientists would leave the federally funded research enterprise if options for outside income were lost. NIH officials had already looked into the 103 cases of possible conflict of interest in 2004, after a congressional inquiry suggested that scores of researchers may have taken drug industry money without approval. As a result of that investigation, NIH Director Elias A. Zerhouni in 2005 banned all such consulting by NIH employees. Agency investigators concluded that about half of those who were suspected of wrongdoing and who were still employed at NIH (and thus available for questioning) had indeed violated policies, including 10 who the agency concluded may have violated federal law. NIH referred only those 10 cases to the HHS Office of Inspector General (OIG), which referred two to the Justice Department for possible prosecution. One resulted in a conviction for criminal conflict of interest; the other is still pending. With new ethics policies in place and the 2008 budget fight starting, many in the agency had hoped that the worst was behind them. But the Levinson letter suggests not. 

A spokesman for Levinson said he was not at liberty to say why the OIG had renewed its interest in the cases. But the letter, made public by the House Energy and Commerce Committee, which has spearheaded inquiries into NIH for years, said the review began about six months ago. That is about when committee members complained loudly that too many of those who were found to have violated NIH rules had gotten off with only modest disciplinary action. In a joint statement released yesterday, Energy and Commerce Chairman John D. Dingell (D-MI) asserted that “NIH bungled the investigation the first time around,” and ranking Republican Joe L. Barton (TX) expressed hope that the inquiry “will finally sort things out so everyone can have confidence that the public's interest is being fully served.” NIH spokesman John Burklow said: “We welcome the additional review; however, we are confident in the rigor of our process.” (Washington Post)

 

Russia sees ill effects of ‘General Winter’s’ retreat

Experts have long feared that Earth’s warming climate would cause tropical diseases such as malaria to spread into more temperate zones, but a dramatic example of an apparently climate-related disease outbreak cropped up this winter in a cold place, Russia. More than 3,000 cases of infections caused by hantaviruses have been reported so far in Russian cities and towns, including many that are within a few hundred miles of Moscow, such as Voronezh and Lipetsk. The viruses can cause a serious, and sometimes deadly, disease known as hemorrhagic fever with renal syndrome, or HFRS. During Russia’s more typically frigid winters, scientists believe, HFRS-causing viruses die off in the consistently below-zero temperatures. But this winter has been anything but cold. On Dec. 7 Moscow hit a record 46 degrees Fahrenheit. HFRS was last on a rampage in Russia in 1997, coinciding with another very warm winter. By mid-spring that year, the number of cases reached more than 20,000. The viruses are transmitted to humans when infected mice set up housekeeping in the nooks and crannies of homes, barns, sheds and other buildings. If droppings left by the mice are disturbed, the viruses waft up and out of the excretions like a miasma, infecting people who breathe the air.  

Biologists estimate that the current population of rodents in Russia is 10 times as high as in previous years, and that one in three mice is infected with an HFRS-causing virus. Most researchers attribute the spike to the unusually warm weather, although some think a natural cycle in mouse populations may play a role. “Global warming has tipped a balance,” said Irina Gavrilovskaya, a scientist and physician at the State University of New York at Stony Brook who has conducted research on HFRS at the Russian Academy of Medical Sciences in Moscow. “Because of the lack of snow cover on Russian fields, the country has had an explosion in numbers of virus-carrying mice.” With the coming of spring, Lyudmial Kirillov, the regional epidemiologist in Lipetsk, is predicting a new outbreak as the little snow that fell this winter melts and hibernating, and virus-carrying, mice awaken.  

Over the past decade, unusually warm winters and large populations of mice have also been responsible for outbreaks in New Mexico and nearby states of a related illness, hantavirus pulmonary syndrome. As of last year, some 10 states had reported 30 or more cases of the syndrome since 1993, when the virus was identified. More than 20 other hantaviruses threaten people in China, Korea, Northern and Western Europe, Argentina, Chile, Brazil, Panama, and Canada. Some of those outbreaks have also been linked to climate change, higher temperatures or altered patterns of rainfall, and its effect on rodents. “Climate change is about more than a warming Earth,” said David Blockstein, senior scientist at the National Council for Science and the Environment, a scientific advocacy group in Washington. “Climate change is turning environmental issues into public health issues.” (Washington Post)
 


CHeS Webinar series focuses on benefits of synchronized product data across the health care industry

The Coalition for Healthcare eStandards (CHeS) is launching an educational Webinar series focusing on the need for supply chain data synchronization to reduce costs and increase efficiencies in the U.S. health care industry. The series brings together industry experts who are championing efforts to launch a health care product data utility (PDU), similar to systems already successfully streamlining the exchange of supply chain information in other large industries. Join CHeS and industry participants in an engaging Webinar series about how a PDU can benefit hospitals and suppliers, as well as the industry as a whole, and learn how to participate in efforts to accelerate adoption of a PDU for health care. Register online at http://chestandards.org/pduwebinars.htm.

 

The schedule is as follows:

Wednesday, April 4, 2 pm - 3 pm Eastern, “PDU: What's in it for Hospitals?”

  

Hospitals have the most to gain from an efficient supply chain, reduced rework, fewer errors, reduced costs and improved patient safety, to name a few advantages.  Find out more about the specific benefits a fully implemented PDU would bring to America's health care providers. This Webinar is lead by Robert Perry, senior consultant, MTS, Inc, 2006 President of the Association for Health care Resource & Materials Management (AHRMM), chair, CHeS Product Data Utility Provider / IDN Working Group and Frank Fernandez, assistant vice president and corporate director of materials management, Baptist Health South Florida, AHRMM member representative, CHeS Board of Directors.

   

Wednesday, April 11, 2pm - 3pm Eastern, “PDU: What’s in it for Suppliers?”

 

Suppliers have the opportunity to reduce business costs and introduce new products to hospitals, faster, with a PDU in place. Learn what one health care supplier, BD, is doing to lead efforts for the industry to adopt a PDU and how other suppliers can participate. This Webinar is led by Joe Pleasant, CIO, Premier, Inc., chair, CHeS Product Data Utility Organizing Committee and Dennis Black, director of e-Business at BD (Becton, Dickinson and Company)

 

 

Thursday, April 26, 1pm - 2pm Eastern, “PDU: How Hospitals Can Take the Lead”

 

Hospital materials managers and financial executives are taking ownership of their supply chain, and adopting best practices to rein in costs. Learn about efforts to control supply chain costs and processes in the industry, and how one hospital is already seeing results. This Webinar is led by Robert Perry, senior consultant, MTS, Inc., 2006 President of the Association for Health care Resource & Materials Management (AHRMM), chair, CHeS Product Data Utility Provider/IDN Working Group and Mike Brown, director of purchasing, University Health Care System. For more information call Peggy Brody of CHeS at 734-677-3300 or email Peggy@CHeStandards.org or CLICK HERE.

 

Amerinet signs exclusive agreement with Ohio Valley Hospital Consortium

Amerinet Inc., a national health care purchasing organization, recently renewed its agreement to serve as the sole-source purchasing agent of the Ohio Valley Hospital Consortium (OVHC), an alliance of regional health care providers in South East Ohio, following a competitive bidding process. Since the initial agreement in 2001, the consortium has achieved nearly $6 million in cost savings through Amerinet’s comprehensive portfolio of contracts and solution-based programs. Amerinet will continue to negotiate custom contracts on behalf of OVHC, and make available an array of competitively priced, quality products and services provided by industry leaders.  

This new five-year agreement creates a partnership of shared responsibility to reduce costs and discover new revenue streams. The partnership will also focus on total supply spend management, and margin improvement tools, including cost reduction, contract evaluation and implementation, and education and program coordination at all of the consortium’s facilities. The Ohio Valley Hospital Consortium is an independent organization of community healthcare providers, working collaboratively to improve the health care delivery system in their communities. The OVHC member organizations include Adena Health System, Chillicothe; Fairfield Medical Center, Lancaster; Holzer Health Systems, Gallipolis; and Marietta Memorial Hospital, Marietta.

 


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