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

hpnonline Daily Update

February 2008
 
February 4 February 5 February 6 February 7 February 8

February 8, 2008  Download print version

Merck to pay $650 million in Medicaid settlement

AHRMM announces grants

New strategy helps reduce errors in obstetrical care 

Severe stressful events early in pregnancy may be associated with schizophrenia among offspring

Pre-chewed baby food said to transmit H.I.V.


Study suggests new therapy for lung disease patients


WHO releases new report on global tobacco control efforts
 

Comatose locusts may help relieve migraines
 


Merck to pay $650 million in Medicaid settlement

Merck agreed yesterday to pay more than $650 million to settle charges that it routinely overbilled the government for its most popular medicines, the arthritis drug Vioxx and the cholesterol drug Zocor, cheating Medicaid out of millions of dollars in discounts over eight years. Prosecutors say the drugmaker gave pills to hospitals at virtually no cost to hook poor patients on expensive medicine. When the patients left the hospital, they often continued taking the drugs, but with the government footing the higher bill. The Merck settlement culminates an investigation that began in 2000 and is one of the first in a series of cases centering on whether drugmakers used unfair pricing practices to bilk the government. The Justice Department is looking into 630 healthcare whistleblower claims.

H. Dean Steinke, a district sales manager for Merck, set off the investigation after he noticed his company was using questionable sales tactics. Steinke complained to his supervisors, who brushed him off, so he turned to federal authorities.Steinke, a 51-year-old Michigan native, will receive about $68 million from the settlement as a whistleblower reward. He said he was prompted to go to authorities after his direct supervisor told him: "I don't care how you do it, but get the damn business," when he questioned the sales practices. "There comes a time when you just dig in your heels and say, 'You know what? They're not going to get away with it,' " Steinke said. 

The agreement yesterday, one of the largest health-care fraud recoveries, also closes a related case about Merck overcharging for the antacid Pepcid. William St. John LaCorte, a doctor in New Orleans who questioned the Pepcid charges, will receive a yet-to-be-determined share of the settlement proceeds. 

Merck did not admit wrongdoing. The country's third-largest drugmaker stood by its pricing strategies but wanted to resolve the disputes, executives said in a statement. Merck agreed to heightened oversight by regulators for five years as part of the deal. The company remains the focus of a separate grand jury investigation related to Vioxx marketing and is striving to execute another multibillion-dollar settlement of thousands of lawsuits filed by people who had heart attacks after taking the painkiller. 

The whistleblowing case centered on Merck's giving hospitals across the country 92 percent discounts on Vioxx, an arthritis drug pulled from the market three years ago for safety concerns; Zocor, a popular cholesterol-lowering medicine that drew intense competition from rivals; and Pepcid, an antacid tablet now sold over-the-counter. Merck offered the pills at the discount under a legal loophole, known as nominal pricing, that Congress created a generation ago to give poor patients access to medicine. 

Merck and industry experts had argued that the pricing strategy fell within the law and helped reduce costs for many government-funded hospitals. But prosecutors said the Whitehouse Station, N.J., drugmaker used the discounts to outflank its competition, offering massive markdowns to hospitals that agreed to put its medicines on a list of preferred drugs or to prescribe them for as many as three-quarters of eligible patients. In some cases, hospitals favored Merck's drugs over cheaper generics. This practice conflicted with the law because Merck did not offer Medicaid the same discounts, authorities said. The law requires the government be charged no more than other customers. (Washington Post) Click here for the complete story.

 

AHRMM announces grants


The Board of Directors of the Association for Healthcare Resource & Materials Management (AHRMM) has donated over $175,000 in research grants to three groups supported by collegiate institutions.


AHRMM contributed $75,000 to ASU to support further development and implementation of SCMetrix - a sophisticated online benchmarking tool to help hospitals compare their supply expense and supply chain processes to those of peer hospitals. AHRMM and the W.P. Carey School of Business began work on the joint project in 2007. In 2006, AHRMM granted ASU $100,000 to determine the study's metrics, build the survey tool and the program's Web site, and host several educational seminars to help hospitals gain a better understanding of SCMetrix and promote project participation. This year's grant will support the tool's continued development and refinement and will further assist with the marketing and educational efforts so that more hospitals will learn how to become part of SCMetrix and begin importing their data into the online system. A hospital does not have to attend the webinar to obtain the tools. Instead, they recommend that you listen to the web recording and download the tools at this site.  The downloadable tools are located on the web page under Participate.


AHRMM also donated $50,000 to the MEHD Group, a healthcare supply chain initiative within the MIT Center for Transportation & Logistics created to drive innovation in the field. The MEHD Group will use the AHRMM grant to create new insights, technologies, and business practices to improve healthcare delivery everywhere. In doing so, they will conduct research to identify the dynamics of the current healthcare supply chain, apply scenario-based planning methodologies to the healthcare supply chain, and recommend and develop innovative strategies, policies, and technologies. The MEHD Group has partnered with several companies to move this initiative forward including Caremark, Pfizer, Cardinal Health, and Cephalon.


CIHL, a collaboration of University of Arkansas researchers, healthcare providers, interested corporations, and government agencies seeking healthcare supply chain and logistic innovations, received $50,000 for its initiative "Identifying Opportunities for Cost and Quality Improvements in Healthcare Logistics." CIHL was established through an initial investment of $1 million and primary funding commitments from strategic partners Wal-Mart, Blue Cross and Blue Shield (of Arkansas, Alabama, and Illinois) and VHA to recover significant costs and achieve new efficiencies through the healthcare supply chain while improving safety, quality, and equity of patient care.

For more information on SCMetrix, please visit. For more information on the work of the MEHD Group, please visit. For more information on CIHL, please visit http://cihl.uark.edu. 

 

New strategy helps reduce errors in obstetrical care 

Researchers at Yale School of Medicine have implemented patient safety enhancements to dramatically reduce errors and improve the staff’s own perception of the safety climate in obstetrical care. Edmund F. Funai, M.D., associate professor in the Department of Obstetrics, Gynecology & Reproductive Sciences at Yale, presented preliminary results from this research at the Society for Maternal Fetal Medicine Annual Meeting. An estimated 44,000 to 98,000 Americans die in hospitals each year as a result of errors. About half of medical errors are linked to communication errors and system failures. Obstetrics has lagged behind other specialties in attempts to improve safety because perinatal adverse events are both relatively uncommon and usually unexpected, occurring in previously healthy patients who are anticipating good outcomes.

Funai and his team designed and implemented clinical patient safety interventions at Yale-New Haven Hospital. These included communication training, standardizing interpretation of fetal monitoring, and creating a novel staff role—the patient safety nurse. In tracking and analyzing 14 markers for adverse outcomes, the team found that the rate of adverse events decreased by about 60 percent over 2.5 years, while the staff’s own perception of the overall safety climate increased by 30 percent, according to a survey given by a third party. Funai said that the main cause of adverse events and patient injury is a breakdown in communication, usually involving failure to recognize the severity of a given situation or condition, often involving a newborn’s status.

Funai said, “After taking these surprisingly simple steps to address safety, both patients and staff report that the care is much more seamless and better organized,” he said. “The staff is more comfortable and empowered to communicate their concerns about a patient. A comfortable staff often leads to more successful patient outcomes.” See this link

 

Severe stressful events early in pregnancy may be associated with schizophrenia among offspring

 

Children of women who undergo an extremely stressful event, such as the death of a close relative, during the first trimester of pregnancy appear more likely to develop schizophrenia, according to a report in the February issue of Archives of General Psychiatry.

 

“The common conception that a mother’s psychological state can influence her unborn baby is to some extent substantiated by the literature,” the authors write as background information in the article. “Severe life events during pregnancy are consistently associated with an elevated risk of low birth weight and prematurity.” Schizophrenia, a disabling condition associated with abnormal brain structure and function, is increasingly believed to begin in early brain development. Environmental factors, including those occurring during pregnancy, and susceptibility genes may interact to influence risk.

 

Ali S. Khashan, M.Sc., of the University of Manchester, England, and colleagues used data from 1.38 million Danish births occurring between 1973 and 1995. Women were linked to close family members using a national registry, and the same registry was used to determine if any of these relatives died or received a diagnosis of cancer, heart attack or stroke during each mother’s pregnancy. Their children were followed from the 10th birthday through June 30, 2005 or until they died, moved out of the country, or developed schizophrenia.

 

During the study period, mothers of 21,987 children were exposed to the death of a relative during pregnancy, 14,206 were exposed to a relatives’ serious illness during pregnancy and 7,331 of the offspring developed schizophrenia. The risk of schizophrenia and related disorders was approximately 67 percent greater among the offspring of women who were exposed to the death of a relative during the first trimester. However, death of a relative up to six months before or any other time during pregnancy was not related to risk for schizophrenia in the child, nor was exposure to serious illness in a relative. The association between a family death and risk of schizophrenia appeared to be significant only for individuals without a family history (parents, grandparents or siblings) of mental illness.

 

Pre-chewed baby food said to transmit H.I.V.

 

Researchers have identified another way that babies can be infected with H.I.V. — through food pre-chewed by an infected parent or caretaker. Although thousands of babies have been infected in the United States over the last 15 years, pre-chewed food has been documented as the cause of just three cases, federal epidemiologists said wednesday. But such transmission may not be so rare, Dr. Kenneth L. Dominguez’s team from the Centers for Disease Control and Prevention said at the 15th Conference on Retroviruses and Opportunistic Infections.

 

Pre-chewing food apparently occurs among many groups in this country and elsewhere. So transmission of H.I.V., the AIDS virus, to infants may be an unrecognized problem in developing countries where dental care is lacking, commercially prepared baby foods and blenders are not available and parents and caretakers may need to soften foods, Dr. Dominguez said in an interview.

His team said there were several reasons for reporting the three cases, dating from 1993, for the first time. One was to make healthcare providers and caregivers of infected children aware of the potential risk of pre-chewing. Another was to ask doctors and family members to report suspected cases to health officials to quantify the threat.

 

Human immunodeficiency virus is present in saliva, but usually in amounts too low to cause transmission. So, presumably, blood, which has larger amounts of the virus, is also needed for transmission. Infected chewers with inflammations or open mouth sores can pass the virus to infants through cuts or other common teething conditions, Dr. Dominguez said.

Although the three cases were among African-Americans born in the United States, pre-chewing is prevalent among many ethnic and racial groups, according to a recent national survey of infant feeding by the C.D.C., Dr. Dominguez said. “It’s likely that some cultural influences are involved, and I am sure that people are doing what their grandmothers and aunties did in practices carried through generations,” Dr. Dominguez said.

 

The first two cases involved boys from Miami infected in the mid-’90s. One boy’s infection was detected when he was 39 months old, shortly before his death, after previously testing negative for the virus twice. The mother, who was infected, reported pre-chewing food for the boy.

The second boy’s mother was uninfected but lived with an infected aunt who pre-chewed his food. He survives. In the third case, a girl from Memphis was found to be infected in 2004 at 9 months old after testing negative for the virus three times. Her mother was infected and pre-chewed food for her daughter.

 

Researchers will try to determine whether other dangerous microbes like hepatitis B virus and Helicobacter pylori might be transmitted through pre-chewed food. (NY Times) http://www.nytimes.com/2008/02/07/us/07hiv.html?ref=health

 

 

Study suggests new therapy for lung disease patients

 

A new study by researchers at Northwestern University's Feinberg School of Medicine may change current thinking about how best to treat patients in respiratory distress in hospital intensive care units. It has been commonly believed that high levels of carbon dioxide (CO2) or hypercapnia in the blood and lungs of patients with acute lung disease may be beneficial to them. Now, for the first time, scientists have shown how elevated levels of CO2 actually have the opposite effect. The excessive CO2 impairs the functioning of the lungs. Jacob Sznajder, M.D., chief of pulmonary and critical care at the Feinberg School, and his research team found that high levels of CO2 make it harder for the lungs to clear fluid.

 

The excess CO2 initiates a signaling cascade leading to the inhibition of the action of sodium “pumps” that help move water out of the air spaces. This creates a greater risk of edema in which the lungs flood with fluid. The investigators worked with rats and human cells for the study, which was published in the February issue of the Journal of Clinical Investigation.

 

"Allowing high levels of CO2 may contribute to the high mortality of patients with diseases like chronic obstructive pulmonary disease (COPD)," said Sznajder, a professor of medicine and of cell and molecular biology at the Feinberg School and a physician at Northwestern Memorial Hospital. "This study argues toward therapies to reduce the high CO2 levels of patients toward normal levels, which is not the current practice in the intensive care unit."

COPD is the fourth leading cause of death in the United States, killing more than 120,000 people, according to the National Institutes of Health. When people have COPD, their lungs lose elasticity and have trouble exchanging carbon dioxide for oxygen. COPD used to be strictly a disease of smokers, but now it's also crippling the lungs of non-smokers.

 

WHO releases new report on global tobacco control efforts

 

WHO has released new data showing that while progress has been made, not a single country fully implements all key tobacco control measures, and outlined an approach that governments can adopt to prevent tens of millions of premature deaths by the middle of this century. In a new report which presents the first comprehensive analysis of global tobacco use and control efforts, WHO finds that only 5% of the world’s population live in countries that fully protect their population with any one of the key measures that reduce smoking rates. The report also reveals that governments around the world collect 500 times more money in tobacco taxes each year than they spend on anti-tobacco efforts. It finds that tobacco taxes, the single most effective strategy, could be significantly increased in nearly all countries, providing a source of sustainable funding to implement and enforce the recommended approach, a package of six policies called MPOWER.

 

The report also documents the epidemic's shift to the developing world, where 80% of the more than eight million annual tobacco-related deaths projected by 2030 are expected to occur. Other key findings in the report include:40% of countries still allow smoking in hospitals and schools; Only 5% of the world’s population lives in countries with comprehensive national bans on tobacco advertising and promotion; Just 15 countries, representing 6% of the global population, mandate pictorial warnings on tobacco packaging; Services to treat tobacco dependence are fully available in only nine countries, covering 5% of the world’s people; Tobacco tax revenues are more than 4000 times greater than spending on tobacco control in middle-income countries and more than 9000 times greater in lower-income countries. High- income countries collect about 340 times more money in tobacco taxes than they spend on tobacco control. See this link

http://www.who.int/mediacentre/news/releases/2008/pr04/en/index.html

 

 

Comatose locusts may help relieve migraines

 

The way locusts react to stress may provide an important clue to understanding what causes human migraines – and how to reduce their painful effects, says Queen’s University, Kingston, ON, Canada, Biology professor, Mel Robertson. With PhD student Corinne Rodgers, Dr. Robertson is using insect models to examine how the nervous system controls breathing when stress is induced through high temperatures and oxygen deprivation. They have discovered that the locust’s reaction to extreme heat is very similar to a disturbance in mammals that has been associated with human migraines and stroke.

 

As a way of temporarily shutting down and conserving energy when conditions are dangerous, the locust’s coma has many of the same characteristics seen in people at the onset of a migraine. “We feel there may be an evolutionary link between the two,” Dr. Robertson suggests. His team’s findings are published on-line in the journal PLoS ONE.

 

The study monitors locust breathing cycles, which are controlled by a collection of nerve cells in the central nervous system. With heat or lack of oxygen, the insects initially breathe more quickly and then go into a coma. They recover when the temperature comes down again, or oxygen levels rise.

 

“We find that the point of coma is always associated with a surge of extra-cellular potassium ions: the same as has been observed in human brain tissue during surgery,” says Rodgers. For the nervous system to work properly, potassium should be high inside cells and low outside, she points out. “What we’re seeing is a failure of that ability to maintain this equilibrium – but in fact, in the locust, it appears to be an adaptive response to protect the system.”

Previous research in Dr. Robertson’s lab has shown a genetic component to this response, which indicates there may be an evolutionary link to what happens during migraines in people. “It’s possible, for example, that the brain architecture necessary for increased sensitivity also predisposes areas of some people’s brains to become over-excited, and that migraines provide a means of temporarily ‘shutting things down,’” he suggests.

 

While migraine has been associated with this disturbance for some time, the mechanisms underlying the phenomenon are not yet well understood. And that understanding will be key to designing new migraine treatments.

 

“We found that we could precondition the locust system to be more stress-tolerant. If the mechanisms are the same as those in humans, then similar manipulations could help to protect brain function under stressful conditions, such as those leading to migraine,” says Dr. Robertson. “Something is triggering events like this,” he adds. “Maybe we can just bias that slightly, so it won’t trigger as often, or the consequences will not be as severe.” See this link

http://qnc.queensu.ca/story_loader.php?id=47ab14cc309b7

 
 

 


February 7, 2008  Download print version

Intensive blood sugar treatment in trial of diabetes and cardiovascular disease changed

Safety of drug imports questioned; Some in Congress want FDA to expand overseas inspections

Last chance to register for the Supply Chain Technology Symposium in Orlando

Broadlane announces strategic relationship with ECRI Institute

Wal-Mart will expand in-store medical clinics


Over half all hospital patients are at risk of venous thromboembolism and need prophylaxis


FDA takes action to stop the marketing of unapproved injectable drugs containing colchicine


Intensive blood sugar treatment in trial of diabetes and cardiovascular disease changed

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped one treatment within a large, ongoing North American clinical trial of diabetes and cardiovascular disease 18 months early due to safety concerns after review of available data, although the study will continue. In this trial of adults with type 2 diabetes at especially high risk for heart attack and stroke, the medical strategy to intensively lower blood glucose (sugar) below current recommendations increased the risk of death compared with a less-intensive standard treatment strategy.

Study participants receiving intensive blood glucose lowering treatment will now receive the less-intensive standard treatment. The ACCORD (Action to Control Cardiovascular Risk in Diabetes) study enrolled 10,251 participants. Of these, 257 in the intensive treatment group have died, compared with 203 within the standard treatment group. This is a difference of 54 deaths, or 3 per 1,000 participants each year, over an average of almost four years of treatment. The death rates in both groups were lower than seen in similar populations in other studies.

“A thorough review of the data shows that the medical treatment strategy of intensively reducing blood sugar below current clinical guidelines causes harm in these especially high-risk patients with type 2 diabetes,” said Elizabeth G. Nabel, M.D., director, NHLBI. “Though we have stopped this part of the trial, we will continue to care for these participants, who now will receive the less-intensive standard treatment. In addition, we will continue to monitor the health of all participants, seek the underlying causes for this finding, and carry on with other important research within ACCORD.”

 

“The ACCORD findings are important, but will not change therapy for most patients with type 2 diabetes. Few patients with high cardiovascular risk like those studied in ACCORD are treated to blood sugar levels as low as those tested in this study, “ said Judith Fradkin, M.D., director, Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “People with diabetes should never adjust their treatment plan or goals without consulting their healthcare providers.” See THIS LINK


 

Safety of drug imports questioned; Some in Congress want FDA to expand overseas inspections

With an ever-larger percentage of prescription drugs and drug ingredients coming to the U.S. market from developing nations such as China and India, Congress is voicing concern that the number of inspections of those plants by the Food and Drug Administration has grown far more slowly. In a Feb. 1 letter to the FDA, Sen. Charles E. Grassley (R-IA) said that the small number of inspections in these newer markets is putting consumers at risk.

In particular, he wrote, he was concerned that the number of inspections in China, a major supplier of active drug ingredients, is small and actually dropped from 18 in 2004 to 11 in 2007. China is believed to have hundreds, if not thousands, of plants that make ingredients for drugs headed to the United States. "I found these numbers very troubling," Grassley wrote. "Since the beginning of FY 2002, the FDA conducted approximately 1,379 inspections of foreign pharmaceutical facilities, often focused in countries with few reported quality concerns."

Other lawmakers and outside experts are worried that drugs from low-cost producers in India, China and elsewhere are not receiving the FDA scrutiny they require. Grassley's staff asked the FDA last year if it is planning to open an office in India. In December, the agency said it was considering a new office only in China. Last month, however, FDA Commissioner Andrew C. von Eschenbach told reporters that he was working on a plan to station inspectors in six regions abroad so they can inspect plants on an "ongoing and continuous basis rather than episodic and periodic."

According to the statistics provided to Grassley, even that kind of inspection does not happen very often. And an overwhelming number of inspections are conducted in nations such as Germany, Switzerland, Italy and Canada rather than in countries with much weaker drug inspection programs of their own. This is largely because the FDA can allocate "user fees" provided by brand-name drug companies to pay for inspections of their plants, many of which are in Europe. The agency does not have nearly as much money to pay for inspections for low-cost generic drugs because those manufacturers do not pay such fees. Grassley said in his letter that "this seems to be a misplacement of limited FDA resources."

The FDA says that consumers still can be confident in the quality of the drugs they take. The agency says it has required improvements in the entire drug manufacturing process and does not rely entirely on inspections. Responding to an October letter from Grassley's staff, Stephen R. Mason, the FDA's acting commissioner for legislation, said it cost the agency $6.2 million in fiscal 2007 to pay for about 300 foreign drug inspections. The Bush administration has proposed a budget increase of 5.7 percent for the FDA, with additional money for foreign inspections, especially of food. But critics said those funds will barely keep up with scheduled pay raises. The Government Accountability Office reported last year that the FDA does not know how many foreign plants are manufacturing products for the American drug market, and is unaware whether they are being inspected effectively. (Washington Post) See THIS LINK

 


Last chance to register for the Supply Chain Technology Symposium in Orlando

The HIMSS-AHRMM pre-conference Supply Chain Technology symposium, previously sold out, has announced that they were able to add room for just 25 more attendees. These spots are available on a first come basis only. For registration information see THIS LINK 

HIMSS (The Healthcare Information and Management Systems Society) is collaborating with the Association for Healthcare Resource & Materials Management (AHRMM) to provide a value-packed, one-day preconference symposium on healthcare supply chain technology, to be held Sunday, February 24, from 8 am to 4 pm ET in Orlando, FL at the Orange County Convention Center.

Educational
sessions will focus on the supply chain process and the information systems that support it. This event is essential for materials managers, Logisticians, Supply Chain Officers and IT professionals to learn about leading practices in the industry, data management and utilization, and integration and implementation solutions. Join AHRMM at the HIMSS08 Annual Conference. Supply chain solutions are constantly moving ahead...don’t get left behind!

Topics of discussion include: “Best practices from around the world that can be applied in the U.S.”; “The next generation in supply chain benchmarking”; “How to create an effective data warehouse in a provider setting”; “How proposed standards could impact quality and patient safety”. Join your peers to learn the very latest in your profession today, and what it could mean for all of us tomorrow. Opening keynote speaker, Jay Kirkpatrick, CMRP, CEO, Nashville Supply Chain Services, will address: “Supply Chain Management from A to Z; Where we are, Where we need to go, and What we need to do to get there”.

To view the agenda see THIS LINK 

For more information on the HIMSS conference see
THIS LINK
 

In addition, there will be an annual Supply Chain Management Special Interest Group (SIG) meeting at the HIMSS conference: "Disaster Planning from the Supply Chain Perspective" on Tuesday, Feb. 26, 1:30- 3 pm, Orlando Convention Center, Room 240C. No registration is necessary for the SIG meeting – please join us!

 


Broadlane announces strategic relationship with ECRI Institute

ECRI Institute, an independent, nonprofit organization that researches the best approaches to improving patient care, will serve as an unbiased expert, offering equipment purchasing clients the inside track on the latest medical equipment at Broadlane’s upcoming Computed Tomography (CT) Live Group Buy. “Roughly 41 percent of hospitals will be purchasing a CT this year,” said Kerry Tucker, vice president, supply chain services, Broadlane. “By combining ECRI Institute’s state-of-the-art technology and marketplace insight with Broadlane’s rigorous Live Group Buy process, attendees should achieve double-digit savings and confidence they are making wise product choices based on the best information available.”

ECRI Institute will present a technology session and be on-hand as an expert resource during the CT Live Group Buy, which will occur March 26-28. ECRI Institute will provide event participants insight into: The state of the marketplace: What technologies are available now and where are they heading? Key clinical issues: What issues are most important when considering a purchase? Recent technological advances: How do these advances impact performance and value?

Participants have three options: 1.) Attend the Live Group Buy with the ECRI Institute technology seminar 2.) Attend only the ECRI Institute technology seminar 3.) Call into an audio conference for key topics in the ECRI Institute seminar

Future Live Group Buys: The Cardiac Cath Lab/Angio Suites Live Group Buy will be held April 23-25; and the MRI Live Group Buy will be held May 28-30. Other Live Group Buys scheduled for 2008 include Ultrasound, Nuclear Medicine/PET-CT, Digital Mammography, Digital Radiography and Radiography and Fluoroscopy (R&F).

The Broadlane Live Group Buy process is unique within the industry: Participants determine and weight the criteria used to evaluate the equipment and suppliers. Participants then rate supplier technology, identify key operational support components, participate in live negotiations and ultimately make a contract award.

If you are interested in attending a Broadlane Live Group Buy or have any other questions, please visit www.broadlane.com/groupbuyad.html or contact Patricia Coffey at 866.276.2356, ext. 7520 or patricia.coffey@broadlane.com.


For more information see THIS LINK.

 

 

Wal-Mart will expand in-store medical clinics

 

Moving to upgrade its walk-in medical clinic business, Wal-Mart is set to announce on Thursday plans for several hundred new clinics at its stores, using a standardized format and jointly branded with hospitals and medical groups. The first of the new Clinic at Wal-Mart walk-in centers, as they will be called, is to open in Little Rock, AR, in April and be run by nurse practitioners employed by the St. Vincent Health System, a three-hospital group in central Arkansas. Wal-Mart also says it plans to brand 200 of the new clinics with RediClinics, one of the Revolution Health companies of Steven Case, the AOL co-founder. Those are to be operated in partnership with various local healthcare providers. RediClinic, which already operates 13 clinics in Wal-Mart stores, plans to open one of the new units in Atlanta in April and another in Dallas next summer.

“We have learned that people are willing to receive their healthcare from the front of a store or the back of a drugstore,” said Dr. John Agwunobi, a medical doctor who is a Wal-Mart senior vice president. “But customers also have said they would rather it be delivered by a trusted name, a local healthcare practice, a trusted local provider of care.”

In all, Wal-Mart plans to have 400 store clinics by 2010, including current units that will be converted to the new brand as their leases come up for renewal. The company currently has 78 in-store clinics around the country, but has had uneven performance in some cases. Wal-Mart does not operate any clinics itself but is seeking local hospitals and medical practices as partners, said Deisha Galberth, a Wal-Mart spokeswoman.

Walk-in medical clinics are a growing industry, with numerous competitors that include big-box retailers, drugstores and even grocery chains around the country. Industry executives say 1,500 to 1,800 clinics will be open by the end of the year. Propelled by the drugstore chains
CVS and Walgreens, by far the biggest sponsors of the clinics to date, more than 700 clinics have opened in the last 15 months. But the business model is unproven so far. Few, if any, clinics are profitable, according to industry analysts, and only a handful have broken even on daily operations. Most have been open a year or less, and executives say it takes up to three years for a clinic to become profitable enough to recover start-up costs.

Medical societies are inclined to be skeptical of the clinics. The
American Academy of Pediatrics opposes them, saying they add to fragmentation in the healthcare system. Dr. Edward Zissman, a pediatrician in central Florida, said he had qualms about hospitals that hook up with the clinics. “Putting their name on a product that I don’t think has the highest quality,” he said, “is going to cost them dearly with physicians.”

The American Academy of Family Physicians and the
American Medical Association have set forth principles for clinics to observe, including sending patients’ medical record to their doctors and finding doctors for patients who do not already have them. Most states require varying degrees of physician supervision of the clinic nurses. Clinic operators say they are complying.

Wal-Mart, for its part, rents store space to clinics operated by eight independent clinic companies and two hospital systems:
Aurora Health in Wisconsin and North Broward Hospital District in Florida. The company plans to convert all of them to the Clinic at Wal-Mart brand as those leases expire, Galberth said. (The New York Times)

 

See THIS LINK 

 

 

 

Over half all hospital patients are at risk of venous thromboembolism and need prophylaxis


More than half of all hospital patients are at risk of venous thromboembolism (VTE), and steps must be taken to ensure that these patients are given appropriate preventive treatment to reduce this risk (prophylaxis). These are the conclusions of authors of an Article published in this week's edition of The Lancet. VTE is a common complication during and after hospitalization for acute medical illness or surgery. One type of VTE, pulmonary embolism, accounts for 5-10% of deaths in hospitalized patients, making VTE the most common preventable cause of in-hospital death (VTE results in over 20 times more hospital deaths than MRSA).

 

A US government review comparing 79 hospital preventive strategies (including hand-washing, antibiotic prophylaxis and pressure care) has rated VTE prophylaxis as the single most important strategy, based on efficacy, safety and cost. While guidelines for VTE prophylaxis have been available for over 15 years, such treatment remains underused, and the proportion of patients who should receive it globally remains unknown. Appropriate treatments include anticoagulant drugs such as heparins and warfarin and mechanical methods such as intermittent pneumatic compression and graduated compression stockings.

 

Dr. Ander Cohen, Vascular Medicine, King's College London, UK, and Professor Ajay Kakkar, Barts and The London School of Medicine and Dentistry, London, UK, and colleagues did the ENDORSE study, which was designed to assess the prevalence of VTE risk in the acute hospital care setting, and determine the proportion of at-risk patients who receive effective prophylaxis. The study analyzed all hospital inpatients aged 40 years or over admitted to a medical ward, or those aged 18 or over admitted to a surgical ward, in 358 hospitals across 32 countries, and assessed them for VTE risk on the basis of hospital chart review. The 2004 American College of Chest Physicians (ACCP) evidence-based consensus guidelines were used to assess VTE risk and determine whether patients were receiving recommended prophylaxis.

 

The researchers found that of 68,183 patients enrolled, 30,827 (45%) were categorized as surgical, and 37,356 (55%) as medical. Using ACCP criteria, 35,329 patients (51.8%) were judged to be at risk for VTE, including 19,842 (64.4%) of surgical patients and 15,487 (41.5%) of medical patients. Of the surgical patients at risk, 11,613 (58.5%) received ACCP-recommended VTE prophylaxis, compared with 6,119 (39.5%) of at-risk medical patients.

 

The proportions of patients receiving ACCP recommended VTE prophylaxis varied widely across the 32 countries, but did not necessarily follow the high-middle-low income gradient. For example, for at-risk medical patients the three countries with the highest proportions receiving prophylaxis were Germany (70%), Spain (64%), and Colombia (64%). Those with the lowest were Bangladesh (3%), Thailand (4%), and Romania (18%). In this category, the US scored 48% and the UK just 37%. For at-risk surgical patients, the best performing countries were again Germany (92%), Hungary (87%) and again Spain (82%); and the worst were again Bangladesh and Thailand (both 0.2%), and Pakistan (10%). The UK scored 74% and the US 71%.

 

The authors say: "The data gathered show that, worldwide, more than half of all hospitalized patients are at risk for VTE, and that surgical patients seem to be at higher risk than medical patients." And, most significantly, they add: "Furthermore, only half of at risk patients received an ACCP-recommended method of prophylaxis." They conclude: "Hospital-wide strategies to assess patients' VTE risk should be implemented, together with measures that ensure that at-risk patients receive appropriate VTE prophylaxis."

 


 

 

FDA takes action to stop the marketing of unapproved injectable drugs containing colchicine


The U.S. Food and Drug Administration announced its intention to take enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure. Individuals and companies must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action which could include seizure, injunction or other legal action deemed appropriate by the agency. After these dates, all injectable colchicine drug products must have FDA approval to be manufactured or shipped interstate.

"Until recently, there was one manufacturer of unapproved injectable colchicine, and that firm has ceased manufacturing the product," said Deborah Autor, director of the FDA's Office of Compliance, CDER. "This serves as the agency's warning that firms wishing to make injectable colchicine in the future must not manufacture the product until they apply for and are granted approval by the FDA to do so."

In addition to being manufactured by pharmaceutical companies, injectable colchicine products are sometimes formulated on a smaller scale by compounding pharmacies, often for use in the treatment of back pain. Three of the deaths from intravenous colchicine occurred in March and April of 2007 and were associated with the use of compounded colchicine that, due to an error in preparation, was eight times more potent than the amount stated on the label. The FDA has not approved colchicine in any dosage form for the treatment of back pain. This action does not affect colchicine products that are dispensed in tablet form and are frequently used to prevent gout attacks. For more information, see THIS LINK.

 

 


February 6, 2008  Download print version

Bill aims to protect patients from paying for hospital errors

Hospital diarrhea germ costs $1.3 billion in U.S.

Three-parent embryo formed in lab

Drug-coated stents better than bare-metal ones in complex cases

UK hospital denies attempt to manipulate MRSA figures


TSO3 announces contract with Broadlane

MedAssets expands relationship with Valley Medical Center
for cash flow and margin enhancement initiatives

WHO60 photo exhibition: public health over the past 60 years
 


Bill aims to protect patients from paying for hospital errors

The Maine Hospital Association recently announced a voluntary statewide initiative aimed at preventing patients and insurance companies from getting billed for the expense of medical errors such as a bedsore, a medication error or the wrong surgery. But a state lawmaker says the voluntary policy doesn’t go far enough and is pushing for an enforceable law that would make it illegal to charge patients or other payers for medical missteps that should never have happened in the first place. "Everyone knows mistakes happen, but that’s no reason to punish the people they happen to," said Rep. Patsy Crockett, D-Augusta, sponsor of LD 2044. "The person who makes the mistake should absorb that cost." By protecting patients and insurance companies, the measure also would help hold down spiraling healthcare costs in Maine, she said.

Crockett’s bill, originally submitted to the Legislature last fall, includes a roster of 27 "never events", as they’re referred to in the healthcare world, because they "never" should occur, including surgery performed on the wrong body part; disability related to the use of contaminated drugs; injuries suffered by falling, serious burns or electrical shocks; and reactions to transfusions of incompatible blood products. The list is drawn from the National Quality Forum, an organization that promotes accurate reporting of health care quality data.

The Maine Hospital Association, which represents all 39 hospitals in Maine, announced last Friday that its board has approved a voluntary measure encouraging hospitals to protect patients from being billed for costly care related to preventable errors. The MHA’s list of "adverse health events" is essentially identical to that included in Crockett’s bill, with the addition of No. 28, "Artificial insemination with the wrong donor sperm or egg." The 28th item reflects the most recent addition to the National Quality Forum list.

Neither Crockett’s proposal nor the MHA policy pertains to potentially lethal infections such as staph or C. difficile. Crockett and Mary Mayhew, vice president of government affairs and communications for the hospital association, concurred that it’s too hard to know whether a patient contracted an infection during a hospital stay or already was carrying the infective organism when admitted. (Bangor Daily News) See THIS LINK


 

Hospital diarrhea germ costs $1.3 billion in U.S.

A bacterial infection that's acquired in hospitals and causes severe diarrhea costs more than $1.3 billion a year to treat in the U.S., a study found. Each infection of the bacteria, called clostridium difficile, costs more than $7,000 to treat, according to the study by researchers at Washington University School of Medicine and the U.S. Centers for Disease Control and Prevention. It was published today in the journal Clinical Infectious Diseases. Clostridium difficile causes about 3 million cases of diarrhea in the U.S. each year, according to a 2005 report by the American Academy of Family Physicians, a professional group based in Leawood, Kansas. The emergence of antibiotic-resistant strains has led to more complications and longer hospital stays, creating demand for new treatments.
 

Clostridium difficile “poses a significant financial burden to our healthcare system and to society in general,” said Erik Dubberke, an assistant professor at the Washington University School of Medicine and author of the study. “The true costs are likely higher than our estimates, as our methods were very conservative.”

 

Researchers analyzed the records of more than 24,000 patients admitted to a hospital in St. Louis, MO, in 2003. Of those, 439 developed clostridium difficile, which affects hospital patients who have taken antibiotics. Treating the disease in the hospital cost from $2,454 to $3,240, and follow-up treatments cost $5,042 to $7,179, the study found.
 

The study only looked at admitted hospital patients and didn't include other acute-care facilities, nursing homes, outpatient visits to the doctor, outpatient medication or costs related to loss of work. Clostridium difficile costs as much as $1.3 billion a year in the U.S., based on the cost per treatment at the St. Louis hospital and the number of estimated hospital cases in the U.S., the study said.

About 178,000 short-term hospitalizations were complicated by clostridium difficile in 2003, according to a 2006 study in the Journal of Emerging Infectious Disease cited in today's report. That increased to as many as 250,000 people in 2005, according to separate CDC data reported in the new study. Genzyme Corp.'s experimental medicine to treat clostridium difficile was less effective than standard treatment with the antibiotic vancomycin, according to a study released in July. Genzyme's tolevamer isn't an antibiotic. It was designed to neutralize toxins released by clostridium difficile that damage the intestines. The drug won't reach the market by 2009 as earlier predicted, Genzyme said in July. (Bloomberg News) See
THIS LINK

 

 


Three-parent embryo formed in lab

Scientists believe they have made a potential breakthrough in the treatment of serious disease by creating a human embryo with three separate parents. The Newcastle University team believe the technique could help to eradicate a whole class of hereditary diseases, including some forms of epilepsy. The embryos have been created using DNA from a man and two women in lab tests. It could ensure women with genetic defects do not pass the diseases on to their children. The technique is intended to help women with diseases of the mitochondria. Faults in the mitochondrial DNA can cause around 50 known diseases, some of which lead to disability and death. About one in every 6,500 people is affected by such conditions, which include fatal liver failure, stroke-like episodes, blindness, muscular dystrophy, diabetes and deafness. At present, no treatment for mitochondrial diseases exists.

The Newcastle team have effectively given the embryos a mitochondria transplant. They experimented on 10 severely abnormal embryos left over from traditional fertility treatment. Within hours of their creation, the nucleus, containing DNA from the mother and father, was removed from the embryo, and implanted into a donor egg whose DNA had been largely removed. The only genetic information remaining from the donor egg was the tiny bit that controls production of mitochondria, around 16,000 of the 3 billion component parts that make up the human genome. The embryos then began to develop normally, but were destroyed within six days.

Experiments using mice have shown that the offspring with the new mitochondria carry no information that defines any human attributes. So while any baby born through this method would have genetic elements from three people, the nuclear DNA that influences appearance and other characteristics would not come from the woman providing the donor egg. However, the team only have permission to carry out the lab experiments and as yet this would not be allowed to be offered as a treatment. Professor Patrick Chinnery, a member of the Newcastle team, said: "We believe that from this work, and work we have done on other animals that in principle we could develop this technique and offer treatment in the forseeable future that will give families some hope of avoiding passing these diseases to their children." Dr. Marita Pohlschmidt, of the Muscular Dystrophy Campaign, which has funded the Newcastle research, was confident it would lead to a badly needed breakthrough in treatment.

"Mitochondrial myopathies are a group of complex and severe diseases," she said. "This can make it very difficult for clinicians to provide genetic counseling and give patients an accurate prognosis." However, but the Newcastle work has attracted opposition. Josephine Quintavalle, of the pro-life group Comment on Reproductive Ethics, said it was "risky, dangerous" and a step towards "designer babies". "It is human beings they are experimenting with," she said. "We should not be messing around with the building blocks of life." Quintavalle said embryo research in the US using DNA from one man and two women was discontinued because of the "huge abnormalities" in some cases. (BBC NEWS) See THIS LINK


 

Drug-coated stents better than bare-metal ones in complex cases

Drug-coated stents are better than the bare-metal kind for treating complex arterial blockages, new research finds. "There are two messages I would take away from the study," said Dr. Robert J. Applegate, a professor of cardiology at Wake Forest University and lead author of a report in the Feb. 12 issue of the Journal of the American College of Cardiology. "The first is that drug-eluting stents are very effective. They were effective in the kind of patients in the initial trials, with simpler problems. Then their effectiveness was broadened to all patients who underwent stent treatment, even in off-label use. All the benefits present in the early trials are showing in the patients that have these high-risk features." High-risk factors include diabetes, kidney failure, a recent heart attack and longer blockages, Applegate said. "All of these have been matters of concern about the use of drug-eluting stents. We saw them to be effective in these patients."

The study compared results of 1,285 people with such complications who got drug-coated stents, flexible tubes implanted to keep blood vessels open after the clot-removing procedure called angioplasty and 1,164 people who had bare-metal stents. After two years, the incidence of nonfatal heart attacks or deaths was 29 percent lower for those getting drug-coated stents. The drug-coated stents were also safer, with the incidence of stent-caused clotting roughly half that seen in the bare-metal stent recipients.

Another study reported in the same issue of the journal was more cautious about the long-term effectiveness of drug-coated stents. The study of 310 people who got stents after heart attacks found that those who got drug-coated stents were better off after a year than those getting bare-metal stents, but that there were worrying indications of a possible higher risk of artery reblockage in the coated-stent group. Stents have been very much in the news lately, with studies such as one that found equal effectiveness of the two drug-coated stents now available in the American market, one sold by Boston Scientific, the other by Cordis. That study was funded by the two companies, as was the newly reported Wake Forest study. Applegate said that financing of the study by industry did not affect the results of the research. "They had absolutely no influence on the study design, the acquisition of data, the interpretation of data or the scripting of the manuscript," he said.
 

Its getting harder to do meaningful medical research in the United States for a variety of reasons, said an accompanying editorial by Dr. Cindy Grines, vice chief of academic affairs at William Beaumont Hospital in Royal Oak, Mich. The somewhat frightening "off-label" designation, which means the U.S. Food and Drug Administration hasn't approved that use, is necessary because of the difficulty of conducting trials in the United States, she explained. "Eighty percent of the studies now are being done outside the United States," Grines said.

Some of the blame goes to the complex rules imposed by the FDA, she said, but the propensity for people claiming damage to file suits also has a constraining effect. "There are Web sites with legal advice," Grines said. "So, it is very defensive medicine that people are practicing. A consent form might be 10 pages long to do a simple study, which becomes financially undoable in most institutions. It would be really nice if we could have more ability to do these studies here." (HealthDay News) See
THIS LINK

 




UK hospital denies attempt to manipulate MRSA figures

An National Health Service (NHS) trust was accused of ordering a cut in blood tests to manipulate figures to reduce its official MRSA rate. Kingston hospital, south-west London, reported a 44% fall in cases of the superbug from 2005-06 to 2006-07. But a disgruntled staff member told the BBC that while hygiene had improved, the fall was partly due to a drive to encourage staff to reduce the number of patients tested. "Certainly there will be a sort of significant reduction simply by doing fewer blood tests. If you are not looking for something you won't pick it up," he told the BBC. "I thought we were all meant to be trying to reduce the risk of MRSA genuinely, rather than simply massaging figures to reduce the number of tests."

In a Kingston hospitals NHS trust email which was leaked to the broadcaster, clinical staff were encouraged to cut the number of tests for the superbug, and to question whether each test was needed. One factor to consider, the email said, was whether an MRSA test would help patients if they were terminally ill. Staff were also warned of the negative impact of finding MRSA cases on patients and were advised it could affect the hospital's ambition to become a foundation trust.

The trust denied the email revealed an attempt to manipulate the figures and reduce the number of MRSA cases reported. It said the trust had been carrying out more blood tests than many others, and aimed to cut test numbers to match those at comparable hospitals. Helen Dirilen, the trust's director of nursing and quality, said: "As part of good practice, a memo was sent to all clinical staff last week (originally circulated in September 2006) to remind them of the correct procedures and indications for the collection of blood culture samples from patients. "The aim is to ensure patient safety and to try and prevent contamination of blood culture samples. Reducing MRSA and all hospital acquired infections is one of our key priorities. "We have received recognition from the Department of Health for our work and areas of excellent practice such as the receptionists in A&E encouraging visitors and patients to use alcohol hand rub. We will continue with this drive for improvement." (The Guardian) See THIS LINK

 


 

TSO3 announces contract with Broadlane

TSO3 Inc. (“TSO3”) announces the signing of an agreement with Broadlane, a supply chain services company that provides technology-oriented business solutions to improve the financial and operational performance of thousands of acute care hospitals, ambulatory care facilities, physician practices and other healthcare providers throughout the United States. This new multi-year contract effective Feb. 1, 2008, offers exclusive pricing and price protection to Broadlane clients on the 125L Ozone Sterilizer, and all TSO3 Service and accessory products.

 


MedAssets expands relationship with Valley Medical Center for cash flow and margin enhancement initiatives

MedAssets Inc. announced that Valley Medical Center signed an agreement to expand their relationship to include MedAssets’ entire range of supply chain solutions. This expands the current relationship through which Valley Medical Center utilizes certain MedAssets Revenue Management capabilities and supply cost management services to help improve the health system’s cash flow and profit margin.       

Valley Medical Center is one of the largest non-profit healthcare providers in the Washington region. Valley Medical Center is located in Renton, WA, and the surrounding area is served by a network of 12 community clinics. The relationship began with medical device cost management through a successful consulting relationship with Aspen Healthcare Metrics, a MedAssets Spend Management segment company, which reduces costs in key service lines. It has now expanded to include group purchasing services for all categories, comprehensive supply chain technology and analytics.

In addition, Valley Medical Center utilizes solutions from MedAssets’ Revenue Management segment including compliance, billing and pricing tools and decision support technology. The facility continuously links its supply cost and charge data via CrossWalk, a MedAssets proprietary tool that ensures that hospital charges provide defensible margins when compared with supply acquisition costs.


 

WHO60 photo exhibition: public health over the past 60 years

As part of the 60th anniversary celebrations of WHO, a photo collection, spanning the 60 years of WHO, will be exhibited around the world in 2008. The exhibit, based on the anniversary theme of "Our health, our future", tells the story of WHO and public health over the last 60 years. It features key public health milestones including, but not limited to: the development of the first successful polio vaccine, the eradication of smallpox, primary health care, tobacco control and the revision of the International Health Regulations. The exhibit also looks to the future and covers themes such as protecting health from climate change, the future of primary healthcare and the use of information and communication technologies for better health outcomes. The exhibit opened at the start of the WHO Executive Board's 122nd session on January 21, 2008. It then travels to the United Nations headquarters in New York to coincide with World Health Day on April 7. The exhibit will then return to Geneva for the World Health Assembly in May and travel to the regions during August and September.

To view the Photo exhibits see THIS LINK
 

 


February 5, 2008  Download print version

President's FY 2009 budget advances food and medical product safety,
and the safety of FDA-regulated imports

FDA receives modest boost in budget plan

New hospital standards needed for pediatric flu vaccines

Lifetime medical costs of obesity may be cheaper than treating fit patients

Class 1 Recall: Medtronic Inc. SynchroMed EL Implantable, Infusion Pump


Class 1 Recall: Cordis Corporation Dura Star RX
and Fire Star RX PTCA Balloon Catheters

Skytron, AIS RealTime, and Awarepoint announce partnership
to improve hospital asset management

The Council of Supply Chain Executives announces new supply chain member
 


President's FY 2009 budget advances food and medical product safety,
and the safety of FDA-regulated imports

The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, is requesting nearly $2.4 billion to protect and promote public health as part of the President's fiscal year (FY) 2009 budget, a 5.7 percent increase over the budget that the FDA received for the current fiscal year. The FY 2009 request, which covers the period of Oct. 1, 2008 through Sept. 30, 2009, includes $1.77 billion in budget authority and $628 million in industry user fees. The budget proposal includes strategic increases to strengthen food protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices. The request also includes funds to cover cost of living increases for FDA employees that perform the agency's scientific and highly specialized public health mission. These investments build on the increases that the FDA received for FY 2008 and will help ensure the safety of the food supply and accelerate the availability of new, safe, and innovative medical products.
 

The FDA primarily delivers its public health mission through its highly trained professional workforce. During FY 2009, the FDA will experience a full-time equivalent staff increase of 526. The FY 2009 budget supports additional staff for priority areas such as food defense and food safety, and drug, blood, and human tissue safety programs. The FDA will also work to assure the safety of domestic and imported food and medical products by conducting more domestic and foreign inspections and more inspections of high risk foods.

The following are the FDA's key proposed budget increases: Protecting America's Food Supply ($42.2 million); Medical Product Safety and Development ($17.4 million, $79.0 million user fees); Management Efficiencies - The FY 2009 budget also captures the productivity savings (-$8.9 million) generated by recent FDA investments and reinvests the savings in priority food safety and medical product programs.
 

For more information on the President's FY 2009 budget for the FDA, see THIS LINK 

 

 

FDA receives modest boost in budget plan

President Bush's proposed 2009 budget falls far short of what many experts say is needed to safeguard the U.S. food supply. The president on Monday proposed the Food and Drug Administration get $2.4 billion for the 2009 fiscal year starting Oct. 1. If approved by Congress, that would be a 5.7% increase from the current budget.

The FDA's food-safety program would get a bigger bump, up 6.8% to $662 million. But pay raises and inflation would eat most of the increase, leaving the FDA with few new resources despite increased concerns about the safety of U.S.-produced food and imported food and drugs. "At least there's not a substantial cut, but the agency won't be able to do much with food or drug safety," said William Hubbard, a former FDA associate commissioner who has joined other former FDA officials in urging the agency's budget be doubled over five years.

The FDA, which regulates $1.5 trillion of goods, has faced intense scrutiny in the past 18 months after a spate of recalls, including E. coli-contaminated spinach grown in California, salmonella-tainted U.S.-made peanut butter and contaminated pet-food ingredients from China that led to the largest-ever pet-food recall. In November, an outside panel of experts set up by the FDA to assess the agency concluded that consumers' lives are at risk because the FDA is so underfunded. At a congressional hearing last week, one panel member, former FDA lawyer Peter Barton Hutt, said the agency needs its funding doubled over two years and its employee count increased by 50%.

Under Bush's proposed budget, the number of full-time FDA employees would jump to 10,501, an increase of 932, or nearly 10%, from fiscal 2007. The number of full-time positions in the FDA's foods program would also increase to 2,810 in fiscal 2009, but that would be down 133 from the 2005 fiscal year. The FDA says it plans to work with the industry to improve food safety, do more domestic and foreign food-plant inspections and open an office in China, the source of numerous food-safety problems last year. The agency's goals are modest, given the scope of the world food industry, including 136,000 domestic and 189,000 foreign facilities.

Hubbard says there's a chance that Congress, which has held numerous hearings on food safety in the past year, will bolster the FDA's budget beyond what Bush has proposed, as it did with the fiscal 2008 budget. If not, the FDA will be "treading water," said Chris Waldrop of the Consumer Federation of America. (USA TODAY) See
THIS LINK


 

New hospital standards needed for pediatric flu vaccines


A new study published in the February 2008 issue of Pediatrics finds that many children hospitalized for influenza have had a recent, previous hospitalization that would have provided an easy, convenient opportunity to receive a hospital-based influenza vaccination. The authors suggest that evaluating and establishing industry standards for flu vaccines for hospitalized children could help prevent additional hospitalizations and complications from influenza.


In the peer-reviewed article “Hospital-Based Influenza Vaccination of Children: An Opportunity to Prevent Subsequent Hospitalization,” the research team led by Danielle M. Zerr, MD, MPH, medical director of infection control at Seattle Children’s Hospital and associate professor of Pediatrics at the University of Washington School of Medicine (UWSOM), evaluated the frequency of previous hospitalizations among children hospitalized with influenza. Overall, they found that 23% of children hospitalized with influenza and another complicating illness had a previous hospitalization during the most recent flu-vaccine season. This suggests that reaching those children at highest risk for influenza complications and reducing rates of pediatric hospitalization for influenza may be aided by providing in-hospital vaccinations when children are hospitalized during flu vaccine season.

The study looked at five years of hospital discharge data from the Pediatric Health Information System (PHIS) database from 2001 through 2006 to determine how many children hospitalized with influenza or respiratory illness had a previous hospitalization during the most recent flu-vaccine season. Subjects included newborns through age 18. Researchers found approximately 16% of those hospitalized with influenza and 23% of those hospitalized with influenza and another underlying condition had previous hospital admissions during the vaccination season. “This information will help pediatricians recognize hospitalization as an important opportunity to vaccinate the highest-risk children, and may hopefully prompt the development of hospital-based flu vaccine programs,” said Zerr.
 

Seattle Children’s has had a long-standing aggressive flu prevention program, offering free flu shots to inpatients, outpatients and staff. In 2007-2008 Seattle Children’s also offered free vaccines to those with close contact with patients such as family members, teachers, day care staff, nannies and more. For more information see THIS LINK  

 



 

Lifetime medical costs of obesity may be cheaper than treating fit patients


A new research paper published in PLoS Medicine suggests that preventing obesity might result in increased public spending on medical care. Many countries are currently developing policies aimed at reducing obesity in the population. However, it is not currently clear whether successfully reducing obesity will also reduce national healthcare spending or not. Pieter van Baal and colleagues, from the National Institute for Public Health and the Environment in the Netherlands, created a mathematical model to try to answer this question.


In their study, van Baal and his co-workers created three hypothetical populations of 1000 men and women, all aged 20 years at the start: a group of obese, never-smoking individuals; a group of healthy-never smoking individuals of normal weight; and a group of smokers of normal weight. The model produced an estimate of the likely proportion of each group who would encounter certain long term (chronic) diseases, and then estimated what the approximate cost of medical care associated with each disease was likely to be. The researchers found that the group of healthy, never-smoking individuals had the highest lifetime healthcare costs, because they lived the longest and developed diseases associated with aging; healthcare costs were lowest for the smokers, and intermediate for the group of obese never-smokers.


However, the authors argue that although obesity prevention may not be a cure for increasing expenditures, it may well be a cost-effective cure for much morbidity and mortality and importantly contribute to the health of nations. A Perspective by Klim McPherson, from Oxford University in the UK, who was not involved in the study, discusses the implications of these findings and comments that “it would be wrong to interpret the findings as meaning that public-health prevention (e.g., to prevent obesity) has no benefits”; the quality of life experienced by individuals, and other factors, must also be taken into account when planning interventions aimed at improving public health. See THIS LINK

 

 

 


Class 1 Recall: Medtronic Inc. SynchroMed EL Implantable, Infusion Pump

Product: Medtronic Inc. SynchroMed El Implantable, Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The programmable pump is part of the SynchroMed EL Infusion System. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

Reason for Recall: There is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors that were manufactured before September 1999. These pumps can stall at a higher rate due to gear shaft wear. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient’s symptoms, and/or symptoms of drug underinfusion or withdrawal. Drug withdrawal from Intrathecal Baclofen (ITB) therapy (in the patient’s spine) can cause death if not treated immediately and effectively.

Consumers with questions may contact Medtronic Neuromodulation Patient Services at 1-800-510-6735. Customers with technical questions may contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.

For more information see THIS LINK

 


Class 1 Recall: Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters

Product: Fire Star RX and Dura Star RX PTCA Balloon Catheters. Products manufactured in Mexico from February, 2007 through December, 2007 and distributed worldwide from March 26, 2007 through January 8, 2008. Dura Star RX was distributed in the U.S. on August 29, 2007 and Fire Star RX was distributed in the U.S. on August 31, 2007. All Fire Star and Dura Star lots 13173912 through 13315455, plus 52 additional lots above 13315455 are affected. (No lots above 13329055 are affected).

Reason for Recall: The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure or death.  

Consumers with questions may contact Cordis Inc. at 1-786-313-2000.

For more information see THIS LINK


 

Skytron, AIS RealTime, and Awarepoint announce partnership to improve hospital asset management

Skytron, AIS RealTime, and Awarepoint Corporation announced Skytron Asset Manager, an integrated active RFID asset management and information resource solution designed to improve hospital patient care, enhance staff productivity and better manage equipment capital and rental expense. While standard real-time location services (RTLS) provide location tracking and reporting of mobile assets via a web-based search application, Skytron Asset Manager adds another critical dimension to information on-demand, incorporating operators’ instructions, maintenance manuals and parts catalogs into the asset tracking RFID platform.  

“Not only does the system provide real-time location information of mobile assets, it further integrates the myriad operators’ instructions for all types of healthcare equipment. Skytron Asset Manager creates a wireless hospital asset management solution which can consolidate medical equipment information and location needs for both mobile and fixed assets,” said Randy Tomaszewski, Skytron’s vice president of marketing. 

The Skytron Asset Manager solution further integrates with Skytron’s SkyVision operating room video and data system to provide total equipment information at the point of care. With it, users can track the location and status of equipment and people, plus have operation, maintenance and technical manuals at their immediate fingertips, without leaving the operating room.

“In addition to tracking the location of mobile equipment and obtaining quick access to product information, the system can be installed within a matter of days with no disruption to patient and staff. The software user interface is fully customizable and easy to use so that hospital staff can be trained in just a matter of a few minutes,” said Tim Bayer, President of AIS RealTime.

Under the new partnership, Skytron’s extensive North American network of independent distributors will sell, install and support the patented active RFID-RTLS technology, powered by Awarepoint’s exclusive ZigBee sensor network. Sensors simply plug into electrical outlets to form the Awarenet mesh network. Once the sensors are plugged in, the mesh network forms automatically to track small battery-powered tags that are attached to equipment or people. Users track location and detailed product information from any accessible hospital-based computer.

For more information see THIS LINK

 


 

The Council of Supply Chain Executives announces new supply chain member

The Council of Supply Chain Executives (The Council) announces the addition of Steve Pitzer, System Director, Supply Chain Management for CHRISTUS Health, to its roster of nationally acclaimed supply chain executives. Pitzer is responsible for all aspects of supply chain management activities for more than 40 hospitals and facilities in six American states and Mexico, with assets of more than $3.4 billion. 

The Council is an organization that allows supply chain executives from across the country to assemble together to offer their best practices and experiences to their peers and to healthcare suppliers in small focus group panels. The Council offers various healthcare suppliers a collaborative forum to ask for feedback and advice from the country’s leading supply chain executives in a neutral and constructive environment.  

The Council of Supply Chain Executives will convene next on November 6-7, 2008 in Franklin, TN. Due to the unique nature and format of The Council of Supply Chain Executives, only a limited number of healthcare suppliers can attend. For more information see THIS LINK

 

 


February 4, 2008  Download print version

Indonesian chickens, and people, hard hit by bird flu

Inhaling pig brains may be cause of new illness

World Cancer Day: February 4

Hot liquids release potentially harmful chemicals in polycarbonate plastic bottles

AACN and AONE announce plans for nurse manager certification exam


FDA issues public health advisory on Chantix

6 simple steps to protect against and stop the spread of noroviruses

Megadyne extends its electrosurgery products with new line of suction coagulators
 


Indonesian chickens, and people, hard hit by bird flu


KONCANG, Indonesia —All around Indonesia, since late 2003, chickens have been dying of bird flu. And more than in any other country, people are dying too, infected by chickens or other sources. Three people died of bird flu this week, pushing the total number of deaths in Indonesia to 101, nearly half of all the human deaths in the world from bird flu. The other countries with the highest reported deaths are Vietnam, with 48; Egypt, with 19; and China and Thailand, each with 17, according to the World Health Organization. The mortality rate in Indonesia is also the highest in the world. Only 24 people reported to have been infected have survived. The virus is known to have infected at least 357 people around the world in 14 countries, killing 224 of them, according to the World Health Organization. Experts say that because of poor reporting of infections and deaths, the true number could be much higher. The concern among health workers is that the virus could mutate to allow easy transmission from human to human, raising the possibility of a worldwide epidemic.


No one is sure why so many people are dying in Indonesia or why the survival rate is so low. Public health experts say that there could be a lag in response and treatment here or that the strain of the virus could be harder to treat than elsewhere. The disease is particularly hard to contain in Indonesia because most chickens run loose around people’s homes in villages and even cities, rather than being cooped in chicken farms, said Trisatya Putri Naipospos, the former director of animal health in the Ministry of Agriculture. Eighty percent of the chicken population of 1.4 billion is scattered in 395 million backyards, where people raise poultry to eat or to sell, she said. The Indonesian authorities have tried to stem the spread of the disease by vaccinating chickens, but Naipospos said this was almost impossible. “You can imagine how difficult it is to catch and vaccinate these chickens,” she said. “How many chickens can you vaccinate in a day?” Some countries have had effective vaccination programs, however. China, for example, has vaccinated billions of chickens.

The government broadcasts television warnings that Naipospos said contained instructions to guard against infection: Wash your hands, don’t touch sick chickens, cook your chickens well and keep your chickens in cages. But if the origins and transmission of bird flu remain unclear to health experts, the disease is more of a mystery to the people here who are at risk. Naipospos said it could be hard to get people’s attention when they lived under constant threat of more immediate disasters. Pummeled by earthquakes, volcanos, tsunamis, ferry sinkings, aviation crashes, floods and deadly mudslides, Indonesia almost seems to have been fated to become the world’s epicenter of bird flu deaths. “A lot more people die of tuberculosis, malaria and dengue fever,” Naipospos said. “If you tell them 100 people have died within two years, do you think it’s enough to explain to people that this is a real threat just in front of them?” (The New York Times) See THIS LINK  

 


Inhaling pig brains may be cause of new illness

Fittingly, the first person to detect a faint signal in all the noise was the interpreter. The 33-year-old woman who worked for eight years working with Spanish-speaking patients at a medical clinic in southern Minnesota noticed something familiar as she translated the story of a young meatpacker last September.

Earlier last summer, she had heard a version of it from two other workers at the same slaughterhouse, and had told it to their doctors, who were different from her current patient's. When the consultation was over, she pointed this out. The interpreter's insight set in motion a story, still unfolding: A new disease has surfaced in 12 people among the 1,300 employees at the factory run by Quality Pork Processors about 100 miles south of Minneapolis. The ailment is characterized by sensations of burning, numbness and weakness in the arms and legs. For most, this is unpleasant but not disabling. For a few, however, the ailment has made walking difficult and work impossible. The symptoms have slowly lessened in severity, but in none of the sufferers has it disappeared completely. While the illness is similar to some known conditions, it does not match any exactly. Nor is the leading theory of its cause something medical researchers have studied. That is because the illness appears to be caused by inhaling microscopic flecks of pig brain. "This appears to be something new," Minnesota's state epidemiologist, Ruth Lynfield, said last week.

The packing house, in Austin, MN, (pop. 23,000), slaughters 1,900 pigs a day, working two meat-cutting shifts and one clean-up shift. Virtually everything is used, including ears, entrails and bone. The 12 sufferers of the neurological illness, most are Hispanic immigrants, all work at or near the "head table" where the animals' severed heads are processed. One of the steps in that part of the operation involves removing the pigs' brains with compressed air forced into the skull through the hole where the spinal cord enters. The brains are then packed and sent to markets in Korea and China as food.

Investigators say there is no reason to suspect that either the brains or the pork cuts were contaminated. Their working hypothesis is that the harvesting technique, known as "blowing brains" on the floor, produces aerosols of brain matter. Once inhaled, the material prompts the immune system to produce antibodies that attack the pig brain compounds, but apparently also attack the body's own nerve tissue because it is so similar.

If this theory is correct, the ailment, for the moment called "progressive inflammatory neuropathy", resembles Guillain-Barre syndrome, an autoimmune condition that sometimes follows fairly benign infections, particularly those caused by an intestinal bacterium called Campylobacter. In the Minnesota cases, however, there appears to be no germ involved. Although far from proved, the theory makes enough sense that the Centers for Disease Control and Infection, in Atlanta, has cast a net to about 25 other large-scale pig slaughterhouses in 13 states, seeking other cases. CDC investigators believe they have found a few at a slaughterhouse in Indiana. Significantly, it is one of only two places other than the Minnesota packing plant that uses compressed air to empty pig skulls. All three have ceased that activity. (Washington Post) See THIS LINK

 


World Cancer Day: February 4


Cancer is a leading cause of death around the world. WHO estimates that 84 million people will die of cancer between 2005 and 2015 without intervention. Each year on 4 February, the World Health Organization (WHO) joins with the sponsoring International Union Against Cancer to promote ways to ease the global burden of cancer. Preventing cancer and raising quality of life for cancer patients are recurring themes. This year's theme is "children and second-hand smoke exposure". Around 700 million children, almost half of the world's children, breathe air polluted by tobacco smoke, particularly at home. In 2008, World Cancer Day aims to send a simple message to parents: "Second-hand smoke is a health hazard for you and your family. There is no safe level of exposure to second-hand smoke. Give your child a smoke-free childhood." For more information see
THIS LINK

 


 

Hot liquids release potentially harmful chemicals in polycarbonate plastic bottles

When it comes to Bisphenol A (BPA) exposure from polycarbonate plastic bottles, it’s not whether the container is new or old but the liquid’s temperature that has the most impact on how much BPA is released, according to University of Cincinnati (UC) scientists. Scott Belcher, PhD, and his team found when the same new and used polycarbonate drinking bottles were exposed to boiling hot water, BPA, an environmental estrogen, was released 55 times more rapidly than before exposure to hot water.

“Previous studies have shown that if you repeatedly scrub, dish-wash and boil polycarbonate baby bottles, they release BPA. That tells us that BPA can migrate from various polycarbonate plastics,” explained Belcher, UC associate professor of pharmacology and cell biophysics and corresponding study author. “But we wanted to know if ‘normal’ use caused increased release from something that we all use, and to identify what was the most important factor that impacts release.” “Inspired by questions from the climbing community, we went directly to tests based on how consumers use these plastic water bottles and showed that the only big difference in exposure levels revolved around liquid temperature: Bottles used for up to nine years released the same amount of BPA as new bottles.”

The UC team reports its findings in the Jan. 30, 2008 issue of the journal Toxicology Letters. BPA is one of many man-made chemicals classified as endocrine disruptors, which alter the function of the endocrine system by mimicking the role of the body’s natural hormones. Hormones are secreted through endocrine glands and serve different functions throughout the body. The chemical, which is widely used in products such as reusable water bottles, food can linings, water pipes and dental sealants, has been shown to affect reproduction and brain development in animal studies. “There is a large body of scientific evidence demonstrating the harmful effects of very small amounts of BPA in laboratory and animal studies, but little clinical evidence related to humans,” explained Belcher. “There is a very strong suspicion in the scientific community, however, that this chemical has harmful effects on humans.”

Belcher’s team analyzed used polycarbonate water bottles from a local climbing gym and purchased new bottles of the same brand from an outdoor retail supplier. All bottles were subjected to seven days of testing designed to simulate normal usage during backpacking, mountaineering and other outdoor adventure activities. The UC researchers found that the amount of BPA released from new and used polycarbonate drinking bottles was the same, both in quantity and speed of release, into cool or temperate water. However, drastically higher levels of BPA were released once the bottles were briefly exposed to boiling water.


AACN and AONE announce plans for nurse manager certification exam

The American Association of Critical-Care Nurses (AACN) and the American Organization of Nurse Executives (AONE) announced that they have expanded their partnership to develop the first certification exam designed exclusively for nurse managers. This latest partnership effort is rooted in AACN’s and AONE’s 6-year collaboration to provide education and development resources for nurse managers. Development of a nurse manager certification program is a logical next step following the highly successful release last year of the Essentials of Nurse Manager Orientation (ENMO), a comprehensive e-learning program on which the two organizations collaborated. Providing tools to support and validate the knowledge, skills and abilities of nurse managers is of vital importance given the high influence they have on the quality of patient care and the work environment in which nurses deliver that care.

AACN Certification Corporation completed a study of nurse manager practices which found that frontline nurse managers are generally prepared for their leadership roles through on-the-job training. This certification will provide a way for nurse managers to validate that they have acquired the essential knowledge and skills necessary to be effective in their role. The relationship between AACN and AONE began in 2002 when the two organizations, in collaboration with the Association of PeriOperative Registered Nurses (AORN), developed the Leadership Learning Domain Framework for nurse managers and the resulting Nurse Manager Inventory Tool. The Inventory Tool and ENMO fill a previously unaddressed need organizations and individuals had for assessing and developing nurse manager leadership skills.

More information on the Leadership Learning Domain Framework, Nurse Manager Inventory Tool, and the Essentials of Nurse Manager Orientation is available on both organizations’ web sites at www.aacn.org and at www.aone.org.


 

FDA issues public health advisory on Chantix

The U.S. Food and Drug Administration (FDA) issued a Public Health Advisory to alert healthcare providers, patients, and caregivers to new safety warnings
concerning Chantix (varenicline), a prescription medication used to help patients stop smokingOn Nov. 20, 2007, FDA issued an Early Communication to the public and healthcare providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

As the agency's review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients.

"Chantix has proven to be effective in smokers motivated to quit, but patients and healthcare professionals need the latest safety information to make an informed decision regarding whether or not to use this product," said Bob Rappaport, M.D., director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products. Chantix was approved by FDA in May 2006 as a smoking cessation drug. Chantix acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking.

In the Public Health Advisory and a Health Care Professional Sheet that was also issued today, FDA emphasized the following safety information for patients, caregivers, and healthcare professionals: Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. Patients should immediately report changes in mood and behavior to their doctor.  Vivid, unusual, or strange dreams may occur while taking Chantix. Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery. For more information see THIS LINK


6 simple steps to protect against and stop the spread of noroviruses


Recent outbreaks of norovirus, also known as stomach flu, indicate the highly contagious, fast-moving virus is again a public health concern. The Association for Professionals in Infection Control and Epidemiology (APIC) has six simple steps to protect families against noroviruses. Norovirus is the second most frequent cause of illness after the common cold. Symptoms include nausea, vomiting, diarrhea, and abdominal pain, and occur between 24 and 48 hours after exposure. Norovirus can be life-threatening for the elderly and immunocompromised.

APIC’s six simple steps to protect against norovirus are available here www.apic.org
 


 

Megadyne extends its electrosurgery products with new line of suction coagulators

To help further ease the hand fatigue experienced by many surgeons during electrosurgery procedures, MEGADYNE announces today the availability of its new line of reusable suction coagulators with a larger, ergonomic handle to maximize comfort, efficiency, safety and ease of use. “We designed this product with the surgeon’s comfort and ease of use in mind, said Michael Hintze, vice president of marketing at MEGADYNE. “We listened to our customers and designed a larger handle to increase comfort, making the product more proportionately sized as well as more ergonomically shaped to help reduce hand fatigue.”
 
Ideal for ear, nose and throat procedures, MEGADYNE’s suction coagulators are available in French sizes, 8, 10 & 12 to better enable the surgeon to correctly match the coagulator to the size of the patient’s anatomy and surgical procedure being performed. Available in both hand switching and foot controlled options, the coagulator is fully insulated to reduce the likelihood of injury to surrounding structures and tissues and its integrated guard prevents user shocks. The hand-controlled versions have a tactile switch so the surgeon is assured when the pencil has been activated. For more information see
THIS LINK


 

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