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hpnonline Daily Update

2013
September 2007
   

September 28, 2007   Download print version

Guidelines help patients reduce risk of cardiac event before surgery

Report assails F.D.A. oversight of clinical trials

Smoking ban helps to cut heart attacks

Kaiser Permanente study: Alcohol amount, not type, triggers breast cancer

CDC awards $35 million to support HIV testing, increase early diagnosis
of HIV among African Americans

Novation’s new cardiovascular portfolio offers Alliance member hospitals
$267 million in total savings


StatCom launches healthcare webcast series
with focus on improving patient throughput

 


Guidelines help patients reduce risk of cardiac event before surgery


People with heart disease should take special precautions before undergoing any kind of surgery, even noncardiac surgery, to reduce their risk of a cardiac event, according to new joint guidelines from the American College of Cardiology and the American Heart Association. The American College of Cardiology/American Heart Association 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery will be published online ahead of print on September 27 in the October 23, 2007, issues of Circulation: Journal of the American Heart Association and the Journal of the American College of Cardiology. The guidelines, an update of those published in 2002, provide a framework for considering a person’s risk of a cardiac event in the “perioperative” (during or immediately after) period of noncardiac surgery. According to the recommendations, patients should not stop taking cholesterol-lowering drugs before surgery. In addition, the guidelines say that many people with heart disease can safely undergo noncardiac surgery without first “fixing” their heart disease with an artery-opening procedure or coronary bypass grafting. The guidelines also address how best to treat those people who need a heart procedure before noncardiac surgery, have coronary stents or require anti-clotting medication. “In the past we had to go on indefinite evidence, but now there are a number of studies published to help us direct best practices,” said Lee A. Fleisher, M.D., chair of the guideline writing committee. “Statin use wasn’t even addressed in the previous guidelines. New trials have shown us that patients should continue taking them.”


In the case of non-emergency or elective procedures, the guidelines say that intervention (such as bypass surgery or angioplasty) is rarely necessary to lower the risk of surgery unless a patient would need the intervention anyway. If the noncardiac surgery is an emergency, heart testing should be forgone and a patient should go straight to an operating room. The guidelines recommend that patients undergo evaluation and treatment before noncardiac surgery only for “active” cardiac conditions such as unstable coronary syndromes (severe angina), decompensated heart failure, significant heart rhythm disturbances (arrhythmias) or severe heart valve disease. The difference in whether heart procedures reduce the risk of surgery is whether a person’s heart disease is either severe or symptomatic, both of which would require treatment regardless of the impending surgery. Fleisher said angioplasty with stenting might even increase the risk of perioperative heart problems. The risk of heart attack increases in the four to six weeks immediately after receiving a stent, so patients are prescribed anti-clotting medication during this period. This risk, and the duration of anti-clotting therapy, is up to one year for patients who received a coated or drug-eluting stent.


Due to the risks of excessive bleeding common to any surgery, patients were previously advised to stop taking their anti-clotting drugs prior to surgery. “We now know that the antiplatelet medication is very important after stent placement, and we advocate stopping it for as little time as possible,” Fleisher said. “In general,” according to the guidelines, “indications for further cardiac testing and treatments are the same as in the non-operative setting, but their timing is dependent on several factors.” These factors include the urgency of noncardiac surgery, the patient’s specific risk factors and the type of surgery (whether it’s a lower-risk or higher-risk procedure). Preoperative testing should be limited to those circumstances in which test results will affect a patient’s treatment. For more information see THIS LINK
 


 

 

Report assails F.D.A. oversight of clinical trials


The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found. In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed. The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.

 

“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania. Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research, Caplan said. Because no one collects the data systematically, there is no way to tell how safe the nation’s clinical research is or ever has been. The drug agency oversees just the safety of trials by companies seeking approval to sell drugs or devices. Using an entirely different set of rules, the Office for Human Research Protections oversees trials financed by the federal government. Privately financed noncommercial trials have no federal oversight. “It’s crazy that we have all these different sets of rules,” said Dr. Ezekiel J. Emanuel, chairman of the bioethics department at the National Institutes of Health. “It would facilitate things a lot if we had one agency overseeing things.”

 

The F.D.A. disqualified investigators from conducting further clinical trials 26 times from 2000 to 2005 and disqualified their data just twice even though the agency found serious problems at trial sites 348 times in that period, the inspector general found. While some of the report’s findings surprised ethicists, its conclusion that the agency’s oversight of clinical trials is disorganized and underfinanced has long been known and is, in many ways, identical to criticisms leveled at other agency functions, including its oversight of imported food, foreign drug manufacturers, animal food and the safety of older medicines. In each case, the size and complexity of the tasks facing the agency have grown enormously as the number of inspectors for those tasks has generally declined. An inspector general’s report in 2000 criticized the oversight of clinical trials and noted that the inspections mostly focused on whether study information was accurate and not on whether human subjects were protected. That is still true. In the present report, the inspector general recommended that the agency create a registry of all continuing clinical trials, an idea signed into law by President Bush on Thursday. The report also recommended that the agency create a complete registry of research ethics boards, create a single comprehensive database to track its research inspections and obtain greater authority to regulate research assistants. (The New York Times) For more information see THIS LINK

 

 

 


Smoking ban helps to cut heart attacks


Government curbs on secondhand smoke in New York led to nearly 4,000 fewer hospital admissions for heart attacks in 2004, according to a new statewide study. In the study, published yesterday in the American Journal of Public Health, the State Department of Health reviewed nearly half a million hospital admissions for acute myocardial infarction, or heart attack. Researchers concluded that such admissions fell more than 8 percent in 2004 from what would have been the expected level of admissions for that year. That was equivalent to 3,813 fewer hospital admissions, they said. At an average cost of $14,772 for each heart-attack admission, the total savings is about $56.3 million, researchers said.

 

The 2003 state ban on smoking in many public places is “a public health intervention that hardly costs anything, so to accrue that kind of savings from an inexpensive intervention is really unparalleled,” said Ursula Bauer, the director of the Health Department’s tobacco control program and an author of the study. The study is more comprehensive than similar studies that covered only a few hospitals in a few counties. It analyzed 10 years of existing data, from 1994 to 2004, covering all of the state’s 62 counties and more than 250 hospitals. It looked at data for admissions for 462,396 heart attacks. Researchers focused on the year after the July 2003 enactment of the Clean Indoor Air Act, which prohibited smoking in bars, restaurants, banquet halls and places where workers were paid tips or wages. Using a statistical model incorporating the 10 years of heart-attack data, state health researchers identified factors associated with heart attacks: people suffer more heart attacks in winter; there are different rates in different counties; heart attacks are dropping anyway because of better medical care; and, more important, local governments have been curbing smoking since 1995. If researchers, in effect, subtract these factors that affect heart attack rates, then what is left is likely to be the effect of the 2003 ban, said Harlan R. Juster, the Health Department’s director of tobacco surveillance, evaluation and research and an author of the study. By this indirect reasoning, the number of hospital admissions for heart attacks should have been 49,225 for 2004, but was 45,412. (The New York Times)

 

 

Kaiser Permanente study: Alcohol amount, not type, triggers breast cancer


One of the largest individual studies of the effects of alcohol on the risk of breast cancer shows that it makes no difference whether a woman drinks wine, beer or spirits (liquor). It is the alcohol itself (ethyl alcohol) and the quantity consumed that increases breast cancer risk. In fact, the increased breast cancer risk from drinking three or more alcoholic drinks a day is similar to the increased breast cancer risk from smoking a packet of cigarettes or more a day, according to Kaiser Permanente researchers Yan Li, MD, PhD and Arthur Klatsky, MD. “Population studies have consistently linked drinking alcohol to an increased risk of female breast cancer, but until now there has been little data, most of it conflicting, about an independent role played by the choice of beverage type,” said Klatsky, who is presenting these findings on September 27th at the European Cancer Conference (ECCO 14) in Barcelona, Spain.


Li, a Kaiser Permanente oncologist, Klatsky, an investigator with the Kaiser Permanente Division of Research in Oakland, CA and their Kaiser Permanente colleagues studied the drinking habits of 70,033 multi-ethnic women who had supplied information during health examinations between 1978-1985. By 2004, 2,829 of these women were diagnosed with breast cancer. In one analysis, researchers compared the role of total alcohol intake among women who favored one type of drink over another with women who had no clear preference. In another analysis, researchers looked at the possible independent role of frequency of drinking each beverage type. Finally, they examined the role of total alcohol intake, comparing it with women who drank less than one alcoholic drink a day. The study found there was no difference between wine, beer or spirits in the risk of developing breast cancer. Even when wine was divided into red and white, there was no difference. However, when researchers looked at the relationship between breast cancer risk and total alcohol intake, they found that women who drank between one and two alcoholic drinks per day increased their risk of breast cancer by 10 percent compared with light drinkers who drank less than one drink a day. The risk of breast cancer increased by 30 percent in women who drank more than three drinks a day.


“A 30 percent increased risk is not trivial. To put it into context, it is not much different from the increased risk associated with women taking estrogenic hormones. Incidentally, in previous research completed at Kaiser Permanente, we have found that smoking a pack of cigarettes or more per day is related to a similar (30 percent) increased risk of breast cancer,” Klatsky said. Although breast cancer incidence varies between populations and only a small proportion of women are heavy drinkers, Dr Klatsky said that a 30 percent increase in the relative risk of breast cancer from heavy drinking might translate into approximately an extra 5 percent of all women developing breast cancer as a result of their habit. Other studies, including research from the same authors, have shown light-moderate alcohol drinking can protect against heart attacks, but Klatsky said that different mechanisms were probably at work. “We think that the heart protection benefit from alcohol is real, and is probably derived largely from alcohol-induced higher HDL (‘good’) cholesterol, reduced blood clotting and reduced diabetes. None of these mechanisms are known to have anything to do with breast cancer. The possible but unproven additional coronary benefit from drinking wine (red or white) may be related to favorable drinking patterns common among wine drinkers or to the favorable traits of wine drinkers, as evidenced by other United States and Danish studies,” Klatsky said.

 

 

 


CDC awards $35 million to support HIV testing, increase early diagnosis
of HIV among African Americans


The Centers for Disease Control and Prevention has awarded $35 million in funding to state and local health departments to increase HIV testing opportunities among populations disproportionately affected by HIV, primarily African Americans. Twenty-three states and major metropolitan areas will receive awards ranging from $690,000 to $5.4 million. “This program seeks to test more than 1 million people with the primary goal of increasing early HIV diagnosis among African Americans,” said Kevin Fenton, M.D., director of CDC′s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. “HIV testing provides a critical pathway to prevention and treatment services to prolong the lives of those infected and help stop the spread of HIV in the hardest hit communities across the United States.” As part of CDC′s efforts to accelerate progress in reducing HIV among African Americans, the program is being targeted to areas of the nation in which African Americans have been most severely impacted. African Americans account for approximately half of the more than 1 million Americans currently estimated to be living with HIV, while comprising 13 percent of the U.S. population.

CDC estimates that a quarter of those living with HIV, more than 250,000 Americans, do not realize they are infected. The testing effort is intended to identify undiagnosed individuals, especially among those populations bearing a disproportionate burden of HIV disease. “We estimate this program alone could identify nearly 20,000 people who are unaware that they are infected, allowing them to seek care for their own health and take steps to protect their partners,” Dr. Fenton said. Through this program HIV tests will be available primarily in clinical settings, such as emergency departments, community health centers, STD clinics, and correctional health facilities. While about 10 percent of the tests will be administered in non-clinical settings, the main focus of the program will be to implement routine, voluntary HIV testing in health care settings, where opportunities to screen patients for HIV are often missed.


Funds will be used to support HIV testing and related activities including linkage to care, partner counseling and referral services, and the purchase of HIV tests. A particular focus for the program will be integrating HIV testing activities with screening and prevention activities for other infections, such as viral hepatitis, sexually transmitted diseases and tuberculosis. Eligibility and funding amounts were based upon the percentage of AIDS cases among African Americans in each jurisdiction. The states receiving funding are: California, Connecticut, Florida, Georgia, Louisiana, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia and Washington, D.C. The cities receiving funding are Chicago, Houston, Los Angeles, Philadelphia, and New York City. The $35 million is part of a new $45 million program to expand access to HIV testing. The remaining $10 million will support a range of CDC programs to provide needed training to healthcare providers, mobilize communities to encourage HIV testing among African Americans, and reach both providers and those at risk with information on the importance of testing.

 

 

Novation’s new cardiovascular portfolio offers Alliance member hospitals
$267 million in total savings

Novation, LLC, the healthcare contracting services company of VHA Inc., and the University HealthSystem Consortium (UHC), two national healthcare alliances, has awarded 33 multi-source agreements for a broad range of cardiovascular products to its new cardiovascular portfolio, which could provide up to $267 million in total savings for alliance member hospitals. “Novation offers the largest and most comprehensive cardiovascular portfolio in the industry,” said Dan Sweeney, senior vice president, contract and program services at Novation. "We work continuously to provide our hospital alliance members with the best prices on the latest technologies available.” Thirty-three agreements were awarded to 13 companies and the agreements take effect Oct. 1, 2007 and run through Sept. 30, 2010. Product categories include electrophysiology, percutaneous coronary intervention, coronary diagnostic, vascular closure devices, peripheral interventional, peripheral diagnostic, thrombus management, neuro interventional and cardiac rhythm management.

The new agreements include the following companies and products: Electrophysiology (Diagnostic Catheters, Ablation Catheters, Mapping Catheter): Bard EP, Boston Scientific; Percutaneous Coronary Intervention (Stents, PTCA Balloon Catheters, Cutting Balloon Catheters, Interventional Guide Wires & Catheters): Abbott Vascular, Boston Scientific, Medtronic; Coronary Diagnostic (Coronary Angiographic Catheters and Wires, Sheaths/Introducers, Biopsy Forceps, Cath Lab Accessories): Abbott Vascular, Boston Scientific, Medtronic, Merit Medical, Terumo; Vascular Closure Devices (Vessel Closure Devices – Collagen, Vessel Closure Devices – Other, Hemostatic Patches): Abbott Vascular, Cardiva Medical, Marine Polymer Technologies, TZ Medical; Peripheral Interventional (Peripheral Stents, Carotid Stents, PTA Balloon Catheters, IR Cutting Balloons): Boston Scientific, ev3, Medtronic; Interventional Guide: Abbott Vascular, Bard, Cook Medical; Peripheral (Peripheral Diagnostic, Peripheral Angiographic Catheters, Diagnostic Wires, Sheaths/Introducers): Boston Scientific, Cook Medical, Merit Medical, Terumo; Thrombus Management (Vena Cava Filters, Distal Protection Filters, Drainage Catheters, Infusion Catheters): Bard Peripheral, Boston Scientific, Cook Medical, ev3, Merit Medical; Neuro Interventional (Neuro Coils, Microcatheters, Neuro Interventional Wires): Boston Scientific, ev3; Cardiac Rhythm Management (Pacemakers, Cardiac Resynchronization Therapy, Pacemakers (CRT-P), Automated Implantable Cardiac Defibrillatorss (AICD), Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Leads Accessories): Boston Scientific (Guidant), Medtronics. For more information see THIS LINK
 
 

 

StatCom launches healthcare webcast series with focus on improving patient throughput

StatCom, a provider of patient flow logistics and tracking software, announced the launch of a healthcare IT focused webcast series. The webcasts will feature industry thought leader guest speakers candidly discussing patient flow logistic challenges, trends, innovations, and technologies. The first webcast in the series, “Hospital Performance Challenges: Are the Flintstones and Jetsons Living in the Same Building?” is now available for viewing. The featured guest speaker, Dr. Marybeth Regan, Ph.D, is a consultant with Reden & Anders, the healthcare consulting arm of Ingenix. Regan has over 20 years of experience in the healthcare and life sciences segments. She is a nationally renowned subject matter expert, writer and public speaker in the areas of patient throughput, disease management and care management. She recently completed her dissertation titled, “Disruptive Innovation: The Acceptance of Technology by Physicians focused on EMR, PHR, ePrescribing and Telemedicine.” “Hospitals can take lessons from other industries,” said Regan. “Look at the express package shipping and automotive industries for example, their processes allow flexibility and change based on demand. Hospitals have made some performance gains with financial systems (ERP) and electronic medical record systems (EMS), yet there continues to be a dependence on manual cross-vertical operational processes. It’s imperative that we identify ways to remove those bottlenecks, improve patient care and reduce the potential for errors.”

Joining Regan in the webcast is Ben Sawyer, executive vice president market and client development for StatCom. Sawyer has over 20 years of experience in hospital operations. His experience demonstrated that sustainable improvement required configurable patient flow management technology. Recently, he has been integral in the development and implementation of the industry’s first patient flow logistics and tracking software system. “An engineering professor recently observed that working with technology in a hospital was like having the Flintstones and Jetsons in the same building,” said Sawyer. “This struck me as a good analogy to what a hospital staff faces every day. Many processes are largely manual, while diagnostic, surgical, and procedural technology is very advanced. As it becomes clear that hospitals need to incorporate new technologies to address patient flow and performance challenges on the operational side, we wanted to create a forum for discussion.” For more information and to register, go to http://www.statcom.com/webcast/.

 


September 27, 2007   Download print version

Medtronic, again questioned over payments to doctors

Report says fixes slow to come at Walter Reed

New York Medicaid program cannot cover cancer treatments
for immigrants, according to CMS

Across Pennsylvania, more patients return to hospital

Drug makers seek clues to side effects in genes

Emergency Health Centre implements ultrasound ED information system
from Patient Care Technology Systems

 


Medtronic, again questioned over payments to doctors


An influential senator is raising new questions about payments made to spine surgeons by Medtronic, one of the nation’s largest makers of medical devices. Medtronic, which reached a $40 million settlement last year with the federal government over accusations that the company had paid illegal kickbacks to doctors for using its spinal devices, has continued to pay doctors millions of dollars in consulting fees, according to a lawyer representing a whistle-blower involved in the case. Senator Charles E. Grassley, (R-IA), has written to Medtronic, asking the company to explain, among other things, any payments made since the period covered by the settlement. The letter is part of a broad inquiry by Grassley into the financial ties that often exist between doctors and the companies that make medical devices and drugs. Medtronic defended the continuing payments as legitimate compensation for work the doctors have done. Medtronic said it welcomed the opportunity to speak with Grassley and his staff. The company also said the payments had been made in the normal course of working with doctors on the best use and design of new medical devices. “Innovation in medical devices does, in fact, depend on the input of the physician,” a Medtronic spokesman, Robert Clark, said.

 

In the case that led to last year’s settlement, the Justice Department accused Medtronic of paying kickbacks through what government officials described as “sham consulting agreements, sham royalty agreements and lavish trips to desirable locations” offered to doctors from 1998 to 2003. In the settlement, Medtronic denied any wrongdoing. Grassley, the senior Republican on the Senate Finance Committee, which oversees the federal Medicare program, sent a letter to Medtronic’s chief executive last week, asking the company to explain its payments to the surgeons after 2003. He also asked the company to explain its financing of organizations involved in providing continuing medical education to these doctors. “Transparency builds trust, and full disclosure about the dollars that device makers give to doctors would let patients know if they should be more or less concerned about a doctor’s allegiance to a particular product line,” Grassley said yesterday.

 

Medtronic’s payments to surgeons appear to have continued for at least several months after the settlement was reached in July 2006. Through much of 2006, the company’s payments included nearly $6 million in consulting fees to dozens of doctors, according to the whistle-blower’s lawyer, Andrew R. Carr Jr. of the firm Bateman Gibson in Memphis, who obtained a list of payments from a former Medtronic employee. Carr filed a lawsuit in 2003 on behalf of Jacqueline Kay Poteet, who managed travel services for Medtronic’s spinal device business. In early 2006, Carr filed an additional lawsuit on Poteet’s behalf, a supplemental complaint that accused the company of continuing to use these improper payments in 2004 and 2005. “The 2006 documents clearly appear to confirm the allegations of my supplemental complaint,” Carr said. He said he had alerted members of Congress to what he sees as an inadequate investigation of his client’s claims by the Justice Department. “The enormous sham consulting payments continue unabated to this date,” Carr said. (The New York Times) To read the complete article see THIS LINK

 

 

Report says fixes slow to come at Walter Reed

More than half a year after disclosures of systemic problems at Walter Reed Army Medical Center and other military hospitals, the Pentagon’s promised fixes are threatened by staff shortages and uncertainty about how best to improve long-term care for wounded troops, according to a congressional report issued yesterday. Army units developed to shepherd recovering soldiers lack enough nurses and social workers, and proposals to streamline the military's disability evaluation system and to provide “recovery coordinators” are behind schedule, according to the Government Accountability Office report. Members of a congressional oversight committee, discussing the report at a hearing yesterday, said the effort to reform the medical bureaucracy has itself become mired in bureaucracy. “After so many promises but so little progress, we need to see more concrete results,” said Rep. Thomas M. Davis III (Va.), the ranking Republican on the panel. His staff hears “appalling stories” every week from soldiers dealing with the disability process, he said, adding that “they’re trapped in a system they don’t understand and that doesn’t understand them.” “The pace of change is frustratingly slow,” said Rep. Henry A. Waxman (D-CA), chairman of the oversight committee.

Members of the House oversight subcommittee on national security laid the blame on the Defense Department, the Army and the Department of Veterans Affairs for what Rep. John F. Tierney (D-MA) termed an “utter lack of urgency.” The preliminary GAO report said the Army has taken steps to streamline its disability evaluation process, which determines whether soldiers are fit for duty and, if not, what disability payments they should receive. Nonetheless, the report noted, “Many challenges remain, and critical questions remain unanswered.” For example, the Army has established “warrior transition units” at 32 installations around the country, with recovering soldiers assigned to a team of physicians, case managers and squad leaders. Whereas the unit at Walter Reed is almost fully staffed, more than half the units had less than 50 percent of workers in place by mid-September, the GAO found. Maj. Gen. Eric B. Schoomaker, the Walter Reed commander, told the subcommittee that the units have 65 percent of their manpower and should be fully staffed by January.

In July, a presidential commission led by former senator Robert J. Dole and former health and human services secretary Donna E. Shalala recommended that “recovery coordinators” be assigned to shepherd each seriously wounded service member through medical care. A high-level oversight committee established by the Pentagon and the VA agreed to begin implementing the recommendation by mid-October. But the oversight committee has not determined how many recovery coordinators will be needed or how to decide which injured soldiers need them, the GAO found. Moreover, the Dole-Shalala commission recommended that the recovery coordinators come from outside the Defense Department or the VA, suggesting instead the Public Health Service. The oversight committee has balked at the suggestion in favor of recovery coordinators supplied by the VA. But the GAO questioned the VA’s ability to handle the job, noting that it “may face significant human capital challenges in identifying and training individuals for these positions.” (The Washington Post)


New York Medicaid program cannot cover cancer treatments
for immigrants, according to CMS

CMS has informed New York officials that chemotherapy does not qualify for a provision of Medicaid that allows coverage for emergency services for undocumented immigrants and other noncitizens, a decision that “sets the stage for a battle between the state and federal governments over how medical emergencies are defined,” the New York Times reports. The provision specifically excludes coverage for organ transplants but leaves to states the determination of whether other procedures qualify as emergency services, and states and courts have fought over the issue for years without a definitive resolution. According to the Times, the CMS decision, reached last month after the conclusion of a federal audit of the New York Medicaid program that began in 2004, comes “amid a fierce national debate on providing medical care to immigrants,” with state officials and critics “saying this latest move is one more indication of the Bush administration's efforts to exclude the uninsured from public health services.” New York officials on Friday in a letter to CMS protested the decision on the grounds that physicians, not the federal government, should determine when chemotherapy is necessary.

New York Health Commissioner Richard Daines said, “There are clearly situations that we consider emergencies where we need to give people chemotherapy,” adding, “To say they don’t qualify is self-defeating in that those situations will eventually become emergencies.” CMS officials declined to discuss the issue, but Dennis Smith, director of the Center for Medicaid and State Operations at the agency, in a statement said, “Longstanding interpretations by the agency have been that emergency Medicaid benefits are to cover emergencies.” The number of other state Medicaid programs that cover chemotherapy for undocumented immigrants remains undetermined because “all emergency services are generally lumped together in state Medicaid reports," but other states have "been challenged on emergency Medicaid claims,” the Times reports. (Kaiser Family Foundation, The New York Times)


Across
Pennsylvania, more patients return to hospital

Readmissions are on the rise at Pennsylvania hospitals, prompting experts to call for improved care for chronic conditions such as lung disease and diabetes. “We need to look at better ways to treat patients and better ways to pay for that treatment,” said Harold Miller, strategic initiatives consultant at the Pittsburgh Regional Healthcare Initiative, which is devising ways to improve the treatment of some of the most common illnesses afflicting Pennsylvanians. “This report signals that we should be paying attention to the issue of readmissions.” Readmission rates jumped from 18.7 to 19.1 percent over three years, according to a report issued by the Pennsylvania Health Care Cost Containment Council. The Harrisburg-based agency said the 57,993 readmissions resulted in nearly $2.3 billion in charges and 352,000 hospital days. About a quarter of those readmissions, 15,057, were caused by complications or infections. “Reducing readmissions, especially those related to infections and other complications, is one possible way to restrain health care costs while improving patient care,” said Marc Volavka, the council’s executive director. The report found a drop in mortality rates in 18 of 26 diagnostic categories, from 4.7 percent in 2004 to 4.4 percent in 2006. The report also provides information about length of hospitalizations and hospital charges for patients admitted to 177 hospitals across the state.

Hospital readmissions, which have emerged as a worry in the healthcare industry, are not necessarily the hospitals’ fault, Miller said. “It can be things that happen outside the hospital,” he said. “The patient may need to take a certain kind of medication and they go home and they don’t follow through.” That means there needs to be better coordination between hospitals and patients about their care after they leave the hospital. For example, a nurse or nurse practitioner could call the patient at home to make sure he’s taking his medication. “A lot of people wind up falling through the cracks between what they get in the hospital and what they get in the community,” he said.

Local hospitals fared well in the report, although some posted significantly higher than expected readmission rates in several categories, the council said. Allegheny General Hospital in the North Side posted significantly higher readmission rates among patients treated for diabetes with amputation. West Penn Hospital in Bloomfield posted higher-than-expected readmission rates because of complications or infections among patients with congestive heart failure. At UPMC Presbyterian in Oakland, there were higher than expected readmission rates because of complications or infections in patients treated for kidney failure, kidney and urinary tract infections and non-hemorrhagic stroke. “It’s important to keep in mind that the data now being reported by (the cost containment council) are dated and may not properly reflect the severity and illnesses for patients treated at (UPMC Presbyterian and UPMC Shadyside), many of whom are transferred to our facilities from other hospitals because of our skill in providing care for more difficult cases,” said Tami Merryman, vice president of UPMC’s Center for Quality Improvement and Innovation. (Pittsburgh Tribune-Review)


 

Drug makers seek clues to side effects in genes


Seven of the largest pharmaceutical companies have formed a group to develop genetic tests to determine which patients would be at risk from dangerous drug side effects. The new group, the International Serious Adverse Events Consortium, is one of a wave of cooperative research efforts sweeping the drug industry, as companies come under pressure to cut costs and increase their success rates in developing medications. The Food and Drug Administration has encouraged the formation of such groups. If drugs could be withheld from patients who have a genetic risk for serious side effects, it could not only protect the patients but might help manufacturers get their drugs approved or avoid having to remove them from the market. “We have to remove drugs that are clearly offering patients benefits because a handful are getting these severe adverse reactions,” said Duncan McHale, a researcher for Pfizer and co-chairman of the consortium’s scientific management committee.

 

The consortium will start by trying to find genetic predictors of two side effects, serious liver toxicity and Stevens-Johnson syndrome, a rare but potentially fatal blistering of the skin. Both effects are associated with numerous drugs. McHale said the side effects were rare enough that no single company had enough cases and enough patient DNA samples to find genetic risk factors. “The way to do the best science is for all to work together to get as many cases as possible,” he said. Arthur Holden, the chief executive of the consortium, said the companies would contribute guidance and money. The actual research will be done by contractors and academic laboratories, including one at Columbia University. The results will be put into the public domain, with none of the corporate sponsors having early access or being able to patent the findings, he said. Once the results are made public, any company or laboratory would be able to develop and sell genetic tests to predict side effects. In addition to Pfizer, the companies involved are Abbott Laboratories, GlaxoSmithKline, Johnson & Johnson, Roche, Sanofi-Aventis and Wyeth. Others might possibly join later. Holden said the companies would each pay about $1 million a year. (The New York Times) To read the original article see THIS LINK
 

 

Emergency Health Centre implements ultrasound ED information system
from Patient Care Technology Systems


Patient Care Technology Systems (PCTS), a subsidiary of Consulier Engineering Inc., announced that Emergency Health Centre (EHC) in Houston, TX, has successfully implemented the Amelior ED patient tracking and charting system. EHC is the first emergency care provider in the nation to implement an emergency department information system which integrates ultrasound-based automatic patient and asset tracking. PCTS integrated its ED information system software with ultrasound locating hardware from business partner, Sonitor Technologies. The Amelior ED system provides comprehensive information management from patient triage to disposition. Core modules include patient tracking, nurse and physician charting, computerized provider order entry, clinical decision support and patient disposition management. PCTS, recognized as a pioneer in automatic patient and asset tracking software for emergency departments, is the first EDIS provider to embed automatic patient and asset tracking software within its documentation system. Earlier this year, PCTS announced its partnership with Sonitor Technologies to integrate ultrasound locating with its tracking and charting systems.
 

Emergency Health Centre is a freestanding emergency care facility which operates 24 hours a day, 7 days a week. It is designed around a concierge emergency medicine model which promises a higher level of service, more customized patient care and more comfortable and upscale waiting and treatment areas. As part of the service commitment, patients are guaranteed that they will be seen within 30 minutes and can check-in using tablet PCs. EHC is staffed by board-certified emergency medicine physicians and contains an on-site full service CLIA certified laboratory and diagnostic center. A 64-slice CT scanner is among the advanced medical technology and diagnostic tools in use. The Amelior ED system integrates location data from real-time locating systems such as Sonitor’s ultrasound indoor positioning system. Wireless patient and asset tags communicate their real-time location using ultrasound signals which remain in the room where they originate to provide 100% room level accuracy. The signals do not create any electromagnetic interference and do not impact hospital LAN bandwidth. Used as part of the Amelior ED system, manual updating of patient location and care status is virtually eliminated. Emergency department workflow intelligence within the Amelior ED system provides caregivers with extensive workflow automation support to anticipate and manage their activities.

 


September 26, 2007   Download print version

New report looks at the latest on breast cancer

WHO: Cholera in Iraq intensifies

US hospitals report infections increasing in frequency and cost

International Classification of Diseases, 9th revision,
Official Guidelines for Coding and Reporting


Massachusetts: Insurers’ hospital payments soon online

Univ. of Cincinnati health provost to step down

The Council of Supply Chain Executives announces new corporate member

Angel Medical Center adopts new infusion pump technology
from B. Braun


New report looks at the latest on breast cancer

 

The breast cancer death rate in the United States continues to fall by around 2% a year, as it has since 1990, according to Breast Cancer Facts & Figures 2007-2008, a biennial report on breast cancer statistics and trends produced by the American Cancer Society. That’s an impressive winning streak for an important indicator of success in the fight against cancer, made possible in large part, the report says, by advances in early detection and treatment. Those advances have benefited women of some races more than others, data shows. For instance, the cancer death rate for white and Hispanic/Latina women fell by 2.4% between 1995 and 2004, but only by 1.6% for African-American women. And during the same time period, no change was seen in cancer death rates of Asian Americans/Pacific Islanders or American Indians/Alaska Natives. Also, authors note a decline in breast cancer incidence, that is, the rate at which new cancers are diagnosed, but suggest it may be due in part to fewer women getting mammograms. “Perhaps most troubling,” said Harmon J. Eyre, MD, chief medical officer of the American Cancer Society, “is the striking divergence in long-term mortality trends seen between African-American and white females that began in the early 1980s and that by 2004 had led to death rates being 36% higher in African-American women.”

 

Other key statistics include: An estimated 178,480 new cases of invasive breast cancer in women will be diagnosed in 2007, and approximately 40,460 deaths will be recorded. Only lung cancer accounts for more cancer deaths in women. In 2004 (the latest year for which figures are available), approximately 2.4 million women living in the US had a history of breast cancer. Breast cancer accounts for more than 1 in 4 cancers in US women. On average, the breast cancer death rate decreased by 2.2% each year between 1990 and 2004. Younger women saw an even more significant decline during that period. Breast cancer incidence among white women fell by 3.7% a year during 2001-2004. Also declining during this time: the use of mammography and hormone replacement therapy (HRT) by white women. There was no significant change in breast cancer incidence among African-American women during this time, coinciding with stable mammography rates and HRT use. Among women 50 and older, incidence rates have been on a steep decline (by 4.8% per year) since 2001. Among women under age 50, incidence rates have remained stable since 1986. Since 2000, the incidence rate of smaller tumors has declined by 3.8% per year. In contrast, the incidence rate of larger tumors (>5.0 cm) has increased by 1.7% per year since 1992. Both trends may be tied to an increase in obesity in postmenopausal women, HRT use, or both.

 

Major risk factors for breast cancer that women have some control over include: Obesity increases a woman’s risk of postmenopausal (but not premenopausal) breast cancer, as does weight gain during adulthood. Women who drink just 2 alcoholic beverages a day face a 21% increase in their risk for breast cancer. Women can lower their risk of breast cancer by exercising vigorously for 45 to 60 minutes on 5 or more days per week. Postmenopausal women can lower their risk, according to one study, with any level of physical activity performed on a regular basis. The report also takes note of groundbreaking breast cancer research, such as studies looking at the chemoprevention of cancer and at the development and testing of so-called “rational therapeutics,” drugs that are tailored to the unique characteristics of each patient and tumor. For more information see THIS LINK

 

 

 

 

WHO: Cholera in Iraq intensifies


Since late August 2007, an outbreak of cholera has spread to 25 districts of Northern Iraq and 4 districts in Southern Iraq and across the centre of the country. It is estimated that more than 30,000 people have fallen ill with acute watery diarrhea, among which 2,116 were identified as positive for Vibrio cholerae. The case fatality rate is 0.52% and has remained low throughout the outbreak, although it continues to spread across Iraq and dissemination to as yet unaffected areas remains highly possible. The outbreak was first detected in Kirkuk province, where 68% of laboratory-confirmed cholera cases have so far been reported, and then spread to Sulaymaniah and Erbil provinces. Additional isolated cases of Cholera have also been identified in other parts of the country, including Tikrit (6 cases confirmed), Mosul (2 cases confirmed), Basra (1 case confirmed), Baghdad (2 cases confirmed) and Dahuk (1 case confirmed).

 

The Government of Iraq has mobilized a multi-sectoral response to the outbreak. Specific control measures have been reinforced and preventive measures to reduce the risk of transmission to unaffected areas have been put in place. However, a severe shortage of chlorination products has been noted and replenishment is urgently needed to enable water supplies to be treated to render it safe for human consumption. Provision of safe water is the highest priority in controlling an outbreak of cholera. The World Health Organization (WHO) continues to support the National and local health authorities in the ongoing response operations. Ten interagency diarrheal disease kits, each sufficient to treat 400 moderate and 100 severe cases, arrived in Erbil International airport on 16 September. Rapid diagnostic tests are being pre-positioned in remote health care facilities. In addition, 10% of all positive stool samples are being sent to NAMRU 3 reference laboratory (US Navy Advanced Research Unit) in Cairo for further confirmation and phenotypic characterization. In controlling the spread of cholera, WHO does not recommend any special restrictions to travel or trade to or from affected areas.

 

 

 


US hospitals report infections increasing in frequency and cost


A new review of inpatient data from US hospitals shows that the number of infections caused by a common bacterium increased by over 7 percent each year from 1998 to 2003. The attendant economic burden to hospitals increased by nearly 12 percent annually. The research is published in the November 1 issue of Clinical Infectious Diseases, now available online. Staphylococcus aureus (also known as staph) is a significant cause of a wide range of infectious diseases in humans, ranging from minor skin infections to life-threatening diseases such as pneumonia and meningitis. In 1998, US hospitals reported a little more than a quarter-million staph infections and slightly over 7 percent of those patients died. By the final year of this study, 2003, hospitals reported nearly 390,000 infections, representing 1 percent of that year’s inpatient stays.

The authors suggest one possible reason for the increase in infections is the documented increase of a particularly dangerous type of antibiotic-resistant staph infection known as MRSA (methicillin-resistant Staphylococcus aureus). A more benign possibility is that doctors and hospitals have improved their infection detection and reporting practices. The good news is that the staph-related in-hospital mortality rate dropped by almost 5 percent each year. The decrease in the in-hospital mortality risk may be due to the introduction of more stringent infection control programs or due to appropriate early treatment of MRSA infections with an effective antibiotic, the authors write.

 

Hospital expenditures associated with staph infections are substantial, increasing from $8.7 billion in 1998 to $14.5 billion in 2003. This economic burden incorporates such factors as extended length of hospitalization and additional surgery, medications, lab tests, and radiologic studies. Lead author Gary Noskin, MD, of Northwestern Memorial Hospital in Chicago, hypothesized that the reason the economic burden increased at a faster pace than the number of infections is because hospital costs are increasing more quickly. The authors used data from the Agency for Healthcare Research and Quality’s Nationwide Inpatient Sample database, which contains data from approximately 7 million hospital stays annually. Unfortunately, the authors were not able to determine the contribution of MRSA infections to costs or outcomes because hospitals generally use the same codes for MRSA and regular staph infections. “We do suggest that coding standards should be changed to more accurately reflect the difference between these two bacteria so we can better understand the impact of MRSA,” said Dr. Noskin.
 

 

International Classification of Diseases, 9th revision, Official Guidelines for Coding and Reporting

Effective October 1, 2007, The Centers for Medicare and Medicaid Services (CMS) and the National Center for Health Statistics (NCHS), two departments within the U.S. Federal Government’s Department of Health and Human Services (DHHS) provide the following guidelines for coding and reporting using the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM). These guidelines should be used as a companion document to the official version of the ICD-9-CM as published on CD-ROM by the U.S. Government Printing Office (GPO). These guidelines are a set of rules that have been developed to accompany and complement the official conventions and instructions provided within the ICD-9-CM itself. Adherence to these guidelines when assigning ICD-9-CM diagnosis and procedure codes is required under the Health Insurance Portability and Accountability Act (HIPAA). The diagnosis codes (Volumes 1-2) have been adopted under HIPAA for all healthcare settings. Volume 3 procedure codes have been adopted for inpatient procedures reported by hospitals.

A joint effort between the healthcare provider and the coder is essential to achieve complete and accurate documentation, code assignment, and reporting of diagnoses and procedures. These guidelines have been developed to assist both the healthcare provider and the coder in identifying those diagnoses and procedures that are to be reported. For more information see THIS LINK

 

 

Massachusetts: Insurers’ hospital payments soon online

 

 

 


Univ. of Cincinnati health provost to step down


The highest-ranking executive at the University of Cincinnati Medical Center has decided to leave her post, citing differences with UC’s board and President Nancy Zimpher. “The vision and the management philosophy used to guide the academic health center by the UC board of trustees and the president is substantially different than the one I was recruited to pursue in 2003,” said Dr. Jane Henney, senior vice president and provost for health affairs, in a Sept. 7 message to employees. In an interview Tuesday, Zimpher indicated that UC will explore “different models for how to organize” its health-related units. That could mean abolishing Henney’s provost position altogether. Zimpher said she’ll spend the next few months consulting with faculty and leadership on the UC medical campus, along with research partners at Cincinnati Children’s Hospital Medical Center. If the provost's office isn’t filled, Zimpher said UC will likely replace it with another structure that clusters health-related colleges under a single management unit.

 

The UC medical campus has been through a rough year, with $89 million in cost overruns in its construction program for new lab space and rising deficits in a multi-year program aimed at bringing 200 new researchers to the school. UC cut that recruitment goal to 68 researchers this year. UC faces additional financial pressure thanks to a decision by Christ Hospital and the St. Luke Hospitals to leave the Health Alliance of Greater Cincinnati. (Business Courier of Cincinnati)


 

The Council of Supply Chain Executives announces new corporate member

The Council of Supply Chain Executives (The Council), a division of the Institute of Healthcare Executives and Suppliers (IHES), announces the addition of Luminetx Corporation to its list of healthcare supplier clients. Luminetx Corporation is a privately held company from Memphis, TN, that discovers, develops, and commercializes bioscience technologies. Their premier product, The VeinViewer, uses a combination of near-infrared light and patented technologies to image vascular structures, which allows physicians, nurses and other healthcare professional to clearly locate subcutaneous veins directly on the skin, thereby eradicating the possibility of numerous needle sticks. The Council provides consulting, insight and educational networking opportunities for leading healthcare suppliers of products and services utilizing a roster of the premier supply chain executives in the country. For more information see THIS LINK
 

 

Angel Medical Center adopts new infusion pump technology
from B. Braun

In an effort to boost patient safety and healthcare efficiency, Angel Medical Center announced its rapid and successful conversion to B. Braun Medical Inc.’s Outlook 300 Safety Infusion System. The hospital’s new infusion system now enables improved patient safety and streamlined patient care, as well as enhanced communication between nurses and pharmacists, through use of the its unique barcoding capabilities and dose monitoring software, DoseTrac. These two cutting-edge safety features help clinicians ensure that the right medication, in the right dose, is delivered to the right patient. Electronic barcoding matches the pharmacy-prepared medication to the patient’s infusion pump, while dose monitoring software helps clinicians monitor the appropriate use and dosing of medications. After reviewing possible options, Angel Medical’s senior leadership selected the wireless Outlook 300 System for its ease of use and advanced features. Angel Medical completed its conversion to the Outlook 300 system within five weeks. For more information see THIS LINK


 


September 25, 2007   Download print version

Death of student raises meningitis concerns

Johnson & Johnson’s risky tactic fails in patent fight

The biggest FDA reform in a decade

Healthcare premiums expected to jump 8.7% in 2008, study says

Getting the bugs out; Washington area hospitals far apart
in applying infection-control measures

Hospitalist care associated with shorter hospital stays for patients

U.S. sues former Ft. Lauderdale Tenet official

 


Death of student raises meningitis concerns

Many barely knew her, but they were stunned by the news that an infection killed one of their schoolmates in a matter of days. By late Monday, 171 University of South Florida (Tampa) students received the vaccination against bacterial meningitis, a contagious disease that struck the outgoing, vivacious Rachel Futterman. Futterman died Monday, two days after she suffered a seizure in the Delta Gamma sorority house on campus. She was 19. Her illness and subsequent death prompted dozens of students to line up outside the campus health center. University health officials had available 200 doses of the vaccine on Monday. By the end of the day, they ordered 200 more.

 

The vaccination, available to students for $90, is not required among those living on campus. Instead, they are shown information about meningitis and asked whether they have been vaccinated. They can acknowledge they received the information, however, and decline the vaccine. The university doesn’t ask for proof of vaccination, as it does for measles or Rubella, said Egilda Terenzi, director of student health services. USF officials now say they may discuss whether to require the meningitis vaccination. “That’s one possibility among others that will be explored,” Terenzi said. Many students aren’t waiting until then. They began arriving at the campus health clinic early Monday - some scared, some ready with the $90 vaccination fee. Terenzi said she doesn’t have the money in her budget to offer the vaccination free. The cost students paid for the vaccine, Menactra, was what the university paid to get each dose, she said. Terenzi spent much of Monday calming students’ fears, assuring them that casual contact with Futterman wouldn’t require antibiotics. As many as 70 of those closest to Futterman, however, received the antibiotic Cipro, Terenzi said. 

Amber Powers, Futterman's roommate, found her after the seizure. Sorority sisters say that Futterman seemed lethargic Friday, one day after she finished her morning shift at Gator’s Dockside restaurant just east of the USF campus. She slept most of the day and complained of an upset stomach, thinking she had the flu, said Alyssa Wennlund, the sorority’s USF chapter president. At 7:30 a.m. Saturday, Futterman suffered her seizure, Wennlund said. Paramedics rushed her to University Community Hospital. University health officials first told the sorority sisters that Futterman had viral meningitis, a relatively common form of meningitis that rarely is fatal. It wasn’t until later Saturday that university and county health officials told the women that Futterman had suffered from the more serious, bacterial form, which inflames the tissue that covers the brain and spinal cord.

Symptoms of meningitis are sometimes mistaken for the flu, and include high fever, severe headache, stiff neck, rash, nausea and vomiting. The disease is contagious and can be spread by sharing a drinking cup or eating utensils and by kissing, coughing and sneezing. It is not transmitted through casual contact, so diners at Gators Dockside, where Futterman worked on Thursday, should not be concerned, said Warren McDougle, epidemiology manager for the Hillsborough County Health Department. Customers served by Futterman would be at “very low risk for the disease,” McDougle said, and probably already would have symptoms. “The vaccine is clearly underused,” said John Sinnott, chief of infectious diseases at USF and Tampa General Hospital. “It offers protection against 70 (percent)-75 percent of the strains.” The vaccine takes about two weeks to become fully effective, Sinnott said, and is good for at least three and as many as five years. (The Tampa Tribune) To read the complete article see THIS LINK




Johnson & Johnson’s risky tactic fails in patent fight

Johnson & Johnson was rebuffed yesterday in an attempt to gain the upper hand in a patent case in which its lawyers tried a high-risk tactic: highlighting safety concerns about the company’s own product. The lawyers hoped to persuade a federal judge in Delaware that because Johnson & Johnson’s drug-coated Cypher stent had been linked in clinical studies to blood clots, it fell outside the safety profile of a Boston Scientific patent. That position appeared to contradict Johnson & Johnson’s repeated assertions in its communications with doctors and the public in the past year that Cypher is no more likely to induce clots than older bare-metal stents. And it did the company no good.

Judge Sue L. Robinson refused to throw out a jury verdict that the Cypher, made by the Johnson & Johnson subsidiary Cordis, infringed on a Boston Scientific patent covering drug coatings. She also upheld a jury verdict against Johnson & Johnson in a separate patent case involving the design of the underlying metal stent. The Johnson & Johnson motion reflected the complexity of the legal maneuvering the companies have tried after back-to-back jury trials two years ago left them in a legal standoff. The juries decided that each company had infringed patents owned by the other. Follow-up trials in which potential damages were to be weighed have been postponed while the two companies sought to overturn the infringement verdicts.

Judge Robinson made all the verdicts final yesterday. Both companies said last night that they would now proceed to appeal the verdicts against them to the United States Court of Appeals for the Federal Circuit in Washington. In the motion related to drug coatings on which Judge Robinson ruled yesterday, the goal of the Johnson & Johnson lawyers was clear enough, the Boston Scientific patent covers stents with a “non-thrombogenic” coating, that is, a coating that does not cause clots. Thus, evidence that Cypher has a significant clotting problem might suggest it does not infringe on the patent. Judge Robinson’s ruling noted that while federal regulators had been concerned about studies showing potential medical risks in using Cypher and the Taxus stent from Boston Scientific, the only drug-coated stents on the American market, they had also concluded that it was not clear whether the drug-coating or some other aspect of the devices was at fault. The judge said the evidence cited by Johnson & Johnson’s lawyers was “too speculative” for her to dismiss Boston Scientific’s patent claim or order a new trial into whether Johnson & Johnson infringed it. (The New York Times)


 

 

The biggest FDA reform in a decade

You wouldn’t know it from the lack of fanfare, but the Food and Drug Administration is getting its biggest overhaul in a decade in a dramatic coda to Merck’s withdrawal of the blockbuster painkiller Vioxx three years ago. A bill to give the FDA more power passed both houses of Congress with only a handful of no votes, and the president is expected to sign it into law. Because the bill is attached to the re-authorization of an important part of the FDA’s funding, a veto is unlikely. If the law doesn’t pass soon, FDA head Andrew Von Eschenbach is going to have to start informing staffers that their jobs are no longer funded. The bill represents a victory for advocates of higher standards for making sure that drug side effects are known and promptly dealt with. Before Vioxx was yanked, some of the changes being made would be unimaginable. Until now the claims drug companies like Merck and Pfizer made about their medicines were, to a degree, negotiated. Labeling discussions between Merck and the FDA dragged on, and as a result, the agency will now be able to dictate what claims companies can make with much more force.

Another change: The FDA will be able to force drug makers to do clinical trials even after a medicine is approved and fine them if they don’t follow through. Previously, many big clinical trials regulators asked for weren’t finished. And there will be more money to study side effects of new medicines post-approval. Companies will pay more in fees when they submit drug applications, increasing the amount of money the FDA gets from industry by 25% to $400 million. One of the farthest-reaching changes may be a new requirement demanding that the drug companies list all of their clinical trials in a registry maintained by the National Institutes of Health accessible to anyone with an Internet browser. After the studies finish, the results will also have to be posted. This will expose drug companies to new levels of scrutiny about the safety of their medicines. (Forbes.com) To read the original article see THIS LINK

 

 

 

 

Healthcare premiums expected to jump 8.7% in 2008, study says

Healthcare premiums of employers and their workers rose by more than twice the rate of inflation in 2007, and cost increases are expected to accelerate next year, with employees picking up a larger slice of the bill, according to a study released Monday by Hewitt Associates, a global human resources company. The cost of providing healthcare benefits to employees rose by 5.3% on average in 2007, down from 7.9% in 2006 and the smallest increase in nine years. However, Hewitt predicts that healthcare costs will jump by 8.7% on average in 2008, bringing the average annual premium cost per employee to $8,676 from $7,982 now. Bob Tate, the chief actuary in Hewitt’s Health Management Consulting business, said that in recent years rate increases have slowed as employers used funds carried over from previous years’ budgets as a cushion. However, “that surplus is now gone,” he said. The Hewitt study comes in the wake of recent surveys by the Kaiser Family Foundation and the Health Research and Education Trust, and a survey by employee-benefits firm Mercer Health & Benefits LLC, predicting an uptick in the rate of premium growth.

Employees are also likely to shoulder slightly more of the financial burden for their healthcare next year. Hewitt predicts that employees on average will contribute $1,859, or 21.4%, toward premiums, compared with $1,690, or a contribution of 21.2%, this year. In 2003, employees paid 17% of the premium. In addition, employees are expected to pay higher out-of-pocket expenses, through higher co-pays, annual deductibles and co-insurance. Overall, employees are likely to pay $3,597, or 10.1% more, in 2008 for healthcare than in 2007. And employers are likely to continue slowly shifting more costs to employees in the coming years, according to Tate. Jim Winkler, practice leader of Hewitt’s Health Management Consulting business, said it was encouraging to see rate increases soften in 2007 because it means that companies are making a concerted effort to manage healthcare costs.

 

However, one of the primary ways employers have been accomplishing this, he said, is by passing a significant percentage of costs to employees, and Hewitt is seeing evidence that this strategy is prompting an increasing number of employees to forego necessary preventative care and/or not comply with prescribed medications. “While some cost-shifting is appropriate, it's critical that companies design their healthcare programs in a way that encourages employees to use them, and use them wisely,” Winkler said. “Otherwise, they are essentially trading preventative care now for ‘rescue care’ later, which will lead to unhealthy employee populations, a decrease in employee productivity and ultimately, higher healthcare costs.”

Hewitt’s research also found that more than 20% of employers offer, or plan to offer, a high-deductible health plan with a tax-advantaged health savings account, or HSA, by the end of this year, and almost half are considering offering one at a future date. While just 3% of employees elected these plans last year, most companies anticipate that enrollment will grow to 20% in five years, according to Hewitt. Hewitt data included than 1,800 health plans throughout the U.S., including 400 large employers, and more than 18 million plan participants in its survey. The results were based on responses from employers that pay premiums to insurance companies for coverage and employers who are self-insured. (The Wall Street Journal) To read the original article see THIS LINK

 


Getting the bugs out;
Washington area hospitals far apart
in applying infection-control measures

In an analysis to be made public today, Consumers Union compared data compiled by the federal Centers for Medicare and Medicaid Services (CMS) showing compliance with infection-control measures for most hospitals in Maryland and Virginia. (Similar data are available for District hospitals, but the nonprofit group, the publisher of Consumer Reports magazine, did not include those in its analysis.) CU, which is advocating for a bill before Congress that would require hospitals to publish their infection rates, found that the hospitals in both states generally performed about as well as hospitals nationwide. But among hospitals in each state, says CU’s Bill Vaughan, adherence to three measures of practice quality varied greatly. The three infection-control measures are: how often preventive antibiotics are given in the hour before surgery, how often the right antibiotic is chosen and how often the drug therapy is halted within 24 hours. “Certain hospitals are more diligent than others in making sure these practices are being followed,” said Lisa McGiffert, manager for Consumers Union’s “Stop Hospital Infections” campaign.

Giving patients an appropriate antibiotic in the hour before surgery has been found to reduce infection risks, as has good hand-washing and other practices. Yet not all hospitals perform such preventive measures with consistency. For example, Sentara Leigh Hospital in Norfolk reported that it gave 97 percent of its surgery patients preventive antibiotics in the hour prior to their operations, the highest percentage reported in Virginia. At the other extreme, Norton Community Hospital in southwestern Virginia took that step in just 22 percent of surgical cases it reported to CMS. Ending antibiotics on time is equally critical: Therapy that lasts longer than a day can breed antibiotic-resistant bacteria, making any infection that does occur more dangerous. In the District, Howard University Hospital ended antibiotic therapy within a day of operating in 86 percent of cases; Georgetown University Hospital reported doing so in just 56 percent of cases. On the same measure, Maryland hospitals ranged from a high of 95 percent to a low of 20 percent. Those numbers, which became available last week, reflect cases treated between January and December 2006. Richard Goldberg, Georgetown’s chief medical officer, said he was “on board with the spirit of the standard,” which calls for the last dose of an antibiotic to be given 24 hours after a surgical incision is made. But, he added, “if you’re over by five minutes,” as sometimes happens at Georgetown, “it’s considered that you haven’t complied with the standard. We don’t want to play a game of eliminating the third dose. But theoretically a hospital could do that and look very good. We’ve chosen not to do that.”


The data are freely accessible at the Web site http://www.hospitalcompare.hhs.gov, which is maintained by CMS. Patients in any hospital can speak up to better the odds that infection-control protocol will be followed, said infection-control expert Michael Tapper. “Where patients see hospital data that is discrepant,” he said, “it’s perfectly appropriate for the patient to ask the surgeon: ‘Can you address this? Can you reassure me, if antibiotics are necessary, that I’m going to get them in a timely fashion?’ ” Tapper, a hospital epidemiologist in New York who speaks for the Infectious Diseases Society of America, said any number of glitches can interfere with good practice. A surgical team may neglect to order a necessary drug, for example, or the drug may be ordered but not delivered on time. Practices surrounding the use of antibiotics aren’t the only factors in preventing post-surgical infections. But the CMS database does not include such basic measures as doctors’ hand hygiene. It also doesn’t track the actual frequency of hospital-acquired infections, said Tammy Lundstrom, an infection-control specialist at Providence Hospital in Southfield, MI. Laws recently passed in Maryland, Virginia and other states will require hospitals to track and publicly report certain kinds of infections. (The Washington Post) To read the original article see THIS LINK

 


Hospitalist care associated with shorter hospital stays for patients

Patients at an academic medical center who are cared for by a hospital-based general physician may have a shorter length of hospital stay than those who are not, especially if the patients require close monitoring or complex discharge planning, according to a report in the September 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Pressure to control costs has led more academic medical centers to hire hospital-based physicians, known as hospitalists, according to background information in the article. These clinicians provide care for medical inpatients and staff medical teaching rounds. William N. Southern, M.D., M.S., and colleagues at Montefiore Medical Center, the University Hospital for Albert Einstein College of Medicine, New York, reviewed data on all patients discharged from a 381-bed teaching hospital between July 1, 2002, and June 30, 2004. The patients were assigned to either a hospitalist or non-hospitalist team by a senior admitting resident at the time of admission. The teams were identical except for the type of physician conducting the rounds. Data on the patients’ demographics, insurance status, health history, diagnosis, length of stay, readmission and death were gathered form the hospital’s clinical information system.

During the study period, there were 9,037 discharges with sufficient data to be included in the analysis. Of these, 2,913 (32.2 percent) were cared for by hospitalists teams and 6,124 (67.8 percent) were cared for by non-hospitalist teams. The average length of stay in the hospitalist group was 5.01 days, compared with 5.87 days in the non-hospitalist group. There were no differences between the two groups in readmission or death rate in the hospital or within 30 days. “Hospitalist care had the strongest association with length of stay in patients with specific diagnoses, including cerebrovascular accidents (strokes), congestive heart failure, pneumonia, sepsis, urinary tract infections and asthma/chronic obstructive pulmonary disease,” the authors write. “The close monitoring and continuous presence offered by hospitalists may allow for earlier discharge because hospitalists are more likely to detect clinical improvement in real time and to make appropriate adjustments in treatment regimens.” Hospitalist care was also more strongly associated with shorter length of stay in patients who had complex discharge planning needs, such as home health care services, rehabilitation or transfer to a nursing facility. “We were able to measure discharge planning needs with the use of a separate discharge disposition code, which was assigned independent of billing at the time of discharge,” the authors write. “We believe that the greater reduction in length of stay associated with complex discharge planning reflects hospitalist skills in working with ancillary staff, such as social workers or discharge planners.”
 

 

U.S. sues former Ft. Lauderdale Tenet official

The U.S. attorney’s office in Miami has taken the unusual step of suing a former official with the Tenet Healthcare hospital chain for events at the North Ridge Medical Center in Fort Lauderdale going back to the 1990s. The government is alleging that Christi R. Sulzbach, a former associate general counsel, should repay more than $18 million because of her role in a kickback scheme involving the hospital and physicians. The dispute goes back to 1997, when a former Tenet administrator, Sal Barbera, filed a whistle-blower lawsuit alleging North Ridge billed Medicare for patients referred by physicians with which the hospital had an improper financial relationship. In March 2004, Tenet settled the whistle-blower case by agreeing to pay $22.5 million. About $5.2 million of that went to Barbera.

In 2006, Tenet agreed to pay $920 million to the federal government to settle a broad variety of accusations. As part of that agreement, Tenet produced some documents that, the U.S. attorney’s office now alleges, indicated Sulzbach acted improperly. In an e-mail response to The Miami Herald, Tenet spokesman Steven Campanini wrote: “This civil lawsuit . . . relates to allegations that are more than 10 years old. . . . Sulzbach resigned from Tenet four years ago in Sept. 2003. . . . Neither Tenet nor North Ridge are parties to this new lawsuit brought against Sulzbach, nor can they be since Tenet and North Ridge were released from liability as a part of the March 2004 settlement. Since 2003 we have built a company with a business strategy focused on quality and transparency in everything it does. Since that time we have a new senior management team and board of directors,” Campanini wrote. In South Florida, Tenet facilities are Coral Gables Hospital, Florida Medical Center, Hialeah, North Shore, Palmetto General and North Ridge. (Miami Herald)

 


September 24, 2007   Download print version

More profit and less nursing at many homes

California closes in on universal healthcare plan;
governor, democrats work to resolve funding

TV’s medical missteps

The Council of Supply Chain Executives announces new member

DataBay Resources announces release of NavigateMD;
new technology for determining physician need

AHRMM & HIMSS co-sponsor Supply Chain Symposium

Sonitor Technologies to showcase ultrasound technology
at RFID Conference for hospitals and healthcare


More profit and less nursing at many homes

For this article, The New York Times analyzed trends at nursing homes purchased by private investment groups by examining data available from the Centers for Medicare and Medicaid Services. The Times examined more than 1,200 nursing homes purchased by large private investment groups since 2000, and more than 14,000 other homes.

Habana Health Care Center, a 150-bed nursing home in Tampa, FL, was struggling when a group of large private investment firms purchased it and 48 other nursing homes in 2002. The facility’s managers quickly cut costs. Within months, the number of clinical registered nurses at the home was half what it had been a year earlier, records collected by the Centers for Medicare and Medicaid Services indicate. Budgets for nursing supplies, resident activities and other services also fell, according to Florida’s Agency for Health Care Administration. The investors and operators were soon earning millions of dollars a year from their 49 homes. Residents fared less well. Over three years, 15 at Habana died from what their families contend was negligent care in lawsuits filed in state court. Regulators repeatedly warned the home that staff levels were below mandatory minimums. When regulators visited, they found malfunctioning fire doors, unhygienic kitchens and a resident using a leg brace that was broken.

Habana is one of thousands of nursing homes across the nation that large Wall Street investment companies have bought or agreed to acquire in recent years. Those investors include prominent private equity firms like Warburg Pincus and the Carlyle Group, better known for buying companies like Dunkin’ Donuts. As such investors have acquired nursing homes, they have often reduced costs, increased profits and quickly resold facilities for significant gains. But by many regulatory benchmarks, residents at those nursing homes are worse off, on average, than they were under previous owners, according to an analysis by The New York Times of data collected by government agencies from 2000 to 2006. The Times analysis shows that, as at Habana, managers at many other nursing homes acquired by large private investors have cut expenses and staff, sometimes below minimum legal requirements. Regulators say residents at these homes have suffered. At facilities owned by private investment firms, residents on average have fared more poorly than occupants of other homes in common problems like depression, loss of mobility and loss of ability to dress and bathe themselves, according to data collected by the Centers for Medicare and Medicaid Services. The typical nursing home acquired by a large investment company before 2006 scored worse than national rates in 12 of 14 indicators that regulators use to track ailments of long-term residents. Those ailments include bedsores and easily preventable infections, as well as the need to be restrained. Before they were acquired by private investors, many of those homes scored at or above national averages in similar measurements.

In the past, residents’ families often responded to such declines in care by suing, and regulators levied heavy fines against nursing home chains where understaffing led to lapses in care. But private investment companies have made it very difficult for plaintiffs to succeed in court and for regulators to levy chainwide fines by creating complex corporate structures that obscure who controls their nursing homes. By contrast, publicly owned nursing home chains are essentially required to disclose who controls their facilities in securities filings and other regulatory documents. The Byzantine structures established at homes owned by private investment firms also make it harder for regulators to know if one company is responsible for multiple centers. And the structures help managers bypass rules that require them to report when they, in effect, pay themselves from programs like Medicare and Medicaid. Investors in these homes say such structures are common in other businesses and have helped them revive an industry that was on the brink of widespread bankruptcy. (The New York Times) To read the complete article see THIS LINK.  


California closes in on universal healthcare plan;
governor, democrats work to resolve funding

With his own party sidelined, California Gov. Arnold Schwarzenegger (R) is working with Democrats to produce a bill that would extend health insurance to everyone in the nation’s largest state if voters approve new taxes to pay for it. “We hope to have a bill very, very soon,” the governor’s press secretary, Aaron McLear, said Friday. Schwarzenegger has invested mightily in the issue, saying California can set a national example on health insurance as it has on energy conservation and other areas. Last week, he called lawmakers back for a special session to find common ground between a Democratic bill and his own proposal to cover about 5 million uninsured Californians. “The main sticking point, as it always is, is the funding formula, and where is the revenue stream?” said Fabian Núñez, the Democratic speaker of the State Assembly. “When you rely on a free-market health system, and you want everyone to participate, the key issue is affordability.”  

The governor’s effort gained momentum last week with endorsements from the state hospital association and the Los Angeles Area Chamber of Commerce. A new poll showed 72 percent of residents favor his $12 billion plan, which resembles the system put in place in Massachusetts and proposed by several Democratic presidential candidates. Schwarzenegger's program would require everyone to buy insurance and fund a pool for subsidized coverage through taxes on doctors and hospitals. Employers that do not provide insurance would give 4 percent of their payroll to the pool. The Democrats’ version calls for 7.5 percent. “I think I see light at the end of the tunnel,” Núñez said of the negotiations. “I think the insurance industry has got to take a haircut. The hospitals pay a fee. Employers pay a fee. Workers pay a share. And then we’re going to have to go out and hustle the voters for a sales tax to make up for the difference.” Voters would likely face the question on the November 2008 ballot. A direct public vote is the only way to raise taxes in California absent a two-thirds majority of the legislature. And Republicans are out of the picture, calling the emerging health insurance plan “a one-way road to disaster,” said GOP Assembly leader Michael Villines. (Washington Post)


 

TV’s medical missteps

Tune in to a medical drama today, and you’re bound to get an eyeful of blood and guts and lots of banter about diseases, procedures and treatments. That’s the point. Attention to all the gory details by small-screen writers, producers and directors is a must, not only to suspend viewers’ disbelief, but also to tell stories responsibly. To that end, many shows rely on consultations with doctors and medical experts, provided by groups such as Hollywood, Health & Society, a partnership with the Centers for Disease Control and Prevention, the National Institutes of Health and the USC Annenberg Norman Lear Center, a research and public policy center, to help them accurately represent health-related storylines. As a result, when doctors on Grey’s Anatomy, ER and House talk shop, they sound like they know what they are talking about. That doesn’t mean, however, that they get everything right. Experts say medical dramas often inaccurately portray organ donation, the range of doctors’ expertise and nurses’ roles, not to mention the level of hospital romance that takes place.

The problem is people get a lot of information from TV shows on many subjects, including medicine and healthcare, without realizing it. After a while, you may not remember where the details or your impressions came from, you’re just sure they’re true. A recent small study by researchers at
Yale University, for instance, showed plastic surgery reality programs, such as Dr. 90210 and Extreme Makeover, played a significant role in cosmetic surgery patients’ perceptions and decisions. Regular viewers cited the shows as influential in their decisions to consult a surgeon, and knew more about procedures than those who never tuned in. Another study found organ donation was a primary storyline in more than 80 episodes of medical dramas, police shows, comedies and daytime soaps in 2004 and 2005. The research, published this summer in the journal Health Communication, found that with a few exceptions, the topic was consistently presented in a negative or inaccurate light, which some say can ultimately affect people's decisions to become donors. That’s what another study, published in Clinical Transplantation in 2005, also concluded. Its researchers found that people who viewed organ donation unfavorably frequently cited what they’d seen on TV as evidence for their opinions.

 

Morgan points to storylines on soap operas such as One Life To Live, in which the hospital’s chief surgeon ran a black market for transplantable organs, and Grey's Anatomy, in which a patient was prematurely declared brain-dead so her organs could be procured, as prime examples. Some nurses have taken issue with their portrayal on these programs as well. ER, for example, commonly depicts physicians doing the work nurses perform in real life, says Sandy Summers, executive director of The Center For Nursing Advocacy. “People will go into the hospital and remark with surprise that the nurses did everything,” Summers said. “They believe from watching these shows that physicians do everything.” Anyone who works in a hospital also will note that in real life there is nowhere near the degree of fraternization among residents, nurses and doctors shown on TV.

Small-screen medical dramas aren’t always off the mark, though. Donate Life Hollywood, a campaign launched this summer to eliminate stolen-kidney storylines, among others, from TV and film, heaped praise on Extreme Makeover Home Edition producers for featuring a woman whose son had died in a car crash and was an organ donor. After the show aired, online donor registration increased 200% in California over the previous week, a spike the campaign attributed to the show. A new study by researchers at the University of Southern California, published this month in the Journal of Health Communication, shows viewers of an ER storyline about teen obesity, hypertension and healthy eating habits were 65% more likely to report a positive change in their behavior after watching. (Forbes.com) To read the original article see THIS LINK.

 

 



 
The Council of Supply Chain Executives announces new member

The Council of Supply Chain Executives is pleased to announce the participation of John Pennell. Pennell is the Vice President of Logistics Management for TriHealth, a $1.5 billion not-for profit health system having hospitals with roots in both the Catholic and Methodist faiths. Pennell is a 29-year veteran of healthcare operations who is corporately responsible for all aspects of Supply Chain Management and Logistics. He is also responsible for the Capital Budgeting, Corporate Real Estate, Food and Nutrition and Environmental Services functions throughout the corporation. While at TriHealth he has been instrumental in consolidating the support services for three facilities as well as implementing major strategic programs around supply chain automation and supply/purchased service expense management. For more information about Pennell and the other Provider Executives see THIS LINK.
 
The Council of Supply Chain Executives (Council) is an organization of America's premier healthcare supply chain executives. The Council's mission is for the supply chain executives to provide their experiences, best practices, and their perspectives to each other and to leading suppliers with the mutual goal of improving the delivery and quality of products and services to the healthcare industry. The third annual meeting of The Council will be held on November 7-8, 2007 in Nashville, TN. Limited slots are available for suppliers to participate. For more information please contact Hays Waldrop, President and CEO, at (615) 794-2501 or see THIS LINK.

 


 

 

DataBay Resources announces release of NavigateMD;
new technology for determining physician need

 

DataBay Resources, a division of Amerinet Inc., and a provider of healthcare market assessment software, announces the release of NavigateMD, an Internet-based system for healthcare strategic planners, marketers and physician recruiters designed to determine the physician supply and community demand of a service area. “NavigateMD is in direct response to the healthcare industry demands to ascertain, as correctly as possible, a physician’s service area. Previously, a physician’s service area was determined only by the zip code of the physician’s practice even though a physician serves a much wider area. NavigateMD combines a multitude of resources and proprietary methodologies to establish a solution,” stated Mary Mort, vice president of DataBay Resources. NavigateMD incorporates new technologies and methodologies to include a physician’s out-of-area influences and does not limit the determination by only the physical location of the physician; adjusts data by region, gender and age for accurate population divisions; provides annually updated supply benchmark ratios, demand ratios, and area demographics; incorporates demand data for both physician specialties and subspecialties such as pediatric subspecialties (cardiology, gastroenterology, hematology/oncology, orthopedics, etc.); and eliminates the guesswork previously associated determining a physician’s service area.

AHRMM & HIMSS co-sponsor Supply Chain Symposium

The Association for Healthcare Resource & Materials Management (AHRMM) and the Healthcare Information and Management Systems Society (HIMSS) are co-sponsoring a pre-conference supply chain symposium on Sun., Feb. 24, 2008, from 8:00 am – 4:00 pm, during the HIMSS08 Annual Conference & Exhibition in Orlando, FL. This is the second year in a row the two associations have partnered to bring technology focused supply chain education to the HIMSS conference. The one day symposium will focus on “Optimizing Supply Chain Performance in the Enterprise” and is beneficial for supply chain management professionals who have a responsibility for facilitating the work of the healthcare supply chain (finance, IT analysts, clinicians, and others who work closely with the Chief Information Officer).

“Without question, the healthcare supply chain continues to grow and develop at an unprecedented pace,” said AHRMM President Jean Sargent. “AHRMM has again joined forces with HIMSS to provide a symposium that teaches healthcare professionals about the latest advancements in supply chain management as well as what the future holds for the industry.” Symposium presentation topics include: “Supply Chain Management from A to Z; Where We Are, Where We Need to Go, and How We Need to Get There”; “The Use of Technology in Supply Chain Management: A Global Perspective”; “An Update on Supply Chain Process Benchmarking in the Health Sector”; “Maximizing Supply Chain Benefits by Centralizing Clinical and Financial Data: One Organization’s Experience”; “Supply Chain Standards: The Impact on Quality and Patient Safety”; and “Establishing The Future’s Supply Chain Platform: Integrating Standards, Benchmarks And Technology To Achieve Excellence In Safety, Quality, And Efficiency.” Registration for the AHRMM and HIMSS supply chain symposium is $250. AHRMM members who attend the HIMSS08 Conference are also eligible to receive the HIMSS member conference rates. For more information and registration, see THIS LINK
 

 

Sonitor Technologies to showcase ultrasound technology
at RFID Conference for hospitals and healthcare

Sonitor Technologies, a sponsor of this year’s “RFID, Barcoding, & Emerging Technologies Conference”, held September 24-26 in Philadelphia, PA, will be showcasing its patented indoor positioning system (IPS), and will demonstrate how Sonitor’s IPS strategically improves the hospital workflow processes and patient safety. Management will be available for one-on-ones to discuss: Ultrasound Technology; Asset and Patient Tracking; Hospital Efficiency; Room-Level Accuracy; Distribution and Use in Hospitals. Sonitor Technologies is the developer, manufacturer and supplier of a proprietary ultrasound indoor positioning system (IPS) that automatically tracks precisely by room the real-time location of moveable equipment and people in complex indoor environments, such as hospitals. For more information see THIS LINK.


 


September 21, 2007   Download print version

F.D.A. weighs flexibility in trials of heart treatment

Minnesota: Hospitals liable for medical errors; patients don’t pay for mistakes

Helped by generics, inflation of drug costs slows

Statement by FDA Commissioner Andrew C. von Eschenbach
on passage of FDA Amendments Act of 2007 (FDAAA)

FDA warns consumers about the risk of cryptosporidium illness
from Baby’s Bliss Gripe Water

Quong Hop & Co. recalls tofu because of possible health risk

FDA proposing phase out of CFCs in metered-dose inhalers for epinephrine

Novation awards contracts  


F.D.A. weighs flexibility in trials of heart treatment

 

Federal regulators should relax restrictions on which patients are included in clinical trials of a widely used treatment for a common heart malfunction, a panel of experts told the Food and Drug Administration on Thursday. This and other suggestions in a daylong discussion spotlighted the problems the agency faces in overseeing the rapidly evolving technology for treating atrial fibrillation, a nonfatal but frightening condition in which electrical short-circuits in the upper chambers of the heart make them contract rapidly and erratically. “We have to be more flexible,” said Dr. Bram Zuckerman, director of the agency’s cardiovascular devices division, after listening to doctors talk about how fast the technology was changing. Most cases of atrial fibrillation are treated with drugs that control the rate and rhythm of the heartbeat. But because the drugs often fail to help or have intolerable side effects, doctors have increasingly been burning or freezing portions of the atrial muscle to eliminate the sources of the irregular pulses or block the pathways they travel. Many of the devices used in the procedure, known as ablation, have been approved to treat other rhythm problems in the heart. But the F.D.A.’s device division and many doctors have become worried that as many as 50,000 atrial ablations are now being performed each year without any manufacturer’s completing the kind of clinical trials the agency requires to prove they are safe and effective for this use. Ablation devices were developed as alternatives to destroying the tissue with surgical scalpels. The most widely used rely on high-frequency radio waves to burn the tissue, but competing devices have been developed using microwaves, lasers, ultrasound and cryogenic tips that destroy cells by freezing instead of burning them.

 

Manufacturers and doctors at the advisory panel hearing told the F.D.A. that it was becoming harder and harder to enroll patients in trials of the devices because those who want ablation are unwilling to accept that they might be randomly assigned to the group receiving arrhythmia drugs instead. Most of the trials now under way have been limited to patients who have already failed at least one rhythm control drug and forbid inclusion of patients who are currently taking amiodarone, the most commonly prescribed drug for atrial fibrillation. As things stand now, CryoCor, a startup company based in San Diego, is likely to be first in line to seek approval for an atrial fibrillation device. CryoCor recently finished enrolling patients in its clinical trial. It must now complete a year of comparing the outcomes of patients treated with its cryogenic device with those of patients treated with a group of anti-arrhythmia drugs. CryoCor and other companies planning or currently conducting trials said that it could take as long as six years to devise and complete such trials.

Dr. Albert Waldo, a Case Western University specialist who spoke on behalf of Biosense Webster, which makes the most widely used ablation device, said Biosense, a Johnson & Johnson subsidiary, was close to finishing enrollment in a trial that began more than three years ago. But that was only after recruiting efforts that included one advertising campaign to doctors in which a $500,000 outlay netted only three additional trial participants, Dr. Waldo said. The meeting highlighted a wide range of challenges to both gathering and interpreting the data. Different measures of success in the numerous studies by individual medical groups and hospitals have led to reports of success rates as low as 28 percent and as high as 100 percent, the F.D.A. said. (The New York Times) To read the original article see THIS LINK

 

 
Minnesota: Hospitals liable for medical errors; patients don’t pay for mistakes

Operating on the wrong limb is one of 27 preventable errors that Minnesota hospitals refer to as “never events.” On Tuesday, the hospitals agreed on a new one: Never bill patients for the costs of these mistakes. While many hospitals waive these charges already, leaders of the state’s hospitals and health insurers said a formal agreement is needed to ensure that patients are treated fairly in all of these rare but traumatic cases. Gov. Tim Pawlenty announced the policy Tuesday in a speech to the Center for Health Transformation in Washington. “Patients, employers and insurers shouldn’t pay for care made necessary by an adverse health event,” he said. Minnesota is the first state to adopt such a policy, the governor said. However, it is already a standard that the nonprofit Leapfrog Group includes in its annual ranking of top U.S. hospitals, also released Tuesday. Minnesota hospitals have publicly reported their so-called adverse events for the past three years in an effort to learn from one another’s mistakes. The events include fatal medication errors, severe bedsores, maternal deaths or disabilities in low-risk pregnancies, severe patient burns and sexual assaults.

The new policy clarifies that hospitals cannot bill patients or their health plans for the consequences of these errors. Patients with operations on the wrong body part wouldn’t have to pay for the operation or for any follow-up operation or hospital care related to the error. Patients injured by severe burns in hospitals wouldn't pay for the wound care or inpatient recovery. Hospitals also must reimburse patients and health plans if they bill them before an adverse event is discovered, said Bruce Rueben, president of the Minnesota Hospital Association. “We want to make sure that the policy is applied any time there is an adverse event for any patient,” he said. One limitation is that the policy does not apply to doctors, regardless of whether they caused the mistake. So patients injured by hospital errors could still receive bills from their primary doctors, radiologists or anesthesiologists. Bills must be waived for costs related to errors but not for patients' entire hospital stays. The existing policy at HealthEast requires clinical leaders from its four east metro hospitals to meet and ensure that all appropriate charges are waived, said Shireen Stone, a financial executive with the health system. “It’s part of our philosophy to take responsibility if we make a mistake,” Stone said.

Earlier this year, Minnesota hospitals reported 154 “never events” and 24 related deaths for 2006. While that was an increase from 2005, state officials aren’t sure whether hospitals actually made more mistakes last year or did a more thorough job of reporting them. The Leapfrog rankings released Tuesday give high marks to almost all Minnesota hospitals for their safety reporting policies, which is no surprise given their public reporting of mistakes. However, Leapfrog also evaluated hospitals by their physician staffing, experience with high-risk procedures and use of electronic medical records. In the end, four Minnesota hospitals made the top list: Methodist Hospital in St. Louis Park, the Mayo Clinic in Rochester and Children’s Hospitals and Clinics in Minneapolis and St. Paul. Minnesota’s annual adverse event report is at health.state.mn.us/patientsafety/. (Pioneer Press)




Helped by generics, inflation of drug costs slows

As overall healthcare costs continue to rise sharply, prescription drugs have emerged as a surprising exception. Annual inflation in drug costs is at the lowest rate in the three decades since the Labor Department began using its current method of tracking prescription prices. The rate over the last 12 months is 1 percent, according to the government’s latest data, released Wednesday. “The way the index is going, it looks like drug price increases are not going to be very painful this year,” said Daniel H. Ginsburg, a supervisory economist at the Bureau of Labor Statistics, where he is involved in compiling the Consumer Price Index. As recently as 2005, inflation in drug prices was running at an annual rate of 4.4 percent. Economists say the slowdown has come about because more people are turning to generics and because generic versions of some of the most common drugs have recently come on the market. In the past year and a half alone, generic equivalents have become available for the cholesterol treatment Zocor, the sleeping pill Ambien and the blood pressure drug Norvasc.

Another factor could be the so-called Wal-Mart effect. Last fall, Wal-Mart began offering many generic prescriptions at $4 a month. Target quickly announced a similar plan, and Kmart expanded its program, which offers a 90-day supply of generic drugs for $15. Other retailers have followed with their variations. Publix, a grocery store chain with 684 pharmacies in five states in the Southeast, announced last month that it would not charge for prescriptions for seven commonly used antibiotics. To be sure, the government still expects spending on medications to rise, to nearly $500 billion a year within a decade, up from an estimated $275 billion this year. That will happen as more people take more drugs and as new drugs are introduced. Also, costs are likely to soar in some specialized categories like cancer treatments and biotechnology drugs. And yet for the average household, the drug index is perhaps a better reflection of the actual day-to-day impact of prices for their most commonly used drugs, like antibiotics, blood pressure pills and cholesterol medicines. According to the nonprofit Kaiser Family Foundation, in 2006 the average brand-name prescription cost more than three times the average generic: $111, compared with $32. But now, tamer drug inflation could add credibility to the platforms of presidential candidates who have embraced generics as part of a solution to rising healthcare costs, according to Dr. Robert Berenson, an M.D. who is a senior fellow at the Brookings Institution.

Three Democratic candidates, Hillary Rodham Clinton, John Edwards and Barack Obama, have included generics in their healthcare proposals. Generics made up 63 percent of prescriptions dispensed in the United States in 2006, up 13 percent from 2005. And these days, the country’s biggest supplier of prescription drugs, as measured by prescriptions filled, is not a high-profile American company like Pfizer or Merck. It is Teva Pharmaceutical, a generic manufacturer based in Israel, according to data from IMS Health, a firm that tracks the market. A Labor Department economist, Francisco Velez, said his office noted a drop in generic drug prices shortly after the large stores’ promotions began, particularly in the South, where Wal-Mart started its program. Wal-Mart and other large chain stores make up 15 to 20 percent of the pharmacies that the government surveys for the index. The fourth quarter of 2006 was the first time in several decades that the index registered three consecutive months in which prices declined. (The New York Times) For more information see THIS LINK
  
 


Statement by FDA
Commissioner Andrew C. von Eschenbach
on passage of FDA Amendments Act of 2007 (FDAAA)

We at FDA are pleased that Congress has passed the FDA Amendments Act of 2007 and thank the Members of Congress and their staff for all their hard work on this important accomplishment. We are particularly pleased that Congress has completed the reauthorizations of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA), two programs accounting for nearly one quarter of FDA's annual budget. Over the past years, the PDUFA and MDUFMA programs have resulted in significant public health gains by making safe and effective, yet increasingly complex, medications and medical devices available to patients faster than was previously possible. The legislation also includes the reauthorizations of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, two statutes that have provided invaluable information to the agency about medical products’ interaction with pediatric populations. These programs are vitally important to the agency and its continued ability to protect and promote the public health.  We look forward to working towards implementation of this legislation.


 

 

FDA warns consumers about the risk of cryptosporidium illness from Baby’s Bliss Gripe Water


The U.S. Food and Drug Administration (FDA) is warning consumers not to consume Baby’s Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (shown as “10/08” on the label), distributed by MOM Enterprises Inc., of San Rafael, CA. FDA confirmed through laboratory analysis the presence of cryptosporidium after investigating the illness of a 6-week-old infant in Minnesota who consumed the product. Cryptosporidium is a parasite that can cause intestinal infections. The most common symptom of infection is watery diarrhea. Other symptoms can include dehydration, weight loss, stomach cramps or pain, fever, nausea and vomiting. Symptoms generally begin two to ten days after becoming infected with the parasite and generally last one to two weeks. While most people with healthy immune systems will recover without treatment, the infection could be serious or life-threatening for certain individuals. Infants, children and pregnant women are susceptible to dehydration resulting from diarrhea, which can be life-threatening. Individuals with weakened immune systems are also at risk for a more serious and life-threatening form of illness.
 

 

 


Quong Hop & Co. recalls tofu because of possible health risk


Quong Hop & Co. of South San Francisco, CA, is recalling all SOY DELI brand tofu with code date DEC 17 2007 and certain varieties of SOY DELI and QUONG HOP brand tofu with code date SEP 23 2007. The recall includes the following products in the following sizes and code dates: All varieties and sizes of SOY DELI TOFU coded DEC 17 2007; 30 OZ SOY DELI NIGARI TOFU coded SEP 23 2007; 12 OZ SOY DELI WATER PACK TOFU coded SEP 23 2007; and 16 OZ QUONG HOP WATER PACK TOFU coded SEP 23 2007. These products are being recalled because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Although healthy individuals may suffer only short term symptoms such as high fever, sever headache, stiffness, abdominal pain and diarrhea, Listeria infection in severe cases can cause miscarriages and still births among pregnant women. Consumers experiencing any of these symptoms should seek immediate medical attention.
 

 


FDA proposing phase out of CFCs in metered-dose inhalers for epinephrine

The U.S. Food and Drug Administration proposed a change to its regulation on the use of chlorofluorocarbons or CFCs in metered dose inhalers (MDIs) for epinephrine. The rule would remove the “essential-use” designation that allows the use of CFCs in these medical devices. Epinephrine MDIs are used for the temporary relief of occasional symptoms of mild asthma. FDA has tentatively concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release CFCs. Under the proposed rule, epinephrine MDIs containing CFCs would be removed from the market by the end of 2010. A 60-day public comment period will commence following publication of the proposed rule in the Federal Register, and an open public meeting on the essential use of epinephrine will be held on a date to be announced later.

The Clean Air Act permits CFCs to be used in medical products, if the use is determined to be essential by FDA. The use of CFCs has been generally banned in consumer aerosols, such as hairspray, in the United States since 1978 because of adverse effects on stratospheric ozone levels. The production of CFCs is being phased out worldwide under the terms of an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer. Most MDIs available in the United States once contained CFCs; however most such products have recently been or are being reformulated to use other substances as propellants. Epinephrine MDIs are the only devices currently marketed over the counter. Should this rule become final, epinephrine MDI users will have to obtain a prescription for alternative drug products if a non-CFC epinephrine inhaler still does not exist. For more information see THIS LINK

 

 



Novation awards contracts  


Novation has awarded new agreements for orthopedic total joint implants to Encore Medical, Stryker Orthopaedics, Smith & Nephew Inc. and Zimmer Inc. The agreements encompass implant products for hips, knees, revisions and endoprosthesis/shoulders.


Novation has awarded dual-source agreements for bone cement to Stryker Orthopaedics and Zimmer Inc. The contracts will include bone cement and bone cement with antibiotic products and OP-1 products.

Novation has awarded an agreement to Bard Medical Division of C.R. Bard Inc. for catheter securement devices. The agreement includes securement devices for I.V. catheters, PICC lines
, central venous catheters, arterial lines, epidural and dialysis catheters, and Huber needles.

All of the above three-year contracts are effective Nov. 1, 2007
.

 

 


September 20, 2007   Download print version

Providers in good shape to fight flu; plentiful supplies of vaccine received

FDA approves nasal influenza vaccine for use in younger children

Study: Home dialysis better for patients

The dialysis business: fair treatment?

Drug resistance gene has spread from East Coast to Midwest

AdvanDx launches first LNA-Based In Vitro diagnostic test
for detection of antibiotic resistant “superbugs”
 

RFID medical cabinets benchmarked head-to-head

FDA approveS Chlorascrub Swabstick and Maxi Swabstick skin antiseptic for inclusion in kits
 


Providers in good shape to fight flu; plentiful supplies of vaccine received

A record amount of flu vaccine is expected nationally this year. Many providers have sizable inventories to start prepping for the influenza season, a welcome change from the disruptions and delays that caused public confusion, shortages and long lines in recent years. Ample supplies and stable, efficient distribution are just what health officials need to significantly boost immunization rates. At a news conference yesterday, the head of the federal Centers for Disease Control and Prevention sounded hopeful that the message would get out. “We have more manufacturers, more doses, more choices of vaccine than we've ever had,” Director Julie L. Gerberding said. The CDC anticipates that as many as 132 million doses of injectable or spray vaccine will have been made available by January, 12 million more than during the 2006-07 flu season. But health experts continue to battle what one official called “a prevention gap.” Despite the virus’s annual toll, including 200,000 hospitalizations and 36,000 deaths in the United States, public response lags. Nearly 15 percent of last winter’s supply went unused and had to be discarded, according to the CDC. The latest agency statistics indicate that only a fifth of young children, and less than a third of adults up to age 49 with medical conditions, may be getting fully immunized, putting them at higher risk. Among health-care workers, who are strongly encouraged to roll up their sleeves for vaccine shots, just 40 percent historically do so. Officials called such rates troubling and “unconscionable.” “It is critical that we use all of these doses to protect as many people as possible,” said Ardis D. Hoven, an infectious disease specialist and trustee of the American Medical Association. The flu season generally peaks in February. (Washington Post)



FDA approves nasal influenza vaccine for use in younger children

The U.S. Food and Drug Administration approved expanding the population for use of the nasal influenza vaccine FluMist to include children between the ages of 2 and 5. Approval for the vaccine, which contains a weakened form of the live virus and is sprayed in the nose, was previously limited to healthy children 5 years of age and older and to adults up to age 49. “The goal of preventing influenza is now more attainable with the availability of FluMist for younger children,” said Jesse L. Goodman, M.D., director, FDA’s Center for Biologics Evaluation and Research. “This approval also offers parents and health professionals a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot.”


The U.S. Centers for Disease Control and Prevention recommends that all children age 6 months to 59 months receive a vaccination to protect against influenza. Studies have shown that children younger than 5 years had rates of influenza-associated hospitalizations similar to those among individuals age 50 through 64 years, emphasizing the need for improved influenza prevention efforts for this younger U.S. population. However, until today, there have been only two vaccines licensed in the U.S. for children under the age of 5. One influenza vaccine, Fluzone, is indicated for people over 6 months of age, while another vaccine, Fluvirin, is available for use in children age 4 and older.


Approximately 6,400 infants and children age 6 months to 59 months received FluMist in three studies to support the vaccine’s safety and effectiveness. Two studies compared FluMist to placebo (no vaccine), both of which demonstrated the vaccine’s effectiveness in preventing influenza illness. A third study compared FluMist to an inactivated or “killed” seasonal influenza vaccine shot. Children under the age of 2 should not receive FluMist because there was an increased risk of hospitalization and wheezing for this age group during the clinical trials. Commonly observed adverse events from the vaccine were generally mild and most often included runny nose and/or nasal congestion, as well as a slight fever in children 2 to 6 years of age. FluMist should not be administered to anyone with asthma or to children under the age of 5 years with recurrent wheezing because of the potential for increased wheezing after receiving the vaccine. People who are allergic to any of FluMist’s components, including eggs or egg products, should also not receive the vaccine. FluMist is manufactured by MedImmune Vaccines Inc., Gaithersburg, MD. Fluvirin is made by Novartis Vaccines and Diagnostics Ltd, Liverpool, England. Fluzone is manufactured by sanofi pasteur Inc., Swiftwater, PA.

 


Study: Home dialysis better for patients

Supporters of treating kidney disease patients at home rather than in dialysis centers where it can be more expensive were given a boost today from a new study showing dramatic improvements in heart condition and certain other outcomes after people were treated in their homes overnight. In the U.S., 90 percent or more of people with end-stage renal disease are treated in dialysis centers in part because the reimbursement for government insurance companies is better for medical-care providers. In addition, kidney disease doctors say there has been resistance to provide in-home care in part because there have not been studies supporting that it would be any better. Such treatment is expensive, costing the Medicare program for the elderly and disabled more than $20 billion annually and rising.


At least one study comparing in-center dialysis to at home dialysis done in Canada showed the in-home care to be 20 percent less expensive, according to a 2003 study published by the International Society of Nephrology in its medical journal. But a study published in Wednesday's Journal of the American Medical Association indicate in-home dialysis at night six times a week showed improvements that included a decrease in left ventricular mass, a common problem for patients with kidney disease. Such in-home “nocturnal” treatment was compared to conventional treatment in dialysis centers three times a week. “This study might convince more people and maybe some policy makers to emphasize a choice for patients and that in-home (dialysis) is a way to go,” said Dr. Bruce Culleton, the study’s lead author and a nephrologist formerly with the University of Calgary who is now a medical director within Baxter International Inc.'s renal business. “The culture in the U.S. is largely driven by reimbursement and not to offer in-home dialysis to patients.”


A movement toward in-home dialysis treatment would be good news for Baxter because the Deerfield-based medical product giant generates more than $2 billion in annual sales from renal products and drugs. Baxter generated more than $10 billion in total annual sales last year. The bulk of Baxter’s revenue comes from in-home dialysis and the company is investing more money on research and development for such in home and alternate site dialysis treatment as more countries outside the U.S. look to save money on dialysis care. In some countries, such Mexico, more than half of dialysis is done in patients' homes and alternate sites. Culleton, who joined Baxter in July and several months after the completion of the study that took two years, said the study was funded by the Kidney Foundation of Canada. Baxter said the company did not provide funding or influence over the research.  (Chicago Tribune)

 


The dialysis business: fair treatment?

Federal officials are cracking down on how companies like El Segundo, CA-based DaVita, a leading provider of dialysis services, makes much of its money: by administering the drug Epogen to treat anemia in dialysis patients. DaVita receives more from Medicare and private insurers for providing Epogen than it pays to buy the drug from its manufacturer, Amgen. Concerns are mounting that such financial incentives are contributing to an overuse of Epogen that may lead to heart problems, blood clots or even premature deaths. “The payment system leads to perverse incentives,” said Rep. Pete Stark, (D-CA), during a Congressional hearing in June at which DaVita was singled out for criticism. The Food and Drug Administration, which has already forced Amgen to provide stricter warnings about Epogen and similar products, convened a panel of experts last week to consider further restrictions on the drug’s use. While the panel advised against such a move, use of the drug is still expected to drop from last year’s levels, industry analysts say. Medicare and Congress are moving to stop separate Medicare reimbursement for Epogen to end the incentives to overuse the drug.  

Law enforcement authorities, including those at the Justice Department and at the Health and Human Services Office of Inspector General, are conducting criminal and civil investigations into how DaVita and some other dialysis providers bill for Epogen. All of this casts an unfavorable spotlight on the dialysis business, which might be the closest thing the United States has to nationalized health care. Medicare pays for almost all dialysis, even for patients younger than 65. More than one in five of the nation’s dialysis patients die each year, a rate as much as double that in Europe and Japan, for reasons that aren’t clear. Some 350,000 or so Americans currently need dialysis; that population is growing about 3 percent a year, fueled by a rise in diabetes. DaVita treats about 106,000 patients in more than 1,300 clinics and appears to be the most aggressive Epogen user among major dialysis chains, according to the United States Renal Data System, a government-funded registry of dialysis data. Epogen accounts for 25 percent of DaVita’s revenue and up to 40 percent of its earnings, according to the Stanford Group Company, a research firm.

DaVita and its main competitor, Fresenius Medical Care, control about two-thirds of the dialysis business. The rest of the industry is composed of smaller chains and independent clinics, some of which are nonprofit operations. Since 2002, DaVita has grown faster in the markets it serves than Fresenius, said an analyst at Deutsche Bank Securities. Dialysis clinics lose money on the fee paid by Medicare for a dialysis treatment because the payments haven’t kept pace with inflation. Yet industry executives say the clinics can typically recoup those losses by getting reimbursed for Epogen and other drugs. Government officials “understood they were subsidizing the cost of dialysis by allowing us to make a profit on the drugs,” said Dr. J. Michael Lazarus, chief medical officer of Fresenius. Amgen offers discounts and rebates to dialysis companies based, in part, on how much Epogen they use and how much that use increases year to year. Protected by patents, Amgen is the only supplier of a drug that dialysis centers cannot do without, giving it strong leverage over the dialysis companies. (The New York Times)  

To read the original article see  THIS LINK.

 

Drug resistance gene has spread from East Coast to Midwest

A resistance gene that allows bacteria to beat an important class of antibiotics has started to appear in microorganisms taken from Midwestern patients, according to researchers at Washington University School of Medicine in St. Louis. Less than a decade ago, scientists first noticed the BlaKPC gene in bacteria taken from East Coast patients. They found bacteria with an active copy of the gene could defeat carbapenems, a relatively young family of antibiotics that works on a wide variety of bacteria. Physicians generally reserve carbapenems for use in the most critically ill patients. The new study, presented this week in Chicago at the Interscience Conference on Antimicrobial Agents and Chemotherapy, is among the first to detect the resistance gene in samples taken from a Midwestern hospital.

Researchers found the gene in only four of 243 samples from 223 patients with bloodstream-based bacterial infections. But BlaKPC spreads easily among bacteria, and scientists found the method most hospitals use to check for resistance genes didn't detect all BlaKPC-positive strains. “It’s relatively easy for us to find this gene, but most hospitals don’t have access to the same high-tech methods that we have at a major medical center,” said senior author David Warren, M.D., assistant professor of medicine. “To help slow the spread of this gene, we need to look at whether we can develop a more effective way to detect it using widely available equipment and procedures.”

BlaKPC was originally identified during an East Coast outbreak of the bacterium Klebsiella pneumoniae. The gene is encoded on a DNA structure known as a plasmid that can be easily copied and passed around not just among bacteria of the same species but also from one bacterial species to another. Subsequent studies found mortality rates climbing as high as 50 percent when bacteria with the resistance gene infected patients. “We can’t say much about BlaKPC's effects on mortality here yet, because we only had four patients test positive for bacteria containing the resistance gene,” noted lead author Jonas Marschall, M.D., a fellow in infectious diseases. Infection with a bacterium carrying an active copy of the resistance gene doesn't mean all treatment options are gone. But detection of BlaKPC can be key both to successful treatment and to containing the spread of the resistance gene by isolating affected patients.

To search for the BlaKPC gene, scientists used a technique known as PCR (for polymerase chain reaction) to isolate and amplify bacterial DNA. But most hospitals test for antibiotic resistance using a more low-tech method that involves directly exposing bacteria to antibiotics in the lab. When researchers used this method to look for BlaKPC-positive bacteria in their samples, it failed to catch all four strains carrying the gene. This may be a result of the resistance gene being inactive in the bacteria. The gene does not convey its carbapenem-fighting abilities until the bacteria make a copy of its protein, and the bacterium may need some stimulus from the environment to start making those copies. Regardless of whether the gene is spreading in active or inactive form, though, Warren asserts that clinicians need a better, more widely accessible method to track it.

 

AdvanDx launches first LNA-Based In Vitro diagnostic test
for detection of antibiotic resistant “superbugs”
 

AdvanDx Inc. announced the launch of vanA/B EVIGENE in Europe, the first LNA-based in vitro diagnostic test for detecting the antibiotic resistant “Superbugs” Vancomycin-Resistant Enterococci (VRE) and Vancomycin-Resistant Staphylococcus aureus (VRSA) in positive blood cultures and clinical isolates. Infections with antibiotic resistant “Superbugs”, such as VRE and VRSA, are serious problems for patients and hospitals worldwide. Rapid and accurate identification of these pathogens is crucial to ensuring early, appropriate and effective therapy that will allow hospitals to reduce mortality, patient length of stay and overall costs while in the long run tackling the problem of antibiotic resistance.  

vanA/B EVIGENE combines the high specificity of Locked Nucleic Acid (LNA) probes with EVIGENE, a signal amplified sandwich hybridization assay platform, to rapidly and accurately detect both the vanA and vanB genes that confer vancomycin resistance in enterococci and Staphylococcus aureus. A study published by the Centers for Disease Control and Prevention in the May 2007 issue of the Journal of Clinical Microbiology concluded that the EVIGENE technology “…demonstrated 100% sensitivity and specificity for the detection of vanA in S. aureus (VRSA) and vanA or vanB in enterococci (VRE).”  “We are extremely excited to see AdvanDx introduce the first LNA-based in vitro diagnostic test. This marks the transition of LNA from a research tool to a clinical diagnostic tool,” said Dr. Henrik Stender, Vice President for Research and Development, at AdvanDx. Dr. Stender continued, “vanA/B EVIGENE compliments our other EVIGENE and PNA FISH products for rapid identification of antibiotic resistant and virulent bacteria that help clinicians improve therapy for patients with these terrible infections. We look forward to leveraging our technology portfolio along with new partnerships, to develop and market rapid, accurate and therapy guiding diagnostic products within infectious diseases as well as within other critical diseases.”

 

RFID medical cabinets benchmarked head-to-head

ODIN technologies has released a benchmark on RFID-enabled Smart Cabinets for use in hospital, university and healthcare settings. The RFID Medical Smart-Cabinet Benchmark compares performance of the leading RFID medical cabinets available in the market today. The report is the first objective, third party analysis of the smart-cabinet product landscape and is the 10th installment in ODIN’s RFID Benchmark Series. The benchmark provides insight into what is important in RFID smart-cabinet selection from a healthcare end-user perspective. It answers such questions as: What performance characteristics are important in an RFID Medical Cabinet? Which user applications are supported in commercial, off-the-shelf systems? What technical and business differences exist between vendors? What questions do you need to ask vendors when buying RFID Medical Cabinets?

ODIN reached out to twenty vendors about the availability of RFID-enabled smart cabinets and found that most offer only custom-built solutions or prototypes and not production units. This research provides telling commentary on the current competitive landscape for RFID medical smart cabinets. The benchmark restricted testing to vendors who can provide products in production quantities today. “The goal of the RFID Medical Smart-Cabinet Benchmark is to provide end users with an objective analysis and comprehensive framework for selecting RFID-enabled medical cabinets,” commented Diana Hage who oversaw the testing for ODIN technologies. “Healthcare and pharmaceutical manufacturers are looking for ways to automate inventory tracking and replenishment to ensure the right materials are available when needed. This report enables end users to better evaluate vendors by understanding the critical performance factors when selecting an RFID medical cabinet to accurately track medical devices, test samples, assets and pharmaceuticals.”

Tests included using both scientific and common use case tests to characterize and compare RFID reader performance, the benchmark provides end users with information to make the best reader selection decision for their respective businesses. The six scientific tests include: Material dependency; Orientation sensitivity; Null spot testing; Product density; RF leakage; Product proximity. Use case tests include: Stocking; Single and partial unit use; Low and out of stock indications; Invoicing; Security; Compliance alerting. Only three vendors were proven to have commercial off-the-shelf products, which were subsequently tested in the Benchmark. They include Mobile Aspects, TAGSYS RFID and Terso Solutions Inc. The RFID Medical Smart Cabinet Benchmark is available for download now at the ODIN technologies Store (www.ODINtechnologies.com/store). The cost is $1,500 for an enterprise use business license and $750 for single user academic license. ODIN technologies does not manufacture RFID readers, tags or smart cabinets, and the company maintains strict independence in testing all RFID gear.

 

FDA approveS Chlorascrub Swabstick and Maxi Swabstick skin antiseptic for inclusion in kits  

PDI announces the FDA approval of Chlorascrub Swabstick and Maxi Swabstick, a 3.15 percent Chlorhexidine Gluconate (w/v) and 70 percent Isopropyl Alcohol (v/v) pre-injection skin antiseptic for inclusion in kits. Recognizing the need for clinicians to have the convenience of kits for a variety of medical procedures, PDI, the Healthcare Division of Nice-Pak Products Inc., has now made its Chlorascrub Swabstick and Maxi Swabstick available to kit manufacturers. The Chlorascrub Swab was approved for kit use earlier this year. Chlorascrub, available as Swab, Swabstick and Maxi Swabstick, is an optimal, cost-effective delivery system for pre-injection skin preparation. The product achieves a >2 log10 reduction in 30 seconds and maintains a >2 log10 reduction for at least 24 hours. All three Chlorascrub products—Swab, Maxi Swabstick and Swabstick, are now approved by the FDA for use in kits, deigned to withstand high-pressure, high-temperature disinfection processes. The Chlorascrub Swabstick and Maxi Swabstick packaging has been specifically designed to withstand the Ethylene Oxide (EtO) sterilization process for the manufacture of finished sterile kits. PDI will also continue to market its current FDA-approved non-kit Chlorascrub Swab, Swabstick and Maxi Swabstick products.

 


September 19, 2007   Download print version

Hospital comparison web sites may offer inconsistent results

Health plan overhauled at Wal-Mart

FDA issues Class 1 Recall: MRL/Welch Allyn AED 20
automatic external defibrillators

Congo’s Ebola outbreak could be worst in years
 

FDA warns Procter & Gamble about unlawful marketing
of hand sanitizer product for school children


ICU Medical Inc. wins summary judgment in Medegen patent lawsuit

Medegen responds to Federal Court’s decision
in ICU Medical patent infringement case; intends to appeal

Post your comments on HPN Blogline: What does ASHCSP’s unification with IAHCSMM
mean for the CS profession?


Hospital comparison web sites may offer inconsistent results

A review of six publicly available hospital comparison Web sites suggests that they display inconsistent results and use inappropriate or incomplete standards to measure quality, according to a report in the September issue of Archives of Surgery, one of the JAMA/Archives journals. A total of 113 million Americans searched for health information on the Internet in 2006, according to background information in the article. Of those, 29 percent searched for information on specific hospitals and physicians. At the same time, pressure from insurance companies and the public for transparency and accountability in healthcare continues to increase.

Data on hospital performance is frequently made available through Web sites aimed at patients, but few researchers have examined these sites and their content. Michael J. Leonardi, M.D., and colleagues at the David Geffen School of Medicine at UCLA, Los Angeles, performed a systematic Internet search in September 2006 to identify publicly available hospital quality comparison sites. Six sites were identified and rated on accessibility, transparency of the data and statistical calculations, appropriateness, consistency and timeliness. Of the six sites identified, one was government-run (Hospital Compare from the Centers for Medicare and Medicaid Services), two were non-profit (Quality Check from the Joint Commission on Accreditation of Healthcare Organizations and the Leapfrog Group’s Hospital Quality and Safety Survey Results), and three were private and proprietary.

“For accessibility and data transparency, the government and non-profit Web sites were best,” the authors write. “For appropriateness, the proprietary Web sites were best, comparing multiple surgical procedures using a combination of process, structure and outcome measures. However, none of these sites explicitly defined terms such as complications.” All data on the sites were at least one year old, and most were two or more years old. To determine consistency, sample searches were conducted on the three proprietary Web sites comparing four Los Angeles–area hospitals on three common procedures (laparoscopic gall bladder removal, hernia repair and colon removal). The searches demonstrated significant inconsistencies, for example, for colon removal, one hospital was ranked best by two sites but worst by the other site, and the hospital ranked best on that site was ranked worst on another. “Further work is needed to improve these issues, particularly the accessibility by patients, the quality and type of data reporting, the statistical method and the criteria by which hospitals and specific operations are compared. It is probably important that surgeons be involved with the development of such reporting Web sites so that the comparisons accurately and appropriately reflect the quality of surgical care.”


Health plan overhauled at Wal-Mart

Wal-Mart, long criticized for its healthcare coverage, unveiled a broad plan that is intended to cut employee costs, expand coverage and offer workers thousands of cheap prescription drugs. Starting Jan. 1, Wal-Mart’s insurance will look a lot like that offered by many other American companies, but with some twists that even longtime critics described as innovative. Independent experts praised several features of the plan and said it could represent a turning point for the retailer, the nation’s largest private employer. Wal-Mart said it would give each employee or family that signs up for coverage a grant of $100 to $500 to defray health expenses while charging premiums as low as $5 a month. It will eliminate expensive hospital deductibles and make 2,400 generic drugs available to employees for $4 a prescription, about 1,000 more than it sells to customers at that price.

The plans with the lowest premiums would still charge annual deductibles as high as $2,000, typical for American corporate health plans, but perhaps steep for Wal-Mart employees, many of whom work part time and earn less than $20,000 a year. And the company’s plans have other limitations, including waiting periods as long as a year for new employees. Wal-Mart Watch, a group long critical of the company, said yesterday that “these plans are still unaffordable due to low wages or inaccessible due to waiting periods.” It is unclear how many of the 125,000 Wal-Mart workers without health coverage would sign up. But industry analysts said the program represented an upgrade for the 636,000 employees who already receive health insurance through Wal-Mart. They said it could force the company’s discount-retailing competitors to offer more generous plans for their own workers. Two years ago, the Maryland legislature took the unusual step of requiring Wal-Mart, and only Wal-Mart, to increase spending on health insurance. The law was later overturned.

The new program, for which workers can sign up starting this month, offers 50 ways to customize coverage, with varying trade-offs like higher premiums and lower deductibles. In one plan, for example, an employee would pay premiums up to $79 a month, receive a health care credit of $100 and pay a deductible of $500. In another, the employee would pay premiums of $8 a month, receive a $100 healthcare credit, but pay a deductible of $2,000. Though many generic drugs will be available for $4, brand-name drugs will cost $30 to $50. About half of Wal-Mart workers have coverage from the company, while 40 percent more get their coverage elsewhere, through a spouse, a parent, a second job or a state program like Medicaid. About 10 percent have no health coverage. (The New York Times)
  


 


FDA issues Class 1 Recall: MRL/Welch Allyn AED 20 automatic external defibrillators

A Class 1 Recall was initiated on August 24, 2007 for MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2005, serial numbers 205787 through 207509. These devices are intended for use by emergency or medical personnel to treat adult and pediatric patients in cardiopulmonary arrest (heart attack). The devices analyze an unconscious patient’s heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm. Recalling firm Welch Allyn Protocol Inc. is located in Beaverton, OR. These recalled devices may display a “Defib Comm” error message on the device display during use which may result in a terminal failure of the device to analyze the patient’s ECG and deliver the appropriate therapy. Customers may call the company at 1-800-462-0777.
         
Welch Allyn sent recall letters on August 29, 2007 to its customers who purchased these devices. Owners of this defibrillator should contact their local Welch Allyn representative to obtain a loaner AED 20 at no cost while their unit is being serviced. Welch Allyn will pay all costs associated with the upgrade required to correct the issue as well as shipping and handling of the devices. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. Healthcare professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX. See THIS LINK

 


Congo’s Ebola outbreak could be worst in years

International medical personnel and supplies are being airlifted to a remote region of central Congo to combat what threatens to become the world’s most serious outbreak of the deadly Ebola virus in years. Only nine cases of the disease have been confirmed by laboratory tests. But medical authorities suspect the virus has killed 168 people and sickened 375 others across a heavily forested region where villages are linked only by deeply rutted dirt roads. Health officials said it is possible that new cases will continue to emerge over the coming months. “It’s a serious outbreak,” said Peter H. Kilmarx, an official with the U.S. Centers for Disease Control and Prevention who toured the area last weekend. “Every day there is a new town with a reported suspect case.” The outbreak’s epicenter, which is serviced by a dirt-and-grass airstrip, consists of three towns in Congo’s Kasai Occidental province, but the affected area appears to stretch for more than 100 miles.

Kilmarx, speaking from the Congolese capital of Kinshasa, said that one village market he visited had been abandoned and that many Congolese in the area appeared reluctant to shake hands for fear of contracting the highly contagious disease. Efforts to control Ebola depend on identifying and isolating those who are infected. There is no cure, and many who contract the virus die, typically from acute flu-like symptoms such as high fever, headaches and diarrhea. Hemorrhaging also is common, and bodily fluids containing the virus are the main source of transmission. In previous outbreaks, caretakers and those involved in burying victims were particularly susceptible. “The only thing you can do is isolate the patient and avoid other infections,” said Josep Prior, the top official with Doctors Without Borders in Congo, speaking from Kinshasa. The international medical aid group has taken the lead in a global response that also includes the World Health Organization and the CDC team. These groups are assisting Congolese medical authorities in tracking the disease, alerting the public and caring for the ill.

Doctors Without Borders has converted a mud-walled building with a tin roof into a 15-bed isolation ward. To prevent infection, members of medical teams wear protective suits along with surgical masks, gloves and boots. Orange plastic fencing, stretched between tree branches pounded into the ground, keeps potential onlookers away. As doctors across the region report suspected new cases, medical teams are preparing to visit villages by truck and motorbike in search of people with symptoms. That process may yield many more cases, and two mobile laboratories being flown to the area will speed the process of confirming cases. Anyone who had contact with an infected person is supposed to be identified, but the logistics are daunting in an area where roadways are so damaged by war and neglect that a trip of only several miles can take an hour. Doctors Without Borders also is assisting Congolese authorities in attempting to keep medical facilities open. Without proper training and protective clothing, some medical personnel are reluctant to treat patients with Ebola. Gregory Hartl, a spokesman for the World Health Organization, said other diseases, including typhoid, malaria and shigellosis, may be responsible for some of the deaths now attributed to Ebola. Reports of suspicious deaths date to April. WHO also has called for international help to control the outbreak. Cases of Ebola have been reported over the past decade in Congo, Sudan, Uganda, Gabon and South Africa. An outbreak in Congo in 2003 killed 128 people; an outbreak there in 1995 killed 250. (Washington Post)


 

FDA warns Procter & Gamble about unlawful marketing
of hand sanitizer product for school children


The U.S. Food and Drug Administration (FDA) sent a warning letter to Procter & Gamble for making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer (Early Defense) product. The agency says the product’s claims and directions for use cause it to be an unapproved new drug under the Federal Food, Drug, and Cosmetic Act. It cited specifically Procter & Gamble promotion of Early Defense for use by schoolchildren to prevent colds and to provide antimicrobial activity for up to three hours. Although FDA is not aware of significant health risks associated with Early Defense, the agency is concerned because this product has not been proven safe and effective for these claims. “FDA is concerned with the marketing of this over-the-counter drug for use by school children and others,” said Steven K. Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. “Over-the-counter (OTC) drugs are often widely used without supervision by a doctor or other healthcare professional, so it is essential that manufacturers obtain FDA approval or fully comply with OTC monographs and agency policies.”

Under its OTC drug monograph system, FDA allows OTC drugs to be marketed without first obtaining agency approval in certain circumstances. These drugs must comply with applicable standards regarding monographs that specify conditions for the drugs’ labeling and formulation. OTC drugs that do not have FDA approval and do not meet these requirements are considered unapproved drugs that are unlawfully marketed. There is a proposed OTC monograph that covers triclosan, the active ingredient in Early Defense. FDA allows companies to market their products (which would otherwise be unapproved new drugs) under proposed monographs, as long as the companies comply with the conditions in the proposed monograph. In this case, the product's claims that it prevents colds and provides up to three hours of antimicrobial activity are not allowed under the proposed monograph. Under the proposed monograph, when antimicrobial products use triclosan as their active ingredient, their labeling must direct consumers to rinse with water after use and Early Defense does not. Early Defense falls outside the proposed monograph and is considered an unapproved new drug because it lacks these directions and makes these impermissible claims.   

 

 

ICU Medical Inc. wins summary judgment in Medegen patent lawsuit

ICU Medical Inc., a manufacturer of safe medical connectors, custom medical products and critical care devices, announced that the United States District Court for the Central District of California granted ICU Medical’s motion for summary judgment of non-infringement of Medegen MMS’s patent. Medegen had filed a lawsuit in 2006 against ICU Medical alleging that ICU Medical infringes one of Medegen’s patents by offering for sale and selling the CLC2000 medical connector. Frank O’Brien, ICU Medical's Chief Financial Officer, commented, “We believed all along that we were not infringing Medegen’s patent and are very pleased that the Court agrees with us.” Still pending are ICU Medical’s claims that the patent Medegen asserted against ICU Medical is invalid and unenforceable due to inequitable conduct of Medegen before the United States Patent and Trademark Office. ICU Medical intends to vigorously pursue its claims.

 



Medegen responds to Federal Court’s decision
in ICU Medical patent infringement case; intends to appeal

In response to today’s motion granted by the U.S. Federal Court for non-infringement in favor of ICU Medical Inc., Medegen Inc. announced it will appeal the decision. Medegen continues to believe that ICU Medical’s valve product, CLC-2000, infringes on the company’s patent for its proprietary valve technology and is very disappointed by and disagrees with the Court’s decision. Medegen intends to pursue an appeal, and is confident of its chances of prevailing on such appeal.

 


Post your comments on HPN Blogline: What does ASHCSP’s unification with IAHCSMM
mean for the CS profession?

At its 2007 Annual Conference in St. Louis, Tuesday, the American Society for Healthcare Central Service Professionals (ASHCSP) announced that it is unifying with the International Association of Healthcare Central Service Materiel Management (IAHCSMM). This unification will further the commitment to safety from healthcare central service and sterile processing (CS/SP) staff and help make certain that patients, healthcare workers, and their families receive the highest level of care.

“The newly unified group will create one organization committed to the education and professional development of CS/SP staff,” said Virginia Sylvestri, executive director of ASHCSP. “This is an exciting opportunity for ASHCSP and IAHCSMM to improve upon our current high level of service to our membership.” The organizations’ announcement of impending unification has been long anticipated by healthcare professionals and product and service suppliers supporting related functions. It is expected that this merger will result in a higher level of public and regulatory recognition and strength.

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September 18, 2007   Download print version

ASHCSP plans to merge with IAHCSMM:
Single group to build stronger voice for CS profession

Dole Fresh Vegetables announces voluntary recall of
 “Dole Hearts Delight” packaged salads

10,000 more birds to be culled in Guangzhou, China

Clinton unveils details of her healthcare plan
 

FDA approves new uses for Evista; Drug reduces risk of
 invasive breast cancer in postmenopausal women


States differ widely in spending on healthcare, study finds

Troubling data on surgeries prompt probe at VA hospital

Doc’s white coats spread contagious diseases, says Britain

Study sees rise in men not washing hands


ASHCSP plans to merge with IAHCSMM:
Single group to build stronger voice for CS profession

ST. LOUIS (September 18, 2007) - At its 2007 Annual Conference being held here today, the American Society for Healthcare Central Service Professionals (ASHCSP) announced its intent to merge with the International Association of Healthcare Central Service Materiel Management (IAHCSMM). This merger represents a significant milestone toward these organizations' ongoing commitment for the Central Service/Sterile Processing profession. A unified organization will create a stronger voice for the industry's professionals, which include technicians, supervisors, managers, directors, and educators, said IAHCSMM president Richard Schule and 2007 ASHCSP president Penny Sabrosky.

"Today's healthcare challenges lead many hospitals to merge. Recruitment for specialists in the sterilization field is getting tough. This unification creates a critical mass that will lead to a stable foundation, eliminate duplication, and allow us to build for the future" said Sabrosky. "It will bring together two nationally recognized organizations for quality and combination of resources in the sterile processing world."

ASHCSP and IAHCSMM promote the merger as an opportunity to provide the healthcare community with stronger educational materials, robust educational conferences, enhanced lobbying efforts, and a single organization to conduct future business in a prompt, efficient manner. Energies, talent and finances spent supporting two organizations will now be focused on one entity to develop new products and enhance existing quality documents and educational resources.

"I, along with the rest of the IAHCSMM executive board, applaud ASHCSP's commitment to the advancement of the profession, a goal that is wholeheartedly shared by IAHCSMM," said Schule. "The group's vision for a unified voice will set the stage for decades to come and enable the CS profession to advance, raise the bar and be truly instrumental to patient care."

Although CS professionals have always been a key contributor to quality patient care delivery, the discipline has become increasingly recognized in the healthcare, legislative and general communities in recent years. Advancing technology and infection control-related challenges, as well as increased regulatory requirements for sterilization and infection control protocols, have led to a more intense focus on the ongoing education and certification of CS staff. "Education, certification and support are critical to the success of CS. Having a unified association tailored to the ever-changing needs of the profession will go a long way in helping CS staff manage the function most effectively," added Schule.

Finalization of this business transaction is expected within the next several weeks.

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Dole Fresh Vegetables announces voluntary recall
of “Dole Hearts Delight” packaged salads

Dole Fresh Vegetables, a division of Dole Food Company Inc., announced that it is voluntarily recalling all salad bearing the label “Dole Hearts Delight” sold in the U.S. and Canada with a “best if used by (BIUB)” date of September 19, 2007, and a production code of “A24924A” or “A24924B” stamped on the package. The “best if use by (BIUB)” code date can be located in the upper right hand corner of the front of the bag. The salad was sold in plastic bags of 227 grams in Canada and one-half pound in the U.S., with UPC code 071430-01038. Symptoms of E. coli O157:H7 exposure could include stomach cramps and diarrhea. Bloody diarrhea may develop. E. coli disease sometimes leads to a complication called hemolytic uremic syndrome (HUS). If you exhibited any of these symptoms within 3 to 5 days of consuming any of the products specified above, seek medical attention.

To date, Dole has received no reports that anyone has become sick from eating these products. The recall is occurring because a sample in a grocery store in Canada was found through random screening to contain E. coli O157:H7. No other Dole salad products are involved. Consumers who may still have any of the “Dole Hearts Delight” salads with a “best if used by date” of September 19 and a production code of “A24924A” or “A24924B” should dispose of the product. This product was sold in Ontario, Quebec and the Maritime Provinces in Canada and in Illinois, Indiana, Maine, Michigan, Mississippi, New York, Ohio, Pennsylvania, Tennessee and neighboring states in the U.S. Consumers can call the Dole Consumer Center toll-free at 800-356-3111. Consumers are reminded that products should not be consumed after the “best if used by” date.


 

10,000 more birds to be culled in Guangzhou, China

Chinese authorities plan to cull another 10,000 domestic birds in the city of Guangzhou, capital of southern Guangdong Province, in a further attempt to contain the latest bird flu outbreak. According to China’s central media agency, Xinhua, at least 36,130 ducks have been culled since a strain of H5N1 bird flu killed 9,830 ducks in the Sixian Village of Panyu District in Guangzhou City. The outbreak was first suspected when the deaths, on five farms, started on September 5. Tests on tissue samples at the National Avian Influenza Reference Laboratory have since revealed the birds died of the highly pathogenic form of H5N1 bird flu, confirmed officials from China’s Ministry of Agriculture. The planned cull of 10,000 birds was announced on Monday, by the Panyu district government. This is in addition to the 36,130 ducks that have already been culled in the area. Compulsory vaccination and disinfection will also be carried out, up to a radius of 5 square kilometres, and all poultry markets inside a 13 kilometre surveillance zone will also be closed.

Six teams of officials have been sent to different parts of Guangzhou to enforce vaccination of all domestic fowl. Farmers in local villages are also having blood tests and undergoing medical examination. Local government will be compensating farmers for their losses, said the report in Xinhua. Ranking first in farm output, where over 300 million farm workers work on mostly small plots of land, China is the world’s largest producer of poultry and other livestock. The last H5N1 bird flu outbreak in China was in Hunan province, in the central part of the country, in May this year. That outbreak killed more than 11,000 domestic birds and nearly 53,000 had to be culled. York Chow, Hong Kong’s Health Secretary, said that Hong Kong will be suspending imports of chilled and frozen duck from southern Guangdong province, according to a report by the Press Association. The suspension is planned to last one week. Up to September 10, the World Health Organization has received 328 laboratory confirmed reports of human cases of H5N1 worldwide since 2003, including 200 deaths. Of these China has reported 25 human cases, of which 16 have resulted in death. (Medical News Today)

 

Clinton unveils details of her healthcare plan

Determined to avoid the fatal flaws of her 1993 plan, Hillary Rodham Clinton proposed an overhaul of the nation’s healthcare system Monday that would require Americans to buy insurance but allow them to keep what they have. The front-runner in the race for the Democratic presidential nomination said that under her new plan, the federal government would spend $110 billion a year to help employers and individuals pay for insurance. About half of the money would come from repealing tax cuts and tax breaks for people with incomes above $250,000; the rest would be saved through efficiencies in the system, such as chronic disease management. “This is not government-run. There will be no new bureaucracy,” Clinton said at a medical center in Iowa, scene of the race’s first caucuses. “You can keep the doctors you know and trust. You can keep your insurance plan if you like it.” That was an effort to differentiate the proposal from the plan she devised as first lady in 1993. That plan, which called for a new federal bureaucracy to oversee and regulate insurance markets, was killed in Congress the following year. Clinton unveiled her plan as Health and Human Services Secretary Mike Leavitt said President Bush wants to achieve universal healthcare before he leaves office. Leavitt told the USA TODAY editorial board that Bush will veto a Democratic plan emerging from Congress that would add $35 billion in taxpayer subsidies to the Children’s Health Insurance Program over five years. In doing so, Leavitt said, Bush will urge Congress to join him in seeking coverage for all Americans. “He’d like to see the larger debate begin,” Leavitt said. “The very best opportunity we have may well be in the next 15 months.”

Clinton was among the last of eight Democratic presidential candidates to lay out her healthcare plan. The two other leading candidates, Sen. Barack Obama of Illinois and former North Carolina senator John Edwards, have proposed similar plans, although Obama does not call for a requirement that individuals buy insurance. Edwards has said his plan would cost between $90 billion and $120 billion a year. Obama’s plan would cost $50 billion to $65 billion a year. Clinton’s plan would mandate that large employers offer health insurance or contribute to a government-run insurance pool. Small businesses would receive tax credits to help them cover employees. Lower-income individuals would be eligible for tax credits to prevent them from paying more than a set percentage of their income on health insurance. They could keep their policies, choose from an array of private plans similar to what federal employees are offered or enroll in a new government-run plan similar to Medicare. Insurers, who helped defeat the Clinton plan in 1994, would not be allowed to discriminate against or overcharge people with expensive medical conditions or risk factors. Karen Ignagni, president of America’s Health Insurance Plans, said Clinton’s plan includes “important ideas” but also “some of the divisive rhetoric reminiscent of 1993.” The plan, like others, is short on details that would be worked out in Congress. For instance, Clinton does not say how she would enforce the mandate that individuals buy insurance. (USA TODAY)

 


FDA approves new uses for Evista; Drug reduces risk
of invasive breast cancer in postmenopausal women

The U.S. Food and Drug Administration approved Evista (raloxifene hydrochloride) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. Evista is only the second drug approved to reduce the risk of breast cancer. Evista is commonly referred to as a selective estrogen receptor modulator (SERM). In reducing the risk of invasive breast cancer, SERMs may act by blocking estrogen receptors in the breast. “Today’s action provides an important new option for women at heightened risk of breast cancer,” said Steven Galson, M.D., M.P.H., director, FDA's Center for Drug Evaluation and Research. “Because Evista can cause serious side effects, the benefits and risks of taking Evista should be carefully evaluated for each individual woman. Women should talk with their health care provider about whether the drug is right for them.”

On July 24, 2007, FDA’s Oncology Drugs Advisory Committee recommended approval of Evista for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in women at high risk for breast cancer. In 1997, FDA approved Evista for the prevention of osteoporosis in postmenopausal women and, in 1999, for the treatment of postmenopausal women with osteoporosis. Invasive breast cancer develops when abnormal cells spread into the surrounding breast tissue. Three clinical trials in 15,234 postmenopausal women comparing Evista to placebo (no drug) demonstrated that Evista reduces the risk of invasive breast cancer by 44 to 71 percent. A fourth clinical trial in 19,747 postmenopausal women at high risk for developing breast cancer compared Evista to tamoxifen. In this trial, the risk of developing invasive breast cancer was similar for the two treatments. The clinical trials were conducted over the last 10 years.

Evista can cause serious side effects including blood clots in the legs and lungs, and death due to stroke. Women with current or prior blood clots in the legs, lungs, or eyes should not take Evista. Evista should not be taken by premenopausal women and women who are or may become pregnant because it may cause harm to the unborn baby. In addition, Evista should not be taken with cholestyramine (a drug used to lower cholesterol levels) or estrogens. The benefits and risks of taking Evista should be carefully weighed in each individual woman. Evista does not completely prevent breast cancer. Breast examinations and mammograms should be done before starting Evista and regularly thereafter. The product is manufactured by Eli Lilly and Company, Indianapolis, IN. For more information see THIS LINK 


 

States differ widely in spending on healthcare, study finds

A new federal study shows huge variations in personal health spending among states, ranging from an average of nearly $6,700 a person in Massachusetts to less than $4,000 in Utah. The study, published on Monday in the Web edition of the journal Health Affairs, said that Massachusetts, Maine, New York, Alaska and Connecticut had the highest per capita spending on healthcare in 2004. The lowest-spending states were Utah, Arizona, Idaho, New Mexico and Nevada. Per capita spending in Utah was 59 percent of that in Massachusetts. Anne B. Martin, an economist at the Centers for Medicare and Medicaid Services who was the main author of the report, said the reasons for the differences included the age and incomes of the population, the concentration of doctors in a state, the generosity of public programs, the extent of private health insurance coverage and the mix of services used by state residents. Health policy experts have also observed that doctors differ in “styles of practice,” including the use of specialists.

In some states with high levels of per capita health spending, the federal researchers said, people “receive more comprehensive employer-based health insurance benefit packages.” The researchers noted differences among states with the highest health spending. Massachusetts, for example, has higher per capita spending on hospital care than any other state, while Maine spends more than other states on home and community-based care. Maine had the second highest level of spending on doctors’ services, after Alaska. Utah had the lowest per capita spending on doctors and hospitals. Sara Rosenbaum, a professor of health law and policy at George Washington University, said, “The variations help explain why some states can achieve healthcare reform on their own, without a huge infusion of federal money, while others cannot.” “In a low-spending state like New Mexico, you have less money in the healthcare system that can be recaptured and invested in coverage for the uninsured,” she said. “In a high-spending state like Massachusetts, the healthcare system has the resources to subsidize coverage of the uninsured.” Experts said, higher spending per capita did not necessarily mean better care. “States that spend more per capita often have a lower quality of care,” said Karen Davis, a health economist who is president of the Commonwealth Fund. (The New York Times) For more information see THIS LINK


Troubling data on surgeries prompt probe at VA hospital

In-patient surgeries have been suspended, and four top officials have been placed on administrative leave or reassigned at the VA Medical Center in Downstate Marion (IL) after a computer analysis uncovered a higher-than-expected number of deaths following operations performed at the facility. Louise Van Diepen, chief of staff at the Veterans Health Administration, declined to disclose details about the information revealed by the National Surgical Quality Improvement Program but said: “There is no question in our minds that it was very serious.” Veterans requiring in-patient surgeries will be referred to nearby VA hospitals and private hospitals during an investigation that is expected to take at least several months. Minor procedures will continue to be performed. The Marion facility, which serves veterans from 52 counties in southern Illinois, southwestern Indiana and western Kentucky, typically performs about two dozen inpatient surgeries per week. The nearest VA hospital is in St. Louis, about 120 miles away.

On Friday, the hospital’s chief of surgery and one of its two anesthesiologists were placed on administrative leave. One day earlier, the VA reassigned the medical center’s director and its chief of staff to administrative positions at other hospitals. “There is sufficient information that brings up the question of the role of leadership in managing the surgical program,” said Van Diepen, who described the moves as the beginning of “a cascade of personnel action” that will be taken at the facility. The Veterans Health Administration is the health arm of the U.S. Department of Veterans Affairs. Also Friday, officials from the group that accredits the Marion facility said an on-site survey was conducted in response to a complaint. Elizabeth Zhani, a spokeswoman for the Joint Commission, based in Oakbrook Terrace, said she could not detail the allegations that prompted the visit Friday but said officials conduct such visits when a complaint is “serious enough that they’re concerned about the safety of patients and quality of care.”

The VA uses a computer-based national quality improvement program to collect data on deaths and complications at its facilities after non-cardiac surgeries. It is used by about 200 public and private hospitals across the country to monitor patient care. In the 12 months before Oct. 1, 2006, the number of surgery-related deaths were lower than the national VA facility average and fell within VA standards, Van Diepen said. After that date, she said, “the number of deaths was higher than what was expected based on a statistical analysis of what we would have expected given the complexity of the cases there.” The analysis triggered a VA case review, first by a panel of surgeons and then by the department’s medical inspector. On Aug. 30, a team from the national quality improvement program recommended that the inpatient surgery program be shut down immediately. Officials at the Marion VA suspended the program the next day. “It is a rare circumstance where we have a situation where we have to go in like this,” Van Diepen said. Zhani said the Joint Commission has a contract with the federal VA to accredit all of its facilities, and the Marion VA was fully accredited after its last full survey in 2004. The surveys determine if medical facilities are in compliance with 200 standards relating to quality of care, safety and management.

Officials determined that the complaint was broadly relevant to the standards in three chapters in the group’s accreditation manual, covering provision of care and services, leadership as well as ethics, rights and responsibilities. If the Marion facility is found to violate any standards, it would have an opportunity to correct the deficiencies, Zhani said. Van Diepen said investigators will review every inpatient surgical case performed at the hospital this year, looking for complications and deaths. Patients or their family members will be notified if they received substandard care, she said. (Chicago Tribune) To read the original article see THIS LINK


 

Doc’s white coats spread contagious diseases, says Britain

British hospitals are banning white coats, neckties, and jewelry in an effort to stop the spread of deadly hospital-born infections, according to new rules published Monday. Hospital dress codes typically urge doctors to look professional, which, for male practitioners, has usually meant wearing a tie. But as concern over hospital-born infections has intensified, doctors are taking a closer look at their clothing. “Ties are rarely laundered but worn daily,” the Department of Health said in a statement. “They perform no beneficial function in patient care and have been shown to be colonized by pathogens.”

The new regulations would mean an end to doctors’ traditional white coats, Health Secretary Alan Johnson said. Fake nails, jewelry and watches, which the department warned could harbor germs, are also out. Johnson said the “bare below the elbows” dress code would help prevent the spread of Methicillin-resistant Staphylococcus aureus, or MRSA, the deadly bacteria resistant to nearly every available antibiotic. Popularly known as a “superbug,” MRSA accounts for more than 40 percent of in-hospital blood infections in Britain. Because the bacteria is so hard to kill, healthcare workers have instead focused on containing its spread through improvements to hospital hygiene. A 2004 study of doctors’ neckties at a New York hospital found that nearly half of them carried at least one species of infectious microbe. In 2006, the British Medical Association urged doctors to go without the accessories, calling them “functionless clothing items.” The dress code comes into force next year. (Fox News)

 


Study sees rise in men not washing hands

The gender gap has widened when it comes to hygiene, according to the latest stakeout by the “hand washing police.” One-third of men didn’t bother to wash after using the bathroom, compared with 12 percent of women, said the researchers who spy on people in public restrooms. They reported their latest findings Monday at a meeting of infectious disease scientists. Two years ago, the last time the survey was done, only one-quarter of men didn’t wash, compared with 10 percent of women. The latest study was based on observations last month of more than 6,000 people in four big cities. Frequent hand washing is the single best thing people can do to avoid getting sick, from colds and the flu to germs lurking in food, doctors say. And a recent Harris Interactive survey found 92 percent of Americans said they always wash up after using the bathroom. But researchers for the American Society for Microbiology found that only 77 percent actually do, when it comes to public restrooms. That’s a 6 percent decline from a similar study in 2005. Carry sanitizer gels and wipes in case the means to wash your hands aren’t handy, suggested microbiologist Judy Daly of Primary Children’s Medical Center in Salt Lake City, who led the project. Nearly three-fourths of Americans said they always wash up after changing a diaper, 78 percent said they do so after handling or eating food; 42 percent after petting a dog or cat, 25 percent after handling money, and 34 percent after coughing or sneezing. (Associated Press)

 

 


September 17, 2007   Download print version

Mayo Clinic recommends universal health insurance plan

Heart treatment wins ‘America’s Nobel’ prize

GHX announces 2007 Best In Class Award winners

 

2007 HIMSS Davies Awards recognize achievement
in health information technology


Olympus introduces Endo Capsule in the United States

Ansell Healthcare Micro-Touch NitraTex sterile exam gloves
now available in singles

Ansell Healthcare unveils new packaging for exam gloves;
clear identification markings make glove selection easier  

Premier Purchasing Partners awards contract to SPSmedical


Mayo Clinic recommends universal health insurance plan

The Mayo Clinic has jumped into the national debate on improving healthcare, calling for every individual to have basic universal insurance as a step toward gradually replacing the current employer-based system. But Mayo, in a proposal hammered out over 18 months by a panel of more than 400 health policy experts, is not advocating a government-run single-payer system. Instead, it suggested that private insurance companies be required to offer standard plans with many options, like the Federal Employees Health Benefits Plan available to government workers. Applicants for this insurance could not be turned down, under the Mayo plan. The policies would be paid for by individuals, in some cases with help from employers. Lower-income people would get government help on a sliding scale. Mayo, the Minnesota-based physician and hospital group, is sending its recommendations to the presidential candidates and all members of Congress. Coincidentally, Senator Hillary Rodham Clinton is expected to offer her own healthcare proposals in a campaign speech scheduled for Monday. “Mayo’s timing is pretty good; next year will be too late,” said Andrew Mekelburg, an executive in Washington for Verizon Communications, which spends $3.5 billion annually on healthcare for 900,000 employees, retirees and dependents.

Mekelburg, who took part in the Mayo project, said the recommendations had “a pretty good chance” of winning serious consideration from policy makers. “Mayo is extremely well respected,” he said. Dr. Denis Cortese, the clinic’s chief executive, said that under the proposals, employees could keep their individual policies when they changed jobs, an important issue for workers. One in four changes jobs each year, and 47 million Americans of all ages do not have health insurance. “It would be nice for our employees to have the portability feature, the freedom to move,” Dr. Cortese said. For the Mayo Clinic, which has 47,000 employees, “this would be an option we could live with very nicely,” he said. Executives of several large employers who took part in the Mayo discussions agreed that rising medical costs and the aging of the baby boomer generation were pushing the current system toward a crisis. But they said they were not ready to abandon their current health plans for employees. “We do not believe in relinquishing the employer-sponsored healthcare system,” said Anthony C. Wisniewski, a Mayo panelist who is executive director of healthcare policy at the United States Chamber of Commerce.

Linda M. Dillman, another participant, who is an executive vice president in charge of health and environmental issues at Wal-Mart, said healthcare should be a shared responsibility. “The employer has a role to play,” she said. “The government has a role, especially for those who are financially unable to provide their own healthcare, and we think individuals also have a responsibility.” Another Mayo panelist, Stuart M. Butler, said “Mayo understands that the era of traditional employer-sponsored insurance is ending and we need to think about the employer’s role evolving into a different model.” Butler is a health policy expert at the Heritage Foundation, a politically conservative research center in Washington. Under the Mayo proposal, Butler said, “smaller employers would no longer sponsor coverage but would contribute to plans that their employees could select” from an outside insurer. (The New York Times) To read the original article see THIS LINK


 

Heart treatment wins ‘America’s Nobel’ prize

Two scientists were honored over the weekend by the Albert and Mary Lasker Foundation for their development of artificial heart valves, which have saved the lives of millions of heart disease patients over the past five decades. Alain Carpentier, a professor of vascular surgery at Hôpital Européen Georges Pompidou in Paris, and Albert Starr, the director of academic affairs at Providence Health System in Oregon, are the recipients of the 2007 Albert Lasker Award for Clinical Medical Research. The awards, often called “America‘s Nobels,” have been given since 1946 to those who have made outstanding contributions to medical research. According to the foundation, 72 winners of the Lasker Awards have gone on to win the Nobel Prize.

Starr, working with the late engineer Lowell Edwards, invented the first successful artificial heart valve in 1958. After two years of testing on dogs, Starr performed the first valve-replacement surgery on a man at the University of Oregon Medical School. Now 90,000 people a year in the U.S. have heart valves replaced. Roughly half of the valves are mechanical. Carpentier’s work in the 1960s with pig-tissue valves mounted in Teflon-coated metallic frames addressed the major shortcoming of synthetic valves: the higher risk of clot formation. Impressed with Carpentier's device, Starr introduced him to Edwards, and the two developed a commercial product. The technique for making Carpentier’s valves is still used today, as is the 1965 version of the Starr-Edwards valve.

Other 2007 Lasker Award winners include: Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, engineered the President's Emergency Plan for AIDS Relief and the strategies to protect the nation from natural biological and bioterrorist threats. He received the Mary Woodard Lasker Award for Public Service. Ralph Steinman, a professor and senior physician at the Laboratory of Cellular Physiology and Immunology at Rockefeller University, received the award for Basic Medical Research. His work over the past 34 years led to the discovery of dendritic cells, which trigger the immune system to respond to microbial invaders. Now these cells are being studied for use in therapies to treat tumors, HIV and autoimmune and allergic disorders. (USA Today)

 


GHX announces 2007 Best In Class Award winners

GHX announced the winners of the fourth annual Best In Class Awards, recognizing medical/surgical and clinical laboratory manufacturers that have achieved top market position in their respective product and market segment categories for distributed products through the end of 2006. The 2007 GHX Best In Class Awards honor 26 leading medical/surgical and clinical laboratory manufacturers in five market segments and 35 product categories, ranging from gloves to wound care. Winners were determined using GHX Market Intelligence reports that analyze national distributed sales transaction data provided by 24 U.S. distributors. While manufacturers are not required to be GHX customers in order to qualify for or win the Best In Class awards, many of this year’s award winners leverage GHX Market Intelligence to gain market share. The awards were presented on September 15, 2007 at the annual Healthcare Industry Distributors Association (HIDA) MedSurg Conference & Expo in Boston.

The 2007 GHX Best In Class product category award winners were honored for achieving the highest year-over-year market share growth in 2006 compared to 2005. They are as follows: Adhesives, Bandages, Dressings, Sponges: Medline Industries, Inc.; Cardiology-Cardiovascular: GE Healthcare; Catheter, Diagnostics, & Therapeutics: Bard Access Systems; Electromedical: Welch Allyn Inc.; Electrosurgical: Covidien, formerly United States Surgical; Enteral Feeding and Medical Nutritionals: Nestle Nutrition; Gloves: Molnlycke Health Care US, LLC; Hazardous Waste Control: Heritage Bag Company; Heat/Cold Therapy: Arizant Healthcare Inc.; Hematology/Coagulation Reagents/Supplies: bioMérieux, Inc.; Immunology Reagents/ Supplies: Inverness Medical Innovations Inc.; Incontinence Products: Medline Industries Inc.; Kits, Packs and Trays – Standard: B. Braun Medical Inc.; Kits, Packs and Trays – Custom: AVID Medical Inc.; Masks: Cardinal Health Inc.; Metal/Plastics/Paper Products: Kimberly-Clark Health Care; Microbiology Reagents and Supplies: Remel Inc.; Needles and Syringes: Novo Nordisk; Ostomy: Coloplast Corp.; Parenteral: B. Braun Medical Inc.; Patient Care Products – Medical: Huntleigh Technology PLC; Point of Care Testing Reagents/Suppliers: Siemens Medical Solutions Diagnostics; Pressure Monitoring: GE Healthcare; Respiratory: Vital Signs Inc.; Skin Care: Enturia Inc.; Solutions/Nutritional: B. Braun Medical Inc.; Specimen Collection Kits and Supplies: Siemens Medical Solutions Diagnostics; Sterilization: Kimberly-Clark Health Care; Surgical Instruments and Devices: 3M Health Care; Urinalysis Reagents/Supplies: Roche Diagnostics; Urological: Coloplast Corp.; Wound Care: Mölnlycke Health Care US LLC; Wound Staples and Endosurgery: Covidien, formerly United States Surgical; Wound Sutures: Covidien, formerly United States Surgical; and Woven and Non-woven Goods: Medline Industries Inc.

The 2007 GHX Best In Class market segment award winners were selected based on the highest sales volumes for 2006. They are as follows: Home Health Care: Johnson & Johnson (multiple operating companies); Hospital: Cardinal Health Inc.; Long Term Care: Medline Industries Inc.; Physician: BD (Becton, Dickinson and Company); Treatment Centers: Medline Industries Inc. For more information, see THIS LINK
 

 

2007 HIMSS Davies Awards recognize achievement
in health information technology


From less waiting time in the emergency department to improved disease tracking throughout the state, recipients of the HIMSS Davies Awards of Excellence understand the value of health information technology. With five examples of interoperability excellence, the Healthcare Information and Management Systems Society (HIMSS) has announced the recipients of the 2007 Nicholas E. Davies Awards of Excellence in the Organizational, Ambulatory and Public Health categories. The Davies Awards recognize excellence in the implementation of the electronic health record. Originally created by CPRI-HOST in 1994, the program is named in honor of Dr. Nicholas E. Davies, a practicing physician who believed that the computer-based patient record was needed to improve patient care.

The recipients of the 2007 Davies Awards are: Organizational: Allina Hospitals & Clinics (Minneapolis, MN). This health system includes 11 hospitals and 65 clinics, an operation that serves Minnesota and western Wisconsin. With its vision four years ago as “One Patient, One Record,” the Allina system shares patient health information among its sites through its extensive EHR and revenue cycle design.

Ambulatory: Valdez Family Clinic (San Antonio, TX). Valdez Family Clinic is a solo-practitioner operation serving an economically disadvantaged and medically underserved community. The practice of Alicia Valdez, MD, achieving real-time data capture of data, diagnosis, orders and plans at the point of care, has decreased her average time spent per patient note from 10 to two minutes. The electronic health record enables this physician to efficiently provide care to seven exam rooms all in a four-day work week.

Village Health Partners (formerly Family Medical Specialists of Texas): Now an eight-physician practice in Plano, TX, this family practice in a suburban community was founded in 2001 by Christopher Crow MD, MBA and Sander Gothard MD. The EHR was implemented in 2003. The group is building a medical village with the goal to improve their lives and their patients' by creating a one-stop shopping medical experience.  

Public Health: Illinois-National Electronic Disease Surveillance System (I-NEDSS) (Springfield, IL). I-NEDSS is a Web-based application used by all 95 local health departments in Illinois and by healthcare providers and laboratory staff throughout Illinois to report and investigate infectious disease conditions, clusters and outbreaks. The I-NEDSS system has significantly increased monitoring of disease occurrences, trends and outbreaks leading to earlier event detection.      

Institute for Family Health (New York City). The Institute for Family Health operates 15 community health centers, two school-based health centers, a counseling center, and eight part-time clinics that serve the homeless, providing services to minority, uninsured and disadvantaged communities throughout the Bronx, Manhattan and the Hudson Valley. All of these practices are federally qualified health centers. The Institute implemented a fully integrated EMR in 2002 with four public health initiatives to improve health care delivered to the community. With an emphasis on prevention, chronic disease management and the elimination of health disparities, the Institute has partnered with the New York City Department of Health and Mental Hygiene to demonstrate the impact that an EMR system can have on public health.

Each of these recipients will present their stories at the 2008 Annual HIMSS Conference & Exhibition. Visit http://www.himss.org/StateDashboard/ to view all Davies Award recipients on the HIMSS State Dashboard. The 2008 Davies Awards Call for Applications opens Jan. 1, 2008. For more information see THIS LINK or see THIS LINK

 


Olympus introduces Endo Capsule in the United States

Olympus announced it has received clearance from the U.S. Food and Drug Administration for the Endo Capsule for the visualization of the small bowel mucosa. The high-resolution system redefines capsule endoscopy by combining operational ease and efficiency of capsule endoscopes with outstanding performance and opto-digital technology. Endo Capsule is part of Olympus’ “EnteroPro” brand, the first total solution of its kind offered by one manufacturer designed to help physicians diagnose and treat small bowel abnormalities. Endo Capsule offers unique features that provide physicians with unprecedented imaging capabilities of the small bowel, including high resolution, a wider field of view and an enhanced depth of field, automatic brightness control, advanced color reproduction and structure enhancement. A portable, lightweight real-time viewer conveniently allows physicians to verify its full functionality before the patient ingests the capsule. Endo Capsule can easily be activated or deactivated, if needed, to conserve battery power prior to ingestion. Patients carry Endo Capsule’s data recorder in a lightweight harness that is convenient and comfortable to wear, allowing them to conduct daily activities while the capsule is recording images. Healthcare professionals across the country will be able to experience these innovations from Olympus by visiting Olympus OnSite, the company’s mobile showroom. For details on the showroom’s tour schedule and other information see THIS LINK.


 

Ansell Healthcare Micro-Touch NitraTex sterile exam gloves now available in singles

Ansell Limited (“Ansell Healthcare”) introduces singles packaging for its Micro-Touch NitraTex Sterile latex-free, powder-free nitrile examination gloves. This new packaging configuration brings all the inherent advantages of the innovative Micro-Touch nitrile line to procedures (non-surgical) where only one sterile exam glove is required. The introduction of NitraTex Sterile singles expands Ansell’s portfolio of nitrile barrier protection products. The newest addition to the Ansell family of premium quality nitrile examination gloves, the Micro-Touch NitraTex Sterile offers textured fingertips and an extended, 12-inch cuff, making it ideal for use in labor and delivery or in any non-surgical procedure where a single, latex-free sterile exam glove is required or preferred. Wearers will experience a superb fit and feel, due to the high elasticity and memory of the glove. The glove also conforms to the shape of the wearer’s hand allowing for better dexterity, a more comfortable and superior fit, less hand fatigue and superior barrier protection. Ansell’s Micro-Touch nitrile family also includes Micro-Touch Nitrile, Micro-Touch Smooth Nitrile and Micro-Touch Nitrile E.P. exam gloves.

This single-use sterile exam glove is made from 100 percent nitrile, which addresses Type 1 (latex-sensitive) allergy concerns, a growing concern for both patients and healthcare workers. The glove’s nitrile film has excellent puncture and chemical resistance, providing additional material protection. And because they are powder-free, the gloves protect healthcare staffs’ skin from cornstarch-induced dryness and irritation while also protecting patients from infections, adhesions and other complications related to glove powder. The gloves are gamma-sterilized to ensure sterility. Available in small, medium and large sizes, Micro-Touch NitraTex Sterile is available in single or pairs, is ambidextrous and features a unique blue color that makes it easily identifiable as a nitrile glove. Its standardized global packaging provides clear user information, color-coding for easy product identification and instant material and size recognition. Nitrile singles will be available for ordering in October 2007.

 



Ansell Healthcare unveils new packaging for exam gloves;
clear identification markings make glove selection easier  

Ansell Limited (“Ansell Healthcare”) unveils new packaging that makes it easier to identify the company’s premium quality examination gloves. The new packaging is based on consultation with customers and the changing marketplace, and makes it easy to identify and select a quality Ansell exam glove with clear user information. “Due to latex allergies, powder sensitivities and other developments in the market, we recognized the need for packaging that makes it easy to identify glove type,” said Heather Campbell, Ansell Healthcare Products LLC’s Product Manager for Exams. “Our new packaging allows medical professionals to quickly and confidently select premium exam gloves based on their requirements or preferences. As we continue to expand our portfolio of products, we realize that packaging which simplifies glove identification is imperative to meet the needs of our customers.”

A full, color-coded palette has been developed for easy product identification. The all-new packaging features color-coded brand banners on the upper left and a color-coded sizing and material icon in the upper right. A “no-latex” symbol is prominently displayed on latex-free products, and a material bar details the specific gloving material on the prime display panel of the box. The clear design and consistency of the packaging makes it easy for nurses and other medical professionals to view glove size and material, as well as to determine whether the glove is powder-free or powdered, and latex or latex-free. Over the next 12 months, the packaging will be incorporated into the complete Micro-Touch glove line, including: DermaClean, Powder, Elite, E.P. Gloves, Affinity, NextStep, Nitrile, Nitrile E.P., NitraTex Sterile, and Smooth Nitrile.

 


Premier Purchasing Partners awards contract to SPSmedical

SPSmedical Supply Corp. (Rush, NY) signed a multi-year agreement with Premier Purchasing Partners, L.P., for Sterilization Assurance products. Effective October 1, 2007, SPSmedical will deliver a comprehensive line of biological indicators, chemical indicators, integrators, bowie dick test packs and recordkeeping products to Premier members nationwide. An advocate of patient safety and continuing education, SPSmedical offers a variety of accredited self-study educational programs and awards monthly Central Service Certification Scholarships to technicians and managers. SPSmedical is the largest sterilizer testing laboratory in North America and was voted to the “Top 100 Companies in Rochester” in 2006. For more information about SPSmedical, or to request a free catalog, please email info@spsmedical.com or call 800-722-1529.

 

 


September 14, 2007   Download print version

Fentora cancer pain drug linked to deaths

San Francisco to offer care for every uninsured adult

Healthcare network for uninsured is planned

New study favorable to drug-coated stents  


New zeal in organ procurement raises fears

Buffalo Filter announces contract with Premier


Fentora cancer pain drug linked to deaths


Drug company Cephalon has sent out a Dear Doctor and a Dear Healthcare Professional letter about safe use of its cancer pain drug Fentora (fentanyl buccal tablet) which has been linked with four deaths recently. The letters, dated September 10, remind pain management specialists and other healthcare professionals that Fentora should only be used to manage breakthrough pain in patients with cancer who are already taking, and are already known to be tolerant, to opioids (substances that act like morphine), for their underlying persistent cancer pain. According to the drug company some patients have died and serious adverse events have occurred linked to Fentora because of “improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution”. The patients who died were not appropriate candidates for Fentora, they wrote. According to a report by the Associated Press (AP), two of the people who died had been prescribed the drug as a headache treatment, a third died because they took the wrong dose and the fourth case involved a suicide. None of the people who died were cancer patients, leading the drug company to believe they were inappropriate candidates, said a spokeswoman from Cephalon.

The letters remind doctors and healthcare professionals that: Fentora must only be prescribed to cancer patients who are “routinely taking around-the-clock opioids”. The drug is indicated for management of breakthrough pain. The patient must already be receiving opioid therapy for persistent underlying cancer pain. The patient must be known to be tolerant to opioids before receiving Fentora. Fentora should not be used to treat: acute pain, postoperative pain, headache/migraine, or sports injuries. Patients should take no more than one tablet per episode once a dose is established. Patients must wait at least four hours before taking another dose. Fentora should not be substituted for any fentanyl-containing pain medication, including Actiq (oral transmucosal fentanyl citrate). The letters explain that Fentora is neither a bioequivalent nor a generic version of Actiq. Fentora contains the active ingredient fentanyl, a Schedule II controlled substance, with a high potential for abuse and overdose, which leads to respiratory depression and death. Fentanyl is a potent analgesic and opioid agonist, like morphine, methadone, oxycodone, hydromorphone, oxymorphone, and has a similar abuse liability as these drugs. Although physicians should be aware of the potential for misuse when prescribing any drug, in the case of Fentora and other opioids they need to be extra careful because of the high potential for misuse, abuse, or diversion of these substances. (Medical News Today)
For more information see THIS LINK 

 


 

 

San Francisco to offer care for every uninsured adult


A new program offers free or subsidized healthcare to all 82,000 San Francisco adults without insurance. The initiative, known as Healthy San Francisco, is the first effort by a locality to guarantee care to all of its uninsured, and it represents the latest attempt by state and local governments to patch an inadequate federal system. It is financed mostly by the city, which is gambling that it can provide universal and sensibly managed care to the uninsured for about the amount being spent on their treatment now, often in emergency rooms. After a two-month trial at two clinics in Chinatown, the program is scheduled to expand citywide to 20 more locations on Sept. 17. Whether such a program might be replicated elsewhere is difficult to assess. In addition to its unique political culture, San Francisco, with a population of about 750,000, has the advantages of compact geography, a unified city-county government, an extensive network of public and community clinics and a relatively small number of uninsured adults. Virtually all the city’s children are covered by private insurance or government plans. At the bustling North East Medical Services clinic, where the staff and the signs are multilingual, doctors and nurses are trying to build trust with patients who may have last sought treatment from an herbalist.

 

Healthy San Francisco provides uninsured San Franciscans with access to 14 city health clinics and 8 affiliated community clinics, with an emphasis on prevention and managing chronic disease. It is, however, not the same as insurance because it does not cover residents once they leave the city. After a phased start-up, the city plans to bring private medical networks into the program next year, expanding the choice of doctors. Until November, enrollment will be limited to those living below the federal poverty line ($10,210 for a single person; $20,650 for a family of four). Then it will open to any resident who has been uninsured for at least 90 days, regardless of income or immigration status. Only then will city officials learn whether the program appeals to middle-class workers, who make up a growing share of the uninsured. And only then can they test whether San Francisco has the medical infrastructure to handle the desired increase in demand, and to do so without raising taxes. So far, enrollment has exceeded expectations.

 

The city projected that 600 to 1,000 people would sign up by the end of August. More than 1,300 did, even though officials have done little marketing. They hope to enroll about 45,000 people, more than half the city’s uninsured, in the first year. Some clinics are adding night hours and small numbers of workers. “We really didn’t know what the interest level would be, so we’re very pleased,” said Mayor Gavin Newsom. “At the same time, we don’t want overexuberance yet because we don’t want to fall of our own weight.” At the two pilot clinics, efforts are first made to qualify patients for Medicaid or other state and federal insurance programs. Those left over receive a Healthy San Francisco card that makes them eligible for primary care, dental exams, mental health and substance abuse services, hospitalization, radiology and prescription drugs. Because the coverage is not portable, officials believe that people with private insurance will have little incentive to drop their policies to take advantage of the city’s cut-rate services. Once enrolled, patients are assigned a physician and encouraged to get blood pressure checks, mammograms and other screenings.  (The New York Times) To read the original article see THIS LINK
 


Healthcare network for uninsured is planned

Howard County officials are expected to propose a health network next month that would provide comprehensive services to all uninsured adults in the county. The plan places Howard at the forefront of local governments seeking to offer affordable health care to all its residents, local officials say. The county, midway between Washington and Baltimore, has the distinction of being one of the wealthiest suburbs in the nation. But officials estimate that 18,000 to 20,000 of the adults in this county of about 270,000 people are uninsured. Although details of the program won't be announced until mid-October, officials said they intend to construct a health-care network that draws on local providers and funding. “We believe affordable, low-cost access [to health care] is a right,” said County Executive Ken Ulman (D), whose new administration has pushed the initiative. “We set that as a goal. We made it a priority.” Howard County Health Officer Peter L. Beilenson said he is drawing together a network “with a lot of moving parts” that will not depend on significant new county funding but instead use existing government dollars, private funding and foundation grants. “If we do it at the local level, people will say, ‘This is not so incredibly complicated. Maybe we can do it at the state or national level,’” said Beilenson, former health commissioner for Baltimore and founder of the Health Care for All Coalition in Maryland. Howard’s plan, which was first reported in the Baltimore Sun yesterday, targets the working poor, whose employers often cannot afford to offer health insurance. For example, a worker at a small business, Beilenson said, may avoid going to the doctor and not receive treatment for a condition such as diabetes until becoming disabled by the disease.

Howard is joining an array of local governments that are attempting to fill the gaps in healthcare coverage as state and national leaders struggle for a broad solution to reach the country's 47 million uninsured. One expert believes that Howard faces a formidable challenge. “I have serious questions about the method of financing,” said Gerard F. Anderson, a professor specializing in healthcare financing at the Bloomberg School of Public Health at Johns Hopkins University. “A county-specific solution is going to be very difficult to pull off.” He said one of the difficult aspects will be dealing with workers whose employers are outside the county and aren’t legally obligated to participate in Howard’s initiative. “It’s all about the money and who’s going to contribute the money,” Anderson said. Nearby Montgomery County, working with the nonprofit Primary Care Coalition Inc., has created eight clinics that deliver primary care to adults and receive $12 million a year in operating funds from the local government, said Ulder Tillman, county health officer and chief of public health services. The system treats 14,000 to 16,000 county residents annually, out of an uninsured population estimated at 80,000. DeMarco’s group is advocating a state cigarette tax increase to pay for expanded healthcare for the poor. (The Washington Post) To read the original article see THIS LINK

 
 

New study favorable to drug-coated stents

Patients who get the leading drug-coated heart stents to prop open coronary arteries rather than bare-metal stents do not run a higher risk of death, according to a new report by a multinational team of doctors. That finding is consistent with several others reported at recent cardiology meetings, and it may help allay safety concerns set off last year by reports of potentially deadly clots forming in the leading drug-coated stents, namely the Taxus, made by Boston Scientific, and the Cypher, by Johnson & Johnson. But the analysis, published in The Lancet, the London-based medical journal, also includes less clear-cut findings that could be troubling for Boston Scientific, which dominates the market. The data suggested that patients who received the Taxus stent were a bit more likely to suffer heart attacks than those who received the Cypher from Johnson & Johnson. The analysis also confirmed the slightly elevated risk of potentially deadly clots forming in Taxus more than 30 days after implantation, compared with bare-metal stents. The researchers said the data did not show that Cypher patients ran that risk. Moreover, fewer Cypher patients needed follow-up procedures, either a new stent or bypass surgery, to deal with a recurrence of their coronary blockage.

The study combines and reanalyzes the latest data available from 38 previously reported clinical trials. Taxus and Cypher are the best-selling drug-coated stents in most overseas markets, and the only such devices approved for sale in the United States, where Taxus controls about 54 percent of the market. Sales of both have tumbled about 40 percent in the last year, because some patients have shifted to bare-metal stents and some patients have decided not to get stents at all. Still, sales of drug-coated stents will total $5.5 billion of the $6.5 billion worldwide stent market this year, says the Millennium Research Group, a market-research company in Toronto. How seriously doctors and patients will take the comparisons between Taxus and Cypher in The Lancet study is unclear. Dr. David E. Kandzari, chief medical officer for Cordis, the Johnson & Johnson subsidiary that makes stents, said in a written statement that the study “significantly enriches the large body of evidence that interventional cardiologists have at their disposal to make the right choice for their patients,” and clarifies the differences between Cypher and Taxus. But Dr. Donald Baim, chief medical and scientific officer at Boston Scientific, said the Lancet study failed to reflect that Taxus was compared in its major trials with a better-performing bare-metal stent than Johnson & Johnson chose for the Cypher trials. (The New York Times) To read the original article see THIS LINK


 

New zeal in organ procurement raises fears

After a long fight with a degenerative disease, Ruben Navarro appeared close to death. So the hospital caring for him alerted the local transplant network, which rushed a team to the medical center to try to salvage the 25-year-old’s organs. But as Navarro hung on, tension mounted in the operating room of Sierra Vista Regional Medical Center in San Luis Obispo, CA. With time slipping away, one of the transplant surgeons ordered repeated doses of the narcotic morphine and the sedative Ativan, jokingly calling the drugs “candy,” according to police reports. Navarro eventually died, but too late for his organs to be useful. Horrified nurses complained, prompting multiple investigations. In July, prosecutors charged Hootan Roozrokh with trying to hasten Navarro’s death, marking the first time a surgeon has faced criminal charges in a transplant case. No one thinks the Navarro case is typical, but it comes as transplant advocates are becoming increasingly aggressive in their efforts to procure hearts, livers, kidneys and other organs in the hope of saving more of the thousands of desperate Americans who die languishing on waiting lists.

For some doctors, nurses and medical ethicists, it represents their worst fear, the extreme end of a spectrum of practices that have been raising alarm in hospital wards, emergency rooms and intensive care units around the country. Organ-donation agencies condemn the Navarro case and argue that they walk a careful line between advocating effectively for those who need transplants and violating ethical boundaries meticulously calibrated to protect dying patients and their families. “That case appears absolutely to be a case of a transplant recovery surgeon crossing a very clear line that should never be crossed,” said Thomas Mone, president of the Association of Organ Procurement Organizations. “Our job is to recover organs and save lives. But we have to do that sensitively, honestly and fairly, keeping the interests of the donors and families in mind. There’s often a fine line there, but we make sure we never cross it.” Even the critics agree that most organ-donation advocates are acutely sensitive to ethical concerns, help save many lives and enable families to find solace in their losses. But they worry that disturbing lapses may be increasingly common. (The Washington Post) To read the original article see THIS LINK


 

Buffalo Filter announces contract with Premier

Buffalo Filter, a worldwide manufacturer of advanced medical devices headquartered in Buffalo, NY, announced that it has been awarded the Premier contract agreement for surgical smoke evacuation systems and accessories. The dates of the agreement are September 1, 2007 to August 31, 2010. Buffalo Filter designs and manufactures products to evacuate and filter hazardous smoke plume and/or aerosols that are generated in over 95% of all surgical procedures. This plume and/or aerosols are by-products of surgical instruments such as lasers, electro-surgical pencils, ultrasonic devices and other surgical devices. Studies have shown that surgical smoke plume contains toxic gases, organic particulate, inorganic chemicals such as benzene, toluene, formaldehyde, cyanide, and carbon monoxide, as well as viruses and bacteria.  Exposure to theses toxins may cause respiratory problems, eye irritation, headaches, fatigue, nausea, weakness, and serious illness.

“The obtainment of the Premier agreement signifies the increasing concern within the healthcare community relating to the hazards associated with the inhalation of surgical smoke and aerosols” said Dan Palmerton, Vice President of Sales and Marketing for Buffalo Filter. Exposure to surgical smoke remains a major concern despite directives from organizations such as the Occupational Health & Safety Administration (OSHA) that state that provisions should be undertaken to control airborne hazards and the spread of infectious decease through transmission of bloodborne pathogens. The National Institute for Occupational Safety and Health (NIOSH) has issued a Hazard warning indicating what measures, including the use of smoke evacuation systems, should be undertaken to protect the health and welfare of the individuals exposed to surgical smoke.  For more information see THIS LINK or THIS LINK 


 


September 13, 2007   Download print version

Child mortality at record low; further drop seen

New foot-and-mouth case in Britain

Hospital bugs get from bottom to bedrail

New human protein offering clue to immune infertility in men and women


Study finds drug spending caps cause some seniors to quit taking key medicines

GAO: Health care 20 years from now: Taking steps today to meet tomorrow’s challenges

Novel virus detection identifies new viruses in study of respiratory infections and asthma attacks


Child mortality at record low; further drop seen

For the first time since record keeping began in 1960, the number of deaths of young children around the world has fallen below 10 million a year, according to figures from the United Nations Children's Fund being released today.This public health triumph has arisen, Unicef officials said, partly from campaigns against measles, malaria and bottle-feeding, and partly from improvements in the economies of most of the world outside Africa.The estimated drop, to 9.7 million deaths of children under 5, "is a historic moment," said Ann M. Veneman, Unicef's executive director, noting that it shows progress toward the United Nations Millennium Development Goal of cutting the rate of infant mortality in 1990 by two-thirds by 2015. "But there is no room for complacency. Most of these deaths are preventable, and the solutions are tried and tested."

Interestingly, Unicef officials said, the new estimate comes from household surveys done in 2005 or earlier, so they barely reflect the huge influx of money that has poured into third world health in the last few years from the Global Fund to Fight AIDS, Tuberculosis and Malaria; the Gates Foundation; and the Bush administration's twin programs to fight AIDS and malaria. For that reason, the next five-year survey should show even greater improvement, they said. The most important advances, Unicef said, included these: Measles deaths have dropped 60 percent since 1999, thanks to vaccination drives; More women are breast-feeding rather than mixing formula or cereal with dirty water; More babies are sleeping under mosquito nets; More are getting Vitamin A drops.

In 1960, about 20 million children died annually, but the drop since then has been steeper than 50 percent because the world population has grown. If babies were still dying at 1960 rates, 25 million would die this year. There are still wide disparities. The highest rates of child mortality are found in West and Central Africa, where more than 150 of every 1,000 children born will die before age 5. In the wealthy countries of North America, Western Europe and Japan, the average is about six. The most rapid progress has been made in Latin America and the Caribbean, in Central and Eastern Europe, and in East Asia and the Pacific. Despite the improvement, two sets of countries have worsened, Unicef said: those in southern Africa that have been hit hardest by AIDS, and those that have been at war recently, like Congo and Sierra Leone. The improving economies of India and China have helped pull world figures upward. More girls are getting education and jobs, they marry later and they have fewer children, more of whom survive. Also, because malnutrition is an underlying factor in 53 percent of all child deaths, anything that feeds children, whether that means large-scale aid during famines or simply better seeds and fertilizer, reduces deaths.

Among countries that made particularly rapid progress since 2000 are the Dominican Republic, Vietnam and Morocco, which all cut child deaths by more than one-third. Madagascar cut its deaths by 41 percent despite going to the brink of civil war in 2002, and São Tomé and Principe managed to cut its deaths by 48 percent. In Madagascar, the difference was Vitamin A drops, which drastically reduce the chances that a child will die of measles, diarrhea or malaria. (The New York Times)

To read the original article see THIS LINK.

 

New foot-and-mouth case in Britain

Four days after declaring that it had successfully eradicated foot-and-mouth disease from Britain's livestock, the government said Wednesday that a new case had been discovered on a farm in Surrey. The Department of Environment, Food and Rural Affairs instantly imposed a national ban on the movement of cattle, sheep, pigs and other livestock to prevent a further spread of the disease, which is highly contagious among animals. It also set up a six-mile control zone with more stringent security measures around Milton Park Farm, in Egham, where the new case was diagnosed, and slaughtered the animals in the affected area. The government also said that it was testing animals on another farm, in Norfolk.

In response, the European Commission banned the export of animals susceptible to the illness, cows and sheep, as well as pigs, and their products from Britain. The commission also said Britain could not import live animals from European countries. Foot-and-mouth disease, a virus, affects humans only very rarely but is often fatal in young animals and can debilitate older animals by, for instance, reducing their milk yields or making them lame. The virus can spread easily through animal-to-animal contact, by contaminated products like milk, by the open movement of animals, people and vehicles from farm to farm, and even through the air. Measures to halt the disease can devastate a country's livestock industry. In 2001, a widespread outbreak in Britain led to the slaughter of more than four million animals, a ban on British beef exports and the closing of vast swaths of the countryside, costing the British economy an estimated $16 billion. (The New York Times)

 

Hospital bugs get from bottom to bedrail

The presence of the bacterium Staphylococcus aureus (S. aureus) in patients’ stools increases the likelihood that it will make its way onto skin, hospital bed rails and other surfaces, according to research published in the online open access journal, BMC Infectious Diseases. Curtis Donskey and colleagues from the Cleveland Veterans Affairs Medical Center, Ohio, US, collected stool samples from inpatients and analysed these for S. aureus. The researchers also took samples from the patients’ nostrils, armpits and groins, as well as surrounding surfaces such as bed rails and bedside tables using a moist cotton swab. To determine whether these bacteria would be transferred to the researchers’ hands they bravely touched each of the skin and environmental sites with one hand previously disinfected with an alcohol hand rub. Handprints in agar jelly before and after testing were used to determine the presence of bacterial transfer.

The study’s most important finding was that patients harboring S. aureus in both their intestines and noses were significantly more likely than those with this bacterium in their nostrils alone to have positive skin cultures. There was also a statistically non-significant trend toward contaminating surrounding surfaces and bacterial transfer to the investigator’s hands. Cultures from environmental surfaces yielded an average of 12.7 colonies with a range of 1 to 80, while cultures from armpits and groins yielded colonies of bacteria “too numerous to count.” Hand cultures after contact with environmental and skin surfaces yielded an average of 15.3 colonies with a range of 1 to 80. Most of the patients colonized with S. aureus had the MRSA (Methicillin-resistant Staphylococcus aureus) strain, which is unaffected by treatment with certain antibiotics. “Because staphylococci on skin may contaminate devices or wounds and be acquired on hands, our data provide support for the hypothesis that colonization of the intestinal tract may facilitate S. aureus infections and nosocomial transmission,” Donskey says.

 

New human protein offering clue to immune infertility in men and women

Most of us have never heard of immune infertility, yet it prevents many prospective parents from conceiving. Immune infertility is one of 80 autoimmune disorders, a group that includes better-known diseases like Multiple Sclerosis and Type 1 Diabetes. This reproductive disorder affects both men and women, causing their immune systems to wage war on sperm. A recent discovery at the University of Virginia Health System may help pinpoint what molecules assist the immune system in attacking sperm. In the July 2007 issue of Gene, UVa researchers reported finding a new human protein, radical radial spoke protein 44 (RSP44).  Exposure to RSP44 caused serum from infertile men to produce antisperm antibodies (ASA) in their serum. "We've spent several years looking for sperm molecules that evoke antibody responses in humans," says Dr. John C. Herr, director of UVa's Center for Research in Contraceptive and Reproductive Health. "The identification of RSP44 gives us additional insight into immune infertility and may prove useful in diagnosing the disorder in a subset of men. Sperm proteins like RSP44 will likely not be a dominant antigens in everyone."

The discovery of RSP44 also promises to broaden scientific thinking about the causes of immune infertility. Women with immune infertility produce ASA in their reproductive tracts. These antibodies neutralize sperm by clumping them together and poking holes in their membranes. ASA also coats over receptors involved in sperm-egg binding and fertilization. An estimated 12 to 15 percent of unexplained infertility in women is linked to ASA. In rare cases, these antibodies have caused women to go into anaphylactic shock upon insemination. In men, immune infertility has several causes, including vasectomies. After a vasectomy, the body can no longer release sperm and produces antibodies to help engulf and clear them. ASA persists for years in the circulation of vasectomized men and may cause reduced fertility in those who have the procedure reversed (vasovasostomy). Several therapeutic procedures available through UVa, such as sperm washing and intra-cytoplasmic sperm injection, have proven beneficial to patients with ASA.

 


Study finds drug spending caps cause some seniors to quit taking key medicines


Many seniors quit taking drugs for chronic illnesses such as diabetes and high blood pressure when they exceed their drug plan’s yearly spending limits, according to a RAND Corporation study issued today. Even when drug benefits resume at the start of a new health plan year, a significant number of seniors do not resume their prescription medications, according to the findings published in the September/October edition of the journal Health Affairs. The study, which examined the behavior of seniors enrolled in a national private health plan, provides insight into how seniors may act under provisions of Medicare’s new drug benefit plan that will leave about one-third of enrollees without drug coverage for some part of each benefit year. “Prescription use falls significantly as patients reach their benefit caps,” said Geoffrey Joyce, the study’s lead author and a senior economist at RAND, a nonprofit research organization. “Most of the drugs we studied help prevent long-term complications of chronic disease so there are likely to be adverse health consequences for seniors who hit their caps.”

 

RAND Health researchers studied prescription drug use from 2003 to 2005 among more than 60,000 people enrolled in a health plan offered to retirees by a large national employer. Enrollees had a choice of two drug plans that offered annual drug benefit caps of $1,000 or $2,500 and one drug plan that had no spending limit. Participants had to pay a portion of individual drug purchases in each of the plans. The study examined enrollees’ use of drugs used to treat high blood pressure, drugs that target cardiac problems, diabetes drugs, ulcer treatments and antidepressants. They also studied prescription pain medications that have over-the-counter substitutes. About 6 percent to 13 percent of the people enrolled in drug plans with caps reached their spending limits in each of the years studied, with about half the affected enrollees going without benefits for more than 90 days, according to the study. High spenders in the capped plans were more likely to discontinue use of their medications than people enrolled in the plan with no spending limits, according to researchers. Discontinuation rates differed by type of drug, ranging from 15 percent for anti-cholesterol medication to 28 percent for cardiac drugs. Rates were higher for pain medications and anti-ulcer drugs where over-the-counter alternatives were available. Researchers say they were surprised that more people did not switch to generic drugs, given they are generally cheaper than name-brand medications. While people were less likely to quit using generic drugs once they reached benefit caps, no widespread move to the lower-cost alternatives was noted.

Among patients who stopped taking a medication in the capped plan, more than half did not restart their prescriptions during the first three months after benefits resumed. “Given the importance of these drugs, it’s distressing that the resumption rates are not higher,” said Dana Goldman, the study’s senior author and director of health economics at RAND. “Drug caps are a cost-saving measure, but our findings raise the issue of whether in the long run they may lead to other medical costs such as increased hospitalizations.” Researchers said the study may help guide policymakers who are concerned with the so-called “doughnut hole” in Medicare prescription drug plans. Spending limits contained in the Medicare drug plan are expected to leave between 24 percent and 38 percent of enrollees without drug coverage for part of each benefit year.


 

GAO: Health care 20 years from now: Taking steps today to meet tomorrow’s challenges

“Unless we fix our health care system—in both the public and private sectors—rising health care costs will have severe, adverse consequences for the federal budget as well as the U.S. economy in the future.” This is one of the key messages that Comptroller General David M. Walker has been delivering across the country in town-hall style meetings, in speeches, and on radio and television programs. Using another format to explore issues with health care experts, Walker convened a forum at the United States Government Accountability Office (GAO) on May 17, 2007. Attendees included health policy experts, business leaders, and public officials selected for their subject matter knowledge and representation of various perspectives. Participants examined health care cost, access, and quality challenges in discussion sessions led by distinguished economists Robert Reischauer and Mark Pauly and other leading health care authorities Carolyn Clancy and Suzanne Delbanco. Nationally known health insurance expert Leonard Schaeffer served as a keynote speaker. At the conclusion of the forum, participants were polled for their views on points raised during the discussions. The poll was conducted using electronic voting technology that produced real-time, but confidential, results.  

The discussion sessions focused on three interrelated topics: cost and personal responsibility; coverage of the uninsured; and quality, standards, and outcomes. The keynote speech focused on related policy challenges. The following are highlights from these discussions and the participant poll. The proceedings are not intended to reflect the views of GAO.  

Health care spending. Participants did not reach agreement on whether the federal government should have an aggregate spending limit, such as a percentage of the federal budget, but supported other measures, such as federal value-based purchasing, reformed tax treatment of health care, and limits on direct-to-consumer advertising of prescription drugs.  

Health insurance coverage. There was near unanimity that ensuring the provision of health care coverage for all Americans should be a federal responsibility. The group also strongly agreed that the federal government should assure the existence of a well-functioning health insurance market, whereas they did not agree on whether the nation should continue to rely on employer-provided insurance as the dominant method through which most Americans obtain their health insurance coverage.

Performance measures. Participants strongly supported the federal government’s taking the lead in developing new indicators of health system outcomes and performance. The group also strongly favored having a broad-based independent body develop national, evidence-based practice standards.

Policy challenges
. The keynote speaker opined that a limited window of time, about 8 to 10 years, remains for the health care community to engage in effective reform. After that, he noted, budget and national security concerns will dominate. Because neither purely regulatory nor purely market-based approaches are politically viable, pragmatism rather than ideology should drive health policy. He concluded that we need a blended strategy, stating, “We have to shape our future now or be its victim.”

To view the report see THIS LINK.

 

Novel virus detection identifies new viruses in study of respiratory infections and asthma attacks

A new study has found an unexpected number of viruses and viral subtypes in patients with respiratory tract infections (RTIs). The technique used in the study may help identify new viruses associated with human diseases. The study is published in the September 15 issue of The Journal of Infectious Diseases, now available online. RTIs, such as the common cold, are associated with some of the most common viral infections, and increase the risk of an asthma attack in those with the condition. Fifty to 80 percent of asthma exacerbations are precipitated by viral upper RTIs, and yet these viruses are still poorly understood. The Virochip technique, a DNA microarray or genome chip developed by researchers at the University of California, San Francisco, uses the most conserved sequences of all known viruses of humans, animals, plants, and microbes for its detection system. The new study is the first to employ this strategy to investigate the viruses associated with RTIs in people with and without asthma. The study, conducted by Amy Kistler, PhD, and colleagues in California, Illinois, and Missouri, used several methods to test 53 asthmatic and 30 non-asthmatic adults for viruses at various stages of health. Compared to the conventional methods of viral culture and the highly sensitive polymerase chain reaction (PCR) method, the Virochip had excellent agreement in terms of identifying viral pathogens, and proved to be both highly sensitive and specific.

The method “detected remarkable and unanticipated diversity” of viruses linked with RTIs and identified “a wholly new branch of the phylogenetic tree,” for the human rhinovirus, one of the causative agents of the common cold virus, Dr. Kistler notes, showing that even with a small test group the Virochip enabled detection of new viruses that were not possible to culture. The researchers also detected 30 distinct known species of rhinoviruses and found that only one of the two coronaviruses thought to be responsible for up to 15 percent of all colds in the United States was detectable in this study population. Instead, two newly described strains of coronaviruses dominated. These findings are particularly important given the poor understanding of the role of viral diversity in RTIs and in asthma exacerbations. As a next step, Kistler suggested that future groups use the Virochip to continue to accumulate knowledge about such viruses. “The range and depth of viral detection [using the Virochip] is significant, since gaining a comprehensive understanding of the viral pathogen diversity associated with asthma exacerbations may enable the development of specific strategies for treating or preventing asthma exacerbations caused by viral respiratory infection.” In an accompanying editorial, James E. Gern, MD and William W. Busse, MD of the University of Wisconsin School of Medicine and Public Health agreed that the Virochip assay could prove an excellent new tool for future studies looking to detect and understand novel viruses associated with respiratory illnesses.

 



September 12, 2007   Download print version


United States continues to have highest level of health spending


Cost of health insurance rises again, but at a slightly slower rate


The hospitalist is in, and taking over a role played by primary care physicians

More studies cast doubt on safety of diabetes drug

CompView Medical forms strategic alliance with GE Healthcare
 

New HIV diagnoses rising in New York City among young men
who have sex with men
 


United States continues to have highest level of health spending

The United States continues to spend the most on healthcare when compared to other Organization for Economic Cooperation and Development (OECD) countries. Healthcare prices and higher per capita incomes are major factors for higher U.S. spending, according to a study by researchers at the Johns Hopkins Bloomberg School of Public Health and Princeton University. Compared to the average OECD country in 2004, the United States has fewer health resources, physicians, nurses and hospital beds, and lower utilization of these resources. Health spending for chronic health issues, such as obesity, alcohol consumption and smoking, also contributes to high health spending in the United States. The study is published in the September/October 2007 issue of Health Affairs. “We spend so much more money on healthcare in the United States than other industrialized countries primarily because our prices are so much higher,” said lead author of the study, Gerard Anderson, PhD, a professor in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health.

Using 2004 data, which is the most recent available, the researchers report the following key study results: U.S. healthcare spending per capita was 2.5 times greater than the median OECD country. The United States spent 15.3% of our gross domestic product on healthcare, which is substantially higher than any other OECD country. U.S. growth in healthcare spending per capita from 1994 to 2004 was similar to the OECD median. The United States has promoted policies to reduce the number of hospital days as a way to contain costs. It is now ranked fourth highest among OECD countries for hospital spending per capita. The United States spent 3.6 times what the median OECD country spent in 2004 for outpatient care. Most of the difference between the United States and other countries is attributable to higher spending on physician services. The United States had fewer physicians, nurses and hospital beds per capita than the OECD median. The United States also had lower utilization rates than the OECD median for physician visits per capita, acute care bed days and average length of inpatient stay. The study authors examined the prevalence of chronic disease as an increasing financial burden in the United States and other countries. Five chronic diseases, diabetes, respiratory disease, cerebrovascular disease, heart disease and malignant neoplasm, cause two-thirds of deaths in the United States. Compared to other OECD countries, we have the highest mortality rate for some of these chronic diseases, but not all.

 

 



Cost of health insurance rises again, but at a slightly slower rate


The cost of employer-sponsored health insurance premiums has increased 6.1 percent this year, well ahead of wage trends and consumer price inflation, but below the 7.7 percent increase in 2006, the Kaiser Family Foundation reported. Because doctor and hospital costs continue to rise at an even faster rate, the modest slowdown in insurance inflation mainly reflects cutbacks in coverage by many health plans, which have found ways to make employees pay more for their care. Industry experts said that without those measures, premium costs would have risen by 9 percent or more. The total average annual cost for family coverage premiums rose this year to $12,106. Drew Altman, president of the Kaiser Foundation, a nonprofit group that produces the annual survey noted that health costs had increased 78 percent since 2001, more than four times the pace of prices and wages.

The 2007 increase was the smallest annual rise since 1999, when health premiums jumped 5.3 percent. Kaiser did not try to project 2008 costs for health premiums. But research houses are forecasting increases for next year that include 6.7 percent by Mercer Health and Benefits; 9.9 percent by PricewaterhouseCoopers; 10.5 percent by the Segal Company; and 11 percent by AON Consulting. The costs of hospital and doctor care seem to be “outpacing premium increases,” said Jon Gabel, a principal investigator for the Kaiser survey. That could squeeze insurance company profit margins, which have been running at 6 percent to 7 percent, he said.

 

Sixty percent of employers offer health benefits, including nearly all large companies with 200 or more workers. But fewer than half of small businesses with three to nine employees do so, the survey found. The telephone survey, which ended in May and was conducted by Kaiser and the Health Research and Educational Trust, queried 3,078 public and private employers and was based on 1,997 that responded to the full survey. It found that employers and workers are still slow to embrace the widely publicized high-deductible plans with savings options that have been promoted by the Bush administration and many insurance companies and banks. Such health savings account plans attained only a “modest enrollment” of 3.8 million workers, according to Kaiser. That was 5 percent of all covered employees, compared with 4 percent in 2006.

 

Almost one in five large employers currently offer some sort of health savings option, combined with high-deductible insurance. But only 2 percent of employers that do not already offer health savings accounts said they were very likely to add them next year. Most preferred-provider organizations, or P.P.O.’s, the networks that cover 57 percent of all workers, now pay for services like immunizations and mammograms without charging the employee. Also, nearly half of all employers that offer health benefits now cover unmarried domestic partners of the opposite sex, and about 37 percent cover same-sex partners. As for drug plans, three in four covered employees are in them, with average out-of-pocket payments of $11 for generic drugs, $25 for the health plan’s preferred brand-name drugs and $43 for brands not on the preferred list. (The New York Times) To read the original article see THIS LINK
 

 

 

The hospitalist is in, and taking over a role played by primary care physicians

In the past 10 years, despite resistance from primary care physicians and fears that the development could erode continuity of care, the ranks of hospitalists have exploded from a few hundred physicians in 1997 to 20,000 today, about as many as there are gastroenterologists or neurologists. That’s the fastest growth for any medical specialty in the country, according to the nonprofit Society of Hospital Medicine (SHM), the professional society for hospitalists. Initially, the trend was driven by hospitals and managed-care groups, seeking to cut costs and improve care quality. But with hospital reimbursement rates failing to keep up with their costs, many primary care physicians are being won over and now find the hospitalist arrangement saves them time and money. And although many patients may resent not having their doctor at their bedside, just when they need him or her the most, the hospitalist movement, by most accounts, is here to stay. “The majority of hospitals in the United States have hospitalists, because it’s a better utilization of resources, of time, of communication skills and quality of care,” said Ahmed Nawaz, who leads a hospitalist practice based at Holy Cross Hospital in Silver Spring.

Yet many patients are unaware of the trend. “We don’t introduce ourselves as ‘hospitalists,’” said Washington internist Michael Molineux, director of the hospitalist program at Georgetown University Hospital. “Most patients don’t know what it is or what it means.” Molineux said he stopped using the word when many patients understood him to say “hospice” and thought they were at death's door. “I say I'm an attending physician in internal medicine and I'll be in charge of the team taking care of them,” he said. That means assuming responsibility for everything from admission to discharge, including making patient rounds and ordering all needed tests and procedures. Most hospitalists are internists; 11 percent are pediatricians. By 2010, SHM projects 30,000 hospitalists will be practicing. Medical students may soon choose which side of the hospital divide they want to work on: inpatient or outpatient. For now, it’s your physician’s choice whether to refer you to a hospitalist or to follow your inpatient care. If you have no primary care physician, a hospitalist will probably manage your hospital stay. Although patients are often confused about the role of hospitalists, hospitals embrace the new model, nationally subsidizing $50,000 to $60,000 of the average hospitalist's $169,000 salary.

Managed-care organizations, such as Kaiser, have established their own hospitalist practices. There is financial incentive to do so: Studies show hospitalists manage care more efficiently and reduce hospital stays. Hospitalists say they think that's because they order tests and procedures more promptly. Hospitals and managed-care organizations are betting that the use of hospitalists will result in better care. In the largest hospitalist study to date, presented at the 2007 Hospital Medicine annual meeting, Peter K. Lindenauer, associate professor of medicine at Tufts University School of Medicine, found that hospital stays are a half-day shorter if managed by a hospitalist, with mortality and readmission risks comparable to those of family physicians or general internists. Smaller studies found improved patient satisfaction and quality of care. Hospitalists’ biggest selling point is that they’re always on-site. But other patient advocates worry that although hospitalists are expert at managing hospital stays, they also may contribute to the fragmentation of care. (The Washington Post) To read the original article see THIS LINK

 

 


More studies cast doubt on safety of diabetes drug

Two more studies published in yet another prominent medical journal have raised questions about the safety of Avandia, a once-popular diabetes medicine. One study found that Avandia, made by GlaxoSmithKline, doubled the risks of heart failure and raised the risks of heart attack by 42 percent. A second study found that Actos, a similar drug made by Takeda, actually lowered the risks of heart attacks, strokes and death but, like Avandia, also raised risks of heart failure. Taken together, some of the authors said, the two studies in The Journal of the American Medical Association confirm what doctors and patients using Avandia have already done in great numbers, that is, switch to another drug. Sales of Avandia have plunged. GlaxoSmithKline said in a written statement that the studies were flawed and “offered no new information on the safety of Avandia.” The company “continues to support Avandia as safe and effective when used appropriately,” the statement said.

In July, a federal advisory panel voted overwhelmingly that Avandia should remain on the market even though it raised the risks of heart attacks. In June, the Food and Drug Administration said it would place its strictest warnings on the labels of both Avandia and Actos because of heart failure risks. Riven by internal disagreements, the drug agency is still pondering further regulatory actions regarding Avandia. Some in the agency say that the drug should be withdrawn, while others say that all diabetes drugs have risks and that doctors need a variety of options. Richard Hellman, president of the American Association of Clinical Endocrinologists, said that the new studies were “more evidence that we should have a very high level of caution” regarding the use of Avandia. The drug agency should further strengthen the warnings on Avandia’s label to make it clear that the drug should be used very sparingly. (The New York Times)
To read the original article see THIS LINK

 


CompView Medical forms strategic alliance with GE Healthcare


CompView Medical, a provider of integrated audio-visual systems for healthcare environments, announced a partnership with GE Healthcare through their General Electric Healthcare OEC Surgery Division (GE OEC), whereby GE OEC will be a distributor of the CompView Medical NuBOOM video integration and equipment management system. This unique agreement enhances the minimally invasive surgical (MIS) procedure market that GE OEC supports as the combined efforts of both companies provide a complete surgical solution for in-patient hospital facilities and outpatient ambulatory surgical centers (ASC's). This is the first time video integration equipment has been represented by a surgical fluoroscopic imaging company. NuBOOM is the only all-in-one equipment management and video visualization system that delivers four fully adjustable high definition (HD) monitors around the operating room table. The system provides surgeons and members of the operating room (OR) staff ergonomically-sound viewing angles of high quality images from anywhere within the operating field. GE OEC, part of the GE Healthcare division, is a provider of Mobile C-Arm Fluoroscopy systems. The company develops computer-based X-ray and fluoroscopic imaging systems for hospitals, outpatient clinics and surgical centers. The firm’s X-ray imaging systems combine radiographic and fluoroscopic imaging with digital image-processing capabilities to improve image quality, lower X-ray dosage and reduce costs.   

 


New HIV diagnoses rising in New York City among young men
who have sex with men

HIV infection is on the rise among young men who have sex with men (MSM) in New York City, according to preliminary data from the Health Department. New HIV diagnoses among MSM under age 30 have increased by 33% during the past six years, the agency reported today, from 374 in 2001 to almost 500 in 2006. New diagnoses have doubled among MSM ages 13 to19, while declining by 22% among older MSM. The under-30 group now accounts for 44% of all new diagnoses among MSM in New York City, up from 31% in 2001. Blacks and Hispanics still bear a disproportionate share of New York City’s HIV burden. Among all MSM, blacks received twice as many HIV diagnoses as whites in 2006 (232 versus 101), and Hispanics received 55% more than whites (157 versus 101). The disparity is even more striking among adolescents; more than 90% of the MSM under age 20 diagnosed with HIV in 2006 were black or Hispanic (81 out of 87). To focus on more recent trends in HIV infection, this analysis excluded MSM who were diagnosed with HIV and AIDS at the same time, generally indicating that the infection has progressed for many years. In 2006, 20% of MSM diagnosed with HIV received a concurrent diagnosis of AIDS (285 men), meaning that they had missed opportunities for care to stay healthy and may have unknowingly spread HIV to others.

 

 

 

 


 

September 11, 2007   Download print version


GAO on Sept. 11: Improvements needed in availability of health screening
and monitoring services for responders


Study shows adverse drug events reported to the FDA
have significantly increased


Community superbug is a growing danger across U.S.
 
Audit cites overpaid Medicare insurers

More kids developing high blood pressure


Proven Terumo coronary guidewire technology is now available in the United States
 

Electronic Healthcare Systems receives Healthcare Innovators Award

 


GAO on Sept. 11: Improvements needed in availability of health screening
and monitoring services for responders

Six years after the attack on the World Trade Center (WTC), concerns persist about health effects experienced by WTC responders and the availability of healthcare services for those affected. Several federally funded programs provide screening, monitoring, or treatment services to responders. This testimony is based on and updates The Government Accountability Office’s (GAO’s) report, September 11: HHS Needs to Ensure the Availability of Health Screening and Monitoring for All Responders (GAO-07-892, July 23, 2007). In this testimony, GAO discusses the status of (1) services provided by the Department of Health and Human Services’ (HHS) WTC Federal Responder Screening Program, (2) efforts by the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH) to provide services for nonfederal responders residing outside the New York City (NYC) area, and (3) NIOSH’s awards to WTC health program grantees for treatment services.

In July 2007, following a re-examination of the status of the WTC health programs, GAO recommended that the Secretary of HHS take expeditious action to ensure that health screening and monitoring services are available to all people who responded to the WTC attack, regardless of who their employer was or where they reside. As of early September 2007 the department has not responded to this recommendation. As GAO reported in July 2007, HHS’s WTC Federal Responder Screening Program has had difficulties ensuring the uninterrupted availability of screening services for federal responders. From January 2007 to May 2007, the program stopped scheduling screening examinations because there was a change in the program’s administration and certain interagency agreements were not established in time to keep the program fully operational. From April 2006 to March 2007, the program stopped scheduling and paying for specialty diagnostic services associated with screening. NIOSH, the administrator of the program, has been considering expanding the program to include monitoring, that is, follow-up physical and mental health examinations, but has not done so. If federal responders do not receive monitoring, health conditions that arise later may not be diagnosed and treated, and knowledge of the health effects of the WTC disaster may be incomplete.

NIOSH has not ensured the availability of screening and monitoring services for nonfederal responders residing outside the NYC area, although it recently took steps toward expanding the availability of these services. In late 2002, NIOSH arranged for a network of occupational health clinics to provide screening services. This effort ended in July 2004, and until June 2005 NIOSH did not fund screening or monitoring services for nonfederal responders outside the NYC area. In June 2005, NIOSH funded the Mount Sinai School of Medicine Data and Coordination Center (DCC) to provide screening and monitoring services; however, DCC had difficulty establishing a nationwide network of providers and contracted with only 10 clinics in seven states. In 2006, NIOSH began to explore other options for providing these services, and in May 2007 it took steps toward expanding the provider network. NIOSH has awarded treatment funds to four WTC health programs in the NYC area. In fall 2006, NIOSH awarded $44 million for outpatient treatment and set aside $7 million for hospital care. The New York/New Jersey WTC Consortium and the New York City Fire Department WTC program, which received the largest awards, used NIOSH’s funding to continue outpatient services, offer full coverage for prescriptions, and cover hospital care. To view the report see THIS LINK

 

 

 

Study shows adverse drug events reported to the FDA
have significantly increased


A new study shows the number of drug-therapy related deaths and injuries reported to the U.S. Food and Drug Administration (FDA) nearly tripled between 1998 and 2005. A researcher at Wake Forest University School of Medicine and colleagues reviewed serious and fatal drug events reported in that eight-year period to the FDA by consumers, health professionals and drug manufacturers, and found that serious adverse drug events increased 2.6-fold, from about 35,000 to nearly 89,000, and adverse drug-related deaths increased 2.7-fold, from about 5,500 to more than 15,000. The study is reported in the Sept. 10 issue of Arc