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Reports to the FDA of drug-related injury and death nearly tripled in the past eight years.


Drug-related injury, death reports to FDA nearly tripled in eight years

Reports to the FDA of drug-related deaths and injuries increased nearly threefold from 1998 to 2005, the Sept. 10 Archives of Internal Medicine reported.

Voluntary reports of serious drug events to the FDA's Adverse Event Reporting System rose 2.6 times, to 89,842 from 34,966, while reports of fatal events rose 2.7 times, to 15,107 from 5,519. The increase was fueled by relatively few drugs, with 20% of the total drugs identified accounting for 87% of the events. A disproportionate number of the drugs associated with fatal events were pain medications or drugs that modify the immune system. Oxycodone and fentanyl were linked with the most deaths, while estrogens, insulin and infliximab topped the list for other serious outcomes.

Adverse events were seen more often with women (55.5%) than men (46.5%), and occurred disproportionately among elderly patients, the authors reported. Increasing population and greater use of drug therapy may account for 25% of the increase, while another 15% of the rise is accounted for by 13 new biotechnology products, including immunomodulators, the authors said. Reported adverse events increased four times faster than did the number of outpatient prescriptions.

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Drugs related to safety withdrawals had less of an effect on results than expected, and their influence declined over time. The authors examined whether the increase could be explained by a trend toward increased reporting of events by health professionals, but determined it was unlikely. The results illustrate that widespread improvements to drug safety systems are needed, the authors concluded.

Health care costs vary from state to state

A recent report found that health care spending varies widely in different parts of the U.S., with residents of some northeastern states spending an average of about $2,000 more per year than people who live in the lowest-spending states.

According to the analysis from CMS, residents of Massachusetts, Maine, New York, Alaska, Connecticut, Delaware, Rhode Island, Vermont, West Virginia and Pennsylvania had the highest spending, with an average of $6,345 per capita. The states with the lowest spending—Utah, Arizona, Idaho, New Mexico and Nevada—had an average of only $4,244 per person. Researchers noted that the higher-spending states generally had the highest concentration of physicians, the highest incomes and the smallest percentages of uninsured, while the lower-spending states were less populous and younger.

The report also compared trends in spending variations among states over time. Researchers found that geographic differences in health care spending grew in 1991-1998 and decreased in 1998-2004. They attributed this change to managed care plans' influence on cost and utilization of health care, which was greater in the earlier time period. The study was published in the Sept. 18 Health Affairs.

An accompanying editorial addressed the impact of the data on state plans for health care reform. The authors said that higher spending does not appear to be related to better health care quality, and they suggested that states should concentrate on quality improvement strategies (including medical homes and pay-for-performance), in addition to expanding coverage. A second editorial noted that the study data revealed significant variations in state Medicaid spending, with higher-spending states spending significantly more on Medicaid programs. The author expressed concern that state-led health care reforms would only widen that gap.

FDA clears rapid test for blood platelet screening

The FDA recently announced that the Platelet Pan Genera Detection (PGD) Test System, the first rapid test to screen platelets for bacteremia before transfusion, has been approved for U.S. marketing.

Contaminated platelets are the leading infectious cause of transfusion-related death, according to an FDA press release. With current methods, platelets are tested for bacteria 24 and 48 hours after donation, but infected platelets may not have enough bacteria present at that time for detection. The new testing system, which involves a disposable testing strip, improves the odds of detection because it can be used on stored platelets closer to the time of transfusion, giving bacteria more time to grow, the FDA said.

The FDA also recently licensed 15 blood grouping reagents that previously were not available in the U.S. The tests, which use monoclonal antibodies, will allow more choice for transfusion services and may help increase testing for rare blood types, an FDA official said in a press release.

Specialty groups issue cardiac rehabilitation guidelines

A coalition of cardiac specialty groups has issued new performance measures aimed at spurring more patients to enter cardiac rehabilitation programs as well as improving the programs' quality.

The performance measures were compiled by the American Association of Cardiovascular and Pulmonary Rehabilitation, the American College of Cardiology (ACC) and the American Heart Association. “This is a call to arms,” said the director of the Mayo Clinic's Cardiovascular Health Clinic in a statement.

Fewer than 30% of eligible patients participate in cardiac rehabilitation programs following cardiovascular disease events, often because they aren't referred, the new guidelines said. Studies have found the programs reduce the risk of death for people with heart conditions by 20% to 25%. Eligible patients include anyone who, in the last year, has had myocardial infarction/acute coronary syndrome, percutaneous intervention, coronary artery bypass surgery, stable angina, heart valve surgery or heart and/or lung transplantation.

One aim of the new performance measures is to make referral to cardiac rehabilitation “as automatic as giving aspirin during a heart attack,” according to an ACC statement. To that end, the document offers sample referral forms and outlines the best way to collect and analyze referral data. Another goal of the measures is to improve the safety and quality of care of the programs by, for example, setting standards on things like medical supervision, patient monitoring, documentation and communication.