Reporting drug side effects: signals and noise

Article Abstract:

An important challenge currently facing the health care system in the United States is the prompt identification of adverse drug reactions (ADRs). Before a new drug is marketed, it is tested in brief clinical trials to evaluate effectiveness and side effects, without causing excessive delays in the introduction of a useful drug. But premarket testing is limited in its capacity to identify the range of possible ADRs. In actual practice, the drug may be prescribed for people of all ages with countless combinations of medical problems. Most drugs are tested only on middle-aged subjects or the 'young' elderly, but many frail and ill elderly persons will also take the drug. A report by Scott et al. in the April 4, 1990 issue of The Journal of the American Medical Association describes a project that motivated physicians to report ADRs to the Food and Drug Association (FDA). After a drug is marketed, doctors often discover side effects not previously identified, and they are expected to report these cases to the FDA. This channel of communication has been underutilized, and the study demonstrated a 17-fold increase in physician reports. These reports did not represent extraneous 'noise' but, rather, signals of significant and sometimes severe ADRs. While an increase in voluntary ADR reporting is to be encouraged, a different kind of data are also needed to put the case reports in perspective. A population-based surveillance system for ADRs is necessary to determine whether the individual reports reflect a coincidental cluster of cases or a real problem of drug toxicity. The FDA would require more funds to carry out such studies, but the results would be extremely valuable. By allowing physicians to choose more appropriate, safer and more effective medications, better decisions could be made, resulting in enhanced health and reduced patient care costs. A related goal is to quantify the risk of various drugs with known side effects, so that interchangeable drugs can be compared. It is surprising that more effort has not been made to obtain such useful information about adverse drug reactions. (Consumer Summary produced by Reliance Medical Information, Inc.)

Medicine, Reports, Complications and side effects, Telecommunications systems, Pharmacy, United States. Food and Drug Administration, Drug interactions, Adverse drug reactions, editorial

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Persistence of use of lipid-lowering medications: a cross-national study

Article Abstract:

Many elderly patients who are prescribed cholesterol-lowering drugs do not get the prescription filled or stop taking the drug over the long-term. Researchers analyzed the percentage of filled prescriptions for these drugs among 5,611 elderly patients covered by New Jersey Medicaid and 1,676 Canadians covered by Quebec's medical care program. During a one-year period, patients failed to fill prescriptions 40% of the time. Five years later, only half the patients were still getting their prescriptions filled. These drugs must be taken long-term for any health benefits to be realized.

Usage, Prescriptions (Drugs), Anticholesteremic agents

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Improving drug use in elderly patients: getting to the next level

Article Abstract:

Many elderly people are taking drugs they don't need or not receiving drugs they do need. This could become even more problematic as managed care plans begin dumping elderly patients, Medicare refuses to pay for drugs, and patients are unable to pay for drugs.

Editorial, Prevention, Medication errors

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