Patient Safety and Quality
Many Federal drug risk alerts fail to achieve the recommended changes in prescribingDrug safety alerts issued by the U.S. Food and Drug Administration (FDA) after a drug is on the market can have mixed results, according to a new review of studies. After approval of a new drug by the FDA, additional information on safety often comes to the Agency once a drug is marketed. This postmarketing surveillance can lead to identification of a new safety concern for a specific subpopulation or requirement of additional clinical or laboratory monitoring for patients taking the drug. The researchers completed a systematic review and identified 49 studies of 16 drug classes or individual pharmaceuticals that evaluated the impact of FDA regulatory actions on prescription drug use.
Nearly half of the studies focused on three drugs or drug classes: antidepressants, glitazones (that target insulin resistance), and cisapride (used to treat symptoms of nighttime heartburn). An additional two studies looked at both antidepressant and antipsychotic drugs. Recommendations for additional clinical or laboratory testing, such as monitoring patients taking antipsychotic drugs for hyperlipidemia or diabetes, had minimal or only temporary effects. In contrast, warnings against coprescribing drugs due to their interactions were effective in changing clinical practice, but often months or years after the warning was issued. Recommendations against use of a drug or use of a drug category in a subpopulation of patients (such as against using antipsychotic drugs in elderly dementia patients) often resulted in large decreases in use among the targeted population but also in modest decreases in use in subpopulations not at risk (i.e., spillover effects).
These findings demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, note the researchers. The review was funded in part by the Agency for Healthcare Research and Quality (HS18996).
More details are in "Impact of FDA drug risk communications on health care utilization and health behaviors," by Stacie B. Dusetzina, Ph.D., Ashley S. Higashi, M.P.H., E. Ray Dorsey, M.D., M.B.A., and others in the June 2012 Medical Care 50(6), pp. 466-478.
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