Off-Label Rx Drug Use Associated With Increased AEs

the Psychiatry Advisor take:

While off-label use of prescription drugs is commonly used by clinicians for certain conditions, new research indicates that the practice may be associated with an increase in adverse events, especially when off-label use is not backed by scientific evidence.

Tewodros Eguale, MD, PhD, of McGill University, Montreal, Canada, and now of Massachusetts College of Pharmacy and Health Sciences, Boston, and colleagues looked at the off-label use of medications and subsequent adverse events on 46,021 patients in Quebec who received 151,305 prescriptions from 2005 through 2009.

The adverse event rate was 19.7 per 10,000 person-months for off-label use compared to 12.5 per 10,000 person-months for on-label use, the researchers reported in JAMA Internal Medicine. Further, off-label use for drugs that lacked strong scientific evidence behind it had an even higher adverse event rate of 21.7.

The results also showed that the risk of adverse events grew as the number of drugs taken increased. A patient taking eight or more drugs was five times more likely to experience an adverse event compared to someone taking only one or two medications.

Physicians and physician organizations should recognize the enormity of the problem and be active participants in the promotion of cautious prescribing of drugs for off-label uses lacking strong scientific evidence,” the authors concluded. “Future [electronic health records] should be designed to enable postmarketing surveillance of treatment indications and treatment outcomes to monitor the safety of on- and off-label uses of drugs.”

Off-Label Rx Drug Use Associated With Increased AEs
The risk of adverse events grew as the number of drugs taken increased.

Off-label use of prescription drugs was associated with adverse drug events in a study of patients in Canada, especially off-label use lacking strong scientific evidence, according to an article published online by JAMA Internal Medicine.

Off-label prescribing of drugs is common and has been identified as a potentially important contributor to preventable adverse drug events (ADEs).

Tewodros Eguale, MD, PhD, of McGill University, Montreal, Canada, and now of MCPHS University (Massachusetts College of Pharmacy and Health Sciences), Boston, and coauthors looked at the off-label use of prescription drugs and its effect on ADEs in 46,021 patients who received 151,305 prescribed drugs from primary care clinics in Quebec, Canada.

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