Study Finds Doctors Frequently Prescribe Drugs Off-Label

A new study finds that doctors are frequently prescribing medications for off-label uses

The study looked at the off-label prescribing practices of primary care physicians in a Canadian network, said Science Daily. The report was published in Online First by the Archives of Internal Medicine, a JAMA network publication; the repot is part of the journal’s Health Care Reform series.

According to the study, off-label practices are common, but vary according to drug, patient, and physician characteristics. As we’ve explained, while drug makers are legally banned from advertising U.S. Food & Drug Administration (FDA)-approved medications for any purposes other than for which those drugs were approved, physicians are free to prescribe medications for any reason for which they see fit. The researchers believe that the practice of off-label prescribing—prescribing drugs for indications for which those drugs did not receive regulatory approval—is adding to preventable adverse medication events, said Science Daily.

Tewodros Eguale, M.D., M.Sc., of McGill University, Montreal, Canada, and colleagues, utilized the Medical Office of the XXI Century primary care electronic health record network research program in Quebec to review off-label drug use, said Science Daily. The team found that 113 primary care physicians wrote 253,347 electronic prescriptions for 50,823 patients from January 2005 through December 2009. Of these, about 11% were prescribed off-label; 79% of the off-label indications were not associated with strong scientific evidence. The researchers pointed out that the magnitude of the off-label use studied was less than what was seen in a U.S. study.

The researchers in this study found that the greatest proportion of off-label prescribing concerned central nervous system medications (26.3%). Anti-infective agents amounted for 17.1% of the off-label prescriptions, and ear-nose-throat medications accounted for 15.2%, wrote Science Daily.

The results also revealed that those drugs that had three or four approved indications were linked to lower off-label uses versus medications with one or two approved uses, said Science Daily. Also, drugs that were approved after 1995 were linked to lower off-label uses than medications approved prior to 1981.

Those doctors who scored highly on evidence-based practice were also less likely to prescribe medications for off-label indications, Science Daily pointed out.

“In conclusion, our findings indicate that off-label prescribing is common in primary care and varies by drug class, the number of approved indications for the drug, the age of the drug, patients’ sex and physicians’ attitude toward evidence-based medicine,” the authors wrote, according to Science Daily. “Electronic health records can be used to document treatment indication at the time of prescribing and may pave the way for enhanced post-marketing evaluation of drugs if linked to treatment outcomes,” the team concluded.

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