Off-label prescribing is a common practice for physicians, particularly when treating some of their sickest patients for whom other remedies have failed, according to an article from the Wall Street Journal.
But the incidence of side effects also rises sharply when drugs are given to patients for other than their intended purposes, new research published in JAMA Internal Medicine revealed, spurring a call for physicians to monitor their off-label prescribing more closely.
For the study, researchers looked at electronic health record data surrounding 151,305 prescriptions for 46,021 patients in Canada (where prescribers are required to note the indication for a drug on the prescription, unlike in the United States) over a five-year period. Overall, about 8 percent of the patients had adverse side effects, according to the report. But when drugs were given off-label, the rate of side effects was 44 percent higher.
When researchers zoomed in on just drugs that were prescribed off-label without strong scientific evidence, such as antidepressants, antipsychotics and anticonvulsants, often used to treat epileptic seizures, side effects increased 54 percent.
Although the study didn't track the severity of side effects, the most commonly reported problems included gastrointestinal, nervous system and respiratory symptoms.
"Our main message is off-label prescribing or use without strong scientific evidence should be discouraged," Tewodros Eguale, an associate professor at the Massachusetts College of Pharmacy and Health Sciences and first author of the study, told the WSJ. "Physicians need to look for other approved drugs." And when they do proceed with off-label prescribing, physicians should be "very vigilant" in using the medication, he said.
Frequently, physicians are unaware of what indications a drug does and does not have FDA approval for, according to the newspaper, and some U.S. doctors would like to see rules changed so that the purposes for prescriptions are included on the label.
Such a change would not only increase awareness and understanding of off-label prescribing, according to the article, but could also improve providers' ability to reconcile which drugs patients no longer need over time.
To learn more:
- see the article
- here's the abstract