That knowledge gap could be filled by supplying clinicians with information regarding drug approval status and the quality of supporting scientific evidence at the point of care, when they write prescriptions into patients’ electronic health records, the investigators noted. This would have the added advantage of facilitating communication among physicians, pharmacists, and patients, and could reduce medication errors such as those caused by giving drugs to the wrong patients or by giving patients sound-alike or look-alike drugs.
No sponsors were identified for this study. Dr Tewodros Eguale and his associates reported having no relevant financial disclosures.
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An arena of the unknown
This study, the most extensive and informative one to evaluate the safety of off-label drug use in adults to date, shows that clinicians often enter an arena of the unknown when they expand prescribing beyond the carefully devised confines of the labeled indication. It provides compelling evidence that off-label prescribing is frequently inappropriate and substantially raises the risk for an adverse event.
Even in cases in which an off-label indication has been studied, the pharmacokinetics, drug-disease interactions, drug-drug interactions, and other safety considerations weren’t studied to the degree required during the drug approval process. Moreover, how many clinicians have the time or motivation to review the evidence for those off-label indications, arriving at a balanced assessment of risks and benefits?
Dr Chester B. Good is in pharmacy benefits management services at the US Department of Veterans Affairs in Hines, Illinois, and the department of pharmacy and therapeutics at the University of Pittsburgh. Dr Good and Dr Walid F. Gellad are in the department of medicine at the University of Pittsburgh and at the Center for Health Equity Research and Promotion in the Veterans Affairs Pittsburgh Healthcare System. Dr Good and Dr Gellad reported serving as unpaid advisers to the Food and Drug Administration’s Drug Safety Oversight Board. They made these remarks in an Invited Commentary accompanying Dr Eguale’s report (Good CB, Gellad WF. Off-label drug use and adverse drug events: turning up the heat on off-label prescribing [published online ahead of print November 2, 2014]. JAMA Intern Med. doi:10.1001/jamainternmed.2015.6068).
Dr Lappin is an assistant professor and an attending physician, department of mergency medicine, New York-Presbyterian Hospital/Weill Cornell Medical College, New York.