Hastings Center News

Hastings Scholar on Ensuring Evidence-based Prescribing of Off-Label Drugs

It is legal and common for physicians to prescribe drugs for uses other than those for which they are approved by the Food and Drug Administration. But in a letter in JAMA: The Journal of the American Medical Association, Hastings Center research scholar Karen J. Maschke points to the important role that clinicians have in ensuring that off-label prescribing practices are based on evidence about the safety and effectiveness of these medications.

Her letter responds to an editorial that recommended regulatory and postmarketing surveillance initiatives to evaluate the safety and effectiveness of medications prescribed off-label. Maschke says that while such proposals are important, there is no guarantee that prescribing behavior will change if postmarketing evidence reveals that off-label medications are not effective for their intended use.  “As those who wield the prescribing pen, clinicians have a responsibility to prescribe drugs off-label only when there is sufficient and reliable evidence for such use,” writes Maschke. She notes that clinicians should not rely solely on information from pharmaceutical companies about safety and effectiveness evaluations of drugs used off-label and that they should establish justifiable and transparent approaches for off-label prescribing. Read her letter here.

In response to her letter, the authors of the editorial said they agreed with her observations, and noted that “greater research and prescribing transparency and shared decision-making efforts can help ensure safe and appropriate use of prescription drugs.”