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Doctors Should Tell Patients When They Prescribe Off-Label

Nov 12, 2008 | Parker Waichman LLP A new article in this week’s issue of PLoS Medicine argues that physicians should be required to tell patients when they are prescribing drugs for off-label purposes.  Michael Wilkes and Margaret Johns from the University of California Davis point out that the ethics related to informed consent and doctor-patient shared decision-making “provide an imperative for doctors to inform patients about the risks of a medical treatment when their use has not been approved by regulators.”

Off-label prescriptions are those prescribed for purposes not approved to by the U.S. Food and Drug Administration (FDA); off-label prescriptions are not in compliance with the FDA’s approved uses.  Regardless, off-label prescribing is legal when handled by the prescribing physician and does account for about half of all prescriptions written in the U.S.; however, such prescribing is often not supported by scientific evidence and—according to the article’s authors—can put patients at risk and increase healthcare costs.  The authors also note that consumers generally believe common prescription drug uses have received FDA approval, but current law does not prevent doctors from prescribing a drug for any use whether it was or was not approved for such purposes.

And while off-label prescribing is common and sometimes necessary, Wilkes and Johns argue that off-label prescribing can also pose potentially serious risks.  The two note that, by definition, no governmental body has conducted a review of the effectiveness or safety of the drug for the off-label use,” they say.  Because of this, “an off-label prescription may be ineffective or detrimental, and could be more costly than existing drugs.”  Wilkes’ and Johns’ argument is that in the same way physicians must comply with the strict requirement to obtain informed consent from patients before enrolling in a research study, they should also obtain the same consent when prescribing a drug off-label, pointing out that a patient taking a drug off-label is similar engaging in a “mini research study.”

"From an ethical perspective," say Wilkes and Johns, "[what is required is] open, honest discussions where doctors tell their patients that the use of the drug will be off-label and thus not approved for this indication, explain the risks, potential benefits, and alternatives, and then ask patients for their permission to proceed."  Current trends in which doctors and patients are sharing decision-making roles also lends itself to full off-label prescription disclosure.  In doing so, the patient retains the option to deny a medication that has not received FDA approval for the prevailing condition and to opt for a medication that has received approval for a specific condition.

A recent PLoS Medicine paper also described techniques in which drug makers covertly promote off-label use, a practice about which we have long been reporting. Adriane Fugh-Berman of Georgetown University Medical Center, Washington DC and Douglas Melnick, a preventive medicine physician discussed the use of "decoy indications" and drug representatives to engage in illegal pharmaceutical marketing, which has "distorted the discourse on off-label uses and encouraged the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown," who add that "Companies that engage in off-label promotion should be heavily fined and their future marketing practices subject to increased scrutiny by regulatory agencies."

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