Doctors should be required to disclose when they are prescribing drugs off-label, argues a new article in this week’s PLoS Medicine. Michael Wilkes and Margaret Johns from the University of California Davis argue that the ethics related to informed consent and 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 that do not comply with the use approved by the Food and Drug Administration (FDA) for the drug. While off-label prescribing is legal and accounts for roughly half of all prescriptions currently written in the US, it is often not supported by sound scientific evidence. Worse, say the authors, off-label prescribing can put patients at risk and drive up healthcare costs.
The public often assumes that all common uses of prescription drugs have been approved by the FDA, say the authors. But current law does not prevent doctors from prescribing a drug to any patient for any use whether it was approved for this use or not.
“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.”
As an occasional patient I’m pleased the relationship I have with my physician is ethical and trusting.
Still, you trust your friends; but, you cut the cards. I’d rather have the ethical requirements spelled out in law – instead of having to rely on a trade commission or the AMA providing assurance.