Doctors should disclose off-label prescribing to their patients
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.
And while off-label prescribing is common and sometimes necessary (as in the area of paediatrics where many drugs have not been tested on children), Wilkes and Johns argue that off-label prescribing can also pose potentially serious risks. By definition no governmental body has conducted a review of the effectiveness or safety of the drug for the off-label use, they say. As a result, an off-label prescription may be ineffective or detrimental, and could be more costly than existing drugs.
Wilkes and Johns argue that the strict requirement that doctors obtain informed consent from patients before enrolling in a research study means they should obtain the same consent when a drug is being prescribed off-label as each such prescription is just like a mini research study. The contemporary expectation for shared decision-making between doctors and patients also supports full disclosure about off-label prescribing, leaving the option open for patients to opt for a drug which has received FDA approval for the condition in question.
‘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.’
Updated 26Nov08:
14 Drugs Identified As Most Urgently Needing Study For Off-label Use
ScienceDaily (Nov. 26, 2008) — Physicians and policy-makers know that drugs are frequently prescribed to treat certain diseases despite a lack of FDA approval — a practice known as off-label prescribing. Yet they say the problem is so big they don’t know how to begin tackling it.But a potential game plan now exists. In a paper to be published in the December issue of Pharmacotherapy, a group of researchers has developed a list of 14 widely prescribed medications most urgently in need of additional study to determine how effective and safe they are for their off-label uses. Antidepressants and antipsychotics are the most prominent classes of drugs on the list, which specifically targets drugs that have high levels of off-label use without good scientific backing.
“Off-label prescribing means that we’re venturing into uncharted territory where we lack the usual level of evidence presented to the FDA that tells us these drugs are safe and effective,” said Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, who is the senior author of the study. “This list of priority drugs might be a start for confronting the problem of off-label use with limited evidence.”
