Off-Label Prescriptions: Another Name For Malpractice?

Would you want to serve as an ignorant guinea pig in a totally unstructured drug experiment the next time you visit your physician? …

The explanations of the practice of off-label prescribing by medical providers are often very simple and direct. Basically, from the providers’ perspective, it is a necessary tool to more properly treat a medical condition.

Unfortunately, bad things happen to some patients because of their use of prescribed medications. When these bad things occur during the use of a drug beyond its FDA approved uses, what appeared to be simple on the prescribing end may turn out to be very different on the complication end.

Would you want to serve as an ignorant guinea pig in a totally unstructured drug experiment the next time you visit your physician? I know my answer, but some patients are not even being asked the question before the experiment begins. These patients are being prescribed a medication for a use “off-label”, one that even the drug manufacturer does not recommend.

Every now and then another attempt to justify the common medical practice of prescribing drugs for uses never approved by the FDA appears. An example of the logic of these attempts was recently posted at the PiperReport Blog:

“Once the Food and Drug Administration (FDA) approves a new prescription drug for one medical indication, physicians are free to prescribe it for virtually any condition. While there are downsides of prescribing drugs “off-label,” it allows patients and payors to benefit as physicians test drugs under real-world conditions and identify new applications.

Because formal clinical trials and the FDA review process can take years, valuable new uses of a drug may be validated by studies in peer-reviewed medical journals years before the new indication becomes officially approved. And because of research and regulatory costs, drug makers cannot justify pursuing FDA approval for new indications, even when a new indication is highly cost-effective for purchasers, plans, and patients. Indeed, some diagnoses have no “on-label” drugs and are treated entirely on an off-label basis.”

The explanations of the practice of off-label prescribing by medical providers are often very simple and direct. Basically, from the providers’ perspective, it is a necessary tool to more properly treat a medical condition.

Unfortunately, bad things happen to some patients because of their use of prescribed medications. When these bad things occur during the use of a drug beyond its FDA approved uses, what appeared to be simple on the prescribing end may turn out to be very different on the complication end.

Maxwell J. Mehlman, J.D., says the “practice is widespread. Although there are no accurate data, estimates run as high as 60% of all drug prescriptions written in the United States in a given year, including a large proportion of chemotherapy and pediatric prescribing.” He elaborates on the issues raised by the practice:

“The practice raises a number of legal and ethical issues. Is off-label prescribing a form of human experimentation, triggering the safeguards established to protect human subjects? When is it appropriate in that it conforms to the standard of care? Could a failure to prescribe off-label leave the physician vulnerable to a malpractice suit? Does the physician have a duty to inform the patient that the product is being prescribed off-label? In prescribing a drug for an unapproved use, does the physician act as a “learned intermediary,” thereby relieving the drug manufacturer of liability for resulting patient harm? How does the FDA regulate off-label prescribing? Can a manufacturer promote a product for an off-label use?”

The lengthy Mehlman article is worth a read at TheDoctorWillSeeYouNow website.

After reading it you may become a better patient and make your doctor a better health care provider.