Ethical Considerations in Off-Label Drug Prescribing

Informed Consent

After the physician has performed due diligence on the evidence base, she has a duty to obtain informed consent from the patient. There are differing opinions in the profession regarding the extent of disclosure the physician is required to provide with OLDP, varying from no duty to inform of the off-label status, to a complete disclosure of that fact. This author believes that full disclosure of off-label status is the best approach, as well as providing what information is available on benefits, risks, adverse reactions, and alternatives to this drug.

In a few cases, there may be no alternatives, or the risk/benefit ratio may be equivocal, and the patient should be so informed. Depending on the severity of risks and adverse reactions in the face of the patient’s medical conditions, the physician may wish to defer prescribing the drug until the patient has had sufficient time for consideration. Alternatively, if the patient has brought the possibility of using the drug to the physician, usually after Internet searches, the physician may request time to perform her own due diligence.

Informed consent for OLDP should be considered on a similar level as informed consent for a surgical procedure, especially if the evidence base is sparse and the risks rather high. Knowledge of the patient’s cognitive capacity for decision making, along with the physician’s experience, is often key to the content and approach for OLDP informed consent. Patients who do not have the capacity to provide informed consent should likely not be considered for OLDP unless the designated surrogate can understand and provide considered consent.

In this clinical scenario, the patient brings a concern to the surgeon regarding his desire to avoid postoperative opioids, if possible, due to his history of substance abuse—a very thoughtful request. In the midst of an opioid “crisis,” physicians are encouraged to expand their armamentarium of analgesics, and gabapentin is one of the current options. However, gabapentin has recently been identified as a new and potential substance abuse drug in the U.S. It is a federal non-controlled drug, although several states are now reclassifying it as a scheduled drug.

Gabapentin abuse seems to be more common in patients with a history of substance abuse, or current substance abuse, which should be a consideration in this particular patient’s case. While it is true that pain after surgery is akin to neurogenic pain, and perhaps gabapentin may be increasingly used for this indication, the risks for this patient may outweigh its benefits. Additional adverse reactions and side effects include the potential for addiction itself, suicidal ideations, and daytime somnolence.

It would be a reasonable clinical judgment to seek consultation on this patient’s postoperative pain care from a specialist in pain management, as well as to seek additional knowledge about the patient from his primary care physician.

A team approach to pain management is an ethical approach, with all due consideration of the patient’s total best interests.