Contrary to the plaintiff’s allegations, off-label prescribing rarely violates the standard of care because it has valid clinical and scientific bases. And don’t acknowledge the PDR as “the Bible,” which it is not; it’s a compilation of PIs. The FDA affirms that once a product is approved for marketing, a physician may choose to prescribe it for off-label use (Box).5
FDA statement on off-label prescribing
The FDA acknowledges that doctors need to treat patients and may prescribe medications off-label. As stated in the foreword to the Physicians’ Desk Reference:
The FDA has also recognized that the [Federal Food, Drug, and Cosmetic] Act does not, however, limit the manner in which a physician may use an approved drug. Once a product is approved for marketing, a physician may choose to prescribe it for uses or in treatment regimens or patient populations that are not included in approved drug labeling. The FDA also observes that accepted medical practice includes drug use that is not reflected in approved drug labeling.5
Standard of care
The real issue for practitioners is the “standard of care.” Violating the standard of care—what a similarly trained clinician would do under similar circumstances—is the first step on the slippery slope to malpractice. Here we can be quite sure that the standard of care and evidence-based medicine are in sync and support the use of off-label, high-dose monotherapy.
Properly documenting your reasoning helps to demonstrate that your prescribing meets the standard of care. Always document and obtain informed consent. Also stay up-to-date about:
- medications you prescribe
- emerging evidence and safety information
- appropriate patient monitoring for clinical response and adverse effects.8
Black boxes and bold lettering
The FDA may mandate that a manufacturer highlight certain information on a PI in 3 ways—bold lettering, black-box warning, and red lettering, in order of presumed increasing seriousness. This system is meant to draw prescribers’ attention to potential safety problems with pharmaceutical agents. No psychiatric medications carry red-letter warnings, a classification usually reserved for antineoplastic agents.
The FDA’s action appears to “level the playing field,” giving patients the misperception that any treatment would carry an equal risk. Therefore, when you prescribe a drug that carries a class-wide warning in its PI, present the evidence in a balanced, objective manner so that the patient can make an informed decision.
Managing risk
Your best protection against liability is to communicate effectively with the patient and document that communication—including informed consent—in the medical record.8 Obtain and document informed consent whenever:
- you initiate a drug or other treatment
- treatment extends beyond the PI-recommended maximum dose.
Potential benefits for patients from updating informed consent include:
- changes in medications or dosages based on the new information
- closer monitoring of potential side effects and other actions
- empowerment to make decisions about stopping a medication or trying alternate medications or treatments.
Documenting informed consent
What to include. View informed consent as an ongoing discussion, not a document that needs to be put into a chart to comply with a legal mandate. Documenting informed consent may be as simple as going through the process and then including pertinent points in the medical record (Table 2). The following is an example of a medical record entry used by one author (NSK) to document an initial informed consent discussion: