Document all steps. There is an adage in medicine that “If it’s not written, it wasn’t done.” To help reduce your liability risk when prescribing off-label, be sure to document the following4:
- your clinical assessment
- information you gleaned from the patient’s medical records
- your review of information regarding both therapeutic and adverse effects of the medication you want to prescribe
- your discussion of informed consent, including documentation that the patient is aware that the medication is being prescribed off-label
- your clinical rationale for why the off-label medication is in the patient’s best interest.
Also, document the steps you take to monitor for adverse events and therapeutic effectiveness.4 Overall, the goal of documentation should be to support the adequate continuing care of our patients.