What must a pharmacist do if they suspect a prescription is for an off-label use?

When a pharmacist suspects that a prescription is for an off-label use, it is crucial for them to consult with both the patient and the prescriber about the intended use of the medication. This is the best practice for several reasons.

First, off-label use means the medication is being prescribed for a condition or in a manner that is not specifically approved by the FDA. While off-label prescribing is legal and common in medical practice, both the pharmacist and the healthcare team need to ensure that the medication is appropriate for the patient and that the prescriber has reasoning based on clinical evidence or guidelines.

Consulting the prescriber can clarify the rationale behind the off-label use and ensure it's a suitable option for the patient's treatment plan. Engaging with the patient helps provide them with the necessary information regarding the medication, including potential risks and benefits associated with off-label use. This communication is important to ensure informed consent and support optimal patient care.

Filling the prescription without question can lead to potential legal and ethical issues if the off-label use is not appropriate for the patient. Reporting the prescription to the FDA is unnecessary unless there are concerns about safety or legality, and outright refusal to fill the prescription may deny necessary treatment without exploring all aspects of patient care and prescriber intent.