What does 'off-label use' of a drug mean?

'Off-label use' of a drug refers specifically to the practice of prescribing a medication for a purpose that has not been approved by regulatory agencies, such as the FDA. When a drug is developed, it goes through rigorous clinical trials to ascertain its safety and efficacy for specific indications. However, once approved, healthcare providers have the discretion to prescribe the medication for other conditions or patient populations based on their clinical judgment and available evidence.

This practice can be based on new research findings, expert opinion, or clinical experiences that suggest the drug may be beneficial for a different condition than what it was originally approved for. It's important to note that while off-label use is legal and often necessary in practice, it should involve thorough discussion with the patient regarding the potential risks and benefits, given that most off-label uses may not have the same comprehensive evidence backing them as the approved uses do.

The other options describe aspects of drug use that do not accurately define off-label use. For example, using a drug outside of its clinical trials encompasses a broader range of actions that may not specifically involve approved indications. Administering a drug without a prescription pertains to legality and oversight rather than the approved indications for which the drug can be used. Finally, using a drug in accordance with its