A consultant wishes to prescribe a licensed drug for an indication outside its licence because evidence supports it and no licensed alternative is suitable. What does GMC guidance say?

Answer and explanation

Correct answer: D. It is acceptable if it better serves the patient, with explanation and responsibility

  1. Step 1: Off-label prescribing is common, especially in paediatrics.
  2. Step 2: The prescriber must be satisfied the use is safe and effective, record reasons and give the patient information.
Answer
It is acceptable if it better serves the patient, with explanation and responsibility.
Why not the others: It is allowed with no explanation to the patient being required: Patients should be given enough information to consent. It is allowed only if the manufacturer agrees to it in writing: A company's permission is not required. It is never allowed for any reason, whatever the evidence available: The GMC does not forbid off-label prescribing.

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