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Making Unlicensed Prescribing Safer

Step 1 - Check the BNF to see if a suitable licensed product is available
Step 2 – Consider a licensed product that might be used outside its licence
Step 3 – Consider whether an unlicensed product is most appropriate

The General Medical Council (GMC) states that when an unlicensed product is prescribed, the prescriber must:

  • Be satisfied that an alternative, licensed medicine would not satisfy the patient’s needs
  • Be satisfied that there is a sufficient evidence base and / or experience of using the medicine to demonstrate its safety and efficacy
  • Take responsibility for prescribing the unlicensed medicine and for overseeing the patient’s care
  • Keep accurate records


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