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I recently started a patient on an unlicensed drug and requested the patient's GP provide repeat prescriptions.
The GP was concerned because she had never heard of the drug before and furthermore, she thought that it was unethical and possibly illegal to prescribe a drug outside of its product licence. What should I do?
Legal responsibility for the decision to prescribe falls to the clinician who signs the prescription so before the GP can provide repeat prescriptions she will need to satisfy herself that she can do so. Of course, it is not for you to give the GP legal and ethical advice, but hopefully the following helps you to understand the position.
In the UK, no medicine can be marketed for human use without a product licence granted by the Medicines and Healthcare products Regulatory Agency. However, the licensing arrangements permit doctors to prescribe unlicensed drugs, and to use drugs for unlicensed indications in specific circumstances.
Doctors have a legal duty to take reasonable care and to act in a way that is consistent with the practice of a responsible body of their professional peers. If a decision to prescribe an unlicensed drug was ever tested, the clinician's decision would have to be capable of support from an informed, reasonable body of clinicians of similar training and experience.
Informed consent is a crucial aspect of off-licence prescribing. Doctors must make it very clear to the patient that the medication is unlicensed, and why that is. Patients must be told why the drug is being prescribed, what alternatives exist, and have all their questions answered fully. You must make a clear record that the indications for the drug and the risks have been explained and that the patient both understands the risks and is willing to accept them. The GMC provides specific guidance on the prescription of unlicensed medications and the prescription of medications outside the terms of their licence.
...it may be helpful for you to provide the GP with information about the drug's safety and value in this particular condition.
Paragraphs 67-74 of Good Practice in prescribing and managing medicines and devices (2013) guidance for doctors states that the prescribing doctor should be satisfied that an alternative, licensed medication would not meet the patient's needs and that there is a sufficient evidence base and/or experience of using the medicine. Additionally paragraph 70 (b) states that the doctor signing and issuing the prescription personally bears the responsibility for that treatment. It is imperative that any GP who is to provide ongoing management understands the patient's condition, the treatment prescribed and can recognise any adverse effects of the medication and should take responsibility for monitoring and any follow up treatment. If the GP agrees to provide repeat prescriptions, it will be important to agree with her when she will take over responsibility for prescribing the drug.
The GMC also specifically addresses the issue of prescribing medicines to hospital outpatients. Paragraph 41 indicates that where a patient's care is shared between clinicians, doctors with responsibility for the continuing management of the patient must be fully competent to exercise their share of this clinical responsibility. If the patient's GP is to be responsible for monitoring the patient, she must be satisfied that she understands enough about the drug to do so.
As you are familiar with the drug, it may be helpful for you to provide the GP with information about the drug's safety and value in this particular condition. Paragraph 40 makes clear that you should be willing to answer the questions posed by a colleague and assist in caring for the patient as required. If the GP is satisfied, she may then be happy to prescribe the drug, but the decision is ultimately hers. She will be responsible if she agrees to continue the prescription.
If the GP agrees, you could set up a formal shared care agreement and consider drawing up a protocol for the GP to follow, making clear the monitoring requirements and indications for dose adjustments. It may also be necessary for the GP to seek approval from the CCG to ensure prescribing the drug in this way complies with any local guidelines on prescribing.
This page was correct at publication on . Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.