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MDU medicolegal adviser Dr Nicholas Norwell advises on the pitfalls of unlicensed medication

With GPs being asked to prescribe unlicensed MMR vaccines manufactured overseas, instead of the usual UK stocks, the MDU has received an increase number of calls from members about the medicolegal implications of prescribing unlicensed medicines. Members ask what extra precautions they need to take, what additional information they need to give patients, and whether there could be legal action should a problem arise. Here, the MDU attempts to address some of the concerns raised about the unlicensed MMR vaccines, and, through looking at a fictional case, about unlicensed drugs in general.

How do I know the unlicensed MMR vaccine is safe to prescribe?

The Department of Health has imported the unlicensed version of the MMR vaccination from Germany (Triplovax) and the US (M-M-RTMII) following a shortage of licensed MMR vaccine.

In recommending these products for use in school and university immunisation campaigns, the department has assured doctors in two letters, May 13 and 26 this year, that both versions of the vaccine have undergone testing to ensure they meet safety, quality and efficacy standards in the EU and the US and that both are identical to the UK product in all respects apart from the product name of the German vaccine and labelling.

Will I be held responsible for the vaccine if it is defective?

As with all medicines the manufacturer retains responsibility for the efficacy and safety of the vaccines under the Consumer Protection Act 1987, subject to them being stored and administered correctly. But if the manufacturer cannot be identified, liability can attach to the supplier. It is therefore important that GPs keep records of the name, batch number and expiry date of any vaccine administered so that, in the unusual event of a problem with safety or efficacy, the drug can be traced back to the manufacturer.

Doctors should also reassure themselves that the medication they wish to prescribe is backed by a responsible body of medical opinion.

The GMC's Frequently Asked Questions on prescribing includes guidance on unlicensed medicines (www.gmc-uk.org). This states that you must:

be satisfied that an alternative, licensed medicine would not meet 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, including monitoring and any follow-up treatment

record the medicine prescribed and the reasons for choosing this medicine in the patient's notes.

Can the unlicensed MMR be administered under a PGD?

No. Unlicensed medicines should be prescribed and administered on a patient-specific basis or prescription rather than using a Patient Group Direction. This is echoed by the department in its advice about prescribing the unlicensed MMR vaccine.

What should I tell patients?

Patients should be told the product is unlicensed when their consent is obtained or, in the case of children, their parents should be informed and their authority obtained.

It may also be appropriate to show patients the letter from the department that recommends use of the unlicensed vaccine. Ensure you record details of this discussion in the clinical notes.

Nicholas Norwell is a medicolegal adviser with the MDU

Case study

Q. A 60-year-old patient came to see me last week claiming to have read on a health website that neuroleptic medicines could be the solution to his long-term sleep problems.

He mentioned various antipsychotic medications that are not licensed for stand-alone sleep problems, but were cited as being useful in conjunction with antidepressants. He has been prescribed antidepressants with little effect on his sleep problems. How should I respond to his request?

A. You can prescribe an unlicensed drug or licensed drugs for an unlicensed indication if, in your clinical judgment, there is a need to do so. But a doctor must take reasonable care and act in a way that is consistent with the practice of a responsible body of medical opinion.

Equally, under the GMC guidelines, a doctor has an ethical obligation to 'prescribe drugs or treatments only where you have adequate knowledge of the patient's health and medical needs'. And the GMC also states: 'You must not give or recommend to patients any investigation or treatment which you know is not in their best interests, nor withhold appropriate treatments or referral' (Good Medical Practice, paragraph 2). The GMC also has specific guidance on prescribing unlicensed medications.

First you should explain to the patient that the drugs, although they have a product licence for certain indications, do not have a UK licence for use as sleep aids and so their use in this way would be, to some extent, experimental.

You should also make it clear what the known side-effects are but also explain that there may be other unknown problems that arise with use.

Make a full note of the conversation in the medical notes. If you intend to prescribe, you should satisfy yourself that there is a responsible body of medical opinion that would support your decision to use these drugs in this way.

If you decide to go ahead with the treatment you should take responsibility for monitoring and reviewing the drug.

A general point about unlicensed drugs obtained direct from the manufacturers: pharmaceutical companies sometimes ask doctors to sign agreements indemnifying the company as a condition of supply. The MDU advises members not to sign such agreements if the company has been negligent in the production or distribution of the drug, the company should accept responsibility.

When confronted with problems with an unlicensed medicine it is always advisable to take advice from your medical defence organisation before taking any action.

copyright MDU 2005

The case mentioned is fictitious, but based on cases from the MDU's files.

Doctors with specific concerns are advised to contact their medical defence organisation for advice.

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