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What are the issues surrounding the use of an unlicensed medicinal product?

Lindsey Gilpin explains why it is important to check that a licensed medicinal product is available before you consider dispensing or obtaining an unlicensed product

By Lindsey Gilpin

Lindsey Gilpin explains why it is important to check that a licensed medicinal product is available before you consider dispensing or obtaining an unlicensed product

The issue of licensed and unlicensed medicines was brought to the fore again in the General Pharmaceutical Council magazine Regul+te (October 2012, p8): “The interim standards for registered premises . . . referred to a requirement to ensure compliance with medicines legislation, including the requirement to supply products with a marketing authorisation where such products exist in a suitable form and are available, in preference to unlicensed products or food supplements. Although the new standards do not make reference to this requirement, our governing council had confirmed that the need to comply with the law in this area remains.”

So what is a marketing authorisation and how would anyone know whether a product had such a licence or not?

Comprehensive regulation of medicines was introduced in the UK in 1971, not least due to the thalidomide tragedy, which caused dreadful devastation to the fetus in women who had taken it for morning sickness. The body which approves marketing authorisations is the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA describes itself as asking the following key questions about a medicine:

• Do the advantages outweigh the disadvantages of taking the medicine?
• Does the medicine do the most good for the least harm for most people who will be taking it?
• Are the side effects acceptable — given of course that, for a medicine for, say, cancer, it may be acceptable for a higher level of side effects than a medicine for, say, hay fever?

The MHRA also inspects factories that produce medicines to ensure that they can do so to a high and consistent standard. It also produces drug alerts. Some of you may have signed up for its email alert service. The MHRA, however, does not assess the cost-effectiveness or value for money of a medicine. These issues are considered by other relevant UK bodies which decide which treatments to recommend to their respective health systems.

Unlicensed medicines

“Specials” are, by their nature, unlicensed, but there are safeguards which can be put in place. Specials manufacturers operate under a manufacturer’s specials licence which, although it guarantees the sourcing of the ingredients, the manufacture, packaging and labelling, etc, does not conduct formal assessments of product safety or efficacy. The manufacturer’s specials license number must be printed on the label but this is still an unlicensed product.
Manufacturers may make specials in batches for which there will be end product analytical testing, or as one-off bespoke medicines which should have a certificate of conformity which confirms that, to the best of the knowledge of the signatory, the final product conforms to the specification supplied by the pharmacist. In the Royal Pharmaceutical Society guidance on dealing with specials (Pharmacy Professional, June 2010, p29; also available at www.rpharms.com), there is an example given of an extemporaneous product of a clobazam liquid for a child which did not give the correct dose because the clobazam is difficult to suspend and some was caked on the bottom even after shaking. However, there is another case when the BP product was unsuitable for a child due to the alcohol in the product and the better option would have been a special.

Medicines may also be made in the pharmacy under the direct supervision of a pharmacist. Older pharmacists will remember a time when a great deal of extemporaneous dispensing was undertaken in community pharmacies. In fact, many of us regret the passing of the time when, in the quietness of the afternoon, we would take out the pestle and mortar and the slab and concoct medicines for our patients. Leaving aside the increased workload which would make that more difficult now, this seemed to change almost overnight when a baby dying following a mistake made in an extemporaneous preparation.

Extemporaneous preparations are still made, of course, but are not licensed products and neither do we have any real way of assessing their stability. This all goes to show that there are no easy answers, especially with children’s medicines, but the RPS echoes the guidance from the GPhC that a non-licensed product should only be used when there is no available licensed product.

Hierarchy of risk

The hierarchy of risk is listed below, as per the RPS decision tree. The lowest risk and preferred option starts at the top:

1    A licensed UK medicine
2    An off-label use of a UK licensed medicine
3    An imported product licensed in the country of origin
4    A UK manufactured special made in MHRA-licensed facilities
5    An extemporaneously dispensed medicine
6    An imported product not licensed in the country of origin
7    A non-UK-made unlicensed medicine or food supplement

The General Medical Council has similar guidance for doctors who prescribe medicines off-licence in its “Good practice in prescribing medicines — guidance for doctors (September 2008)”, which advises that doctors:

• 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, where they are not following common practice, the reasons for choosing this medicine in the patient’s notes

Pharmacists share with prescribers accountability for supplying a special to a patient and should make sure the prescriber is aware of the unlicensed status and, if requested, to make every reasonable effort to identify a UK-licensed product equivalent or near-equivalent to the prescribed special that meets the patient’s clinical needs.

With this guidance perhaps pharmacists would be fairly confident about making an informed choice using the hierarchy of risk to select the appropriate product for patients. It is important to minimise the possibility of inadvertently dispensing unlicensed products and to make sure every pharmacy has licensed products on its shelves for selection.

What is a medicine?

Medicines need a licence, but what is a medicine? Vitamins, for example, do not normally need a marketing authorisation before being sold because they come under legislation which is covered by food safety and labelling legislation.

The Medicines and Healthcare products Regulatory Agency guidance note no. 8 “A guide to what is a medicinal product” explains that deciding whether a product such as a vitamin should be classified as a food or a medicine has to be taken on a case-by-case basis and may vary from country to country.

The MHRA does not normally consider claims to “maintain”, “help to maintain” or “support” a healthy lifestyle to be medicinal. However, claims to help manage conditions such as stress, anxiety and nervous tension, or imply in any way that a product would “prevent” or even “may help with” a specific disease or adverse medical condition could well bring the product into the definition of a medicine.

You can look through the vitamin section of the pharmacy to check whether there is a product licence for a particular product. For glucosamine, for instance, there are now licensed products which are in the Drug Tariff, but will they be on the shelf where you are likely to work and what should you do if they are not but an unlicensed product is?

Will you put patients at risk by supplying unlicensed vitamin D products? What should you supply against a generic prescription for eicosapentaenoic acid ethyl ester (460mg) and docosahexaenoic acid ethyl ester (380mg) when you are certain it has been prescribed for the secondary prevention of post-myocardial infarction and for hypertriglyceridaemia?

An owner or regular pharmacist should be able to ensure that there are licensed products available for prescriptions that are normally presented to the pharmacy. Locum pharmacists have to be just that little bit more careful to protect themselves against this type of inadvertent supply of an unlicensed medicine.

DECLARATION Lindsey Gilpin is a member of Abbott Healthcare Products pharmacy advisory board. A product marketed by Abbott is mentioned in the Panel but Mrs Gilpin was not funded or influenced to write this article by Abbott.

Lindsey Gilpin is a locum community pharmacist

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11115975

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  • A non-licensed product should only be used when there is no available licensed product

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