The use of licensed medicines maximises patient safety while minimising liability, but there are occasions where unlicensed medicines or off-label medicines are prescribed and dispensed. This may be because:
- It is an unusual formulation or strength
- It may be a preservative or additive-free product
- For some diseases there are no licensed medicines
- It might be prescribed for a disease or a type of patient outside of the drug’s Marketing Authorisation
An off-label medicine is a licensed medicine which is used outside its licence. For example a medicine might have a licence for adults, but may be prescribed to a child if a suitable licensed paediatric formulation is not available.
More than 50% of medicines used in children in the European Union have never actually been studied in this age group , so it’s hardly surprising that in the UK unlicensed medicines or off-label products account for :
- 11% of medicines used for children in general practice
- 25% in general hospital wards
- 40% in paediatric intensive care units
- 80% in neonatal intensive care units
Unlicensed medicines may take the form of:
‘Specials’ – medicines made under a specials licence by a manufacturer
Imports – products with a licence, usually in another country, which are imported into the UK
Extemporaneous products – formulations for an individual patient made by a pharmacist compounding ingredients, this can include tablet manipulation by crushing tablets or suspending
Manipulated products – medicines in which the formulation has been altered (this may happen if someone can't swallow tablets) e.g. by crushing tablets or opening capsules and may be undertaken by a pharmacist as extemporaneous dispensing or by the medicines administrator / carer
Specials and licensed imports should be considered first, followed by extemporaneous medicines and then manipulation.
Classification, advantages, considerations and examples of unlicensed products commonly used. Adapted from Tomlin11
|Class||Description||Advantages||Considerations when prescribing and purchasing unlicensed medicines|
|Extemporaneous medicine ('extemp')||
* Specials and licensed imports should be considered first, bearing in mind the pros and cons in each individual case, followed by extemporaneous medicines, and then manipulation
† Although a special should be made to the requirements of the individual patient, it is rare for a prescriber or pharmacist to engage with a manufacturer about formulation and excipients. It is essential that pharmacists understand the requirements of the patient and that prescribers understand the problems that using an unlicensed medicine entails. A specials manufacturer will not be able to provide specific requirements as in a batched special and in reality would have to supply an extemporaneous medicine.
‡ The imported product may be licensed in the originating country for exactly the same condition that it is being imported to treat. However, products are often imported because they are available in the required form but may be licensed for a different indication.