Gluten free medicines

Tariff Tips

Gluten free medicines

Q: I have received a prescription from a new patient who has informed me that they suffer from coeliac disease. They would like to know if there is any gluten in their medication.

A: Gluten is a long-chain protein found in some cereals including wheat and barley. Cereal-derived starches are used as excipients in many medicines – do they contain gluten and could it affect a patient with coeliac disease?

Starches can be used as a tablet binding agent in prescription medicines. There are two principal types used; maize starch and wheat starch. If a starch is used in a medicine it will be listed as an excipient in the product information and packaging.

Maize starch or corn starch, derived from the corn grain, is used as a binding agent and a sweetener. Maize starch does not contain gluten and so would have no potential to cause the symptoms of coeliac disease.

Wheat starch that is used in prescription only medicines is of a highly refined, pharmaceutical grade and is considered to be gluten-free. ‘Gluten Free’ is defined as containing 20 parts per million (ppm) or less of gluten.

The Medicines and Healthcare products Regulatory Agency (MHRA) have informed the charity Coeliac UK that all prescribable, licensed medicines which are listed in the BNF and MIMS are gluten-free, even if they contain wheat starch.

They also advise that any over the counter medications with a Product License (PL) number on the packet would also be considered gluten free.

Please note that coeliac disease, a gluten enteropathy, and wheat allergy are not the same condition. Any patient with a specific wheat allergy should not take any medicine containing wheat due to the risk of a severe reaction.

For more information please see the link below:

https://www.coeliac.org.uk/coeliac-disease/medications-and-vaccinations/medication/

If you have any questions about this particular tip or any other drug tariff query you can call Information Services on 0800 783 5709.

Tariff Tip written by Sue Swift, UK Drug Tariff and Information Technician

Record my learning outcomes

Tariff Tips