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Prescription Drugs: Additives

Question for Department of Health and Social Care

UIN 128764, tabled on 20 February 2018

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure access to compounded medications including antihistamines are free of (a) colourings and (b) preservatives.

Answered on

28 February 2018

Anti-histamines are generally available over-the-counter. Often there are several brands available and it is usually possible to select a colour-free brand or avoid an additive of concern. If an additive can cause allergic reactions or has other known effects it must be named on the outer label of the product as well as included in the list of ingredients stated in the Patient Information Leaflet (PIL).

Information about the ingredients used in medicines is available on the website of the Medicines and Healthcare products Regulatory Agency (MHRA) at the following link:

www.mhra.gov.uk/spc-pil/

Access to the PIL for medicines licensed in the United Kingdom and the list of ingredients in full is available using the link. Alternatively, patients or healthcare professionals may wish to contact the MHRA to ask whether products free from a particular ingredient have a marketing authorisation and identify the authorisation holder.

Although colours may be considered unnecessary they can help to prevent medication errors by assisting the differentiation between products, especially when they are placed in multi-compartment compliance aids.

All colourings permitted for use in medicines are also permitted for use in foods and allergic reactions to them are extremely rare and usually mild. It is a requirement that the warning “may cause allergic reaction” is in the PIL of medicines when azo colouring agents are used although it is accepted that patients cannot always choose whether or not to use a particular medicine.

The European Medicines Agency (EMA) issued guidance in 2008 and 2013 which discourages the use of colourings with allergenic or toxicological potential in new medicines for children and as more new medicines are licensed the number of colour–free medicines available for children should increase.

Concerns in relation to the more general inclusion colours in medicines have been raised by the MHRA at European level, most recently in November 2017. The MHRA is continuing to work with the EMA to develop further guidance in this area and is leading in the preparation of new guidance on warnings in relation to azo colours and is also involved in initiatives aimed at increasing the availability of colour-free products.

Liquid medicines, such as anti-histamines intended for children, need to last for many months to enable their distribution through the supply chain and be kept in the home ready for the occasion when they are needed. This would be impossible without the use of preservatives preventing microbiological spoilage and the risks this would pose to patients. As a consequence of this, the use of preservatives is necessary in such medicines. Alternatives to preservatives such as syrup based medicines or use of alcohols are also unsuitable for, or are not favoured by, a number of patients.