Information on animal-derived ingredients in medicines difficult to obtain
Vegetarians and other patients with dietary restrictions may be unaware that commonly prescribed medicines contain animal products, according to a BMJ analysis article (2014;348:g401). Although common medicines contain lactose, gelatine and magnesium stearate — which can be derived from animals — their source does not always appear within patient information leaflets, the authors found.
After analysing the content of the 100 most commonly prescribed medicines they conclude that information about any animal-derived product was “difficult to obtain, unclear, inconsistently reported, and sometimes incorrect”.
The article reveals that only the Medicines and Healthcare products Regulatory Agency’s product assessment reports contain information about a medicine’s animal product content. But even that information was found to be inconsistent, the authors say.
They are now calling for a change in EU rules so that in future patient information leaflets would include details about whether products contain animal content. Such a move would mirror the system which applies to the sale of foods.
Under current EU rules declaring whether products are suitable for vegetarians or vegan use is prohibited from patient information leaflets on the grounds that any decision not to eat meat is a lifestyle choice.
Changing drug labelling standards to allow outside packaging to include animal derivatives would be another option, the authors say.
But they add: “It is unlikely that any labelling standard could address all dietary requirements, and the ultimate solution would be to eliminate animal-derived products where possible from medications.”
Jayne Lawrence, Royal Pharmaceutical Society science adviser, said: “Transparency of information about medicines is vital for patients and professionals. We would welcome information from manufacturers being included in the patient information leaflet so that individuals can make an informed choice about their medicines.”
A statement from the MHRA, published alongside the BMJ analysis piece, states: “There is no opportunity for the UK to act unilaterally in the area of medicines labelling so we cannot take our own action… . Although some ingredients are derived from animals, many of these are now also derived from plant sources. There is no requirement for a company to declare how an inactive ingredient is sourced at the time of licensing. Only information which is supported by the licence documents can be referenced in the labelling of a medicine.”
Analysis of 100 most commonly prescribed medicines
The researchers based their conclusions on their analysis of the 100 most commonly prescribed medicines in the UK in January 2013.
Of those, 74 contained lactose, gelatine or magnesium stearate.
Lactose was found in 59 medicines, of which 48 had associated public assessment reports. Of these, 10 did not indicate whether the medicine contained animal products. The remaining 38 reports mentioned animal product content but information about the method used for the production of lactose varied, with only eight declaring the use of calf rennet.
Magnesium stearate was found in 49 of the 100 products with the animal form declared in four products and the vegetarian form in 31. Some 14 products had no information on provenance, they found.
Gelatine was present in 20 of the medicines but two of the product assessment reports wrongly stated that there was no animal content and seven failed to mention animal product content, they say. Of the 11 that listed ingredients of animal origin, eight failed to specify which animal.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11133897
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