The Pharmaceutical Journal
27 JUL 2007

People have a right to know if their medicines contain animal ingredients

Recently, the presence of rennet, a product from calves’ stomachs, in confectionery was highlighted when vegetarians pressured Masterfoods into reversing its decision to use it in Mars Bars.

The use of animal ingredients in medicines is far less talked about but it is a major problem for the five million people in the UK who avoid some or all animal products for reasons of faith, ethics or allergy. With the advent of legislation such as the Equality Act 2006 there is mounting concern that the ethical, spiritual and dietary needs of these groups should be properly recognised and addressed in respect of all goods and services, including those offered by the pharmaceutical and medical sectors.

The Act will see the establishment of The Equality Commission in October, but the Department of Health is ahead of the game — it has already appointed a director of equality and human rights, Surinder Sharma, to ensure that it meets the requirements of the new legislation. This is particularly important considering that many medical goods and services are of necessity and are provided when the receiver is at his or her most vulnerable.

Vitamin K injection is a prime example. The injection, which is routinely administered to newborn babies to prevent haemorraghic disease of the newborn, used to be free of ingredients derived from animals but the formula was recently changed to include a substance derived from bovine bile, making it unsuitable for Buddhists, Hindus, Jains, Sikhs, vegetarians and vegans, to name but a few.

Neither the change in composition nor the availability of any alternative was properly publicised and, as a result, many babies have been, and continue to be, injected with cow products without their parents’ knowledge or consent.

A plant-based alternative is available on a named patient basis but most health care staff seem to be unaware of this. (Admittedly, this product is currently supplied in a gelatine capsule, but the manufacturer has expressed willingness to change this.)

Gelatine is commonly encountered in medicines. Derived from animal collagen (mainly porcine and bovine), it is used in the preparation of pastes, pastilles, suppositories and capsule shells, immediately rendering these products unacceptable to many vegetarians. An intravenous infusion is also used as a plasma volume expander. In addition, some over-the-counter aspirin and antacid preparations contain lactose or non-plant stearates, used to enhance the production of the tablets. Often this is only mentioned in the small print on the leaflet within the packaging and some people find themselves unwittingly consuming substances that they would find unacceptable.

Moreover, many pharmacists are unable to identify reliably which products do not include these ingredients. For equality and respect for the rights of others to be increased there needs to be change from the bottom up. Pharmacists and other health care workers need to be aware that some substances may be unacceptable to certain people, and they need to be well informed about which products contain these substances and if there are any alternatives.

In addition, the pharmaceutical industry must highlight the presence of all animal ingredients as clearly as is required of the food industry. For example, medicines could be labelled “suitable for vegetarians”. This would remove the need for people to read every ingredient in a medicine and to work out if it is of animal origin.

“The Vegetarian Society would welcome any initiative that facilitates the choice of vegetarian patients and customers. The society urges the medical profession to take into account vegetarians’ beliefs as far as is practicable when prescribing medicines,” said Chris Olivant, information manager at the Vegetarian Society.

There is a great deal to be done. After two years of knocking on doors in the pharmaceutical industry, a breakthrough came when Mr Sharma hosted a meeting between various stakeholders, including Hindu and Jain representatives and members of the procurement and pharmaceutical sectors of the health service.

The meeting, in March, identified the enormous scale of the problem facing thousands of patients and health care workers every day, and the need for better information at every point in the chain between producer and consumer, including consultations with a health care professional and the dispensing and sale of medicines. As well as informing patients and customers, pharmacists could play a crucial role in informing procurers and other health care professionals.

A further meeting, held in May, was attended by representatives from the Association of the British Pharmaceutical Industry, the Medicines and Healthcare products Regulatory Agency, and drug companies, like Wyeth Research. The purpose of the meeting was to:

• Inform and highlight the issue of medicines containing animal products to the pharmaceutical industry
• Hear the pharmaceutical industry’s views and concerns about producing viable animal-free medicines
• See how the NHS can produce a best practice policy to inform vegetarian and vegan patients about the contents of medicines and of alternatives available

Industry representatives were concerned about the cost factors involved but also highlighted that substituting an animal ingredient could alter the potency of a formulation. However, as a result of the meeting, Richard Barker, director general of the ABPI, promised to highlight the issue at all levels of the industry. It was also agreed that pharmacists have a key role to play in helping industry to understand and meet the needs of patients in our modern, multicultural world. Mr Sharma undertook to look into producing a good practice guide for all hospitals.

Good relationships between pharmacists, consumers and health care staff are of paramount importance in giving information about ingredients that might be unacceptable to particular individuals and what the alternatives are. Equally important is a reliable flow of accurate information from the industry to pharmacists, pointing out any changes in formulation and any ingredients that may pose a problem.
On a wider scale, the medical establishment, as well as the NHS, must take the cultural, religious and dietary practices of clients into account when prescribing medicines, in the same way that these are taken into account when food is provided in hospitals. Of course, in terms of medicines, there may not always be alternatives to offer, but it is a matter of ensuring that patients have the necessary information to give informed consent to taking a medicine.

With co-operation and goodwill solutions can be found and put into practice. I hope that everyone involved in producing, purchasing, prescribing, supplying and administering medicines will take on board our concerns and that a code of good practice can be put in place as soon as possible.

Nitin Mehta MBE