Adverse Drug Reactions (Hansard, 29 February 2000)

§ The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath)

The Yellow Card Scheme provides for voluntary reporting of suspected adverse drug reactions (ADRs) by general practitioners, hospital doctors, dentists, coroners and pharmacists. The Medicines Control Agency (MCA) receives approximately 17,000–18,000 United Kingdom reports of suspected adverse reactions to all medicines each year, of which 55 per cent are serious and 3 per cent are fatal. A report of a suspected reaction does not necessarily mean that it was caused by the medicine. As the scheme is voluntary, not all adverse reactions are reported.

The Yellow Card Scheme was extended to include unlicensed herbal remedies in October 1996. Since then the MCA/Committee on Safety of Medicines (CSM) has received 119 serious reports of ADRs associated with the use of herbal remedies, 55 of which are for unlicensed remedies. None was fatal.

In the same period, 209 reports of serious ADRs associated with vitamin and mineral supplements (excluding injectable supplements) were received through the Yellow Card Scheme, 11 of which were fatal. These fatal reports are confounded by a number of factors including underlying conditions and other medicines. There is no system to record adverse reactions and deaths from food supplements.

Suspected adverse drug reactions reported to the CSM are recorded according to the active drug substance and reports for homoeopathic medicines are not specifically identified as such. It is therefore not possible to provide a list of reported ADRs to homoeopathic medicines.

Herbal medicines, homoeopathic medicines and vitamin and mineral supplements are often supplied without prescription and are not taken on the advice of a doctor or pharmacist, practitioners capable of submitting Yellow Card reports. It is generally recognised that the reporting rate for medicines supplied over the counter is lower than that of suspected adverse reactions associated with prescription medicines. Therefore, data obtained on suspected adverse reactions associated with herbal medicines, homoeopathic medicines and vitamin and mineral supplements through the Yellow Card Scheme cannot be directly compared to reporting for licensed pharmaceutical medicines.