Yellow Card Scheme

HC Deb 12 July 2002 vol 388 cc1264-5W

Dr. Murrison

To ask the Secretary of State for Health how many(a) adverse incidents and (b) deaths have been reported under the yellow card scheme since 1997 involving (i) proprietary analgesics, (ii) aspirin-based products, (iii) paracetamol-based products, (iv) non-steroidal anti-inflammatory drug-based products and (v) anti-histamines. [67424]

Mr. Lammy

Reports of suspected adverse drug reactions (ADRs) to medicines are collected by the Medicines Control Agency (MCA) and the Committee on Safety of Medicines (CSM) through the spontaneous reporting scheme, the yellow card scheme.

The number of suspected ADR reports including reports with a fatal outcome received via the yellow card scheme from 1 January 1997 to 4 July 2002 for aspirin-based products, paracetamol-based products, non-steroidal anti-inflammatory drug (NSAID) based products and anti-histamines are provided in the following table.

	No. of ADR reports	No. of reports with a fatal outcome
Aspirin-based products	572	41
Paracetamol-based products	368	38
NSAID-based products	7833	256
Anti-histamines	1039	19

Proprietary analgesics are difficult to define as a group and include aspirin-based, paracetamol-based and NSAID based products, the data for which are provided in the table above. These data should be seen in the context of the very wide usage of these drugs with millions of patients being treated every year in the United Kingdom.

It is important to note that submission of a suspected ADR report does not necessarily mean that it was caused by the drug. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication and the underlying disease.

Data from the yellow card scheme cannot be used to measure the frequency of an adverse reaction as it is associated with a degree of underreporting which varies between different medicines.

The MCA/CSM has provided guidance on safe prescribing of NSAIDs to health professionals in 1994 and most recently in April 2002.