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Prescription Drugs: Side Effects

Volume 468: debated on Thursday 29 November 2007

To ask the Secretary of State for Health how many patients in England (a) were admitted to hospital and (b) died because of a negative reaction to prescription drugs in each of the last three years. (167921)

Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission for Human Medicines (CHM) through the spontaneous reporting scheme, the yellow card scheme. Approximately 20,000 reports of ADRs are reported to the MHRA/CHM through this scheme each year. The scheme collects ADR reports from across the whole United Kingdom and includes all medicines, including those from prescriptions, over-the-counter or general retail sales. Reports are also received for herbal medicines and other unlicensed medicines.

The following table shows the number of UK suspected ADR reports received by the MHRA between 2004 and 2006 which have: had a fatal outcome; or resulted in or prolonged hospitalisation.

Year received by MHRA

Number of UK suspected ADR reports received which resulted in or prolonged hospitalisation

Number of UK suspected ADR reports received with a fatal outcome

Number of UK suspected ADR reports received which resulted in or prolonged hospitalisation and had a fatal outcome

2004

4,429

861

222

2005

4,579

1,021

220

2006

4,635

964

203

It is not possible to estimate from the yellow card scheme the number of people who suffer adverse reactions to drugs since the scheme is associated with an unknown level of under-reporting. In addition, it is important to note that the 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.