Prescribed Drugs (Hansard, 20 May 2002)

§ Ms Blears

[holding answer 14 May 2002]A recent pilot study conducted in Liverpool has investigated the frequency of adverse drug reaction-related hospital admissions. The findings of this study suggest that the proportion of such reactions has not altered significantly in the last decade; that is, around 5.5 per cent. of all hospital admissions are due to adverse drug reactions156W (ADRs). A follow-up study is anticipated which should identify areas in which prescribing issues and practices should be addressed in order to reduce the incidence of ADRs in the United Kingdom.

The ADRs observed during the pilot study were subsequently submitted via the Yellow Card Scheme to the Medicines Control Agency, which is responsible for monitoring the safety of all marketed medicines to ensure that medicines meet acceptable standards of safety and efficacy. Spontaneous reporting schemes, such as the UK's Yellow Card Scheme which has been in operation since 1964, are one of the primary tools used in monitoring drug safety and provide an 'early warning' of previously unrecognised drug safety hazards in association with medicines.

The Committee on Safety of Medicines/Medicines Control Agency receive reports of suspected ADRs from doctors, dentists, pharmacists and coroners and there is a legal requirement for companies to report suspected ADRs to their drugs. Approximately 18,000–19,000 suspected ADR reports are received each year via this scheme. The number of reports received via the Yellow Card Scheme does not directly equate to the number of people who suffer adverse reactions to drugs for a number of reasons, as this scheme is associated with an unknown level of under reporting. It is important to note that the reporting of a reaction does not necessarily mean it was caused by the drug and may relate to other factors such as the patient's underlying illness or other medicines taken concurrently.

Over the last 20 years, suspected ADRs submitted via the Yellow Card Scheme with a fatal outcome account for less than 3 per cent. of these reports. The Office for National Statistics also collates data on deaths certified by doctors and coroners as due to adverse effects of drugs in therapeutic use. The quality of these data may be inconsistent as many thousands of doctors write certificates with a wide variation in knowledge, training and practice. In 2000 a total of 159 deaths were certified as due to adverse effects of drugs in therapeutic use.