§ Mr. BurstowTo ask the Secretary of State for Health what percentage of adverse drug reactions he estimates are reported; and if he will make a statement. [163493]
§ Ms Rosie WintertonIn the United Kingdom, the yellow card scheme allows health professionals to report suspected adverse drug reactions (ADRs) on a248W voluntary basis to the Medicines and Healthcare products Regulatory Agency (MHRA) and the Committee on Safety of Medicines (CSM). There is a legal requirement for companies to report suspected ADRs to their drugs.
All voluntary reporting systems suffer from under-reporting. The proportion of suspected adverse drug reactions, which are reported, is very variable. Under reporting is thought to occur less frequently with newly identified, serious and unlabelled reactions (those reactions which are not yet included in the product information).
Studies in UK hospitals (Smith et al 1996) and general practice settings (Martin et al 1998, Heeley et al 2001) have estimated that around five to ten per cent. of all suspected adverse drug reactions experienced by patients are reported to CSM and MHRA through the yellow card scheme. The study in general practice carried out by Heeley et al (2001) combined serious and non-serious ADRs in this estimate of under reporting of ADRs. This study also provided a breakdown of the estimates of under-reporting of reactions classified as serious or non-serious and labelled or unlabelled, and estimated that general practitioners report between 30 and 50 per cent. of serious unlabelled adverse reactions to CSM and MHRA via the yellow card scheme.
Under-reporting does not necessarily detract from the ability of drug safety monitoring systems to identify new and important drug safety hazards. The MHRA and CSM are continually working to increase the quality and quantity of reports received via the Yellow Card Scheme in order to increase the potential for rapid identification of new drug safety hazards.
References:
Heeley E, Riley J, Layton D, Wilton RV and Shakir S (2001) Prescription event monitoring and reporting of adverse drug reactions' Lancet 358: 1872–1873
Martin RM, Kapoor K V, Wilton LV and Mann RD (1998) 'Underreporting of suspected adverse drug reactions to newly marketed ("black triangle") drugs in general practice: observational study' BM 1 317:119–120
Smith CC, Bennett PM, Pearce HM, Harrison PI, Reynolds DJ M, Aronson JK, Grahame-Smith DG (1996) 'Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines' British Journal of Clinical Pharmacology 42 (4): 423–429