§ Mr. Ian StewartTo ask the Secretary of State for Health what assessment he has made of the present methods of reporting adverse reactions to vaccination; and if he will make a statement. [88806]
§ Ms JowellThe safety of medicines, including vaccines, in the United Kingdom is continuously monitored by the Committee on Safety of Medicines (CSM) and the Medicines Control Agency (MCA). Various data sources are used including spontaneously reported adverse drug reactions (ADRs), company produced periodic safety update reports, clinical trials and epidemiological studies such as the recent North Thames study on MMR vaccine.
Under the UK spontaneous reporting (Yellow Card) Scheme, doctors, dentists, hospital pharmacists and coroners may report adverse drug reactions to the CSM and MCA. Pharmaceutical companies have a statutory obligation to report suspected adverse reactions received world wide in relation to their products.
The Yellow Card Scheme is regularly reviewed by the MCA and CSM and initiatives are undertaken to strengthen reporting when necessary.
The reporting of suspected ADRs to vaccines through the Yellow Card Scheme was specifically reviewed by the MCA and CSM in 1997.