§ Mr. EtheringtonTo ask the Secretary of State for Health what plans he has to review the operation of the Yellow Card Scheme. [86156]
§ Ms JowellThe Yellow Card Scheme is run on a day-to-day basis by the Medicines Control Agency (MCA) on behalf of the Committee on Safety of Medicines (CSM), the expert advisory committee to the Licensing Authority, which has responsibilities under the Medicines Act 1986 for the promotion of collection and investigation of information relating to adverse reactions (ADRs).
The MCA and the CSM regularly review all aspects of Yellow Card Scheme including:
- 1. The number of reports received, trends in reporting, the source of reports and their quality.
- 2. The proportion of serious adverse drug reactions compared to non serious and by reporting group.
- 3. The recent extension of the Yellow Card Scheme to include hospital pharmacists as reporters and the inclusion of community pharmacists later this year.
- 4. The progress of special reporting initiatives such as:
- i. The HIV Adverse Drug Reaction Reporting Scheme.
- ii. Pilot schemes for extending the Yellow Card Scheme to include nurses and to investigate reporting of suspected ADRs in children.
- iii. Development of electronic Yellow Cards.
- 5. Feedback from focus groups investigating GPs perceptions about the Yellow Card Scheme and how it might be improved.
- 6. Providing feedback to reporters in regular bulletins such as "Current Problems in Pharmacovigilance".
The work of activities of the four MCA/CSM Regional Monitoring Centres in Merseyside, Northern Region, Wales and the West Midlands is reviewed at an annual meeting with the MCA.
§ Mr. EtheringtonTo ask the Secretary of State for Health how many Yellow Card Scheme reports since 1989 have been received by the Medicines Control Agency regarding adverse reaction to metrizamide/myodil; and if he will make a statement. [86158]
§ Ms JowellThe total number of suspected adverse drug reaction reports for reactions to metrizamide and myodil received under the United Kingdom spontaneous reporting scheme (Yellow Card Scheme) for the period from 1 January 1989 was none and 8 respectively. It should be noted that some of these reactions have been reported retrospectively and were reported to have occurred between 1972–1989.