Report of an Independent Review of Access to the Yellow Card Scheme

Author:

Independent Steering Committee

Publisher:

TSO (The Stationery Office)

The Review was initiated by an increase in requests from outside the MHRA for access to Yellow Card data which raise major issues in relation to public health.

Since 1964, when the Yellow Card Scheme was initiated to collect reports of suspected adverse drug reactions (ADRs), the analysis of Yellow Card data has been undertaken almost entirely in house by the Medicines and Healthcare products Regulatory Agency (MHRA), and its predecessor organisations on behalf of its independent advisory committee, the Committee on Safety of Medicines (CSM).

The primary purpose is to consider the circumstances and conditions in which the MHRA should release data from the Scheme for independent research and public health purposes.

Other issues considered during the review include:

• The opening of the Scheme to reports from patients

• What can be done to improve the quality and frequency of ADR reporting rates

• What safeguards are necessary to protect patients and reporters while allowing maximum benefit to be achieved from use of the data .

Extent	124 Pages	ISBN	9780117034099
Size	A4	Price	£20.00
Format	Paperback	Published	04 May 2004
Availability	Out of Print: but may be available to order	Delivery	Delivery options and charges