Review of Access to Yellow Card Data
Room 14-111 Market Towers 1 Nine Elms Lane London SW8 5NQ
INDEPENDENT REVIEW OF ACCESS TO YELLOW CARD DATA: LETTER TO STAKEHOLDERS
6 October 2003
Independent Review of Access to Yellow Card Data
This letter is addressed to all the organisations and individuals who have an interest in the collection and analysis of data on suspected adverse drug reactions (Yellow Card data). The Terms of Reference for the Review are attached at A and were announced by Lord Warner on 21st July. We would welcome all views.
Since 1964, the "Yellow Card Scheme" has been collecting information on suspected adverse drug reactions to medicines in the UK from health professionals (see Annex B). The Scheme is the cornerstone of medicines safety monitoring and has been used by the Medicines and Healthcare products Regulatory Agency (MHRA) and its predecessors, and its expert advisory body, the Committee on Safety of Medicines, as a key tool to protect public health. The Scheme provides a system for both the early detection of emerging drug safety hazards and the routine monitoring of all medicines in clinical use.
It is vital that any change in access to the Yellow Card data should not damage the Schemes ability to protect public health by discouraging reporters on whose continued support the Scheme is entirely dependent.
A short account of the Yellow Card Scheme is attached at C to provide background.
The primary purpose of the Review of Access to Yellow Card data is to consider whether, and if so under what conditions and for what purposes, the data should be made more widely available. It has been stimulated in part by increasing numbers of requests by independent researchers in academia and clinical institutions, who wish to use the data for research and audit purposes and in part by the potential for new uses, e.g. in researching the use of genetics to reduce the burden of adverse drug reactions. Other aspects of the Scheme will be considered during the Review.
Each event reported through the Yellow Card Scheme relates to what happened to an individual patient, who may or may not know that his/her experience has been reported. Although the Yellow Cards have been anonymised since 2000 (and earlier reports have been anonymised retrospectively), widening the access to these data poses questions of patient confidentiality, ethics and the law that need to be carefully considered against the potential benefits to patient safety, public health and other improvements.
The Steering Committee for the Review, whose membership is attached at D, would welcome your comments on the following issues:
Should data submitted in confidence to MHRA/CSM be made more widely available for uses outside monitoring and control of medicines safety?
What are the implications for patient safety, public health and the future of the Scheme of widening access to data or changing the reporting procedures?
What are the ethical issues raised in offering wider access to use of Yellow Card data?
If the data were to be used for research, how should the ethics of individual research proposals be evaluated?
Should research be permitted with or without the agreement of the patient whose suspected adverse event has been reported?
Should research that includes genetic information or analysis be permitted?
Controls on use of Yellow Card Data
What safeguards are required to ensure use of the data is likely to promote public health?
Should aggregated data be made available to NHS trusts/primary care trusts for their use? If so, in what form and for what purposes?
Conditions on access
If these data are to be more widely available to researchers external to the MHRA, what conditions of access [ethical/financial/potential impact on public health] should be applied?
Should data from the Yellow Card Scheme be made available for direct or indirect financial gain?
Does the existing legal framework sufficiently protect data subjects and reporters or in any way inhibit the reporting of adverse drug reactions?
If so what changes are required for improvement?
As the Government has a statutory responsibility to have such a scheme in place, how should financial consequences of wider access to data be addressed?
What are the operational implications of wider access e.g. for the maintenance of the database and its continued utility for drug safety monitoring?
What implications might changes to the use of the data have on reporting to the scheme?
Strengthening of the Yellow Card Scheme
How might the reporting Scheme better promote and protect public health if changes are made to access to the data?
How might the reporting Scheme be strengthened?
Any other issues
Are there any other issues we need to consider in the context of altered access to the Yellow Card data?
Please do share this letter with anyone who you feel may have an interest in this area.
Your response and those of all stakeholders interested in the issues raised by altered access to Yellow Card data will be welcomed by the Steering Committee for the Review. Responses should be sent to the above address by 9 January 2004.
To help informed debate on the issues raised by this consultation exercise, and within the terms of the Code of Practice on Access to Government Information (Open Government), the agency intends to make copies of comments received publicly available. Unless you state otherwise we will assume that you have no objections to your comments being publicly available.
Dr Jeremy Metters CB
On behalf of the Steering Committee for the Review
INDEPENDENT REVIEW OF ACCESS TO YELLOW CARD DATA
Membership of the Steering and Advisory Committee assisting Dr Jeremy Metters in running the Review and in preparing the report from it.
Professor Gordon W Duff
Dr Simon Thomas
Mr Philip Webb
Dr Sandy Thomas
Dr Jane Richards OBE
Mr Simon Williams
Professor Christine Bond
Ms Kirstin McCarthy
INDEPENDENT REVIEW OF ACCESS TO YELLOW CARD DATA
The terms of reference for the review are, taking into account the role the Yellow Card Scheme has played in protecting public health since it was set up in 1964 and with potential for strengthening this role in future, to;-
1. identify and describe the range of issues which should be considered when considering access to data generated by the Yellow Card Scheme including
statutory (including open Government/FOI).
identify relevant stakeholders to the Scheme and to define how such interests arise.
consider in what circumstances access to the data generated by the scheme could be said to be in the public interest and the extent to which this falls within existing legal provisions.
make proposals for guiding principles for handling such requests and
make recommendations for action.
The Review should report to the Chairman of the MHRA by the end of 2003.