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The Pharmaceutical Journal
Vol 271 No 7270 p483
11 October 2003

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Independent review of access to yellow card data (Microsoft Word document)


Data confidentiality review starts for yellow card reporting scheme

A wide ranging review of the confidentiality of data on adverse drug reactions (ADRs) held by the Medicines and Healthcare products Regulatory Agency has begun (PJ, 26 July, p110).

The aim of the review, led by Dr Jeremy Metters, a former Department of Health deputy chief medical officer, is to consider whether ADR data can be made more widely available and, if so, for what purposes and under what conditions. It has been prompted partly by increasing numbers of requests for access to ADR data by researchers in academic and clinical institutions. There is also potential for the data to be used for researching any genetic basis for ADRs that could result in their reduction.

A concern that the review intends to address is how to guarantee that increasing access to the data does not reduce ADR notifications, and thus put public health at risk because contributors become concerned about potential breaches of confidentiality.

Comments can be sent to
Review of Access to Yellow Card Data
Room 14-111, Market Towers
1 Nine Elms Lane
London SW8 5NQ

until 9 January 2004.

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