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Chapter: Pharmacovigilance: Spontaneous Reporting - UK

The public health importance of controls on the safety of medicines was dramatically brought to the attention of the public in the early 1960s by the thalidomide tragedy.



The public health importance of controls on the safety of medicines was dramatically brought to the attention of the public in the early 1960s by the thalidomide tragedy. In the wake of this tragedy, many countries introduced systems for the systematic collection of reports of adverse drug reactions. In the United Kingdom, the Committee on Safety of Drugs (subsequently the Committee on Safety of Medicines (CSM) and now the Commission on Human Medicines (CHM) was set up. One of the responsibilities of this new committee was to collect and disseminate information relating to suspected adverse effects of drugs (Griffin, 1992). To address this objective, the United Kingdom’s spontaneous reporting Scheme was introduced in 1964, when Sir Derrick Dunlop (the chairman of the Committee on Safety of Drugs) wrote to all doctors and dentists in the United Kingdom to announce the launch of the new Scheme (Griffin and Weber, 1992).

In his landmark letter, Sir Derrick asked ‘every member of the medical/dental profession in the United Kingdom’ to report ‘promptly details of any untoward condition in a patient which might be the result of drug treatment’ and stated that ‘All the reports or replies that the Committee receive from doctors/dentists will be treated with complete professional confidence by the Committee and their staff.’

This established four key principles of the Scheme, namely:

1. Suspected adverse reactions should be reported; reporters do not need to be certain or to prove that the drug caused the reaction.

2. It is the responsibility of all doctors and dentists to report.

3. Reporters should report without delay.

4. Reports could be made and would be treated in confidence.

Reports were to be made on specially provided yellow reporting forms, a supply of which was provided with Sir Derrick’s letter. The significance of the yellow colour of the card is probably no more than that there was by coincidence a large supply of yellow paper unutilised at that time; however, as a result, the Scheme has come to be known as the Yellow Card Scheme. In almost 40 years since the introduc-tion of this Scheme, the design of the reporting form has changed progressively, to include guidelines on reporting and to ask for additional specific pieces of information (e.g. Lawson, 1990; Griffin and Weber, 1992; Anon, 2000a). Reports are also received via the pharmaceutical industry, which has a statutory obli-gation to report suspected adverse reactions (Waller, Coulson and Wood, 1996). The CHM continues to be responsible for the Yellow Card Scheme, which is run on the Commission’s behalf by the MHRA, using a specialised database to facilitate rapid processing and analysis of reports and detection of signals of drug safety hazards. Four Regional Monitoring Centres (RMCs), introduced in the 1980s, provide valuable support for the running of the Scheme in Merseyside, the Northern region, Wales and the West Midlands (e.g. Houghton et al., 1996). A fifth RMC was opened in Scotland in October 2002 and the Northern RMC expanded its activities into Yorkshire in the Septem-ber of the same year. The RMCs are now known as Yellow Card Centres.

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