Yellow Card Scheme

Voluntary adverse reactions reporting system the yellow card scheme ... 

This spontaneous adverse reaction reporting system was the brainchild of Professor Leslie Witts and was, and still is, based upon the submission of ADR reports by doctors and dentists by means of reply-paid yellow cards, and hence it is popularly known as the Yellow Card Scheme. ... 

By 1965, the value of the Yellow Card Scheme was clearly established and two other countries had introduced a similar scheme. By the beginning of 1967, the Committee was also cooperating in the WHO s Pilot Study on the Monitoring of ADRs at an international level. By the end of 1968, a total of 10 countries were participating in this Pilot Study. This study matured into the international WHO ADR Monitoring Centre based in Uppsala (Sweden), with a membership that now stands at 67 coimtries with six others enjo)dng associate status. 

The Yellow Card Scheme was soon beginning to pay dividends. In early 1966, the YeUow Card Scheme had identified methyldopa as a cause of haemolytic anaemia and an appropriate advice was issued. Another success was the detection of a faulty batch of a particular product, which the manufacturer immediately withdrew, underlining the value of an efficient procedure for tracing a batch. During June 1967, the Committee distributed a leaflet on the use of aerosols in asthma. This was prompted by the death rate amongst asthmatic patients aged 5 to 34 years that had risen some 300% above the level in 1959-60 when such preparations were introduced. By September 1968, the rate had dropped to only 50% above that seen in 1959-60 despite sales having dropped only 20%. 

The Yellow Card Scheme, at first restricted to receive reports from doctors, dentists and coroners, has been gradually expanded to receive reports from other sources. From October 1996, the Scheme was extended to include reporting of suspected adverse reactions to unlicensed herbal remedies. In April 1997, the Yellow Card Scheme was further extended to include hospital pharmacists as recognised reporters of suspected ADRs. In addition, there are specially targeted extensions of the Scheme such as adverse reactions to HIV medicines and adverse reactions in children. Over the period, the Scheme has been gradually extended further to receive reports from community pharmacists and in October 2002, from nurses, midwives and health visitors. 

On 4 May 2004, the CSM/MHRA celebrated fortieth anniversary of the Yellow Card Scheme. 

In a 5-year toxicological study of traditional remedies and food supplements carried out by the Medical Toxicology Unit at Guy s and St. Thomas Hospital, London, 1297 symptomatic enquiries by medical professionals were evaluated (28). Of these, an association was considered to have been confirmed, probable, or possible in 12, 35, and 738 cases respectively. Ten of the confirmed cases were related to Chinese or Indian herbal remedies. As a result of these findings, in October 1996 the UK Committee on Safety of Medicines extended its yellow card scheme for adverse drug reaction reporting to include unhcensed herbal remedies, which are marketed mostly as food supplements in the UK (the scheme had always apphed to hcensed herbal medicines) (29,30). This was an important milestone in herbal pharmacovigilance. 

Anonymous. Extension of the Yellow Card scheme to unlicensed herbal remedies. Curr Prob Pharmacovig 1996 22 10. 

The availability of additional data The first year after launch can be a difficult time as very few of the important data sources are fully functional apart from the yellow card scheme. Thus, the Medical Department needs to monitor the Drug Analysis Print very carefully and review... 

Yellow Card Scheme The UK national spontaneous ADR reporting scheme (see p. 5). 

Medicines and Healthcare Products Regulatory Agency (2009) Yellow Card Scheme First Anniversary for Patient Reporting - Reports from the Public Up 50%, Medicines and Healthcare Products Regulatory Agency, London. 

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