Suspected Adverse Reactions Reporting Scheme

The Suspected Adverse Reactions Reporting Scheme - United Kingdom... 

A. Gray, Suspected Adverse Reaction Surveillance Scheme (SARRS). 1990 report. Vet. Rec., 1991, 129, 62-65. 

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. 

The numbers of adverse reactions in humans reported to the VMD is shown in Figure 15.1 for the period 1985 to 2010. The increase in reactions in the early 1990s is probably due to a number of factors including the greater publicity given to the scheme and to its applicability to human adverse reactions. In addition, at about the same time, there was an increased interest in a specific topic, namely suspected adverse reactions to organophosphorus-containing sheep dips, and the numbers of reports for these rose dramatically. This will be discussed later in this chapter. 

Veterinary Products Committee (VPC), Appraisal Panel for Human Suspected Adverse Reactions to Veterinary Medicines. Report of Human Suspected Adverse Reactions Received by the Veterinary Medicines Directorate from 1985 2001 and Findings of the Appraisal Panel from Meetings in 2001, Veterinary Medicines Directorate, Addlestone, 2002. K. N. Woodward, Veterinary Pharmacovigilance. Part 2. Veterinary pharmacovigilance in practice - the operation of a spontaneous reporting scheme in a European Union country - the UK, and schemes in other countries, J. Vet. Pharmacol. Ther., 2005, 28, 149-170. 

The ramifications of the thalidomide tragedy were many-fold but the key lesson for the development of pharmacovigilance was that active systems for detecting hazards are needed. Within a few years this had been taken forward with the introduction of voluntary (or spontaneous ) schemes for reporting of suspected adverse drug reactions (ADRs). These have stood the test of time as an alerting mechanism or early warning system and wiU be covered in more detail in Chapter 3. 

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