United Kingdom adverse drug reactions

Where a clinical trial was proposed with a marketed product then the CTMP scheme could be used. This was a streamlined process based on the fact that there were no quality issues with a product that had already been granted a marketing authorisation. The applicant submitted a copy of the trial protocol, provided information on the investigators and, depending on whether or not the applicant was the MAH, information on the procedures for reporting adverse drug reactions. It was only possible to use this procedure for UK marketed products. It did not apply to unauthorised products manufactured specifically for trial or to products, which were licensed only in countries other than the United Kingdom. 

Belton KJ, Lewis SC, Payne S, Rawlins M. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol 1995 39 223-6. 

The benzodiazepine drug, triazolam, is used to treat severe insonmia. With the risk of psychiatric adverse drug reactions, it has been withdrawn from the United Kingdom, however, it is still marketed in the United States. 

In the United Kingdom, the present yellow card system had its origins in 1965, when Witts, who was then a member of the Committee on Safety of Drugs (the precursor to the CSM), published a method for the collection of suspected adverse reactions to drugs. 

In March of 2002, Public Citizen filed a petition calling for the FDA to ban Meridia. Public Citizen quoted from FDA documents that showed that use of sibutramine was allegedly associated with 29 deaths and 400 adverse medical reactions. Those incidents occurred throughout the world, and Italy had banned the drug. The issue was also being studied by the United Kingdom, which banned phentermine in 2000. The ban was prompted by concern that it could cause heart disease. 

The spontaneous adverse reaction reporting system in the United Kingdom is based on the submission of ADR reports by doctors and dentists by means of reply-paid yellow cards . The system was introduced in 1964 by Professor Witts, the first chairman of the Adverse Reactions Subcommittee of the original Committee on Safety of Drugs (CSD). The system has continued unchanged to the present time, and the number of reports and fatal reactions each year of the scheme s operation is shown in Table 33.3. 

Black triangle drugs are those recently licensed and still being monitored for adverse reactions unlicensed medicines are those not licensed in the United Kingdom.)... 

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