Yellow Card system

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. 

Since then there have been many publications and reviews of the UK yellow card system and spontaneous reporting systems internationally.A summary of the capabilities and limitations of the method is given in Table 15.6. Although these have been discussed in the greatest detail over the past three decades, the obligations that exist for pharmaceutical companies in the reporting of adverse events to the regulatory authorities at both national and international levels make it essential to review them in this chapter. 

Systematic spontaneous reporting of possible drug caused adverse effects began with the Yellow card system in the UK in 1964. It was a medium for doctors to report their concerns on marketed drugs, thereby enhancing the limited pre-marketing clinical data on safety. Now 83 countries around the world have similar systems, and many warnings of adverse dmg reactions and some deletions from the market have been made on the basis of such reports. 

Voluntary reporting. Doctors, nurses and pharmacists are supplied with cards on which to record suspected adverse reaction to drugs. In the UK, this is called the Yellow Card system and the Committee on Safety of Medicines collates the results and advises the government s Medicines Control Agency. It is recommended that for ... 

A yellow card system exists which can be used by physicians, dentists cind pharmacists to report the adverse drug reactions (ADRs) that their patients are experiencing. Companies can also voluntarily communicate ADRs. Post-marketing surveillance in Belgium is regulated by the following laws ... 

Since then there have been many publications and reviews of the UK yellow card system and spontaneous reporting systems internationally. ... 

Healthcare professionals may report ADRs by telephone 1800 FDA 1088 Fax 800 FDA 0178 or maU Med Watch, 5600 Fishers Lane, Rockville, MD 20852-9787or through the Medwatch internet site www.fda.gov/ medwatch. Medwatch provides feedback to healthcare professionals though the FDA Medical Bulletin and the Medwatch home page (www.fda.gov/ medwatch). In Europe and other countries individual Ministries of Medicine may have a system in place such as Irelands yellow card system. One might also contact The World... 

Any adverse events that may be attributable to enoxaparin should be reported to the CSM using the yellow card system... 

Professor Ian K Wong qualified as a pharmacist in 1992. He worked at the former Medicines Control Agency on the Yellow Card system, at the David Lewis Centre for Epilepsy, Northwick Park Hospital and the University of Bradford. In 2002, Professor Wong set up the Centre for Paediatric Pharmacy Research in the School of Pharmacy, University of London, Great Ormond Street Hospital for Children and Institute of Child Health, University of London. His main research interests are paediatric drug safety and health service research. He was awarded a Department of Health Public Health Career Scientist Award in 2002 and Chemists and Druggists Pharmacy Practice Research Medal in 2004 for his research in paediatric medicines. 

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