Prescription-Event and other forms of epidemiological monitoring of side-effects in the UK
N. Dunn and R. D. Mann
Drug Safety Research Unit, Bursledon Hall, Blundell Lane Southampton, SO31 1AA, UK and the Faculty of Medicine, Health and Biological Sciences, University of Southampton, Southampton, UK
Summary
The post-marketing surveillance (PMS) of drugs is necessary because of the limited size of the clinical safety database at the time of marketing. The principal hypothesis-generating methods of PMS are spontaneous reporting (e.g. the yellow card) and Prescription Event Monitoring. These methods are discussed in this chapter and certain basic pharmacoepidemiological issues that are relevant are briefly reviewed.
KEY WORDS - adverse drug reactions, pharmacoepidemiology, spontaneous reporting,yellow card scheme, prescription-event monitoring
