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Keywords:

  • adverse drug reactions;
  • pharmacoepidemiology;
  • spontaneous reporting;
  • yellow card scheme;
  • prescription event monitoring

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.