Adverse drug reactions are an important cause of serious illness and death. 1, 2 Yet we
become aware of new adverse events only very slowly, long after the drugs have been …

“If someone's on 10 different medications and they have a life-threatening skin reaction, the
person who is reading [the resulting report] has no idea which of those drugs might have …

The Committee in Safety of Drugs (CSD), chaired by the late Sir Derrick Dunlop was
established as a direct result of the thalidomide tragedy. In 1963-4 a medical secretariat was …

Post‐marketing surveillance of drugs in Australia operates predominantly through the
spontaneous reporting of suspected adverse drug reactions (ADRs). Approximately 50% of …

That was the message conveyed to more than 100 physicians and pharmaceutical industry
representatives at a recent seminar on postmarketing surveillance and adverse drug …

This chapter takes a practical look at the handling of post-marketing drug safety issues. The
process of handling such issues is shown in Figure 8.1, and this forms the basis on which …

The surveillance of adverse drug reactions (ADRs) is an unqualified must. However, the
optimal means of surveillance is still unclear. Although anecdotal reports are the backbone …

Pharmacovigilance is a social as well as a technical task. The production of data on new
adverse drug reactions (ADRs) depends on the reporting of problems by patients to their …

established. This system could be adapted for use in Canada, with a similar symbol
appearing in the Compendium of Pharmaceuticals and Specialties and on all promotional …

This paper provides an overview of the history of Canada's adverse drug reaction monitoring
program. The program's place within Health Canada is covered, as are development …