Designing a spontaneous adverse drug reaction reporting form: An exercise for medical students

摘要

Spontaneous adverse drug reaction (ADR) reporting schemes have been a major source of information in pharmacovigilance [6]. Spontaneous reporting can prevent new medicine tragedies from developing and can improve the labeling of many effective pharmaceutical products [2,9]. However, spontaneous reporting schemes are associated with relatively low levels of reporting. It is likely that less than 10% of serious reactions are notified. Problems of motivating reporters, commitment, lack of clarity about what should be reported and fear of recrimination for errors may be some of the factors responsible. The scheme operates on the basis of reporting all ADRs despite uncertainty about a causal relationship [5].