Clinical assessment
Manual in-depth assessment of case reports and series is used to determine if an identified suspected adverse drug reaction is causally related to a medicinal product.
Medicine–adverse effect combinations needing in-depth assessment are reviewed by UMC's signal team in consultation with external clinical experts to assess the seriousness and impact of the suspected side effect on public health and prioritise combinations for in-depth assessment.
Typically, more than one case report is required to identify a safety signal, resulting in the necessity to assess case series describing the same adverse event. For causality assessment of multiple case reports, UMC uses the Bradford Hill criteria for causation, developed by Sir Austin Bradford Hill in 1965. Once reports on suspected side effects have been individually assessed and summarised, and the scientific literature reviewed for additional evidence, a decision is made whether the strength of the case indicates that a signal should be formulated and communicated.
The WHO-UMC system for causality assessment of single case reports has been developed in consultation with the WHO PIDM and is meant as a practical tool for the assessment of case reports – taking into account the clinical-pharmacological aspects of the case history and the quality of the documentation of the observation.