Considerations on causality in pharmacovigilance.

摘要: Causality has been a topic of debate by philosophers, scientists, lawyers and for centuries. It is essential to define as precisely possible all steps in the logical chain events, since each may strengthen or confound an argument. Almost always there are issues missing conflicting data that need be addressed specifically. In pharmacovigilance, many other situations, not just one causation effect but several. Each must evaluated given context probability. There also likely causal events adverse under consideration, considered. individual patient diagnosis components history, clinical findings various laboratory test combined point probability patho-physiological diagnosis, which turn related causes with strength determined constellation findings. The established Bradford-Hill criteria valuable considering factors. Pharmacoepidemiology allows population incidences particular effects therefore provides priori listing competing causes, at least cause against background others control group. Since medicines generally rare, it exclude drug reliance on epidemiological evidence alone, only argue incidence below level statistical power, study studies combined. Other areas society concerned process inference, this especially true legal cases judgements made personal injury drugs.