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Evaluation of causality
Individual level
Case Collection
Importance of Case definition (confirmation of diagnosis): CIOMS , MSSO Importance of quality Necessity: reported adverse event maybe related to concomitant medication or coexisting disease
biological plausibility
lack of alternative explanation - concomitant drug or disease typical adverse drug reaction (low background rate)
Explanatory culpability
Completeness Biological Balancing No a priori constraints
From Detection of New Adverse Drug Reactions Editor, MDB Stephens, JCC Talbot, PA Routledge, 4th edition
From Detection of New Adverse Drug Reactions Editor, MDB Stephens, JCC Talbot, PA Routledge, 4th edition
Probability of 3 cases occurring with 300,000 treated patients (Begaud et al, 1995)
One month Expected number Agranulocytosis TEN Guillain Barre Synd P of 3 cases One year Expected number P of 3 cases
0.0005
1.800
PRR AD/ BC
Signal (PRR >3) + (Chi -squared >5) +(Number of cases>3) Remains one aspect of causality assessment subject to usual biases inherent in spontaneous reporting (Waller 1998)
Causality classification at Pharmacovigilance centers in the European Community; Meyboom RHB and Royer RJ, Pharmacoepidemiology and Drug Safety , Vol 1: 87-97(1992)