Problems with Causality Assessment Criteria for Individual Case Safety Reports

摘要

The purpose of this study was to clarify the causality assessment information items necessary to improve the usefulness of individual case safety reports (ICSRs) from medical facilities as adverse drug reaction (ADR) information. To do this, we investigated standard causality assessment items used by pharmaceutical companies. The number of the companies responding was 76, 93.8% of all Japan Pharmaceutical Manufacturers Association (JPMA) member companies. We found that the use of algorithms for causality assessment, the grades and expressions used to describe causality, and criteria for determining whether reactions were ADRs or not varied among the companies as well as their divisions (whether they conducted clinical trials or post-marketing surveillance). Having such a variety of assessment criteria is inconvenient for the reporters who have to judge it and also lowers the validity of judgments. It also hampers the overall assessment of ADR information and may cause great differences in ADR frequencies. We therefore feel that it is desirable to agree on international criteria for causality assessment as soon as possible.