Standardizing “Expectedness” and “Seriousness” for Adverse Experience Case Reporting

Recent harmonization initiatives have led to the idea of a core safety data sheet. Even with a single company statement, however, there can well be debate and sometimes discrepant views between personnel within an organization as to what the safety data mean. Such a nonstandardized company view can lead to the same adverse event (AE) case history being reported to some authorities and not to others, even when assessed against the same source reference document, or similar regulations.

The opportunity was, therefore, taken to informally survey views on some selected borderline AE cases from attendees at Drug Information Association (DIA) Safety Monitoring Workshops held in Europe and the United States. In addition, 22 physician monitors employed by either Glaxo or SmithKline Beecham Pharmaceuticals completed the exercise.

The results of the survey are analyzed and guidelines proposed. Whether or not the reader agrees with all of these suggestions, the authors recommend an agreed company position with regard to assessing “expectedness” and “seriousness.”