Evaluation of Published Case Reports’ Standards and Notification

Purpose. Pharmaceutical postmarketing surveillance includes evaluation of reported adverse events and published case reports. We sought to evaluate the quality of case reports and the notification patterns of these reports. Methodology. Case reports entered into our safety database were evaluated for data completeness, and to determine whether the case was reported prior to publication. In addition, we reviewed authors’ instructions for the 10 most commonly cited medical journals. Results. Two hundred eighty-four case reports were identified. Forty-five percent of these reports had complete data. The company was notified prior to publication 24% of the time. Few of the most commonly cited medical publications provided guidance on case report content or notification. Discussion. Case reports often lack data necessary for thorough evaluation, and authors receive little guidance. Furthermore, drug manufacturers are seldom informed prior to case report publication. The guidelines from the Council for International Organizations of Medical Sciences (CIOMS) V Working Group provide a minimum a standard for writing and publishing case reports.