Approach to Publishing Adverse Event Case Reports in Biomedical Journals

摘要

Case reports describing suspected adverse events of drugs and medical products are important for post-marketing safety monitoring. Such reports could help identify potential product-associated risks and serve as signals of possible events that may require further studies. They also serve as legal documents and have been used as evidence in “toxic tort” litigation. Lack of relevant details in the reports would render them of limited value and misleading. Deficiencies in the previously published adverse event case reports in some biomedical journals from developing countries clearly illustrate a need for guidelines. A properly documented report should provide details to enable readers make differential diagnoses, ascertain the causality of the reaction to the suspected drug, and provide pharmacological and biological explanations for the reaction. Authors should also report the suspected events to the National Pharmacovigilance Centre to ensure their inclusion in adverse drug reaction databases. Reviewers and journal editors should be well familiar with adverse drug event reporting guidelines to enable them weed out junk manuscripts. It would seem reasonable to include such guidelines in the instructions for authors, should a journal continue to publish case reports of adverse drug events.