Tropical
Journal of Pharmaceutical Research, February 2011;
10(1):
3-9
Abstract
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.
Keywords:
Adverse drug
events, Reporting and publishing, Biomedical journals,
Developing countries