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Published on: September 20, 2018
Guidelines for submitting adverse event reports for publication
William N Kelly1, Felix M Arellano, Joanne Barnes
1William N. Kelly Consulting, Inc., Oldsmar, Florida 34677, USA. wnkelly@earthlink.net
Drug Safety
|May 3, 2007
Summary
Publishing adverse event case reports is crucial for postmarketing surveillance. New guidelines aim to improve the quality and completeness of these reports for better drug safety assessment.
Area of Science:
- Pharmacovigilance and Drug Safety
- Medical Device Surveillance
- Herbal and Complementary Medicine Monitoring
Background:
- Publication of adverse event case reports is vital for postmarketing surveillance and identifying potential drug risks.
- Deficiencies in published case reports often limit their value for assessing causality and understanding mechanisms.
- Existing journal requirements for publishing adverse event reports are often minimal or non-existent.
Framework:
- Development of standardized guidelines for reporting suspected adverse events associated with drugs and medical products.
- Guidelines focus on essential information for differential diagnosis, causality assessment, and biological plausibility.
- Endorsement by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP).
Implementation:
- Recommendations for information to be included in case reports submitted for publication.
- Encouraging biomedical journals to adopt and enforce these reporting guidelines.
- Promoting the integration of these guidelines into healthcare professional education curricula.
Implications:
- Enhancing the quality and utility of published adverse event case reports.
- Improving the detection and evaluation of potential risks associated with medical products.
- Strengthening postmarketing surveillance systems for better public health protection.
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