International Medicinal Product Information Documents: A Quantitative Content Analysis of Instructions for Preventing, Mitigating, and Monitoring Adverse Drug Reactions
This study suggests that PIDs often do not contain complete instructions for prevention, mitigation, and monitoring of ADRs. Extending existing regulatory cooperation globally would enable regulators to access clinical characteristics and instructions from different regions.
Authors
- Daniele Sartori (ORCID: https://orcid.org/0000-0003-3634-0317)
- Michele Fusaroli (ORCID: https://orcid.org/0000-0002-0254-2212)
- Igho Onakpoya (ORCID: https://orcid.org/0000-0002-2420-0811)
- J K Aronson
- G. Niklas Norén
Institutions
- Uppsala Monitoring Centre (SE)
- University of Oxford (GB)
- Nuffield Health (GB)
Publication Details
- Journal
- Drug Safety
- Published
- 2026-03-21
- DOI
- https://doi.org/10.1007/s40264-026-01666-6
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- article
- Field-Weighted Citation Impact
- 0.00