Journal article
International medicinal product information documents: a quantitative content analysis of instructions for preventing, mitigating, and monitoring adverse drug reactions
- Abstract:
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Introduction
Medicinal product information documents (PIDs) detail clinical characteristics and instructions for monitoring, preventing, and mitigating adverse drug reactions (ADRs). They vary across countries, but there have been no recent international comparisons. We have therefore quantified and compared the completeness of the information given in drug labelling from different countries.
Methods
From the websites of 35 regulatory agencies, we retrieved the PIDs of medicinal products that were involved in signals communicated by regulators in 2014–2019. We developed a data extraction framework based on the Dose-relatedness, Time course, Susceptibility (DoTS) clinical classification of ADRs and used its implications for prevention and mitigation to score the completeness of related instructions in PIDs. To extract and classify monitoring instructions, we used a modified Systematic Instructions for Monitoring (SIM) method. PIDs had sufficiently complete instructions for prevention when the DoTS score was ≥ 5/12, and sufficiently complete monitoring instructions when the SIM score was ≥ 3/6. We used proportions of PIDs having a score ≥ 1 to determine the relative availability of clinical characteristics or instructions in a country, compared with all other countries. We quantified their pairwise disagreements using Jaccard’s distance and identified clusters with similar patterns of completeness using agglomerative hierarchical clustering.
Results
PIDs were available on the websites of 18 of 35 regulatory agencies. They concerned 364 distinct medicinal products, which were involved in 627 signals. Across all countries, the instructions for prevention or mitigation met sufficient completeness for a median of 30% of PIDs (IQR 28–33%), while instructions for monitoring were sufficiently complete for a median of 22% (IQR 19–25%). The information given by the European Union (EU) and Canada had the highest relative availability of clinical characteristics and prevention or mitigation instructions, with a proportion of 0.86. Canadian and EU PIDs also had the highest relative availability of monitoring instructions, with proportions of 0.79 and 0.70. Two clusters of countries showed low disagreements: Malaysia and Singapore; Australia and New Zealand.
Conclusions
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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 1.5MB, Terms of use)
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- Publisher copy:
- 10.1007/s40264-026-01666-6
Authors
- Publisher:
- Springer
- Journal:
- Drug Safety More from this journal
- Publication date:
- 2026-03-21
- Acceptance date:
- 2026-03-03
- DOI:
- EISSN:
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1179-1942
- ISSN:
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0114-5916
- Language:
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English
- Keywords:
- Pubs id:
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2395312
- Local pid:
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pubs:2395312
- Source identifiers:
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W7139974875
- Deposit date:
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2026-03-27
- ARK identifier:
Terms of use
- Copyright holder:
- Sartori et al.
- Copyright date:
- 2026
- Rights statement:
- © The Author(s) 2026. Open Access. This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.
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