ArticleDrug safety2025
Strategies and Challenges in Coding Ambiguous Information Using MedDRA
Article in Drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway.British journal of clinical pharmacology · 2026Article
- Application of Artificial Intelligence in MedDRA Coding: A Practical Exploration from Clinical Data Management Perspective.Therapeutic innovation & regulatory science · 2026Article
- A Comprehensive Disproportionality Analysis of Drug-Related Head Injury Reports Using the FAERS Database.Brain and behavior · 2026Article
- A real-world pharmacovigilance study of romidepsin based on FDA adverse event reporting system database.Frontiers in oncology · 2026Article
- Profiles of neuropsychiatric toxicity associated with different endocrine therapies for breast cancer: a global pharmacovigilance study based on FAERS and VigiAccess.Frontiers in pharmacology · 2026Article
- Indications and Adverse Events of Toradol: Based on FDA Adverse Event Reporting System (FAERS).Pain research & management · 2026Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe Medical Dictionary for Regulatory Activities (MedDRA
objectiveWe explored the reasoning and strategies employed by pharmacovigilance officers when coding selected ambiguous adverse events to MedDRA
methodsPharmacovigilance officers from the Norwegian public health sector were invited to participate in a survey-based, cross-sectional study followed by focus group interviews. The survey consisted of 11 coding tasks, with varying degrees of ambiguity, purposively sampled from the Norwegian pharmacovigilance registry. Participants selected the appropriate MedDRA
resultsIn total, 26 coders (79% of the eligible population) completed the survey. Of the survey answers, 36% were identical to the STS; answers consistent with the STS varied across the specific coding tasks and did not align with the perceived difficulty of the tasks. The most common inconsistency (30% of the survey answers) arose from substituting one of multiple MedDRA
conclusionsTailored training programs and clear institutional guidelines are needed to target the sources of coding inconsistencies suggested by this study.
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Registered trials
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