ArticleJournal of clinical medicine2022
Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information-A Comparative Qualitative and Quantitative Analysis.
Article in Journal of clinical medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed, 5 citations in OpenAlex.
- Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New Format.Therapeutic innovation & regulatory science · 2026Article
- Physicians' and pharmacists' perspective on clarity and clinical relevance of absolute contraindications in "Summaries of Product Characteristics".British journal of clinical pharmacology · 2025Article
- Leveraging digitization to decarbonize healthcare - medication prescribing information as an exemplar.The journal of climate change and healthArticle
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
Abstract
Contraindications (CIs) in Summaries of Product Characteristics (SmPCs)/Prescribing Information (PI) that lack clarity may pose a risk to medication safety and increase the risk for adverse drug reactions. We assessed and compared SmPCs/PI from three major drug markets regarding comprehensibility from the prescriber perspective, as well as usability in clinical decision support systems. 158 drugs met the following inclusion criteria: marketed in Germany (DE), United Kingdom (UK) and United States (US) and belonged to the 100 most recently FDA approved and/or 100 most frequently prescribed drugs in either country. In the 474 (3 × 158) SmPCs/PI all expressions for absolute CIs were identified, divided into 3999 stand-alone terms and evaluated according to 'clarity' and 'codability'. The average number of absolute CIs per drug differed drastically between the three markets (DE: 11.7, UK: 9.0, US: 4.6). Expressions were frequently unclear (DE: 27.2% (95% CI 25.2-29.2%), UK: 28.5% (26.2-30.9%), US: 22.6% (19.7-25.8%)). Moreover, 60.9% (58.6-63.1%), 63.6% (61.0-66.0%), and 64.7% (61.2-68.1%) of the expressions were not codable in DE, UK, and US, respectively. Taken together, in three major drug markets, statements regarding CIs in SmPCs/PI substantially differ in frequency and frequently lack clarity and codability which poses an unnecessary obstacle to medication safety.
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Registered trials
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