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Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information—A Comparative Qualitative and Quantitative Analysis

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 fr...

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Detalles Bibliográficos
Autores principales: Then, Melanie I., Andrikyan, Wahram, Fromm, Martin F., Maas, Renke
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9316253/
https://www.ncbi.nlm.nih.gov/pubmed/35887930
http://dx.doi.org/10.3390/jcm11144167
Descripción
Sumario: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.