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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...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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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 |
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author | Then, Melanie I. Andrikyan, Wahram Fromm, Martin F. Maas, Renke |
author_facet | Then, Melanie I. Andrikyan, Wahram Fromm, Martin F. Maas, Renke |
author_sort | Then, Melanie I. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9316253 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-93162532022-07-27 Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information—A Comparative Qualitative and Quantitative Analysis Then, Melanie I. Andrikyan, Wahram Fromm, Martin F. Maas, Renke J Clin Med Article 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. MDPI 2022-07-18 /pmc/articles/PMC9316253/ /pubmed/35887930 http://dx.doi.org/10.3390/jcm11144167 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Then, Melanie I. Andrikyan, Wahram Fromm, Martin F. Maas, Renke Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information—A Comparative Qualitative and Quantitative Analysis |
title | Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information—A Comparative Qualitative and Quantitative Analysis |
title_full | Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information—A Comparative Qualitative and Quantitative Analysis |
title_fullStr | Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information—A Comparative Qualitative and Quantitative Analysis |
title_full_unstemmed | Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information—A Comparative Qualitative and Quantitative Analysis |
title_short | Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information—A Comparative Qualitative and Quantitative Analysis |
title_sort | comprehensibility of contraindications in german, uk and us summaries of product characteristics/prescribing information—a comparative qualitative and quantitative analysis |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9316253/ https://www.ncbi.nlm.nih.gov/pubmed/35887930 http://dx.doi.org/10.3390/jcm11144167 |
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