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Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications—A Systematic Analysis of SmPCs/PI of Major Drug Markets
Liver disease is a common condition worldwide that can cause alterations in drug disposition and susceptibility to drug toxicities, with increased risk of adverse drug reactions. European Summaries of Product Characteristics (SmPCs) and United States Prescribing Information (US PI) should therefore...
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/PMC9000103/ https://www.ncbi.nlm.nih.gov/pubmed/35407541 http://dx.doi.org/10.3390/jcm11071933 |
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author | Weisbach, Laura Schuster, Anna K. Hartmann, Michael Fromm, Martin F. Maas, Renke Farker, Katrin |
author_facet | Weisbach, Laura Schuster, Anna K. Hartmann, Michael Fromm, Martin F. Maas, Renke Farker, Katrin |
author_sort | Weisbach, Laura |
collection | PubMed |
description | Liver disease is a common condition worldwide that can cause alterations in drug disposition and susceptibility to drug toxicities, with increased risk of adverse drug reactions. European Summaries of Product Characteristics (SmPCs) and United States Prescribing Information (US PI) should therefore be comprehensible to prescribers regarding their liver-associated contraindications to ensure safe prescribing. This study aimed to evaluate the ambiguity of terminology used in communicating liver-associated absolute contraindications in SmPCs/PI of commonly prescribed drugs in four major drug markets (Germany, Switzerland, the United Kingdom, and the United States) by assigning wordings to different categories and analyzing their clinical comprehensibility. For US PI, 79% did not contain liver-related contraindications, compared to 2, 13, and 6% of German, Swiss, and British SmPCs, respectively. Study findings indicate that out of 228 examined SmPCs/PI containing liver-related contraindications, 77, 79, 76, and 52% contained unclear wording in the German, Swiss, British, and American drug market, respectively. Only 40% (German), 52% (Swiss), 39% (British), and 29% (American) of SmPCs/PI included terms with explicit wording. Including more precise statements in SmPCs/PI based on laboratory parameters (such as albumin) or scores (e.g., the Child–Pugh score) to objectify the severity of liver disease may improve the clarity of SmPCs/PI and the safety of drug prescription. |
format | Online Article Text |
id | pubmed-9000103 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-90001032022-04-12 Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications—A Systematic Analysis of SmPCs/PI of Major Drug Markets Weisbach, Laura Schuster, Anna K. Hartmann, Michael Fromm, Martin F. Maas, Renke Farker, Katrin J Clin Med Article Liver disease is a common condition worldwide that can cause alterations in drug disposition and susceptibility to drug toxicities, with increased risk of adverse drug reactions. European Summaries of Product Characteristics (SmPCs) and United States Prescribing Information (US PI) should therefore be comprehensible to prescribers regarding their liver-associated contraindications to ensure safe prescribing. This study aimed to evaluate the ambiguity of terminology used in communicating liver-associated absolute contraindications in SmPCs/PI of commonly prescribed drugs in four major drug markets (Germany, Switzerland, the United Kingdom, and the United States) by assigning wordings to different categories and analyzing their clinical comprehensibility. For US PI, 79% did not contain liver-related contraindications, compared to 2, 13, and 6% of German, Swiss, and British SmPCs, respectively. Study findings indicate that out of 228 examined SmPCs/PI containing liver-related contraindications, 77, 79, 76, and 52% contained unclear wording in the German, Swiss, British, and American drug market, respectively. Only 40% (German), 52% (Swiss), 39% (British), and 29% (American) of SmPCs/PI included terms with explicit wording. Including more precise statements in SmPCs/PI based on laboratory parameters (such as albumin) or scores (e.g., the Child–Pugh score) to objectify the severity of liver disease may improve the clarity of SmPCs/PI and the safety of drug prescription. MDPI 2022-03-30 /pmc/articles/PMC9000103/ /pubmed/35407541 http://dx.doi.org/10.3390/jcm11071933 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 Weisbach, Laura Schuster, Anna K. Hartmann, Michael Fromm, Martin F. Maas, Renke Farker, Katrin Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications—A Systematic Analysis of SmPCs/PI of Major Drug Markets |
title | Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications—A Systematic Analysis of SmPCs/PI of Major Drug Markets |
title_full | Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications—A Systematic Analysis of SmPCs/PI of Major Drug Markets |
title_fullStr | Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications—A Systematic Analysis of SmPCs/PI of Major Drug Markets |
title_full_unstemmed | Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications—A Systematic Analysis of SmPCs/PI of Major Drug Markets |
title_short | Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications—A Systematic Analysis of SmPCs/PI of Major Drug Markets |
title_sort | inconsistencies and ambiguities in liver-disease-related contraindications—a systematic analysis of smpcs/pi of major drug markets |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9000103/ https://www.ncbi.nlm.nih.gov/pubmed/35407541 http://dx.doi.org/10.3390/jcm11071933 |
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