Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Weisbach, Laura, Schuster, Anna K., Hartmann, Michael, Fromm, Martin F., Maas, Renke, Farker, Katrin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
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
_version_ 1784685352848457728
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
work_keys_str_mv AT weisbachlaura inconsistenciesandambiguitiesinliverdiseaserelatedcontraindicationsasystematicanalysisofsmpcspiofmajordrugmarkets
AT schusterannak inconsistenciesandambiguitiesinliverdiseaserelatedcontraindicationsasystematicanalysisofsmpcspiofmajordrugmarkets
AT hartmannmichael inconsistenciesandambiguitiesinliverdiseaserelatedcontraindicationsasystematicanalysisofsmpcspiofmajordrugmarkets
AT frommmartinf inconsistenciesandambiguitiesinliverdiseaserelatedcontraindicationsasystematicanalysisofsmpcspiofmajordrugmarkets
AT maasrenke inconsistenciesandambiguitiesinliverdiseaserelatedcontraindicationsasystematicanalysisofsmpcspiofmajordrugmarkets
AT farkerkatrin inconsistenciesandambiguitiesinliverdiseaserelatedcontraindicationsasystematicanalysisofsmpcspiofmajordrugmarkets