Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications-A Systematic Analysis of SmPCs/PI of Major Drug Markets.

ABSTRACT: 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

SUBMITTER: Weisbach L 

PROVIDER: S-EPMC9000103 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature