ArticleJournal of clinical medicine2022
Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications-A Systematic Analysis of SmPCs/PI of Major Drug Markets.
Article in Journal of clinical medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.
- Dose Recommendations for Common Drugs in Patients with Liver Cirrhosis: A Systematic Literature Review.Clinical drug investigation · 2023Pooled it
- Development and analysis of a SmPC-based machine-readable dataset of contraindications for clinical decision support and real-world data analysis.European journal of clinical pharmacology · 2026Article
- Application of the Child-Pugh Classification in Japanese Drug Labeling: A Cross-Sectional Analysis of Contraindications, Dose Recommendations, and Pharmacokinetic Rationale.Therapeutic innovation & regulatory science · 2026Article
- Dose Recommendations for Drugs in Patients With Liver Cirrhosis (The ALIVe Study): Protocol for a Multiphase Validation and Consensus Study.JMIR research protocols · 2026Article
- Recommendations on Drug Selection and Dose Adjustment for Patients with Liver Cirrhosis: Results from a Multidisciplinary Expert Panel.Clinical drug investigation · 2026Article
- Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New Format.Therapeutic innovation & regulatory science · 2026Article
- Physicians' and pharmacists' perspective on clarity and clinical relevance of absolute contraindications in "Summaries of Product Characteristics".British journal of clinical pharmacology · 2025Article
- Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics.Pharmaceutical medicine · 2024Article
- Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information-A Comparative Qualitative and Quantitative Analysis.Journal of clinical medicine · 2022Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
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-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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.