Evidence-Based Recommendations to Improve the Safe Use of Drugs in Patients with Liver Cirrhosis

Rianne A. Weersink (), Margriet Bouma, David M. Burger, Joost P. H. Drenth, S. Froukje Harkes-Idzinga, Nicole G. M. Hunfeld, Herold J. Metselaar, Margje H. Monster-Simons, Katja Taxis and Sander D. Borgsteede
Additional contact information
Rianne A. Weersink: Health Base Foundation
Margriet Bouma: Dutch College of General Practice
David M. Burger: Radboud University Medical Center
Joost P. H. Drenth: Radboud University Medical Center
S. Froukje Harkes-Idzinga: Royal Dutch Pharmacists Association (KNMP)
Nicole G. M. Hunfeld: Erasmus University Medical Center
Herold J. Metselaar: Erasmus University Medical Center
Margje H. Monster-Simons: Dutch Medicines Evaluation Board
Katja Taxis: University of Groningen
Sander D. Borgsteede: Health Base Foundation

Drug Safety, 2018, vol. 41, issue 6, No 6, 603-613

Abstract: Abstract Introduction The presence of liver cirrhosis can have a major impact on pharmacodynamics and pharmacokinetics, but guidance for prescribing is lacking. Objective The aim of this study is to provide an overview of evidence-based recommendations developed for the safe use of drugs in liver cirrhosis. Methods Recommendations were based on a systematic literature search combined with expert opinion from a panel of 10 experts. The safety of each drug was classified as safe, no additional risks known, additional risks known, unsafe, unknown or the safety class was dependent on the severity of liver cirrhosis (Child–Pugh classification). If applicable, drug-specific dosing advice was provided. All recommendations were implemented in clinical decision support systems and on a website. Results We formulated 218 recommendations for a total of 209 drugs. For nine drugs, two recommendations were formulated for different administration routes or indications. Drugs were classified as ‘safe’ in 29 recommendations (13.3%), ‘no additional risks known’ in 60 (27.5%), ‘additional risks known’ in 3 (1.4%), and ‘unsafe’ in 30 (13.8%). In 57 (26.1%) of the recommendations, safety depended on the severity of liver cirrhosis and was ‘unknown’ in 39 (17.9%) recommendations. Large alterations in pharmacodynamics were the main reason for classifying a drug as ‘unsafe’. For 67 drugs (31%), a dose adjustment was needed. Conclusions Over 200 recommendations were developed for the safe use of drugs in patients with liver cirrhosis. Implementing these recommendations into clinical practice can possibly enhance medication safety in this vulnerable patient group.

Date: 2018
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DOI: 10.1007/s40264-017-0635-x

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