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Evaluating the safety and dosing of drugs in patients with liver cirrhosis by literature review and expert opinion

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Author(s)
Weersink, R.A. (Rianne A.)
Bouma, M. (Margriet)
Burger, D.M. (David)
Drenth, J.P.H. (Joost)
Hunfeld, N.G.
Kranenborg, M. (Minke)
Monster-Simons, M.H. (Margje H.)
Van Putten, S.A.W. (Sandra A.W.)
Metselaar, H.J. (Herold)
Taxis, K. (Katja)
Borgsteede, S.D. (Sander)
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Keywords
drug safety
expert opinion
literature review
Liver cirrhosis
practice guideline

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URI
http://hdl.handle.net/20.500.12424/2007557
Online Access
http://repub.eur.nl/pub/96149
Abstract
Introduction: Liver cirrhosis can have a major impact on drug pharmacokinetics and pharmacodynamics. Patients with cirrhosis often suffer from potentially preventable adverse drug reactions. Guidelines on safe prescribing for these patients are lacking. The aim of this study is to develop a systematic method for evaluating the safety and optimal dosage of drugs in patients with liver cirrhosis. Methods and analysis: For each drug, a six-step evaluation process will be followed. (1) Available evidence on the pharmacokinetics and safety of a drug in patients with liver cirrhosis will be collected from the Summary of Product Characteristics (SmPC) and a systematic literature review will be performed. (2) Data regarding two outcomes, namely pharmacokinetics and safety, will be extracted and presented in a standardised assessment report. (3) A safety classification and dosage suggestion will be proposed for each drug. (4) An expert panel will discuss the validity and clinical relevance of this suggested advice. (5) Advices will be implemented in all relevant Clinical Decision Support Systems in the Netherlands and published on a website for patients and healthcare professionals. (6) The continuity of the advices will be guaranteed by a yearly check of new literature and comments on the advices. This protocol will be applied in the evaluation of a selection of drugs: (A) drugs used to treat (complications of ) liver cirrhosis, and (B) drugs frequently prescribed to the general population. Ethics and dissemination: Since this study does not directly involve human participants, it does not require ethical clearance. Besides implementation on a website and in clinical decision support systems, we aim to publish the generated advices of one or two drug classes in a peer-reviewed journal and at conference meetings.
Date
2016-10-01
Type
info:eu-repo/semantics/article
Identifier
oai:repub.eur.nl:96149
http://repub.eur.nl/pub/96149
doi:10.1136/bmjopen-2016-012991
urn:hdl:1765/96149
DOI
10.1136/bmjopen-2016-012991
Copyright/License
info:eu-repo/semantics/openAccess
ae974a485f413a2113503eed53cd6c53
10.1136/bmjopen-2016-012991
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