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Gastroenterology and hepatology
Protocol
Evaluating the safety and dosing of drugs in patients with liver cirrhosis by literature review and expert opinion
  1. Rianne A Weersink1,2,
  2. Margriet Bouma3,
  3. David M Burger4,
  4. Joost P H Drenth5,
  5. Nicole G M Hunfeld6,
  6. Minke Kranenborg7,
  7. Margje H Monster-Simons8,
  8. Sandra A W van Putten9,
  9. Herold J Metselaar10,
  10. Katja Taxis2,
  11. Sander D Borgsteede1,11
  1. 1Health Base Foundation, Houten, The Netherlands
  2. 2Department of Pharmacy, Unit of Pharmacotherapy, -Epidemiology & -Economics, University of Groningen, Groningen, The Netherlands
  3. 3Department of Guideline Development, Dutch College of General Practice, Utrecht, The Netherlands
  4. 4Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands
  5. 5Department of Gastroenterology, Radboud University Medical Center, Nijmegen, The Netherlands
  6. 6Department of Pharmacy and Department of Intensive Care, Erasmus University Medical Center, Rotterdam, The Netherlands
  7. 7Centre for Information on Medicines, Royal Dutch Pharmacists Association (KNMP), The Hague, The Netherlands
  8. 8Dutch Medicines Evaluation Board, Utrecht, The Netherlands
  9. 9De Brug Pharmacy, Almere, The Netherlands
  10. 10Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands
  11. 11SIR Institute for Pharmacy Practice and Policy, Leiden, The Netherlands
  1. Correspondence to Dr Sander Borgsteede; s.d.borgsteede{at}rug.nl

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.

  • liver cirrhosis
  • drug safety
  • practice guideline
  • expert opinion
  • literature review

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-012991

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    Footnotes

    • Acknowledgements The authors thank Corine Colijn, Jan-Kees Huyts, Peter Mol, José Willemse, Froukje Harkes-Idzinga and Marleen Journée-Gillissen for their contribution towards study funding.

    • Contributors RW and SB wrote and drafted the protocol. MB, JD, NH, HM and SB contributed to the application for study funding. All authors contributed to the development of the study protocol and read and approved the final manuscript.

    • Funding This work was supported by ZonMw GGG-STIP grant number 836044009. ZonMw is the Dutch national organisation for health research and healthcare innovation. ZonMw's main commissioning organisations are the Ministry of Health, Welfare and Sport and the Netherlands Organisation for Scientific Research. ZonMw did not influence the content of the guideline.

    • Competing interests DB has received research grants from BMS, MSD and ViiV and has performed teaching for Abbvie, BMS, Gilead, MSD and ViiV, outside the submitted work. JD has received research grants from Abbvie and Janssen and has been a member of advisory boards of AbbVie, BMS, Gilead, Janssen, and Merck, outside the submitted work. HM has received research grants from AbbVie, Astellas, Novartis and Gilead and has been a member of advisory boards of AbbVie, Astellas and Novartis, outside the submitted work.

    • Provenance and peer review Not commissioned; externally peer reviewed.