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Drugs and the Liver
Drugs and the Liver
A guide to drug handling
in liver dysfunction

Edited by
Penny North-Lewis
BPharm, MRPharmS, ClinDipPharm, MSc

Lead Paediatric Liver Pharmacist, Leeds Teaching Hospitals NHS Trust,

Leeds, UK

London • ChicagoM
Published by the Pharmaceutical Press
An imprint of RPS Publishing

1 Lambeth High Street, London SE1 7JN, UK

100 South Atkinson Road, Suite 200, Grayslake, IL 60030-7820, USA

© Pharmaceutical Press 2008

is a trade mark of RPS Publishing

RPS Publishing is the publishing organisation of the

Royal Pharmaceutical Society of Great Britain

First published 2008

Typeset by Photoprint, Torquay, Devon

Printed in Great Britain by TJ International, Padstow, Cornwall

ISBN 978 0 85369 710 7

All rights reserved. No part of this publication may be reproduced, stored in a

retrieval system, or transmitted in any form or by any means, without the prior
written permission of the copyright holder.
The publisher makes no representation, express or implied, with regard to the
accuracy of the information contained in this book and cannot accept any legal
responsibility or liability for any errors or omissions that may be made. Although
the authors have made every effort to ensure that the information contained in
this reference is correct, no responsibility can be accepted for any errors.
The right of Penny North-Lewis to be identified as the author of this work has
been asserted by her in accordance with the Copyright, Designs and Patents Act,
1988.

A catalogue record for this book is available from the British Library
Contents

Preface vii
About the editor ix
Contributors xi
Acknowledgements xv
Introduction xvii

Part One: Understanding liver function 1

1 An introduction to the anatomy of the liver 3
2 Functions of the liver 23
3 Causes of liver disease and dysfunction 49
4 Assessing liver function 73

Part Two: Principles of drug use in liver disease 101

5 Pharmacokinetics of drugs in liver disease 103
6 Undesirable side effects 135

Part Three: Putting the theory into practice 145

7 Applying the principles – introduction 147
8 The aide mémoire 157
9 Scenario 1 – Choice of analgesic 171
10 Scenario 2 – Choice of antiemetic 211
11 Scenario 3 – Choice of anti-hyperlipidaemic agent 225
12 Scenario 4 – Choice of hormone replacement therapy
(HRT) 257
13 Scenario 5 – Choice of contraceptive 275

Appendix 1: Detailed description of the patient cases 295

Appendix 2: Drugs in liver dysfunction blank aide
mémoire form 305

Index 309
Preface

It is well recognised that the majority of medicines pass through the liver
on their journey around the body, but little is published on how differ-
ent types and degrees of liver dysfunction affect the body’s ability to
handle those medicines. This is because clinical studies are typically con-
ducted in small numbers of patients with a specific liver disease, usually
classified generically as ‘mild to moderate’. The results of these studies
are often misguidedly extrapolated to all types of liver dysfunction. To
exacerbate the problem, because of the scarcity of data, pharmaceutical
companies frequently suggest dose reductions or the avoidance of a par-
ticular medicine in liver dysfunction. These effects combine to leave
patients with liver disease disenfranchised from medicine use by the lack
of information available to assist prescribers.
To make a judgement on medicine and choice of dose in an indi-
vidual patient with a certain type of liver dysfunction, one must often
return to first principles to make an educated guess. The aim of this
book is therefore:
• To enable the practitioner to assess liver function using biochemical markers
(e.g. liver function tests), other tests, signs, symptoms and disease knowledge
• To identify which pharmacokinetic and pharmacodynamic parameters of a
drug are likely to be affected by different types of liver disease
• To consider the impact of a drug’s side effects on a patient with liver disease.

This book is written by pharmacists and clinicians in the field of

hepatology and is designed to assist practitioners to make these deci-
sions. It is aimed primarily at clinical pharmacists, but may be of value
to anyone making medicine choices in patients with liver impairment, as
well as to students of pharmacokinetics. It is not aimed at academics
and does not negate the need for further investigation, but it will enable
practitioners to make pragmatic choices for their patients.

Penny North-Lewis
June 2007
About the editor

Penny North-Lewis graduated from Nottingham University in 1989

with a BPharm(Hons). She went on to complete the London School of
Pharmacy Clinical Diploma in 1992, and a Master of Science in Clinical
Pharmacy at Brighton University in 1998.
Penny has been working in the field of hepatology since 1993, when
she became the first clinical pharmacist to work with the paediatric liver
unit at King’s College Hospital, London. She remained there until 1998,
and, after a short period working in adult medicine, moved to Leeds in
2000 to establish the clinical pharmacy service for the new Paediatric
Liver and GI Unit at St James’s University Hospital, where she has
remained ever since. Her role entails close liaison with the consultants,
including participation in their daily ward rounds and attendance at out-
patient clinics. She has also been closely involved with the development
of guidelines for managing patients with liver disease.
Penny has been involved with a wide range of clinical studies in
children with liver disease. These include several that relate to pharma-
cokinetics, in both liver disease and after liver transplantation. She has
presented her research work and given lectures and workshops at
national and international congresses, including the International
Pediatric Transplant Association, the European Society of Clinical
Pharmacy and the Neonatal and Paediatric Pharmacists Group (NPPG)
conferences.
She is a founder member of the UK and Eire Liver Transplant
Pharmacists Group, which was set up in 1994 to provide pharmacists in
this field with the opportunity to learn, share ideas and help solve prob-
lems. She is also on the committee of the NPPG.
Contributors

Michael Bowe, BPharm, MRPharmS, ClinDipPharm

Lead GI and Liver Pharmacist (at the time of writing)
Pharmacy Department, Freeman Hospital
Newcastle-upon-Tyne, UK

Faye Croxen, BPharm, MRPharmS, ClinDipPharm

Lead Adult Liver Pharmacist
Pharmacy Department, Leeds Teaching Hospitals NHS Trust
Leeds, UK

Bridget Featherstone, BSc(Hons), MRPharmS, DipClinPharm, SP

Lead Pharmacist Transplantation and Surgery
Pharmacy Department, Cambridge University Teaching Hospitals
NHS Trust, Cambridge, UK

Kylies Foot, BPharm(Hons) (University of South Australia),

MRPharmS
Liver Specialist Medicines Information Pharmacist (at the time of
writing)
Medicines Information Centre, Pharmacy Department
Leeds Teaching Hospitals NHS Trust
Leeds, UK

Andrew Holt, MBChB(Hons), MRCP

Honorary Clinical Fellow in Hepatology
Liver Research Laboratory, MRC Centre for Immune Regulation
University of Birmingham, UK
xii Contributors

Catherine Hughes, BPharm(Hons), MRPharmS, DipClinPharm

Lead Adult Liver Pharmacist (at the time of writing)
Pharmacy Department, Leeds Teaching Hospitals NHS Trust
Leeds, UK

Trevor N Johnson, BPharm, MSc, PhD, MRPharmS, MCPP

Senior Pharmacist, Pharmacy Department, Sheffield Children’s
Hospital and Senior Scientist, Simcyp Limited
Sheffield, UK

Fionnuala Kennedy, BSc(Pharm), BA(Econ), MA(Healthcare Manag),

MPSI
Clinical Pharmacy Manager/Lead Liver Pharmacist
Pharmacy Department, St Vincent’s University Hospital
Dublin, Ireland

Sarah Knighton, MPharm, MRPharmS, DipClinPharm

Liver Pharmacy Team Leader
Pharmacy Department, King’s College Hospital
London, UK

Saw Keng Lee, MPharm, MRPharmS, DipPharmPrac

Senior Liver Pharmacist (at the time of writing)
Pharmacy Department, King’s College Hospital
London, UK

Penny North-Lewis, BPharm, MRPharmS, DipClinPharm, MSc

Lead Paediatric Liver Pharmacist
Pharmacy Department, Leeds Teaching Hospitals NHS Trust
Leeds, UK

Aileen Parke, MRPharmS, SP, MSc

Women and Children’s Pharmacy Team Leader
Pharmacy Department
King’s College Hospital
London, UK
 Contributors xiii

Amanda Smith, BPharm, MRPharmS, DipClinPharm

Lead Pharmacist, Liver and Solid Organ Transplantation
Pharmacy Department, University Hospital Birmingham NHS
Foundation Trust
Birmingham, UK

Alison H Thomson, MSc, PhD, MRPharmS, MCPP

Area Pharmacy Specialist, Western Infirmary and Senior Lecturer
Strathclyde Institute of Pharmacy and Biomedical Sciences, University
of Strathclyde
Glasgow, UK

Janet Tweed, BPharm, MRPharmS, DipClinPharm, Certificate in

Pharmaceutical Information Management
Medicines Information Service Development Manager
Medicines Information Centre, Pharmacy Department
Leeds Teaching Hospitals NHS Trust
Leeds, UK

Sheetal (Tina) Vaghjiani, BSc(Hons)Pharm, MRPharmS,

DipClinPharm
Senior Pharmacist – Hepatology, Gastroenterology and Nutrition
Pharmacy Department, Royal Free Hampstead NHS Trust
London, UK
Acknowledgements

This book could not have been written without the enormous commit-
ment of my fellow collaborators in the UK and Eire Liver Transplant
Pharmacists Group. My thanks go to every member for their role in
ensuring this goal has been realised. I would especially like to extend my
thanks to Katherine Davidson for reviewing chapters with a fresh eye,
to Helen Whiteside for helping at the planning stage, to Janet Tweed
(nee Darlington) for being unstintingly conscientious despite staffing
shortages and getting married, to Catherine Hughes for being endlessly
supportive, and to Richard Coverdale for project managing me. I am
also indebted to Professor Liz Kay for allowing me and others at Leeds
Teaching Hospitals the time and resources to complete this project, to
all the medical colleagues involved for their interest, support and assist-
ance in reviewing each chapter in the book, and the staff at
Pharmaceutical Press for their patience and support.
Introduction

How to use the book

In order to understand the extent of a patient’s liver dysfunction you
need to understand how the liver works and what it does. If you are
unfamiliar with hepatology you should read Chapters 1 and 2, which
provide an outline of normal anatomy, physiology and functions of the
liver. They enable you to visualise how blood moves around the liver
and so understand the implications of a portal vein thrombosis; to
understand hepatocyte function, which helps explain why your patient
has coagulopathy; to imagine how bile flows and the pathophysiology
of gallstones. You may not need to refer to it again, but it is a useful
resource if you are confronted with something you have not come
across before.
Once you have grasped the basics of hepatology, Chapter 3 gives
examples of some of the more common liver diseases seen in adults and
children, and highlights what changes they make to the liver’s
metabolic/eliminative function. There are hundreds of liver diseases, but
we have only mentioned the most common: the Further Reading section
gives recommendations for where to find more information about
specific diseases not discussed here.
Chapter 4 guides you in understanding how a patient’s signs and
symptoms of liver disease, coupled with liver function and other labor-
atory or diagnostic tests, give an indication of the severity of the liver
dysfunction.
Having assessed liver function, you need to go back to basic prin-
ciples of pharmacokinetics: what does the liver normally do and what
types of dysfunction may affect drug handling? In Chapter 5 we have
incorporated the theory with practical advice that you can apply to a
patient. Chapter 6 considers the impact of a drug’s side-effect profile on
a patient with liver dysfunction.
xviii Introduction

This is a practical guide rather than a scientific tome, finishing in

Part 3 with worked examples of commonly asked questions: which
analgesic should you recommend for a patient with acute liver failure?
What is the best lipid-lowering agent for someone with chronic liver dis-
ease? The idea of this section is also to guide you through the questions
you need to ask to be able to answer the more unusual queries for your-
self – going back to first principles of assessing liver function and drug
pharmacokinetics. It is not possible to give an answer to the question of
whether or not a particular drug can be used in a patient with liver dis-
ease because everything depends on the patient in front of you, and
there are too many possible permutations. The aide mémoire is a tool to
help you remember which aspects of the patient and the drug you need
to be especially aware of.
This is our first attempt at providing a practical method to help
pharmacists answer questions about drug use in this group of patients.
It illustrates the way in which experienced liver pharmacists deal with
these problems and distils our experience into a user-friendly form.
I welcome any feedback on the approach taken in this book.
Part One

Understanding liver function

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