Lecture Notes in Pharmacy Practice Lecture Notes in Pharmacy Practice Edited by Lilian M Azzopardi BPharm(Hons), MPhil, PhD, MRPharmS Associate Professor and Head of Department, Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta London • Chicago Dedicated to Captain Pearce for his feline perseverance in being present during the writing of this book. 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 2010 is a trade mark of RPS Publishing RPS Publishing is the publishing organisation of the Royal Pharmaceutical Society of Great Britain First published 2010 Typeset by New Leaf Design, Scarborough, North Yorkshire Printed in Great Britain by Cromwell Press Group, Trowbridge ISBN 978 0 85369 766 4 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. The right of Lilian M Azzopardi to be identified as the author of this work has been asserted by them in accordance with the Copyright, Designs and Patents Act, 1988. A catalogue record for this book is available from the British Library. Contents Foreword xi Preface xiii Acknowledgements xiv About the editor xv Contributors xvi How to use this book xvii Abbreviations xviii Part 1 Introduction to Pharmacy 1 1 Historical perspectives 3 2 Pharmacy practice and the healthcare system 9 3 Medicine presentation and administration 13 4 Medicine safety 20 5 Community pharmacy practice 29 6 Dispensing prescriptions 33 7 Health promotion 36 8 Communication skills and patient counselling 39 9 Compliance, adherence and concordance 44 10 Mathematical principles of drug therapy 47 11 Point-of-care testing 54 Part 2 Clinical Pharmacy and Pharmacotherapeutics 63 12 Pharmaceutical care plans 65 13 Medicine action 70 14 Clinical pharmacokinetics 76 15 Constipation and diarrhoea 80 16 Gastro-oesophageal reflux disease and peptic ulcer disease 86 17 Inflammatory bowel disease and other chronic bowel disorders 92 18 Emesis 97 19 Cardiovascular disorders 101 20 Hypertension 107 21 Ischaemic heart disease 121 22 Congestive heart failure 127 23 Hyperlipidaemia 132 24 Thrombosis 138 25 Allergic rhinitis, asthma and chronic obstructive pulmonary disease 143 26 Schizophrenia 150 27 Mood disorders 157 28 Anxiety disorders 165 29 Sleep disorders 171 30 Eating disorders 178 31 Pain management and fever 184 32 Dementia and Alzheimer’s disease 194 33 Parkinson’s disease 198 34 Anti-infective agents 203 vi | Contents 35 Human immunodeficiency virus infection 216 36 Viral hepatitis 221 37 Thyroid disorders 225 38 Diabetes mellitus 230 39 The menopause and hormone replacement therapy 238 40 Menstrual cycle disorders and contraception 243 41 Genito-urinary disorders 251 42 Cancer chemotherapy and palliative care 256 43 Anaemia and drug-induced blood dyscrasias 264 44 Rheumatoid arthritis 269 45 Osteoarthritis and gout 276 46 Bone disorders 281 47 Skin disorders 287 48 Wound management 295 49 Drug therapy in geriatric patients 299 50 Drug therapy in paediatric patients 304 51 Drugs used in pregnancy and during lactation 311 52 Critical care therapeutics 317 53 Recent advances in pharmacotherapy 321 Part 3 Responding to Symptoms in Community Pharmacy 325 54 Colds and influenza 327 55 The eyes 333 56 Oral and dental problems 340 57 The feet 345 Contents | vii 58 Ear problems 350 59 Musculoskeletal disorders 355 60 Abdominal pain, and perianal and perivulval pruritus 360 61 Travel medicine 367 Part 4 Pharmacy Information and Research 373 62 Pharmacy literature and medical information 375 63 Medical writing 379 64 Research methodology 383 Part 5 Pharmacy Systems 391 65 Primary care health services 393 66 Community pharmacy management 396 67 Hospital pharmacy services 401 68 Formulary systems 406 69 Medicines regulatory affairs 410 70 Quality standards in community pharmacy practice 415 Bibliography 421 Index 423 viii | Contents Each of us learned during our secondary school days that frogs are cold-blooded creatures. By definition, we came to know that frogs would adapt their body temperatures to their external surroundings. Through this process, the metabolic and circulatory systems of the frog could adjust the temperature of its blood and thereby survive the external environment. In contrast to the frog, social systems and their constituents do not adapt so effectively or efficiently. This is particularly evident in healthcare systems, owing to continuous global dialogue on access to care, organisation of health delivery, financing of healthcare services and products, and assuring safety and quality. Few countries have determined perfect solutions. Some have extreme difficulty adjusting to the events of the external environment. In the devel- oped world, it is becoming clear that current health- care systems may not be sustainable in the future. Major human, fiscal and infrastructure resources are required in the developing and transitional countries in order to provide a basic set of essential healthcare services to their respective populations. These phenomena are particularly applicable to pharmaceutical and biological agents and their use. Over 5000 chemical entities are currently in use around the globe. In the United States of America over 18 000 drugs and their dosage forms are approved for marketing and sales. Large protein substances have been introduced along with nanotechnological targeted delivery systems. Complex drug regimens are used daily by patients for acute and chronic condi- tions. And a growing number of drugs are being used for indications that have not been approved by the regulatory agencies of a number of countries. Consequent on a dramatic increase in the number of drugs and biologicals, coupled with increased utilisation of these agents, it is not surprising that an increasing number of published reports allude to serious injury and death attributable to drug therapy gone awry. Errors of commission and omission in medication use are well documented in the profes- sional and scientific literature. High levels of non- adherence are reported. A majority of patients do not even get their physicians’ prescriptions filled. Further, a high proportion of patients do not respond to drugs in the way that they are expected to respond. These matters have come to be debated as issues in public policy. From strengthening the regulatory oversight and approval processes to credentialing physicians in order to prescribe certain drugs, a variety of policy directions to protect patients is being taken around the world. One of these issues centres on the beginning and continuing competence of health professionals. Some countries are doing random competence assessments of pharmacists in order to determine whether licences to practise should remain valid. Other nations are requiring pharmacists to maintain dossiers for public inspec- tion that attest to their competence. Many hospitals now require advanced credentials in order to take responsibility and accountability for expanded scopes of practice. Like the frog in water that is becoming increas- ingly warmer, the profession of pharmacy must adjust and adapt to an environment that calls for improved patient care and safety in drug therapy. We must understand our limitations in competence and adjust our practice accordingly. As we expand our interest in partnering with patients and other healthcare profes- sionals to assure appropriate outcomes associated with rational drug therapy, we need to continuously commit our learning of new developments and clinical findings and controversies in therapeutics. That is where Lecture Notes in Pharmacy Practice comes in. Azzopardi and eminent faculty members and practitioners have assembled this text to aid Foreword pharmacists in their efforts to stay abreast and main- tain competency. This text provides both context for its content as well as an impressively broad array of topics that represent contemporary pharmacy prac- tice’s knowledge system. It also should remind and stimulate practitioners to know what they do not know. That takes regular personal reflection and action. This text, as the Editor notes, should be supple- mented by regularly consulting the professional and scientific literature in pharmacy, the pharmaceutical sciences, medical specialty areas and other disciplines related to practice. Moreover, intense engagement with patients and other health professionals enhances good clinical judgement. Our profession continues to evolve as a patient- centred and medication therapy-competent occupa- tion. Our patients need us. So do our colleagues in medicine and nursing. Henri R Manasse, Jr, PhD, ScD, FFIP Executive Vice President and Chief Executive Officer American Society of Health-System Pharmacists Bethesda, Maryland United States of America May 2009 x | Foreword Lecture Notes in Pharmacy Practice follows and complements three other books that were also edited by Professor Lilian M Azzopardi: MCQs in Phar- macy Practice (2003), Further MCQs in Pharmacy Practice (2006) and MCQs in Clinical Pharmacy (2007). In this fourth book Professor Azzopardi shares an insight of the developments in the field of pharmacy practice over the last few years, something that she directly experienced, has been part of and also has spearheaded from an academic as well as from a practice perspective. This book presents pharmacy practice within the content of a social and real-life healthcare setting. It will help to prepare students for what they will experience when they start practising. And will also apply to practitioners in their day-to-day work. ‘Pharmacy practice’ may be misinterpreted by many as being a subject relevant only to those in the pharmacy professions. This is a great misconception as the principles for the use of medicines are relevant and applicable to any healthcare professionals, whatever their roles and responsibilities in the processes of research, manufacture, regulation, supply, prescribing, dispensing, administration and use of medicines. The main beneficiaries of all these processes are the patients and therefore pharmacy practice must focus on patients and their needs. Patients have increased access to information on medicines and their use from various sources and through various means. The types of relationship and communication between healthcare professionals and patients have evolved, with the approach shifting from a paternal- istic one to the empowerment of patients, enabling them to take a leading role in their treatment and healthcare. This evolution increases the expectations of patients and increases the need for healthcare professionals to keep abreast of ongoing develop- ments in all areas of practice. The information presented in this book can be applied to the various cultural and professional environments in which pharmacy practice is implemented. Through her publications Professor Azzopardi fills a lacuna in appealingly styled books in the area of pharmacy practice and the lecture notes are struc- tured in such a way as to give a framework that helps knowledge and understanding of the basic principles in pharmacy practice. The lecture notes are useful for students and help them to get a comprehensive overview of the subject and also to revise. The lecture notes together with the MCQs provide students with a good tool to study pharmacy practice. I recommend that students start off with the lecture notes and then test their knowledge using the MCQs. The lecture notes will also appeal to practitioners, particularly those for whom pharmacy practice is a complementary subject. The lecture notes bridge classical textbooks (which most practi- tioners become allergic to) and specialised practice journals, which often assume a level of knowledge of the subject, and thus they are an ideal source of condensed comprehensive information on this rapidly evolving subject. Dr Patricia Vella Bonanno Chief Executive Officer Medicines Authority Malta April 2009 Preface I am deeply indebted to the many dedicated colleagues with whom I have discussed the concepts in this book and who have freely given advice, support and time. In particular I would like to thank Professor Anthony Serracino-Inglott and Dr Maurice Zarb Adami from the Department of Pharmacy for their encouragement and advice, the contributing authors for their unique contributions to the various aspects of the book, Professor Godfrey LaFerla, Dean of the Faculty of Medicine and Surgery, and Professor Juanito Camilleri, Rector of the University of Malta, for their support. I am indebted to Henri Manasse, executive vice president and chief executive officer of the American Society of Health-System Pharmacists and Patricia Vella Bonanno, chief executive officer of the Medicines Authority of Malta for contributing to the Foreword and Preface of this publication. I would like to especially thank my colleagues at the Faculty of Medicine and Surgery and the support staff for their assistance while I was developing this work. In the selection of material for this book I have drawn on the contributions to the curriculum by the academic staff at the department of pharmacy, namely Edwina Brejza, Marise Gauci, Mary Ann Sant Fournier, Claire Shoemake, Lilian Wismayer, as well as of a number of visiting staff at the department and members of staff from faculties at the University of Malta and from universities in other countries. In particular I would like to thank pharmacists Alison Anastasi, Francesca Wirth and Marie Claire Zammit for their assistance in the compilation of material and colleagues from the Faculty of Medicine and Surgery who reviewed parts of the text. The preparation of this textbook draws on my experience in the teaching of pharmacy practice, which has been enjoyable due to the enthusiasm of pharmacy students whom I have had the privilege to meet during my academic career. I would also like to acknowledge the assistance received from staff at Pharmaceutical Press, partic- ularly Christina DeBono, Louise McIndoe and Linda Paulus, and all my staff at the Department of Phar- macy, particularly Amanda Calleja. Finally I would like to thank my family, particu- larly my mum for her assistance in proofreading the text and my sister Louise, a clinical pharmacist at Mater Dei Hospital, for her comments and for reviewing parts of the text. Acknowledgements Lilian M Azzopardi studied pharmacy at the Univer- sity of Malta, Faculty of Medicine and Surgery. In 1994 she took up a position at the Department of Pharmacy, University of Malta as a teaching and research assistant. Professor Azzopardi completed an MPhil on the development of formulary systems for community pharmacy in 1995, and in 1999 she grad- uated a PhD. Her PhD thesis led to the publication of the book Validation Instruments for Community Pharmacy: Pharmaceutical care for the third millen- nium published in 2000 by Pharmaceutical Products Press, USA. She worked together with Professor Anthony Serracino Inglott who was a pioneer in the introduction of clinical pharmacy in the late 1960s. In 2003 Professor Azzopardi edited the book MCQs in Pharmacy Practice published by the Pharmaceu- tical Press, London, which was followed in 2006 by the book Further MCQs in Pharmacy Practice and in 2007 by the book MCQs in Clinical Pharmacy. Professor Azzopardi is currently an associate professor in pharmacy practice at the Department of Pharmacy, University of Malta and is responsible for coordinating several aspects of teaching of pharmacy practice including clinical pharmacy for undergrad- uate and postgraduate students as well as supervising a number of pharmacy projects and dissertations in the field. She is an examiner at the University of Malta for students following the course of pharmacy and is an assessor in determining suitability to practice. For a short period Professor Azzopardi was interim director of the European Society of Clinical Pharmacy (ESCP) and is currently coordinator of the ESCP newsletter. She served as a member of the Working Group on Quality Care Standards within the Community Pharmacy Section of the Interna- tional Pharmaceutical Federation (FIP). She was a member of the Pharmacy Board, the licensing authority for pharmacy in Malta for a number of years and Registrar of the Malta College of Pharmacy Practice which is responsible for continuing educa- tion. In 1997 she received an award from the FIP Foundation for Education and Research and in 1999 the ESCP German Research and Education Founda- tion grant. She has practised clinical pharmacy in the hospital setting and she practises in community pharmacy. Professor Azzopardi has published several papers on clinical pharmacy and pharmaceutical care and has actively participated at congresses organised by FIP, ESCP, RPSGB, APhA and ASHP. She has been invited to give lectures and short courses in this area in several universities. She has been a member of scientific committees for European conferences and chaired a number of oral communication sessions reporting research work in the field of pharmacy practice. She has received funding for her research projects from national and European institutions. In 2008 a European Union-funded project on auto- mated dispensing of pharmaceuticals and pharmacist interventions was completed. In 2008 Professor Azzopardi was appointed head of the Department of Pharmacy at the University of Malta. About the editor Lilian M Azzopardi BPharm(Hons), MPhil, PhD, MRPharmS Associate Professor, Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Malta Margarida Caramona Professor of Pharmacology, Faculty of Pharmacy, University of Coimbra, Portugal Benito del Castillo García Professor and Honorary Dean, Faculty of Pharmacy, Complutense University of Madrid, Spain, Past- president of the European Association of Faculties of Pharmacy Victor Ferrito BSc, MSc, PhD(Wales), CSci, FRSH, FIFST Professor, Institute of Health Care, University of Malta, Malta Steve Hudson MPharm, FRPharmS Professor of Pharmaceutical Care, Division of Pharmaceutical Sciences, University of Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, UK Sam Salek PhD, RPh, MFPM(Hon) Professor and Director, Centre for Socioeconomic Research, Welsh School of Pharmacy, Cardiff University, UK Anthony Serracino Inglott BPharm, PharmD, MRPharmS Professor, Department of Pharmacy, University of Malta, Malta Vincenzo Tortorella PhD, DIC(Lond) Distinguished Emeritus Professor, Faculty of Pharmacy, University of Bari, Italy Maurice Zarb Adami BPharm, BPharm(Lond), PhD Senior Lecturer, Deparment of Pharmacy, University of Malta, Malta Contributors