Clinical Risk Management in Community Pharmacy - Henk Buurma
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Clinical risk management in community pharmacy - Henk Buurma CLINICAL RISK MANAGEMENT IN COMMUNITY PHARMACY HENK BUURMA Clinical risk management in community pharmacy - Henk Buurma Cover illustration: Heleen Swart Cover design: Martijn Pieck (DGV, Department of Pharmaceutical Sciences, Utrecht University Lay-out inside work: Francis te Nijenhuis Printed by: Optima Grafische Communicatie, Rotterdam The work presented in this thesis was performed at the Division of Pharmacoepidemiology and Pharmacotherapy of the Utrecht Institute for Pharmaceutical Sciences (UIPS), in collaboration with the SIR Institute for Pharmacy Practice and Policy (Leiden) and the Department of Clinical Pharmacy of the Radboud University Nijmegen Medical Centre. CIP-gegevens Koninklijke Bibliotheek, Den Haag Buurma, H. Clinical risk management in community pharmacy Thesis University Utrecht – with ref. – with summary in Dutch ISBN-10: 90-393-4318-7 ISBN-13: 978-90-393-4318-0 © 2006 Henk Buurma Clinical risk management in community pharmacy - Henk Buurma CLINICAL RISK MANAGEMENT IN COMMUNITY PHARMACY RISICOMANAGEMENT IN DE ZORGPRAKTIJK VAN DE OPENBARE APOTHEEK (met een samenvatting in het Nederlands) PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Universiteit Utrecht op gezag van de rector magnificus, prof.dr. W.H. Gispen, ingevolge het besluit van het college voor promoties in het openbaar te verdedigen op woensdag 4 oktober 2006 des middags te 2.30 uur door HINDRIK BUURMA geboren op 3 november 1950 te Groningen Clinical risk management in community pharmacy - Henk Buurma PROMOTOREN: Prof.dr. A.C.G. Egberts Prof.dr. P.A.G.M. de Smet (Radboud University Nijmegen) Financial support of several institutions and organizations for conducting parts of the presented studies as well as for the publication of this thesis are gratefully acknowledged: Scientific Institute of Dutch Pharmacists (WINAp); Health Base Foundation (SHB); PRISMA foundation; the Ministry of Health, Welfare and Sport; and the ‘Stichting KNMP fondsen’. Clinical risk management in community pharmacy - Henk Buurma Voor Heleen, Marleen, Jorien Als je doet wat je leuk vindt, hoef je nooit te werken. Mahatma Gandhi Clinical risk management in community pharmacy - Henk Buurma Clinical risk management in community pharmacy - Henk Buurma CONTENTS Chapter 1 Introduction 3 Chapter 2 The process 2.1 Frequency, nature and determinants of pharmacy 21 compounded medicines in Dutch community pharmacies 2.2 Nature, frequency and determinants of prescription 41 modifications in Dutch community pharmacies 2.3 Clinical risk management in Dutch community 57 pharmacies: the case of drug-drug interactions Chapter 3 Quality 3.1 Disease and intolerability documentation in electronic 79 patient records 3.2 Adherence to a national guideline on the management of 97 drug-drug interactions in Dutch community pharmacies Chapter 4 The patient 4.1 Evaluation of the clinical value of pharmacists’ 117 modifications of prescription errors 4.2 Pharmacy shopping: determinants and the relation with 135 heavy use of psychotropic drugs Chapter 5 General discussion 157 Summary 179 Samenvatting 189 Een woord van dank… 201 List of co-authors 209 List of publications (since 1996) 213 About the author 219 Clinical risk management in community pharmacy - Henk Buurma Clinical risk management in community pharmacy - Henk Buurma Chapter 1 INTRODUCTION Clinical risk management in community pharmacy - Henk Buurma Clinical risk management in community pharmacy - Henk Buurma Introduction INTRODUCTION Medicines constitute a crucial backbone of both prevention and therapy of disease in modern health care. However, pharmaceutical agents only provide efficacious and safe care to patients when they are applied in a sustained, monitored and safeguarded usage environment. Like in many countries, Dutch (community) pharmacists have contributed to the development and implementation of patient-oriented systems to boost up the balance sheet of the benefits and risks of drug therapy. These efforts to improve the outcomes of drug therapy for the individual patient have been fuelled by a paramount transition in pharmacy practice and policy itself during recent years. Scientists, pharmacists and others have redefined modern pharmacy practice in definitions, descriptions and concepts: as a line of action for pharmacy practice itself and, among others things, to be accountable for the outer world. According to Barber “the mountain in its entirety is far too complex to be defined from one viewpoint”.1 The description of a mountain will be different depending on the direction one is nearing the mountain. Like the mountain, concepts mostly describe reality from one viewpoint. Because of inadequacies and limitations these concepts tend to evolve and new concepts will emerge. Depending on the starting point upon which the concept will be used (e.g. rational use of medicines, cost containment, risk management, patient centred care) or the setting or party by whom the concept will be applied (regulators, pharmacists, other health professionals, patients or consumers) one finds concepts underlying pharmacy practice that are in essence patient oriented or system oriented. The pharmaceutical professions in different countries embraced the patient centred concept of pharmaceutical care emerging from the concept of clinical pharmacy and mainly based upon the definition put forward by Hepler and Strand in 1990.2-4 The more recently introduced concordance concept aims at a more active role of the patient himself in both the medical and pharmaceutical decision making process and the execution of the treatment.5-7 Other more organizational concepts were developed as well, such as the strategy of medicines management (by the NHS in the United Kingdom), the concept of health or medical technology assessment and more recently the clinical risk management strategy.1,4,8,9 While on the one hand these concepts intend to describe pharmacy practice focusing on the pharmacy profession either as part of a (health care) system or standing on its own, there is on the other hand a need for evidence-based pharmaceutical 10 practice, from a scientific as well as from a societal and strategic perspective. 3 Clinical risk management in community pharmacy - Henk Buurma Chapter 1 What is the scientific basis of all these changes in pharmacies since the 1970s and therefore for all these definitions?11 In this thesis, an array of studies will be presented with the objective to increase our knowledge and understanding of pharmacists’ contribution to patient care in the modern healthcare system. Although there are basically no differences between community and hospital pharmacy concerning the main responsibilities and although several developments that will be described below are applicable to both professions,12 we will confine ourselves to community pharmacy. As an introduction to the presented studies we will elaborate on the role of community pharmacists using the concept of ‘pharmaceutical care’, meaning patient oriented pharmacy practice, and the rather recently introduced concept of clinical risk management. RECENT HISTORY OF COMMUNITY PHARMACY PRACTICE Until the 1950s pharmacists’ tasks consisted mainly of compounding (including quality control) and of distributing medicines, which were prescribed by physicians. The image of a pharmacy as presented in the thesis of Rypkema from 1954, that can be specified as an early pharmacy practice research study, is completely different and opposite from that of the modern pharmacy and its prescriptions nowadays.13 Along with the rise of modern medicine in general and the discovery, development and introduction of several important and effective drugs in particular, the number of compounded medicines in pharmacies decreased significantly until it stabilized between 1970 and 1990 to about 7% of all dispensed prescriptions.14 Since the beginning of the 1970s the role of the community pharmacist changed rapidly, particularly in the Netherlands. There are three mutually linked developments, described by Leufkens, by which the transition of the profession can be described: reprofessionalization in pharmacy, drug use in a ‘risk society’ and medical information systems.15 The reprofessionalization in pharmacy, expressed by the adoption of three new tasks, namely patient information, consulting with physicians, and medication surveillance, led from a product oriented (compounding and quality control) to a more drug therapy (i.e. patient) oriented attitude of pharmacists.16 A key report in the Netherlands was the concrete description of the tasks of the community pharmacist by a multidisciplinary commission, the so-called Commissie 2000, in 1979, by which 4 Clinical risk management in community pharmacy - Henk Buurma Introduction this new role was formally sanctioned by professional organizations, the government and the health insurance system.15,17 There were several developments in society and healthcare that were in favour of this reprofessionalization. Worth mentioning is the tendency to cooperate more in primary healthcare (also reflected by democratization of health care, patient empowerment and societal accountability) which has led to structured pharmacotherapy consultation groups of physicians and pharmacists.16 The other two above-mentioned notions, however, were important as well. Since the thalidomide crisis in the beginning of the 1960s, the perception of risk and the benefit-risk ratio due to the use of health care provisions and