Jochen Pfeifer. German Community Pharmacists. From Product-Oriented Suppliers to Patient-Oriented Health Care Professionals. Nomos

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1 Jochen Pfeifer German Community Pharmacists From Product-Oriented Suppliers to Patient-Oriented Health Care Professionals Nomos

2 Jochen Pfeifer German Community Pharmacists From Product-Oriented Suppliers to Patient-Oriented Health Care Professionals Nomos

3 Die Deutsche Nationalbibliothek lists this publication in the Deutsche Nationalbibliografie; detailed bibliographic data is available in the Internet at a.t.: Bremen, Univ., Diss., 2014 Original title: Advancing the professionalization of German community pharmacists and creating a new mission statement using select international best practice standards ISBN (Print) (epdf) British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library. ISBN (Print) (epdf) Library of Congress Cataloging-in-Publication Data Pfeifer, Jochen German Community Pharmacists From Product-Oriented Suppliers to Patient-Oriented Health Care Professionals Jochen Pfeifer 148 p. Includes bibliographic references. ISBN (Print) (epdf) 1. Edition 2014 Nomos Verlagsgesellschaft, Baden-Baden, Germany Printed and bound in Germany. This work is subject to copyright. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, re-cording, or any information storage or retrieval system, without prior permission in writing from the publishers. Under 54 of the German Copyright Law where copies are made for other than private use a fee is payable to Verwertungs gesellschaft Wort, Munich. No responsibility for loss caused to any individual or organization acting on or refraining from action as a result of the material in this publication can be accepted by Nomos or the author.

4 The physician thinks, decides and orders; the pharmacist obeys - obeys; of course, with discretion, intelligence, and skill - yet in the end obeys and does not originate. Abraham Flexner, 1915

5 Acknowledgements Firstly, I would like to thank my PhD Advisor, Prof. Dr. Gerd Glaeske, for his continuous support, encouragement, and confidence in me. I deeply appreciate his valuable advice, our fruitful discussions, and his generosity in always finding time to advise me on my thesis as well as for his understanding and leadership in occasionally very hectic times. Special thanks go to Ms. Frieda Hoefel for her support, patience, and her very valuable advice and to all colleagues at the Zentrum für Sozialpolitik of the University of Bremen for their kind support. I am also very grateful for Prof. Dr. Georg Hempel for supporting me both while preparing my thesis, but also for his participation in implementing new forms of international cooperation with pharmacy students from the U.S. and Germany in cooperation with the University of Minnesota. I would like to thank Prof. Dr. Hartmut Derendorf for his support in starting my career in international pharmacy after becoming one of the first German International WPPD students at the University of Florida and for the projects we did since I graduated from Florida with a PharmD degree in My thesis would not have been possible without the continuous support of Prof. Dr. Linda Strand over many years. In our conversations, discussions, and meetings Dr. Strand predicted the difficulties I would encounter implementing changes into Germany community pharmacy and those obstacles did indeed occur. I am also extremely grateful to Dean Prof. Dr. Marilyn Speedie and the entire faculty and staff of the University of Minnesota, College of Pharmacy for their support and for allowing me to create the very first International Advance Pharmacy Practice Experience for U.S. students in a German community pharmacy. This project, created especially for my thesis, would not have been possible without their help. Many thanks to my Australian friends for their support and their friendship, Prof. Dr. S.I. Charlie Benrimoj, Sydney and Dr. Tim Chen, Sydney. A big Thank you also to my colleagues Andreas Niclas Förster and Christian Schulze for their continuous support. 7

6 Acknowledgements All my friends and colleagues deserve my special gratitude for their support during the time I spent working on my thesis, especially my colleagues in my pharmacy who supported me during the busy times when writing my thesis. I would like to dedicate this book to my mother, Gertrud Pfeifer, who passed away on November 21, 2004 and to my father, Friedhelm Pfeifer who is now retired. Both were excellent pharmacists who provided the best possible patient care and who inspired me to work very hard to achieve my dreams. My mother died shortly before I was awarded the Doctor of Pharmacy Degree at the University of Florida but her inspiration lives on. 8

7 Table of Contents List of Abbreviations 13 Summary Professional Status of German community pharmacists Community Pharmacists in Germany: History and Challenges History Overview Differences between Pharmaceutical Advice and Pharmaceutical Care Introduction Pharmaceutical advice Pharmaceutical care Evidence based approaches Selective care projects in Germany Geriatric Pharmacy Pharmacist-led intervention to improve inhalation technique in asthma and chronic obstructive pulmonary disease patients Relevance of Foucault s work to pharmacy practice Introduction Foucault s Birth of the Clinic Power and knowledge Pharmacists taking control over patients Patients exercising power and control Discussion 47 9

8 Table of Contents 4. German community pharmacists social authority and professionalization 4.1 Introduction Abraham Flexner: Physician thinks, pharmacist obeys The trait approach Impure Status of community pharmacists Mystique of community pharmacists role Talcott Parsons concept of the sick role Community pharmacists professionalization and the U.S. Supreme Court 4.8 Norman Denzin s incomplete professionalization Introduction Control over social objects by community pharmacists in Over-qualification of pharmacists Full autonomous control over prescription drugs Full autonomous control over OTC medication Social positioning of community pharmacists Psychological reactance Discussion Quality of pharmacy practice Introduction Definition Donabedian s model of evaluating community pharmacists quality 5.4 FIP s and WHO s Quality standards Distribution Assessment of patient health status and needs Management of medication therapy Educating prescribers Monitoring of patients outcomes Providing information on health related issues

9 Table of Contents 5.5 The Seven-Star-Pharmacist concept of the United Nations Implementation of international best practice elements Definition of Best practice Implementation process Education Germany U.S.A Australia France United Kingdom Discussion Essential community pharmacy services Advanced services Medication Therapy Management (MTM) Consulting Pharmacists Collaborative pharmacy practice including prescribing rights for the community pharmacist Patient Centered Medical Home Implementation of advanced services into German community pharmacies New forms of payment The International Advanced Pharmacy Practice Experience of the University of Minnesota, College of Pharmacy, in a German community pharmacy Implementation of advanced pharmacy services into German community pharmacy according to the recommendations of the ADVISORY COUNCIL on the Assessment of Developments in the Health Care System Introduction New forms of direct patient care Practice Management Implementation in German community pharmacies using the concept of Diffusion of innovation

10 Table of Contents 8.5 Discussion Proposal: Mission Statement for German pharmacists Introduction of a mission statement Proposition of a new mission statement Outlook 127 Bibliography

11 List of Abbreviations ABDA Bundesvereinigung Deutscher Apothekerverbände APhA American Pharmacists Association ApoBetrO Apothekenbetriebsordnung APPE Advance Pharmacy Practice Experience Art. Article BAK Bundesapothekerkammer BGH Bundesgerichtshof BPS Board of Pharmacy Specialties BVDAK Bundesverband der Apothekenkooperationen BVerfG Bundesverfassungsgericht BVerwG Bundesverwaltungsgericht cf. compare to DAZ Deutsche Apotheker Zeitung DES Diplome d Etudes Spécialisées $ Dollar DRP Drug related problems EuGH European Court of Justice FIP Fédération internationale pharmaceutique GPhC General Pharmaceutical Council Euro e.g. for example et al. et alii, et aliae ICDC International Statistical Classification of Diseases and Related Health Problems MAP Medication Action Plan Mpharm Master of Pharmacy MPJE Multistate Pharmacy Jurisprudence Examination MR Medication Review MTM Medication Therapy Management MTR Medication Therapy Review NABP National Association of Boards of Pharmacy NAPLEX North American Pharmacist Licensure Examination N Norm Size n.d. no date NRW Nordrhein-Westfalen 13

12 List of Abbreviations OLG Oberlandesgericht OTC Over the Counter Medication p Page PA Pharmaceutical Advice PA 1-3 Pharmaceutical Advice Levels 1-3 PC Pharmaceutical Care PC 1-3 Pharmaceutical Care Levels 1-3 PCMH Patient Centered Medical Home PCNE Pharmaceutical Care Network Europe PharmD Doctor of Pharmacy PhD Philosophiae Doctor PMR Personal Medication Record pp Pages PQA Pharmacy Quality Alliance PSA Pharmaceutical Society of Australia PTA Pharmazeutisch Technische AssistentIn PZ Pharmazeutische Zeitung RPhS Royal Pharmaceutical Society of Great Britain RBRVS Resource-based-Relative Value Scale System Rx Prescription Drug ( receipe ) v. versus UK United Kingdom WHO World Health Organization Notes: Even though this book uses the male gender for simplification, both females and males are referred to in this thesis (gender neutrality). 14

13 Summary The objectives of this book are to advance the professionalization of German community pharmacists using international best elements to implement new advanced pharmaceutical care practice standards into German community pharmacy. Starting in 2009, the University of Minnesota is offering 4 th year pharmacy students an International Advance Pharmacy Practice Experience (APPE) in a German community pharmacy, developed for this thesis by the author to analyze those pharmaceutical care standards. The evolution of German community pharmacists professional roles will be analyzed using among others Foucauldian exploration of power relations and knowledge claims. For the first time a distinction will be made between the legally required pharmaceutical advice and newly developed forms of advanced pharmaceutical care practices in which specially trained pharmacists are taking responsibility for a patient s drug therapy needs and are held accountable for their commitment. Even though German community pharmacists in 2013 are highly trained and respected health care specialists working for the benefit of their patients, they still lack full autonomous control and authority over certain essential areas of their expertise resulting in an incomplete professionalization. In order to advance the professionalization of community pharmacists to health care professionals, they need to implement advance pharmacy practice standards into their pharmacies. Finally, a new mission statement ( Leitbild ) for German community pharmacists is developed. For this thesis, the Model Act of the National Association of Boards of Pharmacy of the U.S.A. has been adapted for use in Germany by the author with specific authorization by the NABP. 15

14 1. Professional Status of German community pharmacists Over 40 years ago, Shaw (1972) analyzed U.S. community pharmacists lack of social acceptance as true professionals. For Shaw pharmacists were generally alienated from a professional orientation due to the training they received, the structure of interpersonal social relationships in the pharmacy, economic constraints, the lack of ego-autonomy (Shaw, 1972, p. 109) and the mistakes made by the professional organizations of the pharmacists. In Germany, community pharmacists today face a similar paradoxical situation as their American colleagues over 40 years ago. They are expected to have gained the basic technical and theoretical knowledge needed to be entrusted with the health of their patients; however, the teaching of social-professionalism is usually not part of the universities curricula. Indeed, not only do German graduates lack basic concepts of social interaction, official German pharmacy misses the necessity for such training (Morck, Rücker, 2009). In 2012, Smith (2012) published an assessment of the U.S. pharmacists. We will explore if this assessment is also applicable to their German colleagues, especially concerning to their education, their professionalization, and their relationships with patients. Although the pharmacist workforce is well-trained and highly accessible, these community-based health care professionals are underutilized. The general public and health care professionals equate a pharmacist's role and responsibilities with what they see in their own communities and daily lives: pharmacists who primarily dispense prescriptions and perform medication counseling (usually upon request), and have limited interaction with patients. Most patients or other consumers have minimal or no knowledge of a pharmacist's training and expertise. They do not know the depth of pharmacists' training in pharmacology, pharmacokinetics, pharmaceutics, and pharmacoeconomics compared to that of other health care professionals. They do not know that some pharmacists have advanced clinical training through residencies or board certification in pharmacy specialties, including a new specialty in ambulatory care. They do not know that pharmacists perform medication management services in collaboration with physicians and other health care professionals in primary 17

15 1. Professional Status of German community pharmacists care practices. They do not know that pharmacists intervene on a daily basis to prevent or resolve drug therapy problems that can occur with complex regimens, multiple prescribers, multiple pharmacies, or at times of care transition (Smith, 2012, p. 1569). Analyzing the work of German pharmacists in the 21 st century, full autonomous control over their area of expertise exists undisputedly only for those pharmacists working in hospital pharmacy, pharmaceutical industry, research, and regulatory affairs. The current discussion about a mission statement for pharmacists should help community pharmacists to unify in pursuit of achieving full professionalization as health care professionals by redefining their roles and responsibilities. Pharmacy is maturing as a clinical profession and presently is well positioned to transform itself from a product- oriented to a patient-oriented profession. At the root of this change is a movement to revisit the true focus of the profession, namely the patient. The profession as a whole must unequivocally dedicate itself to a philosophy of practice that clearly identifies the patient as its primary beneficiary. (The) inculcation of this new philosophy will require a rational, practical and inclusive approach that engages all segments of the profession (American College of Clinical Pharmacy, 2000, p. 91). Community pharmacists need to combine their two different identities being a health care practitioner and establishing a commercially successful community pharmacy practice. About one hundred years ago, those distinct identities were compatible (Higby, 2010). Over recent years, though, changes have taken place in the way German community pharmacists perform their work. Much of the dispensing work can nowadays be undertaken by less qualified personnel such as the PTA technicians. New tasks have arisen which are all talk based (Pilnick, 2009, p. 268). For Henkel (2011) a pharmacist cannot become a fully qualified health professional solely because of his qualifications as a natural scientist. Pharmacy studies qualify pharmacists to use their competency in chemistry, biology, and technology within the community pharmacy practice. Community pharmacists have not yet successfully implemented those competencies into a health professional context, because a natural scientist cannot work as a health care specialist without any additional qualifications (Pfeifer, 2013 b). In 2012, Pfeifer and Förster published an analysis of the status of pharmaceutical care practice in Germany (2012). Based on this analysis, there is recognition for new pharmaceutical services, also in Germany. (Cipolle 18

16 1. Professional Status of German community pharmacists et al., 2012): While the clinical method used to solve adverse drug events receives universal appeal, there remains the challenge of tailoring the particulars of any medication management system to the actual sociopolitical, legal and cultural context of the country in question. These factors will play a highly significant role in shaping the nature of any medication management system (Cipolle et al., p. 440). Of particular interest in this context is the role of the PTA technicians. In Germany, technicians are considered professionals with a 2.5-year preparation. It is indeed an advantage to delegate a significant portion of the dispensing process to qualified technicians, thereby freeing the pharmacist from the time-consuming task and facilitating her commitment to the more cognitive dimensions of pharmaceutical care, leading to medication management services. The role of technicians is central to the full utilization of the pharmacist s knowledge and problem-solving role. However, the question remains as to whether the retail commercial environment will support a comprehensive patient care service (Cipolle et al., 2012, p. 440). Standardized pharmaceutical projects, as currently performed by some German community pharmacists, may have the potential for a valueadding contribution to overall patient care. Considering the current standards in German community pharmacy practice, however, a comparison with advanced pharmaceutical care practices in other countries would be beneficial to achieve the best possible outcome in patient care. Thus, the objectives of this book are to advance the professionalization of German community pharmacists by using international best practice elements to implement advanced pharmaceutical care practices into German community pharmacy. The current, more conservative perspective of pharmacy in Germany will be challenged. In Chapter 2, we will analyze the development and structure of community pharmacists, their historical development, and their challenges in For the first time a distinction will be made between the legally defined pharmaceutical advice and newly developed forms of advanced pharmaceutical care practices. We will introduce consulting pharmacists and other highly trained specialists who take responsibility for a patient s drug therapy needs and are held accountable for their commitment. Michel Foucault ( ) was an influential but controversial French philosopher and social theorist. Even though Foucault s work did not include studies on pharmacy, we will adapt and analyze the effects of 19

17 1. Professional Status of German community pharmacists Michel Foucault s theories on German community pharmacy practice and their status of professionalization in Chapter 3. Chapter 4 looks at German community pharmacists social authority and professionalization. Using different sociological theories, the status of German community pharmacists professionalization as health care specialists and their relationship with physicians will be analyzed with particular regard to Denzin s and Metlin s theory of pharmacists incomplete professionalization. While Chapter 5 defines quality in pharmacy practice, we will introduce select international best practice elements for German community pharmacists in order to achieve full professionalization in Chapter 6. In contrast to the current conservative approach that all German community pharmacists are providing the same kind of service, Chapter 6 also explores a possible differentiation between essential and advanced services and introduces a new payment structure. In cooperation with the University of Minnesota, College of Pharmacy, the author established the first International Advanced Pharmacy Practice Experience for American students in a German community pharmacy under U.S law and regulations in This APPE is part of the official rotation curriculum for the American students. As of 2013, there have been five groups to visit Germany for a five-week rotation each. The implementation of international best practice standards is one of the key curriculum components of this APPE project and will be analyzed in Chapter 7. In 2009, the ADVISORY COUNCIL on the Assessment of Developments in the Health Care System published its report Coordination and Integration Health Care in an Ageing Society (Advisory Council, 2009), a completely new approach to pharmacy practice, which at that time did not exist in Germany, but was already available in other countries such as the U.S.A., UK, or Australia. Chapter 8 looks at methods to implement those recommendations into German community pharmacy, with particular regard to Rogers Diffusion of Innovations concept (Rogers, 2003). Chapter 9 explores the new mission statement ( Leitbild ) for German pharmacists. The Model Act of the National Association of Boards of Pharmacy of the U.S.A. has been adapted for use in this book with specific authorization by the NABP (NABP, 2013). Finally, Chapter 10 will offer an outlook to the future of community pharmacy practice in Germany. 20

18 2. Community Pharmacists in Germany: History and Challenges 2.1 History The profession of pharmacy dates back to the Sumerian population, living in modern day Iraq. From around 4000 BC, the Sumerians used medicinal plants such as liquorices, mustard, myrrh, and opium (Anderson, 2001). Different people were preparing medicines and in charge of diagnosis and treatment. These precursors to pharmacists (RPhS, n.d) also combined their roles with that of a priest. The Ancient Egyptians had specific preparers of medicine. Pharmacy was viewed as a high status branch of medicine (RPhS, n.d.), and again, like the Sumerians, these pharmacists were priests who worked and practiced in the temples. The term apothecary, used in Britain between the 1600s and 1800s, refers to pharmacists and physicians (but not surgeons), diagnosing and dispensing medicines that they themselves prescribed (Anderson, 2001). Even though the apothecary's practice included a strong dispensing element, apothecaries were also examining and treating patients. They did, however, not charge for this service (Buchholz, 2006), they only charged for the medicines supplied. There were other groups involved in the sale and supply of medicines, the chemists, and druggists (Anderson, 2001). Following a ruling in the Rose Case ( /4), apothecaries became legal members of the medical profession, able to prescribe as well as dispense medicines. Because apothecaries were now moving into a more advisory role, pharmacists could develop their own area of preparation and supply of medicines. However, this put them in fierce competition with the apothecaries, which were also still involved in the same business (Jones, 2006). With the Apothecaries Act of 1815, pharmacists gained control over making medicines. In Germany such a separation between the work of physicians and pharmacists became law almost 400 years earlier. In 1240, the German Emperor Frederick II issued an edict that essentially separated the practice of medicine from pharmacy (Braun, 2000). This edict differentiated between the responsibilities of physicians and those of pharmacists. It laid down regulations for their respective professional practices (Anderson, 2011). This decree provided the basis for simi- 21

19 2. Community Pharmacists in Germany: History and Challenges lar legislation in other European countries. In 1271, the Basle Apothecaries Oath stated that no physician who cares for sick people should own an apothecary s business in Basel (Anderson, 2011). One of first forms of cooperation between pharmacists and physicians was the Nuovo Receptario of 1498 between the Guild of Apothecaries and the Medical Society in Florence, Italy (Anderson, 2011). Until 1945, German pharmacies operated under any one of three possible types of permits (Kremers et al., 1976). Privilegia that could be disposed of as the owners decided Real-Konzession that could be transmitted either by sale or inheritance; however, government confirmation of each transfer was required. Personal-Kozession that gave the right to the operation and the income of one particular pharmacy for a person s lifetime based on professional merit and mainly of length of service as an employed pharmacist. As it was a personal concession to one particular pharmacist, it could not be sold or inherited. Exceptions were pharmacies owned by communities, by organizations, or by the old aristocracy. After the end of World War II the law in the four military occupation zones in Germany regulated the ownership of community pharmacies in different ways. While the British and French zones remained mainly with the concession system, the Americans introduced a complete freedom for operating community pharmacies. In the Soviet zone, the pharmacies came under socialized government operation, which continued also after the foundation of the German Democratic Republic. Within the Federal Republic of Germany, a decision of the Bundesverfassungsgericht, Germany s Supreme Court, in 1958 completely changed community pharmacy and the legal interpretation of Art. 12 of the German Constitution (Bundesverfassungsgericht, 1958). As a result, each registered pharmacist was permitted to open his pharmacy anywhere in Germany as long as the pharmacy was built and operated according to the regulations of German pharmacy law. No more concessions were needed. This historical overview shows us that the professional relationship between pharmacists and physicians always has been subject of intense discussions and legal quarrels- ongoing even today. However, both pharmacists and physicians have to accept new structures in order to achieve a better care process for the patient (Pfeifer, 2013 a). 22