DISSERTATION „Renal clinical pharmacy services“ Mag.pharm. Gunar Stemer angestrebter akademischer Grad Doktor der Naturwissenschaften (Dr.rer.nat.) Wien, 2011 Studienkennzahl lt. Studienblatt: A 091 449 Dissertationsgebiet lt. Studien- Pharmazie blatt: Betreuerin / Betreuer: Ao. Univ. Prof. Mag. Dr. Rosa Lemmens 2 e pensando di lei mi sopragiunse uno soave sonno ego dominus tuus vide cor tuum e d’esto core ardendo cor tuum lei paventosa umilmente pascea appreso gir io ne vedea piangendo la letizia si convertia in amarissimo pianto io sono in pace cor meum io sono in pace vide cor meum Dante Alighieri La Vita Nuova ~1293 Gewidmet meinen Eltern Annelies und Franz, in aufrichtiger Dankbarkeit und Liebe Dedicated to my parents Annelies and Franz, in sincere gratitude and love 3 4 ACKNOWLEDGEMENTS This thesis would not have been possible without the continuous support, help, and contributions of so many colleagues, companions, friends, and beloved family members. First, I want to express my deepest gratitude to my doctoral advisor, Mrs. Prof. Rosa Lemmens, for her commitment in supervising my thesis work, her support during the writing of this thesis, several constructive discussions with her, and her critical comments. My sincerest thanks are extended to the head of the pharmacy department of the Vienna General Hospital, Mrs. SR Mag. Elfriede Dolinar, for providing me with this unique opportunity to work on the topic of clinical pharmacy and, thus, contribute to the evolution of the complete hospital pharmacy and clinical pharmacy discipline in Austria. I would like to thank her for her trust in my capabilities to succeed in this demanding project over the last three years by implementing new services, her vision regarding the discipline of hospital pharmacy, her overall contribution to the development of the profession of hospital pharmacy, and her continuous belief in the value of clinical pharmacy services. My work would not have been possible without the support and commitment of the nephrology team of the Vienna General Hospital. You deserve my deepest thanks for welcoming me as a member of the ward round team, participating in constructive discussions, asking critical questions and providing empa- thy during our collaboration. Furthermore, I would like to thank all my colleagues from the pharmacy department of the Vienna General Hospital, who have been very supportive during this time. I would like to offer special thanks to my highly appreciated colleagues from the drug information service of the pharmacy department, who played a critical role in the evolution of this thesis. All of my beloved and close friends who accompanied this long journey deserve my greatest thanks. Thanks to all of you for being there when I needed you, for making me ‘put my feet back on the ground’, for being a calming influence during hard and demanding times, and for representing the anchor that one so desperately needs in his life. Finally, and most important, I would like to express my sincerest and endless gratitude and my deepest love and affection to my parents and siblings for standing by me, continuously supporting me, being there for me throughout my life, and providing me with unconditional love and affection. 5 6 TABLE OF CONTENTS 1 INTRODUCTION AND FUNDAMENTAL PRINCIPLES ................................. 9 1.1 DEFINITIONS, CONCEPTS, AND TERMINOLOGY............................................................... 9 1.1.1 HOSPITAL PHARMACY.................................................................................................. 9 1.1.2 CLINICAL PHARMACY ................................................................................................. 11 1.1.3 PHARMACEUTICAL CARE........................................................................................... 13 1.1.4 CLINICAL PHARMACY AND PHARMACEUTICAL CARE.......................................... 15 1.1.5 DRUG-RELATED PROBLEMS ..................................................................................... 16 1.1.6 EVOLUTION OF CLINICAL PHARMACY SERVICES.................................................. 19 1.1.7 CLINICAL PHARMACY SERVICES IN AUSTRIA ........................................................ 20 1.2 RENAL CLINICAL PHARMACY SERVICES........................................................................ 23 1.2.1 DEVELOPMENT AND CONCEPT OF RENAL CLINICAL PHARMACY SERVICES .. 23 1.2.2 RENAL FUNCTION AND ITS IMPAIRMENT ................................................................ 26 1.2.2.1 The kidney and its function .................................................................................. 26 1.2.2.2 Evaluation of kidney function............................................................................... 26 1.2.2.3 Types of kidney failure .......................................................................................... 27 1.2.2.4 Risk factors............................................................................................................. 28 1.2.2.5 Clinical presentation of CKD and management of comorbidities .................... 29 1.2.3 ETIOLOGY AND EPIDEMIOLOGY OF RENAL IMPAIRMENT.................................... 31 1.2.4 SUSCEPTIBILITY FOR DRUG-RELATED PROBLEMS IN PATIENTS WITH RENAL IMPAIRMENT................................................................................................................. 33 2 AIM OF THE THESIS.................................................................................... 37 3 SCIENTIFIC WORK ...................................................................................... 39 3.1 CLINICAL PHARMACY ACTIVITIES IN CHRONIC KIDNEY AND END-STAGE RENAL DISEASE PATIENTS: A SYSTEMATIC LITERATURE REVIEW ........................................ 41 3.2 CLINICAL PHARMACY SERVICES AND SOLID ORGAN TRANSPLANTATION: A LITERATURE REVIEW ......................................................................................................... 65 3.3 EVALUATION OF RISK FACTOR MANAGEMENT OF PATIENTS TREATED ON AN INTERNAL NEPHROLOGY WARD: A PILOT STUDY ........................................................ 79 3.4 INTERIM RESULTS OF NEWLY IMPLEMENTED CLINICAL PHARMACY SERVICES ON AN INTERN NEPHROLOGY WARD..................................................................................... 89 3.5 PRESCRIBING PATTERNS ANALYSIS ON AN INTERN NEPHROLOGY WARD: THE “RENAL” FOCUS!................................................................................................................. 93 3.6 THE CLINICAL PHARMACIST’S CONTRIBUTIONS WITHIN THE MULTIDISCIPLINARY PATIENT CARE TEAM OF AN INTERN NEPHROLGY WARD...........................................111 3.7 COMPREHENSIVE EVALUATION OF CLINICAL PHARMACISTS’ INTERVENTIONS IN A LARGE AUSTRIAN TERTIARY CARE HOSPITAL..........................................................121 7 3.8 SEX-SPECIFIC DIFFERENCES IN METABOLIC CONTROL, CARDIOVASCULAR RISK, AND INTERVENTIONS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS................... 141 3.9 A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, PROSPECTIVE TRIAL TO EVALUATE THE EFFECT OF VILDAGLIPTIN IN NEW-ONSET DIABETES MELLITUS AFTER KIDNEY TRANSPLANTATION................................................................................ 155 4 DISCUSSION ................................................................................................ 163 5 SUMMARY.................................................................................................... 173 5.1 ABSTRACT ENGLISH.......................................................................................................... 173 5.2 ABSTRACT DEUTSCH ........................................................................................................ 174 6 REFERENCES.............................................................................................. 175 7 ABBREVIATIONS......................................................................................... 183 8 APPENDIX.................................................................................................... 185 8.1. INTERIM RESULTS OF NEWLY IMPLEMENTED CLINICAL PHARMACY SERVICES ON AN INTERN NEPHROLOGY WARD ..................................................................................... 185 8.2 PRESCRIBING PATTERNS ANALYSIS ON AN INTERN NEPHROLOGY WARD: THE “RENAL” FOCUS!................................................................................................................. 187 8.3 CLINICAL PHARMACY SERVICES IN THE LARGEST AUSTRIAN TERTIARY CARE HOSPITAL ............................................................................................................................. 189 9 CURRICULUM VITAE.................................................................................. 191 8 1 INTRODUCTION AND FUNDAMENTAL PRINCIPLES 1.1 DEFINITIONS, CONCEPTS, AND TERMINOLOGY 1.1.1 HOSPITAL PHARMACY According to the definition of the European Association of Hospital Pharmacists (EAHP), hospital pharmacy is “the health care service, which comprises the art, practice, and profession of choosing, preparing, storing, compounding, and dispensing medicines and medical devices, advising healthcare professionals and patients on their safe, effective and efficient use. Hospital pharmacy is a specialised field of pharmacy which forms an integrated part of patient health care in a health facility“ (EAHP 2010). The centre and overarching goal of hospital pharmacists regarding all medicine-related activities in the hospital is to apply the “seven rights”, which are as follows: