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A Survey of Medicine Use in Children and Adolescents in Austria

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A Survey of Medicine Use in Children and Adolescents in Austria A survey of medicine use in children and adolescents in Austria Doctoral thesis at the Medical University of Vienna for obtaining the academic degree Doctor of Medical Science Submitted by Mag. pharm. Elisabeth Rauch Supervisor: Univ. Prof. Dr. Christoph Male MSc Department of Paediatrics and Adolescent Medicine Waehringer Guertel 18-20 A-1090 Vienna Vienna, date of submission: 10/2016 DECLARATION This thesis project was realised at the Department of Paediatrics and Adolescent Medicine, Medical University of Vienna. Study concept was prepared by Univ. Prof. Dr. Christoph Male MSc and Elisabeth Rauch. Data collection, analysis and interpretation as well as preparation of the original manuscript was done by Elisabeth Rauch under the supervision of Univ. Prof. Dr. Christoph Male MSc (Department of Paediatrics and Adolescent Medicine, Medical University of Vienna) and the co-supervisors Univ. Prof. Dr. Harald Herkner (Department of Emergency Medicine, Medical University of Vienna) and PD Dr. Florian Lagler (Paracelsus Medical University and Clinical Research Center Salzburg). Data amalgamating and statistical analysis was done with support of Ao. Univ. Prof. Mag. Dr. Walter Gall and his students at the Center for Medical Statistics, Informatics and Intelligent Systems (CeMSIIS), Section for Medical Information Management of the Medical University of Vienna. Further statistical support was given by Univ. Prof. Dr. Harald Herkner. The project was financially supported by the Austrian Paediatric Society. ii TABLE OF CONTENTS LIST OF FIGURES ................................................................................................................vi LIST OF TABLES ................................................................................................................vii ABSTRACT ........................................................................................................................ viii ZUSAMMENFASSUNG ........................................................................................................ix ABBREVIATIONS .................................................................................................................xi ACKNOWLEDGEMENTS ....................................................................................................xii 1. GENERAL INTRODUCTION ......................................................................................13 1.1. Children as therapeutic orphans ..................................................................................13 1.2. Legal requirements and their impact on paediatric practice .........................................15 1.2.1. The EU Paediatric Regulation ...................................................................................15 1.2.2. Survey of all paediatric uses of medicinal products in Europe ...................................16 1.3. Evidence of medicine use in children ..........................................................................16 1.4. Status quo of paediatric medicine use in Austria .........................................................18 1.5. Rationale .....................................................................................................................18 2. OBJECTIVES OF THIS THESIS .................................................................................20 2.1. Primary objective .........................................................................................................20 2.2. Secondary objectives ..................................................................................................20 3. METHODS .......................................................................................................................21 3.1. ATC Coding.................................................................................................................21 3.2. Data sources ...............................................................................................................22 3.3. Paediatric medicine use in primary care setting ...........................................................22 3.3.1. Data collection ..........................................................................................................22 3.3.2. Data preparation and coding .....................................................................................24 3.3.3. Challenges and limitations ........................................................................................24 3.3.4. Data analysis ............................................................................................................24 3.4. Paediatric medicine use in hospital care setting ..........................................................25 3.4.1. Data collection ..........................................................................................................25 3.4.2. Data preparation and coding .....................................................................................26 3.4.3. Challenges and limitations ........................................................................................28 3.4.4. Data analysis ............................................................................................................28 3.5. Comparison of paediatric medicine use in primary versus hospital care setting ...........29 3.5.1. Data preparation and coding .....................................................................................29 3.5.2. Data analysis ............................................................................................................30 3.6. Evaluation of off-label use ...........................................................................................30 3.6.1. Definition of off label use ...........................................................................................31 3.6.2. Evaluation of off-label use (according to pre-defined criteria) ....................................32 3.7. Qualitative assessment of use .....................................................................................32 3.7.1. Interviews with selected primary care paediatricians in Vienna .................................32 iii 3.7.2. Analysis of qualitative prescription data regarding approval status ............................36 3.7.3. Analysis of qualitative prescription data in comparison to quantitative primary care data ......................................................................................................37 3.7.4. Variability of prescription habits .................................................................................37 4. RESULTS ........................................................................................................................38 4.1. Prescription frequency of medicines for children and adolescents in primary care setting .....................................................................................................38 4.1.1. Study population .......................................................................................................38 4.1.2. Prescription frequency on ATC level 1 (anatomical class) .........................................40 4.1.3. Prescription frequency on ATC level 2 (therapeutic class) ........................................45 4.1.4. Prescription frequency on ATC level 5 (chemical substance) ....................................49 4.1.5. Prescription frequency of anti-bacterials for systemic use in primary care .................54 4.2. Prescription frequency of medicines for children and adolescents in hospital care setting ....................................................................................................58 4.2.1. Study population / data coverage ..............................................................................58 4.2.2. Prescription frequency on ATC level 1 (anatomical class) .........................................59 4.2.3. Prescription frequency on ATC level 2 (therapeutic class) ........................................63 4.2.4. Prescription frequency on ATC level 5 (chemical substance) ....................................67 4.2.5. Prescription frequency of anti-bacterials for systemic use in hospital care ................71 4.3. Prescription frequency of medicines in primary care versus hospital care setting ........74 4.3.1. Comparison on ATC level 1 (anatomical class) .........................................................74 4.3.2. Comparison on ATC level 2 (therapeutic class) .........................................................76 4.3.3. Comparison on ATC level 5 (chemical substance) ....................................................79 4.3.4. Comparison of prescription frequency of anti-bacterials for systemic use..................80 4.4. Evaluation of licence status of medicines used in children and adolescents ................81 4.4.1. Off-label use in primary care setting ..........................................................................81 4.4.2. Off-label use in hospital care setting .........................................................................82 4.5. Qualitative assessment of medicine use in children and adolescents ..........................85 4.5.1. Qualitative assessment of prescription habits by interview ........................................85 4.5.2. Evaluation of off-label use (based on interviews) ......................................................88 4.5.3. Comparison of qualitative data based on interviews to quantitative data obtained from reimbursement institutions
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