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JANA LASS Epidemiological and Clinical Aspects of Medicines Use in Children in Estonia

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JANA LASS Epidemiological and Clinical Aspects of Medicines Use in Children in Estonia DISSERTATIONES JANA LASS MEDICINAE UNIVERSITATIS TARTUENSIS 203 Epidemiological and clinical aspects of medicines use in children in Estonia Epidemiological and clinical aspects of medicines use in children JANA LASS Epidemiological and clinical aspects of medicines use in children in Estonia Tartu 2012 ISSN 1024–395X ISBN 978–9949–32–204–6 DISSERTATIONES MEDICINAE UNIVERSITATIS TARTUENSIS 203 DISSERTATIONES MEDICINAE UNIVERSITATIS TARTUENSIS 203 JANA LASS Epidemiological and clinical aspects of medicines use in children in Estonia Institute of Microbiology, University of Tartu, Estonia Dissertation is accepted for the commencement of the degree of Doctor of Philosophy in Medicine on 19.12.2012 by the Council of the Faculty of Medicine, University of Tartu, Estonia. Supervisor: Professor Irja Lutsar, MD, PhD Institute of Microbiology, University of Tartu, Tartu, Estonia Reviewers: Professor Jyrki Tapio Heinämäki, Dr. Pharm Pharmacy Faculty, University of Tartu, Tartu, Estonia Kersti Oselin, MD, PhD, specialist State Agency of Medicines, Bureau of Clinical Assessment, Tartu, Estonia Opponent: Professor Dr. Jörg Breitkreutz Institute of Pharmaceutical Technology and Biopharmacy Heinrich-Heine University, Düsseldorf, Germany Commencement: 31st of January 2013 Publication of this dissertation is granted by Tartu University. This research was supported by the European Regional Development Fund and by the European Social Fund ISSN 1024–395X ISBN 978–9949–32–204–6 (print) ISBN 978–9949–32–205–3 (pdf) Copyright: Jana Lass, 2012 University of Tartu Press www.tyk.ee Order No 654 TABLE OF CONTENTS LIST OF ORIGINAL PUBLICATIONS ...................................................... 7 ABBREVIATIONS ....................................................................................... 8 1. INTRODUCTION .................................................................................... 10 2. REVIEW OF LITERATURE ................................................................... 11 2.1. Licensing of medicines ...................................................................... 11 2.1.1. Licensing of paediatric medicines .......................................... 12 2.2. Paediatric drug utilisation studies ...................................................... 14 2.2.1. Methodology of drug utilisation studies in children ............... 14 2.2.2. Paediatric drug utilisation studies in practice ......................... 17 2.3. Off-label (OL) and unlicensed (UL) use of medicines in children ... 18 2.3.1. Definitions .............................................................................. 18 2.3.2. Extent of OL/UL use of medicines ......................................... 20 2.3.3. OL use according to the therapeutic groups and products ...... 28 2.3.4. What problems may OL/UL use of medicines cause? ............ 28 2.3.5. Data sources for paediatric medicines information ................ 30 2.4. Pharmaceutical excipients ................................................................. 32 2.4.1. Paediatric and neonatal issues with pharmaceutical excipients ................................................................................ 33 2.5. Summary of the literature .................................................................. 36 3. AIMS OF THE RESEARCH .................................................................... 38 4. PATIENTS AND METHODS .................................................................. 39 4.1. Ethics ................................................................................................. 39 4.2. Design of the studies and data collection .......................................... 40 4.3. Age categories of study population ................................................... 41 4.4. Assessment of licensing status of the medicines ............................... 42 4.5. Classification of excipients according to their potential toxicity to neonates ............................................................................................ 43 4.6. Analysis of the data ........................................................................... 43 5. RESULTS AND DISCUSSION ............................................................... 45 5.1. Demographics of the study populations ............................................ 45 5.1.1. Ambulatory patients in Estonia and Sweden .......................... 45 5.1.2. Hospitalised neonates ............................................................. 45 5.2. Drug utilisation pattern ...................................................................... 47 5.2.1. Ambulatory drug utilisation .................................................... 47 5.2.2. Prescription pattern of antibiotics in Estonia compared to Sweden ................................................................................... 49 5.2.3. Prescriptions for hospitalised neonates ................................... 52 5.3. OL use of medicines .......................................................................... 55 5.3.1. Ambulatory OL use ................................................................ 55 5 5.3.2. OL medicines use in hospitalised neonates ............................ 62 5.3.3. Contraindicated medicines ..................................................... 64 5.4. Extent of UL use of medicines .......................................................... 66 5.5. Availability of paediatric medicines information .............................. 67 5.5.1. Drug information for ambulatory prescriptions ...................... 67 5.5.2. Neonatal medicines information ............................................. 70 5.6. Extent of excipient use ...................................................................... 72 5.6.1. Classification of excipients ..................................................... 72 5.6.2. Neonatal exposure to excipients ............................................. 72 6. GENERAL DISCUSSION ........................................................................ 76 6.1. Studies on the paediatric prescription pattern and OL medicines use 76 6.2. Evidence-based paediatric drug information – from where should it come? ................................................................................................ 76 6.3. Prioritisation of paediatric medicines research ................................. 78 6.4. What to do with the UL medicines? .................................................. 80 6.5. Drug formulation excipients and safer neonatal pharmacotherapy ... 81 6.6. Limitations of the study ..................................................................... 82 6.7. Suggestions for future research ......................................................... 83 7. CONCLUSIONS ....................................................................................... 84 8. REFERENCES .......................................................................................... 86 9. SUMMARY IN ESTONIAN .................................................................... 96 ACKNOWLEDGEMENTS .......................................................................... 101 PUBLICATIONS .......................................................................................... 103 CURRICULUM VITAE ............................................................................... 157 6 LIST OF ORIGINAL PUBLICATIONS I Lass J, Irs A, Pisarev H, Leinemann T, Lutsar I. Off-label use of pre- scription medicines in children in outpatient setting in Estonia is com- mon. Pharmacoepid Drug Safety 2011; 20: 474–481. II Lass J, Käär R, Jõgi K, Varendi H, Metsvaht T, Lutsar I. Drug utili- sation pattern and off-label use of medicines in Estonian neonatal units. Eur J Clin Pharmacol 2011; 67:1263–1271. III Lass J, Naelapää K, Shah U, Varendi H, Käär R, Turner M, Lutsar I. Hospitalised neonates commonly receive potentially harmful excipients. BMC Paediatrics 2012; 12: 136. IV Lass J, Odlind V, Irs A, Lutsar I. Antibiotic prescription preferences in paediatric outpatient setting in Estonia and Sweden. Springer Plus 2012 (submitted) Degree of the applicant’s personal contribution to the publications: In all publi- cations Jana Lass participated in study design, data collection, analysis and interpretation of data from studies. She drafted all manuscripts and was respon- sible for the responses and updates throughout the review process. 7 ABBREVIATIONS ADR Adverse drug reaction BNFC British National Formulary for Children EHIF Estonian Health Insurance Fund EMA European Medicines Agency EOS Early onset sepsis EU European Union FDA Food and Drug Administration GCP Good clinical practice GA Gestational age GFR Glomerular filtration rate GW Gestational weeks ICH The International Conference on Harmonization ISPE International Society for Pharmacoepidemiology LOS Late onset sepsis MA Marketing authorisation NSAID Non-steroidal anti infective drugs OTC medicines Over-the-counter medicines OL Off-label PDCO EMA Paediatric Committee PICU Paediatric intensive care unit PIP Paediatric investigation plan PK Pharmacokinetics PMA Postmenstrual age PNA Postnatal age PUMA Paediatric Use Marketing Authorisation SPC Summary of product characteristic SSRI Selective serotonin reuptake inhibitors TCH Tallinn Children’s Hospital TEDDY Task-force in Europe for Drug Development for the Young TUC Tartu University Clinics UL Unlicensed 8 DEFINITIONS Crude 1 year Proportion of the paediatric population who had one prevalence of drug use or more prescriptions issued during the study period. Medicinal product
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