title: Utilisation and off-label prescriptions of respiratory drugs in children.
abstract: Respiratory drugs are widely used in children to treat labeled and non-labeled indications but only some data are available quantifying comprehensively off-label usage. Thus, we aim to analyse drug utilisation and off-label prescribing of respiratory drugs focusing on age- and indication-related off-label use. Patients aged ≤18 years documented in the Bavarian Association of Statutory Health Insurance Physicians database (approx. 2 million children) between 2004 and 2008 were included in our study. Annual period prevalence rates (PPRs) per 10,000 children and the proportion of age- and indication-related off-label prescriptions were calculated and stratified by age and gender. Within the study period, highest PPRs were found for the fixed combination of clenbuterol/ambroxol (between 374-575 per 10,000 children) and the inhaled short acting beta-2-agonist salbutamol (between 378-527 per 10,000 children). Highest relative PPR increase was found for oral salbutamol (approx. 39-fold) whereas the most distinct decrease was found for oral long-acting beta-2-agonist clenbuterol (-97%). Compound classes most frequently involved in off-label prescribing were inhaled bronchodilative compounds (91,402; 37.3%) and oral beta-2-agonists (26,850; 22.5%). The highest absolute number of off-label prescriptions were found for inhaled salbutamol (n = 67,084; 42.0%) and oral clenbuterol/ambroxol (fixed combination, n = 18,897; 20.7%). Off-label prescribing due to indication was of much greater relevance than age-related off-label use. Most frequently, bronchodilative compounds were used off-label to treat respiratory tract infections. Highest off-label prescription rates were found in the youngest patients without relevant gender-related differences. Off-label prescribing of respiratory drugs is common especially in young children. Bronchodilative drugs were most frequently used off-label for treating acute bronchitis or upper respiratory tract infections underlining the essential need for a more rational prescribing in this area.
authors.affiliation: Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany; Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Wuppertal, Germany.
authors.forename: Sven
authors.initials: S
authors.lastname: Schmiedl
authors.affiliation: Pneumologische Praxis München-Pasing, Munich, Germany.
authors.forename: Rainald
authors.initials: R
authors.lastname: Fischer
authors.affiliation: Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain; Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Luisa
authors.initials: L
authors.lastname: Ibáñez
authors.affiliation: Novartis Farmaceutica S.A., Barcelona, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Fortuny
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Division Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands.
authors.forename: Olaf H
authors.initials: OH
authors.lastname: Klungel
authors.affiliation: Epidemiology, Pfizer, New York, New York, United States of America.
authors.forename: Robert
authors.initials: R
authors.lastname: Reynolds
authors.affiliation: National Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany.
authors.forename: Roman
authors.initials: R
authors.lastname: Gerlach
authors.affiliation: National Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Tauscher
authors.affiliation: Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany; Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Wuppertal, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Thürmann
authors.affiliation: Institute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universitaet, Munich, Germany.
authors.forename: Joerg
authors.initials: J
authors.lastname: Hasford
authors.affiliation: Institute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universitaet, Munich, Germany.
authors.forename: Marietta
authors.initials: M
authors.lastname: Rottenkolber
mesh_terms: D002648:Child; D002675:Child, Preschool; D011307:Drug Prescriptions; D004363:Drug Utilization; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008297:Male; D056687:Off-Label Use; D015995:Prevalence; D012140:Respiratory Tract Diseases / Q000188:drug therapy*