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.
Highlights
Respiratory drugs are frequently prescribed to paediatric patients for a wide range of airway diseases but most of these drugs are only approved for asthma and COPD from a particular age onwards [1,2]
Drug utilization Within the study period, highest annual period prevalence rates (PPRs) were found for the fixed combination of oral clenbuterol/ambroxol and the inhaled short acting beta-2agonist salbutamol
Regarding relative PPR changes, highest increases were found for oral salbutamol and the fixed combination beclomethasone whereas the most distinct decrease was found for oral clenbuterol (297%) and inhaled terbutaline (277%, figure 1)
Summary
Respiratory drugs are frequently prescribed to paediatric patients for a wide range of airway diseases but most of these drugs are only approved for asthma and COPD from a particular age onwards [1,2]. Respiratory drugs are frequently used for symptomatic improvement of airway diseases (e.g. acute respiratory infections) or are prescribed as a diagnostic instrument to confirm a diagnosis of asthma [1,2]. All these reasons contribute to a high fraction of children receiving respiratory medication as off-label treatment [1,2], a factor which has been reported as a risk for adverse drug reactions [4,5,6]. Some other aspects as for example time trends in off-label prescriptions or gender-related aspects have not been analysed in detail in these studies
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
