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Published on: April 6, 2017
Utilisation and off-label prescriptions of respiratory drugs in children
Sven Schmiedl1, Rainald Fischer2, Luisa Ibáñez3
1Department 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.
Insights
Off-label respiratory drug use in children is common, particularly for bronchodilative compounds prescribed for infections like acute bronchitis. This highlights a need for more rational prescribing practices in pediatric respiratory care.
Area of Science:
- Pediatric Pharmacology
- Respiratory Medicine
- Drug Utilization Research
Background:
- Respiratory drugs are frequently prescribed for children, encompassing both approved and unapproved uses.
- Comprehensive data on the extent and patterns of off-label respiratory drug use in pediatric populations are limited.
Purpose of the Study:
- To analyze the utilization patterns and off-label prescribing of respiratory drugs in children.
- To specifically investigate age- and indication-related off-label use of these medications.
Main Methods:
- Utilized data from the Bavarian Association of Statutory Health Insurance Physicians database (2004-2008) covering approximately 2 million children (age ≤18 years).
- Calculated annual period prevalence rates (PPRs) per 10,000 children.
- Determined the proportion of age- and indication-related off-label prescriptions, stratified by age and gender.
Main Results:
- Fixed combination clenbuterol/ambroxol and inhaled short-acting beta-2-agonist salbutamol showed the highest period prevalence rates.
- Oral salbutamol exhibited the largest relative increase in PPR (approx. 39-fold), while oral clenbuterol showed a significant decrease (-97%).
- Inhaled bronchodilative compounds and oral beta-2-agonists were most frequently involved in off-label prescribing; indication-related off-label use was more prevalent than age-related use, often for respiratory tract infections, particularly in younger children.
Conclusions:
- Off-label prescribing of respiratory drugs is a significant issue in pediatric care, especially for young children.
- Bronchodilative drugs are commonly prescribed off-label for conditions such as acute bronchitis and upper respiratory tract infections.
- There is a clear need for more evidence-based and rational prescribing of respiratory medications in the pediatric population.
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.
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