gms | German Medical Science

Background: Respiratory drugs are widely prescribed to children but there are only limited data quantifying the extent of off-label prescribing. In particular for Germany, comprehensive studies taking into account different types of off-label prescribing are missing. Hence, we aim to analyse off-label prescribing due to age and/or indication of respiratory drugs in children.

Materials and Methods: Patients aged ≤ 18 years and documented in the Bavarian Association of Statutory Health Insurance Physicians database (KVB, approx. 2 million children) between 2004 and 2008 were included in this study. In this claims database, a prescription was recorded only if it was prescribed and filled at the pharmacy. Diagnoses and drugs were coded according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10-GM) and the Anatomical Therapeutic Chemical (ATC-) classification system, respectively. All analyses were restricted to drugs of the ATC class ‘R’ with an annual period prevalence rate for the year 2008 of at least 0.1 per 10,000 children in the KVB database. Off-label prescriptions of respiratory drugs were presented as proportion and stratifications by type of off-label prescriptions (‘age’, ‘indication’, and ‘age&indication’), patient’s age (one-year age groups) and gender were performed. Off-label prescribing was defined based on the lower approved age and the approved indication according to the summary of product characteristics (SPC) and the Pharmaceutical Index for Germany for the years 2004 and 2008.

Results: For the year 2008, inhaled bronchodilative compounds (n=91,402; 37.3%) and oral beta-2-agonists (n=26,850; 22.5%) were the compound classes most frequently involved in off-label prescribing. 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%). Indication-related off-label prescribing was present in more patients compared to age-related off-label use for most of the drug classes. For bronchodilative compounds, the most frequent off-label indications were acute bronchitis and upper respiratory tract infections. The proportion of patients with off-label prescriptions was highest in youngest children without relevant gender-related differences. Regarding changes over time (2004 versus 2008), the increase in the absolute number of off-label prescriptions was highest for inhaled salbutamol (n=21,841; +48.3%) whereas the highest decrease was found for cromoglicic acid (n=-10,195; -75.8%).

Conclusion: Off-label prescribing of respiratory drugs is common in particular in young children of both genders. Bronchodilative drugs were most frequently used off-label for treating acute respiratory tract infections. Since there is some evidence for an increased risk for adverse drug reactions in children receiving off-label treatment, our data underline the essential need for a more rational prescribing in this field.