Utilisation and off-label prescriptions of respiratory drugs in children. PloS one 9: e105110. doi: 10.1371/journal.pone.0105110 PMID

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 (297%). Compound classes most frequently involved in off-label prescribing were inhaled bronchodilative compound