In‐label and off‐label use of respiratory drugs in the Italian paediatric population

Abstract

In Italy, many respiratory drugs are approved for the treatment of paediatric respiratory diseases, but a remarkable percentage of their prescriptions is off-label. This pharmaco-utilization study demonstrates that there is a need to perform clinical studies aimed at increasing the current knowledge on marketed paediatric drugs, and to revise and re-label the existing regulatory documents to reduce their off-label uses.

Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review

“…In the case of the respiratory system, anticholinergic and β 2 adrenoreceptors agonists are drugs to treat associated diseases, and our findings show that off-label and/or unlicenced prescriptions included items such as ipratropium bromide [19,21,31,42] and salbutamol [19,21,23,25,42]. Some authors [58][59][60] reported that drugs used for the respiratory system were widely administered and that a high percentage of such drugs were prescribed off-label, accounting for 20 % of all prescriptions.…”

Utilisation and Off-Label Prescriptions of Respiratory Drugs in Children

“…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]. In young children, diagnosing asthma is difficult due to general limitations (e.g.…”

“…In addition, 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]–[6].…”

“…Whereas some data are available about anti-asthmatic drug utilisation in children [7], [8], the extent of off-label usage for these compounds has been quantified only in few studies [1], [2], [9]. Furthermore, generalizability of off-label results is limited due to e.g.…”

Respiratory drugs prescribed off-label among children in the outpatient clinics of a hospital in Malaysia

“…However, research on the safety and efficacy of these drugs with children is still lacking [8]. Baiardi et al [9] reported that a significant percentage of the medicines used for pediatric respiratory diseases in Italy were prescribed offlabel. The evidence available for the use of medicines in children with respiratory diseases has been reviewed by the European Respiratory Society task force which highlighted the gaps and research priorities in this area [10].…”