Abstract

CASARES ALONSO, I.; CANO GARCINUNO, A.; BLANCO QUIROS, A.  and  PEREZ GARCIA, I.. Off-label prescription of anti-asthmatic agents in Primary Care. Rev Pediatr Aten Primaria [online]. 2015, vol.17, n.67, pp.237-246. ISSN 1139-7632.  https://dx.doi.org/10.4321/S1139-76322015000400005.

Introduction and objectives: off-label prescribing is when performed outside of the official information of the product. Overall figures of off-label prescribing in primary care in different countries are 3-67%. The aim of the study was to determine the intensity of this type of prescription in anti-asthmatic agents in a recent period of time, in Castilla y León. Methods: the requirements for the therapeutic subgroup R03 (anti-asthmatic agents) prescribed in children less than 14 years of age in the Castilla-León health service from 2005 to 2010 were analyzed. Information on off-label prescribing is shown in number of anti-asthmatic prescriptions consumed at doses and/or at ages not recommended in its technical specifications. Results: a total of 394 876 prescriptions for anti-asthmatic agents were performed to an exposed population of 1 580 229 person-years. Children under four years received the highest levels of anti-asthmatic agents. The maximum prescription of bronchodilators occurred in children under 2 years, and of montelukast and single inhaled corticosteroids at one year of age. 46% of prescriptions of systemic salbutamol and 15.9% of maintenance therapy prescriptions were made in an off-label manner. Conclusions: the study shows an important and very early use of anti-asthmatic agents at ages where it is difficult to make a diagnosis of asthma and also a remarkable consumption of controller therapy at not authorized dose and/or ages. Off-label prescription do not presuppose inappropriate prescription but it should have a real benefit to the patient and be supported by scientific guarantees to justify its use.

Keywords : Off-label use; Anti-asthmatic agents; Drug utilization studies; Primary Care; Children; Retrospective studies.

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