Abstract

CABRAL, António Jorge  and  MORAIS-ALMEIDA, Mário. Beyond the leaflet: Off-label prescription for allergic disease in pre-school children. Rev Port Imunoalergologia [online]. 2013, vol.21, n.1, pp.9-18. ISSN 0871-9721.

Background: Several studies have demonstrated that off-label use of medication is common in children with allergic disease. In Portugal, few studies refer to this subject and none have specifically studied drugs used in allergic disease. Objectives: Characterization of off-label prescription for asthma, allergic rhinitis and atopic eczema in preschool children accompanied in an immunoallergology consultation. Methods: Revision of clinical files of children 6 years old and under accompanied in an immunoallergology consultation with phenotypes of asthma and/or allergic rhinitis and/or atopic eczema in a total of 500 patients, consecutively observed from January to June 2012. The data collected included gender, age, diagnosis and prescriptions with respective daily dosage. Results: A total of 1224 prescriptions were registered. The most prescribed medications were oral antihistamines (34.6%), antileucotrienes (22.6%), topical nasal steroids (20.3%) and inhaled steroids (17.7%). From the total of prescriptions, 422 (34.5%) were considered off-label, for age (62.6%), dosage (31.7%) or clinical indication (5.7%). Mometasone, fluticasone and levocetirizine had the most off-label prescriptions. Off-label use was more frequent in children younger than 2 years with 73.5% of all prescriptions at this age. Conclusions: Off -label use of anti-allergy drugs in pediatrics for the treatment of asthma, allergic rhinitis and atopic eczema is high due to lack of clinical trials. This happens for a several reasons, namely the low economic interest from the pharmaceutical companies, the need for age -appropriate equipment and techniques and the presence of ethical issues. However, these prescriptions aren’t necessarily wrong and are recommended in many guidelines. Randomized controlled studies are limited by methodological difficulties creating the need for more observational studies in order to further evaluate the safety and efficacy of drugs used in children.

Keywords : Asthma; atopic eczema; child; infant; off-label prescription; preschool; rhinitis.

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