Off-label prescribing for allergic diseases in pre-school children. 2014

M Morais-Almeida, and A J Cabral
Immunoallergy Department, CUF Descobertas Hospital, Lisbon, Portugal. Electronic address: mmoraisalmeida@netcabo.pt.

BACKGROUND Several studies have demonstrated that medication is commonly used off-label in children with allergic diseases. The aim of this study was to characterise off-label use of prescriptions for allergic diseases in pre-school children from an allergology outpatient unit. METHODS The clinical files of children aged ≤ 6 years seen in a reference allergology consultation with asthma, allergic rhinitis, and/or atopic eczema were reviewed. A total of 500 patients were consecutively observed from January to June 2012. The data collected included gender, age, diagnosis, and prescriptions with the respective daily dosage. RESULTS A total of 1224 prescriptions were registered. The most prescribed medications were oral antihistamines (34.6%), antileukotrienes (22.6%), topical nasal corticosteroids (20.3%), and inhaled corticosteroids (17.7%). From all prescriptions, 422 (34.5%) were considered off-label for age (62.6%), dosage (31.7%), or clinical indication (5.7%). Off-label use was more frequent in children aged <2 years, with 73.5% prescribed for children of this age. CONCLUSIONS Off-label use of drugs for the treatment of paediatric allergic diseases is high. However, these prescriptions are not necessarily wrong, and are recommended in many guidelines. Randomised 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.

UI MeSH Term Description Entries
D006967 Hypersensitivity Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen. Allergy,Allergic Reaction,Allergic Reactions,Allergies,Hypersensitivities,Reaction, Allergic,Reactions, Allergic
D007223 Infant A child between 1 and 23 months of age. Infants
D008297 Male Males
D010818 Practice Patterns, Physicians' Patterns of practice related to diagnosis and treatment as especially influenced by cost of the service requested and provided. Clinical Practice Patterns,Physician's Practice Patterns,Clinical Practice Pattern,Pattern, Clinical Practice,Patterns, Clinical Practice,Practice Pattern, Clinical,Practice Patterns, Clinical,Practice Patterns, Physician's,Prescribing Patterns, Physician,Physician Practice Patterns,Physician Prescribing Pattern,Physician Prescribing Patterns,Physician's Practice Pattern,Physicians' Practice Pattern,Physicians' Practice Patterns,Practice Pattern, Physician's,Practice Pattern, Physicians',Practice Patterns, Physician,Prescribing Pattern, Physician
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D056687 Off-Label Use The practice of prescribing or using a drug or a vaccine outside the scope of the drug's official approved label as designated by a regulatory agency concerning the treatment of a particular disease or condition. Dose-Sparing Drug Use,Fractional Dose Drug Use,Off-Label Prescribing,Reduced-Dose Drug Use,Unlabeled Indication,Dose Sparing Drug Use,Dose-Sparing Drug Uses,Indication, Unlabeled,Off Label Prescribing,Off Label Use,Off-Label Prescribings,Off-Label Uses,Prescribing, Off-Label,Reduced Dose Drug Use,Reduced-Dose Drug Uses,Unlabeled Indications
D018926 Anti-Allergic Agents Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) Anti-Allergic,Anti-Allergic Agent,Anti-Allergy Drug,Antiallergic,Antiallergic Agent,Antiallergic Drug,Anti-Allergics,Anti-Allergy Drugs,Antiallergic Agents,Antiallergic Drugs,Antiallergics,Antiallergy Agents,Agent, Anti-Allergic,Agent, Antiallergic,Agents, Anti-Allergic,Agents, Antiallergic,Agents, Antiallergy,Anti Allergic,Anti Allergic Agent,Anti Allergic Agents,Anti Allergics,Anti Allergy Drug,Anti Allergy Drugs,Drug, Anti-Allergy,Drug, Antiallergic,Drugs, Anti-Allergy,Drugs, Antiallergic

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