Off-label prescribing for allergic diseases in children

World Allergy Organization Journal

Mário Morais-Almeida³  Ignacio Ansotegui¹  Diana Silva² 

[1] Department of Allergy and Immunology, Hospital Quirón Bizkaia, Carretera de Leioa-Unbe, 33 Bis., 48950 Erandio, Spain;Immunoallergology Department, CUF Descobertas Hospital, R. Mário Botas, 1998-018 Lisboa, Portugal;Center for Research in Health Technologies and Information Systems, University of Porto, Porto, Portugal

关键词: Drugs;    Anti-asthmatic agents;    Rhinitis;    Atopic dermatitis;    Urticaria;    Asthma;    Unlicensed;    Off-label use;    Preschool child;    Child;   

Others  :  802619
DOI  :  10.1186/1939-4551-7-4

 received in 2013-09-03, accepted in 2014-01-22,  发布年份 2014

【 摘 要 】

The majority of drugs prescribed have not been tested in children and safety and efficacy of children’s medicines are frequently supported by low quality of evidence. Therefore, a large percentage of prescriptions for children in the clinical daily practice are used off label. Despite the several recent legislation and regulatory efforts performed worldwide, they have not been successful in increasing availability of medicines adapted to children. Moreover, if we consider that 30% of the prescribed drugs for children are for the respiratory field and only 4% of new investigation projects for children research were proposed to access drugs for respiratory and allergy treatment, there is a clear imbalance of the children needs in this therapeutic area. This narrative review aimed to describe and discuss the off-label use of medicines in the treatment and control of respiratory and allergic diseases in children. It was recognized that a large percentage of prescriptions performed for allergy treatment in daily clinical practice are off label. The clinicians struggle on a daily basis with the responsibility to balance risk-benefits of an off-label prescription while involving the patients and their families in this decision. It is crucial to increase awareness of this reality not only for the clinician, but also to the global organizations and competent authorities. New measures for surveillance of off-label use should be established, namely through population databases implementation. There is a need for new proposal to correct the inconsistency between the priorities for pediatric drug research, frequently dependent on commercial motivations, in order to comply to the true needs of the children, especially on the respiratory and allergy fields.

【 授权许可】

   
2014 Silva et al.; licensee BioMed Central Ltd.

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