Smyth A, Merkus P, Barbato A, Beydon N, Bisgaard H, de Boeck K, Brand P, Bush A, Fauroux B, de Jongste J, Pijnenburg M, Korppi M, O'Callaghan C, Ratjen F, Southern K, Spencer D, Thomson A, Vyas H, Warris A
Respiratory medicines for children: current evidence, unlicensed use and research priorities. [JOURNAL ARTICLE]
Eur Respir J 2009 Nov 6.
Our task force, has reviewed the evidence for paediatric medicines in respiratory disease, occurring in adults and children. We describe off license use, research priorities and ongoing studies.Off license and off label prescribing in children is widespread and potentially harmful. Research areas in asthma include novel formulations/regimens and individualised prescribing. In cystic fibrosis, future studies will focus on screened infants and robust outcome measures are needed. Other areas include new enzyme/antibiotic formulations and the basic defect. Research into pneumonia should include evaluation of new antibacterials/regimens and rapid diagnostic tests and, in pleural infection, antibiotic penetration, fibrinolytics and surveillance. In uncommon conditions, such as primary ciliary dyskinesia; congenital pulmonary abnormalities or neuromuscular disorders, drugs indicated for other conditions (e.g. dornase alfa) are commonly used and trials are needed. In neuromuscular disorders, the beta agonists may enhance muscle strength and need evaluation. Studies of antibiotic prophylaxis, immunoglobulin and anti-fungal drugs are needed, in immune deficiency.We hope that this summary of the evidence for respiratory medicines in children, highlighting gaps and research priorities, will be useful to the pharmaceutical industry, the Paediatric Committee of the European Medicines Agency (EMEA), academic investigators, and the lay public.
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