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PP-36 Therapeutic indications for use of extemporaneous glucocorticoid formulations in children – the glufic study
  1. Schmidt1,
  2. Haslund-Krog1,
  3. Jørgensen2,
  4. LambrechtseHolst
  1. 1Bispebjerg Hospital, FREDERIKSBERG, Denmark
  2. 2Department of Paediatric and Adolescence Medicine, Nordsjællands Hospital, HILLERØD, Denmark

Abstract

Background The majority of young children with wheezing have transient symptoms typically associated with viral upper respiratory tract infections and do not have increased risks of asthma later in life. Episodes with severe respiratory symptoms are reported in these chil-dren too. How to diagnose these patients makes clear ev-idence based treatment guidelines unfeasible. Children aged 0–5 years with wheezing may be symptomatically treated with inhaled short-acting beta-2-adrenergic-ago-nist therapy. If no relief of symptoms or severe symptoms, treatment guidelines recommend oral or systemic gluco-corticoids. Since no exact therapeutic interval exists for oral glucocorticoids, there is inconsistency on the dosing recommendations. Moreover, currently the only licensed glucocorticoid preparations in Denmark are tablets or i.v. formulations. These formulations are not suitable, since young children are unable to swallow tablets, and i.v. ad-ministration is associated with unnecessary discomfort. In consequence, children younger than 5 years are treated with extemporaneous preparations, off-label, or unli-censed medications. Use of extemporaneous formula-tions prelude several drawbacks e.g. formulation diversity, differences in bioavailability, limited shelf-live, safety-pro-file, taste etc. Despite the wide therapeutic index of glu-cocorticoids, it is important that they are administrated at the lowest effective dose as a considerable number of dose dependent adverse events exist for these drugs.

Objective To describe the use of extemporaneous glu-cocorticoids in children≤5 years of age diagnosed with acute symptoms of asthmatic bronchitis, compared to existing guidelines across three regional paediatric depart-ments. Second, to examine if high or low dose glucocor-ticoid influences the length of hospitalisation.

Methods A descriptive, chart-based study including three paediatric departments in the Capital Region of Denmark. All patients 0–5 years of age diagnosed with acute symptoms of asthmatic bronchitis in 2013–2015 were eligible for inclusion at the day they received at least one extemporaneously prepared administration of pred-nisolone.

Results During the three-year period almost 560 ad-missions were included, of which 70% were boys. The average age was 22,3 months±13,3, and the average weight 12,2 kg ±2,9. A priori, the paediatric wards used dif-ferent dosing regimens, which were reflected in the data, primarily varying from 1 mg/kg to 2 mg/kg for the first dose administrated. The patients received eight different kinds of extemporaneous formulations, with no obvious pattern of choice. For statistical analyses COX-regression were used. No coherence between dosing and length of hospitalisation were found.

Conclusion This survey shows that the paediatric depart-ments used a variety of extemporaneous liquid prednis-olone formulations interchangeably. The degree of in-consistency raises issues concerning optimal dosing and potential toxicity. Since no association between higher doses and shorter length of hospitalisation were found we hope to encourage the paediatric departments to align the choice of formulation and dosing in order to select lowest effective dose.

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