Variation in Extemporaneous Glucocorticoid Formulations and Doses for Asthma-like Symptoms in Children

Abstract

Treatment strategies for asthma-like symptoms are challenging with no international consensus on dose of systemic glucocorticoids. Despite, asthma-like symptoms remain one of the most common medical conditions seen in infants and preschool children. This is further complicated by limited licensed preparations and use of various extemporaneously prepared formulations in some countries. In Denmark, all extemporaneous formulations are produced according to GMP, which is different from other European countries. This retrospective cohort study examined the type and dose of extemporaneously prepared glucocorticoid formulations prescribed to infants and preschool children 0-5 years of age with acute asthma-like symptoms over a three-year period at three paediatric departments in the Capital Region of Denmark covering 1.8 mill inhabitants. In total 4877 patients were screened for eligibility. In addition, length of hospitalisation, prescribed co-medication, readmission, and adverse events were registered. Almost one in ten of the patients were treated with extemporaneous prednisolone. Eight different formulations were used interchangeably despite lack of studies supporting therapeutic equivalence between these formulations. Further, a higher dose did not result in shorter hospitalisation.

Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review

“…The previous study observed variations in the extemporaneous glucocorticoid for asthma therapy in children. It was confirmed to affect the length of hospitalization and other adverse effects (12 cases found) [ 38 ]. Therefore, it is necessary to establish standards for the compounding process, including standard formulas, appropriate equipment, and trained personnel [ 39 ].…”