Neumann, U., Burau, D., Spielmann, S. et al. (4 more authors) (2017) Quality of compounded hydrocortisone capsules used in the treatment of children. European Journal of Endocrinology, 177 (2). ISSN 0804-4643
Abstract
Objectives: Due to the lack of paediatric licensed formulations, children are often treated with individualized pharmacy-compounded adult medication. An international web-based survey about the types of medication in children with adrenal insufficiency (AI) revealed that the majority of paediatric physicians are using pharmacy-compounded medication to treat children with AI. Observations of loss of therapy control in children with congenital adrenal hyperplasia with compounded hydrocortisone capsules and regained control after prescribing a new hydrocortisone batch led to this "real world" evaluation of pharmacy-compounded paediatric hydrocortisone capsules. Methods: Capsule samples were collected randomly from volunteering parents of treated children suffering from congenital adrenal hyperplasia from all over Germany. Analysis of net mass and hydrocortisone content by HPLC-UV (high performance liquid chromatography) method were performed based on the European Pharmacopeia. Results: In total 61 batches were sent in. 5 batches could not be analyzed because of missing dose information, insufficient number of capsules or were not possible to be evaluated. 56 batches containing 1125 capsules were evaluated. 21.4% of the batches revealed insufficiency in uniformity of net mass or drug content and additional 3.6% failed because they did not contain the labelled drug. Conclusions: Compounded medication is a possible cause of variation of steroid doses in children with adrenal insufficiency or congenital adrenal hyperplasia, putting these vulnerable patients at risk of poor disease control and adrenal crisis. These data may apply to other individualized compounded oral medication as well, emphasizing the need for development of licensed paediatric formulations approved by regulatory authorities.
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Copyright, Publisher and Additional Information: | © 2017 European Society of Endocrinology. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by/3.0/), which permits non-commercial reuse, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
Keywords: | Compounded hydrocortisone; paediatric endocrinology; congenital adrenal; hyperplasia; adrenal insufficiency; pharmacotherapy in children |
Dates: |
|
Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > The Medical School (Sheffield) > Division of Genomic Medicine (Sheffield) > Department of Oncology and Metabolism (Sheffield) The University of Sheffield > Sheffield Teaching Hospitals |
Funding Information: | Funder Grant number EUROPEAN COMMISSION - FP6/FP7 TAIN - 281654 |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 31 May 2017 14:54 |
Last Modified: | 10 Oct 2023 08:53 |
Published Version: | https://doi.org/10.1530/EJE-17-0248 |
Status: | Published |
Publisher: | Bioscientifica |
Refereed: | Yes |
Identification Number: | 10.1530/EJE-17-0248 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:117082 |