Aim Approximately 17,000 children in the UK require nutritional support via enteral feeding tubes,1 many of whom administer medicines via this route. Availability of medications in an appropriate formulation to ensure safe and effective administration via enteral tubes is limited. European Medicines Agency guidance states that companies should include information in the summary of product characteristics (SmPC) if administration through an enteral tube is very likely.2
This project aimed to determine if medications prescribed and administered to paediatric inpatients via enteral tubes were licensed for this route of administration and whether manipulation of the product outside of its product license was required in order to administer via an enteral tube.
Method Data was collected in a specialist children’s hospital on January 6th 2021. Eligible patients were identified from their electronic patient records and by speaking to the nurse responsible for their care. The medicine and brand used was recorded on Microsoft Excel. The SmPC of each product was reviewed to determine whether it was licensed for children and for administration via enteral tubes. Patients on critical care and oncology wards were excluded due to time constraints. The audit was registered with the hospital’s clinical audit department. Ethical approval was not required.
Results There were 104 inpatients on the wards included on the day of the audit, 23 of whom (22%) were receiving medication via an enteral feeding tube. A total of 172 medicines were prescribed and administered via enteral tubes to these patients including 72 different medicinal products. Four (5.5%) of the 72 medicines were licensed for administration via this route. Seventeen medicines (24%) were unlicensed products, 8 (11%) of the licensed products were not licensed for children under 12 years of age and 19 (26%) had an age restriction to the license. Twenty eight (39%) were licensed for children of any age. Forty seven (27%) of the 172 medication administrations required manipulation of the medicine before being administered via an enteral tube (29 liquids further diluted (16.7%); 9 capsules opened (5.2%); 8 tablets dispersed in water and a proportion given (4.6%); 1 tablet crushed (0.5%).
Conclusion This audit has identified that very few medicines administered to paediatric inpatients via enteral tubes are licensed for this route. Over half of medicines administered via this route are either unlicensed products or not licensed for use in children. Manipulation of medicines prior to administration to children via enteral tubes is regularly required. The lack of age appropriate medicines licensed for use via enteral tubes in children should be highlighted to the pharmaceutical industry and regulators
Smith T, et al. Annual BANS Report, 2011. Artificial Nutrition Support in the UK 2000-2010. A report by the British Artificial Nutrition Survey (BANS), a committee of BAPEN (British Association for Parenteral and Enteral Nutrition). Available at: https://www.bapen.org.uk/pdfs/bans_reports/bans_report_11.pdf
European Medicines Agency. Reflection paper on the pharmaceutical development of medicines for use in the older population. EMA/CHMP/QWP/292439/2017. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-pharmaceutical-development-medicines-use-older-population-first-version_en.pdf
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