P38 An audit of excipients of one manufacturer’s unlicensed liquid preparations in a tertiary paediatric hospital

Background Many unlicensed medicinal products routinely used to treat the paediatric population do not undergo same rigorous assessment that adult preparations prior coming market. This means many are authorised for use and consequently there is widespread of medicines ‘off-label’ licensed medicines. Evaluation excipients in an integral part assessing their suitability patients. 1 Excipients concern include (but limited to) propylene glycol, ethanol, hydroxybenzoates, artificial sweeteners. Medicines carefully selected based on agreed criteria. The tool this centre ‘New Products Assessment Form’ helps assessor identify potential issues with excipients. Aim review aimed reassess one manufacturer’s portfolio liquid preparations, stocked regularly at centre. An informed decision could then be made switch a more suitable alternative if necessary. Method A list was compiled, 14 total. company contacted requested provide comprehensive New Form completed each product, which identified excipients, line European Agency (EMA) guidelines. all where exceeded acceptable daily intake (ADI) made. Based dosing regimens weight/age ADI excipient calculated documented. Where preparation particular manufacturing request reformulation Alternative were sought from other specialist companies Each product assessed manner. Pharmacy colleagues consulted throughout process provided feedback available. Concerns around labelling similarities products, cost reimbursement status, whether tablets crushed dispersed water as highlighted discussed. Relevant prescribing consultants also informed. indicated. Results In total, fourteen conducted. Five out (36%) changed appropriate terms Four (29%) patients across age groups. neonates (suitable groups). Of four, two prescribed neonates. One removed remaining considered respective indications regimens. Conclusion Unlicensed neonate must before use. 1–3 risk benefit 4 should conducted establish medicine prescribers notified any concern. References Annex Commission guideline ‘Excipients package leaflet human use’ (SANTE-2017-11668). Available at: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003412.pdf Agency. Committee Medicinal Human Use (CHMP): Information regarding ethanol (EMA/CHMP/43486/2018); September 2018. https://www.ema.europa.eu/en/documents/scientific-guideline/information-package-leaflet-regarding-ethanol-used-excipient-medicinal-products-human-use_en.pdf NPPG Neonatal Paediatric Pharmacists Group Newsletter No 61 Autumn 2016. Children. www.nppg.scot.nhs.uk/wp-content/uploads/2017/04/NPPG-61.pdf Royal College Paediatrics Child Health, UK. Using Standardised Concentrations Liquid Children . April 2020. https://nppg.org.uk/wp-content/uploads/2020/04/NPPG-Position-Statement-18-01-V5-April-2020.pdf