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P38 An audit of excipients of one manufacturer’s unlicensed liquid preparations in a tertiary paediatric hospital
  1. MM Worrall,
  2. AM Fitzpatrick,
  3. J Fanning
  1. Children’s Health Ireland at Crumlin


Background Many unlicensed medicinal products routinely used to treat the paediatric population do not undergo the same rigorous assessment that adult preparations do prior to coming to market. This means that many preparations are not authorised for paediatric use and consequently there is widespread use of unlicensed medicines and ‘off-label’ use of licensed medicines. Evaluation of excipients in unlicensed medicines is an integral part of assessing their suitability for use in paediatric patients.1 Excipients of concern include (but are not limited to) propylene glycol, ethanol, hydroxybenzoates, artificial sweeteners. Medicines are carefully selected for use based on agreed criteria. The assessment tool used in this centre is the ‘New Products Assessment Form’ and helps the assessor identify potential issues with excipients.

Aim This review aimed to reassess excipients in one manufacturer’s portfolio of unlicensed liquid preparations, stocked and regularly used at this centre. An informed decision could then be made to switch to a more suitable alternative if necessary.

Method A list of the manufacturer’s unlicensed liquid preparations was compiled, 14 in total. The company was contacted and requested to provide a comprehensive list of excipients. A New Products Assessment Form was completed for each product, which identified potential issues with excipients, in line with European Medicines Agency (EMA) guidelines. A list of all preparations where excipients exceeded acceptable daily intake (ADI) was made. Based on dosing regimens and weight/age the ADI of each excipient was calculated and documented. Where a preparation exceeded ADI for a particular excipient the manufacturing company was informed and a request for reformulation made. Alternative preparations were sought from other specialist manufacturing companies where necessary. Each product was assessed in the same manner. Pharmacy colleagues were consulted throughout the process and provided feedback on alternative preparations available. Concerns around labelling and similarities with other products, cost and reimbursement status, whether tablets could be crushed and dispersed in water as an alternative were highlighted and discussed. Relevant prescribing consultants were also informed. An informed decision was made to switch to an alternative product where indicated.

Results In total, a review of fourteen preparations stocked was conducted. Five out of 14 (36%) were changed to an alternative more appropriate preparation in terms of excipients. Four of the fourteen (29%) were suitable for use in patients across all age groups. Four of the fourteen (29%) exceeded the ADI for a particular excipient for preparations for use in neonates (suitable for all other age groups). Of the four, two were not routinely prescribed in neonates. One preparation was removed from the market. The remaining two products were considered suitable for use for their respective indications and dosing regimens.

Conclusion Unlicensed medicines and medicines that are used in neonate and paediatric patients must be carefully assessed for excipients before use.1–3 A risk benefit assessment4 should be conducted to establish if an unlicensed medicine should be used and prescribers notified of any excipients of concern.


  1. Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668). Available at:

  2. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP): Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use (EMA/CHMP/43486/2018); September 2018. Available at:

  3. NPPG Neonatal and Paediatric Pharmacists Group Newsletter No 61 Autumn 2016. Excipients in medicines for Children. Available at:

  4. Neonatal and Paediatric Pharmacists Group and Royal College of Paediatrics and Child Health, UK. Using Standardised Concentrations of Unlicensed Liquid Medicines in Children. April 2020. Available at:

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