Quality & use of medicines
European Paediatric Formulary
The European Paediatric Formulary (PaedForm) is a freely available, pan-European collection of formulations for unlicensed pharmaceutical preparations currently described in national formularies and formulations that are already well established in European countries. Its aim is to give clinicians, pharmacists and healthcare providers access to formulations of appropriate quality, allowing the preparation of medicinal products for children when no licensed alternative is available on the market.
Work programme
Three additional monographs were finalised in 2023, increasing the number of texts included in the formulary from four to seven and bringing the formulary nearer to its objective of being a useful resource for pharmacists and clinicians. Chloral hydrate 100 mg/mL oral solution (F0010) was published in the European Paediatric Formulary in October 2023. Clonidine hydrochloride 10 µg/mL oral solution (F0018) and Furosemide 2 mg/mL oral solution (F0003) are pending adoption by the CD-P-PH and should be published in the formulary in spring of 2024.
All three texts underwent laboratory verification in line with the adapted procedure prior to public consultation in 2023. When issues were discovered in literature sources, it was decided to routinely verify the test methods and the microbiological quality, where relevant, of preparations. By confirming the microbiological quality, the European Paediatric Formulary can provide additional backing to the formulations published, as typically only the chemical stability of formulations is confirmed for a number of unlicensed formulations published in formularies.
Three new monographs, Amiodarone oral solution, Nifedipine oral liquid and Simple syrup (with preservatives) were added to the work programme, which now includes 17 texts. The PaedF Working Party (WP) dedicated a significant amount of time in 2023 to reviewing medicines intended to satisfy unmet paediatric needs and determine if products were actually available in the countries where they are licensed. Unfortunately, several licensed paediatric medicines are not marketed. The WP is therefore considering adding monographs for these products to the work programme.
The PaedF WP has 17 members from all over Europe, including a member from the EMA Paediatric Committee (PDCO). The WP met six times in 2023 (two in-person meetings and the rest by videoconference), both to discuss and progress the items on the work programme and to reflect upon its working methods going forward.
Communication with partners and stakeholders
The EDQM maintained its vital link with professional associations such as the EAHP and the industry-oriented European Paediatric Formulation Initiative (EuPFI). Continued communication with these associations ensures that the PaedF WP’s priorities reflect actual needs in the field.
The EDQM looks forward to continued partnerships with national formularies, hospital pharmacies and universities, and to developing connections with other stakeholders.
