null European Paediatric Formulary: two draft texts released for public consultation

EDQM Strasbourg, France 14/01/2022
European Paediatric Formulary: two draft texts released for public consultation

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 4 of Pharmeuropa PaedForm, which contains two texts for public consultation, Simple syrup (preservative-free) and Phosphate 60 mg/mL Oral solution, prior to their inclusion in the European Paediatric Formulary.

The Simple syrup (preservative-free) monograph was selected to provide users with a standardised vehicle for oral liquids that could be cross-referenced in other European Paediatric Formulary monographs. This simple syrup can also be used as a standardised vehicle in which to suspend or dissolve solid dosage forms immediately before administration. A review of simple syrups used in Europe revealed that concentrations varied between 63% and 66%; 64% was selected for the monograph because this was the most commonly used concentration. The consolidated monograph was drafted taking into account existing test methods and limits present in monographs in Europe. The production steps and test methods were verified experimentally.

The other text, Phosphate 60 mg/mL Oral solution, is the first European Paediatric Formulary monograph to undergo revision. Like all European Paediatric Formulary monographs, Phosphate 60 mg/mL Oral solution is intended to be used by pharmacists to prepare extemporaneous preparations when a suitable licensed product is not available. The monograph is being republished for public consultation to gather comments on the introduction of a tailored annex – potentially to be extended to all Formulary monographs – comprising a list of known licensed options (product name, market authorisation holder and countries in which the product is licensed) that prescribers or pharmacists may consider when treating individual patients. Licensed products remain the gold standard and the aim is to draw attention to medicines that could be suitable for use and that are licensed in at least one European country. Annexing such valuable information to the monograph makes it readily available to clinicians and pharmacists throughout Europe, and enhances the usefulness of the formulary.

An annex can be updated rapidly to reflect the current licensing status of products. It is therefore particularly suitable in this context because the information may be incomplete and is also subject to change. It should be noted that new information affecting an annex will not be published in Pharmeuropa PaedForm for comment, but will instead be published as corrections to the text. The EDQM encourages users to submit their suggestions for updates to annexes in order to ensure that the data is as current as possible.

The PaedF Working Party welcomes all comments from users and interested parties on both the new Simple syrup (preservative-free) monograph and the new annex to the Phosphate 60 mg/mL Oral solution monograph.

The European Paediatric Formulary gathers together, at a European level, monographs on formulations for extemporaneous preparations that are either described in national formularies or well established in Europe. Once these monographs, which are not legally binding, have been approved by the European Pharmacopoeia Commission and adopted by the European Committee on Pharmaceuticals and Pharmaceutical Care, they are made available to pharmacists and clinicians to help them prepare paediatric medicines when no authorised alternative is available.

Both the European Paediatric Formulary and Pharmeuropa PaedForm are free of charge and can be accessed online after creating an account.

The deadline for comments on the texts in Pharmeuropa PaedForm is 31 March 2022.