In 2013 the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission launched the initiative to develop a pan-European Paediatric Formulary (PaedForm).
Authorised medicines are not always available for the treatment of children. Therefore, national or regional formularies on pharmacy preparations still play an important role today.
The aim of the project is to provide a platform to make freely available throughout Europe a formulary for extemporaneous formulations for paediatric medicines. The formulary will be a compilation of monographs for the preparation of such formulations based on the best approaches currently available in national or regional formularies within Europe.
A first group of experts has elaborated, under the auspices of the CD-P-PH, suitable criteria for evaluation of existing formulations for inclusion in the European Paediatric Formulary as well as the relevant criteria for maintenance and vigilance. These documents, together with the working procedure for the European Paediatric Formulary, were adopted by the CD-P-PH at the end of 2015.
A second working party under the auspices of the European Pharmacopoeia Commission has been set up in order to evaluate existing formulations, to elaborate the content and to maintain the formulary.
- The European Paediatric Formulary is intended to provide clinicians and pharmacists with a compilation of appropriate formulations, easily and freely accessible all over Europe. Healthcare providers will be offered a way to prepare unlicensed medicines of acceptable quality.
- The European Paediatric Formulary will complement the efforts of recent EU and international legislation designed to increase the number of authorised paediatric medicines. This involves, in particular, medicines containing active substances whose patent has expired and which are not contained in any appropriately licensed medicines currently available for children. The European Paediatric Formulary aims at providing healthcare providers with formulations which can be considered for prescription and extemporaneous preparation.
- Easy and free access is a prerequisite to help users and to promote the health of children who are in need of such medicines.
A poster with a more detailed overview of the project status and a summary of the criteria is downloadable here.