Background The European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission (for which the EDQM provides the Scientific Secretariat) have launched an initiative to improve the availability of extemporaneous formulations of paediatric medicines of appropriate quality by providing a formulary on a European level. Criteria for inclusion and evaluation of formulations were adopted at the end of 2015.
Purpose The aim of the European Paediatric Formulary is to collect together the most appropriate formulations currently described in national formularies, or those which are well established in European countries, to provide clinicians and pharmacists with appropriate formulations to allow preparation when no licensed product is available.
Materials and methods Monographs available in individual countries have been provided by the member states. Prioritisation, selection and transfer to a common format are being performed by a dedicated working party with 17 experts from hospital pharmacies, academia and national authorities from 14 countries.
Inclusion criteria include therapeutic relevance and clinical justification of the formulation and its active substance, as well as quality criteria.
Initially, the work will be prioritised based on paediatric needs published by the EMA Paediatric Committee and set criteria supplemented with, for example, recently filed Paediatric Investigation Plans. In a second step, the formulations available for a specific preparation of high priority will be screened and a final selection will be made. The online formulary will start with a limited number of formulations and then subsequently be extended.
Results Prioritisation according to need has been partially completed. Further, the first two pilot monographs – hydrochlorothiazide 0.5 mg/mL oral solution and sotalol 20 mg/mL oral solution – are in the drafting phase. All monographs will be made available for public consultation by the EDQM before their finalisation to encourage feedback from all stakeholders.
Conclusion The project is still in its infancy and relies heavily on the information available. With input from all stakeholders, the final formulary will in future fulfil its aims: to be an easily accessible online tool with a collection of appropriate formulations that supports its users and promotes the health of children who are in need of medicines for which no licensed alternative is available.
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