Rationalising Optimal Dosing of Phytotherapeutics For Use In Children: Current Status – Potential Solutions – Actions Needed

Author:

Hensel Andreas1ORCID,Bauer Rudolf2ORCID,Heinrich Michael3ORCID,Hempel Georg4,Kelber Olaf5,Kraft Karin6,Lehmann Birka7,Medà Montserrat Mesegué8,Nieber Karen9,Roether Bernd10,Rollinger Judith Maria11ORCID,Wiebelitz Rüdiger12

Affiliation:

1. Institute of Pharmaceutical Biology and Phytochemistry, University of Münster, Germany

2. Institut für Pharmazeutische Wissenschaften, Pharmakognosie, Universitaet Graz, Austria

3. School of Pharmacy, University College London, United Kingdom of Great Britain and Northern Ireland

4. Pharmaceutical and Medical Chenistry, University of Münster, Germany

5. Research and Development, Bayer Consumer Health, Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany

6. Centre of Internal Medicine, University Medicine Rostock, Germany

7. University of Bonn, Germany

8. Hospital Sant Joan de Déu, Barcelona, Spain

9. University of Leipzig, Germany

10. Bionorica SE, Neumarkt, Germany

11. Department of Pharmaceutical Sciences, University of Vienna, Austria

12. Practice for Pediatric and Adolescent Medicine, Perleberg, Germany

Abstract

Abstract“Children are not small adults with respect to the treatment with medicinal products.” This statement of the WHO was the basis for the initiative of the European Commission for the establishment of a paediatric regulation in 2007 to improve the health of children by facilitating the development of medicines for children and adolescents. Seventeen years later, in the field of herbal medicinal products, results are still sobering. Therefore, the Foundation Plants for Health, Society for Medicinal Plants and Natural Products Research, and German Society for Phytotherapy organised a symposium to assess the status quo for the paediatric use of herbal medicinal products (HMPs), to analyse the causes of the current situation, and to discuss strategies for establishing the proof of safe and efficacious HMPs for children.The current situation for HMPs and their use in children is not fulfilling the requirements of legislation. HMPs in paediatrics are effective and safe, but considering the needs of children is necessary. In European countries, the use, registration, and marketing of HMPs are different, depending on the respective national regulations and specific traditions. EU herbal monographs are the best common denominator for such procedures. Emerging safety discussions must be considered. New approaches with real-world data might be a solution. The regulatory framework is to be adapted. Defining rationalised dosing for HMPs can be achieved by the extrapolation of data from adults, by using existing clinical data for children, and by using RWD. Therefore, a strong need for revising restrictions for the use of HMPs in children and rationalising defined dosage regimes is obvious.

Publisher

Georg Thieme Verlag KG

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