Hensel, Andreas;
Bauer, Rudolf;
Heinrich, Michael;
Hempel, Georg;
Kelber, Olaf;
Kraft, Karin;
Lehmann, Birka;
... Wiebelitz, Rüdiger; + view all
(2024)
Rationalizing optimal dosing of phytotherapeutics for use in children: Current status - potential solutions - actions needed.
Planta Medica
10.1055/a-2294-5259.
(In press).
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Abstract
“Children are not small adults with respect to the treatment with medicinal products”. This statement of WHO was the basis for the initiative of the European Commission for establishment of a paediatric regulation in 2007 to improve 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 organized a symposium to assess the status quo for paediatric use of herbal medicinal products (HMPs), to analyse the causes for the current situation, and discuss strategies for establishing the proof of safe and efficacious HMPs for children. Current situation for HMPs and their use in children is not fulfilling requirements of legislation. HMPs in paediatrics are effective and safe, but considering needs of children is necessary. In European countries the use, registration, and marketing of HMPs are different, depending on 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 by real world data might be a solution. The regulatory framework is to be adapted. Defining rationalized dosing for HMPs can be achieved by extrapolation of data from adults, by using existing clinical data for children, and by using RWD. Therefore a strong need for revising restrictions for use of HMPs in children and rationalizing defined dosage regimes is obvious.
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