Wegener Tankred
Consulting HMP, Registration-C and NC Expert Reports-Studies, Brückstrasse 11, 69469 Weinheim, Germany.
Wien Med Wochenschr. 2013 Feb;163(3-4):46-51. doi: 10.1007/s10354-013-0175-7. Epub 2013 Feb 2.
The limited extent of data available for herbal medicinal products (HMPs) in the paediatric population is related to missing documentation of their use in practice and in literature. Therefore, information for properly evaluating indications, posology, length of treatment and safety in children is often lacking. Frequently, these documentation gaps are reflected in the product information of HMPs as final result of regulatory decisions. On the other hand, there is long-term experience of HMPs as well established and traditionally used medicinal products, which also covers the use in the paediatric population, as applied by parents themselves, and the recommendations of physicians, other health practitioners and pharmacists. The methodology of pharmaco-epidemiologic studies is a valuable tool to evaluate data of the practical use of HMPs in children. The documentation gap may be closed by such methodologies, and HMPs may be applied prospectively on the basis of well-documented empirical knowledge.
儿科人群中可获得的草药药品(HMPs)数据有限,这与实践和文献中缺乏其使用记录有关。因此,往往缺乏用于正确评估儿童适应症、剂量、治疗时长和安全性的信息。这些文件空白常常在HMPs的产品信息中体现出来,这是监管决策的最终结果。另一方面,HMPs作为成熟的传统药品,有着长期的使用经验,其中也涵盖了家长自行使用以及医生、其他医疗从业者和药剂师推荐下在儿科人群中的使用情况。药物流行病学研究方法是评估HMPs在儿童中实际使用数据的宝贵工具。通过这些方法可以填补文件空白,并且可以基于充分记录的经验知识前瞻性地应用HMPs。