Department of Biological Sciences, Center for Ethnobotanical and Ethnopharmacological Studies (CEE), Universidade Federal de São Paulo (UNIFESP), Rua Arthur Riedel, Diadema, SP, 275-09972-270, Brazil.
Drug Saf. 2013 Jan;36(1):1-12. doi: 10.1007/s40264-012-0005-7.
Typically, ethnobotanical/ethnopharmacological (EB/EP) surveys are used to describe uses, doses/dosages, sources and methods of preparation of traditional herbal medicines; their application to date in examining the adverse effects, contraindications and other safety aspects of these preparations is limited. From a pharmacovigilance perspective, numerous challenges exist in applying its existing methods to studying the safety profile of herbal medicines, particularly where used by indigenous cultures. This paper aims to contribute to the methodological aspects of EB/EP field work, and to extend the reach of pharmacovigilance, by proposing a tool comprising a list of questions that could be applied during interview and observational studies. The questions focus on the collection of information on the safety profile of traditional herbal medicines as it is embedded in traditional knowledge, as well as on identifying personal experiences (spontaneous reports) of adverse or undesirable effects associated with the use of traditional herbal medicines. Questions on the precise composition of traditional prescriptions or 'recipes', their preparation, storage, administration and dosing are also included. Strengths and limitations of the tool are discussed. From this interweaving of EB/EP and pharmacovigilance arises a concept of ethnopharmacovigilance for traditional herbal medicines: the scope of EB/EP is extended to include exploration of the potential harmful effects of medicinal plants, and the incorporation of pharmacovigilance questions into EB/EP studies provides a new opportunity for collection of 'general' traditional knowledge on the safety of traditional herbal medicines and, importantly, a conduit for collection of spontaneous reports of suspected adverse effects. Whether the proposed tool can yield data sufficiently rich and of an appropriate quality for application of EB/EP (e.g. data verification and quantitative analysis tools) and pharmacovigilance techniques (e.g. causality assessment and data mining) requires field testing.
通常，民族植物学/民族药理学（EB/EP）调查用于描述传统草药的用途、剂量/剂量、来源和制备方法；它们在迄今为止检查这些制剂的不良反应、禁忌症和其他安全方面的应用有限。从药物警戒的角度来看，将其现有方法应用于研究草药的安全性概况存在诸多挑战，特别是在土著文化中使用时。本文旨在通过提出一个包含一系列问题的工具，为 EB/EP 实地工作的方法学方面做出贡献，并扩大药物警戒的范围，这些问题可以在访谈和观察研究中应用。这些问题侧重于收集传统知识中嵌入的传统草药安全性概况信息，以及识别与使用传统草药相关的不良或不良影响的个人经验（自发报告）。还包括关于传统处方或“配方”的确切成分、其制备、储存、管理和剂量的问题。讨论了该工具的优缺点。从 EB/EP 和药物警戒的交织中产生了一个传统草药民族药物警戒的概念：EB/EP 的范围扩大到包括探索药用植物的潜在有害影响，并将药物警戒问题纳入 EB/EP 研究为收集关于传统草药安全性的“一般”传统知识提供了新的机会，重要的是，为收集可疑不良反应的自发报告提供了渠道。拟议的工具是否可以产生足够丰富且质量适当的数据，以应用 EB/EP（例如数据验证和定量分析工具）和药物警戒技术（例如因果关系评估和数据挖掘），需要进行现场测试。
