Pharmacovigilance of herbal medicines - A UK perspective
Pharmacovigilance of herbal medicines - A UK perspective
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DOI：
10.2165/00002018-200326120-00001
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发表时间：
2003-01-01
期刊：
影响因子：
4.2
通讯作者：
Barnes, J
中科院分区：
文献类型：
--
作者：
Barnes, J
人们越来越多地认识到制定草药药物警戒实践的必要性。目前的药物警戒模型及其相关工具是针对合成药物而开发的，除了传统药物所描述的挑战之外，应用这些方法来监测草药的安全性还提出了独特的挑战。有几个问题与草药的命名、认知、来源和使用方式有关。英国当前的草药监管框架还带来了其他重要挑战。目前在英国，药品安全委员会/药品和保健品监管机构（CSM/MHRA）的药物不良反应（ADR）报告“黄卡”计划是监测草药安全性的主要方法。尽管最近采取了鼓励报告与草药相关的可疑 ADR 的举措，例如将该计划扩展到未经许可的草药产品，并将社区药剂师纳入认可报告者，但 CSM/MHRA 收到的草药 ADR 报告数量仍然相对较低。报告不足是自发报告计划不可避免的重要限制，对于草药来说可能很重要，因为用户通常不会就其使用此类产品寻求专业建议，也不会在遇到不良反应时报告。英国的草药行业在黄卡计划的基础上发起了各种自发报告计划，但主要针对草药从业者。重要的是，这些计划必须与 CSM/MHRA 建立联系，这样才不会错过潜在的信号。用于传统药物药物警戒的其他几种工具，例如处方事件监测和计算机化健康记录数据库的使用，目前无法用于评估草药和其他非处方药的安全性。欧盟拟议的传统草药产品立法将要求根据新的国家计划注册的产品制造商遵守药物警戒的监管规定。从长远来看，草药安全监测的其他改进可能包括修改现有方法、患者报告以及在优化草药安全性时更多地考虑药物遗传学和药物基因组学。
There is an increasing awareness at several levels of the need to develop pharmacovigilance practices for herbal medicines. The current model of pharmacovigilance and its associated tools have been developed in relation to synthetic drugs, and applying these methods to monitoring the safety of herbal medicines presents unique challenges in addition to those described for conventional medicines. Several problems relate to the ways in which herbal medicines are named, perceived, sourced, and utilised. Other important challenges arise from the current regulatory framework for herbal medicines in the UK.In the UK at present, the Committee on Safety of Medicines/Medicines and Healthcare products Regulatory Agency's (CSM/MHRA) 'yellow card' scheme for adverse drug reaction (ADR) reporting is the main method of monitoring the safety of herbal medicines. Despite recent initiatives to stimulate reporting of suspected ADRs associated with herbal medicines, such as extending the scheme to unlicensed herbal products, and including community pharmacists as recognised reporters, numbers of herbal ADR reports received by the CSM/MHRA remain relatively low. Under-reporting, an inevitable and important limitation of spontaneous reporting schemes, is likely to be significant for herbal medicines, since users typically do not seek professional advice about their use of such products, or report if they experience adverse effects. The herbal sector in the UK has initiated various spontaneous reporting schemes, based on the yellow card scheme, but targeted mainly at herbal-medicine practitioners. It is important that these schemes have a link with the CSM/MHRA so that potential signals are not missed. Several other tools used in pharmacovigilance of conventional medicines, such as prescription-event monitoring, and the use of computerised health-record databases, currently are of no use for evaluating the safety of herbal and other non-prescription medicines.Proposed European Union legislation for traditional herbal medicinal products will require manufacturers of products registered under new national schemes to comply with regulatory provisions on pharmacovigilance. In the longer term, other improvements in safety monitoring of herbal medicines may include modifications to existing methodology, patient reporting and greater consideration of pharmacogenetics and pharmacogenomics in optimising the safety of herbal medicines.