A Scoping Review of Published Literature on the Contributions of the Natural Health Products (NHPs) Industry to Pharmacovigilance for NHPs.

IF 3.8 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Xin Yi Lim, Sanyogita Ram, Shane Scahill, Joanne Barnes
{"title":"A Scoping Review of Published Literature on the Contributions of the Natural Health Products (NHPs) Industry to Pharmacovigilance for NHPs.","authors":"Xin Yi Lim, Sanyogita Ram, Shane Scahill, Joanne Barnes","doi":"10.1007/s40264-025-01587-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The natural health products (NHPs) industry is a key stakeholder in pharmacovigilance for NHPs. However, the specific contributions that the NHPs industry makes to pharmacovigilance for NHPs are not well-understood.</p><p><strong>Objective: </strong>This scoping review aimed to identify and map published literature describing the contributions of the NHPs industry to pharmacovigilance activities for NHPs. Assessment of benefit-harm balance for individual NHPs/natural ingredients is outside the scope of this review.</p><p><strong>Methods: </strong>Using predetermined keywords and Medical Subject Headings, seven international electronic biomedical journal databases were searched to identify articles describing the contributions of the NHPs industry to pharmacovigilance for NHPs in relation to product surveillance and stakeholders' views on the NHPs industry and its pharmacovigilance activities.</p><p><strong>Results: </strong>Of the 2285 records identified, 40 articles (representing 40 studies) met the inclusion criteria for this review. Among these, 33 described post-marketing surveillance activities and seven explored stakeholders' views. Of the articles describing post-marketing surveillance studies, 22 were authored and/or sponsored by the industry; the remaining 11 involved contributions from the NHPs industry in the form of safety data submitted as spontaneous reports to a national or state pharmacovigilance database. Contributions of the NHPs industry were primarily through passive surveillance via spontaneous reporting. In total, 13 active surveillance studies were undertaken by the NHPs industry, mainly in clinical care settings such as medical centres, hospitals, and private practices, and were focused on single products. There were limited findings relating to stakeholders' views on pharmacovigilance and the NHPs industry's involvement.</p><p><strong>Conclusions: </strong>The NHPs industry contributes to pharmacovigilance for NHPs primarily through passive surveillance measures. Active surveillance involving the NHPs industry was typically undertaken in non-community settings. Additional research exploring stakeholders' views on and preparedness for participating in active surveillance involving the industry, focusing particularly on models based on the consumer-industry reporting pathway, could identify new strategies for strengthening post-marketing safety monitoring for NHPs.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40264-025-01587-w","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

Abstract

Background: The natural health products (NHPs) industry is a key stakeholder in pharmacovigilance for NHPs. However, the specific contributions that the NHPs industry makes to pharmacovigilance for NHPs are not well-understood.

Objective: This scoping review aimed to identify and map published literature describing the contributions of the NHPs industry to pharmacovigilance activities for NHPs. Assessment of benefit-harm balance for individual NHPs/natural ingredients is outside the scope of this review.

Methods: Using predetermined keywords and Medical Subject Headings, seven international electronic biomedical journal databases were searched to identify articles describing the contributions of the NHPs industry to pharmacovigilance for NHPs in relation to product surveillance and stakeholders' views on the NHPs industry and its pharmacovigilance activities.

Results: Of the 2285 records identified, 40 articles (representing 40 studies) met the inclusion criteria for this review. Among these, 33 described post-marketing surveillance activities and seven explored stakeholders' views. Of the articles describing post-marketing surveillance studies, 22 were authored and/or sponsored by the industry; the remaining 11 involved contributions from the NHPs industry in the form of safety data submitted as spontaneous reports to a national or state pharmacovigilance database. Contributions of the NHPs industry were primarily through passive surveillance via spontaneous reporting. In total, 13 active surveillance studies were undertaken by the NHPs industry, mainly in clinical care settings such as medical centres, hospitals, and private practices, and were focused on single products. There were limited findings relating to stakeholders' views on pharmacovigilance and the NHPs industry's involvement.

Conclusions: The NHPs industry contributes to pharmacovigilance for NHPs primarily through passive surveillance measures. Active surveillance involving the NHPs industry was typically undertaken in non-community settings. Additional research exploring stakeholders' views on and preparedness for participating in active surveillance involving the industry, focusing particularly on models based on the consumer-industry reporting pathway, could identify new strategies for strengthening post-marketing safety monitoring for NHPs.

关于天然保健品(NHPs)行业对NHPs药物警戒贡献的已发表文献的范围综述。
背景:天然保健品(NHPs)行业是天然保健品药物警戒的关键利益相关者。然而,卫生保健产品行业对卫生保健产品药物警戒的具体贡献尚不清楚。目的:本综述旨在识别和绘制描述NHPs行业对NHPs药物警戒活动贡献的已发表文献。个别NHPs/天然成分的利弊平衡评估不在本综述的范围之内。方法:使用预先确定的关键词和医学主题标题,检索7个国际电子生物医学期刊数据库,以确定描述NHPs行业在产品监测方面对NHPs药物警戒的贡献以及利益相关者对NHPs行业及其药物警戒活动的看法的文章。结果:在确定的2285条记录中,40篇文章(代表40项研究)符合本综述的纳入标准。其中,33篇描述了上市后的监督活动,7篇探讨了利益相关者的观点。在描述上市后监测研究的文章中,有22篇是由行业撰写和/或赞助的;其余11项涉及国家卫生服务提供者行业以安全数据的形式提交给国家或州药物警戒数据库的自发报告。国家卫生服务提供者行业的贡献主要是通过自发报告进行被动监测。国家卫生服务提供者行业总共开展了13项主动监测研究,主要是在临床护理机构,如医疗中心、医院和私人诊所,并集中于单一产品。有关利益相关者对药物警戒和国家卫生服务提供者行业参与的看法的调查结果有限。结论:NHPs行业主要通过被动监测措施为NHPs的药物警戒做出贡献。涉及国家卫生服务提供者行业的主动监测通常在非社区环境中进行。进一步研究探讨利益相关者对参与涉及行业的主动监测的看法和准备情况,特别关注基于消费者-行业报告途径的模型,可以确定加强NHPs上市后安全监测的新战略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信