基于网络的“购买事件”强化监测方法在天然保健品药物警戒学中的评估：新西兰开发工作的经验教训和启示。

Evaluation of a Web-Based, 'Purchase Event' Intensive Monitoring Method for Pharmacovigilance of Natural Health Products: Lessons and Insights from Development Work in New Zealand.

机构信息

School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, New Zealand.

Mercury, Mercury Building, 33 Broadway, Auckland, New Zealand.

出版信息

Drug Saf. 2020 Oct;43(10):981-998. doi: 10.1007/s40264-020-00963-y.

DOI:10.1007/s40264-020-00963-y

PMID:32596765

Abstract

INTRODUCTION

Intensive monitoring methods are used in pharmacovigilance for prescription medicines but have not yet been implemented for natural health products (NHPs).

OBJECTIVES

Our objective was to assess feasibility issues with a new 'purchase event' intensive monitoring method for pharmacovigilance of NHPs, including pharmacy and NHP purchaser recruitment rates, collection of NHP purchaser key patient identifier information for data linkage and quality and completeness of data.

METHODS

For the Ginkgo study, 213 community pharmacies in the Auckland (Aotearoa New Zealand) District Health Board area were invited to participate. Staff in participating pharmacies (n = 3 [1.4%]) recorded ginkgo product sales and gave purchasers a study invitation card (October 2015-January 2016). Ginkgo purchaser participants were emailed links to web-based baseline and follow-up questionnaires about adverse events occurring during/after taking ginkgo. Participating pharmacists and consumers were invited to provide qualitative feedback about the study. For the NHP-Lite study, all NHPs were included for monitoring. Community pharmacies in the Green Cross Health network were invited to participate. Participating pharmacy staff gave all NHP purchasers a study invitation card over a 2-week period (May 2016). NHP purchaser participants were emailed links to web-based baseline, follow-up and feedback questionnaires.

RESULTS

Few community pharmacists (Ginkgo study, n = 3; NHP-Lite study, n = 18) and NHP purchasers (Ginkgo study, n = 0; NHP-Lite study, n = 4) participated. Pharmacists (Ginkgo study, 3/3; NHP-Lite study, 11/18) described several reasons for participating and suggested ways to increase consumer recruitment, including simplifying study procedures.

CONCLUSIONS

These web-based, purchase event, intensive monitoring studies, with cohorts built through NHP purchases in pharmacies, identified substantial issues with recruiting pharmacists/pharmacies and NHP purchasers that, at present, render such studies unfeasible. Future studies need to consider other methods of recruiting NHP purchasers and develop a simple method for recording NHP purchases.

摘要

简介

在药物监测中使用强化监测方法，但尚未将其应用于天然保健品（NHPs）。

目的

我们的目的是评估一种新的“购买事件”强化监测方法用于 NHPs 药物监测的可行性问题，包括药房和 NHP 购买者的招募率、收集 NHP 购买者关键患者识别信息进行数据链接以及数据的质量和完整性。

方法

在银杏研究中，邀请了奥克兰（新西兰）地区卫生委员会地区的 213 家社区药房参与。参与药房的工作人员（n=3[1.4%]）记录银杏产品的销售情况，并向购买者发放研究邀请卡（2015 年 10 月至 2016 年 1 月）。银杏购买者参与者通过电子邮件收到有关服用银杏后/期间发生不良事件的在线基线和随访问卷的链接。参与的药剂师和消费者被邀请提供有关研究的定性反馈。在 NHP-Lite 研究中，所有 NHP 都被纳入监测范围。邀请绿十字健康网络的社区药房参与。参与药房的工作人员在两周的时间内向所有 NHP 购买者发放研究邀请卡（2016 年 5 月）。NHP 购买者参与者通过电子邮件收到了在线基线、随访和反馈问卷的链接。