Doctor of Philosophy Program in Social, Economic, and Administrative Pharmacy, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand.
Thai Traditional Medicine Research Institute, Department of Thai Traditional and Alternative Medicine, Ministry of Public Health, Nonthaburi 11000, Thailand.
Int J Environ Res Public Health. 2022 Apr 7;19(8):4447. doi: 10.3390/ijerph19084447.
Patients are recognized as important players in the pharmacovigilance system. This study aims to describe and compare the characteristics of patient reporting systems, reporting forms, awareness raising-activities, and the statistics related to patient reporting in the selected countries. Fifteen countries (eight Western countries and seven Asian countries) were purposively selected. A questionnaire survey was distributed to national pharmacovigilance authorities in those countries. Nine countries (five Western countries and four Asian countries) returned the questionnaire. A review of the websites of national pharmacovigilance centres was conducted. The proportion of patient reports in the selected Western countries ranged from 57.83% to 14.37%, while it was accounted for less than 1% in the selected Asian countries. Currently, patients in all nine countries can report adverse drug reactions online via a website. The number of clicks from the national pharmacovigilance website to reach the online reporting form range from one to five clicks. Countries with higher patient reporting rates seemed to share the following characteristics; provision of feedback, engagement with patient organizations, and implementation of several activities to raise the awareness of the general public on the importance of pharmacovigilance. To increase the number of patient reports, the strengths of each country's system should be adopted.
患者被视为药物警戒系统中的重要参与者。本研究旨在描述和比较选定国家的患者报告系统、报告表格、宣传活动以及与患者报告相关的统计数据的特点。选择了 15 个国家(8 个西方国家和 7 个亚洲国家)。向这些国家的国家药物警戒当局分发了一份问卷。有 9 个国家(5 个西方国家和 4 个亚洲国家)返回了问卷。对国家药物警戒中心的网站进行了审查。在选定的西方国家中,患者报告的比例范围为 57.83%至 14.37%,而在选定的亚洲国家中,这一比例不到 1%。目前,所有九个国家的患者都可以通过网站在线报告药物不良反应。从国家药物警戒网站点击次数到在线报告表格的点击次数范围从一次到五次。报告率较高的国家似乎具有以下共同特征:提供反馈、与患者组织合作以及实施多项活动,提高公众对药物警戒重要性的认识。为了增加患者报告的数量,应该采用每个国家系统的优势。