Kitisopee Tanattha, Assanee Jirunya, Sorofman Bernard A, Watcharadmrongkun Suntaree
Faculty of Pharmaceutical Sciences, Chulalongkorn University, 254 Phayathai Road, Pathumwan, Bangkok, 10330, Thailand.
College of Pharmacy, The University of Iowa, 115 South Grand Avenue, Iowa City, IA, 52242, USA.
J Pharm Policy Pract. 2022 Mar 14;15(1):19. doi: 10.1186/s40545-022-00417-z.
Adverse drug event (ADE) reporting is a significant process to increase consumer care and consumer safety associated with the use of medicines. An in-depth investigation into low ADE reporting by consumers and community pharmacists was undertaken to uncover interventions to improve reporting.
In-depth interviewing of the three parties; consumers, pharmacists and employees of the Pharmacovigilance Center in Thailand, was used to collect the data. They were interviewed about ADE reporting experiences and contributing factors and problems of ADE reporting. Thematic analysis was used to interpret the results.
The HPVC received few ADE reports from consumers. Most community pharmacists received ADE reports from consumers; however, the Pharmacovigilance Center received few ADE reports from community pharmacists. ADE reporting of community pharmacists and consumers were influenced by many factors which were categorized into four themes which were (1) "Cognition" (awareness, attitude and responsibility); (2) "Reporting process" (complication, competency, information deficiency, feedback, and resource); (3) "Inducer" (service orientation, acquaintanceship, motivation, severity level, regulatory and reward); and (4) "Obstacle" (doubt, belief and prosecution).
Health professionals should motivate consumers to report ADEs. Building social responsibility and benefits and increasing knowledge of reporting process, channels, and system to both community pharmacists and consumers were recommended. Providing rewards and making community pharmacists feel comfortable to report ADEs by simplifying the ADE form and providing training, guidelines, and an ADR assessment tool can drive them to report ADEs. Feedback to consumers by confirming whether it was ADE and feedback to pharmacists that the Pharmacovigilance Center received their reports and their reports were utilized were also important.
药品不良事件（ADE）报告是提高与用药相关的消费者护理和消费者安全的重要过程。对消费者和社区药剂师低ADE报告率进行了深入调查，以发现改善报告的干预措施。
通过对三方进行深入访谈来收集数据，这三方分别是消费者、药剂师以及泰国药物警戒中心的员工。就ADE报告经历、促成因素和ADE报告问题对他们进行了访谈。采用主题分析法来解读结果。
HPVC收到的消费者ADE报告很少。大多数社区药剂师收到过消费者的ADE报告；然而，药物警戒中心收到的社区药剂师的ADE报告很少。社区药剂师和消费者的ADE报告受到多种因素影响，这些因素可分为四个主题：（1）“认知”（意识、态度和责任）；（2）“报告流程”（复杂性、能力、信息不足、反馈和资源）；（3）“诱因”（服务导向、相识度、动机、严重程度、监管和奖励）；（4）“障碍”（怀疑、信念和起诉）。
卫生专业人员应鼓励消费者报告ADE。建议培养社区药剂师和消费者的社会责任意识和利益意识，并增加他们对报告流程、渠道和系统的了解。通过简化ADE表格、提供培训、指南和药品不良反应评估工具来提供奖励并让社区药剂师放心报告ADE，可以促使他们报告ADE。向消费者确认是否为ADE并向药剂师反馈药物警戒中心已收到其报告且报告已被采用，这也很重要。
