一个积极监测工具的观察试点研究,以加强巴西的药物监测
Dhelio Batista Pereira1, Marcus Vinícius Guimarães Lacerda2, Pavandeep Bilkhu3
1Centro de Pesquisa em Medicina Tropical de Rondônia, Porto Velho, Rondônia, Brazil.
Malaria journal
|March 3, 2025
概括
使用WhatsApp的Seta技术成功地促进了在偏远地区报告不良事件 (AE) 和怀孕的情况. 这种数字工具增强了药物监测,使得25个以前未报告的病例可以被记录下来.
科学领域:
- 药监和药物安全 药监和药物安全
- 数字卫生技术数字卫生技术
- 全球健康 全球健康
背景情况:
- 积极监测系统对于药物管理后的不良事件 (AE) 监测至关重要.
- 塞塔技术是为了改善资源有限和偏远地区的AE和怀孕监测而开发的.
- 塞塔利用WhatsApp消息来积极参与参与.
研究的目的:
- 评估Seta技术在促进报道AE和怀孕方面的有效性.
- 评估Seta在巴西地理上具有挑战性的地区加强药物监督方面的作用.
主要方法:
- 一项涉及巴西亚马逊地区疟疾患者的观察试点研究.
- 参与者在第7天和第8周通过Seta收到了WhatsApp消息,以报告意外意外事件或怀孕.
- 药监协调员 (PVC) 对积极反应进行了跟进,以收集详细的数据并向ANVISA报告.
主要成果:
- 149名参与者被录取;79%的人在第7天响应了最初的Seta消息,其中45人报告了潜在事件.
- 在第8周,55%的初始响应者提供了更新,其中10人报告了副作用或怀孕.
- 在PVCs成功的后续呼叫后,向ANVISA报告了25起副作用或怀孕.
结论:
- 像Seta这样的数字工具可以显著改善远程环境中的药物监管.
- 塞塔增强了现有的信号检测方法,使得可能无法记录的事件可以被报告.
- 该研究强调了移动技术在服务不足的人群中强大监测药物安全的潜力.
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