了解菲律宾不充分报告药物不良反应:一种混合方法研究
Mark Ryann A Lirasan1, Mark Harvey B Adamson2, Vieno Gino Cruz3
1Pharmacovigilance Section, Product Research and Standards Development Division, Center for Drug Regulation and Research, Food and Drug Administration, Muntinlupa City, Philippines.
Drugs - real world outcomes
|May 30, 2025
概括
由于知识差距和系统复杂性,菲律宾的医疗保健专业人员低估了药物不良反应 (ADRs) 的报告. 改善报告流程和工具对于药物安全和药物监管至关重要.
科学领域:
- 药物监督 药物监督 药物监督
- 药物安全 药物安全
- 医疗保健 专业教育 医疗保健 专业教育
背景情况:
- 药物不良反应 (ADR) 报告对于药物监测至关重要,但菲律宾仍然没有报告.
- 人们对国家药物监督中心 (NPVC) 和其作用的认识有限,有助于应对这一挑战.
研究的目的:
- 调查影响菲律宾医疗保健专业人员 (HCP) ADR报告不足的因素.
- 评估医疗人员关于ADR报告的知识,态度和实践 (KAP).
- 评估在线ADR报告系统的可用性.
主要方法:
- 一种混合方法的方法,结合了调查和焦点小组讨论 (FGDs) 与HCPs.
- 收集了KAP和系统可用性量表 (SUS) 评分的定量数据.
- 来自FGD的定性数据探索了上下文障碍和误解.
主要成果:
- 医疗保健人员表现出知识缺口,特别是在未经批准的药物方面,对NPVC的认识有限.
- 报告实践不一致,许多人不知道可用的选择,更喜欢纸质方法.
- 障碍包括培训不足,对法律问题的恐惧和复杂的在线报告工具;在线系统获得了"okay"的可用性评级 (68.81).
结论:
- 显著的知识差距和ADR报告的感知复杂性阻碍了HCP在菲律宾的参与.
- 解决法律问题和简化报告工具对于加强药物监督至关重要.
- 政策建议包括提高ADR报告系统的用户友好性和效率.
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