Lirasan Mark Ryann A, Adamson Mark Harvey B, Cruz Vieno Gino, Capuchino Julie Ann T, De Jesus Leslee Ann Lorna D, Peñaloza Roland Amiel C, Francisco Jover D, Gulmatico Maureen Allysandra G, Valiente John Eric R, Soriano Maria Glezilda R, Oquendo Rizza Ann A
Pharmacovigilance Section, Product Research and Standards Development Division, Center for Drug Regulation and Research, Food and Drug Administration, Muntinlupa City, Philippines.
School of Pharmacy, Philippine Women's University, Manila, Philippines.
Drugs Real World Outcomes. 2025 May 30. doi: 10.1007/s40801-025-00492-z.
Adverse drug reaction (ADR) reporting is a crucial element in ensuring medication safety and effective pharmacovigilance. However, underreporting of ADRs remains a significant challenge in the Philippines despite efforts made by the national pharmacovigilance center (NPVC). This study aims to explore the factors contributing to underreporting of ADRs among healthcare professionals (HCPs) in the Philippines, with a focus on understanding their knowledge, attitudes, and practices (KAP), as well as evaluating the usability of the online ADR reporting system.
A mixed-methods approach was employed, integrating quantitative and qualitative research methods. The study involved a KAP survey and focus group discussions (FGDs) with HCPs, including pharmacists, nurses, and physicians. The survey gathered quantitative data on KAP related to ADR reporting, while FGDs provided qualitative insights into contextual factors, misconceptions, and barriers. In addition, a system usability survey (SUS) was conducted among participants at the 1st Philippine Pharmacovigilance Summit to assess the usability of the online ADR reporting system. Data collection spanned 4 weeks, followed by thematic analysis of FGD data and descriptive statistical analysis of survey and SUS data.
The study revealed that HCPs generally recognize the importance of ADR reporting for FDA-approved drugs, vaccines, and antineoplastics, but there is a knowledge gap regarding the reporting of FDA-unapproved drugs. Awareness of the NPVC is limited, with less than half of HCPs (n = 4363) aware of its existence, and even fewer understanding its roles. Reporting practices are inconsistent, with many relying on paper-based methods, and a significant portion of HCPs are unaware of available reporting options. While 71.08% of participants expressed a high likelihood of reporting ADRs if familiar with the process, only 21.54% had actually reported one. Thematic analysis from focus group discussions identified several barriers to effective ADR reporting, including insufficient training, inconsistent practices, fear of legal repercussions, and low adoption of digital tools. The SUS results showed an "okay" usability rating for the online ADR reporting system, with a score of 68.81 (grade C). This shows that while many users found the tool acceptable and fairly easy to use, nearly half of the respondents felt it was too complex.
This study reveals significant knowledge gaps among HCPs in the Philippines regarding ADR reporting. While HCPs acknowledge the importance of ADR reporting for patient safety, many perceive the process as complex and burdensome, which discourages consistent participation. The study highlights key barriers, including legal concerns and complexity of online reporting tools. A key policy implication is the need for government agencies, such as the Food and Drug Administration (FDA) and the Department of Health (DOH), to simplify the ADR reporting process and enhance the design of reporting tools, making them more user-friendly and efficient for healthcare professionals.
药品不良反应（ADR）报告是确保用药安全和有效开展药物警戒的关键要素。然而，尽管菲律宾国家药物警戒中心（NPVC）做出了努力，但ADR报告的漏报在该国仍是一项重大挑战。本研究旨在探究菲律宾医疗保健专业人员（HCPs）中ADR漏报的影响因素，重点了解他们的知识、态度和行为（KAP），并评估在线ADR报告系统的可用性。
采用混合方法，将定量和定性研究方法相结合。该研究包括对HCPs（包括药剂师、护士和医生）进行KAP调查和焦点小组讨论（FGDs）。调查收集了与ADR报告相关的KAP定量数据，而FGDs则提供了关于背景因素、误解和障碍的定性见解。此外，在第一届菲律宾药物警戒峰会上对参与者进行了系统可用性调查（SUS），以评估在线ADR报告系统的可用性。数据收集持续了4周，随后对FGD数据进行了主题分析，并对调查和SUS数据进行了描述性统计分析。
研究表明，HCPs普遍认识到FDA批准的药物、疫苗和抗肿瘤药物的ADR报告的重要性，但对于FDA未批准药物的报告存在知识差距。对NPVC的认知有限，不到一半的HCPs（n = 4363）知晓其存在，了解其职责的更少。报告行为不一致，许多人依赖纸质方法，并且很大一部分HCPs不知道可用的报告选项。虽然71.08%的参与者表示如果熟悉报告流程，很有可能报告ADR，但实际报告过的只有21.54%。焦点小组讨论的主题分析确定了有效ADR报告的几个障碍，包括培训不足、做法不一致、担心法律后果以及数字工具采用率低。SUS结果显示在线ADR报告系统的可用性评级为“尚可”，得分为68.81（C级）。这表明虽然许多用户认为该工具可以接受且相当易于使用，但近一半的受访者认为它过于复杂。
本研究揭示了菲律宾HCPs在ADR报告方面存在重大知识差距。虽然HCPs承认ADR报告对患者安全的重要性，但许多人认为该过程复杂且繁琐，这阻碍了持续参与。该研究突出了关键障碍，包括法律问题和在线报告工具的复杂性。一个关键的政策含义是，食品药品监督管理局（FDA）和卫生部（DOH）等政府机构需要简化ADR报告流程，并改进报告工具的设计，使其对医疗保健专业人员更用户友好且高效。
