ArticleDrugs - real world outcomes2025
Understanding Underreporting of Adverse Drug Reactions in the Philippines: A Mixed Methods Study.
Article in Drugs - real world outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Type, severity, frequency and management of adverse reactions associated with ultrasound contrast agents: a systematic review and meta-analysis.European radiology · 2026Pooled it
- Adverse events in bedaquiline- and pretomanid-based regimens for drug-resistant tuberculosis from trial, implementation and pharmacovigilance studies.British journal of clinical pharmacology · 2026Pooled it
- Barriers to Adverse Drug Reaction Reporting Among Physicians, Nurses, and Pharmacists: A Scoping Review Comparing High-Income Versus Low-/Middle-Income Countries.Healthcare (Basel, Switzerland) · 2026Review
- Underreporting of Adverse Events Following COVID-19 Vaccination Among Healthcare Professionals in Poland: Potential Implications for Vaccine Hesitancy.Tropical medicine and infectious disease · 2025Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdverse 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.
methodsA 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.
resultsThe 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.
conclusionsThis 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.