| アブストラクト | BACKGROUND: The completeness of adverse event (AE) reports, crucial for assessing putative causal relationships, is measured using the vigiGrade completeness score in VigiBase, the World Health Organization global database of reported potential AEs. Malaysian reports have surpassed the global average score (approximately 0.44), achieving a 5-year average of 0.79 (SD 0.23) as of 2019 and approaching the benchmark for well-documented reports (0.80). However, the contributing factors to this relatively high report completeness score remain unexplored. OBJECTIVE: This study aims to explore the main drivers influencing the completeness of Malaysian AE reports in VigiBase over a 15-year period using vigiGrade. A secondary objective was to understand the strategic measures taken by the Malaysian authorities leading to enhanced report completeness across different time frames. METHODS: We analyzed 132,738 Malaysian reports (2005-2019) recorded in VigiBase up to February 2021 split into historical International Drug Information System (INTDIS; n=63,943, 48.17% in 2005-2016) and newer E2B (n=68,795, 51.83% in 2015-2019) format subsets. For machine learning analyses, we performed a 2-stage feature selection followed by a random forest classifier to identify the top features predicting well-documented reports. We subsequently applied tree Shapley additive explanations to examine the magnitude, prevalence, and direction of feature effects. In addition, we conducted time-series analyses to evaluate chronological trends and potential influences of key interventions on reporting quality. RESULTS: Among the analyzed reports, 42.84% (56,877/132,738) were well documented, with an increase of 65.37% (53,929/82,497) since 2015. Over two-thirds (46,186/68,795, 67.14%) of the Malaysian E2B reports were well documented compared to INTDIS reports at 16.72% (10,691/63,943). For INTDIS reports, higher pharmacovigilance center staffing was the primary feature positively associated with being well documented. In recent E2B reports, the top positive features included reaction abated upon drug dechallenge, reaction onset or drug use duration of <1 week, dosing interval of <1 day, reports from public specialist hospitals, reports by pharmacists, and reaction duration between 1 and 6 days. In contrast, reports from product registration holders and other health care professionals and reactions involving product substitution issues negatively affected the quality of E2B reports. Multifaceted strategies and interventions comprising policy changes, continuity of education, and human resource development laid the groundwork for AE reporting in Malaysia, whereas advancements in technological infrastructure, pharmacovigilance databases, and reporting tools concurred with increases in both the quantity and quality of AE reports. CONCLUSIONS: Through interpretable machine learning and time-series analyses, this study identified key features that positively or negatively influence the completeness of Malaysian AE reports and unveiled how Malaysia has developed its pharmacovigilance capacity via multifaceted strategies and interventions. These findings will guide future work in enhancing pharmacovigilance and public health. |
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| 組織名 | Centre of Compliance & Quality Control, National Pharmaceutical Regulatory;Agency, Petaling Jaya, Malaysia.;Graduate Institute of Biomedical Informatics, Taipei Medical University, Taipei,;Taiwan.;Uppsala Monitoring Centre, Uppsala, Sweden.;International Center for Health Information Technology, Taipei Medical;University, Taipei, Taiwan.;Clinical Big Data Research Center, Taipei Medical University Hospital, Taipei;Medical University, Taipei, Taiwan.;Research Center of Big Data and Meta-Analysis, Wan Fang Hospital, Taipei Medical;School of Gerontology and Long-Term Care, Taipei Medical University, Taipei, |
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