P306: Analysis and Evaluation of 2024 Drug Defect Reports in Taiwan
Poster Presenter
Houshen Kuo
reviewer
Taiwan's Food and Drug Administration (TFDA) Taiwan
Objectives
To systematically analyze the 2024 drug defect reports in Taiwan to assess quality risks, reporting trends, and the effectiveness of corrective actions for ensuring medication safety.
Method
Data was retrieved from the "Post-Market Quality Management System" for the period of January to December 2024.Analysis included source tracking, dosage form distribution, root cause identification, and usage-adjusted reporting rate calculations.
Results
In 2024, a total of 1,075 drug defect reports were analyzed, with domestically manufactured drugs accounting for 43.4% and imported drugs for 56.6%. However, after adjusting for National Health Insurance consumption data, the reporting rate for imported drugs significantly increased to 75.2%, highlighting a higher frequency of defect reports compared to domestic products. Among the 181 cases categorized as high-risk or high-concern (A+/A level), domestic drugs accounted for 105 cases, while imported drugs accounted for 76. Injectable preparations (561 cases) and oral preparations (406 cases) were the most frequently reported dosage forms. The primary defect types identified were product packaging (47.9%) and appearance abnormalities (25.2%). Root cause investigations revealed that 30.9% of defects were attributed to improper storage or usage by users, 22.8% to manufacturing process deficiencies, and 12.6% to poor transportation. In response, manufacturers primarily implemented corrective actions such as user-end education (32.6%) and process improvements (17.4%). Hospitals remained the dominant reporting source, contributing to 97.6% of the total cases. Additionally, seven drugs were recalled during the year due to defect reports, including six domestic products.
Conclusion
This study demonstrates that Taiwan’s surveillance system effectively identifies post-market quality risks, particularly revealing a disproportionately higher reporting rate for imported drugs (75.2% after usage adjustment) compared to domestic products. Our analysis pinpoints "improper user handling" and "manufacturing deficiencies" as the primary root causes, providing a data-driven basis for targeted regulatory interventions. By integrating these findings with emerging AI-based monitoring technologies, TFDA is advancing a proactive, risk-oriented oversight model that bridges the gap between reported defects and systemic quality improvement, ultimately ensuring global supply chain reliability and patient safety.
