摘要：鑒於食安事件與食安危機層出不窮，各界對於食品衛生安全管理的重視逐漸提升，而藥品的使用安全、管理與民眾健康也息息相關，如何進行風險預警與管理成為目前政府刻不容緩、亟需解決的課題。藉由資訊科技的協助，有系統地建立、整合食品監測資料並進行分析，除了能夠了解食安問題發生的原因、趨勢外，也找出可能的危險因子，以科學實證分析作為評估危害嚴重性與擬訂風險管理政策優先順序的判定基礎，並於事件發生前發揮有效的預警功能。政府已建立許多後市場監測之食品安全監測系統，但由於我國現行相關食品監測系統之建立時序與使用目的不盡相同，且各系統分類無統一輸入原則，加以各系統資料龐大，致使資料可能因品項名稱或分類不一致，不同系統間的資料無法直接串檔，而使資料搜尋無法確切針對食品安全問題進行全面性的分析與監測。本計畫希望透過彙整我國食品相關監測系統歷年的資料，持續進行資料除錯、偵錯、反覆驗證及確效校對，以確認該品項名稱及類別歸類原則，藉由不同系統資料的整合，俾利了解我國食品安全問題的全貌，進一步分析造成食品不合格率偏高產品的原因，作為評估日後持續監測必要性的判定參考依據。因此，本計畫預計針對「產品通路管理便捷查詢系統」(PMDS)、「輸入食品邊境查驗自動化資訊系統」(IFI) 及「檢驗管理系統」(INSP) 這三個食品相關監測系統，檢視其資訊正確性，並對系統資料進行偵錯處理；此外，為能有效整合系統資料，我們將延伸建構適合用以檢視我國食品問題的產品品項歸類原則，進行原則確效及合適性檢討，以此設計監測系統資料轉譯語法及撰寫相關學術論文。再運用已完成校正的資料，進一步分析造成食品不合格率偏高產品的原因，透過風險因子分析提出需持續監測及加強稽查的食品類別及品項，作為行政決策之參考依據。另外，藥品名稱混淆是非常重要的藥物安全管理議題，藥名形音相似易造成醫囑開立、處方調劑或給藥上的混淆，是用藥錯誤的最常見原因之一。然而，目前仍缺乏系統性的研究來彙整我國常見的藥名混淆錯誤，也亟需建立我國適用的藥名混淆偵測系統，來過濾現有藥品之潛在混淆問題，並提供新藥申請上市時審核命名適當性之依據。故本計畫擬進行加值研究服務，預計蒐尋相關文獻報告及提請醫療院所提供常見之藥名混淆組合，來彙整我國常見藥名混淆錯誤清單，以利未來針對混淆錯誤進行嚴重程度之等級評值，執行風險評估之研究；此外，亦將探索如何參考美國現有之藥名混淆偵測系統，匯入所有經食藥署許可之藥品品項，以提供建置我國英文藥名混淆偵測系統之政策建議。
Abstract: With the issues and events of food safety continued to emerge over the past few years, the importance of food safety management can never be overemphasized. The safety of medication use and its management are also closely related the population health. How to manage the risk, identify safety signals and initiate early warnings is a crucial task and lesson to learn for the current government. Maintaining integrative and comprehensive information systems has become one of the key factors for managing food and medication safety effectively and efficiently. With the development of information technology and the establishment of food surveillance systems, we can conduct empirical data analysis and assess the hazards scientifically. Analyzing historical data of relevant food surveillance system can help to identify the trend of safety problems, evaluate possible risk factors for effective early warning before events, and allow us to formulate the basis for prioritizing risk management policies. Our government has established a number of post-market food safety surveillance systems. However, since the establishment timing and purpose of use differ, there is a lack of unified and consistent data entering rules (e.g., with regard to item name or classification) for the current systems. This issue has made the data from different food information systems hard to link, search, or use for comprehensive safety analysis and monitoring.This project aims to examine the data of three post-market food safety surveillance systems, including the Product Management Distribution System (PMDS), Imported Food Inspections (IFI), and Inspection Management System (INSP). We propose to perform data debugging and correction, and repeat the verification process. In addition, in order to effectively integrate data among different systems, we will continue to inspect item names and standardize the principles of product classification. We plan to design program language for data translation and draft a related manuscript. After data inspection and cleaning, we will carry out further analysis to investigate the food products with high inspection failure rate. We will run descriptive and statistical analyses by SAS software to identify important risk factors and their influential weights associated with safety problems. The results will help to determine the food categories and items that should be continuously monitored for administrative purpose in Taiwan.In addition, drug name confusion is a very important drug safety management issue, and it is one of the most common causes of medication errors. Medications with look-alike or sound-alike names can easily lead to errors in drug prescribing, dispense or administration. However, there is a lack of systematic study to summarize the confusing drug names with a high error rate in Taiwan. Also, it is urgent to establish a drug name confusion detection system in Taiwan to filter out the potential confusion of existing drugs and provide as a tool to examine the appropriateness of new drug names. Therefore, this project proposes to carry out a value-added research service related to the issue of drug name confusion. In order to generate a comprehensive list of confusing drug names with a high error rate in Taiwan, we propose to review literature reports and request relevant lists from the medical institutions. Moreover, we will explore the feasibility to build a drug name confusion detection system, which could be modified from the existing drug name confusion detection system in the United States but will contain the drug information of all the approved medications in Taiwan.