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  • 學位論文

利用RFID建立藥品履歷制度之關鍵因素分析

CSF Analysis in Implementing Traceability System by using RFID for the Medicinal

指導教授 : 陳凱瀛

摘要


醫療藥品具有專業性高及風險大之特性。世界衛生組織(WHO)估計全球10%的藥物屬於偽藥,其中發展中國家更可能高達40%;另外在醫院和藥物的管理過程中,用藥錯誤經常會出現,導致病患的死亡。因此如何利用資訊科技的技術也是製藥產業需要思考的課題。 FDA在2004年開始提出將RFID用於藥品管理的研究方案,主要針對藥品的標籤、電子紀錄和藥品製造、流通、使用等等藥品遞送流程。目前國內廠商大多使用條碼系統、紙本抄寫記錄藥物流程,而隨著科技的進步,RFID系統有機會取代目前所使用的方式,因為RFID系統具備型態多樣、重複使用、多樣讀寫、儲存擴充…等特色,可以建置完整的藥品履歷制度,防止市場上偽藥的產生並降低藥品危害生命的風險。 本研究探查瞭解國內外各個領域導入RFID系統的關鍵成功因素,以國內產、官、學、研等資深專家人士作為問卷調查對象,再運用德菲法進行專家問卷及分析層級程序法問卷,彙集專家意見,進而歸納出下列幾點: 1. 組織資源、策略層面、技術成熟性及環境因素為第一層級架構來考量,並作問卷結果整理,在此四項構面中,以「環境因素」(32.28%)最為重要;「技術成熟性」(31.81%)次之,二者占了64%。 2. 在第二層級17項因素中,整理出重要的關鍵性成功因素分別為「法規需求」(14.33%)、「法規遵循性」(11.55%)、「客戶要求」(10.12%)、「高階主管支持」(7.90%)及「系統整合」(6.73%)等因素。 本研究結果,符合藥品行業的發展現況及特殊需求,可供相關廠商進行改善參考。

並列摘要


Medicinal has high-professional and high-risk characteristics. The World Health Organization estimates that 10% of the medicinal are counterfeit around the world, which developing countries could be as high as 40%. In addition, hospitals and medicinal management process, medication errors often occur, leading to the death of patients. Therefore, how to use of Information Technology is also the pharmaceutical industry need to think. FDA proposed RFID for medicinal management research program in 2004, focused on the manufacturing, label, electronic records, distribution and usage, during the delivery process. Most domestic manufacturers use the bar code system and the paper records to record medicinal management process. With the advancement of technology, RFID systems have the opportunity to replace used. RFID systems have characteristics of the type variety, re-use, diverse reading and writing, storage extensibility. It will build a complete pharmaceutical record system, to prevent the counterfeit drugs circulate the market and reduce the risks of the drugs to endanger life. This study will to understand the critical success factors for implementing traceability RFID systems in the various fields. Survey subjects include domestic manufacturers, officials, Educators, researchers and other senior experts. Then use the Delphi method and Analytic Hierarchy Process, to bring togetherexpert opinions. Conclude and summarized as follows: 1. The first level of study consideration includes the organizational resources, the strategic level, the maturity of the technology and the environmental factors. The most important are environmental factors (32.28%) and maturity of the technology (31.81%). These two dimensions accounted for 64%. 2. In 17 factors, the important critical success factors are regulatory requirements (14.33%), Compliance (11.55%), customer requirements (10.12%), the executives’ support (7.90%) and systems integration (6.73%) and other factors. The results of this study, corresponds the current state of development and special needs of the pharmaceutical industry will be a good reference for manufacturers to implement traceability system by using RFID for the Medicinal.

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