2016-01-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/660579摘要：關鍵詞：鴉片類藥品 優良疼痛照護 管制藥品濫用 藥品流用 防止濫用劑型 社會負擔 醫療照護支出 研究背景:台灣社會相較於歐美國家對於管制藥品使用相對保守而管制藥物之使用與規範亦較嚴格，且品項亦少。然現今社會對優良疼痛照護的要求日益增加，政府已於近年逐步引進多種管制第一第二級鴉片類藥品提供臨床醫學使用。然而歐美國家之鴉片類管制藥品流用與濫用造成藥物過量甚至致死的案數甚多，且造成重大之社會負擔與醫療照護體系的巨額支出，實為我國在引進相關藥品與政策成型及藥品使用指引制定上的另一考量。研究方法:本研究計畫將細分為兩大研究階段:資料收集階段及國際接軌暨成果整理發表，其中資料收集階段為研究成果信度與效度之關鍵，尤其著重於相關資料之檢索查找之全面性與完整性，本研究團隊將系統性與全面性地查找各藥物之相關資訊，由於部分資訊無法由已發表之學術論文中獲得，本研究團隊亦將查詢各國政府藥政單位之公開文件及統計資料。國際接軌暨成果整理發表階段除積極參與相關國際學會外，並將進行國內有關鴉片類藥品使用與監控教育訓練課程之研擬、相關報告及學術論文之撰寫與投稿，協助政策研議。預期完成目標:1.研析近10年(至少含民國94-103年)國際(搜集美洲(包括美國、加拿大)、大洋洲(包括紐西蘭、澳洲)、歐洲(包括英國、德國、法國)、亞洲(包括日本、新加坡、中國)使用第一、二級管制藥品之品項、成分、含量、劑型、藥理作用使用情形。2.研析近10年(至少含民國94-103年)國際(至少包括美國、英國、日本、新加坡及中國大陸等5國)使用第一、二級管制藥品，同一成分新舊劑型濫用風險的比較。3.蒐集國際間設計防止藥物濫用第一、二級管制藥品之處方、劑型及專利資料，至少5項。4.依研究成果撰寫正式報告及可投稿文章1篇。<br> Abstract: keywords： Controlled Substance, Opioid Analgesics, Good Pain Management, Drug Abuse, Diversion, , Social Impact, Medical Expenditure Background and Aim of the Study: Compared to western countries, opioid medication used as analgesic drug in Taiwan is relatively conservative and tightly regulated. The available items among different opioid analgesics are also much less than most western countries. As concept of “good pain management as a human right” is gradually being accepted by general population, our governmental agency also tries to import more and more schedule one and schedule two controlled opioid analgesics for medical purpose. However, the use of prescription opioid medications has increased greatly in western countries especially Unitied States during the past two decades. The problem of prescription opioid medication abuse, diversion, related emergency room visit and medical expenditure results in enormous social impact. For example, in 2010, there were 16,651 opioid-related deaths in United States. Proper policy formulation and setting up appropriate regulation rule is paramount when considering import a new opioid analgesic. Methods:This study will subdivide to 2 stages.In the first stage, we will do comprehensive research and summary for current data of opioids use among different countries. We will further focued on the impact of abuse-deterrant formulation on incidence of opioid diversion, abuse and opioid-related ER visit and death.In the second stage, as a fundamental jov, our team will set up formal connections with important societies focused on opioid issue and also connect to international research group. We will also set up serial educational courses, drafting formal report and submit for publication.Expected Possible Results:1.Comprehensively collect data of schedule one and schedule two medical opioid analgesics including items, ingredients, formulations, pharamacologic properties and countrywise usage indifferent countries in the recent 10 years (2005-2014) including North America (United States, Canada), Oceania (Australia, New Zealand), Europe (UK, Germany, France) and Asia (Japan, Singapore, China).2.Collect prescription pattern, formulation details, patent files of at least five different “Abuse-deterrant formulation” of schedule one and schedule two medical opioid analgesics.3.Analysis of changing pattern of prescription, countrywise usage and abuse risk reduction of “Abuse-deterrant formulation” of opioid analgesics among different countries.4.Summarize research results, complete formal report and prepare one submission ready scientific paper draft.鴉片類藥品優良疼痛照護管制藥品濫用藥品流用防止濫用劑型社會負擔醫療照護支出Controlled SubstanceOpioid AnalgesicsGood Pain ManagementDrug AbuseDiversionAbuse-Deterrant FormulationSocial ImpactMedical Expenditure