台灣管制藥品使用之管理政策法規整合研究-以麻黃素類製劑及醫源性濫用為例

Study on the Integration of the Policy Management and Regulations of the Controlled Drugs Use - Case Studies of Ephedrine Products and Iatrogenic Abuse

余萬能(Wan-Nan Yu)

指導教授 ： 鄭慧文

臺北醫學大學/藥學院/藥學系(碩博士班)/博士(2018年)

摘要

我國管制藥品管理，配合聯合國1961年「麻醉藥品單一公約」、1971年「影響精神物質公約」及1988年「禁止非法販運麻醉藥品和精神物質公約」，綜整我國藥品管理、管制藥品濫用防治及毒品防制之法律體系，修正《藥事法》、《管制藥品管理條例》及《毒品危害防制條例》三法，因各法皆有其立法目的及規範對象，構成要件亦非相同，因此常造成法條之間多有扞格，適用上亦生困境，致有麻黃素製劑流為製造安非他命之問題，以及醫源性成癮等之管制藥品濫用等問題。
麻黃素類製劑醫療常用為治療感冒、咳嗽或過敏，取得容易，因其成分結構與安非他命相近，化學反應相對簡單，多以含量60mg之單方或複方，流為製造第二級毒品安非他命之原料來源。國際間多採取限量包裝、限量供應、藥品不得開架陳列及設簿冊登載購買者相關資料等防制措施加以管制，我國則以限制包裝為鋁箔盒裝，以及以成人七日用量為限之管制方式加強管理，並就可能流用之各種通路規範相關責任。
醫源性濫用管制藥品，其態樣包括不當連續就醫（doctor shopping）、偽造處方及偷盜醫院藥局之藥品：常見被濫用之管制藥品，多為鴉片類鎮痛劑，以及安眠鎮靜類之精神治療劑「苯二氮平類藥物」(BZD)，包括「氟硝西泮」（Flunitrazepam，或稱FM2）。國際間除針對管制藥品以法規嚴予規範外，另多以建立指引等方式，嚴予規範臨床醫師處方使用管制藥品，並由病人端之關懷照護系統，減少藥物濫用需求，例如美國以「監控處方計畫」(PDMPs)，輔以資訊系統之勾稽方式，強化管理，減低醫源性成癮之機會。
我國為防制醫源性濫用管制藥品，採取與美國及日本相同之「管制藥品使用執照」勾稽策略，惟因我國對於管制藥品之管轄組織，不若美國及日本之衛生及司法機關明確分工，共同合作防制不當處方使用管制藥品之行為，無法成就管制藥品使用執照之有用性。又司法實務上對於管制藥品「正當醫療目的使用」如何適用《管制藥品管理條例》或《毒品危害防制條例》之認定基礎有不同見解，亦造成查緝不法之難度。
本文乃試由各法律之目的及適用結果之差異，探討三法可能之問題所在，重新審視管制藥品管理相關法規政策與組織結構，研擬健全管制藥品及麻黃素類製劑之管理制度，以及強化法規實務管理機制，防杜醫源性濫用成癮，並以組織重構及法條修正為方法，達到提升管制藥品管理相關法規及政策品質之目的。就評估分析結果，擬議「醫療使用麻黃素類製劑之防制及管理機制」三階段政策，建議制定《製造販賣麻黃素類製劑業者檢查辦法》，並研擬「地方衛生主管機關查核麻黃素類製劑之作業程序及處置方式」及「衛生司法機關防制麻黃素類製劑流為製造毒品之協調查處作業流程」，修正《毒品危害防制條例》相關條文，建議使用執照納入第四級管制藥品並建立繼續教育訓練控管機制，提出管制藥品使用、監測與醫療資訊整合之政策建議，納入健保卡電子資料智慧型處理功能機制，限制開立管制藥品給予自己或直系親屬，整合醫療資訊以監測管制藥品之處方行為，修正《管制藥品管理條例》相關條文。並建議衛生福利部依據《藥事法》第6-1條之規定，公告麻黃素類製劑為追溯或追蹤系統之藥品類別，參考美國DEA或日本麻藥取締官之司法體系介入專責管理毒品危害防制業務，事權統一，加速進行組織再造，以全面落實執行我國醫療使用流通管制藥品之管理，澈底防制管制藥品濫用，畢其功於一役。

關鍵字

管制藥品 ； 藥物濫用 ； 醫源性濫用 ； 不當連續就醫 ； 麻黃素類製劑 ； 苯二氮平類藥物 ； 氟硝西泮

並列摘要

Amendments to Pharmaceutical Affairs Law, Controlled Drugs Act and Narcotics Hazard Prevention Act were made to comply the legal system of Taiwan with the Single Convention on Narcotic Drugs (1961), Convention on Psychotropic Substances (1971) and United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988) of UN. Each law has different legislative purposes, subjects and constituent elements, which caused conflicts and difficulties in application and resulted in controlled drug abuse problems such as ephedrine preparations being used to produce amphetamines and iatrogenic addiction.
Ephedrine products are often used to treat cold, cough or allergy and they are easy to obtain. Single compound or combinations of ephedrine products became material sources to produce amphetamines due to the similar chemical structures and simple chemical reactions. Measures such as limited packaging, limited supply, only sold behind the counter, and keeping record of purchases are commonly used to manage ephedrine products internationally. In Taiwan, we restrict the ephedrine products to pack into aluminum foil boxes and put a 7-day dose limit for adults. We also specified the responsibilities for the possible trafficking methods.
Opiate analgesics and Benzodiazepines usually lead to iatrogenic abuse and would result in problems such as doctor shopping, forged prescriptions and drug thefts. Internationally controlled drugs guidances are provided for the doctors to follow and caring systems are built to reduce the drug abuse. In the U.S. , Prescription drug monitoring programs (PDMPs) are established to strengthen the management.
To prevent the iatrogenic abuse of controlled drugs, the licenses for the use of controlled drugs are issued here in Taiwan like the U.S. and Japan. But the jurisdictions in Taiwan are not as distinguishable as they are in the U.S. and Japan. And how to apply legitimate medical purposes to Controlled Drugs Act or Narcotics Hazard Prevention Act is also a judicial practice issue.
In this article we examine the differences in the purposes of Pharmaceutical Affairs Law, Controlled Drugs Act and Narcotics Hazard Prevention Act and the results of their application and we also explore the possible problems of the three regulations by reviewing the policies and organization structures to prevent iatrogenic abuse and develop a sound management system for controlled drugs and ephedrine products. We tried to improve the quality of regulations and policies through organization restructuring and regulation amendments. Systems including “management of medical use of Ephedrine products” and “medical use, monitor and integration of medical database of drug misuse and to conduct early warning system” were developed. And we suggested to set up Regulations of Manufacturer and Distributors Inspection of Ephedrine products combined with amendments of Controlled Drugs Act and Narcotics Hazard Prevention Act by introducing the electronic data intelligence processing function mechanism into the Health insurance card system and includes the restrictions for prescribing controlled drugs to oneself or ones direct relatives. We recommend that the Ministry of Health and Welfare should establish a traceability system for ephedrine products as article 6-1 of Pharmaceutical Affairs Act regulates. The Judicial system should to intervene in the management of drug hazards prevention and control business referring to the systems of U.S. and Japan. The reorganization should be accelerated and fully implemented to prevent controlled drug abuse thoroughly.

並列關鍵字

controlled drugs ； drug abuse ； iatrogenic abuse ； doctor shopping ； ephedrine products ； BZD(Benzodiazepines) ； FM2（Flunitrazepam）

參考文獻

1.藥事法第1條第2項「所稱藥事，指藥物、藥商、藥局及其有關事項。」之規定參照。

2.立法院公報第82卷第4期第400-401頁院會紀錄。

3.藥事法第6條之規定參照。

4.藥事法於93年4月21日修正公布第11條為「本法所稱管制藥品，係指管制藥品管理條例第三條規定所稱之管制藥品。」，再將其回歸管制藥品管理條例。

5.新興合成毒品，係聯合國毒品及犯罪問題辦公室（UNODC;United Nations Office on Drugs and Crime）將未列入1961年「麻醉藥品單一公約」及1971年「精神藥物公約」之濫用物質，可因此規避法律制裁，但是其濫用會造成公共衛生威脅。包括模仿已知非法藥物之結構微幅修改進行化學合成之「設計藥物」(Designer Drugs)及「新興精神活性物質」（NPS; New Psychoactive Substances）。例如愷他命、類大麻活性物質（K2）、MDPV（浴鹽）等。