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

• Main Authors: Wan-Nan Yu, 余萬能
• Other Authors: Hui-Wen Cheng
• Format: Others
• Language: zh-TW
• Published: 2018
• Online Access: http://ndltd.ncl.edu.tw/handle/vu2ub2

博士 === 臺北醫學大學 === 藥學系(碩博士班) === 106 === 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.