의료용 마약류의 국내외 관리지침 비교분석을 통한 마약류의약품의 합리적 관리방안 연구

Abstract

As usage of controlled drugs at medical institutions is growing steadily and regulations to the management of controlled drugs are being strengthened, the management of controlled drugs at hospital pharmacies is being pressured considerably. In particular, due to the enhanced management of controlled drugs caused by the abuse of propofol, hospital pharmacists spend great time managing controlled drugs in addition to preparations and clinical tasks, which are their fundamental duties. Accordingly, this study compares the management of controlled drugs in Korea to that of foreign countries, especially England, where medical systems are regulated nationally based on Safer Management of Controlled Drugs: A guide to good practice in secondary care published by Royal Pharmaceutical Society in October, 2007 and General hospital management guidelines of controlled drugs by Korean Food and Drug Administration. Safer Management of Controlled Drugs: A guide to good practice in secondary care in England is a rather specifically described manual than a guidelines. According to this, non-medicated controlled drugs that are most severely regulated are classified as schedule Ⅰ, and the possession, production, supply and sale of them require authorization from the Ministry of Home. Moreover, medicated controlled drugs are classified as schedule Ⅱ by the severity of possibility and danger of abuse. Most drugs in the benzodiazepine class are classified by schedule Ⅳ, then it can be stored in open place not a safe and regulations are not strict. Therefore, for the more practical and feasible improvement plans and alternatives, this study suggests new classification systems of controlled drugs which separate the medicated from the non-medicated. Revision of the law is necessary in order to solve the practical problems of the current management of controlled drugs, such as patient-returned, management of residual controlled drugs and disposal for effective pain management for cancer patients of hospital pharmacists. In order to achieve this goal, medicated controlled drugs should be separated from illegal ones, as in the U.S. or England. In addition, regulations for prescriptions, storage facilities, and keeping records of drugs in schedule Ⅱ are necessary; for other drugs, flexible regulations by category are needed. In particular, similar to the Safer Management of Controlled Drugs: A guide to good practice in secondary care in England as aforementioned, the management guidelines of medicated controlled drugs are necessary.