Status of management of controlled drugs in Taiwan: Inspection during 2002-2011

C.-J. Chang
M.-H. Wu
M.-T. Hsieh
Y.-L. Hsieh
W.-I. Tsay

Abstract

The three major United Nations international drug control conventions set a supportive and complementary system to effectively control the production (manufacture), trafficking and abuse of drugs. In response to the spirit of the United Nations drug control treaties, Taiwan has instituted a framework of classification administration and license issuance. There is also circulation control for managing the diversion of controlled drugs from pharmaceutical plants and medical institutions, as well as the use of controlled drugs among pharmaceutical and medical professionals under the Controlled Drugs Act. Most of the controlled drug registration licenses and prescription licenses issued by the Taiwan Food and Drug Administration by the end of 2011 were for clinics (7186) and physicians (39,329), respectively. This article examines the results of the inspection from 2002 to 2011 on controlled drugs carried out by the Taiwan Health Department. A total of 2254 violations from 159,494 inspections were reported, resulting in a non-compliance rate of 1.41%. The majority of the violations involved a failure to keep correct records in the controlled drug logs. The failure to report as regulated the inventory status by registrants increased in the past decade. On the contrary, there was a significant decrease in the failure to keep records of the inventory status of controlled drugs over the same period. In addition, the inappropriate prescription of controlled drugs has become a growing concern. The findings revealed that not only diversion, but also abuse of controlled drugs is a major concern in Taiwan. Finally, it is important to develop educational programs and practice guidelines to help physicians prescribe appropriately, as well as to prevent diversion and abuse. Copyright © 2013, Food and Drug Administration. Published by Elsevier Taiwan LLC. All rights reserved.

ScienceDirect Link

10.1016/j.jfda.2013.05.014

Recommended Citation

Chang, C.-J.; Wu, M.-H.; Hsieh, M.-T.; Hsieh, Y.-L.; and Tsay, W.-I. (2013) "Status of management of controlled drugs in Taiwan: Inspection during 2002-2011," Journal of Food and Drug Analysis: Vol. 21 : Iss. 2 , Article 9.
Available at: https://doi.org/10.1016/j.jfda.2013.05.014