Chapter 3
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Chapter 3. Controlled Drugs Management
In order to strengthen management of controlled drugs used for medical and scientific purposes in Taiwan, TFDA has established management systems that include regulations, certification, distribution management of controlled drugs as well as early warning, monitoring, and abuse prevention. Total quality validation was also implemented for the Factory of Controlled Drugs in order to improve drug quality and to prevent abuse or illegal use of controlled drugs. Usage for Schedule 1 and Schedule 2 controlled drugs has been increasing because of Taiwan's aging society and increased incidence of various diseases. There was also a drastic growth in the use of sedatives and hypnotics in Taiwan, which was accompanied by incidents of improper prescriptions. In order to prevent improper or illegal use of controlled drugs, management of controlled drugs must be strengthened accordingly.
Section 1. Controlled Drugs Regulations and Distribution Management
Current Status
Drug abuse is a common problem faced by various countries around the world. Improper use of addictive controlled drugs or its illegal distributions make such drugs as dangerous as illegal drugs. Taiwan has imposed controls on narcotics, psychotropic substances, and their preparations according to the Single Convention on Narcotic Drugs, Convention on Psychotropic Substances, and the Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of the United Nations. The Narcotics Hazard Prevention Act was also established to enforce stringent controls. However, some drugs and substances are classified as controlled drugs because of their usefulness in medical applications or scientific research, and are subject to the provisions of the Controlled Drugs Act and a control framework composed of license, scheduling, and distribution management (Figure 2-3-1).
Controlled drugs management framework
Addictiveness Controlled drugs registration license
(institutions and businesses) Controlled drugs prescription license (physicians and other professionals)
Permit for exporting, importing, and manufacturing (source management)
Relevant licenses: Transportation permit, letter of approval for medical education, research, and trail purposes
Recording ReportingHealth authorities Inspection Institutions
Figure 2-3-1
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Policies and Outcomes
1. Amendments to the Schedules of Controlled Drugs
Controlled drugs are divided into four Schedules according to their addictiveness, dependence, potential for misuse, and social hazards. These Schedules are reviewed by the Ministry of Health and Welfare Controlled Drugs Review Committee and submitted to the Executive Yuan to be publicly announced accordingly. The Committee held two meetings in 2015 and added five additional controlled drugs (listed in Table 2-3-1) in the following Executive Yuan announcement.
Table 2-3-2 lists the number of controlled drugs as of the end of 2015.
Statistics on the number of controlled drugs in each Schedule as of 2015 表 2-3-2
Date Regulated
Schedule Name of the controlled drug Reason for control
March 26 Schedule 2 Methoxymethcathinone A central nervous system stimulant with hallucinogenic properties. It can be abused and has the potential for causing social hazards.
March 26 Schedule 2
Beta-Keto-Methylbenzodioxolylpentanamine (Pentylone)
A central nervous system stimulant with hallucinogenic properties. It can be abused and has the potential for causing social hazards.
October 7 Schedule 2 Lisdexamphetamine A derivative of amphetamine can be metabolized as such in the body, so it is controlled as amphetamine.
October 7 Schedule 3 N-(1-amino-3-methyl-1-oxobutan-2- yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide, AB-CHMINACA
The effect is like the cannabinoids and it may be abused and caused social hazards.
March 26 Schedule 4 Propofol
It is known colloquially as niunaizhen (milk of amnesia) and used to induce and maintain general anesthesia.
It has been abused by drug addicts to stave off addictions, leading to multiple incidents of death or loss of consciousness.
chedule of Controlled Drugs Schedule 1 Schedule 2 Schedule 2 Schedule 2 Schedule 4 API Total
Number 9 179 38 73 7 306
2. Management for the Medical-Use of Controlled Drugs
In 2015, a total of 3 Medical-Use Controlled Drug Monitoring Committee meetings were carried out to review 134 cases submitted by regional hospitals or larger medical institutions on long-term use of narcotic drugs for patients with chronic intractable non-cancer pain. In 2015, cases suspected of improper medical prescriptions of controlled drugs found by health agencies were reviewed. The outcomes verified a total 6 cases of improper medical prescriptions of controlled drugs. These said cases were penalized according to law.
3. Management of Controlled Drug Licenses
Refer to Table 12 of Annex I for statistics and data of businesses with controlled drugs registration licenses and individuals with controlled drugs prescription licenses as of the end of 2015. A license, letter of agreement, or letter of approval must be applied for and acquired before manufacturing, importing, exporting, or using controlled drugs for medical, educational, research, and trail purposes. A total of 1,727 such licenses or letters were approved and issued in 2015.
Revisions to controlled drugs schedules in 2015 Table2-3-1
Table2-3-2
43 4. Management of Controlled Drugs Inspection
Refer to Table 13 of Annex I for detailed statistics of controlled drug inspection carried out in 2015. Institutions that exhibited relatively higher growth or usage quantities of prescriptions of hypnotics issued in 2013 were screened and selected for the inspection process. 237 institutions were audited. 25 were found to be nonconforming with a violation rate of 10.55%, including 2 cases of medical improper prescriptions. The said violations were penalized according to the relevant laws.
5. Training for Controlled Drugs
To improve familiarity with laws and management practices related to controlled drugs amongst local health agencies, a total of three basic courses and two advanced courses on controlled drug management and laws were held in 2015. These courses were attended by a total of 442 individuals.
Section 2. Pharmaceutical Plant of Controlled Drugs Management
Current Status
According to the Controlled Drugs Act, import, export, manufacture, and sales of Schedule 1 and Schedule 2 controlled drugs can only be carried out by the TFDA Pharmaceutical Plant of Controlled Drugs. The mission of the Pharmaceutical Plant of Controlled Drugs is to meet the pain control medical requirement of Schedule 1 and Schedule 2 controlled drugs, and to supply the relative pharmaceutical products during disasters and emergency mobilization.
The TFDA Pharmaceutical Plant of Controlled Drugs must comply with PIC/S GMP as well as regulations pertaining to the management, production, distribution, and loss of controlled drugs provided in the Controlled Drugs Act in order to ensure the quality and safety of the controlled drugs.
Policies and Outcomes
1. Supply of Schedule 1 and Schedule 2 Controlled Drugs
In order to provide a sufficiency of Schedule 1 and Schedule 2 controlled drugs needed by medical services in Taiwan, Pharmaceutical Plant of Controlled Drugs apply three main methods of self-production, commissioned production, and imports. The following lists the outcomes of such measures:
(1) Pharmaceutical Plant of Controlled Drugs independently produces nine products in compliance with the PIC/S GMP specifications to ensure product quality, safety, and therapeutic efficacy.
The turnover from selling drugs amounted to NT$ 586,406,000 in 2015. Refer to Table 14 of Annex I for statistics for the revenue of Pharmaceutical Plant of controlled drugs.
(2) Production for a total of five Schedule 1 and Schedule 2 controlled drugs with greater demands in medical institutions and the market was commissioned to domestic pharmaceutical manufacturers that have demonstrated excellent performance, under the conditions that the said manufacturers must enforce safety and quality management measures aligned with those of Pharmaceutical Plant of Controlled Drugs.
(3) To provide more diverse selection for pain medication during treatment, the TFDA developed new chemical entities (NCE), new delivery paths, and new dosage forms of opioids according to the needs of the medical institutions and patients. In 2015, the fentanyl buccal soluble films was imported for the first time as an acute moderate to severe painkiller agent, benefiting patients suffering from severe pain.
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2. Continuing Improvement to Product Quality and Standards of Pharmaceutical Plant of Controlled Drugs
(1) The Morphine Sulfate Sustained Release FC Tablets - 30 mg were rewarded with the Symbol of National Quality (SNQ) in the modern pharmaceuticals category in 2014 as well as in 2015.
(2) Post-marketing tracking studies were carried out for Morphine Sulfate - 15 mg to ensure product quality, safety, and therapeutic efficacy.
(3) On-job-training for personnel was enhanced for PIC/S GMP, controlled drugs, and medicinal product management
3. Building New PIC/S GMP Factories
To expand independent production capacities for Schedule 1 and Schedule 2 controlled drugs and improve product quality, the TFDA initiated the New Production Building Construction and Renovation Project for Pharmaceutical Plant of Controlled Drugs. Every step of the construction project monitored closely which allowed the progress to be slightly ahead of schedule. The new factory building was set for completion in 2017 and shall be used for production purposes after qualifying PIC/S GMP assessments in order to supply public and medical institutions with Schedule 1 and Schedule 2 controlled drugs they require.
Section 3. Controlled Drug Alerts and Monitoring
Current Status
Drug abuse is becoming an increasingly global and complex challenge. Abuse of illegal drugs gravely affects physical and mental health, economic development, social stability, public security, and may even impact overall national competitiveness.
To effectively prohibit and prevent drug abuse and build a healthy society well-protected from the hazards of narcotics, prevention must be regarded as the main goal of policies for preventing drug abuse which shall start with source management and early warning systems.
Core activities include compilation of drug abuse reports and information, establishing a comprehensive early warning system, enhancing management efforts for controlled drugs, and strengthening regional strategic alliances against drug abuse in order to achieve early warning functions and eliminate rampant drug abuse in Taiwan.
Policies and Outcomes
1. Collecting and Compiling National Drug Abuse Information
To get an insight to status of domestic drug abuse and control the medication patterns in Taiwan, monitor current status of national drug abuse, and identify trends drug abuse behaviors, statistics such as drug abuse urine tests, non-urine tests of suspected drugs and controlled drugs cases, and discovery of illegal drugs in the Taiwan region shall be compiled to form the Drug Abuse Cases and Testing Statistics.
2. Notification on the Prevention of Controlled Drugs Abuse
(1) To achieve effective understanding of epidemic trends in the abuse of controlled drugs, the TFDA established the Drug Abuse Reporting System (http://dars.fda.gov.tw/) that compiles analyses and report data every month. In 2015, a total of 18,399 drug abuse cases were reported by medical institutions. The top 3 drug abuse categories were heroin with 11,697 individuals (63.6%), (meth) amphetamine with 5,672 individuals (30.8%), and ketamine with 1,556 individuals (8.5%).
45 45 (2) Demographics of the reported cases were analyzed, the drug abuse cases by gender consists
of male and is mostly distributed in between 30 years and 40 years old (35.9%) and between 40 years and 50 years (32.9%). Among the drug categories used by all age groups, ketamine was the most common drug abused by those below 19 years of age, (meth) amphetamine was the most common drug abused by those of 20 to 29 years of age, and heroin was the most common drug abused by those over 30 years of age . Individuals aged over 70 years (inclusive) primarily abused zolpidem.
(3) Analysis for the most common sites for drug abuse were friend’s residence, on streets, and at the dance clubs/pub/hotel. The leading sources of illegal substances were drug dealers/
vendors followed by friends. The top reasons for drug abuse were dependence (36.3%) followed by stress relief (17.5%).
2. Integrating the Cross-departmental Narcotics and Drug Abuse Reporting System Database (1) The drug abuse issue is extremely complex. The Ministry of Justice (MOJ), Ministry of the
Interior (MOI), Ministry of Education (MOE), Ministry of Health and Welfare (MOHW), and Ministry of Labor (MOL) have been authorized to tackle this issue. To accurately observe the state of drug abuse in Taiwan, the Executive Yuan has assigned all relevant ministries to contribute their ideas and build a consensus to integrate various narcotics and drug abuse reporting system databases from multiple ministries and departments. The aim was to employ big data analytics to clarify the three major aspects of drug abuse: (1) Narcotics User Profile, (2) Effective Treatment Model, and (3) Narcotics Production and Marketing Course, an accurate understanding of drug related data and analysis. These information can then be used as a reference to propose various preventive strategies.
(2) As of December 2015, a total of 17 narcotics and drug abuse reporting system database (from the MOJ, MOI, MOE, and MOHW) were integrated and placed under the data science center of the MOHW (Figure 2-3-2) as a reference for implementing early warning or preventive strategies.
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Major achievements of drug abuse assay technologies and database establishment in 2015.
Results Benefits
Completed the synthesis of 13 standards, including five synthetic cannabinoids, six aminophenones, two stimulants ,phenazepam, and establishment standard spectrum database.
Established standards and spectrum database for comparing test results and meet the techniques for drug abuse.
Established the 96-well solid phase extraction plate for urine pre-treatment and UPLC-Q-LIT mass spectrometer and developed a high performance assay to 210 abuse drugs in urine.
Accelerated the development and optimization of systematic techniques for drug abuse.
Established a pre-treatment technique for solid phase extraction and GC-MS/MS quantitative urine assays for 38 drugs that include synthetic cathinones and synthetic phencyclidines.
To accelerate analysis time for synthetic cathinones and synthetic phencyclidines.
System (No ID) Household registration system
Urine Test for Drug Abuse Reporting
Ministry of Education Ministry of the Interior
1. National Health Insurance database 2. High risk children and youths 3. Drug addicts and AIDS
4. Protection Database
3. Establishment of Technology and Database for Drug Abuse
In response to the deteriorating drug abuse and addiction issues, TFDA continues to dedicate the developing new technology and establishing databases to achieve the prevention effectively and control of drug abuse. Important outcomes of 2015 are listed in Table 2-3-3.
Integration of narcotics and drug abuse reporting system database from multiple departments Figure 2-3-2
Table2-3-3
Section 4. Preventing the Abuse of Controlled Drugs
Current Status
Drug abuse and addiction issues have recently became a crucial problem that is in urgent need of solution by the health agencies of government. Drug abuse can easily harm personal health, even lead to mental problems, and also increased unemployment rate and crime which
47 47 cause negative impacts to social stability and national development. Therefore, it' s necessary to
make efforts in strengthening knowledge of controlled drugs abuse prevention amongst the public, and draft a more effective strategy. Educate actively on the harm of drug abuse and camouflage drugs patterns to enhance people's self-protection ability.
Policies and Outcomes
1. Multi-agency Collaboration for the Prevention of Drug Abuse
(1) Worked with the MOJ and MOE to implement the Anti-Drug Abuse Education and Advocation Project. TFDA joined forces with drug abuse prevention centers in every cities to organize 10 Freedom from Drugs advanced instructor training courses attended by a total of 3,241 individuals. The TFDA also hosted the art competition of creative performing against drug abuse named Theatrical Anti-Drug Abuse-Show Yourself. A total of 8 winning teams were selected, and performances of the winning entries were compiled in a digital video disk and sent to every local health bureaus, medical institutions, NGOs, and drug abuse education resource centers for reference purposes.
(2) Worked jointly with the MOHW Health Promotion Administration (HPA) to host the Integrated Marketing Plan for Promoting Educational Programs on the Prevention of Addictive Substance Abuse. In 2015, an alliance was formed with 52 businesses, allowing pharmacists to hold 53 sessions of educational seminars for preventing the abuse of addictive substances at business locations. The 4 Cell Manga Competition against Cigarette Smoking, Betel Nuts Chewing, and Drug Abuse was held. Youths, college students, and adults alike unleashed their creativity to highlight the health hazards caused by tobacco products, drugs, and betel nuts. Total of 565 entries submitted by the colleges, universities, and adults category as well as the youth category, 8 winning works were selected from each group.
2. Seed Instructor Training for the Prevention of Drug Abuse
(1) In 2015, a total of six sessions of advanced seed instructor training were held for 319 candidates in northern, central, and southern Taiwan. These seed instructors shall then lead training courses to strengthen public understanding on correct usage of controlled drugs and prevention of drug abuse.
(2) In 2015, a total of 12 sessions of Training on the Correct Usage of Controlled Drugs were held in northern, central, southern, and eastern Taiwan for 903 physicians from anesthesiology, psychiatry, and family medicine departments to improve their familiarity with the proper issuance of prescriptions as well as laws on controlled drugs.
Part II - Key Administrative Results Controlled Drugs Management