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2015 Annual Report








Risk Assessment

Management and

Research Outcomes





Laboratory and

Testing Network

Risk Communication

and Consumer



Cooperation and

Cross-Strait Exchange






Policy and


2. The Management for the Medical Purpose of Controlled Drugs

(1) The Ministry of Health and Welfare has set up a

Medical Purpose of Controlled Drugs Review


. In 2014, the committee had reviewed 130 cases with the long term controlled drugs

prescription due to non-cancer intractable pain to ensure all the narcotic prescriptions were not


(2) When the health bureaus found any cases involved with improper controlled drug prescriptions

will be sent to the committee for review. The resolved solutions varied, from correction, consulting

to penalizing, per the severity of the each individual case. In 2014, there are 20 violation cases

regarding to the improper prescription.

3. Management of Controlled Drug Licenses

(1) As of the end of 2014, there were a total of 14,857 businesses with controlled drugs registration

licenses and 49,059 individuals with prescription licenses for the use of controlled drugs. Appendix

1 Annex Table 10 provides detailed statistics on the licenses of controlled drugs.

(2) All the controlled drugs used for manufacturer, import and export vendors, health related

researches and experimental purpose need license through certificate, agreement and approval

documents. In 2014, a total of 1833 such licenses were issued.

4. Management of Controlled Drugs Audits

(1) TFDA has closely supervised all the health bureaus to reinforce the audit of controlled drugs. In

2014, there were 17,057 cases had onsite inspections, a total of 304 had violation. The violation

rate of 1.78%. The most common violation cited during an inspection were

the improper or

inaccurate records in the controlled drugs log

followed by

failure to declare controlled drug

transactions on a regular basis

. All violations were penalized accordingly. Appendix 1 Annex Table

11 provides detailed statistics on controlled drugs audit results.

(2) In 2014, a special program-

Program for Strengthening Prescription Audits for the controlled drug


was conducted to improve the proper prescribing of Zolpidem. TFDA conducted a data

analysis and the high out-of-pocket costs related to the prescribing of Zolpidem were examined. A

total of 302 facilities were inspected, 45 violating facilities were noted. The violation rate of 14.9%.

All violations, which included 18 cases of medical malpractice, have been handled according to

the relevant regulations.

5. Training for Controlled Drugs

Seminars on updates to laws and regulations and licensing procedures were given to local health

agencies as well as central veterinarian authorities. In 2014, a total of three basic courses and one

advanced course was held, attended by a total of 344 trainees.