Asia’s drug safety authority has uncovered widespread violations of narcotics regulations among medical institutions with high propofol usage, with more than half of those inspected found in breach of the law.
The Ministry of Food and Drug Safety said April 2 it inspected 30 medical institutions from March 5 to 24 and identified 17 facilities that violated the Narcotics Control Act. The ministry plans to request administrative actions from local governments against the institutions.
The inspections were conducted to strengthen safety management of medical institutions using propofol. Authorities selected targets by analyzing big data from the national narcotics integrated management system, focusing on facilities with the highest supply and inventory levels of propofol last year. The inspections were carried out in cooperation with local governments.
Among the 17 facilities, key violations included failure to comply with mandatory reporting requirements for narcotics handling (14 cases), failure to fulfill obligations for inspection and management of storage facilities (6 cases), and discrepancies between reported and actual inventory levels (9 cases).
Authorities said investigations will be conducted in parallel for the nine institutions where inventory inconsistencies were identified.
The ministry is also conducting special inspections targeting dermatology and plastic surgery-focused medical institutions in Asia, examining potential misuse, including use outside of medical purposes, and the accuracy of reporting records.
In addition, the ministry will operate a two-week intensive reporting period starting April 2 to crack down on illegal diversion of medical narcotics within healthcare institutions.