The range of medical narcotics that doctors are barred from prescribing or administering to themselves will expand sharply from propofol alone to 22 substances, including fentanyl and etomidate.
The Ministry of Food and Drug Safety said on the 21st that it has issued a public notice of proposed revisions to the enforcement rules of the Narcotics Control Act and will accept comments until Nov. 17.
The core of the revision is to broaden the scope of medical narcotics subject to the self-prescription ban to cover injectable narcotics and psychotropic drugs. At present, only propofol injections are banned from self-prescription and self-administration, but the list will grow to 22 substances in total — nine narcotics and 13 psychotropic drugs. Doctors who need these drugs will have to undergo an objective examination by another medical professional.
The narcotics include remifentanil, morphine, sufentanil, alfentanil, oxycodone, oliceridine, pethidine, fentanyl and hydromorphone. The psychotropic drugs include nalbuphine, diazepam, remimazolam, lorazepam, midazolam, butorphanol, etomidate, ketamine, thiopental, phenobarbital, pentazocine, pentobarbital and propofol.
The revision also clarifies how the reporting period is calculated for narcotics lost or damaged in accidents. Current rules require a report within five days of learning of such an incident, but the proposed revision would exclude the day of discovery as well as Saturdays and public holidays from that count. The ministry will also create standards for reducing administrative penalties for certain failures to report, in cases where a report is confirmed to have been filed through external software at hospitals or pharmacies linked to the integrated narcotics management system.
The revision includes follow-up steps stemming from an amendment to the Narcotics Control Act in May. It introduces fees for requests to confirm whether a substance falls under narcotics regulations and for narcotics approval applications, and sets out the related application procedures and methods in the enforcement rules.
"We expect this overhaul to help prevent the misuse and abuse of medical narcotics and to reduce confusion over related applications and reporting procedures," an official at the ministry said.