The Ministry of Food and Drug Safety on Wednesday distributed a new safe use standard for prescriptions and administrations of one kind of ADHD drug and three prescription antitussives among narcotics for medical use.

The ministry said narcotic ADHD treatments containing methylphenidate would be subject to the new standard. Such medications include Jannsen Korea’s Concerta OROS ER Tab., Mundipharma Korea’s Bisphentin Controlled-Release Cap., and Myungin Pharmaceutical’s Medikinet Retard Cap.

The three antitussives subject to the new standard include psychotropic drugs containing codeine, dextromethorphan, and zipeprol to suppress cough. The product names are Hana Pharm’s Dicode SR Tab., Youngil Pharm’s Copuron Tab., and Aju Pharm’s Respilene Tab.

However, ultra-narcotic drugs containing codeine or dihydrocodeine and over-the-counter (OTC) drugs containing dextromethorphan are not subject to the safety standard.

The MFDS said the latest safety use standard for ADHD drugs and cough suppressants was reviewed and revised through consultations with experts based on the ministry’s research project between 2019 and 2021. The standard was finalized at the Narcotics Safety Management Review Committee’s meeting on Aug. 9.

The safety standard states that ADHD treatments should be used in children six or older and adults and should treat only patients diagnosed with ADHD based on medical diagnostic criteria.

Physicians should prescribe an ADHD drug for three-month use at maximum. If a patient needs a long-term medication longer than three months, a doctor should regularly evaluate the patient’s condition and prescribe the drug.

As some antitussives are not narcotics, physicians should recommend a non-narcotic drug first to prevent abuse or misuse of narcotics. In addition, the ministry said that narcotic antitussives should be used only for a short term to suppress coughs in adults aged 19 or more, and two or more narcotic antitussives should not be combined.

To prevent the over-prescription of narcotics, the MFDS recommended physicians check the patient’s history of using narcotics for medical use at data.nims.or.kr.

Also, the MFDS said it would actively utilize an “advance notice system” to prevent abuse or misuse of ADHD drugs and antitussives.

The ministry analyzes big data on medical narcotics collected through the integrated narcotics management system, provides prescription information to doctors who prescribed outside the safe use standard, urges caution, and conducts on-site inspections if necessary.

Earlier, to establish safe use standards for all medical narcotics, the regulator set up the safety standard for appetite suppressants, zolpidem, propofol, analgesics, and anxiolytics consecutively, considering social issues, usage volume, and expert opinions.