MOHW has announced potential regulations concerning 'OTC overdose'

Attention is focused on mandating pharmacist medication counseling for OTC products susceptible to misuse or abuse

"Agreement on establishing safeguards on repeated OTC purchases…will pursue improved framework through consulting with the Ministry of Food and Drug Safety (MFDS) and pharmacies"

MFDS, "Several details of Rep. So Byung-hoon’s legislative inquiry diverge from the drug classification criteria"

Amid growing societal concern over adolescents overdosing on over-the-counter (OTC) drugs to achieve hallucinogenic effects, South Korea's Ministry of Health and Welfare (MOHW) has drawn the pharmaceutical industry's attention by announcing plans to overhaul the dispensing and distribution oversight system for OTC products in community pharmacies.

In a written response to a legislative inquiry submitted by Representative So Byung-hoon of the Democratic Party to the National Assembly’s Health and Welfare Committee on the 1st, the MOHW stated that it agrees on the necessity of establishing safeguards within the pharmacy retail system to prevent adolescents from intentionally overdosing on specific OTC products for recreational or hallucinogenic purposes.

Under the current Pharmaceutical Affairs Act, OTC medicines may be purchased without a prescription. However, Article 6 of the Enforcement Rule of the Pharmaceutical Affairs Act (Code of Ethics for Pharmacists and Oriental Herbal Pharmacists) strictly prohibits selling quantities exceeding an appropriate therapeutic dosage to minors or other individuals when there is a risk of misuse or abuse. Violations can result in administrative sanctions, including the suspension of a pharmacist's professional license.

To terminate adolescent OTC overdoses, the MOHW has stepped up proactive surveillance by requesting formal cooperation from the Korean Pharmaceutical Association (KPA) on two separate occasions, in January and March of this year.

Specifically, these administrative measures included ▲issuing directives to verify the intended indication of drugs carrying hallucinogenic risks while enforcing rigorous medication counseling (issued in January by the Mental Health Policy Division) ▲restricting excessive sales of abuse-prone medicines to adolescents and mandating strict compliance with ethical dispensing standards (issued in March by the Division of Pharmaceutical Policy).

The MOHW plans to formulate actionable regulatory measures aligned with the legislative intent of the Pharmaceutical Affairs Act amendment bill introduced by Representative So.

Representative So’s proposed amendment centers on mandating pharmacist medication counseling for OTC products susceptible to misuse or abuse, legally prohibiting the dispensing of quantities exceeding standard therapeutic regimens to minors, and requiring pharmacists to verify purchaser personal details and maintain transaction logs.

An official from the MOHW’s Division of Pharmaceutical Policy stated, "The MOHW will comprehensively evaluate the positions of the primary regulatory authority, the Ministry of Food and Drug Safety (MFDS), and pharmacies represented by the KPA," and emphasized that "The ministry will establish a workable, pharmacy-level OTC management framework."

While concurring with the legislative intent behind mandating OTC medication counseling, the MFDS pointed out that the bill partially conflicts with the nation’s existing pharmaceutical classification framework.

Under Korea’s current regulatory system, the "drugs subject to misuse·abuse control" designation is applied exclusively to prescription-only medicines (ethical pharmaceuticals, or ETCs). Products with low potential for abuse are categorized as OTCs. Consequently, statutory provisions authorizing the MFDS Minister to designate a separate subset of OTCs as drugs subject to misuse or abuse create structural friction with the binary ETC/OTC classification system.

The proposed measure cited the Pharmaceutical Affairs Act as the statutory basis, which legally defines OTC drugs as therapeutics with a low risk of misuse or abuse and that can be expected to demonstrate safety and efficacy even when administered without a physician's prescription.

The MFDS stated, "Mandating the Minister to designate specific OTC drugs vulnerable to misuse or abuse warrants careful legal review, Rep. So's proposal diverges from the drug classification criteria established under the same statute," and concluded, "However, defining conditions for repeated OTC purchases by minors and prescribing pharmacist counseling standards fall within the administrative jurisdiction of the MOHW. The ministry will actively cooperate on necessary regulatory follow-ups."