Obesity drugs likely to be designated as drugs at risk of misuse or abuse

Central Pharmaceutical Affairs Council recommends designation… rising pediatric prescribing also cited as a cause

MOHW and MFDS expected to regulate the drugs’ indiscriminate prescribing and sales for cosmetic purposes

The Ministry of Food and Drug Safety’s Central Pharmaceutical Affairs Council has issued an advisory opinion that GLP-1-based obesity treatments such as Wegovy and Mounjaro should be designated as drugs at risk of misuse and abuse.

As GLP-1 obesity injections have gained popularity nationwide, indiscriminate prescribing and sales in areas exempt from the separation of prescribing and dispensing, as well as a sharp increase in pediatric prescribing, are said to have influenced the recommendation.

According to the pharmaceutical industry on the 9th, following discussions on the validity of designating obesity treatments as drugs of concern for misuse or abuse, the Central Pharmaceutical Affairs Council agreed on the need to designate GLP-1 injectables as such.

If regulations are finalized in line with the council’s recommendation, GLP-1 injections are expected to be designated as drugs of concern for misuse or abuse in the near future.

Industry sources say that this decision was driven by a sharp rise in cases where GLP-1 obesity drugs are prescribed and sold for cosmetic purposes beyond obesity treatment, by exploiting areas exempt from the separation of prescription and dispensing, as well as growing risks associated with off-label prescriptions for children without approved indications.

In fact, the Ministry of Health and Welfare has been working with the MFDS since last year to address misuse and abuse of newer obesity injections such as Wegovy and Mounjaro.

To regulate indiscriminate prescriptions for cosmetic purposes, they have established an administrative policy to discuss designating these drugs as “drugs of concern for misuse or abuse” and to strengthen crackdowns on in-house dispensing by medical institutions that violate the principle of separation of prescribing and dispensing.

GLP-1 obesity drugs have been associated with adverse effects ranging from relatively mild gastrointestinal side effects such as nausea, vomiting, and diarrhea to severe complications, including pancreatitis and intestinal obstruction.

In particular, some medical institutions have also been criticized during NA audits for undermining the prescribing-dispensing separation principle by directly selling GLP-1 injections within hospitals through irregular in-house dispensing practices.

If GLP-1 injectables are designated as drugs of concern for misuse or abuse in the future, they will be subject to much stricter distribution, prescription, and sales regulations compared to general prescription drugs.

First, GLP-1 injectables will no longer be sold without a prescription, even in areas exempt from the separation of prescription and dispensing.

In addition, product containers, package inserts, and outer packaging will be required to clearly display wording indicating that they are drugs at risk of misuse and abuse, so that consumers and healthcare professionals can immediately recognize the risk.

Distribution oversight and surveillance will also be strengthened. The MFDS and the Ministry of Health and Welfare will more closely monitor distribution records among pharmaceutical companies, wholesalers, medical institutions, and pharmacies. If abnormal bulk purchases or prescribing patterns are identified, entities may face administrative penalties following intensive on-site inspections.

A pharmaceutical industry official stated, “As Wegovy, Mounjaro, and similar agents have become extremely popular, usage has risen sharply, and GLP-1 prescriptions surged in conjunction with telemedicine during the early stages when regulations were absent. Even now, telemedicine continues to serve as a conduit linking medical institutions with patients seeking GLP-1 obesity prescriptions. In this context, the Central Pharmaceutical Affairs Council appears to have concluded that designation as drugs with a risk of misuse or abuse is unavoidable in order to control adverse effects.”

Meanwhile, drugs designated as being at risk of misuse and abuse have so far included erectile dysfunction treatments such as sildenafil and tadalafil, premature ejaculation treatment dapoxetine, diuretics, and anabolic steroids. No obesity drug has previously been designated.