Everyone is saying “I want to lose weight” and turning to Wegovy·Mounjaro··· If designated as ‘Medicines of concern for misuse and abuse’, will patients be unable to get prescriptions - 경향신문

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At a pharmacy in Jongno-gu, Seoul, a pharmacist explains the anti-obesity drug Wegovy. Yonhap News Agency

‘Miracle drug’ is hardly an overstatement. GLP-1 class anti-obesity medicines such as Wegovy and Mounjaro show superior weight-loss effects compared with existing therapies and are establishing themselves as new options for treating obesity and diabetes.

However, as expectations for therapeutic effects grow, concerns about misuse and abuse are spreading. People without a medical need are seeking the drugs for cosmetic purposes, yet there is criticism that oversight to ensure appropriate prescribing in clinical settings is insufficient. Prescriptions and supply volumes for anti-obesity medicines are also increasing rapidly. This is the backdrop to the government’s move to designate these medicines as ‘Medicines of concern for misuse and abuse’.

According to reporting by the Kyunghyang Shinmun on the 9th, the process to designate GLP-1 anti-obesity medicines as Medicines of concern for misuse and abuse is nearing its final stage. The Ministry of Food and Drug Safety said it sought advice from the Central Pharmaceutical Affairs Advisory Committee in April and issued an administrative pre-announcement in June, and that it is currently undergoing regulatory review by the Regulatory Rationalization Committee. Once the review is completed, the Ministry of Food and Drug Safety will finalize the plan and revise and promulgate the related notice. A specific implementation date has not yet been set.

If designated as Medicines of concern for misuse and abuse, wording to that effect must be displayed on drug containers or packaging. Even in areas exempt from the separation of prescribing and dispensing, pharmacies will not be allowed to compound or sell these medicines without a physician prescription. Under the current Pharmaceutical Affairs Act, exceptions allow pharmacists in areas without nearby medical institutions to dispense certain prescription-only medicines without a prescription, but Medicines of concern for misuse and abuse are excluded from those exceptions.

Because there will be little change to routine prescribing and dispensing, warning of misuse and abuse risks appears to be the main effect of this designation. In its June pre-announcement, the Ministry of Food and Drug Safety said it expected the effect of “providing a wake-up call to healthcare professionals and users through the ’Medicines of concern for misuse and abuse’ label.” At the Central Pharmaceutical Affairs Advisory Committee meeting in April, participating members were also reported to have supported the designation, stating that it could “serve as a reminder to members of the public who may not recognize that these are prescription-only medicines that they should take caution again.”

However, considering how anti-obesity medicines are prescribed and used, it is uncertain whether this measure alone can sufficiently prevent misuse and abuse. In real-world clinical settings, medication counseling does not appear to be occurring at a level commensurate with the surge in prescriptions.

According to an analysis of anti-obesity medicine consultation data from the telemedicine platform ’Doctor Now’, released on the 6th by the office of Rep. Baek Sun-hee of the Cho Kuk Innovation Party, who sits on the National Assembly Health and Welfare Committee, 93.0% (683,872 cases) of the 735,285 total applications involved patients directly selecting the drug and dose. By drug, this accounted for 97.3% of Mounjaro applications and 69.8% of Wegovy applications. In other words, it is widespread for patients to pre-select the drug and dose they want before requesting a consultation.

Supply volumes of anti-obesity medicines are also surging. According to the Integrated Information Center for Pharmaceutical Management (KPIS), the monthly supply of GLP-1 anti-obesity medicines such as Wegovy, Mounjaro, and Saxenda increased more than 19-fold, from about 160,000 units in October 2024 to 3,119,941 in July this year. Cumulative supply from January through August this year reached 18,410,000 units.

People pass through a dense cluster of pharmacies near Jongno 5-ga in Seoul, a hot spot for hair-loss medication and Wegovy, in September last year. By Lee Jun-heon

The rate at which safety information provided during the prescribing process led to actual prescription changes was also low. According to materials submitted by the Health Insurance Review and Assessment Service to People Power Party lawmaker Han Ji-a, from the domestic launches of Wegovy and Mounjaro through June this year, the prescription change rates following Drug Utilization Review (DUR) alerts were just 2.8% and 5.8%, respectively.

DUR is a system that provides information such as contraindicated combinations, duplicate therapy, and dose cautions when physicians or pharmacists prescribe or dispense medicines. While a DUR alert does not necessarily mean a prescription is inappropriate, it is still necessary to examine how effectively safety information provided at the prescribing stage is being used in practice.

In this context of rapidly growing use of anti-obesity medicines, simply designating them as Medicines of concern for misuse and abuse may be limited in steering appropriate use.

Some say that, in addition to regulations to prevent misuse and abuse, measures are also needed to improve access to medicines for patients who require treatment.

Kim Dae-jung, a professor in the Division of Endocrinology and Metabolism at Ajou University School of Medicine, said, “It is a problem when people who are not obese use these drugs, but I would also like attention paid to environments where people who need the drugs cannot use them properly.” He continued, “These medicines are remarkably effective for treating diabetes and obesity, yet because they are expensive and not covered by health insurance, patients who truly need them are unable to use them due to cost burdens.” Kim added, “As media coverage highlights adverse effects tied to misuse and abuse, there is concern that patients who actually need prescriptions may come to view them as dangerous medicines.”

However, discussions on including anti-obesity treatment in health insurance coverage have seen little progress. For both Wegovy and Mounjaro, the manufacturers have not applied for health insurance listing for the obesity treatment indication. Only the diabetes treatment ’Ozempic Prefilled Pen’, which contains the same semaglutide ingredient as Wegovy, is covered for certain diabetes patients who meet specific reimbursement criteria.

Even without a company application, the government can pursue listing for reimbursement ex officio. However, because ex officio listing is decided by strictly weighing the availability of alternative treatments, disease severity, clinical effectiveness, and other rigorous criteria, applying it to Wegovy and Mounjaro does not appear easy. An official at the Ministry of Health and Welfare said, “In light of precedent, ex officio listing appears difficult.”