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- 2026-05-07 20:36:36
- Policy
- What to expect from the upcoming 2-day HIRA DREC meeting
- by Lee, Tak-Sun Sep 07, 2023 05:31am
- The industry’s attention is focused on the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting that is being held for an unprecedented 2 days this month. The industry predicts that the 2-day term reflects the difficulty the committee will have in reaching a conclusion on the agendas set for DREC review. In particular, the issues of interest are the reimbursement reevaluation of HA eye drops that have a market size of over KRW 200 billion and the review of reimbursement adequacy of the neurofibromatosis treatment ‘Koselugo Cap’ that was set to receive redeliberations. According to industry sources on the 6th, DREC will hold its 9th meeting on the 6th and then its 10th meeting on the 7th. In other words, the meeting will be held for two days. In the 2-day meeting, the committee members will be deliberating the drug reimbursement adequacy reevaluation results on one day, and the other to deliberate on the decision on long-term care benefits and whether to approve reimbursement for prescription drugs. The industry expects DREC will have difficulty making decisions this time, as the agendas are serious and important to the state and its deliberation requires 2 days. ◆Industry interest rises on whether the use amount of HA eye drops will be restricted In particular, whether the use amount of HA eye drops will be restricted as a result of reimbursement reevaluations remains an issue. The authorities have also been reviewing whether to drop reimbursement for extrinsic diseases, but limiting its usage is the key focus of industry interest. Moreover, the industry is concerned that if the annual limit is set at 4 boxes, their usage will be cut in half. As for the other ingredients subject to reevaluations, their deliberation is expected to proceed without issue as their reimbursement status will not change significantly. According to the industry, it is expected that reimbursement for rebamipide and levosulpiride may be maintained while reimbursement for limaprost alphadex, loxoprofen sodium, and epinastine hydrochloride may be restricted for secondary indications rather than primary indications. ◆Orphan drug Koselugo to be redeliberated for reimbursement, Will Leclaza’s competitor Tagrisso pass deliberations this time? Among newly deliberated drugs, whether Koselugo will pass review is the industry’s primary interest. The committee had decided to rediscuss Koselugo’s reimbursement at the 8th DREC meeting. As it has recently been reported that the HIRA and pharmaceutical companies have reached an agreement on a risk-sharing plan for this drug, attention is being paid to whether it will be able to pass the DREC review this time. Koselugo is the only drug that was judged non-reimbursable by DREC last year. On the 5th, the Korean Organization for Rare Diseases submitted a petition to the Human Rights Commission of the Republic of Korea, calling for coverage of 'Koselugo.’ After its reimbursement was discussed as an agenda item for DREC, patient groups have been strongly calling for its reimbursement. Also, whether the plan to extend reimbursement for Tagrisso to the first line for non-small cell lung cancer, which passed review by the Cancer Disease Review Committee in March, will be reviewed by DREC is receiving attention. The analysis is that if Tagrisso passes the DREC review this time, it could be listed for reimbursement faster than its competitor ‘Leclaza,’, which passed CDDC last month. The results of the DREC meeting will be announced through a press release on the evening of the 7th, the day the 10th meeting is scheduled to end.
- Opinion
- [Reporter's view] Massive drug price cuts
- by Kim, Jin-Gu Sep 06, 2023 05:36am
- Generic proliferation. It is the root of all evil. At least that's the case from the government's perspective. When the valsartan incident occurred in 2018 and the ranitidine incident the following year, everyone knew that the essence of the incident was impurities, but the government continued to point out that the proliferation of generics was the problem. The government said it would reduce the proliferation of generic drugs. A new drug pricing system was proposed in July 2020. The new rule set by the government was that the drug price would be reduced if one of the two was not done, whether it was conducting an in-house BA test or using registered raw drug products. It is an ambitious plan by the government to prevent the proliferation of generics. Finally, the time has come to reevaluate already registered generics. The government proposed qualifications such as its own BA testing and use of registered raw drug substances. They said they would reduce the price of drugs by up to 27% for drugs that do not have these two pieces of data. Approximately 23,000 generics suddenly underwent this qualification verification. Pharmaceutical companies face a moment of choice. More than 7,000 generic drugs accepted the fate of lower drug prices. As of September 5, the government lowered the prices of 7,355 generic products. The pharmaceutical industry is expected to lose more than 300 billion won per year. Can the government, which seeks to resolve the proliferation of generic drugs and further secure the financial soundness of health insurance, be free? Initially, the government proposed a new drug pricing system, saying it would solve the proliferation of generics, and at the same time gave a grace period of nearly two years. During the grace period, pharmaceutical companies approved generics as if it were their last chance. Pharmaceutical companies received approval for insurance use of drugs they had no intention of selling, and these products became the subject of this reevaluation of generic drug prices. It is time for generics to be sorted out. Many of the targets of this drug price cut were for insurance purposes, not for sales. The government is required to take a more responsible attitude. A sufficient explanation is needed to resolve the issue caused by incorrect policy judgment using a different logic. It is difficult to look at the direct and indirect losses to the pharmaceutical industry, distribution industry, and pharmacy prices resulting from the price reduction of 7,000 generic drugs as if it were someone else's problem.
- Policy
- Daewoong withdraws its Herceptin biosimilar Ogivri from mkt
- by Lee, Hye-Kyung Sep 06, 2023 05:36am
- Pic of Ogivri sold in the U.S. ‘Ogivri Inj. 150mg (trastuzumab),’ the third Herceptin biosimilar to be approved in Korea, is withdrawing from the Korean market. The Ministry of Food and Drug Safety announced on the 4th that Daewoong Pharmaceutical voluntarily withdrew its license for Ogivri in Korea. Ogivri was developed by the Indian pharmaceutical company Biocon. Alvogen Korea received domestic approval for the product on August 25, 2020, and the license holder was later changed to Daewoong Pharmaceutical. The company received insurance reimbursement for the drug on November 1, 2020, in preparation for releasing Ogivri. However, referring to its non-existent performance for 3 years since its approval and reimbursement, the company suddenly withdrew its reimbursement listing on May 1 and prepared to withdraw from the domestic market. Meanwhile, Sam-oh Pharm had received approval for a same-ingredient drug ‘Tuzepta Inj. 150mg, 440mg,’ which was also supplied by the Ogivri-producer Biocon on July 10th. This was why there were speculations that Daewoong Pharmaceutical may receive a transfer of domestic sales rights for Tuzepta from Samo Pharmaceutical. A Daewoong Pharmaceutical official said, "We decided to withdraw our license for Ogivri due to a change in our company’s global sales strategy. We plan to continue on our biosimilar business in the mid-to long- -term, but are considering conducting our own CDMO business rather than selling other companies' products." Meanwhile, the market share of Roche's original Herceptin, which was approved in Korea in 2005 as a biopharmaceutical for HER2-positive breast cancer and metastatic gastric cancer, has been decreasing since the release of its biosimilars. According to market research institution IQVIA, Herceptin's sales decreased by 25% from KRW 80 billion in 2018 to KRW 60 billion last year. The original's market share decreased from 91% to 63%. On the other hand, the market share of Herceptin biosimilar increased by 28% points in 4 years from 9% in 2018 to 37% last year. Looking at the domestic Herceptin biosimilar approval status, Celltrion received approval for ‘Herzuma’ in November 2014, and Samsung Bioepis obtained approval for ‘Samfenet’ in November 2017. Herzuma’s sales increased 3.7 times in 4 years from KRW 7.7 billion in 2018 to last year. Samfenet’s sales increased 2.5 times in 3 years from KRW 2.2 billion in 2019. Daewoong Pharmaceutical's Ogivri was the 3rd biosimilar to be approved, but the company withdrew its approval after 3 years without launching the product in the market. With the 4th biosimilar also approved in Korea, the production of Herceptin biosimilars continues. Last May, Prestige Biopharma held a preliminary meeting with the European Medicines Agency (EMA) to apply for product approval for its Herceptin biosimilar 'HD201', and in August, Aprogen and Aprogen Healthcare & Games signed an agreement for the joint development of a Herceptin biosimilar, AP063, and completed global Phase 1 clinical trials in the United States.
- Opinion
- [Desk’s View] Compensate for the value of novel drugs
- by Lee, Tak-Sun Sep 06, 2023 05:36am
- The Ministry of Health of Welfare plans to soon announce an appropriate compensation plan for the innovative value of new drugs, including novel homegrown drugs. The health authorities’ plan is to deliberate its plan by the Health Insurance Policy Review Committee within the month and release the results to the public soon. The domestic pharmaceutical industry is hoping that this measure will provide additional points to non-inferior new drugs. Non-inferior new drugs contain new active ingredients and have proven to be non-inferior to existing drugs. Most new drugs developed in the domestic pharmaceutical industry fall into this category. The novel homegrown drugs, No. 36 'Envlo Tab,' No. 34 'Fexuclue Tab,' and No. 30 'K-CAB' have all demonstrated their noninferiority to existing drugs in clinical trials. However, the insurance price ceiling for these drugs had been set below the weighted average price of their alternatives because they were unable to demonstrate superiority over existing drugs. As a result, the price of Envlo Tab was set below 90% of previously released SGLT-2 inhibitors in the same class, and Fexuclue Tab was priced below the weighted average price of previously released P-CAB class drugs and PPI class drugs. K-CAB, which was listed with reimbursement in March 2019, was able to receive a relatively high price as it had benefitted from the ‘global innovative new drug pricing premium’ that was applied at the time. However, the preferential pricing plan for global innovative new drugs arose as a discriminatory element during the Korea-US FTA negotiations and was nearly non-existent at the time. The pharmaceutical industry has been criticizing how the current price calculation method for domestically produced new drugs is not sufficient to compensate for the industry’s new drug development efforts. The MOHW’s compensation plan for the innovative value of new drugs under review this time is the result of the continuous efforts of the domestic industry that has continuously raised the need to provide preferential pricing for domestically produced new drugs. In 2013, the MOHW reported to the National Assembly that the development of a domestic new drug costs an average of KRW 22.2 billion and takes 9 years and 8 months. As these results were from 10 years ago, the average cost of new drug development would have only increased further since then. In Korea, where drugs are covered by health insurance, companies need to receive a high insurance drug price to make up for the enormous costs of developing new drugs. The companies can determine when they could retrieve their investment according to drug price. Moreover, as the companies that developed the homegrown new drugs seek to expand overseas after initial release into the domestic market, it is beneficial for the companies to receive a high insurance price for their drugs in Korea, as it will serve as a future reference price for their price abroad as well. Above all, if the government wants to foster and improve the competitiveness of Korea’s pharmaceutical industry, it has to provide preferential treatment to these homegrown new drugs. The profit margins of the domestic pharmaceutical industry have been dropping significantly as generic drugs, which had been the main driver of the industry until now, are not making enough profit as they are constantly subject to price cuts to ensure the financial soundness of the National Health Insurance. The losses arising from the price ceiling reevaluations that were conducted this time are expected to amount to KRW 300 billion. In this environment, who would want to develop a new drug and suffer the huge amount of costs incurred? If lowering the price of generic drugs, which companies depend on to fund new drug development, is inevitable, the value of new drugs must be recognized to create a virtuous cycle that encourages new drug development. In addition to providing preferential drug pricing at the time of initial listing, the government should fully compensate for the value of homegrown new drugs by ensuring that the prices are not later reduced through post-marketing control measures such as price-volume agreements. We need new drugs to raise the competitiveness of the Korean pharmaceutical industry in overseas markets. If the government has set its sights on fostering homegrown new drugs, it should focus on what it needs to support and stop being indecisive.
- Policy
- What about digital therapy devices awaiting approval
- by Lee, Hye-Kyung Sep 06, 2023 05:36am
- Younglim Lee, Head of the Medical Device Review Department In addition to digital treatment devices for improving insomnia, the Ministry of Food and Drug Safety is expecting applications for licenses for digital treatment devices No. 3 and 4 aimed at improving symptoms in the fields of neurology and psychiatry, respiratory rehabilitation, visual disturbances, and tinnitus. Lee Young-rim, head of the medical device review department at the Korea Food and Drug Safety Evaluation Institute, said in a press briefing for a specialized magazine on the 5th, "As of the end of August, there are 47 digital therapeutic devices for which clinical trial plans have been approved," and "among them, confirmatory clinical trials will be conducted in 2021 and 2022." “As there are 14 products for which the trial plan has been approved, it is expected that the application for approval will be made as soon as the clinical trials are completed,” he said. Digital therapeutic devices are software medical devices that provide evidence-based therapeutic intervention to patients to prevent, manage, and treat medical disorders or diseases. Instead of drugs or injections, digital therapeutic devices stimulate organs, tissues, and nerves with electric ultrasounds, etc. to treat diseases. It provides a treatment method different from Electroceutical, which refers to an electronic device that produces a treatment effect. Currently, there are two products approved as digital therapy devices in Korea, DTx/Digital Therapeutics Somzz and WELT-I, which treat insomnia by installing a mobile app on a smartphone after consulting a doctor. Since it has not yet been approved by health insurance, it has not yet been used in clinical settings, and the effectiveness of its actual use information, or performance has not been verified. Director Lee said, “Only when it is used in clinical settings will we be able to hear the opinions of doctors, patients, etc.,” and added, “As it has not yet been used in medical treatment, it appears that time will be needed to collect information or investigate its effects.” Regarding items expected to be approved after the digital treatment device for insomnia, 64% of products approved for confirmatory clinical trials also represent these fields, perhaps because items 1 and 2 are diseases in the neurological and psychiatric fields. Confirmatory clinical plans were approved for rehabilitation (respiratory, orthopedic) 21% and 15% other than neuropsychiatric fields such as generalized anxiety disorder, mild cognitive impairment, alcohol/nicotine disorder, depressive disorder, and eating disorder. Manager Lee said, “As two products have been approved for the treatment of insomnia, many people are waiting for digital treatment devices for various diseases.” He added, “Recruiting patients for clinical trials requires IRB approval, but recruiting patients has been difficult due to COVID-19. “There was an aspect. It is expected that clinical trials will be conducted for many products starting this year.” The expected digital therapy device is one aimed at improving rehabilitation, and clinical trials are underway for a variety of products, including devices for respiratory rehabilitation for elderly patients. He also added that he is conducting various discussions with IT companies called 'Big Tech' to improve regulations on cutting-edge medical products. Director Lee said, “We held on-site consultation meetings with big tech companies such as Naver, Kakao Healthcare, LGU+, KT, and Kakao Brain and identified requirements for regulatory improvement and support.” He added, “Considering the characteristics of generative artificial intelligence medical devices, they are approved as medical devices.” “We decided to prepare licensing and review guidelines that can be used when entering overseas markets and provide consulting and support for licensing, such as clinical trials and verification,” he explained. Regarding Naver, Lunit, Welt, etc. developing ChatGPT in the medical field and examining the possibility of using it for AIMD, Director Lee is working with industry-academic cooperation experts to develop the "Generative AIMD Permission/Examination Guidelines" by November 2024. “We will develop it,” he emphasized, adding, “We are trying to establish screening standards for safety and effectiveness when it is approved as a medical device.”
- Policy
- Reimb of HA eye drops will be restricted in KOR
- by Lee, Tak-Sun Sep 06, 2023 05:36am
- As a result of the government’s reimbursement reevaluations, patients will be unable to receive reimbursement when using hyaluronic acid eye drops for extrinsic diseases, and the amount of their use will also be restricted. The government has also been known to be discussing limiting reimbursement to 4 boxes per year. According to industry sources on the 5th, the Health Insurance Review and Assessment Service is said to have set such a direction regarding the reimbursement of HA eye drops after conducting reevaluations on the adequacy of their reimbursement this year. HA eye drops, rebamipide, limaprost oxiracetam, loxoprofen sodium, levosulpiride, and epinastine hydrochloride were subject to reevaluations on their reimbursement adequacy this year. Among them, the market for the HA eye drops that are used as artificial tears, has the largest market amounting to KRW 200 billion. Industry rumors are that the post-marketing subcommittee, which held a meeting before the Drug Reimbursement Evaluation Committee deliberations set for the 7th of this month, decided to focus on limiting the use amount of the HA eye drops. The plan was to restrict the amount of use to 4 boxes and set a separate reimbursement standard for additional use. In addition, it has been reported that the committee to remove the reimbursement for extrinsic diseases among extrinsic and intrinsic diseases. Currently, HA eye drops are used for intrinsic diseases such as Sjögren's syndrome, mucocutaneous ocular syndrome (Stevens-Johnson syndrome), and dry eye syndrome, as well as extrinsic diseases caused by surgery, drugs, trauma, or contact lens wear. The industry is regarding this as a win as its use for extrinsic diseases is relatively low. The argument that the amount of use of HA eye drops should be limited was raised by the National Evidence-based Healthcare Collaborating Agency in 2020. In the report, 'Post-marketing evaluation of Specialized OTC-ETC Classified Drugs: Focusing on Hyaluronic Acid Eye Drops (Shin Sang-jin)', NECA argued that 12 boxes of disposable eye drops should be set as the amount recognized for reimbursement and that the number of reimbursable prescriptions should be limited to a maximum of 5, like in Australia. However, as many have been arguing that the reimbursement of HA eye drops should be maintained, it remains to be seen whether a clear conclusion will be reached at the DREC meeting on the 7th. HIRA has decided to change its original policy of non-disclosure of the DREC meeting results and release the results through a press release on the same day.
- Company
- Hanmi’s Rolontis post sales of KRW 4.8 bil in H1
- by Chon, Seung-Hyun Sep 05, 2023 05:40am
- Hanmi Pharm’s new drug ‘Rolontis’ has been slowly increasing its influence in the domestic market. In the first half of the year, 2 years into its release, the drug has posted sales of nearly KRW 5 billion. The drug has also been achieving fair results in the early stages of its release in the U.S. According to the pharmaceutical research institution IQVIA, Hanmi Pharm’s Rolontis posted sales of KRW 4.8 billion in 1H and rose over 10 times from the previous year. Rolontis is a new biodrug that Hanmi Pharmaceutical licensed out to Spectrum Pharmaceuticals in 2012. The drug is indicated for the treatment or prevention of neutropenia in cancer patients who receive myelosuppressive chemotherapy. As a granulocyte colony-stimulating factor (G-CSF) class that stimulates the granulocyte to increase neutrophil production, the drug has a similar mechanism of action with Amgen’s blockbuster drug ‘Neulasta (pegfilgrastim).’ In Korea, Rolontis was approved in March as the 33rd homegrown novel drug and listed for reimbursement in November 2021. Quarterly Sales of Rolontis(Unit: KRW ! million, Data: IQVIA) Rolontis exceeded KRW 1 billion in sales in Q4 last year. Sales continued to rise to KRW 2.3 billion and KRW 2.5 billion in Q1 and Q2 this year, respectively. At this trend, sales are expected to exceed KRW 10 billion this year, in only the second year of its release. Rolontis’s cumulative domestic sales have recorded KRW 8 billion. Rolontis is receiving much attention after successfully entering the U.S. market. Rolontis was approved by the U.S. FDA under the brand name Rolvedon in September 2021. The drug was successfully commercialized and released into the U.S. market 10 years after the licensing-out deal was made. With the approval, Rolontis became the first new drug to receive FDA marketing authorization among those being developed by Hanmi Pharm. It is the first new drug to be sold in the US market after being produced at a domestic plant (Pyeongtaek Bio Plant) that has received on-site inspections from the FDA. Rolontis was released in the U.S. market in earnest in October last year. The U.S. neutropenia treatment market is worth KRW 3 trillion a year. Since its launch, Rolontis has been showing smooth performance in the U.S. market. Rolvedon recorded sales of USD 15.6 million (about KRW 20 billion) in the Q1. In Q2, sales amounted to $21 million (about KRW 28 billion), up 34.6% from the previous quarter. Rolvedon initially received FDA approval after the technology was licensed out to Spectrum Pharmaceuticals, and in April, Spectrum was acquired by Assertio Holdings, a pharmaceutical company specializing in central nervous system, pain, and inflammation. In its Q2 performance earnings report, Assertio explained, “The acquisition of the Spectrum and Rolvedon asset has brought significant changes to the company. We plan to maintain a highly effective sales and marketing organization to expand the success of the new asset.”
- Policy
- Evaluating Tagrisso's primary benefit
- by Lee, Jeong-Hwan Sep 05, 2023 05:40am
- The Ministry of Health and Welfare announced that it is conducting a cost-effectiveness evaluation regarding the expansion of health insurance coverage for the first-line treatment of AstraZeneca's lung cancer drug Tagrisso. On the 4th, the Ministry of Health and Welfare responded as follows to a written question from People Power Party Rep. Choi Young-hee, a member of the National Assembly Health and Welfare Committee.
- Company
- HK Inno.N releases its GERD drug K-CAB in Singapore
- by Chon, Seung-Hyun Sep 05, 2023 05:40am
- Professor Prakash Gyawali (Department of Gastroenterology at Barnes-Jewish Hospital, Washington University Hospital) is giving a lecture at the K-CAB Launch Symposium in Singapore On the 4th, HK Inno.N announced that it had officially released its novel gastroesophageal reflux disease (GERD) treatment K-CAB in Singapore. HK Inno.N held a symposium to celebrate K-CAB’s launch at the Conrad Centennial Singapore Hotel on August 31st. K-CAB was approved in February in Singapore under the same brand name, K-CAB. HK Inno.N will export the finished product to its local partner, United Italian Trading Corporation (UITC), which will be in charge of local sales and marketing of K-CAB in Singapore. The symposium, which was held for gastroenterologists in Singapore, was hosted by UITC. At the symposium, Professor Prakash Gyawali (Department of Gastroenterology at Barnes-Jewish Hospital, Washington University Hospital) and Professor Hwoon-Yong Jung (Department of Gastroenterology at Asan Medical Center) shared the latest knowledge in using K-CAB. During his presentation, Professor Gyawali focused on the superiority and safety of K-CAB, emphasizing the drug’s rapid onset of action and safety in terms of hepatotoxicity over other P-CAB class drugs. Professor Jung shared his prescription experience with K-CAB in Korea. Professor Jung said, “K-CAB had provided a better treatment option for GERD patients in Korea.” K-CAB has been exported as a technology or finished product to 35 countries overseas. Among them, the drug has been launched locally in China, Mongolia, the Philippines, Mexico, Indonesia, and Singapore. Also, the company is preparing to launch K-CAB in Peru after receiving approval in July. Dal-won Kwak, CEO of HK Inno.N, said, “Singapore’s pharmaceutical market stands out among Southeast Asian countries, as it has been showing 11% YoY growth for the past 3 years. We will continue to work closely with our local partners to ensure the successful approval and launch of K-CAB overseas. K-CAB, which was released in March 2019, is a new drug for gastroesophageal reflux disease (GERD) in the P-CAB (potassium-competitive acid blocker) class. It has a new mechanism of action that inhibits gastric acid secretion by competitively binding to the proton pump and potassium ion located in the final stage of acid secretion. Its sales exceeded KRW 100 billion in prescriptions in its 3rd year of release in 2021 and recorded sales in the KRW 100 billion range for 2 consecutive years thereafter. Also, K-CAB posted prescriptions amounting to KRW 74.1 billion in the H1 this year, heralding a record that exceeds KRW 100 billion for three consecutive years.
- Policy
- Drug crime regulation,
- by Lee, Jeong-Hwan Sep 05, 2023 05:40am
- It is expected that a bill that would impose an obligation on doctors and pharmacists who prescribe and dispense drugs with a risk of misuse, such as narcotics, to check medication history through the Drug Safety Information System (DUR) will quickly pass the National Assembly. This is because a large number of drug-related crimes have occurred, such as the so-called 'Rolls Royce Man on Drug Suspicion' incident, and social consensus on the need for stronger regulations has grown, and the Yoon Seok-yeol government has also announced mandatory DUR confirmation of medication history as a measure to strengthen surveillance of medical drugs. On the 4th, Jeon Hye-sook, an official from the Democratic Party of Korea's office, explained, "We have secured a consensus not only on the government but also on the ruling and opposition parties on the need to make it mandatory to check the medication history of patients who prescribed and dispensed narcotics through DUR." The amendment to the Medical Service Act and the Pharmaceutical Affairs Act, proposed this time by Rep. Jeon Hye-sook, are a method of establishing new regulations on medicine and pharmacists in the 'confirmation of drug information' provision commonly stipulated in both laws. Specifically, the 'confirmation of drug information' clause stipulated in Article 18-2 of the Medical Service Act and Article 23-2 of the Pharmaceutical Affairs Act will be revised. Rep. Jeon Hye-sook's bill stipulates that in order to ensure the safe use of medicines, the Minister of Health and Welfare or the Minister of Food and Drug Safety must check whether the same ingredients have been administered in the past when prescribing, directly dispensing, or dispensing medicines that are recognized as having a risk of abuse, such as narcotics. In addition, DUR was proposed as a method for doctors, dentists, and pharmacists to check a patient's medication history for the same narcotic ingredient, and a fine of up to 1 million won could be imposed if the verification obligation was not followed. The Yoon Seok-yeol government declared war on drugs last April and announced comprehensive government-wide measures. At that time, as the Gangnam Academy District drug drink incident and famous celebrities' drug use crimes such as propofol and methamphetamine continued to occur, the Office for Government Policy Coordination announced that it would be mandatory to check prescription drug history using DUR, starting with drugs with a high risk of abuse such as fentanyl. With administration consistent with the purpose of the bill proposed by former lawmakers, an environment has been created in which the speed of processing can be accelerated when the bill is later reviewed by the National Assembly. There is a possibility that the medical community will oppose legislation mandating drug use history DUR. In the past, medical and hospital groups strongly opposed the amendments to the Medical Service and Pharmaceutical Affairs Act in the 20th National Assembly, which mandated the use of DUR when prescribing and dispensing medicines and imposed fines on violators. At the time, the medical and hospital communities considered the fact that punitive regulations were created without support measures such as fees or compensation for medical institutions, that doctors' judgments regarding drug prescriptions and dispensing could be excessively restricted, and that there were limits to clinical usefulness. rebelled against. The Ministry of Health and Welfare, the responsible ministry, and pharmacists' organizations supported the bill to strengthen drug safety by increasing DUR utilization. Rep. Jeon Hye-sook, who proposed the bill, plans to speed up the review of the bill by putting legislative feasibility first in order to prevent drug crimes from becoming increasingly rampant. She plans to push for legislation mandating the use of DUR when prescribing and dispensing non-reimbursed high-risk drugs and narcotic psychotropic drugs, following legislation mandating DUR confirmation of narcotic medication history.
