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- 2026-04-17 03:16:38
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- Reimbursement talks on first CMV prophylaxis soon to begin
- by Eo, Yun-Ho May 07, 2020 06:01am
- The reimbursement approval talk is about to get started for Prevymis, a medicine to prevent cytomegalovirus (CMV) infection in stem cell transplant recipient. Korean pharmaceutical industry sources reported MSD’s Prevymis (letemovir) that was passed by Economic Evaluation Subcommittee last month would be deliberated by Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) on May 7. Reactivation of CMV in patients, who have undergone a stem cell transplant, could cause diseases like pneumonia, hepatitis, myocarditis, gastroenteritis and encephalitis. Despite a low level of CMV viral load in blood, it could increase the risk of mortality. A study found that in early hospitalization stage of CMV-positive patients who had stem cell transplant, the risk in overall mortality could be 3.5 times higher than in non-infected patients, whereas the mortality rate in patients with CMV viremia have 2.6 times greater risk of overall mortality than patients with no viremia up to 60 days after the transplant. However, the current CMV treatment in allogenic hematopoietic stem cell transplantation (HSCT) recipients mostly relies on pre-emptive therapy, which injects antiviral medication when the viral load exceeds a certain level. In 2018, Korean Ministry of Food and Drug Safety (MFDS) has approved of Prevymis to be used to help prevent CMV infection and disease in adults who have received an allogenic HSCT. The treatment has both injection and tablet formulation options and it can be administered once-daily from the day of or within 28 days of HSCT for up to 100 days after the transplant The U.S. Food and Drug Administration (FDA) has approved the use of Prevymis in 2017 and also designated it as a Breakthrough Therapy, Priority Review Drug and Fast Track Drug. President Yoon Sung-soo of Korean Society of Hematology (Department of Internal Medicine at Seoul National University School of Medicine) explained, “The limitation of the existing pre-emptive therapy is clear as it initiates treatment only when the CMV viral load reaches the threshold level. The medical demand on Prevymis is surging as it is a crucial treatment option for the survival of high-risk patients.” Clinical studies have confirmed Prevymis hindering the reactivation of CMV and lowering the risk of mortality. The studies reported no observation of adverse reactions like myelosuppression or renal toxicity. In the 2019 guidelines published by the National Comprehensive Cancer Network (NCCN) and European Conference on Infections on Leukemia (ECIL), Prevymis has been recommended as a prophylaxis in CMV-seropositive allogeneic HSCT recipient.
- Company
- Temptation to reduce the cost of DMF
- by Kim, Jin-Gu May 07, 2020 06:01am
- About 7 out of 10 DMF that pharmaceutical companies have registered for use are from India and China. Compared to 10 years ago, the share of DMF in India and China is also increasing significantly. It is an analysis that pharmaceutical companies have increased demand for inexpensive Indian·Chinese drug products to cut costs. According to the MFDS on the 4th, the number of DMF last year was 601. Excluding 71 cases in Korea, 530 cases were registered overseas. By country, India had the largest number of DMFs. The total number was 254, accounting for 42.3% of the total. China was followed by 153 cases (25.5%). The share of the rest of the countries was less than 5%. India and China combined account for 67.7% of the total. 7 out of 10 DMF were made in India or China. Top 10 countries for DMF in 2019. Of the total 601 cases, 407 cases were from India and China (67.7%) (Source: the MFDS) Cumulative number of DMF in 2009-2019. Of the 5,523 cases, India·China accounted for 61.5% (the MFDS)From 2009 to 2019, a total of 5,523 DMF were registered for 11 years (including re-registration). Of these, Korea had 875 cases (15.8%) In the cumulative DMF, India was the largest with 2,066 cases (37.4%). China was followed by 1,329 cases (24.1%). Excluding Korea, 227 cases in Italy (4.1%), 183 cases in Spain (3.3%), and 84 cases in Germany (1.5%) were followed. Looking at the changes for the past 10 years since 2009, the proportion of registration of DMF from India·China is increasing. In 2009, only 17.9% of Indian·Chinese ingredients were registered. Then, it increased to 39.4% in 2010, and has remained in the mid to late 60% since 2011. Compared to 2012, when DMF notification system was changed to a registration system, the share of DMF in India and China increased by 9.8% p from 57.9% to 67.7%. On the contrary, the proportion of Korean DMF is generally small. It decreased from 47.4% in 2009 to 11.8% last year, down to a quarter level in 10 years. The share of DMFs in India·China over the past 10 years (Source; the MFDS) It is analyzed that the biggest reason for the increase in the share of DMF registration in India and China is the low price. It is known that Indian and Chinese ingredients are about 20 to 30% cheaper than domestic ones. As pharmaceutical companies are looking for inexpensive DMF to cut costs, registration of drug products from India and China seems to have increased. There are also some institutional reasons. In 2011, the MFDS changed the regulations to register as a DMF if salts or hydrates are different even if the same active ingredient is used. As a result, the number of DMF registrations exploded. In the process, registration of DMF from India and China has also increased significantly. At that time, 377 cases were made in India and 194 cases in China in one year.
- Policy
- People with hepatitis C tx shouldn't take birth control pill
- by Lee, Tak-Sun May 07, 2020 06:01am
- Patients receiving hepatitis C DAA (direct-acting antiviral drugs) will not be able to take the contraceptive containing Ethinylestradiol. This is because the MFDS is pursuing an order to change the permit to add the DAA administration group as a contraindication to patients taking contraceptives based on EMA’s information. Previously, only Viekirax (Ombitasvir/Paritaprevir/Ritonavir), the treatments for hepatitis C, was contraindicated. The MFDS announced that it will instruct the change on the 12th of May through the preliminary notice period until May 11th for the changes in the permits. Since Ethinylestradiol is one of the female hormones Estrogen, it regulates the menstrual cycle, so it is mostly contained in pre-contraceptives. It is also contained in domestic market leading items such as Mercilon (Alvogen Korea), Myvlar (Dong-A Pharm), and Yaz (Bayer Korea), and 26 items of 14 companies are instructed to change the permit including these items. It has significantly higher levels of ALT in females using Ethinylestradiol-containing agents in clinical trials of Ombitasvir/Paritaprevir/Ritonavir that are at least 5 times higher than normal peak (ULN). Only Ombitasvir/Paritaprevir/Ritonavir, the treatments for hepatitis C, was contraindicated when taking pre-contraceptives. On the other hand, it was added that ALT elevation was observed when the combination of hepatitis C antiviral agent containing Glecaprevir/ Pibrentasvir (Maviret) and oral contraceptives containing Ethinylestradiol was added. Accordingly, the target of contraindications was expanded to patients with direct hepatitis C direct-acting antiviral (DAA). The DAA-based hepatitis C treatments released in Korea are 8 items including Viekirax, Maviret, Exviera, Sovaldi, Harvoni, Zepatier, Daklinza, and Sunvepra. The MFDS said that after the comprehensive review of the current status of domestic and foreign permits and submitted opinions regarding the safety information of the European Medicines Agency (EMA) containing Ethinylestradiol, an opinion inquiry was conducted. On the 12th, it was announced that the final permit change order will be announced.
- Company
- Cancer Committee lets down both Keytruda and Tagrisso
- by Eo, Yun-Ho May 07, 2020 06:01am
- Apparently, neither one of Keytruda and Tagrisso won the Cancer Deliberation Committee’s nod. According to the pharmaceutical industry sources on May 1, Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee convened a meeting after postponing it twice due to COVID-19, and decided to ‘defer’ the reimbursement decision on MSD’s Keytruda (pembrolizumab) and ‘unapproved’ AstraZeneca’s Tagrisso (osimertinib). Basically, the reimbursement expansion on immunotherapy Keytruda and targeted therapy Tagrisso would unlikely to happen any time soon in Korea. The Cancer Deliberation Committee reviewed granting reimbursement on Keytruda’s five indications, including as a first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. In March 2017, Keytruda monotherapy has been approved as a first-line treatment in patients with NSCLC. And the MSD Korea has submitted an application for reimbursement approval on the monotherapy indication to be used as a first-line treatment in September 2017, and continued the talk with the government for over two years. Regardless of the effort, the talks fell through in September last year. Considering the health authority’s decision, MSD showed its commitment by submitting unasked-for economic evaluation data on the first-line treatment in NSCLC to seek for the reimbursement expansion. But the Cancer Deliberation Committee rather demanded additional data on reducing the cost and deferred the decision. As for Tagrisso, the result was even grimmer. AstraZeneca Korea has submitted a reimbursement expansion application for the first-line indication of its osimertinib treating epidermal growth factor receptor (EGFR)-mutated NSCLC. Although the company has expressed its assertive intention to reduce the financial burden as proposed by the government, the committee members (oncologists) raised the issues on the treatment’s clinical efficacy and insisted on not approving the reimbursement. The anticancer treatment has been deferred by the committee once already in last October. The committee’s decision then was due to the Asian subset analysis result of the FLAURA Phase 3 trial in Tagrisso, specifically confirming the overall survival (OS) value. The study found the median OS with osimertinib was 38.6 months, 6.8 months longer than first generation EGFR-TKIs, Iressa (gefitinib) and Tarceva (erlotinib). However, hazard ratio (HR) in the Asian subset analysis recorded a value of 0.995. Compared to the standard value of ‘1,’ the value difference of 0.005 meant no significance. Regarding the study result, some academics have questioned the efficacy of Tagrisso as a first-line therapy in Asian race. Meanwhile, others have raised concern over the committee applying double standard as first and second generation EGFR-TKIs, Iressa, Tarceva and Giotrif (afatinib), have been listed for reimbursement as first-line therapies without concrete evidence on the OS. Some also argued the solution is in drug pricing adjustment. Based on the speculations, AstraZeneca also persuaded its headquarters and expressed its intention to adjust the pricing, but the deliberation result was a let-down.
- Policy
- Truth behind COVID-19 and using antihypertensives
- by Lee, in-bok May 06, 2020 06:33am
- Although a hypertension treatment angiotensin-converting enzyme (ACE) inhibitor has aroused controversy while seeking for COVID-19 treatment, the drug’s safety issues is getting resolved by a series of related clinical investigations. Multiple clinical trials of using ACE inhibitors on COVID-19 patients have confirmed the safety of the drug and actually discovered it helps patients fighting against COVID-19. The safety concerns of using the antihypertensive and COVID-19 soon to be concluded According to medical scholars on May 5, safety concerns regarding the use of antihypertnesives amid COVID-19 pandemic has been raised early. A series of clinical studies have been published confirming the correlations between COVID-19 and antihypertensive ACE inhibitors Because the novel coronavirus uses ACE, especially ACE2, as a receptor to spread, some medical experts argued angiotensin II receptor blockers (ARBs) and ACE inhibitors could possibly worsened the disease condition. And an animal study result supported the theory as it found ARBs and ACE inhibitors upregulating the expression of ACE2, and hence, allow the virus to more actively invade lungs and heart, where ACE2 is expressed. Although internationally renowned medical organizations like World Congress of Cardiology (WCC), American College of Cardiology (ACC) and European Society of Cardiology (ESC) have urged the prescribers to maintain the prescription of the medications as suspending the treatment would cause more damage than benefit, the medical experts are still arguing over the issue. This is the background behind why so many COVID-19 related clinical trials around the world are testing the safety of using the hypertension treatments. In conclusion, however, the concerning theory was proven groundless. Three studies have already concluded in same findings—the hypertension treatments ‘do not affect COVID-19 patients at all.’ Safety test results on ACE inhibitors report “suspending prescription is more dangerous” A multiregional multicenter study led by Professor Yun Feng of Jiao Tong University at Shanghai found that halting the prescription of the hypertension drugs could threatened the patients with hypertension even worse (doi.org/10.1164/rccm.202002-0445OC). Clinical trials reported so far have refuted the claim that ARBs and ACE inhibitors affect prevalence and severity of COVID-19 Running a head-to-head comparison trial on 476 COVID-19 patients, the researchers confirmed the patient group that halted the antihypertensive prescription showed higher possibility of worsening their condition. In fact, only four out of 33 patients (12 percent) with hypertension who took ARB and ACE inhibitor have become severely ill, whereas 36 out of 80 patients (45 percent) who stopped taking the medications have become severely ill. As a result, the study has proven that stopping the medication out of the concern could actually worsen the COVID-19 condition. Another study also claims the concern over safety is baseless. Comparing groups of patients either taking or not taking the antihypertensive and without comorbidity has shown no significant difference. An investigation led by Professor Guang Yang of Hubei Provincial Academy of Traditional Chinese Medicine analyzed 126 patients with hypertension and 125 patients without the underlying condition, and also compared them to 1,942 patients who visited hospital prior to the spread of COVID-19 (doi.org/10.1101/2020.03.31.20038935). Moreover, the researchers subdivided the patient group with hypertension either administered with ARB and ACE inhibitor or not, and compared the effect of using the drugs. The study found 35.4 percent of hospitalized patients with hypertension before the spread of COVID-19 used ARB and ACE inhibitor and 34.1 percent of the patients after the spread of COVID-19 used the medications, which demonstrated no significant difference. It also meant the concern of administering ARB and ACE inhibitor raised from the animal study is not meaningful in clinical terms (P=0.756). In some cases, hospitalized patients with COVID-19 who were administered with ARB and ACE inhibitor showed lower severity level and mortality rate than the ones that did not take the medications. But the figure did not have statistical meaning, and the researchers recommended interpreting the result to understand that the medications do not worsen the disease severity. A study led by Professor Yingxia Liu at Southern University of Science and Technology of China also resulted in similar outcomes. The investigators analyzed 78 COVID-19 patients with the hypertension comorbidity, and discovered the administration of ARB or ACE inhibitor did not affect prevalence or severity of the disease (doi.org/10.1101/2020.03.20.20039586). 24.3 percent of the study participants had taken ARB and 3.8 percent had been prescribed with ACE inhibitor. But each group only had 15.8 percent and 2.6 percent of severe cases, respectively. The study also saw the group that was prescribed with ARB and ACE inhibitor had lower severity in the disease than the group with hypertension but had not taken the drugs. Compared to the control group, only 54 percent of the ARB-prescribed patient group had severe cases of COVID-19 and ACE inhibitor-prescribed group showed the similar result with 57 percent. Large-scale clinical trials in preparation to “seek evidences for continuing prescription” Based on the study results refuting the claim of ACE inhibitors affecting the prevalence and severity of COVID-19, the international scholars’ clinical reasoning and recommendation to continue the antihypertensive medications would likely to be accepted more widely. Medical experts anticipate these investigations would provide evidences supporting the medical scholars’ recommendations to continue prescribing the hypertension treatments WCC, ACC, ESC and Korean Society of Hypertension (KSH) have urged on maintaining the prescription, but it was rather a clinical reasoning than from concrete evidence. However, their recommendation is gaining more support as more and more clinical evidences are generated in continuous investigations on the matter. Besides the published study results, there are large-scale randomized, double-blinded, head-to-head clinical trials in progress globally, and they would provide more concrete evidences in May. A KSH official stated, “The already available study outcomes are sufficient enough to say ARB and ACE inhibitor prescription should be maintained,” but “the findings are only based on observational studies with limitation. Regardless, the soon-to-be-published randomized double-blinded placebo-controlled studies would provide more clear direction.”
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- Toujeo passed DC of big 5 general hospitals
- by Eo, Yun-Ho May 06, 2020 06:32am
- Next-generation insulin Toujeo can be prescribed at the Big 5 General Hospitals. According to the related industry, 'Toujeo inj Solostar (gene recombination insulin Glargine)' recently passed DC of Seoul National University Hospital, Seoul St. Mary's Hospital, Samsung Medical Center, and AMC including Severance Hospital. In addition, it has been approved for indications for type I and type II diabetes in children and adolescents over 6 years of age in the US and Europe. Toujeo's expansion of pediatric indications was based on the results of the EDITION JUNIOR clinical trial. The EDITION JUNIOR study compared Toujeo to Gla-100 in 463 children and adolescents (aged 6 to 17 years) treated for type I diabetes for at least one year and with HbA1c between 7.5% and 11.0% at screening. Participants continued to use their existing mealtime insulin. The study met its primary endpoint, confirming non-inferior reduction of HbA1c with Toujeo vs Gla-100 after 26 weeks. An official from the KDA said that next-generation insulins that solved existing adverse effects such as hypoglycemia would be a useful treatment option for children and adolescents with diabetes, as they have excellent drug effects. Meanwhile, Toujeo was listed on the insurance benefits list in November after domestic approval in August 2015. Toujeo's insurance premium per insulin unit is about ₩153 (₩15,306 per 100 units).
- Product
- The KPA, criticized the MFDS/the Regulatory Reform Committee
- by Kang, Shin-Kook May 06, 2020 06:32am
- The Korean Pharmaceutical Association (KPA) strongly objected to the withdrawal of step-by-step abolition policy for generic co-biological equivalence testing. On the 28th, the Korean Pharmaceutical Association (Chairman Dae-up Kim) announced that the Regulatory Reform Committee recommended the withdrawal of the amendment to the 'Regulation for Pharmaceutical Approvals, Notifications and Reviews', which contains the phased abolition of the generic bioequivalence test, and the MFDS, which accepted this without policy alternatives, is pursuing lush policy. The KPA said, "Even if there are three or four alternative generics available in the pharmacy, the patients will have to experience the inconvenience of searching for drugs, and the cost of illegal rebate due to excessive competition is being passed on to the public." In addition, there is a high social cost for the retrieval of excess medicines and the retrieval of hazardous drugs, and the proportion of pharmaceutical expenses in health insurance finances is increasing day by day. In the current situation, due to the drug price system that guarantees the high price for most of the licensed drugs, there is no limit to the extent to which the number of generic items will increase. The MFDS and the Regulatory Reform Committee are playing into each other's hands. The KPA asked that the Regulatory Reform Committee should play a role in recognizing the problems more seriously and painfully in the pharmaceutical industry as well as in the fields, and it should play a role of deliberating and coordinating policies in the direction of restoring to the pharmaceutical industry and health care in addition to reviewing regulations. The necessity of improving drug management efficiency by improving the difficulty of generic drugs due to the NDMA impurities has been strongly raised, but the situation is further exacerbated by governments that have to implement policies that must prevent the indiscriminate approval of generic drugs. This is due to the MFDS' irresponsible policy promotion and recommendation by the Regulatory Reform Committee. The KPA said that it should reorganize the abnormal generic license system, which can even drop generic drugs that are in good quality and safety management at a low price. The KPA aurged the immediate enforcement of a policy that prohibits the use of different brand names of generic drugs and only permits the same ingredient names (generic names).
- Company
- 902 trials around the world seeking for COVID-19 treatment
- by Kim, Jin-Gu May 06, 2020 06:32am
- 100 days have passed since the first confirmed case of COVID-19 was reported in Korea. While Korea seems to have flattened the curve, other countries like the U.S. and European countries are still enforcing strict emergency orders. Meanwhile, the global community is unprecedentedly speeding up the treatment and vaccine development. As of Apr. 27, total 902 cases of COVID-19 related clinical trials are reportedly in process. Compared to 66 cases reported in early March, the number has multiplied by 13.6 times. The world’s largest clinical trial registry by the U.S. National Institutes of Health (NIH), ClinicalTrials.gov has been keeping up with the number. Among those trials, 404 cases are testing pharmaceuticals. 190 drugs or candidate medicine are undergoing clinical trial to be labeled as a COVID-19 treatment. Most of the ongoing studies around the world are for drug repurposing. Instead of testing new candidate medicine, the studies aim to reevaluate existing drugs as a COVID-19 treatment. COVID-19 related clinical trials conducted around the world as of Apr. 27 (Source: ClinicalTrials.gov) Currently, hydroxychloroquine has been the most popular medicine to be tested. Total 114 cases are confirming hydroxychloroquine’s efficacy and safety profile (including redundant cases). And axithromycin is the second most popular medicine with 28 cases. Industry sources see that the U.S. President Donald Trump’s comments have heavily affected the number of studies in hydroxychloroquine and axithromycin. At the White House press conference, President Trump has expressed his optimism for those two drugs to be the game changer amid pandemic. Unlike his words, however, the outcome seems to have been rather disappointing. An interim report of a U.S. study found the treatment did not demonstrate significant effect, but almost doubled the mortality rate. Following those two drugs, AbbVie’s HIV treatment Kaletra (lopinavir plus ritonavir) is running 21 clinical trials. But Kaletra also had a number of studies reporting no significant effect on COVID-19 treatment. The sources say the drug would unlikely to be labeled as a COVID-19 treatment, unless it reports otherwise in other studies. Tocilizumab (Brand name: Actemra) used for treating multiple myeloma has ranked itself on the fourth spot with 20 ongoing trials. The interleukin-6 inhibitor is expected to prevent the cytokine storm. As a majority of the COVID-19 patients experience cytokine storm, a form of systemic inflammatory response syndrome, pharmaceutical experts have high hopes for the treatment. Interestingly, a number of hypertension treatments were included in the COVID-19 treatment related studies. 12 studies are testing losartan and other angiotensin II receptor blockers (ARBs), eight studies are testing angiotensin-converting enzyme (ACE) inhibitors, and calcium-channel blockers (CCB) and diuretic each have one study in progress. In total, there are 22 antihypertensives in testing. Among ARBs, losartan (6), telmisartan (2), candesartan (1) and valsartan (1) have the most number of ongoing tests, in the order. Two other studies have undisclosed substances in trial. Other drugs like myelofibrosis treatment ruxolitinib (Brand name: Kakavi) and a corticosteroid methylprednisolone have 11 and 10 clinical trials in progress, respectively. Remdesivir, a highly anticipated potential COVID-19 treatment, has total of nine trials in progress at the moment, which the three of them are conducted in Korea. The results of remdesivir clinical trials would be unveiled next month at earliest. Also, Japanese-made favipiravir (Brand name: Avigan), a rheumatoid arthritis treatment sarilumab co-developed by Sanofi and Regeneron, and an antiprotozoal medicine nitaxosanide respectively have eight trials in process. While a gout treatment colchicine and a rheumatoid arthritis treatment anakinra have seven and six ongoing trials, a Soviet-developed flu drug Arbidol and a corticosteroid medication dexamethasone each have five ongoing clinical trials.
- Policy
- Calculation criteria for COVID-19 are being considered
- by Kim, Jung-Ju May 06, 2020 06:32am
- The government said it was in the process of evaluating the calculation standards for medical institutions that participated in Corona 19 response. It means that various types of compensation appear due to treatment segmentation and environment different from that of MERS in the past. Yoon Tae-ho, a senior health ministry official of the Central Disaster Management Headquarters, answered this through a question and answer at the regular briefing at the COVID-19 Central Disaster and Safety Countermeasure Headquarters today (28th). The government had previously set up a committee for deliberation on compensation for loss and paid some of the losses from the hospitals participating in COVID-19 outbreak in the form of advance payment by rough estimate on the 9th. However, there are opinions that compensation is insufficient due to the fact that the official standards such as targets and items for compensation for loss have not been finalized. Regarding this, Yoon Tae-ho, a senior health ministry official of the Disaster Management Headquarters explained that it has the basic principle that appropriate compensation should be given to hospitals that actively participate in treatment and participate in government policies in relation to COVID-19. According to him, the 3rd Professional committee for deliberation on compensation for loss is held today. It is expected that some details will be made regarding loss compensation. Yoon Tae-ho, a senior health ministry official said that the advance payment by rough estimate on the 9th was only partially paid in consideration of the urgency, and further compensation measures will be made in the future. Also he added that new types of compensation are emerging, such as community treatment centers, screening clinics, and hospitalizations for severely ill patients, and appropriate calculation standards are prepared for each institution type and are being considered.
- What's the reason for the rapid increase for Dantrolene?
- by Lee, in-bok Apr 29, 2020 06:20am
- Dantrolene, a muscle relaxant that was supplied in a very small quantity to be designated as an orphan drug, has recently attracted attention in the background as demand has increased in Korea. In the past, it was required to hold only in emergency medical centers in each region, but demand was low. However, there are increasing cases of using this as part of safety marketing for the recent increase in anesthesia. #According to the KSA (Korean Society of Anesthesiologists) on the 28th, demand for an orphan drug, Dantrolene has been increasing recently. Dantrolene is a drug that is mainly used as a muscle relaxant as a muscle vesicle inhibitor. There are two types, oral and injectable. Among these, oral drugs are used for stiffness symptoms of chronic diseases with high severity, such as cerebral palsy, according to the original purpose, but injections are used for malignant hyperthermia, one of the fatal anesthesia side effects. Malignant hyperthermia is a disease in which the body temperature rises rapidly every 5 minutes, and muscle spasticity, respiratory acidosis, and hyperkalemia appear, and the fatality rate reaches 70%. However, in reality, demand was extremely rare because malignant hyperthermia itself was a very rare anesthesia side effect with 4 to 5 cases per 10,000 patients. For this reason, Dantrolene is designated as an orphan drug and can only be supplied through the KOEDC. In particular, it is true that there was only a small amount of inventory in that the expiration date was only one or two years. An official from the KSA said, "It is true that the distribution of Dantrolene injections is complicated and the expiration date is short, so it is true that there was almost no inventory other than the regional center." In fact, as of April, the inventory of Dantrolene injections reported to the KOEDC is only 21 ampules in 8 regional centers nationwide, including Seoul National University Hospital and Kyungpook National University Hospital. There was virtually no more demand for the fact that when the stock was used, it was operated in a form that only the inventory was adjusted through the KOEDC. However, it has been recently reported that the demand for Dantrolene has doubled compared to the previous year. Then, why is there a sudden increase in demand for rare drugs that are consumed only a small number each year? Experts are analyzing this as the demand for primary and secondary medical institutions that have large-scale non-reimbursed procedures such as skin and beauty has increased. In recent years, an anesthesia accident occurs during a surgery or procedure in a medical institution, and negative public opinion is being formed, and thus, there is a case of having Dantrolene as part of marketing. #An official at the KSA said that he knew that some clinics were equipped with Dantrolens to conduct marketing, and that the local clinics may have more than the regional centers. In fact, hospital-grade plastic surgery, dentistry, and dermatology in Gangnam, Seoul are widely promoting the provision of Dantrolene and stressing the safety of anesthesia. It is used as a publicity that a kind of safety device has been created for patients concerned with anesthesia. An official from the KSA said that there are often no problems with anesthesiologists in hospital-level medical institutions. However, some organizations are looking carefully at the fact that some institutions do not have anesthesiologists. He said that most of them are for publicity purposes, and the probability of actually using them is extremely rare, and it would be dangerous to make a fatal heart and liver side effect if they were injected incorrectly.
