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- 2026-04-17 09:57:03
- Policy
- MOHW to require reimbursement negotiation for generic
- by Kim, Jung-Ju Feb 19, 2020 06:32am
- Even generic drugs, reimbursed pricing decided according to set formula, would have to negotiate with the insurer about the insurance benefit. The government is aiming to establish legal basis to prevent companies evading pricing reduction by listing the same drug as another, and also to require post-management. Basically, the revision is constructing legal foundation for further drug pricing system revision. Korea’s Ministry of Health and Welfare (MOHW) posted a draft of revised ‘Regulation on National Health Insurance Reimbursement Standard’ on Ministry of Government Legislation’s board. The draft has been more specified than the version unveiled at Health Insurance Policy Deliberation Committee’s (HIPDC) subcommittee meeting in last December, as a part of this year’s drug pricing system revision plan. MOHW would improve generic drug pricing system by mandating negotiation track for generics, currently exempted from pricing negotiation before reimbursement listing, to fine-tune contract terms, and by preventing companies to wiggling out of pricing reduction penalty. Also the revision would stipulate the government to authorize maximum reimbursed price as well. The draft focuses on four following issues; improving reimbursement decision-making principle with detailed pharmaceutical reimbursement deciding principles and prioritization system; stipulating rejection on reimbursement applicant evading drug pricing reduction penalty; unifying pharmaceutical reimbursement application procedure; and establishing government-authorized track and revising related procedure. First, the government plans to set detailed reimbursement deciding principles and implement pharmaceutical reimbursement prioritization system. With the changes, the government would be able to decide on listing items considering sustainability of limited National Health Insurance resources. At the same time, the changes in detailed principle and prioritization system would be stipulated on the regulation. Another new regulation would stipulate the government regulator rejecting pharmaceutical companies avoiding drug pricing reduction. When the change is finalized, the government regulator could legally shut off a company penalized to reduce drug pricing for providing illegal rebate but trying to evade it by applying for reimbursement as another item under company’s subsidiary. The pharmaceutical reimbursement listing procedure would be unified as well. All drugs that passed reimbursement feasibility review would have to complete negotiation within 60 days and decide on an outcome. This would legally require a generic item, or non-negotiated drug automatically priced by set formula, to negotiate with National Health Insurance Service (NHIS). NHIS not only negotiates reimbursed price of a new drug, but also handles contract regarding supplier’s responsibility, patient protection (accessibility) and financial stability. And the insurer would be able to include generic in their scope as well. A pre-negotiation with the president of NHIS could be conducted, for the manufacturer to flawlessly process the actual negotiation procedure. Also a new track would be available for pricing negotiation-exempted drug to expedite the negotiation procedure. Reporting to the Minister of Health and Welfare would follow after Drug Reimbursement Evaluation Committee (DREC) deliberation, and the result would be notified to the president of NHIS. The streamlined procedure seems to be the government’s solution to the new DREC changing the reimbursement listing procedure and requiring face-to-face briefing for DREC that slowed down the expedited non-negotiated track. The revision would touch up the government-authorized pricing calculation and listing procedure as well. The changes would apply for when reimbursement standard needs adjustment based on a change in label, overseas label and reimbursement status, and clinical evidence. This would also legally stipulate the listed drug reevaluation, the government is lately pushing on. In detail, the government could order a negotiation between NHIS and applicant company when it is needed for stable supply. But when the government authorizes the negotiation, the reimbursement decision would have to be made after it to properly reflect the amended listing procedure. Considering the drug pricing system revising plan the government has, the above changes would be specified and finalized before the second half of the year.
- Product
- What drug will be replaced by Belviq’s withdrawal?
- by Lee, in-bok Feb 18, 2020 10:49am
- As Ildong’s Belviq, which dominated the obese drug market for a long time, is finally exiting the market, there is a growing interest in which drug will fill this gap. Obesity experts are predicting that safety-oriented prescriptions may be available for the time being, while Saxenda and Qsymia are expected to benefit directly. The Ministry of Food and Drug Safety recently decided to stop selling and recall Belviq(lorcacerin) because of the risk of cancer. The U.S. Food and Drug Administration (FDA) has recommended its recovery, saying the risk is greater than the benefit. As a result, Eisai in charge of the U.S. sales, immediately took over its own collection, and Ildong, a domestic sales company, is also in the process of collecting it. According to IQVIA, a global market research firm, Belviq has been overwhelmingly occupying the No.1 ranking in the obese market until 2018 since it landed in Korea in 2015. Indeed, in 2018, Belviq's outpatient prescriptions amounted to ₩9.07 billion, the highest in the obese drug market, beating Dietamin(₩8.48 billion) and Hutermin (₩7.86 billion). Literally the market dominated by the number one leader suddenly withdrawn from the market is bound to be a big ripple Obesity experts point out that safety will be an issue for obesity prescriptions for the time being. It is believed that Belviq could also create the same situation, reflecting on the safety controversy that has been taking place for the time being after the 2010 Reductil(Sibutramine) eviction Professor A, a member of the Korean society for the study of obesity, said, "The safety issue for obesity drugs persisted for a while even when Reductil was evicted as a cardiovascular safety issue, and Belvik is also likely to create such a situation". What kind of drugs are obese experts considering as a substitute for Belviq? First of all, Saxenda(Liraglutide) is expected to be nearing peak item. Prescriptions have already increased since last year, conquering the obese drug market, and safety issues cannot be ignored. Professor A said, "I think that the Saxenda, which was developed with GLP-1 diabetes, will benefit as much as it has been tested for safety, also, it's already been imprinted on obese patients and for now it's almost the only drug that is free from safety issues". In fact, Saxenda has already led the reorganization of the overweight drug market, surpassing Dietamin(₩9.3 billion) and Belviq(₩8.8 billion), recording outpatient prescription amounts of ₩15.1 billion in the third quarter of 2019. With the disappearance of the biggest competitor among them, there is a prospect that Saxenda’s prescription may be accelerated. However, some are expecting the limited competitiveness of the Saxenda. Rather, Oral medications will be more popular because the characteristics of the drugs are completely different An executive of the DAOR said, “Saxenda has long-term safety data, but it just quotes past clinical trials. Furthermore, there may be a difference in compliance when switching to injection in that Belviq is oral”. He said, "While Qsymia is likely to benefit from the new drug effect, some people are considering Phentamines, which have been prescribed for a long time". Some experts predict that Belviq's withdrawal will not have a big impact on the market right away. Obesity drugs are not a long-term use treatment itself, and it is not urgent enough to change the prescription to another drug right now. Professor B, a member of the Korean society for the study of obesity, said, "Stopping a medication used to treat obesity right away does not cause a problem immediately. Belviq's withdrawal will not have a big impact on the market". In addition, the professor said, "Because it is a drug that has been prescribed a lot, Pharmaceuticals will go for the potion and aggressively market it, but I think that the potion won't be moved to other drugs right now, although the potion may come down".
- Policy
- NSCLC targeted therapy Vizimpro approved in Korea
- by Lee, Tak-Sun Feb 18, 2020 06:35am
- Pfizer Pharmaceutical Korea’s non-small cell lung cancer (NSCLC) targeted therapy Vizimpro has been approved to market in Korea. The treatment is a second-generation targeted therapy like Boehringer Ingelheim’s Giotrif. On Feb. 14, Ministry of Food and Drug Safety (MFDS) has approved Pfizer Pharmaceutical Korea’s three Vizimpro tablets (dacomitinib) in 15 mg, 30 mg, and 45 mg doses. The treatment has been indicated as a first-line therapy for locally advanced or metastatic NSCLC patients with epidermal growth factor receptor (EGFR) gene deletion in exon 19 or exon 21 L858R substitution mutations. AstraZeneca’s Tagrisso also shares the same indication. Apparently, EGFR is overexpressed in more than 70 percent of NSCLC patients, which affects proliferation of cancer cells and metastasis. EGFR tyrosine kinase inhibitor (TKI) targeted therapy generally defines all treatments with mechanism of using a molecule to block EGFR in cells. The EGFR TKI even has third-generation targeted therapy that overcame the initial tolerance in earlier drugs. AstraZeneca’s Iressa (gefitinib), Roche’s Tarceva (erlotinib) are first-generations, Boehringer Ingelheim’s Giotrif (afatinib) is a second-generation. And AstraZeneca’s Tagrisso (osimertinib) is a third-generation. Lazertinib, currently in development by Yuhan, is also a third-generation EGFR TKI treatment. Newly approved Pfizer’s Vizimpro is in the same class of second-generation EGFR TKI as Giotrif. However, it would also compete straight against Tagrisso as well, because they share the same indication. But Tagrisso’s reimbursement has not been cleared for first-line treatment. In a transnational clinical study with 452 patients, Vizimpro demonstrated statistically meaningful improvement in progression-free survival, compared to that of gefitinib. Sub-analyzing Asian-region patient group treated with the second-generation targeted therapy, the median progression-free survival was recorded at 16.5 months, whereas the first-generation gefitinib group was at 9.3 months. The pharmaceutical industry predicts the follow-on EGFR TKI treatment Vizimpro would set lower pricing than predecessors to ease into the market. The targeted therapy has won the U.S. Food and Drug Administration’s approval in September 2018.
- Policy
- Avastin additional coverage approved for colorectal cancer
- by Lee, Hye-Kyung Feb 18, 2020 06:35am
- Combination therapy of Avastin (bevacizumab) plus irinotecan plus low-dose capecitabine (mCAPIRI)’ treating metastatic colorectal cancer would receive insurance benefit from Mar. 1. Moreover, indications to treat patients with stage IIB or later mycosis fungoides, primary cutaneous anaplastic large cell lymphoma (pcALCL), or Sézary disease have been added to Adcetri’ (brentuximab). The drug’s current reimbursement is limited to second-line or later treatment for relapse or refractory CP30 positive anaplastic large cell lymphoma. Health Insurance Review and Assessment Service (HIRA) is collecting public opinion on the said changes made. Without any issue, they would come in effect from Mar. 1. HIRA has reviewed expanding coverage of Avastin to also cover for an ‘irinotecan plus mCAPIRI plus bevacizumab combination therapy.’ Initially, the drug was approved to treat metastatic colorectal cancer as a combination therapy with fluoro pyrimidine class chemotherapy. According to a literature review on textbook, guideline and clinical trial studies, the combination therapy has not been mentioned on either text or National Comprehensive Cancer Network (NCCN) guideline. But a 2018 guideline by European Society of Medical Oncology (ESMO) has mentioned it to have ‘study in progress,’ and a Phase 3 clinical trial comparing noninferiority of 'FOLFIRI plus bevacizumab’ and FOLFIRI has confirmed noninferiority with median overall survival of 16.8 months and 15.4 months. The combination therapy has been granted for reimbursement as a second-line treatment. HIRA explained, “The reimbursement on the drug has been granted for treating metastatic colorectal cancer as it could enhance convenience of outpatient treatment better than the already reimbursed therapy, and it could also provide more option of treatment to patients.” Additionally indicated to treat patients with CD30 positive cutaneous T cell lymphoma, who has been treated with one or more systemic treatment, Adcetris is recommended as category 2A by NCCN guideline for treating mycosis fungoides, primary cutaneous anaplastic large cell lymphoma (pcALCL), or Sézary disease. In Phase 3 ALCANZA study, the patient group with stage IIB or later mycosis fungoides and primary cutaneous anaplastic large cell lymphoma (pcALCL) demonstrated overall reaction rate (ORR) of 70.8 percent, and specifically 62.5 percent of the group had reaction over four months. And 18.8 percent of the group experienced complete response. HIRA official said, “The reimbursement on the treatment was approved considering the specific indication lacks other alternative treatment option.”
- Company
- GSK and Pfizer intensify treatment conflicts after merger
- by An, Kyung-Jin Feb 18, 2020 06:34am
- There is a friction over the integration process of Pfizer Korea and GlaxoSmithKline's Consumer Health Division. Pfizer Pharmaceutical's union raises suspicions that GSK will endorse unfair changes in working conditions in the process of employee succession. There are ten days left to launch an integrated corporation, and a possibility that variables may arise during the merger process if employees refuse to transfer largely. According to the related industry on the 14th, Pfizer Korea’s labor union had an emergency meeting with about 50 employees of Consumer Health Division in the afternoon. The intent is to seek a response to GSK's notification that Pfizer's Consumer Health Division employees must submit a written consent by this coming 17th to agree to transfer to GSK on the condition that they agree to change the disadvantage of working conditions. Pfizer and GSK Korea have been pursuing related procedures since the merger with Consumer Healthcare in 2018. As GSK establishes a joint venture with 68% of the joint venture and Pfizer's remaining 32%, GSK is committed to 100% succession of Pfizer employees. The organization of the headquarters has already completed the establishment of a joint venture and transfer of its employees in August last year, and GSK & Pfizer Consumer Health Korea is expected to launch a corporation on the 24th as the related procedure has reached its final stage. The problem arises from the fact that labor negotiations over working conditions have not progressed even though the date of incorporation is approached ten days in advance. Pfizer's union argues that GSK, the owner of the negotiating bargaining agreement, has asked Pfizer employees to change their working conditions to be 100% identical to GSK, and the gap has not narrowed. It is pointed out that the employee's options were limited because the company insisted employees should approve changes of disadvantages in working conditions if employees want to transfer with GSK for more than two months since last December On the 10th, Pfizer's labor union, Pfizer's human resources officers and GSK's human resources officers agreed that even if employees want to transfer, whether they agree to changes of disadvantages in working conditions are left to the opinion of individuals. But, they took back their words in four hours. It also uncovered that employees of Pfizer Pharmaceutical Consumer Business Division of Korea had to submit an agreement by e-mail by the 17th that they would agree to change the disadvantage of working conditions and change the retirement pension system if they want to transfer work. Yun-gyu Park, the chairman of Korea Pfizer labor union, said, “It is a serious offense to allow GSK transfers under the conditions of work conditions and retirement pension, and employees who were unilaterally notified by e-mail are not able to get out of shock”. Pfizer Korea's HR team tipped off that GSK had an attitude problem and raised objections to the headquarters. According to Park, most employees complain about the wide difference in working conditions such as benefits and ranks. For example, Pfizer has six ranks and GSK has three levels. According to the GSK standard, even if there are paid health leave, sick leave and other leave, medical expenses support, and retirement pension system, the company must bear a considerable disadvantage. Apart from the difference in the basic labor system, he also pointed out that the entire agreement contained many poisonous clauses. It was also predicted that confusion would be inevitable if the majority of the 53 members of the Consumer Health team refused to do so. It is pointed out that the launch of an integrated corporation may have a problem. The two companies have not disclosed their official position. Pfizer and GSK officials said, "There is currently no formal issue that can be revealed, except that the two companies are in the process of merging the consumer healthcare business".
- Company
- Belviq was withdrawn voluntarily by Ildong
- by Chon, Seung-Hyun Feb 18, 2020 06:34am
- Ildong Pharmaceuticals voluntarily discontinued the sale of its obesity drug, Belviq. In the United States, it was advised to withdrawal of permission because of the risk of developing cancer, and it has preemptively discontinued sales in Korea. According to the industry on the 14th, Ildong Pharmaceutical decided to stop selling Belviq in Korea. Ildong Pharmaceutical said, “The FDA recommended discontinuing sales in the US because of the increased incidence of cancer,and we are proactively discontinuing Belviq's sales and are discussing with MFDS for further actions”. In this regard, the US FDA recommended Belviq’s withdrawal. Due to the increased risk of developing cancer, and has asked Belgian developer Belviq’s developer, Eisai to withdraw of the market. The FDA said last month that the results of Belviq's safety assessment trials indicate a new increased risk of cancer during the trial. In a clinical trial involving 12,000 patients in a five-year trial to evaluate heart-related problems by Eisai, patients taking Lorcaserin(generic for Belviq) were more likely to be diagnosed with cancer than those taking placebo. .In Korea, the official position of the Food and Drug Administration has not been determined in relation to Belviq's sale or discontinuation of prescriptions .Although the MFDS has not decided, Ildong plans to discontinue its sales and follow up with safety verification .Belviq was the drug that had been expected to be a safe obesity drug since its introduction to the market .Belviq, which was domestically licensed in February 2015, is a new drug approved for weight control by the FDA in 13 years .Belviq is a drug that selectively acts on the serotonin receptor, a neurotransmitter that regulates appetite and emotions, suppressing appetite and improving satiety .According to drug research institution IQVIA, Belviq ranked No.1 in obesity treatments with 2018 sales of ₩9.8 billion in Korea .After the emergence of Saxenda in the second quarter of 2018, it was handed over to the top spot for obesity treatment, but it was still regarded as a highly preferred obesity treatment .Cumulative sales for the third quarter of last year stood at ₩6.6 billion .However, the sale was put into the worst crisis due to this withdrawal .Ildong Pharmaceuticals official said, “We will implement further measures as soon as consultation with MFDS is completed, and will faithfully do all measures with the patient's health first”.
- Policy
- The MFDS collects 900 Metformins & tests for carcinogens
- by Lee, Tak-Sun Feb 17, 2020 06:26am
- The MFDS is conducting extensive testing of carcinogens in the drug 'Metformin', which is used as the primary treatment for type II diabetes. It is known that as many as 900 items to be inspected. As the US FDA announced the results of the survey yesterday, the MFDS is expected to speed up the survey in order to advance the publication date. According to the Ministry of Food and Drug Safety on the 4th, after conducting a raw material system survey with Metformin manufacturers in last December, the raw materials stored by the companies are collected and tested for impurities. On the 15th of last month, NDMA (N-nitrosodimethylamine) test method for carcinogens using GC-MS / MS has been announced, The MFDS is said to have identified the raw materials to be investigated based on systematic investigations. Nevertheless, it is explained that the survey period is getting longer because there are about 900 items. Currently, there are 640 finished products containing Metformin. The MFDS has been investing a lot of people recently to address COVID-19 infection issues. In particular, 30 people were dispatched to investigate the excessive profits of masks, and related departments are checking daily supply and demand, making it difficult to take the plunge on the Metformin survey. However, some research has been conducted, and results from other countries are coming up one after another. The investigation into NDMA, which is a carcinogen for Metformin, began on Dec 4 when Singapore health authorities recovered three Metformin products. At the time, Singapore health officials said more than 96 ng of NDMA were detected per day in Metformin products. The MFDS confirmed that the ingredients of the same manufacturer of the product recovered by the authorities of Singapore were introduced in Korea, and carried out a full-fledged investigation. Afterwards, a systematic investigation was conducted to ask domestic manufacturers to submit data on the source of production items. Meanwhile, the US FDA reported on the 4th that a sub-standard NDMA was detected in six lots of two of the 10 products. However, it is safe to use because it has a small amount of 10 to 20 nanograms per tablet. To date, no country has issued a prohibition on sales or a recovery order because no NDMA above the baseline has been detected in Metformin products except Singapore. Therefore, the prospect that Korea will have no problem is coming out cautiously. Major domestic manufacturers and sellers are also reporting that NDMA has not been detected through their own research. The domestic market for Metformin preparations is about ₩400 billion, which is widely used in both single and combination drugs. Single drugs include Diabex of Daewoong Pharmaceutical, Glucophage of Merck. If NDMA is detected above the threshold and sales bans or recovery measures are taken, a huge impact is expected, and the pharmaceuticals are unable to let go of tensions.
- 3 variables of Xcopri ahead of US release
- by Kim, Jin-Gu Feb 17, 2020 06:26am
- SK Biopharm's most anticipated product, Xcopri (Cenobamate) is making its debut soon in the US. SK Biopharm aims to release the US in the second quarter There are three major variables that will determine Xcopri's success of the US market. Its competitive effect with existing leading products such as 'Vimpat', conservative prescription trends, and direct sales influence. It is very optimistic on the stock market. It is expected to increase from about ₩30 billion in 2020, the first year of launch, to ₩155.1 billion in 2021 and ₩257.5 billion by 2022. ◆Seizure suppression effect is better than ₩1.5 trillion 'Vimpat' First is a competitive drug. When Xcopri is released, it is expected to compete with UCB's Vimpat. Vimpat has annual sales of ₩1.5 trillion in the US market. Vimpat is classified as a third generation epilepsy treatment. It is prescribed for intractable patients who do not improve with existing primary and secondary treatments. This intractable patient is estimated to be around 30% of the total. Currently, there are about 3.33 million people with epilepsy in the United States. Arithmically, more than 1 million people use third-generation drugs. In clinical trials, the efficacy and effectiveness of Xcopri have been shown to be ahead. Xcopri has demonstrated superior seizure suppression effects in its control trial with Vimpat. The median frequency of seizures in Xcopri was 55% in Study 013·17. Given that 20~40% of competing drugs, including Vimpat, Xcopri is competitive enough as a new drug. In addition, complete seizure loss effect that was not found in other products is also observed. In the relevant trials, 28% of the treated groups had a complete seizure loss. In addition, the expansion of indications in 2023 is another factor that adds expectations. Xcopri currently has indications for partial seizures only. The successful completion of clinical trials for ongoing systemic seizures is expected to increase indications as early as 2023. SK Biopharm ◆Conservative trends, how much will change Second is the uniqueness of the US market. Efficacy itself has a comparative advantage, but it may not lead directly to earnings. Like South Korea, US physicians are said to be conservative in changing prescriptions. It is predicted that it will be hard to skip the proven effects and safety based on 10 years of experience. The US healthcare system, which is built around private insurance, will also be a factor. According to how each insurer evaluates Xcopri, it will affect the doctor's prescription to some extent. The key is the drug price. Depending on the price of Xcopri, private insurers are expected to evaluate the value of Xcopri differently. ◆Direct sales, ‘like a double-edged sword’ Third is the sales distribution network. SK Biopharm has declared direct entry into the US for the first time among the domestic pharmaceutical industry. The company intends to have a local distribution network without a sales contract. SK Biopharm's direct sales are attributed to the disease characteristics of epilepsy. There are not many patients, and the doctors who care for them are more limited. In fact, there are between 12,000 and 14,000 neurologists who deal with epilepsy in the United States. As few doctors prescribe most prescriptions, SK Biopharm expects to build a sales network that closely marks them. It is pointed out that this direct sales strategy is like a double-edged sword. It is clear that direct sales can maximize profit margins. But it is also true how strange new drug companies will be in the conservative US healthcare system. A pharmaceutical industry official said, "It is difficult to predict the results because it is the first time a Korean pharmaceutical company is directly challenged in the United States. It depends on how quickly the doctor's prescription pattern for Vimpat, which has been used in the past 10 years, is quickly converted to Xcopri". It is very optimistic on the stock market. In a recent report, Yuanta Securities expects sales to exceed ₩1 trillion in 2023, the fourth year in the US.
- Opinion
- [Column] Pharmacist's role during COVID-19 outbreak
- by Jung, Heung-Jun Feb 17, 2020 06:26am
- “Do you have hand sanitizer?” “Do you have masks?” These were the most frequently asked questions at my pharmacy starting from Lunar New Year holiday season when the first case of COVID-19 in Korea was confirmed. It is disheartening to see people looking for hand sanitizer in every pharmacy as if not owning one would kill them. Obviously, a public place required have one is unavoidable. But thinking that hand sanitizer would give immunity to virus is a problem. I tried to tell people to carry personal liquid soap and wash their hands at public restrooms as Korea has clean and convenient facilities. But it frustrates me to see people trusting information from the Internet. Nevertheless, I am glad the government and the people are reacting much better after experiencing a number of major respiratory virus outbreaks. During the 2009 flu pandemic, the health authority took almost two weeks to disseminate responsive guideline. The country was confused and restless for a long while, because disease preventive guideline was not presented promptly. I owned a small pharmacy back then as well. I remember informing customers, based on the fact the novel flu’s pathogen is an influenza virus, soap and alcohol could kill the virus and simple single-use mask would also be effective to prevent droplet infection even if it is not difficult to acquire N95 mask. And obviously, my expertise as a pharmacist has helped me to make a judgment. Lately, health issues affecting the society have been occurring more frequently. Besides respiratory virus outbreaks, events with harmful and toxic substances have also been reported. Humidifier disinfectant incident was a case that toxic substance stirred the public. Presumably, the consumers were shocked even more as disinfectant, supposedly protecting human body, was actually damaging the people. Pharmacist should not only talk about drugs. All pharmacists study toxicology at university. As Paracelsus said, “All things are poison,” all chemical substance found in daily life could be toxic or bad for human body. So it is pharmacist’s social responsibility to warn and advise about toxic substance or health risk the public is unaware of. We do need to reflect back on ourselves to see if the pharmacist organization has been playing a key role when a social health issue breaks out. We also need to ask ourselves if we are playing the role of a watchdog forewarning an upcoming risk. The pharmacist organization could not raise a voice to warn about the humidifier disinfectant. Regardless of being an expert of substance acting on human body, the organization could not even explain the problem or present a counteraction plan when the problem arose. If the pharmacists have been constantly warning about various toxic substances, the public would have listened to the pharmacists opposing against the government opening the pharmaceutical market to convenient store. This was a quite regretful incident. It is unfortunate that today’s pharmacy visitors are looking for hand sanitizer and not listening to my advice. But before I blame such state, we need to ponder over what should do as an expert rebuilding trust and authority. Korean Pharmaceutical Association (KPA), representing Korean pharmacists, should always explore health risks and constantly speak up on various safety issues. And also they should be able to promptly provide trustworthy information whenever public health incidents surface. Credibility of a person continuing to speak up for good cause would naturally solidify. I can assure such effort would change the attitude of pharmacy-visiting consumers.
- Policy
- The TF agrees on COVID-19 treatment, 2 tabs of Kaletra BID
- by Kim, Jung-Ju Feb 17, 2020 06:25am
- Although the development of 'COVID-19' treatment has not been completed, the principle has been established that the treatment can be considered by administering two tablets of Abbvie’s Kaletra twice a day. Chloroquine, an antimalarial drug, is also considered, but not domestically distributed. Instead, Hydroxychloroquine, which is used as a drug for autoimmune diseases, may be considered. The National Medical Center held the 6th video conference with the COVID-19 Central Clinical TF, which consists of medical staff and experts in the COVID-19 confirmed patients care hospital nationwide, and agreed on the treatment principles on the 12th. According to the TF, there are currently no treatments for COVID-19 that have proven effective in humans. Therefore, the agreement is the most important clinical decision of the attending physician for the decision of antiviral treatment, the selection of treatment, and the duration of treatment. However, the summary of the agreement is based on the scientific literature published and the experience of TF team members, and is an important reference for treatment. According to the agreement of the TF, if the symptoms of young and healthy patients without the underlying disease are relatively mild, they can be observed without antiviral treatment. In particular, if more than 10 days after onset and symptoms are relatively mild, anti-viral therapy may be less likely. Conversely, antiviral therapy should be considered in patients with old or underlying disease and in patients with relatively severe COVID-19. If the patients are treated with antiviral treatment, it may be theoretically helpful to start dosing as soon as possible. Administration of Kaletra as an antiviral therapy may be considered. The TF can consider two tablets of Kaletra once a day (LPV/ r 400mg/100mg po bid) or Chloroquine 500mg po qd, but Chloroquine is not distributed in Korea, so Hydroxychloroquine 400mg po qd could be considered. It is the TF's judgment that there is no evidence that the combination of Kaletra and Chloroquine (or hydroxychloroquine) is superior to monotherapy. Combination of these drugs can cause serious arrhythmias and drug interactions with increased QT interval (electrocardiogram QRS wave time). Therefore, this combination therapy should be administered carefully in very limited cases. Antiviral treatment, on the other hand, may seem appropriate for 7 to 10 days, but may be shortened or extended depending on the patient's progress at the clinical site. The TF said that Ribavirin, hepatitis C treatment and Interferon, a substance that inhibits viral infection and proliferation in the human body, are not recommended as they have severe side effects, and the use of Ribavirin or Interferon are considered in limited circumstances where Kaletra or Chloroquine(or Hydroxychloroquine) is ineffective or difficult to administer.
