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Product
Claiming a more expensive drug than a generic
by
Kim JiEun
Nov 11, 2021 06:00am
Pharmacist A, who did not give a follow-up notice of general submission and charged for a drug that was more expensive than an alternative drug, filed a lawsuit claiming that it was an unfair disposition, but the court refused to accept it. The Seoul Northern District Court recently dismissed a claim filed by pharmacist A against the NHIS for the return of unfair gains. Pharmacist A did not notify the doctor after generic substitution of the drug from the MOHW in 2016, and was suspended for 50 days, claiming that the NHIS was unfairly paid about 34 million won. Afterwards, the NHIS disposed of the collection of about 34 million won in unfair claims through notification of the results of the on-site investigation by the MOHW. Since then, it has been executed in a way that deducts medical care benefits to be paid to pharmacies operated by pharmacist A. After the disposition, pharmacist A filed a lawsuit with the Seoul Administrative Court, and in 2018, the pharmacist won the case. For this reason, the court explained, "Some of the periods under investigation lack proof of the reasons for disposition, but the illegal parts of the disposition cannot be clearly distinguished, and some of the facts that were the basis for discretionary judgment are not recognized, forcing cancellation of all relevant dispositions." Immediately after that, the MOHW appealed to the Seoul High Court, but the pharmacist's victory was confirmed. Based on the ruling, the pharmacist filed a lawsuit against the corporation to recover unfair profits. Since the related disposition of the MOHW was canceled through administrative litigation, the disposition of the corporation, which recovered 34 million won in the name of unfair claims based on the same reason, is also illegal, so the recovered amount must be returned. However, the court did not accept it. It noted the reason why the court, which ruled in the previous ruling to cancel the administrative disposition of the MOHW, revealed it. The court explained that just because the MOHW's disposition was canceled, there was no reason to cancel the separate disposition, the NHIS' redemption measure, saying it was unfair. The court said, "The reason for canceling the disposition in an administrative lawsuit against the cancellation of the disposition of the MOHW is that there is a lack of proof of facts regarding 'part' of the reasons for the disposition." As a lack of proof of some of the reasons for disposition, it falls under the case where the presence or absence of the defect is revealed only when the facts are accurately investigated. It is difficult to say that the defect in the disposition of this case has reached a significant and obvious degree, it said. He then said, "It is a separate and independent disposition based on a separate provision of the (former) National Health Insurance Act, even though the facts and the previous disposition of the MOHW are common." The court said, "Even if the related disposition is canceled, the NHIS cannot be ordered to return the disposition because the degree of defect in separate disposition has not naturally reached invalidity. The pharmacist's claim is dismissed for no reason, it said.
Product
PO treatment for COVID-19 "Molnupiravir" will be released
by
Whang, byung-woo
Oct 29, 2021 05:53am
The emergence of Molnupiravir of MSD, known as the first oral treatment for COVID-19, is drawing attention to how it will affect the war against COVID-19. While it is compared to Tamiflu and is evaluated as a game changer, there are mixed views on the other side that its role may be limited due to price limitations. According to the interim results of phase 3 clinical trials of MOVe-OUT, which evaluated the efficacy of the oral corona treatment Molnupiravir by MSD on the 1st, 775 patients with mild and moderate symptoms had reduced hospitalization and mortality by about 50%, satisfying the primary evaluation index. At this time, the dose of Molnupiravir was taken twice a day, 10 times for 5 days, and as a result, 7.3% of patients worsened to severe and there were no deaths. 14.1% of patients taking placebo worsened to severe and 8 died. Based on these clinical results, MSD terminated the clinical trial early without the registration of additional clinical patients originally planned and submitted an application for emergency use approval to the FDA. Considering the trend so far, Molnupiravir, which has been effective in clinical trials, is cheaper than conventional injections, so it will not be too much to win the title of the first oral treatment for COVID-19. The FDA will closely review safety and effectiveness data to determine whether to approve or not, and a final conclusion is expected within a few weeks. "The reason for getting a vaccine is to prevent it from going from mild to severe, that is, how severe it is even if it is a breakthrough infection," said Kang Jinhan, head of the Vaccine Bio Research Institute at Catholic University. "In the case of flu, the prevention rate is only about 50%, but the oral treatment of COVID-19 will be meaningful in that way." Director Kang said, "There is a need for oral treatments as a strategy to go to the so-called With Corona like the flu," adding, "I think it will be a concept that prevents medical confusion by administering it early so that mild patients do not get serious." Can Molnupiravir, which has been proven effective, be like Tamiflu? One question here is whether Molnupiravir can play the same role as Tamiflu or Xofluza, a flu treatment, at a time when many experts predict that COVID-19 will become endemic like the flu in the future. According to the most recently developed CAPSTONE-1 clinical study by Xofluza, the median time required for the Xofluza administration group to relieve symptoms after administration was about 2.3 days (Tamiflu 3.3 days). In addition, the median time it took to fever was about 1 day (Tamiflu 1.8), and the effect of reducing virus levels was reduced by half in about 1 day (Xofluza about 4 days). Choi Young-joon (pediatric infection), a professor at Korea University Anam Hospital, said, "I remember that Tamiflu was first introduced as an endpoint and gradually expanded to shorten the duration of symptoms," adding, "Molnupiravir aims to treat death and severe infections in public health and may expand the scope of treatment in the future." In fact, according to the MOVe-OUT clinical evaluation index that evaluated the efficacy of Molnupiravir, the primary evaluation index is the rate of hospitalization, death, and side effects, but the second evaluation index is the decomposition or improvement time of the coronavirus, so the possibility remains. Another variable is that the expected price of Molnupiravir is set at about 830,000 won ($700). As a result, the current market for oral treatments for COVID-19 is expected to form from about 7 trillion won (6 billion dollars) to about 8 trillion won (7 billion won).
Product
Smoking cessation tx, sold out due to impurities
by
Kim JiEun
Oct 01, 2021 06:08am
According to local pharmacies on the 1st, most Bupropions used for smoking cessation treatment are sold out or lack of inventory, making it difficult to order at online malls. This out of stock is related to the recent controversy over the detection of impurities in the Varenicline. As NNV, a carcinogen, was detected in Champix (Varenicline), the company decided to voluntarily recover it. The MFDS explained that N-nitroso-varenicline (NNV) is very low in the domestic Varenicline, but concerns about the ingredients remained in the market. Pharmacists say that most hospitals and clinics, which have consulted and prescribed patients under the government's anti-smoking treatment support project, often prescribe alternatively with Bupropion. A local pharmacist said, "I was contacted by the hospital to recommend a replacement drug," adding, "It was extremely rare for the hospital to ask the pharmacy to prescribe the drug first, but I was also embarrassed." Pharmacies that need to prepare related drugs are experiencing considerable confusion. In particular, the situation is more serious in pharmacies where nearby hospitals and clinics participate in the government's anti-smoking treatment support project and have a large number of related prescription preparations. These pharmacy pharmacists complain that it is not easy to secure inventory of medicines that are usually prescribed. Currently, Bupropion, where hospitals and clinics have replaced the existing Champix (Varenicline), is a total of 6 products, including Nicopion Sr (Hanmi), Healthpion ER(Myungin), Addpion SR 150mg(Whanin), Papion(Korea Pharma), Well SR(Unimed), and Wellviewderma ER(Hutecs). These items can be prescribed for the government's anti-smoking treatment support project, and most of them are currently out of stock at online drug malls or only a few are in stock. Another pharmacist in Seoul said, "In the past, Champix monopolized the prescription of smoking cessation treatment," adding, "We contacted a nearby hospital and asked them to prescribe even a small amount of products in stock."
Product
Take Ibuprofen after Pfizer COVID vaccine??
by
Kim JiEun
Sep 06, 2021 05:58am
Following Tylenol, the purchase of related drugs is increasing as Ibuprofen-containing painkillers have been raised to prevent side effects of COVID vaccines in certain companies. According to outpatient pharmacies on the 6th, patients who have recently been vaccinated (Pfizer vaccines) have frequently sought Ibuprofen-containing anti-inflammatory drugs. If manufacturers have purchased Tylenol before or after COVID vaccine, they have recently been looking for Ibuprofen, particularly IBU 600mg, among Pfizer vaccine or Moderna vaccine. The reason why people only look for Ibuprofen is that videos of some specialists have been affecting online or YouTube recently. This is because some media have suggested that myocarditis, and pericarditis caused by Moderna vaccine or Pfizer vaccine should be prevented by Ibuprofen's anti-inflammatory action. Some of the experts who actually run YouTube recommend taking Ibuprofen if they find chest pain after vaccination or prevention of myocarditis, one of the possible side effects of Pfizer vaccine. Pharmaceutical companies with Ibuprofen also posted advertisements in online malls exclusively for pharmacists to take medicine for abnormal reactions such as fever and pain after vaccination. A pharmacist in Seoul said, "There are quite a few patients who get Ibuprofen 600mg," explaining on YouTube that it is good to take Ibuprofen-containing anti-inflammatory pain medication for muscle pain after getting the shot. "I dion't know how to explain this," he said. As the number of patients wishing to purchase Ibuprofen-containing anti-inflammatory painkillers before vaccination increases, many pharmacists are also explaining the related information through blogs and YouTube. Outpatient pharmacists are struggling with medication guidance to patients who believe in in information that has not been immediately confirmed. Another pharmacist in Seoul said, "Acetaminophen was initially recommended after COVID vaccine because it was believed that taking anti-inflammatory anti-inflammatory drugs could interfere with antibody formation. If there are any side effects to Acetaminophen, it is okay to take other anti-inflammatory drugs. However, it is not true to say that Ibuprofen is the only drug after the Pfizer vaccination. Another pharmacist said, "Patients mistakenly believe that Pfizer vaccine can lead to cardiomyopathy, and that Ibuprofen can cure myocarditis" However, if the patient still wants to take Ibuprofen, we have no choice but to do so.
Product
Disturbance to secure inventory of Diovan and Exforge
by
Jung, Heung-Jun
Sep 05, 2021 08:26pm
Pharmacists suffered from inventory after six products, including Diovan and Exforge, by Novartis Korea, were announced to local pharmacies on the afternoon of the 1st. When there were concerns that impurities were detected, Novartis Korea explained that the quality was fine, but it was a lot release that was decided due to administrative delays. According to local pharmacies on the 1st, four products including Diovan, Co-Diovan, Exforge, and Entresto by Novartis Korea and Kotarec and Tarec by Sandoz Korea will be suspended from September. It said the lot release was suspended because it did not submit safety inspection data to the MFDS until the end of August. Upon hearing the news, pharmacists rushed to secure inventory, and all products were sold out at pharmacies-only online malls. Pharmaceutical companies immediately explained that the decision to suspend lot release is not a matter of quality. "Azido impurities were not detected in Valsartan raw materials used in that product," a Novartis Korea official said. "We have been conducting investigations for many years to confirm that there is no problem, and right after the incident, the headquarters submitted the manufacturing process verification data to major European and overseas countries and confirmed that there was no problem." Although the related documents were recently submitted to the MFDS, it took some time to confirm, so the lot release was inevitably decided from September 1. "Lot release is scheduled as soon as the reply comes," the company added. Later in the day, Novartis sent an official letter to hospital doctors and pharmacists, explaining that there was no problem with the quality of the products mentioned. A pharmacist in Seoul said, "We received an answer that we will try to release the product as soon as possible once we prepare the prescription with our inventory." "I'm glad to hear that." Another pharmacist in Gyeonggi do (in an online mall) seems to have hoarded some pharmacies because of anxiety. "I think it's going to work out faster than I thought."
Product
"Inhibiting ANO1 activity has effect on treating psoriasis"
by
Lee, Jeong-Hwan
Aug 05, 2021 06:02am
A study result has shown that inhibiting the activity of the Anoctamin-1 (ANO1) protein may be effective in treating psoriasis, an intractable skin disorder. The results are expected to aid further research in developing ANO1 inhibitors for the treatment of intractable diseases such as psoriasis and cancer. On the 4th, the joint research team of Gyeonggi-do Regional Research Center and Professor Young Duk Yang’s team at the CHA University School of Medicine announced the results of the study that contained these findings. Psoriasis is an intractable skin condition that causes a build-up of extra dead cells and inflammation that occurs due to abnormal function of the immune system. The joint research team found that effectively blocking one of the ion channels that exist in the body – the ANO1 ion channel – reduced key symptoms of psoriasis such as rash, erythema, white scales, etc. while reducing inflammation-inducing substances that cause psoriasis Accordingly, the teams plan to expand their scope of research to develop new ANO1 inhibitors for the treatment of intractable diseases such as psoriasis and cancer. ANO1 is a membrane protein that acts as a channel for chloride ion transport. Professor Young Duk Yang said, “Psoriasis is an intractable skin disorder with no identified cause that is difficult to treat and recurs well. The study results may be used as a new breakthrough in the development of treating psoriasis.” The study results were published in the International Journal of Molecules Sciences in July 2021.
Product
Consult with MD about controversy over Champix?
by
Jul 07, 2021 05:53am
Concerns over the detection of carcinogens in the anti-smoking supplementary drug Champix (Varenicline), pharmacies are also making a series of inquiries. However, there are no clear guidelines for existing patients, adding to the confusion. As part of preemptive measures related to the impurity crisis, the domestic supply has been completely suspended and the investigation is underway at the global headquarters level, but no guidelines have been prepared for refunds or suspension. Therefore, pharmacists explain that it is difficult to respond to questions about whether pharmacies continue to take them. Pharmacist A said, "There have been more than a few recent inquiries from existing users asking if they can continue taking the medicine after hearing media reports." "There is a risk of cancer, so we are asking the pharmacy whether the dose continues or not," he said. Pharmacist B also had patients taking Champix asking the same question through the pharmacy, and he was confused when he asked Pfizer whether to take it continuously. The pharmacist asked the patient how to guide him in terms of safety, and the pharmaceutical company replied, "We can't give you advice that you can't take it steadily, so I have to discuss it with the doctor in charge." "It is sensitive to give accurate and clear answers because it is currently under investigation. As there are people who have already been prescribed and taken, we expect many inquiries from pharmacies." The pharmacist said, "It is absurd why they ask us to consult a doctor about impurities," and added, "There should be guidance from pharmaceutical companies on how to respond." The pharmacist actually asked the lawmaker, but the doctors also did not give a clear answer. He stressed the need to prepare guidelines for refunds and inquiries. The MFDS has launched an investigation into the impurities of the Sartan hypertension drug and the anti-smoking drug Varenicline. Regarding the guidelines, Pfizer explained, "We are currently investigating the possibility of Nitrosamine impurities, so we are guiding you to consult with a doctor about whether to take them. It is said that it is difficult for pharmaceutical companies to express their position on the suspension or recommendation of medication because they have not received additional recommendations from regulators other than the suspension of supply. The official predicted that follow-up guidelines will be prepared based on the results of the inspection. "The risk of exposure to Nitrosamine from taking Varenicline is very low," a Pfizer headquarters spokesman said. "The benefits of taking drugs are better than the risks," he said.
Product
AZ-Pfizer vaccine mix is "confirmed safe and effective"
by
Jul 05, 2021 05:54am
With community pharmacists who have received their first vaccination of AstraZeneca’s COVID-19 vaccine awaiting their second jab with the Pfizer vaccine this month, the health authorities announced that there are no safety concerns regarding the ‘mix-and-match' of the vaccines. The authorities explained that though mild side effects were observed, no severe adverse events were reported after receiving the vaccine mix, therefore, there are no safety issues pertaining to mixing doses of the two vaccines. Guidelines with the said information was issued by the COVID-19 Vaccination Promotion Team in response to the safety concerns raised by some ahead of the ‘temporary mixed-dose inoculation’ that will be provided to the 76,000 people who are working in vulnerable facilities, flight attendants, healthcare workers, and essential workers that already received their 1st dose with the AstraZeneca vaccine from April to May. The move for this mix and match schedule passed deliberation of the Korea Advisory Committee on Immunization Practice (KAICP) with a review on the efficacy and safety of the mixed-dose vaccination to address the delay of the 835,000 vaccine doses that were initially scheduled to arrive by the end of June through the COVAX facility. In other words, the mixed two-dose schedule that uses the Pfizer vaccine as a second dose is a temporary measure decided upon in consideration of the current supply shortage. Community pharmacists under the age of 50 (born after January 1st, 1972) who already received their first vaccinations will have to receive their second shot with the Pfizer vaccine due to age restrictions that were set on using the AstraZeneca vaccine. However, pharmacists who are 50 years or older (born before December 31st, 1971) may receive the AstraZeneca vaccine if they desire. Reservations for the second dose are automatically made to the same institution at which the individual received their first dose, on the 7th day of the 11th week after his/her first vaccination. Individuals may change their vaccination date in the 11th-12th week period after their first vaccination. They may postpone the date by 1 week at most from the originally scheduled date, and it may not be pulled forwarded to an earlier date. “Other countries such as Germany, France, Canada, Norway, Sweden have been recommending mixing use of mRNA vaccines to those who were first vaccinated with the AstraZeneca vaccine. Also, the safety and efficacy of using the Pfizer vaccine as a second dose was confirmed in people who were first vaccinated with the AstraZeneca vaccine in Canada and Spain,” said the COVID-19 Vaccination Promotion Team. Studies from Spain and Germany have shown that vaccinating with the AstraZeneca-Pfizer mix showed a better immune effect with increased neutralizing activity against the COVID-19 variants than one or two shots of the AstraZeneca vaccine. The team added that a study on this mixed-dose vaccination is also currently underway in Korea and that the initial results will be shared in early July. Regarding the adverse events of the dose-mixing, the team added, “Dose-mixing studies abroad have shown that fever increased when the AstraZeneca vaccine was administered first and followed by Pfizer compared to when a same vaccine was administered both times. The results were also the same for the occurrence of mild adverse events such as fatigue, injection site pain, headaches, and muscle pain, but no serious abnormalities were confirmed." The inoculation schedule for the administration of the mixed second dose will follow the period set during the first vaccination. The mix currently planned is the 1st AstraZeneca-2nd Pfizer vaccine mix, and will be administered with an 11-12 week dosing interval according to the AstraZeneca vaccine’s dosing interval. People who must postpone receiving their second shot while following the AstraZeneca-AstraZeneca vaccine schedule are recommended to receive their shots within 16 weeks, which means the second dose should be administered from July 26th to July 31st. In cases where ‘an individual does not receive their second dose due to fear of mixing vaccines,’ the team said, “The second vaccination, as in the first vaccination, will be administered based on each individuals’ consent, so we cannot force an individual to vaccinate with a different vaccine if he/she is not comfortable receiving the AstraZeneca-Pfizer mix. Those who wish to receive the AstraZeneca vaccine rather than Pfizer’s may be able to receive their shots after August 1st, depending on the supply situation.”
Product
Sales prices have risen due to increased Tylenol demand?
by
Jung, Heung-Jun
Jun 23, 2021 05:54am
Pharmacists are upset when it is pointed out that pharmacies have raised the sales price of Tylenol due to increased demand for Tylenol. It is a misunderstanding that pharmacies are making great profits by raising prices unlike existing sales prices, which was actually a price change in some pharmacies due to differences in supply prices. Some media reported that the price of Tylenol, which was previously purchased at ₩2,000, rose due to the price adjustment due to the shortage. Recently, the price of Tylenol exceeded ₩2,000, forcing pharmacists to protest against the report. local pharmacist A also sent a protest mail to the media company, attaching a transaction statement with the unit price of supply. The unit price of pharmacies has already exceeded ₩2,000 (Pharmacist A said, "It is seriously distorted. Should consumers pay by credit card at ₩2,000, lower than the unit price supplied to pharmacies?" He said, "It further hurt pharmacists suffering from inappropriate comments on Tylenol." The supply price of 5 million tablets of Tylenol, which were recently divided into the first and second rounds, increased by about 10% compared to the supply price of individual pharmacies. Therefore, some pharmacies were adjusting their selling prices slightly. "As Tylenol is supplied equally across the country, the purchase price has risen slightly to pharmacies. Pharmacists are also unhappy about that," he said. "Some pharmacies have adjusted their sales prices and raised our pharmacies by ₩500 because they have already risen from the previous price." The first and second supplies to pharmacies nationwide will be distributed early this week. While 5 million tablets were supplied, Hangaram Pharmaceutical Co., Ltd., which is in charge of distribution, was not receiving any separate orders. With all the units supplied, Hangaram Pharmaceutical will resume its individual orders at pharmacies.
Product
Tylenol sales increased 10 times to peak in May
by
Jun 21, 2021 05:50am
Pharmacies' difficulties have reached their peak due to the surging demand for Tylenol, which is said to be "more precious than COVID-19 vaccine." This is because Tylenol has become so precious that it is rarely found in pharmacies. Then how popular was Tylenol? Analysis of POS data from 185 pharmacies showed that sales of Tylenol 500 mg and Tylenol ER 8HR increased 10 times compared to the beginning of this year. According to a survey of sales at 185 pharmacies, Care Insights recorded a peak in May after steadily increasing in March and April since the COVID-19 vaccination began on February 26. In particular, demand more than quadrupled compared to the average year in May. According to this year's sales, 12,467 in January, 12,222 in February, 20,756 in March, 29,447 in April and 54,340 in May. From January to May, 129,232 units were sold. Compared to 126,590 in 2018, 138,327 in 2019, and 173,687 in 2020, the company sold a year's worth in five months. The market share of Tylenol in Pharmacies was also overwhelming with 92.4%. Other APAP formulations accounted for only 7.6%. Considering that the average Tylenol sales share was 82.6% last year, the market share itself has risen further. An official from Care Insights said, "The more Tylenol is mentioned through the media, the more Tylenol sales tend to increase." The official said, "Although 100 to 200 Tylenols are supplied per pharmacy, this is believed to be the amount that can only be sold for about 15 days," and added, "As the vaccination rate is increasing, it seems necessary to come up with measures."
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