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Shortage of cheap drugs has eased this year. Most of the drugs are irreplaceable.

Time：2019-06-26 14:54:42 Source： Author：

Since this year, Shanghai, Shandong, Hunan, Guizhou and other places have announced that allopurinol, cytarabine, methotrexate, nitroglycerin, retinoic acid and other drugs are out of stock or in short supply. Recently, the cut-off of nitroglycerin has also attracted the attention of Premier Li Keqiang of the State Council. He urged that "we should ensure stable supply of commonly used medicines and first-aid medicines, never cut off goods and never willfully raise prices".The State Health and Health Commission and other departments jointly promulgated a series of policies to solve the problem of drug shortage and targeted drug supply. Recently, Beijing News reporters visited several online and offline pharmacies and found that the shortage of drugs has eased, but there are still individual drugs out of supply, and there is no alternative.

Nitroglycerin out of stock due to rising raw material prices

Since this year, the news of the disconnection and price increase of nitroglycerin has been frequently reported in newspapers. 100 tablets/bottles of nitroglycerin have risen from 4 yuan to 45 yuan. Many pharmacies are out of stock. Patients have to spend nearly 100 yuan to buy 25 tablets/bottles of imported drugs.

At the end of April, the Beijing Pharmaceutical Administration disclosed that the relevant departments had coordinated with pharmacies to purchase nitroglycerin tablets. Nearly 600 chain pharmacies in Beijing could buy nitroglycerin tablets.

However, a reporter from the Beijing News visited several substantive pharmacies in Beijing on June 22 to learn that the supply of nitroglycerin is still relatively tight, some pharmacies are out of stock, and some pharmacies are short of stock. The staff of Tongyudian, Beijing Renren Kangtai Pharmacy, located in Yizhuang, revealed that the store sells nitroglycerin from Beijing Yimin Pharmaceutical Industry, but it is out of stock at present. "When to arrive is uncertain and how much to arrive is uncertain. Generally, only a few bottles can be obtained at a time. Three bottles and eight bottles are all possible. They can be sold out very quickly, sometimes even bought by one person. The drugstore will continue to ask the manufacturer for goods and wait for distribution. The staff of Tongrentang Drugstore in Yizhuang Libao Square said, "There is only one box of nitroglycerin left", which is allocated to 10 boxes at a time and will soon be sold out.

Subsequently, the reporter of the new Beijing newspaper saw from the flagship stores of many pharmacies on the platform of a pharmacy network and a large pharmacy in the east of Beijing that nitroglycerin was basically in stock. Renhetang Pharmacy flagship store customer service said that despite the status of goods, but inventory will change at any time.

Since this year, the names of nitroglycerin have also appeared frequently in notifications of drug shortages in Gansu, Ningxia, Shanghai, Guizhou, Shandong and other places. For example, on April 26, Gansu Pharmaceutical Material Platform released 14 withdrawal of commonly used medicines due to production line transformation, rising costs, shortage of raw materials, including shortage of nitroglycerin, cytarabine and so on. The main reasons for the cut-off and increase of nitroglycerin supply and price are the rising price of raw materials, the small number of manufacturers, the tightening of environmental protection supervision and the shutdown and relocation of enterprises. Previously, the media reported that two pharmaceutical companies, Beijing Yimin Pharmaceutical Industry and Beijing Shunxin Xiangyun Pharmaceutical Industry, could not produce drugs until the new plant was put into use because of the removal of equipment and withdrawal from Shunyi. Hebei Medical University Pharmaceutical Factory and Shandong Xinyi Pharmaceutical Company are due to environmental factors in winter heating season and the tightening of purchasing channels of raw materials, resulting in a decline in production.

Shortage drugs such as allopurinol tablets are mostly irreplaceable

According to the information about drug shortage published in various places this year, besides nitroglycerin, it also includes cytarabine, allopurinol, methotrexate, mercaptopurine, mitomycin and so on. On February 21, Hunan Health and Health Commission issued a list of shortages of drugs in medical institutions in 2018, which showed that 24 kinds of drugs, including methotrexate and allopurinol tablets, were not replaced. By February this year, six of the unreplaceable drugs had been restored.

For example, Mitomycin for Injection, which had been discontinued for 18 months before, has invested tens of millions of yuan in developing reagents and submitting applications with the support of the State Health Commission and the State Administration of Pharmaceutical Supervision, and completed all pre-market approval procedures through the rapid approval green channel. It will be available on the market in August 2018. The price is also higher than before. However, the name of mitomycin appeared again in this year's drug shortage announcement issued by Guizhou and Shandong.

Another type of cytarabine for injection for hematological cancer treatment is due to Pfizer's announcement in early January of this year that the Italian manufacturer will stop working and repair, and its cytarabine injection aseptic powder (trade name "Cedessa") will be in short supply in some markets worldwide from January 2019. It is preliminarily expected that Cedessa will gradually resume supply after July of this year. Should. According to the PDB, Pfizer Sedessa accounts for more than 97% of the total cytarabine market.

According to the information of the State Pharmaceutical Administration, there are four production enterprises of cytarabine hydrochloride in China, including Haizheng Pharmaceutical Company, Lingnan Pharmaceutical Company, Leibotong Pharmaceutical Company and Slian Pharmaceutical Company. There are 11 batches of cytarabine hydrochloride for injection, which belong to six enterprises, including Chenxin Pharmaceutical Company, Furen Pharmaceutical Company, Haihui Pharmaceutical Company and Yixin Pharmaceutical Company.

Following Pfizer's announcement, the Pharmaceutical Department of the State Health and Health Commission issued a circular on 7 January on how to ensure the supply of cytarabine injections. The circular said that the National Office of the Consultative Linkage Mechanism for the Supply and Guarantee of Drugs in Shortage communicated with two domestic enterprises currently in production and would make every effort to maintain market supply. Since January, Yixin Pharmaceutical Co., Ltd. began to expand its production capacity and concentrate its efforts on supplying the market. Hanhui Pharmaceuticals also guarantees uninterrupted supply.

However, as initially anticipated, cytarabine still faces a tight supply. Cytarabine was listed in the second batch of shortage drug list issued by Guizhou Province on June 20.

Expert voice

"New prescriptions" are still needed to crack the shortage of cheap drugs

Since 2018, the State Health and Health Commission has taken a series of policy measures in conjunction with other departments to conduct joint investigation and Research on drug shortage, price increase and monopoly; strengthen consultation among departments to promote the establishment of a drug shutdown reporting system; strengthen monitoring, early warning and classified response to form a list of shortage-prone drugs requiring attention at the national level; and promote the concentration of shortage drugs. Production and reserve; cracking down on illegal practices, continuously strengthening price regulation in the pharmaceutical field, etc., to solve the supply of more than 100 kinds of drugs, such as protamine, mercaptopurine and so on.

On June 20, the State Health and Health Commission announced the first list of recommendations to encourage generic drug catalogues. Thiopurine and methotrexate tablets were among the 34 drugs in short supply.

Zeng Yixin, deputy director of the State Health and Health Commission, has pointed out that the State Health and Health Commission will continue to play the role of the linkage mechanism of consultation on shortage drug supply security and promote the establishment of a shortage drug supply security system. We should not only monitor and warn the shortage situation, but also establish a list, increase the effective supply of medicinal raw materials, promote market matching and the construction of centralized production bases for small varieties, and achieve stable production and supply of 100 kinds of small varieties of drugs by 2020. We will investigate and crack down on hoarding, monopolizing supply and deliberately raising market prices, and improve drug procurement policies and reserve mechanisms. Finally, we should further improve the ability of drug research and development and the capacity of imitation production, form a shortage of drug supply security system, and fundamentally solve the problem of drug shortage.

"Nowadays, the bidding price of cheap drugs and basic drugs is less than two or three years, or even four or five years before an adjustment is made. The environmental protection supervision factors, monopoly of raw materials and other factors lead to the increase of drug cost. The original bidding price is not applicable, the amount of hospital can not be guaranteed, and the pharmaceutical enterprises are unwilling to pay for it, so the cases of discontinuation of supply and rejection of bidding are frequent." Shi Lichen, founder of Beijing Dingchen Pharmaceutical Management Consulting Company, believes that in order to solve the problem of shortage of cheap drugs and basic drugs thoroughly, it is necessary to purchase drugs in a unified volume by the Medical Insurance Bureau in accordance with the "4+7" pilot city drug collection mode. At the same time, we should monitor the situation of hospital stocks to prevent the phenomenon of drug "out-of-supply" caused by the artificial factors that doctors do not like to prescribe low-cost drugs.

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Shortage of cheap drugs has eased this year. Most of the drugs are irreplaceable.