The new version of "Drug Administration Law" will be implemented. "Star drugs" in large hospitals can’t be sold online.

  "Star" hospital preparations were sold on the Internet, and "life-saving" medicines were in short supply, so it was difficult to distinguish the authenticity of traditional Chinese medicine … … In the future, these problems related to people’s "taking medicine" are expected to find a solution. On December 1st this year, the newly revised Drug Administration Law of People’s Republic of China (PRC) will be officially implemented. In the new version of "Drug Administration Law", a series of new policies have been introduced to ensure that people eat drugs more standardized and safely.

  Change one

  Online sales of hospital preparations will be illegal.

  The provisions of the new law: preparations prepared by medical institutions should be inspected for quality in accordance with regulations; Qualified, with a doctor’s prescription in this unit. With the approval of the drug supervision and administration department of the State Council or the drug supervision and administration department of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government, the preparations prepared by medical institutions can be used among designated medical institutions. Preparations prepared by medical institutions shall not be sold in the market.

  At present, due to the difficulty in finding a medicine or trying to save trouble, many merchants in Wechat business and Taobao have increased their prices to sell "star" hospital preparations in major hospitals online, and they have repeatedly banned them. In the interview, the reporter found that there are many kinds of in-hospital preparations sold online, such as "Fule Cream" used by the first child to treat eczema in children, diphenhydramine hydrochloride Cream used by Union Medical College Hospital for pruritic skin diseases, and "Chushi Pill" & HELIP; … It can be described as oral and external use, and everything is available.

  The "popular trauma cream" in the Third Hospital of Beijing Medical University was formerly called trauma massage cream, which is a kind of "star" preparation for external use in the Third Hospital of Beijing Medical University, and is mostly used for sports injuries and rheumatoid arthritis. Because of the good effect, many people rushed to the Third Hospital of Beijing Medical University for this medicine, and some even opened more than a dozen bottles. As a result, the hospital later had to limit the purchase of the drug, and each person could only open 2 bottles at a time. There is also the famous medicine "Brown Ammonium Mixture" made by Union Medical College Hospital, which has always been highly praised by many people: "This cough medicine, although it tastes bad, is more effective than other cough medicines."

  The new "Drug Administration Law" issued this time is undoubtedly a "prohibition order" for hospital preparations prepared by medical institutions.

  "The behavior of selling hospital preparations online is terrible and must be severely cracked down." Liu Qingquan, president of Beijing Association of Integrated Traditional Chinese and Western Medicine and president of Beijing Hospital of Traditional Chinese Medicine, said that hospital preparations should not and cannot be sold in the market. Because in-hospital preparations are not over-the-counter drugs, and not everyone can use them at will, they must be used in a standardized, scientific and reasonable way under the guidance of relevant experts in specific hospitals.

  "It is very likely that patients will blindly use hospital preparations in private." He said, for example, Dingtong Ointment, an in-hospital preparation for treating traumatic injuries in Beijing Hospital of Traditional Chinese Medicine, patients must use this external medicine according to the symptoms and scope of pain under the guidance of medical staff. Under different circumstances, the thickness and duration of application are different. If the patient applies the medicine for too long, it is likely to cover the skin, which will aggravate the condition after infection. Another example is the "Chushi Pill" developed by Zhao Bingnan, a leading dermatologist in Beijing Hospital of Traditional Chinese Medicine. This classic medicine for eczema may cause a series of problems such as diarrhea, abdominal pain and loss of appetite if people with spleen and stomach deficiency and cold take it.

  Liu Qingquan reminded the general public that hospital preparations can only be used after being diagnosed by doctors. He revealed that in the future, hospital preparations may be gradually converted into prescription drugs after further research, so that they can be circulated among major hospitals and convenient for patients to use.

  Change 2

  Take many measures to "ensure supply" of drugs in short supply

  Provisions of the new law: The state encourages the research and production of drugs in short supply, and gives priority to the review and approval of drugs in short supply urgently needed in clinic and new drugs for preventing and treating major infectious diseases and rare diseases. The State Council may restrict or prohibit the export of medicines in short supply. When necessary, relevant departments in the State Council can take measures such as organizing production, price intervention and expanding imports to ensure drug supply.

  Recently, it was reported that the commonly used drugs such as nitroglycerin tablets and allopurinol tablets for treating gout were once out of stock in Beijing, and many pharmacies could not find them anywhere. In fact, in recent years, there has been a shortage of drugs, especially cheap drugs.

  "To solve urgent problems quickly, a long-term mechanism must be established." In this regard, a pharmacist in a top-three hospital in this city said that the reasons for the shortage of drugs are very complicated. Although some drugs are not expensive, they are clinically necessary, but the profit-seeking characteristics of enterprises determine that they lack motivation to produce such cheap drugs; The supply of raw materials for some drugs is greatly affected by the seasons, which may cause shortages in a specific period. He bluntly said that it is very meaningful for the country to write the shortage of drugs into the legal provisions this time, especially the article "restricting or prohibiting the export of shortage drugs", which is very tough and also provides a guarantee for the supply of drugs.

  He suggested that in the future, a monitoring and early warning platform for the production and supply of short drugs should be established all over the country, and real-time dynamic monitoring of clinically short-lived drugs should be started from the production end and even the raw material end. At the same time, government departments can also require relevant pharmaceutical manufacturers to regularly submit the inventory of drugs, so as to warn the risk of drug shortage in advance and respond in time.

  Relevant government departments are also actively responding to the "New Drug Administration Law". The National Medical Insurance Bureau has also indicated that it will study the establishment of a record system for the suspension of production of medicines and APIs in short supply, and screen a number of medicines that are urgently needed in clinic and are prone to shortage in market supply to implement normal storage.

  Change three

  Ensure the traceability of Chinese herbal medicines

  The provisions of the new law: Chinese herbal pieces production enterprises fulfill the relevant obligations of drug marketing license holders, implement the whole process management of Chinese herbal pieces production and sales, and establish a traceability system for Chinese herbal pieces to ensure the safety, effectiveness and traceability of Chinese herbal pieces.

  There is a popular saying in the field of traditional Chinese medicine, "Good medicinal materials make good medicine". Chinese herbal medicine is the source of Chinese medicine, and it is also the foundation of industry development. The primary processing of Chinese herbal medicine is closely related to the processing of Chinese herbal pieces. Nowadays, there are many adulteration methods, such as dyeing, weight gain, sulfur fumigation and shoddy, which are used by some unscrupulous operators in pursuit of economic benefits.

  This time, "establishing the traceability system of Chinese herbal pieces" was formally written into the new version of the Drug Administration Law.

  "The same medicinal material, such as different places of origin, will have great differences in medicinal properties." Liu Qingquan said that Zhejiang Fritillaria and Sichuan Fritillaria, although both of them are Fritillaria, have different medicinal properties, which can be said to be completely different. There has been a saying that "one piece is worth one gold" since ancient times in Huazhou, Guangdong Province. The reason why the orange here is good is that the soil contains lapis lazuli, so the orange has a good expectorant effect. The orange in other places, compared with the orange, is much weaker.

  However, the medicinal materials are similar in appearance. How can ordinary people tell the authenticity of these Chinese medicinal materials?

  "The traceability system of Chinese herbal pieces is directly related to the quality of Chinese herbal medicines and the safety of people’s medication. This is a huge national project. From local governments, pharmaceutical companies, medical institutions, to the entire Chinese medicine industry, we should pay attention to this matter. " Liu Qingquan bluntly said that in the past, the prescriptions of old doctors all indicated the origin of traditional Chinese medicine, such as "Radix Codonopsis Lu, Sichuan Yalian, Sichuan Brocade Rhubarb" … … In the future, we should strive to realize that every Chinese medicine prescribed by doctors to patients has its own "ID card". In addition, the information codes of Chinese herbal medicines can be found by means of modern science and technology, and the origin of these Chinese herbal medicines can be known by simply scanning the codes, so that the sources of Chinese herbal medicines can be traced back.

  "At present, our hospital is exploring the traceability system together with relevant Chinese medicine experts." Liu Qingquan said that when Chinese herbal pieces are truly "traceable in source, verifiable in destination and accountable", Chinese herbal pieces will be truly brought into the scientific and standardized management system.

  Change four

  Chinese medicine will be more convenient to take.

  Provisions of the new law: The state encourages the use of modern science and technology and traditional Chinese medicine research methods to carry out scientific and technological research and drug development of Chinese medicine, establish and improve a technical evaluation system that conforms to the characteristics of Chinese medicine, and promote the inheritance and innovation of Chinese medicine.

  In the past, the classic Chinese medicine preparations commonly used by people, such as pills, powders, ointments and Dan, have great advantages, but they also have obvious disadvantages. With the rapid development of society, the soup is bitter and difficult to eat, and the black pill is even more difficult to swallow. There are also some external ointments that are smeared on the body in a dark place, and people can’t even go out after using the medicine … …

  "Chinese medicine must be integrated with modern science and technology in order to truly move towards a new era." Liu Qingquan said that with the legal basis, in the future, Chinese medicine experts can use modern scientific and technological means to form brand-new Chinese medicine preparations in accordance with the theoretical system of Chinese medicine, making Chinese medicine look good, delicious and easy to use. "Now there are many new dosage forms of traditional Chinese medicine, such as dropping pills, which concentrate the medicine into tiny dropping pills and have good curative effect; Another example is effervescent tablets. After adding corrective, Chinese medicine becomes better and more convenient to take. "

  "In the future, we can consider applying nano-wrapping technology in traditional Chinese medicine, that is, using different techniques to wrap different pharmaceutical ingredients, and designing the path, time and target of drug release in advance to accurately reach the disease." According to Liu Qingquan, according to the theory of meridian introduction of traditional Chinese medicine, ephedra belongs to the lung meridian, that is to say, drugs will act on the lungs, but affected by various factors, and there are not many drug components that eventually reach the lungs. With the advanced technology of nano-coating, the effective components of ephedra can reach the lungs of patients directly, and the efficacy is more accurate.

  Liu Qingquan said that the changes in the new version of the Drug Administration Law have brought more opportunities for the development of China’s pharmaceutical industry, but the relevant detailed rules and documents supporting the law should be implemented as soon as possible, otherwise the law may become a dead letter once it fails to land. (Reporter Liu Huan)