CCTV News:A few days ago, official website City, National Medical Products Administration issued an announcement to revise the instructions of Bupleurum Injection, in which "Children are forbidden" was added to the taboo. For people born in the middle and late 20th century, this is undoubtedly a kind of "emotional robbery" from childhood, so that when it is mentioned that "another commonly used drug for children has become a banned drug", many people may not remember that this drug was recommended for use because of its "few side effects", but they can always recall the "myth" of "going to the hospital with a fever, and getting an injection at their parents’ words" the disease will be cured ". … After the injection, I was still crying and being carried out of the hospital by adults.
Back to reality, Bupleurum injection will "quit" the ranks of antipyretic drugs for children. According to insiders, in pharmacy, banned drugs are the most stringent restrictions and must not be used. What does this mean? Some analysts said that this is a sign of progress, which is good from the perspectives of clinical safety, Chinese medicine supervision and economic benefits.
What are the reasons for the change from "commonly used drugs" to "prohibited drugs"?
In the 1940s, Bupleurum injection, as the world’s first traditional Chinese medicine injection, began to be used in clinic. At that time, during the Anti-Japanese War, drugs were scarce, and Bupleurum was boiled into decoction, which was further made into injection by decocting and distilling to treat fever caused by colds and malaria. In that special period, it played a certain role. According to insiders, "Bupleurum Injection" is a beneficial attempt of traditional Chinese medicine injection, but it is not a successful product.
As early as 2007, Bupleurum Injection was listed in the "List of Injections with Serious Adverse Reactions" by the State Food and Drug Administration. National Medical Products Administration requested to add warning words in the revision of the instruction manual of Bupleurum Injection. The contents should include: the adverse reactions of this product include anaphylactic shock, which should be used in medical institutions with rescue conditions. Users should be trained in anaphylactic shock rescue, and allergic reactions or other serious adverse reactions after taking the drug should be stopped immediately and treated in time. The report and monitoring of adverse drug reactions directly affect the use of drugs. An important job of hospital pharmacists is to observe, collect and sort out adverse reaction reports, and report them to the ADR monitoring center through the monitoring system at the first time. At the same time, through the analysis of the collected adverse reaction reports, preventive measures to prevent adverse reactions are put forward to ensure the safety of patients’ medication.
With the gradual improvement of drug management, the concept of disease treatment is also developing. In the past, it was said that "a shot will cure you", but now when you walk into the hospital, the slogan "You can take it orally without intramuscular injection, but you can inject it without infusion" can be seen in the fever clinics of hospitals at all levels. Insiders pointed out that at present, China’s drug use for special groups such as children and pregnant women is more strictly regulated. This is a matter of principle and is in line with international practice. At present, Bupleurum injection is widely available, safe and effective for children to reduce fever. Under the principle that it can be taken orally without intramuscular injection, it is reasonable for Bupleurum injection to be changed from a commonly used drug for children to a banned drug.
The proportion of injections in adverse drug reactions remains high. According to the National Annual Report on Adverse Drug Reaction Monitoring (2017), according to the statistics of drug administration routes, intravenous drug administration accounted for 61% of adverse drug reactions/events reports, up 1.3% over the previous year; The monitoring reports in recent two years show that injection accounts for more than 80% of the distribution of drug dosage forms involved in children’s adverse drug reactions/incidents reports. Re-evaluation of drugs after listing is undoubtedly the top priority.
What does the re-evaluation of traditional Chinese medicine injection reflect?
In the 1970s, there were more than a thousand kinds of traditional Chinese medicine injections, but there were quite a few or even the vast majority of basic research deficiencies and defects. This has also become one of the reasons for frequent adverse reactions of traditional Chinese medicine injection. In 1985, China implemented the Drug Administration Law, and the supervision of traditional Chinese medicine injections was gradually strengthened. Drugs with large side effects and low safety began to be phased out. By the 1990s, after rectification, the varieties of traditional Chinese medicine injections were 10 times lower than before — — There are more than 100 varieties. In view of the safety problems of more than 100 kinds of traditional Chinese medicine injections or stocks, in 2002 and 2006, National Medical Products Administration has been rectified twice.
The "2017 Drug Evaluation Report" released in March 2018 pointed out that the key work to be carried out in 2018 includes studying and starting the re-evaluation of traditional Chinese medicine injections and formulating the technical guiding principles for re-evaluation. It is worth mentioning that Jiao Hong, the director of National Medical Products Administration, who took office in March 2018, had been in charge of the field of medical devices for a long time. As soon as he took office, he intensively conducted research in the field of traditional Chinese medicine, and listened to the constructive opinions of relevant experts on the re-evaluation of traditional Chinese medicine injections, the supervision of traditional Chinese medicine decoction pieces and traditional Chinese medicine formula granules, and the proper handling of landmark upgrading to the national standard. Insiders pointed out that these directly refer to the problems left over from the history of traditional Chinese medicine.
In October 2017, the General Offices of the General Office of the Central Committee of the CPC and the State Council issued the Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices, proposing that the review and approval of pharmaceutical injections should be strictly enforced, and the listed pharmaceutical injections should be re-evaluated according to the progress of pharmaceutical science, so as to be basically completed in about 5 to 10 years. At that time, Bi Jingquan, the former director of the State Food and Drug Administration (now the Party Secretary of the State Administration of Markets), had to accelerate the evaluation of consistency of drug quality and efficacy, explore the methods of consistency evaluation of injection quality and efficacy, and start the re-evaluation of the safety and effectiveness of traditional Chinese medicine injections.
As early as July 2009, the State Food and Drug Administration issued a series of documents, such as "Notice on Doing a Good Job in Safety Re-evaluation of Traditional Chinese Medicine Injections", and started the re-evaluation of the safety of traditional Chinese medicine injections, which has achieved initial results.
Looking back on the road of "re-evaluation" of traditional Chinese medicine injections in recent 9 years, it can be described as twists and turns. According to insiders, the reason is nothing more than two points: high cost and lack of enthusiasm of pharmaceutical companies; It is difficult to implement and the working rules are not clear. In order to make the development of Chinese medicine industry more orderly and meet the people’s demand for drugs, we must persist in taking the people as the center, deepen the reform of the evaluation and approval system, and ensure that all reform tasks are put in place within the time limit.
Children’s safe drug use is a cliche. How to come up with new ideas?
Let’s go back to another protagonist of Bupleurum injection "Children are forbidden". There are 280 million children in our country, and the country is strong if the children are strong! Let children grow up healthily and happily, which is the greatest wish and expectation of every family, and also the foundation and support for the country to become prosperous and strong. We should always give priority to the healthy development of children and promote the priority supply of drugs for children.
At present, the current situation of children’s medication in China is as follows: among more than 6,000 pharmaceutical enterprises, there are only more than 10 enterprises specializing in the production of children’s medication, accounting for about 0.17%; There are more than 3,600 kinds of prescription drugs for adults, and only more than 60 kinds of special drugs for children, less than 1.7%; There are more than 176,000 drug approvals in China, but there are only more than 3,500 children’s drugs, accounting for only 2% of the total drug approvals.
The shortage of drugs for children is mainly affected by three factors: imperfect laws and regulations such as market access and price policy; Drug research and development is difficult, and children’s drug research and development is one of the most expensive, time-consuming and complicated fields in clinical trials, and it is difficult to recruit (children volunteers) for clinical trials; The market space is small.
The report of the 19th National Congress of the Communist Party of China proposed to improve the drug supply guarantee system. In view of the shortage of children’s drugs and the lack of research and development motivation, the state has also introduced a series of policies and measures. In the 2017 edition of the medical insurance drug list, 91 kinds of children’s drugs were added, and there were 540 drugs or dosage forms clearly suitable for children in the drug list; The priority evaluation system for children’s medication has been continuously improved, and the protection of children’s medication has been strengthened; In the State Council’s opinion on drug procurement, it is suggested that generic drugs for women and children can be directly purchased online without bidding, but these are far from enough.
To solve the problem of children’s drug shortage, some experts said that traditional Chinese medicine with relatively mild properties has become a new field of children’s drug research. Classic prescriptions, historical prescriptions and folk prescriptions have relatively exact effects on the treatment of children’s diseases and should be used scientifically and reasonably. In the government work reports of the two sessions this year, it is pointed out that it supports the inheritance and development of Chinese medicine. While inheriting ancient books, we should further promote the utilization and development of traditional Chinese medicine by means of modern science and technology. (Text/Zhang Ke)
