Another Chinese medicine injection instruction manual was modified!
Yesterday, the State Drug Administration issued an announcement saying that according to the results of adverse drug reactions and safety evaluation results, in order to further ensure the safety of the public’s medication, it was decided to add warnings to the Chaihu injection instructions, and to [adverse reactions] [taboo] [note] [note] Matters] Eliminate items to revise. Under the taboos, “children’s disable” must be listed.
Official website of the State Drug Administration
Warning: Children are disabled, the elderly and pregnant women use it with caution
Chaihu injection is the first Chinese medicine injection variety in the world. It was born during the Anti -Japanese War and has a history of 77 years. Earlier, Chaihu injection was mainly used for fever caused by colds, malaria, etc., which was an injecting medicine in the muscle. The medicine has always been a recommendation medicine for children’s cold and fever. In the “The Most Popular Pediatric Anti -fevering Drug List” circulating in the field, Chaihu injection is recommended on the grounds that “the heating effect is slow and weak, and the side effects are small”.
In the announcement issued by the State Drug Administration, the “adverse reaction” of Chaihu injection clearly increased 8 species, including allergic reactions, systemic reactions, and skin and its annexes, respiratory systems, cardiovascular systems, nerve spiritual spirit Adverse reactions of systems, digestive systems, medication sites, etc. In addition to the “contraindication] items must be listed in the” children’s disable “, the announcement also requires to add special groups such as the elderly, pregnant women, liver and kidney function abnormalities, and patients who use Chinese medicine injections for the first time. Strengthen monitoring “many items.
Ji Lianmei, the founder and well -known pharmacist of the public account of “Ask Pharmacist”, said that for children’s fever, she does not recommend using the injection method to relieve the symptoms.
The official website database of the State Drug Administration shows that there are currently 77 batches of Chaihu injection, involving 75 pharmaceutical companies. According to Mine.com data, in 2016, the sales of Chaihu injection in Chinese urban public hospitals, county -level public hospitals, urban communities, and township health centers terminals were 38.91 million yuan, an increase of 74.21%year -on -year. Now that the instructions are modified, the industry believes that it may have an impact on these more than 30 million markets.
Traditional Chinese medicine injection is frequently criticized
Public information shows that since the occurrence of Chaihu injection in 1941, in the following decades, the field of traditional Chinese medicine injection therapy has continued to expand, and the product types have emerged endlessly. In the 1980s, there were more than 1,000 Chinese medicine injections, and then gradually eliminated. In 2008, the white paper in the “China Drug Safety Supervision Status” published by the State Council News Office showed that there were 123 Chinese medicine injections on the market.
As a unique injection of injection injection in my country, compared with chemical drugs, due to the unclear material foundation, insufficient research, and inherently inherent reasons of injection types, lack of clinical effectiveness and safety data, pharmacological data as support as support It has been criticized.
According to the “Annual Report on the Monitoring of National Past China Pharmaceutical Reactions” from 2011 to 2016, the National Traditional Chinese Medicine Injection Bad Report Report in total is 677,000 cases. Among them, Qingkai Lingju, Shuanghuanglian injection, blood plug -in radiation, and thrombosis radiation agent are frequent customers in the adverse reaction report.
2011 to 2016 “Annual Report on the Monitoring of National Pharmaceutical Adverse Reactions”
Due to the “congenital insufficient” reasons, the “sequelae” of Chinese medicine injection significantly appeared, which also increased the attention of the security of traditional Chinese medicine injection to the new height.
In 2013, CFDA announced the new standards of 13 traditional Chinese medicine injection varieties such as ginseng injection, Shuanghuanglian injection, Chaihu injection, and Xiyanping injection, including the production of medicinal materials, prescriptions, and processes, and conducted daily spot checks.
In February 2017, the Ministry of Human Resources and Social Security announced the “Catalog of National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drugs (2017 Edition)”. The directory limited the traditional Chinese medicine injection commonly used in class 26 -only medical institutions above the second level or above could only be able use.
(Specific drugs include: double Huanglian injection/injection of double Huanglian (frozen dried), Qingkai spirit injection, lotus bidalize injection, thermal poisoning injection, Xiyanping injection, phlegm and heat cleansing, fish, fish, fish Alphabet injection, bitter yellow injection, ginseng injections, wake -up liquid injection, ginseng injection, raw pulse injection, Xiangdan injection, Sandium ginseng injection, Dan red injection, vein ratheron injection solution, veins, nobility injection solution, veins, and nobel injections, veins, and context injection, veins, and context injection, veins, and context injection, veins, and context injection, veins, and nobility, Safflower injection, bitter dish injection, injection for injection, vein polyphenolic acid, triple saponin injection preparation, lamp injection preparation, crown Xinning injection solution, blood dredging injection, ginkgo leaf injection preparation, melon skin injection fluid injection solution , Kidney Kang injection.)
National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 edition)
In addition to the use of some traditional Chinese medicine injections at the grassroots level, CFDA also conducts strict investigation of traditional Chinese medicine injection.
On September 23, 2017, CFDA posted a post, called Xiyan Ping injection liquid produced by Qingfeng Pharmaceuticals, and safflower injection produced by Zhendong Ant, Shanxi.
On November 28, 2017, the CFDA was fully revised to the Shengmai injection instructions. The raw pulse injection should increase the “allergic shock” warning, and add adverse reactions.
On April 28, 2018, the State Drug Administration issued an announcement on the amendment to the revised ginseng injection instructions, requiring the instructions to increase the “allergic shock” warning, and add adverse reactions.
Restarting traditional Chinese medicine injection and then evaluation is urgent
In fact, whether the safe injection of traditional Chinese medicine injections in 2006, the safety of Chinese medicine injection has become a public issue. In 2009, the state launched a special operation of the National Medicine Injection Safety Re -Evaluation, and was equipped with technical principles and evaluation standards. But unfortunately, this time I couldn’t evaluate it again. On October 9, 2017, Wu Yan revealed that when introducing the reform and approval of drug review and approval and encouraging innovation work: The country’s plan for the safety re -evaluation of traditional Chinese medicine injections has been initially formed. One step will formulate specific evaluation methods. At this point, the Chinese medicine injection is officially put on the agenda.
However, after eight years, it is still difficult to start the Chinese medicine injection again. Wu Yan bluntly stated that the Chinese medicine injection was evaluated “huge difficulty, much greater than ordinary preparations”. The difficulty is that it is necessary to study a scientific and reasonable evaluation method. “The design is five to ten years, maybe five years or ten years.”
“Injection, especially intravenous injection, is a high -risk agent, which must be strictly supervised.” In October 2017, the former director of the State Food and Drug Administration, currently the secretary of the Party Group and deputy director of the State Administration of Market Supervision and Management Bi Jingquan in the National Drug Administration TV Television Television Conference Emphasizing the re -evaluation of the injection, and “shouting” related pharmaceutical companies: “Who do this to do this early?”
On May 22 this year, Jiao Hong, director of the State Drug Administration, went to the Chinese Academy of Traditional Chinese Medicine to communicate with the opinions of experts on the supervision of Chinese medicine. At the meeting, experts from clinical, scientific research and industries discussed the reform of deepening drug review and approval systems, strengthened the supervision of traditional Chinese medicine, and re -evaluated Chinese medicine injections, Chinese medicine drinks and traditional Chinese medicine formula supervision, and properly handled landmarks to the national standards. Put forward constructive opinions.
Expert analysis means that the restart of the Chinese medicine injection and the evaluation of the work have been on the string.
Attachment: Revision Revisor of Chaihu Injection Line instructions
1. The warnings should be added, and the content should include:
The adverse reactions of this product include allergic shock. They should be used in medical institutions with rescue conditions. Users should receive an allergic shock rescue training. Allergic reactions or other serious adverse reactions must be discontinued immediately after medication.
2. [Bad reaction] item should be added to the following:
Allergic reactions: red or pale, rash, itching, difficulty breathing, palpitations, palpitations, purple stomachs, blood pressure decrease, allergic shock, allergic response, etc.
Separational reactions: chills, chills, fever, pain, fatigue, etc.
Skin and its attachments: It can express a variety of rash, mainly with urticaria and dermatitis.
Respiratory system: holding breath, shortness of breath, difficulty breathing, etc.
Cardiovascular system: palpitations, chest tightness, purple magpie, decreased blood pressure, etc.
Nervous mental system: dizziness, headache, numbness, dizziness, syncope, convulsions, blurred consciousness, etc.
Gastrointestinal: dry mouth, nausea, vomiting, abdominal pain, diarrhea, etc.
Drug sites: pain, rash, itching, local redness and swelling.
3. [Contraindications] items should include:
1. For those with allergies or serious adverse reactions in this product or the auxiliary materials listed in this product or the ingredients listed in the ingredients.
2. Children are disabled.
4. [Precautions] items should include:
1. The adverse reactions of this product include allergic shock, which should be used in medical institutions with rescue conditions. Users should receive an allergic shock rescue training. Allergic reactions or other serious adverse reactions must be discontinued immediately after medication.
2. Strictly use the functions specified in the pharmaceutical manual, and prohibit the use of super functional medication.
3. This product is an antipyretic antidote.
4. The usage of the usage of the use of the pharmaceutical manual strictly, especially pay attention to the non -dosage and continuous medication for a long time.
5. Before taking the medicine, you should carefully inquire about the situation of the patient, the history of medication, and the history of allergies. Those with a history of drug allergies or allergies should be used with caution.
6. Those who have a family allergies should be used with caution.
7. Improper preservation of this product may affect the quality of the medicine. Before medication, you should carefully check this product. It is found that the pharmaceutical liquid changes in the pharmaceutical characteristics such as turbidity, precipitation, color change, crystallization, and the bottle body with air leakage and cracks. Essence
8. It is strictly forbidden to mix compatibility and take care of them with caution. This product should be used separately, and taboo is used with other medicines.
9. Special groups such as elderly people, pregnant women, liver and kidney function abnormalities, and patients who use Chinese medicine injections for the first time should be used carefully to strengthen monitoring.
10. Strengthen drug monitoring. During the medication, the reaction should be observed closely, especially for 30 minutes. Discover abnormalities, stop the medicine immediately, and adopt active treatment measures to treat patients. (Finish)
Anti -fever Nechahu injection liquid banned children’s use (“Legal Evening News”)
In order to evaluate the “shouting” pharmaceutical company, Bi Jingquan revealed the direction of traditional Chinese medicine injection (Jianxian Bureau)