Note that this kind of over 100 million Chinese patent medicine specifications need to be revised!

[product information of chinapharma.com] on July 3, the State Food and Drug Administration issued a notice (No 42, 2018) (hereinafter referred to as the "notice") on Revising the instructions of Qingkailing injection and Yiqi Fumai (freeze-drying) for injection According to the announcement, in order to further ensure the safety of public drug use, the State Food and Drug Administration decided to add warning words to Qingkailing injection, Qingkailing for injection (freeze-drying) and Yiqi Fumai (freeze-drying) instructions for injection, and revise the contents of [adverse reactions], [contraindications] and [precautions] according to the evaluation results of adverse drug reactions   Among them, the [taboo] items of Qingkailing injection should include: those who are allergic to or have a history of serious adverse reactions to this product or bile acid, mother of Pearl (powder), Hyodeoxycholic Acid, gardenia, buffalo horn (powder), isatis root, baicalin, honeysuckle preparations and ingredients, those who are allergic or have a history of serious adverse reactions, newborns, infants, pregnant women, those who are allergic, those who have a history of family allergy, etc; Hypokalemia including a history of periodic paralysis associated with hypokalemia is prohibited The warning words to be added include: the adverse reactions of this product include anaphylactic shock, which should be used in the medical institutions with rescue conditions The user should have received the training of anaphylactic shock rescue If there is anaphylactic reaction or other serious adverse reactions after medication, the drug should be stopped immediately and treated in time According to the author's understanding, before that, the unreasonable use of Qingkailing injection has occurred repeatedly, and the tragedy caused by the unreasonable use of children's drugs has attracted the attention of the society On April 20, 2009, the former State Food and Drug Administration issued a document to guard against serious adverse reactions of Qingkailing injection Among them, in terms of Qingkailing injection for children, 27% of the dead patients were children under 14 years old Most of the children had the phenomenon of multiple groups of liquid and multiple drugs mixed infusion The infusion volume was large, and 2 of them died of ineffective rescue of left heart failure, which may be related to the large infusion volume and fast infusion speed In 2015, according to the national ADR monitoring annual report issued by the former State Food and drug administration, in 2015, the national ADR monitoring network received 127000 reports of traditional Chinese medicine injection, including 9798 serious reports (7.7%); in 2015, the proportion of injection was 51.3% Among the top five drugs reported, Qingkailing injection ranked first Others are Shenmai injection, Xuesaitong injection, Shuanghuanglian injection and Shuxuening injection In recent years, traditional Chinese medicine injection has become a serious disaster area, safe and reasonable use, scientific guidance is imminent The author found that since the establishment of the State Food and drug administration, Shenmai injection, Xuesaitong injection and Shuanghuanglian injection have been ordered to revise the instructions, and can only be used conditionally in hospitals above the second level in the 2017 new version of the medical insurance catalogue In this regard, some insiders also speculated that in the 2017 new version of the medical insurance catalog, 26 restricted Chinese patent medicines are all likely to be ordered to revise the drug instructions This also shows that the state attaches great importance to the safety of drug use, especially for children, which will further ensure the needs and interests of patients According to statistics, there are 7 well-known pharmaceutical enterprises in China involving over 100 million large varieties of Chinese patent medicine Qingkailing injection According to the announcement, relevant pharmaceutical enterprises shall report to the provincial food and Drug Administration for filing before August 31, 2018, and replace the ex factory drug instructions and labels within 6 months after the supplementary application for filing.