249 drug instructions have been revised since 2017

▍ 249 drug instructions have been revised since 2017, with an accelerated frequency trend Recently, the State Food and Drug Administration issued the notice of the State Food and Drug Administration on Revising the instructions of Xuesaitong injection and Xueshuantong injection (No 46, 2018), which is the 38th time since 2017 and the 22nd time since 2018 to half a year It can be seen that the frequency of the revision of the instructions is increasing Since 2017, a total of 38 batches of 249 drugs have been modified, mainly chemical drugs, mainly due to 132 drugs involved in the modification of the drug specifications of fluoroquinolones on July 5, 2017 Among them, there are 20 batches of 179 chemicals, 17 batches of 69 Chinese patent medicines, and 1 batch of 1 biological product But in 2018 alone, Chinese patent medicine is the main drug A total of 23 batches of 75 drugs were released, including 12 batches of 54 Chinese patent drugs and 10 batches of 20 chemical drugs It can be seen that in the future, the key target of the modification of the drug specification may be Chinese patent drugs, especially some products with large dosage, wide indications and taboos, and "unclear" or "no" adverse reactions From January 2017 to now, the revision announcement of the drug specification and the situation of the drug varieties involved are shown in the table below: Note: it is arranged according to the announcement of the State Food and Drug Administration for reference The revision of some drug instructions will greatly reduce the number of drug users, which will have an impact on the sales of pharmaceutical enterprises For example, Chaihu Injection has been used for children in the previous clinical practice, but it will be greatly affected if it is clear that it can not be used for children after the revision of the drug instructions There are also some drugs, such as Xuesaitong injection, which are forbidden for children, because these drugs are not used for children in clinic, so the impact is relatively small ▍ there are two main reasons for the revision of the drug Manual: disclosure of the drug Manual of Chinese patent medicine, which mainly includes drug ingredients, properties, usage and dosage, taboos, precautions, and substance interaction, etc.; description of chemical medicine mainly includes important scientific data, conclusions and information of safety and effectiveness, which are used to guide the safe and reasonable use of drugs All drug instructions shall fully contain the information of adverse drug reactions, and shall specify the adverse drug reactions in detail The network monitoring of adverse drug reactions is improved, and the old accounts are left over With the improvement of the national drug monitoring network, the feedback system of adverse drug reactions is constantly improved In the process of transformation and evaluation of many drugs whose original landmarks have been upgraded to national standards in China's drug registration, the quality safety and re evaluation of many drugs are lagging behind or missing, which leads to the "unclear" items in many drug descriptions and adverse reactions on the market at present, especially for Chinese patent drugs, the vast majority of drugs are "unclear" in these two columns " The State Drug Administration is working hard to solve the historical problem of arrears in the process of national drug review, and constantly improve the drug instructions ※ monitoring drug use risks and improving drug use safety According to the 2017 national ADR annual report, through the revision of the drug manual, the ADR information bulletin, the pharmacovigilance express and other announcements, the National Bureau analyzes and evaluates the ADR monitoring data through daily monitoring, weekly summary, quarterly analysis and other working mechanisms, deeply excavates drug risk signals, and takes corresponding risk management measures Measures At present, due to the lack of drugs for children, many drugs are used by children in half However, considering the safety of children's drug use, the State Food and drug administration clearly increased the requirements of "children's prohibition" for multiple drugs In addition, it may also be due to many objective factors during the pre marketing clinical research process, such as few cases, short research time, narrow age range of subjects, strict control of medication conditions, etc Therefore, there are defects and deficiencies in the discovery of adverse reactions of drugs, which will continue to improve with the increase of the number of drug users ▍ there are also a large number of drugs on the way of revision According to the revision trend of this year's drug specification, the focus is on traditional Chinese medicine injection, and the revision focuses on the content of drug interaction, taboo "not clear" or "not yet", and most of them are traditional Chinese medicine injection The author found that there was "no relevant information" or "not clear" in the column of drug interaction or taboo, and the adverse reactions of most traditional Chinese medicine injections were "not clear" through searching the product specifications of some injections with large market sales scale According to the national drug regulatory trend, these varieties will become the focus, and also the focus of the future revision of the drug specification Some key items of the manual that may need to be revised are as follows: Note: arrange according to the public information for reference Of course, it does not rule out that other drugs will also cause the modification of drug instructions due to new findings in the monitoring statistics of side effects after they are put on the market, or new use risks and warnings However, according to the trend over the past year, it is found that similar varieties in the above table will probably need to modify the instructions ▍ what should pharmaceutical companies do? It is only a new starting point for the approved marketing of drugs Pharmaceutical enterprises need to find out the problems in the follow-up clinical use, improve and improve the quality and efficacy of drugs, and standardize the clinical use of drugs To cope with the revision of drug specifications, pharmaceutical enterprises should mainly make efforts from the following aspects: first, to ensure the standardization, scientificity and preciseness of drug research and development process Only by ensuring the standardization, scientificity and preciseness of every stage and process in the process of drug research and development, can we ensure that there are no problems in the indicators of drugs and that they can be found in every column of the drug manual Only in every step of the R & D process, we can make sure that the preparation of the drug specification conforms to the principles and requirements of the preparation of the national drug specification, and that the specification is rigorous Only in this way can we avoid the possibility of mistakes and the revision of the specification after the drug is approved for marketing Second, we will earnestly and vigorously promote the reevaluation of drugs According to the latest academic level of pharmacy, from the main aspects of pharmacology, pharmaceutics, clinical medicine, drug epidemiology, pharmacoeconomics and drug policy, this paper makes a decision on whether the efficacy (effectiveness), adverse reactions (safety), drug use plan, stability and economics of drugs officially approved for marketing conform to the principle of safe, effective and economic rational drug use Scientific evaluation and estimation Instead of the so-called safety re evaluation made by some traditional Chinese medicine injections, it is only the evaluation of marketing nature, lacking convincing clinical tracking data Third, we should actively make preparations for the modification of the manual According to the safety and effectiveness records after the drug is put on the market, the drug manufacturing enterprises shall modify the instructions in time, and continuously improve the quality management of the whole life cycle of drugs For those with major quality risks confirmed, pharmaceutical enterprises shall timely revise the instructions and send risk warnings to medical users according to the requirements of regulatory authorities, and require strict inspection before use to prevent unqualified or defective drugs from being used for clinical treatment.