2021 National ADR Monitoring Annual Report Released

On March 20, the State Food and Drug Administration issued an announcement stating that in order to fully reflect the monitoring of adverse drug reactions in China in 2021, improve the level of safe drug use, and better protect the safety of public drug use, the National Adverse Drug Reaction Monitoring Center organized the compilation of "National Adverse Drug Reaction".
Response Monitoring Annual Report (2021)
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Chapter 1 Monitoring of Adverse Drug Reaction In 2021, the National Adverse Drug Reaction Monitoring Center, under the leadership of the State Drug Administration, will thoroughly implement the decisions and deployments of the Party Central Committee and the State Council, and take General Secretary Xi Jinping's "four strictest" requirements as the Follow the fundamental principles, carry out the monitoring and evaluation of adverse drug reactions, gradually improve the monitoring and evaluation system, gradually improve the laws and regulations, steadily improve the number and quality of reports, more mature monitoring and evaluation methods and methods, and achieve obvious results in various tasks, providing scientific research for drug supervision.
Strong support to effectively protect and promote public health
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The first is to strengthen the layout plan and promote system and capacity building
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Promote the implementation of the General Office of the State Council's "Implementation Opinions on Comprehensively Strengthening Drug Regulatory Capacity Building" and "The State Food and Drug Administration's Opinions on Further Strengthening the Monitoring and Evaluation System and Capacity Building for Adverse Drug Reaction", speed up the construction of a "one body and two wings" work pattern, and continuously improve monitoring Evaluation system and continuous improvement of monitoring and evaluation capabilities
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The second is to improve the legal system and introduce supporting technical specifications
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Published China's first "Pharmacovigilance Quality Management Standard", completed the drafting and solicitation of "Guidelines for Pharmacovigilance Inspection" and "Guidelines for Writing Pharmacovigilance System Master Documents", and instructed drug marketing authorization holders (hereinafter referred to as holders) to carry out monitoring, Report, analyze and evaluate work, and promote the establishment and improvement of the pharmacovigilance system
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The third is to scientifically analyze and evaluate, and play a role in technical support
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Pay close attention to domestic and foreign regulatory developments, and strengthen monitoring data analysis and evaluation
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According to the evaluation results, timely release drug safety warning information
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In 2021, 2 announcements on the cancellation of the registration certificates of medicines such as Pediatric Phenol Amicamin Granules will be released, and 48 announcements on the revision of drug instructions will be released
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Fourth, effectively monitor risks to ensure the overall situation of epidemic prevention and control
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Strictly implement the normalized epidemic prevention and control measures, continue to strengthen the monitoring, analysis and evaluation of new coronary pneumonia prevention and treatment drugs, closely follow the drugs listed in the "New Coronavirus Pneumonia Diagnosis and Treatment Plan", and focus on relevant early warning signals, mass incidents and bad drugs Respond to reports and effectively ensure the safety of drugs for epidemic prevention and control
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Fifth, optimize the information system to help the development of monitoring and evaluation
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Completed the construction of E2B (R3) electronic data management system, and realized the functions of online reporting and extensible markup language format file submission in multiple ways
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Improve the national adverse drug reaction monitoring information system, improve the efficiency of data analysis, and improve the efficiency of monitoring and evaluation
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Chapter 2 Adverse Drug Reaction/Event Reporting 2.
1 Overall Report 2.
1.
1 2021 Adverse Drug Reaction/Event Reporting In 2021, the National Adverse Drug Reaction Monitoring Network received 1.
962 million copies of the Adverse Drug Reaction/Event Reporting Form
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From 1999 to 2021, the National Adverse Drug Reaction Monitoring Network has received a total of 18.
83 million copies of the Adverse Drug Reaction/Event Report Form (Figure 1)
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Figure 1 Growth trend of the number of adverse drug reaction/event reports in the country from 1999 to 2021 2.
1.
2 New and serious adverse drug reaction/event reports New and serious adverse drug reaction/event reports received by the national adverse drug reaction monitoring network in 2021 597,000 reports; new and serious adverse drug reaction/event reports accounted for 30.
4% of total reports during the same period
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In 2021, the National Adverse Drug Reaction Monitoring Network received 216,000 serious adverse drug reaction/event reports, accounting for 11.
0% of the total number of reports during the same period (Figure 2)
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Figure 2 Proportion of new and serious and serious adverse drug reaction/event reports from 2004 to 2021 Tips: How to correctly understand adverse drug reaction reports? Adverse drug reactions refer to the harmful reactions of qualified drugs that are not related to the purpose of drug use under normal usage and dosage.

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Adverse drug reactions are inherent properties of drugs.
Generally speaking, all drugs will have more or less, or mild or serious adverse reactions
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Adverse drug reaction monitoring is an important support for the safety supervision of drugs after the market, and its purpose is to detect and control drug safety risks in a timely manner
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Holders, operating enterprises, and medical institutions shall report adverse drug reactions found, and the state encourages citizens, legal persons and other organizations to report adverse drug reactions
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Through the efforts of all parties, the enthusiasm of holders, operating enterprises, and medical institutions to report adverse drug reactions has gradually increased, and the number of adverse drug reaction reports in China is generally on the rise
.
The ratio of serious adverse drug reaction/event reports is one of the important indicators to measure the overall quality and availability of reports.
The monitoring and evaluation of adverse drug reactions has always focused on the collection and evaluation of new and serious reactions
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The number of new and serious adverse drug reaction reports, especially the high number of serious adverse drug reaction reports, does not mean that the level of drug safety is declining, but means that the regulatory authorities have more and more comprehensive information, and have a better understanding of the risks of drugs.
Controllable, more evidence-based evaluation of drugs, and more accurate regulatory decisions
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Similarly, in medical practice, being able to understand the manifestations and extent of adverse drug reactions in a timely manner and avoid them to the greatest extent is also an important measure to ensure patient medication safety
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2.
1.
3 Average number of reports per million population The average number of reports per million population is one of the important indicators to measure the level of ADR monitoring in a country
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In 2021, the average number of reports per million population in China will be 1,392
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2.
1.
4 County-level reporting ratio of adverse drug reactions/events The county-level reporting ratio of adverse drug reactions/events is one of the important indicators to measure the balanced development and coverage of adverse drug reaction monitoring in China
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In 2021, 98.
0% of county-level regions nationwide reported adverse drug reactions/events
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2.
1.
5 Sources of Adverse Drug Reaction/Event Report Holders, operating companies and medical institutions are responsible for reporting adverse drug reactions
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According to report sources, in 2021, reports from medical institutions accounted for 86.
3%; reports from operating companies accounted for 9.
4%; reports from holders accounted for 4.
1%; and reports from individuals and other reporters accounted for 0.
2% (Figure 3)
.
Figure 3 Sources of ADR/Event Reports in 2021 According to the number of reports, a total of 81,000 ADR/Event reports will be submitted by holders in 2021, a year-on-year increase of 22.
3%
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Among them, new and serious adverse drug reaction/event reports accounted for 34.
7% of the total number of holder reports, which was higher than the proportion of new and serious adverse drug reaction/event reports in the overall report
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2.
1.
6 Occupation of reporters According to the occupational statistics of reporters, doctors accounted for 55.
6%, pharmacists accounted for 25.
5%, nurses accounted for 13.
0%, and other occupations accounted for 5.
9% (Figure 4)
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Figure 4 Occupational composition of reporters in 2021 2.
1.
7 The patients involved in adverse drug reaction/event reports In 2021, there are more women than men in adverse drug reaction/event reports, with a sex ratio of 0.
86:1
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In terms of age distribution, children under the age of 14 accounted for 8.
4%, and elderly patients aged 65 and over accounted for 31.
2% (Figure 5)
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Figure 5 2021 Adverse Drug Reaction/Event Report Involving Patient Age were 3.
0% (Figure 6)
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Figure 6 2021 Adverse Drug Reaction/Event Report Involving Drug Category Statistics by route of administration, in 2021 adverse drug reaction/event reports, injection administration accounts for 55.
3%, oral administration accounts for 37.
9%, and other administration routes account for 6.
8%
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Among the injections, intravenous injections accounted for 90.
5%, and other injections accounted for 9.
5% (Figure 7)
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Figure 7 Adverse drug reactions/events reported in 2021 involving routes of administration 2.
1.
9 Adverse drug reactions/events involving organ systems Among the adverse drug reactions/events reported in 2021, the top 3 organ system involvements were gastrointestinal diseases , skin and subcutaneous tissue diseases, systemic diseases and various reactions at the administration site
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Figure 8 Adverse drug reactions/events involving organ systems in 2021 2.
2 Monitoring of chemical drugs and biological products 2.
2.
1 Overall situation In 2021 adverse drug reactions/events reports, 2.
104 million suspected drugs were involved, of which chemicals accounted for 82.
0%, Biological products accounted for 2.
0%
.
In 2021, serious adverse reaction/event reports involved 278,000 suspected drug cases, of which chemical drugs accounted for 87.
7% and biological products accounted for 4.
3%
.
2.
2.
2 Involved patients In the 2021 adverse reaction/event report of chemical drugs and biological products, the ratio of male to female patients was 0.
87:1, and there were more females than males
.
Reports from pediatric patients under 14 years of age accounted for 8.
6%, and reports from elderly patients aged 65 years and older accounted for 31.
4%
.
2.
2.
3 Drugs Involved Among the chemical drugs involved in the 2021 ADR/Event Report, the top 5 categories in terms of number of cases are anti-infective drugs, tumor drugs, cardiovascular system drugs, analgesics, and digestive system drugs
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Among the serious adverse drug reactions/events involving chemical drugs in 2021, the largest number of reports were oncology drugs, accounting for 33.
2%; followed by anti-infective drugs, accounting for 28.
1%
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According to the proportion of serious reports in this category of reports, the proportion of serious reports of oncology drugs is the highest, at 43.
0%, followed by exercise system drugs, at 19.
9%
.
Among the biological products involved in adverse drug reaction/event reports in 2021, cytokines accounted for 71.
7%, antitoxin and immune serum accounted for 16.
0%, blood products accounted for 0.
8%, and diagnostic biological products accounted for 0.
2%
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According to dosage form statistics, in the 2021 chemical drug adverse reaction/event reports, the proportions of injections and oral preparations were 59.
5% and 34.
8%, respectively, and other dosage forms accounted for 5.
7%
.
Among biological products, injections and oral preparations accounted for 83.
5% and 0.
2% respectively, and other preparations accounted for 16.
3%
.
2.
2.
4 Analysis of the overall situation There is no significant change in the reporting of adverse reactions/events of chemical drugs and biological products in 2021 compared with 2020
.
In terms of the age of the patients involved in adverse reactions, the proportion of children under the age of 14 continued the downward trend of last year, but the decline has slowed down, and the safety of children's medication is still generally good; Clinical attention should be paid to the safety of medication in elderly patients
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From the perspective of pharmaceutical dosage forms, the proportion of injections is still on a downward trend, and the risk is further reduced
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In terms of drug categories, the number of reports of anti-infective drugs ranks first, and its proportion has been declining for ten consecutive years.
The rational use of anti-infective drugs has shown obvious effects; the proportion of anti-infective drugs continues to rise, and its proportion of serious reports ranks first.
This suggests that the clinical need to continue to strengthen the risk management of such drugs
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The proportion of biological products reported has increased, and the proportion of cytokines has increased relatively prominently, which is mainly related to the rapid increase in the number of new types of PD-1/PD-L1 oncology drugs listed in recent years and the inclusion of some varieties in the medical insurance catalog
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Tips: Adverse reactions of PD-1/PD-L1 new tumor drugs PD-1/PD-L1 immunotherapy is a new anti-cancer therapy in addition to conventional surgery, radiotherapy and chemotherapy and targeted therapy.

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Programmed cell death receptor-1 (PD-1) and its ligand (PD-L1) inhibitors are new anti-tumor drugs developed in the past two years.
T cells can perform normal immune function, recognize tumor cells and eliminate them
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In 2018, China approved the first PD-1 antitumor drug, nivolumab, and more than ten PD-1/PD-L1 products have been launched in the following three years, such as toripalimab, sindili Monoclonal antibody, camrelizumab, atezolizumab, etc.
, and some varieties have also entered the medical insurance catalog
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While the clinical dosage of PD-1/PD-L1 drugs has increased, their safety has also attracted people's attention
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According to the results of meta-analysis of clinical studies published in authoritative journals, common and occasional adverse reactions of PD-1/PD-L1 drugs include fatigue, itching, diarrhea, rash, nausea, decreased appetite, anemia, and dyspnea
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Adverse reactions related to immunotherapy that should be paid attention to clinically include pneumonia, elevated liver enzymes, hypothyroidism/hyperthyroidism, adrenal insufficiency, hypophysitis, etc.
Some of them may be life-threatening and require active medical treatment
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The incidence of adverse reactions and the risk of serious adverse reactions of oncology drugs are higher than those of other types of drugs, but they can save or prolong the lives of patients
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Patients should understand the adverse reactions and treatment measures of anti-tumor drugs, and cooperate with doctors to actively treat and rationally use drugs, so as to obtain the greatest health benefits
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2.
3 Monitoring of traditional Chinese medicines 2.
3.
1 General situation In 2021, the adverse drug reaction/event reports involved 2.
104 million cases of suspected drugs, of which traditional Chinese medicine accounted for 13.
0%; the serious adverse drug reaction/event reports in 2021 involved 278,000 cases of suspected drugs, of which Traditional Chinese medicine accounted for 5.
1%
.
2.
3.
2 Involved patients In the 2021 TCM adverse reaction/event report, the ratio of male to female patients was 0.
81:1
.
Children under the age of 14 accounted for 5.
7%, and elderly patients aged 65 and over accounted for 29.
3%
.
2.
3.
3 Involving Drugs Among the traditional Chinese medicines involved in adverse drug reaction/event reports in 2021, the top 5 categories in terms of number of cases are the drugs for promoting blood circulation and removing blood stasis in Lixueji (24.
5%), and the heat-clearing and detoxifying drugs in Qingreji (11.
7%).
%), heat-clearing and dehumidifying herbs (7.
1%), wind-dispelling and dampness-dispelling herbs (5.
2%), and qi-nourishing and yin-boosting herbs (4.
9%)
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In 2021, the top 5 categories in the number of reported cases of serious adverse reactions/events of traditional Chinese medicine are blood-relieving agents (39.
0%), nourishing qi and nourishing yin (10.
7%), and heat-clearing agents.
Antidote (8.
6%), orifice-relieving agent Zhongliang herbal medicine (6.
4%), nourishing agent Zhongliang medicine (4.
2%)
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In 2021, the reports of adverse reactions/events of traditional Chinese medicines were counted according to the route of administration, with injection administration accounting for 27.
5%, oral administration accounting for 60.
5%, and other administration routes accounting for 12.
0%
.
Among the injections, intravenous injections accounted for 97.
2%, and other injections accounted for 2.
8%
.
2.
3.
4 Analysis of the overall situation Compared with 2020, the number of reports of adverse reactions/events of traditional Chinese medicine in 2021 will increase, but the proportion of serious reports will decrease
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In terms of administration route, the proportion of injection administration decreased significantly
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In terms of drug categories, the number of reports of drugs for promoting blood circulation and removing blood stasis still ranks first, but the proportion has decreased slightly
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From the overall situation, the proportion of traditional Chinese medicine in the total adverse reaction/event reports in 2021 will show a downward trend, but it is still necessary to pay attention to safe drug use
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Tips: Why do Chinese medicines cause adverse reactions? "It is a medicine with three points of poison", Chinese medicine, like other medicines, may also produce certain adverse reactions while playing a therapeutic role
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Syndrome differentiation and treatment is the basic principle of TCM to recognize and treat diseases.
The use of traditional Chinese medicines in strict accordance with the functions and indications specified in the instructions will help reduce and avoid the occurrence of adverse reactions/events
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However, if the principle of TCM treatment based on syndrome differentiation is not followed, or if the syndrome differentiation is inappropriate, and the function of the main drug is taken off-label, the risk of adverse reactions/events of TCM may increase.

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With the improvement of the level of awareness, the clinical use of traditional Chinese medicine has become more and more extensive, and the adverse reactions of traditional Chinese medicine should also be paid attention to
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2.
4 Monitoring of essential medicines 2.
4.
1 General situation of national monitoring of essential medicines In 2021, the National Adverse Drug Reaction Monitoring Network received a total of 946,000 reports of adverse reactions/events of the varieties included in the National Essential Medicines List (2018 Edition), of which serious There were 113,000 reports, accounting for 11.
9%
.
The reports involved chemical drugs and biological products accounted for 88.
6%, and Chinese patent medicine accounted for 11.
4%
.
2.
4.
2 Analysis of the situation of national essential medicinal chemicals and biological products There are a total of 417 (category) varieties of chemical drugs and biological products in the National Essential Medicines List (2018 Edition)
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In 2021, the National Adverse Drug Reaction Monitoring Network received a total of 897,000 reports of adverse drug reactions/events of national essential medicinal chemicals and biological products, of which 135,000 were serious reports, accounting for 15.
0%
.
In 2021, the national basic medicinal chemicals and biological products adverse reactions/events reports are counted according to drug categories, and the top 5 reports are antimicrobial drugs, cardiovascular system drugs, anti-tumor drugs, hormones and endocrine-influencing drugs, and therapeutic spirit.
Obstructive drugs; the top 5 involved organ systems are gastrointestinal system diseases, skin and subcutaneous tissue diseases, various nervous system diseases, systemic diseases, various reactions at the administration site, and various examinations
.
2.
4.
3 Analysis of National Essential Medicines Chinese Patent Medicines The National Essential Medicines List (2018 Edition) involves a total of 268 varieties of Chinese patent medicines
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In 2021, the National Adverse Drug Reaction Monitoring Network received 115,000 reports of adverse reactions/events of national essential medicines and proprietary Chinese medicines, of which 5,950 were serious reports, accounting for 5.
2%
.
In 2021, among the 7 major categories of Chinese patent medicines as national essential medicines, the total number of adverse drug reactions/events reported in descending order are internal medicine, orthopedics, gynecology, surgery, otolaryngology, pediatrics, and ophthalmology.

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The above monitoring data show that the overall situation of national essential drug monitoring in 2021 will basically remain stable
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Tips: Varieties included in the National Essential Medicines List (2018 Edition) From November 1, 2018, China officially launched the National Essential Medicines List (2018 Edition)
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The catalog is mainly divided into three parts: chemical drugs and biological products, Chinese patent medicines and Chinese herbal decoction pieces
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Among them, chemical drugs and biological products include 26 types of drugs such as antimicrobial drugs, antiparasitic drugs, and anesthetics, and Chinese patent medicines include 7 categories of drugs such as internal medicine, surgical medicine, and gynecological medicine
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Compared with the 2012 version of the Essential Drug List, a total of 187 drugs were transferred to the 2018 version of the Essential Drug List, and 22 were transferred (17 of which were chemical drugs).
417 kinds and 268 kinds of Chinese patent medicines
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Chapter 3 Relevant Risk Control Measures According to the 2021 adverse drug reaction monitoring data and analysis and evaluation results, the State Drug Administration will promptly take corresponding risk control measures for drugs with potential safety hazards to ensure the safety of public medication
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Announcement 2 of the cancellation of the registration certificates of 10 varieties of medicines such as Xiaoer Phenol Aminocamin Granules and Amfecca Tablets was issued
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Published a total of 48 announcements on the revision of drug instructions such as Dahuoluo preparations, sulfasalazine preparations, and methimazole preparations, and added or improved the warnings, adverse reactions, precautions, contraindications and other safety information in the instructions of 74 (categories) varieties.

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Published 12 issues of "Pharmacovigilance Express", reporting 52 foreign drug safety information
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Chapter 4 of the monograph analyzes the adverse reaction reports of anti-infective drugs, cardiovascular system drugs, metabolism and endocrine system drugs, and injections according to the monitoring results of adverse drug reactions and public concerns, and suggests the safety risks as follows: 4.
1 Anti-infective drugs Monitoring of adverse reactions Anti-infective drugs refer to drugs that have the effect of killing or inhibiting various pathogenic microorganisms, including antibiotics, synthetic antibacterial drugs, antifungal drugs, antiviral drugs, etc.
It is one of the most widely used clinical drug categories.
The number of reports of adverse reactions/events has always ranked first, and is the focus of monitoring of adverse drug reactions
.
In 2021, the national adverse drug reaction monitoring network received a total of 551,000 anti-infective drug adverse reaction/event reports, of which 62,000 were serious reports, accounting for 11.
2%
.
The number of anti-infective drug adverse reaction/event reports accounted for 28.
1% of the total number of reports in 2021
.
4.
1.
1 Drugs involved The top 3 drug categories in the number of anti-infective drug adverse reactions/event reports in 2021 are cephalosporins, quinolones, and macrolides, and the top 3 serious adverse reactions/event reports The top drug categories are cephalosporins, quinolones, and anti-tuberculosis drugs
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In the 2021 adverse reaction/event reports of anti-infective drugs, injections accounted for 76.
3%, oral preparations accounted for 19.
8%, and other dosage forms accounted for 3.
9%; compared with the overall reported dosage form distribution of drugs, the proportion of injections was high
.
Of the serious adverse reaction/event reports, injections accounted for 78.
6%, oral formulations accounted for 20.
1%, and other formulations accounted for 1.
3%
.
4.
1.
2 Involvement of Organ System In the 2021 anti-infective drug adverse reactions/events reports, the overall and serious reported adverse drug reactions/events involving organ systems are shown in Figure 9
.
Compared with the overall reports of anti-infective drugs, the proportion of serious reports of systemic diseases and various reactions at the administration site, immune system diseases, respiratory system, thoracic and mediastinal diseases is significantly higher.

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Figure 9 In the overall report of adverse drug reactions/events involving anti-infective drugs involving organ systems in 2021, the top 5 organ systems involved in oral preparations were gastrointestinal diseases, skin and subcutaneous tissue diseases, various Nervous system diseases, hepatobiliary system diseases, systemic diseases and various reactions at the administration site; the top 5 organ systems involved in injections are skin and subcutaneous tissue diseases, gastrointestinal system diseases, systemic diseases and various drug administration sites.
Reaction, various neurological diseases, immune system diseases
.
In the serious adverse drug reaction/event reports of anti-infective drugs, the top 5 organ systems involved in oral preparations are skin and subcutaneous tissue diseases, hepatobiliary system diseases, various examinations, metabolic and nutritional diseases, and gastrointestinal system diseases; injections involved The top 5 organ systems are skin and subcutaneous tissue diseases, systemic diseases and various reactions at the administration site, immune system diseases, gastrointestinal system diseases, and various examinations
.
4.
1.
3 Monitoring situation analysis and safety risk reminder In recent years, the proportion of anti-infective drug adverse reaction/event reports in the overall report has shown a continuous downward trend.
The number is still high, suggesting that the risk of using anti-infective drugs should continue to be concerned
.
Tips: What should be paid attention to in clinical use of azlocillin sodium for injection? Azlocillin is a semi-synthetic broad-spectrum penicillin with a similar antibacterial mechanism to penicillin
.
As with other penicillins, patients receiving azlocillin sodium for injection are at risk of severe allergic reactions, including anaphylactic shock, which can lead to death
.
Allergic reactions are more likely to occur in patients with a history of penicillin allergy and/or allergy to multiple allergens, patients with a history of significant allergies and/or asthma (allergies such as asthma, eczema, hay fever, urticaria, etc.
) history of sexually transmitted diseases) should be used with caution
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Intravenous azlocillin in high doses or in patients with severe renal insufficiency may cause neurotoxic effects, including hyperreflexia, myoclonic convulsions, convulsions, and coma
.
In addition, this product should be used immediately when used clinically, and should not be placed or used in combination with other drugs.
The infusion set should be replaced when it is used sequentially with other drugs
.
4.
2 Monitoring of adverse drug reactions in the cardiovascular system Drugs in the cardiovascular system refer to drugs used for the treatment of heart disease, vascular protection, blood pressure and blood lipid regulation, including hypotensive drugs, antianginal drugs, vasoactive drugs, and anti-atherosclerotic drugs , antiarrhythmic drugs, cardiotonic drugs and other cardiovascular system drugs
.
In recent years, the number of reports of adverse drug reactions/events in the cardiovascular system and the proportion of serious reports have shown an upward trend, suggesting that more attention should be paid to the risks of such drugs
.
In 2021, the National Adverse Drug Reaction Monitoring Network received a total of 186,000 adverse reaction/event reports of cardiovascular system drugs, accounting for 9.
5% of the overall reports; of which 11,129 were serious reports, accounting for 6.
0%
.
4.
2.
1 Involving drugs The top 3 drug categories in the number of reports of adverse reactions/events of cardiovascular system medication in 2021 are blood pressure lowering drugs, anti-angina pectoris drugs, and anti-atherosclerotic drugs; the number of serious reports of cardiovascular system drugs ranks top The third-ranked drug category is anti-atherosclerotic drugs, antihypertensive drugs, and antianginal drugs
.
In 2021 adverse drug reaction/event reports of cardiovascular system drugs, injections accounted for 29.
4%, oral preparations accounted for 69.
3%, and other dosage forms accounted for 1.
3%; in serious reports, injections accounted for 40.
2%, oral preparations accounted for 58.
5%, and other dosage forms accounted for 1.
3%
.
4.
2.
2 Involvement of Organ Systems In the 2021 adverse drug reaction/event report of the cardiovascular system, the top 5 organ systems involved in oral preparations are various nervous system diseases, gastrointestinal system diseases, systemic diseases and various drug administration sites.
Reaction, respiratory system, thoracic and mediastinal diseases, skin and subcutaneous tissue diseases; the top 5 organs involved in injections are various nervous system diseases, gastrointestinal system diseases, skin and subcutaneous tissue diseases, systemic diseases and administration sites Various reactions, heart disease (Fig.
10)
.
Figure 10 Cardiovascular system adverse drug reactions/events involving organ systems in 2021 4.
2.
3 Monitoring situation analysis and safety risk prompts In 2021 cardiovascular system adverse drug reactions/events reports, the proportion of oral preparations was significantly higher than that of injections, suggesting that Cardiovascular adverse reactions/events are reported more from the oral route of administration
.
In the reports of serious adverse reactions/events, the top two reported atorvastatin and rosuvastatin are statins.
for the prevention of such diseases
.
In addition, it cannot be ruled out that there are situations caused by unreasonable and irregular use and drug interactions, suggesting that medical staff and patients should pay attention to the risks of such drugs
.
Tips: What should patients pay attention to when using statins? Statins are 3-hydroxy-3-methylglutaryl-CoA reductase inhibitors, which can reduce total cholesterol and low-density lipoprotein, as well as reduce triacylglycerol and increase high-density lipoprotein to a certain extent
.
Clinically, it is mainly used to lower cholesterol, especially low-density lipoprotein-cholesterol, and treat atherosclerosis.
It is an effective drug for the prevention and treatment of coronary heart disease and ischemic stroke
.
Patients using statins should be especially vigilant for myopathy and hepatic adverse reactions
.
The clinical manifestations of statin-related myopathy include muscle soreness, myositis, and rhabdomyolysis, and laboratory tests can show increased phosphokinase; liver function impairment is manifested by increased serum alanine aminotransferase and aspartate aminotransferase, and liver enzyme increases are mostly transient Sexuality usually occurs in the first 3 months of starting treatment or increasing the dose.
Generally, the level of liver enzymes can decrease after the drug is stopped
.
Patients should carefully read the safety information such as adverse reactions, precautions, warnings and contraindications in the drug insert before taking the medicine.
If they feel discomfort during the taking of the medicine, they should contact their doctor or pharmacist in time to avoid serious adverse reactions.

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4.
3 Monitoring of adverse drug reactions in metabolism and endocrine system Drugs in metabolism and endocrine system refer to drugs for the treatment of endocrine and metabolism-related diseases, including glucocorticoids, diabetes treatment drugs, anti-gout drugs, thyroid disease drugs, and pituitary disease drugs
.
In recent years, the number of reports of adverse drug reactions/events in the metabolic and endocrine systems and the proportion of serious reports have shown an upward trend, suggesting that more attention should be paid to the risks of such drugs
.
In 2021, the National Adverse Drug Reaction Monitoring Network received a total of 81,000 reports of adverse drug reactions/events in the metabolic and endocrine systems, of which 7,422 were serious reports, accounting for 9.
2%
.
Metabolic and endocrine system adverse drug reaction/event reports accounted for 4.
1% of overall reports in 2021
.
4.
3.
1 The top 3 drug categories in terms of the number of adverse drug reactions/events reported in the metabolic and endocrine system in 2021 are glucocorticoids, biguanides, and other diabetes treatment drugs (except insulin, insulin secretagogues, biguanides, α-glucosidase inhibitors, other diabetes treatment drugs other than thiazolidinediones, the same below), the top three drug categories in the number of serious adverse reactions/event reports are glucocorticoids, insulin, and antithyroid drugs
.
In the 2021 metabolic and endocrine system drug adverse reaction/event reports, oral preparations accounted for 56.
6%, injections accounted for 37.
2%, and other dosage forms accounted for 6.
2%
.
Of the serious adverse reaction/event reports, oral formulations accounted for 50.
7%, injections accounted for 42.
0%, and other formulations accounted for 7.
3%
.
4.
3.
2 Involvement of Organ System In the 2021 adverse drug reaction/event report of metabolic and endocrine system, the overall and serious reported adverse drug reaction/event involving organ system is shown in Figure 11
.
Compared with the overall reports of metabolic and endocrine system drugs, serious reported adverse drug reactions/events involving organ systems, metabolic and nutritional diseases, various neurological diseases, various examinations, respiratory system, thoracic and mediastinal diseases, cardiac Organ disease composition ratio is significantly higher
.
Figure 11 Metabolic and endocrine system drug adverse reactions/events involving organ systems in the overall adverse reactions/events reports of metabolic and endocrine system drug use in 2021, the top 5 organ systems involved in oral preparations are gastrointestinal system diseases, skin and subcutaneous tissue types Diseases, metabolic and nutritional diseases, various neurological and systemic diseases and various reactions at the administration site; the top 5 organ systems involved in injections are gastrointestinal system diseases, skin and subcutaneous tissue diseases, metabolic and nutritional diseases Diseases, systemic diseases and various reactions at the administration site, various neurological diseases
.
In the serious adverse drug reaction/event reports of metabolic and endocrine system drugs, the top 5 organ systems involved in oral preparations are gastrointestinal system diseases, metabolic and nutritional diseases, skin and subcutaneous tissue diseases, various nervous system diseases, various Inspection; the top 5 organs and systems involved in injections are metabolic and nutritional diseases, gastrointestinal system diseases, various nervous system diseases, skin and subcutaneous tissue diseases, and various inspections
.
4.
3.
3 Monitoring situation analysis and safety risk warning From the absolute number of reports, the number of diabetes treatment drugs reported the largest increase compared with 2020; Therapeutic drugs (eg, pegylated loxenatide, dulaglutide, dapagliflozin) rose faster in the rankings
.
On the one hand, this may reflect the increase in the incidence and/or diagnosis rate of diabetes due to the aging of the population and the improvement in the level of medical security in China, which has led to the expansion of the number of people using diabetes treatment drugs.
On the other hand, it also suggests that prescribers and patients are choosing Risks associated with diabetes treatment medications, especially newer medications, should be considered
.
Tips: What are the main serious adverse reactions of methimazole? Methimazole is a thiourea antithyroid drug, which is listed in the 2018 edition of the National Essential Medicines List
.
The main adverse reactions of methimazole include hematological toxicity, liver toxicity and skin reaction
.
Hematological toxicity is commonly manifested as leukopenia and neutropenia; occasionally severe agranulocytosis, with clinical manifestations of stomatitis, pharyngitis, fever, etc.
, can lead to death in severe cases; pancytopenia and Aplastic anemia
.
Hepatotoxicity is mainly manifested by elevated liver function tests, rare liver failure, and rare cases of cholestatic jaundice and toxic hepatitis
.
Skin reactions are mainly rash and itching, and severe skin reactions include systemic dermatitis and lupus erythematosus
.
There are also some serious but rare adverse reactions, including pancreatitis, anti-neutrophil cytoplasmic antibody-related small vessel vasculitis,
etc.
The use of methimazole should be prescribed by a doctor, and blood routine and liver function should be checked regularly according to the doctor's instructions and instructions.
Seek immediate medical attention
.
In addition, methimazole may cause congenital malformations, and women of childbearing age should use effective contraception during use.
The use of methimazole in pregnant women must be strictly assessed by physicians for individual benefits/risks, and pregnant women, fetuses, and newborns should be closely monitored.

.
4.
4 Monitoring of adverse reactions of injections In 2021, the overall number of reports of adverse reactions/events for injections (excluding vaccines) increased by 14.
7% compared with the same period in 2020, and the proportion in the overall drug reports was basically the same as the overall situation in recent years
.
According to dosage form statistics, in 2021, injections (excluding vaccines) accounted for 55.
5% of the overall adverse drug reaction/event reports, and injections (excluding vaccines) accounted for 70.
9% of serious reports
.
According to the statistics of drug classification, in the overall report of injections (excluding vaccines), chemical injections accounted for 87.
8%, traditional Chinese medicine injections accounted for 6.
4%, biological products accounted for 3.
1%, and those that could not be classified accounted for 2.
7%; Pharmaceutical injections accounted for 87.
4%, traditional Chinese medicine injections accounted for 4.
7%, biological products accounted for 5.
7%, and those that could not be classified accounted for 2.
2%
.
4.
4.
1 Drugs The top 3 drug categories in the number of reported chemical injections are anti-infective drugs, tumor drugs, electrolytes, acid-base balance and nutritional drugs (Figure 12)
.
Figure 12 2021 chemical drug injection adverse reactions/events report involving drug categories The top 5 categories of Chinese medicine injections in the overall report category are blood-regulating agents, tonic agents, orifice-relieving agents, heat-clearing agents, and expectorants (Figure 13)
.
Figure 13 Drug categories involved in traditional Chinese medicine injection adverse reactions/events reports in 2021 System diseases, systemic diseases and various reactions at the administration site, various neurological diseases and various examinations
.
Among the serious adverse reactions/events of injection, the top 5 involved organ systems are blood and lymphatic system diseases, various examinations, skin and subcutaneous tissue diseases, systemic diseases and various reactions at the administration site and gastrointestinal system diseases ( Figure 14)
.
Figure 14 Injectable adverse reactions/events involving organ systems in 2021 4.
4.
3 Surveillance analysis and safety risk reminders From the statistics of dosage forms, the overall number of reports of adverse reactions/events for injectables (excluding vaccines) in 2021 increased compared with the same period in 2020 14.
7%, the proportion in the overall drug report is basically consistent with the overall situation in recent years
.
Judging from the statistics of the drug users, the number of adverse reactions/events reported by injections (excluding vaccines) in children increased by 19.
7% compared with the same period in 2020, and the overall proportion was basically the same as the overall situation in recent years
.
According to the monitoring situation of injections, it is recommended that clinicians read the product instructions carefully before taking medication, focus on relevant safety content, conduct adequate benefit and risk analysis before prescribing, and always follow the medication principle of "can take medicine without injections, and be able to take injections without infusion" Reasonable choice of medication
.
As a special drug group, children are more sensitive to drugs and have poor tolerance due to factors such as incomplete organ development, and should be used with caution
.
Tips: How to choose the route of administration reasonably? There are various routes of administration in clinical practice, mainly including the route of gastrointestinal administration and the route of parenteral administration
.
Gastrointestinal route of administration, that is, oral route of administration, common dosage forms such as tablets, granules, capsules, powders, solutions, pills, etc.
; parenteral route of administration, that is, other than oral route of administration All other routes, such as injection administration, respiratory administration, skin administration, etc.
, common dosage forms such as injections, sprays, topical solutions, eye drops, suppositories,
etc.
Wherein, the route of administration by injection includes subcutaneous injection, intradermal injection, intramuscular injection, intravenous injection and the like
.
Different routes of administration have different clinical significance.
For example, oral route of administration is the most commonly used route of administration, which is relatively safe, convenient and economical.
After passing through the natural barrier of the human body, it directly enters the body, which can cause tissue damage, pain, infection, and even serious adverse reactions
.
Clinically, according to the actual drug use, follow the principle of "do not use injection for oral administration; do not choose intravenous injection or drip administration for intramuscular injection", and choose the route of administration reasonably
.
Chapter 5 Relevant Explanations 5.
1 The data in this annual report comes from the data reported by regions from January 1, 2021 to December 31, 2021 in the National Adverse Drug Reaction Monitoring Database
.
5.
2 Like most countries, adverse drug reaction reports in China are collected and entered into the database through the spontaneous reporting system.
There are limitations of the spontaneous reporting system, such as omissions, irregular filling, incomplete information, and inability to calculate the occurrence of adverse reactions.
rate
etc.
5.
3 The number of reports of adverse drug reactions/events for each drug is affected by many factors such as the dosage of the drug and the incidence of adverse drug reactions.
Therefore, the number of reports of adverse drug reactions/events does not directly represent the level or severity of the incidence of adverse drug reactions.
degree
.
5.
4 When this annual report is completed, some serious reports and death reports are still in the process of investigation and evaluation.
All statistical results are a true reflection of the current data collection situation and do not represent the final evaluation results
.
5.
5 The Medical Dictionary for Regulatory Activities (MedDRA) was used for statistics in this annual report, and the World Health Organization Adverse Reaction Terminology (WHO-ART) was used in the past.

.
MedDRA is a standardized international medical terminology developed under the auspices of the International Council for Harmonization of Technical Requirements for Medicinal Products for Human Use (ICH) for regulatory communication and data evaluation related to medical products for human use
.
Exams are a system organ class in MedDRA and include exam names with qualifiers (eg, elevated, lower, abnormal, normal) and without qualifiers
.
5.
6 Professionals will analyze the correlation between drugs and adverse reactions/events, extract drug safety risk information, and decide whether to take relevant measures according to the prevalence or severity of risks, such as adding safety information to drug inserts and updating drugs.
Information on how to use it safely,
etc.
Drugs are also withdrawn when the benefits no longer outweigh the risks
.
5.
7 The data in this annual report are all from the National Adverse Drug Reaction Monitoring Network, and do not include the monitoring data of vaccine adverse reactions/events
.