In order to fully reflect the monitoring situation of adverse drug reactions in our country in 2020, improve the level of public drug use safety, the National Adverse Drug Reaction Monitoring Center organized the compilation of
Chapter 1 Adverse Drug Reactions/Event Reports
1.1 The overall situation of the report
1.1.1 Adverse drug reaction/event reports in 2020
In 2020, the National ADR Monitoring Network received 1.676 million copies of the "Adverse Drug Reaction/Event Report Form". From 1999 to 2020, the National ADR Monitoring Network has received a total of 16.87 million copies of the Adverse Drug Reaction/Event Report Form.
1.1.2 New and serious adverse drug reactions/event reports
In 2020, the National ADR Monitoring Network received 506,000 new and serious ADR reports; new and serious ADR reports accounted for 30.2% of the total number of reports in the same period.
In 2020, the National ADR Monitoring Network received 167,000 severe adverse drug reaction reports, and serious ADR reports accounted for 10.0% of the total number in the same period.
1.1.3 Average reporting status 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. In 2020, the average number of reports per million people in my country is 1,251.
1.1.4 ADR report ratio at county level
The ratio of ADR county-level reports is one of the important indicators to measure the balanced development and coverage of our country's ADR monitoring work. In 2020, 98.3% of county-level regions across the country reported ADR events.
1.1.5 ADR report source
MAH, sale companies and medical institutions are responsible for the reporting of adverse drug reactions. According to the report source statistics, in 2020, reports from medical institutions accounted for 85.4%; reports from sale companies accounted for 10.6%; reports from holders accounted for 3.9%; reports from individuals and other reporters accounted for 0.1% .
1.1.6 ADR reports involving drugs
According to the statistics of suspected drug categories, chemical drugs accounted for 83.0%, traditional Chinese medicine accounted for 13.4%, biological products accounted for 1.1%, and those that could not be classified accounted for 2.5%
According to the statistics of administration route, in 2020, injection administration accounts for 56.7%, oral administration accounts for 38.1%, and other administration routes account for 5.2%. Among injections, intravenous injections accounted for 91.1%, and other injections accounted for 8.9% .
1.1.7 Adverse drug reactions/events involving organ systems
Among the ADR reported in 2020, the top 3 organ systems involved are gastrointestinal diseases, skin and subcutaneous tissue diseases, systemic diseases, and various reactions at the administration site.