China reported over 850,000 adverse drug reactions/events in 2011

In 2011, the Chinese government received a total of 852,799 reports of adverse drug reactions/events.

Yan Min, deputy director of the Department of Drug Safety Supervision of the State Food and Drug Administration, disclosed the above information. At the press conference held here today, she read out the 2011 annual report on the monitoring of adverse drug reactions in the country. In 2011, she reported 145,769 new and serious adverse events/events, which accounted for 17.1% of the total number of reports in the same period.

In the annual report, the number of reported anti-infective drugs accounted for 51.2% of the total number of chemical drugs, and the most common category reported in severe cases of chemical drugs was also anti-infective drugs. Among the serious reports of all anti-infective drugs, the number of case reports exceeding 1,000 were cephalosporins (34.8%), penicillins (14%), and quinolones (12.2%). Case reports for these three drugs The number accounts for 61% of the total number of anti-infectives.

In this regard, Du Xiaotong, deputy director of the National Food and Drug Administration Drug Evaluation Center, pointed out that anti-infective drugs must be prescribed by doctors. They must be clearly indicated when they are used. For example, most common colds are caused by viral infections, and the use of antibiotics is not only The treatment effect may also cause adverse reactions.

In addition, intravenous administration accounted for 55% of adverse reaction reports in terms of route of administration. Du Xiaoyu said that the reasons are many, for example, may be related to the characteristics of the dosage form itself, and the possibility of serious adverse reactions occurring when the drug is directly injected into the blood is greater than other routes of administration; in addition, the intravenous route mainly occurs in medical institutions. The incidence of adverse events is also high.

The annual report released on that day comes from the data reported by various regions in the National Adverse Drug Reaction Monitoring Network from January 1, 2011 to December 31, 2011. Yan Min admitted that the number of adverse drug reactions/incidents reported for each drug would be affected by many factors such as the number of drugs used and the incidence of adverse reactions of the drug. Similar to other countries adopting the spontaneous reporting model, the Chinese drug adverse reaction monitoring network collects them. The data also has limitations, such as underreporting, underreporting, and lack of details.