From the ADR report of 2010-2014 to see the improvement of drug safety in China

Source: Medical observer report 2015-8-14 with the annual expansion of the coverage of China's drug monitoring network, and the enhancement of the ability to find and collect adverse drug reaction information, in the past five years, the total number of ADR reports in China has continued to rise, and the cumulative number of ADR reports received by China's drug adverse reaction monitoring center from 2010 to 2014 reached about 5.4 million In terms of specific drugs, although the categories and dosage forms of anti infective drugs and traditional Chinese medicine injections are the "serious disaster areas" where adverse reactions have occurred in recent years, the data also reflect that these categories of adverse reactions are being paid attention to, and the overall drug safety situation tends to improve Overall: the monitoring coverage has been expanded year by year According to the data reports received by the national ADR monitoring network center in 2010-2014, the number of ADR reports in China has maintained a sustained and stable growth trend In 2014, China received a total of 1.328 million ADR / event reports, an increase of 0.8% over 2013; in 2013, China's ADR reports totaled 1.317 million, an increase of 9% over 2012; in 2012, there were more than 1.2 million ADR reports, an increase of 40.71% over 2011; in 2011, there were more than 850000 ADR / event reports, an increase of 23.08% over 2010; in 2010, there were 1.317 million ADR reports, an increase of 9% over 2012 The total number of annual reports is over 690000, an increase of 8.4% over 2009 (see Figure 1) At the same time, over the years, new and serious ADR / event reports have been the focus of ADR monitoring, and the new and serious reporting proportion, especially the serious reporting proportion, is one of the important indicators to measure the overall reporting quality and availability Data shows that in 2014, the national ADR monitoring network received 341000 new and serious ADR / event reports, an increase of 17.0% compared with 291000 in 2013, and 212% compared with 109000 in 2010 (see Figure 2) The increase of the total number is due to the improvement of the ability of ADR monitoring in China It is understood that in 2010, there were only 40000 online users of ADR monitoring network in China; by 2014, there were more than 240000 medical institutions and drug production and marketing enterprises registered as ADR monitoring network users in China, and ADR reports were submitted through the network And the coverage of more than 240000 "users" is far beyond the international indicators According to the recommendation of the World Health Organization, the average number of reports per million population should reach 200-400; and the goal of the 12th Five Year Plan for drug safety issued earlier in China is also that the average number of reports per million population should reach 400 - in 2013, the number reached 983 In 2014, the average number of reports per million people in China reached 991, an increase of 0.8 percentage points compared with 2013, which is about 2.4 times higher than the target set in the 12th Five Year Plan Meanwhile, the county-level reporting rate of adverse drug reactions / events in 2014 was 94.4%, an increase of 0.6 percentage points compared with 2013 More in-depth, under the situation that the overall scale of drug use in China is growing, whether the number of reports is increasing, the quality of reports is improving, or the coverage of drug safety monitoring is expanding and the regulatory network is developed, it shows that the ability to detect and collect adverse drug reaction information in China is further enhanced In fact, since the implementation of the new measures for the management of ADR reporting and monitoring in July 2011, the new national ADR monitoring system was put into full use in 2012, which greatly enhanced the early warning, statistics and analysis functions of the monitoring system Original address: http://www.yygcj.com/info/2015-08/34235.html