The coverage rate of the annual national ADR monitoring report at county level is 93.8%

Source: Medical Economic News May 16, 2014 medical network may 16 May 14, CFDA issued the annual report on ADR monitoring (2013) The report shows that in 2013, the county-level coverage rate of ADR reports reached 93.8%, and the average number of ADR reports per million population in China reached 983, meeting the requirements of the 12th Five year plan ahead of time With the joint efforts and cooperation of drug regulatory departments, health administrative departments, ADR monitoring institutions and medical institutions at all levels, ADR monitoring work maintained a good development trend in 2013 In 2013, the national ADR monitoring network received more than 1317000 ADR / event reports, an increase of 9.0% over 2012 Among them, 291000 new and serious ADRs / events were reported, accounting for 22.1% of the total reported in the same period At the same time, the monitoring system has been further improved, and the coverage of monitoring has been expanded; the level of monitoring information has been further improved, and the security early warning mechanism has become more mature; the ability of analysis and evaluation has been further enhanced, and the level of risk management has been improved; the communication channels have been further expanded, and the social participation has been more extensive Statistical analysis shows that in 2013, ADR / event reports were still mainly from medical institutions, and the reports of drug manufacturers increased compared with 2012 From the perspective of drugs involved, the safety of national essential drugs is stable, the reported proportion of anti infective drugs has been declining for four consecutive years, and the reported proportion of cardiovascular system drugs has increased by 0.4 percentage points compared with 2012; the reported proportion of injections has increased by 0.2 percentage points after several consecutive years of decline In terms of the patients involved, 17.8% of them were over 65 years old, which was significantly higher than that in 2012 CFDA took a series of risk control measures in time for the drugs with safety risks: first, it issued the drug safety warning information in a timely manner, and issued 7 adverse drug reaction information circulations in the whole year, which reported 8 (class) drug safety problems; 12 drug warning letters, which reported more than 70 drug safety information; The second is to organize the modification of 22 instructions of citalopram and other drugs, and to add safety warning information; the third is to cancel the drug approval documents of Buflomedil and methylalanine ester preparations; the fourth is to organize the investigation and disposal of serious adverse drug events; the fifth is to interview or inform individual enterprises of the risk signals found in the monitoring.