Major drug injuries in China

Replay of Major Drug Injury Events in China in Recent Years

200 1 through ADR monitoring, it was found that the treatment of psoriasis with bimorpholine may cause leukemia.

In 2002, it was found that benzyl alcohol may cause gluteal muscle contracture in children.

In 2003, serious adverse reactions of mannatide were found, and SFDA took timely measures to modify the drug instructions.

In 2004, after monitoring and evaluation, it was determined that "Puerarin Injection" caused hemolysis, and the drug instructions were immediately revised.

In 2005, according to the monitoring of adverse drug reactions, measures were taken to modify the drug instructions of Lianbizhi injection, Chuanhuning injection and non-steroidal anti-inflammatory drugs, and 12 varieties such as Baiqianbiyan tablets and chloramphenicol eye drops were changed from over-the-counter drugs to prescription drugs.

In May 2006, the Yao Qier incident.

According to the monitoring of adverse drug reactions, in June 2006, SFDA suspended the use and approval of seven injection varieties, including Houttuynia Cordata Injection.

In September, 2006, SFDA reported "Be alert to the abnormal blood sugar caused by Gatifloxacin, the relationship between acyclovir and acute renal failure, and the safety of ribavirin".

"Is the medicine I use safe?"-Call the police!

Drug regulatory agencies, media, people from all walks of life

Pay wide attention to

The whole society discusses "drug safety monitoring mechanism"

1998 to 2006, the National Adverse Drug Reaction Monitoring Center received a total of 5 19 to 369392 reports of adverse drug reactions. The average annual growth rate is 170%. The quality of reports is gradually standardized, and the utilization rate of reports is increased year by year. The pace of informatization construction has been accelerated; Establish an information notification system for adverse drug reactions;

Adverse drug reaction reports provide a lot of data for drug supervision.

Make drug supervision more scientific and reasonable.

-The discovery and utilization of drug warning signals, that is, the technical support and service function of adverse drug reaction monitoring for drug safety supervision began to appear.

Important findings monitored by adverse drug reaction reporting system

Drug injury event

In April 2006, Guangdong Adverse Drug Reaction Monitoring Center found that the Third Affiliated Hospital of Sun Yat-sen University used "Yao Qier" to produce armillarisin A injection with symptoms of acute renal failure-diethylene glycol;

In July, 2006, Qinghai Adverse Drug Reaction Monitoring Center found through the monitoring and reporting system that patients had serious adverse reaction symptoms after using clindamycin phosphate glucose injection, Anhui Huayuan, which was illegally produced, and failed to sterilize according to the approved process parameters.

In July 2007, the National Center for Adverse Drug Reaction Monitoring reported that some children with leukemia had symptoms such as lower limb pain, fatigue and difficulty in walking after using methotrexate-intrathecal injection of methotrexate was suspended in some batches.

Looking back on these ADR monitoring events discovered in recent years, we can find that ADR monitoring has played an irreplaceable role in drug safety monitoring, timely detection and narrowing the scope of "ADR".

Current situation of monitoring data of adverse drug reactions in China

Current situation of monitoring data of adverse drug reactions in China

The above-mentioned several important drug accidents reflect the quality problems of counterfeit drugs and inferior drugs found in China's ADR reporting system, and China's ADR database also reflects a huge hidden danger of drug use, which is the most concerned irrational drug use problem in clinic.

In 2007, Guangdong ADR Monitoring Center randomly selected more than 50,000 historical data of ADR in Guangdong ADR database, and investigated and reviewed nearly 20,000 ADR reports, involving 28,202 kinds of drugs.

Analysis of irrational drug use in Guangdong ADR database