In p>21, it was found through ADR monitoring that bimorpholine may cause leukemia in the treatment of psoriasis
In p>22, it was found that benzyl alcohol may cause gluteal muscle contracture in children
In p>23, it was found that mannatide had serious adverse reactions, and SFDA took timely measures to revise the drug instructions
In p>24, After monitoring and evaluation, the hemolysis phenomenon caused by puerarin injection was determined, and the drug instructions were revised immediately < P > In p>25, according to the monitoring of adverse drug reactions, measures were taken to modify the drug instructions for "Lianbizhi injection", "Chuanhuning injection" and "non-steroidal anti-inflammatory drugs", including "Qianbai Biyan tablets" and "chloramphenicol eye drops". The second drug incident.
In June 26, SFDA suspended the use and approval of seven kinds of injections, such as Houttuynia Cordata Injection, according to the ADR monitoring.
In September 26, SFDA notified "Be alert to the abnormal blood sugar caused by gatifloxacin, acyclovir is associated with acute renal failure, and the safety problem of ribavirin"
"Is the drug I use safe"-alarm bell.
Drug regulatory agencies, media and people from all walks of life
The whole society discussed the "drug safety monitoring mechanism"
From p>1998 to 26, the National Adverse Drug Reaction Monitoring Center received 519 to 369,392 reports of adverse drug reactions; The average annual growth rate is 17%. The report quality is gradually standardized and the utilization rate of the report is improved year by year. The pace of informatization construction has been accelerated; Establishment of information notification system for adverse drug reactions;
ADR reports provide a large amount of data and basis for drug supervision, which makes drug supervision more scientific and reasonable.
—— The discovery and utilization of drug warning signals, that is, the technical support and service function of ADR monitoring for drug safety supervision began to appear.
Major ADR incidents discovered through ADR reporting system
In April p>26, Guangdong Adverse Drug Reaction Monitoring Center found that the third affiliated hospital of Sun Yat-sen University used "Qi Er Yao" to produce armillarisin A injection with acute renal failure symptoms-diethylene glycol;
In July p>26, 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 produced in violation of regulations and failed to sterilize according to the approved process parameters
In July p>27, the National Adverse Drug Reaction Monitoring Center reported that some children with leukemia suffered from lower limb pain and fatigue after using methotrexate. Then walking difficulties and other symptoms-stop using some batches of methotrexate for injection for intrathecal injection
Looking back at these drug injury incidents discovered in time from ADR monitoring system in recent years, we can find that the monitoring of adverse drug reactions has been in the monitoring of drug safety. It plays an irreplaceable role in finding and reducing the influence scope of "drug harm" in time.
The status quo of ADR monitoring data in China
The above-mentioned several important drug harm incidents reflect the quality problems of counterfeit drugs and inferior drugs found in China's ADR reporting system, and the ADR database in China also reflects a huge drug hidden danger problem. In p>27, Guangdong Adverse Drug Reaction Monitoring Center sampled more than 5, pieces of ADR historical data in Guangdong ADR database, and investigated and audited nearly 2, ADR reports, * * * involving 28,22 kinds of drugs.
Irrational drug use in Guangdong ADR database.