Traditional Chinese medicine injection, unreasonable use magnifies the safety risk.


Release time:

2017-12-15

Recently, Wu Zhen, deputy director of the State Food and Drug Administration, revealed when interpreting the policy on deepening the reform of the review and approval system that the re-evaluation plan for Chinese medicine injections in my country has been initially formed and opinions may be solicited in the near future. In recent years, due to the occurrence of adverse reactions of Houttuynia cordata injection and other events, there has been a dispute over the preservation and abolition of traditional Chinese medicine injections in the industry. However, it is biased to focus only on the traditional Chinese medicine injection itself and to explore whether it is safe and effective.

Traditional Chinese medicine injection is a unique drug category in our country. In the era of lack of medicine and medicine, it enriches doctors' diagnosis and treatment methods and plays a role in curing diseases and saving lives. However, because most of the varieties of traditional Chinese medicine injections were approved by the original local drug administration department before 1985, limited to the conditions at that time, the clinical effectiveness data and safety data were seriously insufficient; at the same time, due to the inability to conduct systematic monitoring, it is difficult to assert whether they are safe. After the establishment of the national adverse drug reaction monitoring network in 1999, traditional Chinese medicine injection has become the key monitoring object, so it has attracted more attention.

"Unreasonable dosage form" is considered by the industry to be the main cause of adverse reactions of traditional Chinese medicine injections. Compared with western medicine, the composition of traditional Chinese medicine injection is more complex, coupled with the limited production process of traditional Chinese medicine injection, it is inevitable that the phenomenon of too large particles and residual impurities will occur. Compared with oral traditional Chinese medicine, intravenous administration increases the safety risk of patients.

In addition, the use of unreasonable also magnified the safety risk, the "basic principles of clinical use of traditional Chinese medicine injection" requires the application of syndrome differentiation, the prohibition of super-functional indications, the prohibition of mixed compatibility ...... and these principles have not been strictly enforced. According to the 2015 National Adverse Drug Reaction Monitoring Annual Report, the combined use of the top 20 drugs in the overall report of traditional Chinese medicine injections in 2015 (accounting for 87.6 per cent of the annual report of traditional Chinese medicine injections) was analyzed. The overall report involved combined use of drugs accounted for 43.4 per cent, and serious reports involved combined use of drugs accounted for 56.5 per cent. The reason is that, on the one hand, many prescribers of traditional Chinese medicine injections are not traditional Chinese medicine doctors but Western doctors. Western doctors generally do not use drugs according to the principle of "syndrome differentiation and treatment", which leads to adverse reactions because the drugs are not "syndrome"; on the other hand, the high profit of traditional Chinese medicine injections is also a factor in their overuse in clinic.

In addition, monitoring shows that the grass-roots level is a high risk area for the safety of traditional Chinese medicine injections. In primary medical institutions, doctors' clinical skills are not high and facilities are insufficient; traditional Chinese medicine injections are widely used because of their wide applicability, which leads to a higher risk of adverse reactions.

The National Food and Drug Administration has long noticed the risks of traditional Chinese medicine injections. In 2009, it required a re-evaluation of traditional Chinese medicine injections. In 2013, it announced new standards for 13 varieties, which improved its quality and safety. However, because the composition of traditional Chinese medicine injection is not as clear as chemical drugs, the systematic evaluation of traditional Chinese medicine injection has not been carried out. At present, some traditional Chinese medicine injection manufacturers have actively carried out relevant safety re-evaluation research, but the research level is uneven. Therefore, industry experts call for the urgent need to form a scientific and reasonable evaluation method, which is a "much more difficult than ordinary preparations" work. Wu Zhen said bluntly that it would take more time, "maybe five years, maybe ten years".