Ｃｈｉｎｅｓｅ Ｍｅｄｉｃｉｎｅ Ｉｎｊｅｃｔｉｏｎ Ｆａｃｅｓ Ａ Ｂｉｇ Ｔｅｓｔ

The threshold for the evaluation of Chinese medicine injection will be further improved after some safety problems came out. The evaluation will be stricter than the one of western medicine injection.

The National Center for Adverse Drug Reaction Monitoring published the 21st Report of Information on Adverse Drug Reaction (hereafter Report) on April 21, reminding the doctors and drug enterprises to pay attention to the serious adverse reaction to Qingkailing injection.

Presently, there are 8 enterprises in China having the qualification to produce the Qingkailing injection. As a Chinese medicine compound preparation, this injection is widely used in the clinical medicine to cure the acute hepatitis, upper respiratory infection and pneumonia. When SARS and bird flu broke out, this kind of medicine plays a very important role in emergent medical care.

However, adverse drug reaction events are often seen in recent years. The injections of Chinese medicine the Herba Houttuyniae, Manyprickle Acathopanax Root, Anti-hepatitis-jaundice and so on have been reported to cause adverse reactions. After the report about the adverse reaction to Qingkailing injection, people have less trust in Chinese medicine injection. The discussions about the reasonability and safety of Chinese medicine injection and its future development never end.

Adverse Events of Qingkailing Injection

The National Center for Adverse Drug Reaction Monitoring said that most of the serious adverse reactions/events of Qingkailing injection it knew in recent years damaged peoples respiratory system or whole body. In addition, there were also the damages to skins, nervous system and cardiovascular system.

The Report showed the analysis about death caused by adverse reactions to Qingkailing injection: 81% of the dead patients used another kind of drug together with Qingkailing injection; 8% have drug combination of Qingkailing and other medicines. Apart from the medical reasons, the factors of deteriorating disease, allergic constitution and wrong medicine use may also result in death. Meanwhile, 27% of the dead patients are children younger than 14 years old.

Li Zhenjiang, Board Chairman of the largest Qingkailing injection producer said that the adverse events of Chinese medicine injections are mainly attributed to wrong medicine use and irregular clinic application, not the safety of injections.

He said the doctors professionalized in western medicine lack the knowledge of how to use the Chinese medicine injection clinically. They usually enlarge the application scope of the Chinese medicine application, resulting in the wrong medicine use and excessive medicine use which may cause adverse drug events.

Discussion about “Shuanghuanglian”

There are the same problems in the adverse drug events of Shuanghuanglian injection which happened before.

In February 2009, 3 patients in Qinghai had adverse reactions to Shuanghuanglian injection produced by a Jiamusi, Heilongjiang-based drug enterprise and one of them died of this accident.

The State Food and Drug Administration (SFDA) issued the investigation report about this case, saying: “the quality of the drugs and cleanness of the production place are OK. However, according to the primary judgment of the clinic medicine use, the Shuanghuanglian injection produced in this enterprise is closely related with the adverse drug events in Qinghai.”

It is known that this enterprisehas stopped the production of Shuanghuanglian injection after the investigation and no longer resume it.

“We have already submitted the report of a research conducted by a third party on drug combination to the SFDA. The report shows that the adverse drug events in Qinghai were mainly attributed to the doctors unreasonable drug combination and wrong medicine use,” said the Board Chairman of this enterprise Wang Shugui.

He gave out the prescriptions of the three dead patients in Qinghai, as well as the report from Harbin Medical University which showed that drug combination could be seen in all the three events. It is also said that the doctors used the drugs which are forbidden to be used with the injection in these events.

Wang Shugui said: “the instructions of our Shuanghuanglian injection write clearly that the injection can not be used with the Virazole and the similar kinds of drugs as well as Vitamin C. However, all the three dead patients used Virazole or Vitamin C before or after the injection, which was a pharmacological incompatibility strictly forbidden in the package inserts of our product.”

Shortcoming: Complicated Contents

“The adverse drug events of Shuanghuanglian injection have resulted in a crisis over the whole Chinese medicine injection industry. The consumers didnt trust the Chinese medicine injection like before. The medical institutions also avoid using the Chinese medicine injection as much as possible,” said a management person of Changshu Leiyunshang Pharmaceutical Company.

A director of another pharmaceutical company gave out his own opinion on the frequently-seen events of Chinese medicine injection. He said that his enterprise has stopped all the production and research of the Chinese medicine injection.

Wu Feichi, Board Chairman of Hunan Zhengqing Pharmaceutical Company said: “Right now we are very confused. Because the patients have different constitutions, all medicine can result in the adverse drug reactions. So far as we know, once 150 people died from the adverse drug reactions to a kind of western medicine injection, but no one paid attention to it. Why do people care so much about the Chinese medicine injection which has quite a few adverse drug events? Actually, the adverse drug events of Chinese medicine injection happen much less frequently than the western medicine injection.”

Du Xiaoxi, Deputy Director of the Center for Drug Reevaluation, SFDA gave out a speech in the “Forum of Chinese Medicine Injection”. He said: “the frequency of adverse drug reactions to Chinese medicine injection is really much less than the western medicine injection. However, the composition of Chinese medicine injection is much more complicated than the western ones. This is one of the reasons why the government and medical institutions cautiously use the Chinese medicine injection.”

Hu Jun, Head of the First Department of the Center for Drug Evaluation, SFDA said that 60% to 80% of what most Chinese medicine injections contain has not yet been studied. This is the most worrying factor about the safety of the Chinese medicine injection.”

Shi Yingkang, director of Huaxi Hospital, said: “the Chinese medicine injection has complicated composition. Apart from the effective ingredients, most of the ingredients have not been made dear. Our hospital use more than 700 kinds of drugs, but the Chinese medicine injection takes a small part.”

A director of a Harbin-based medical institution said that presently the large-sized medical institutions in China use quite a few Chinese medicine injections. The rural areas and remote places in China are the main market of Chinese medicine injection. Those places are where the qualified medical care providers are insufficient and where the abuse of drugs can be frequently seen.

It is known that the SFDA will heighten the threshold for the evaluation of Chinese medicine injection. “The enterprises must clarify the necessity of the change to the form of drugs when applying for the evaluations of Chinese medicine injection, which means that the injection must have a better medical effect than the congeneric oral liquid. In other words, if the oral liquid has the same medical effect with the injection, we will prefer the former,” said Hu Jun.