by Eric Brand

Adverse Drug Reactions, or ADRs, are an extremely hot topic in medicine today. Without a doubt, most of us have noticed an increase in discussions on herb-drug interactions and increased attention towards identifying safety issues with herbal medicine. At present, there is not a tremendous amount of hard data on issues of herb-drug interactions, and as a profession we currently lack a centralized reporting system for adverse effects that we witness on a case-by-case basis. Today’s blog will look at some of the trends in Asian ADR reporting systems related to herbal medicine.

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I should preface this discussion by saying that I personally favor minimal regulation of the private sector. As a practitioner of Chinese medicine, I have seen countless inspiring cases and I generally believe that Chinese medicine is an extremely safe and effective system of medicine. Nonetheless, there are crucial issues that practitioners must be aware of, ranging from issues of proper herb identification to increased awareness of potential herb-drug interactions and other side effects of herbal medicine. In a nutshell, I favor minimal regulation but high standards in practitioner education.

There is a tendency for people with minimal exposure to Chinese medicine to take an alarmist tone with regard to herbal medicine, and I think it is easy for the risks of herbal medicine to be exaggerated without attention to the benefits and the overwhelming evidence that most herbal medicine use is quite safe. Recently, I’ve been helping to coordinate efforts to compile an herbal medicine safety database between NIH researchers and experts in Taiwan, Hong Kong, and mainland China. One of the greatest challenges that we face relates to educating biomedical practitioners in the risks of Chinese herbal medicine while keeping these risks in perspective. It is important to recognize that some herb-drug interactions may be possible and some herb toxicity issues do exist, but it is equally important to ensure that these risks are not blown out of proportion. If the risks are exaggerated without attention to the fact that herb-drug interactions and herb toxicity issues are actually quite rare in professional clinical practice, I fear that increased regulatory scrutiny could limit the development of herbal medicine.

At present, there is very limited data available regarding herb-drug interactions, and comprehensive ADR reporting systems for Chinese herbal medicine are still in their infancy. As I understand it, adverse event reporting will become a requirement in the new generation of cGMP laws regulating dietary supplements and prepared herbal medicines, so as a profession we will no doubt need to grow quickly in this arena. To this end, I am working on setting up a coordinated effort to promote data sharing between Beijing, Hong Kong, Taipei, and Western practitioners. In fact, there is a fair amount of information available, but it isn’t very integrated at present.

Taiwan and Hong Kong have the best systems set up for adverse event reporting. Despite the fact that some authorities in mainland China say that thousands of research papers have been published on herbal ADRs, so far China appears to lack any centralized reporting system where all this information can be easily accessed.

Taiwan has a centralized herbal ADR reporting center where patients and doctors can submit adverse events. After submission, doctors go through the cases to evaluate which ones suggest a high likelihood of a true ADR (vs. cases that have confounding variables that make the herbal connection inconclusive). This allows them to grade the different case reports based on their validity, and the data eventually ends up in a single database. This database will soon be translated into English, and I will be sure to update the Blue Poppy blog with some of the most interesting findings. Perhaps the single most important finding is that despite a vast number of herbal prescriptions, so far relatively few adverse events have been reported. Of course, the relative lack of adverse events is just as important a component of the data as the reported adverse events themselves.

In addition, the Taiwanese government hosts a database of herb-drug interactions. Many of the referenced case reports and studies actually come from the Western literature, but they have been compiled into a single database to make them centrally accessible. This database can only be searched with traditional Chinese characters, but it is a treasure house of information on this hot topic.

Over the next few weeks, I will be meeting with the chief coordinator of Hong Kong’s herbal medicine ADR reporting system, as well as the head of Beijing’s international TCM research division at Guang An Men hospital (Beijing’s top TCM hospital). Following this, I will be meeting with a cGMP focus group in the United States and will continue to help coordinate efforts with the NIH group. As soon as new information and new developments surface, I will post the latest updates and the most interesting findings here to the Blue Poppy blog.

At Blue Poppy, we are constantly seeking to stay on the forefront of practitioner education. We aim to be THE primary resource for practitioners to stay on the cutting edge of current developments in the field, and we work tirelessly both abroad and at home to keep practitioners in the loop about all relevant issues of safety and clinical developments. Check our blog frequently, as I will be sure to keep the blog updated with all of the vital developments that I encounter in the field. And by all means, contact us with any questions that you may have regarding the safe and effective practice of Chinese medicine. We are committed to the growth of the profession, and we aim to always be a leader and trusted resource in the field of Chinese medical education and products.

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