I have just recently returned from a trip to Europe - France to be exact. At the hotel, I constantly heard the phrase, "ask the concierge." After the first several days of hearing this over and over again, I began to think that this phrase is used in that country in much the same way as "Ask your doctor" is used in the United States. This got me thinking. What if people began to "ask the acupuncturist" as a matter of routine? How would their health improve?
Several of the important questions that are beginning to be asked of acupuncturists concern herbs and herbal safety versus the health, safety, and effects of pharmaceuticals. These questions are unlikely to be answered by their medical doctor. As greater numbers of people look for alternatives to western medicine, a fact shown in a number of recently released federal surveys, a logical source of information will be acupuncturists.
Practitioners will be asked questions like: "Where do these herbs come from?" "What is in them?" "Are they safe?" "Do they really work?" One way to increase your personal knowledge is the FDA's current Good Manufacturing Practices (CGMP).
The FDA CGMP regulations become operative in July 2010 for individual providers. The regulations involve more than 500 pages of information. After reading this document, it is apparent to me that allof those pages contain valuable information that is necessary for acupuncturists to know.
You may be wondering exactly what the CGMP is attempting to accomplish. According to the CGMP summary: "The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health."
Furthermore, you may also wonder why the CGMP is so important in the first place. Again, as the rule states: "Well-established principles of CGMP require process controls at each step of the manufacturing process as early in the production process as possible. Quality cannot be tested into the [supplement] product only at the end. Instead, the quality of the dietary supplement must be built into the product throughout the manufacturing process; quality begins with the starting material and continues with the product being manufactured in a reproducible manner according to established specifications. It is not sufficient, nor effective, to rely solely on end product testing to assure the quality of the individual dietary supplement product sold to the consumer."
Each practitioner must begin to look at their own clinic and also ask questions of themselves. Where is the herbal dispensary in your clinic? How can I ensure the safety of the herbs I prescribe? Am I asking patients about any other medications they are taking?
During this next year, the Consortium for Oriental Medicine Research and Education (COMRE) is going to be providing an informational seminar regarding herbal dispensary guidelines, procedures and protocol. This course will cover all necessary information for practitioners to be knowledgeable about the CGMP. The class will provide CEUs or PDA units. A certificate that can be hung on your office wall to show patients you are in compliance with current herbal guidelines, will be issued at the end of the class.
The money from these classes will be given to aid acupuncture research and federal legislation. Some money will also go to support the addition of traditional medicine into the next round of International Classification of Disease codes (ICD-11). In short, the money from these seminars is going back into the profession. I hope you will support these classes in the coming year. They will be coming to an acupuncture school near you. Check your e-mail or this space for more information from me.
Thank you in advance for your support. I believe this will help our profession. When a patient asks you, the acupuncturist, about herbs you will have regulatory-compliant answers.
Be informed and certified about dispensary guidelines and the CGMP. Only then will patients be able to ask any acupuncturist their questions about herbs and herbal safety and be assured that the practitioner will have CGMP-compliant answers.
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