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Chinese Herb Saftey

“The Cleveland Clinic, one of the country's top hospitals, is a surprising venue for the dispensing of herbs, a practice that is well established in China and other Eastern countries but has yet to make inroads in the U.S.…Patients must be referred by a doctor and will be monitored to ensure that there are no drug-herbal interactions or other complication” 
(Wall Street Journal, 2014).
 
Now that the Cleveland Clinic has introduced Chinese herbal medicine into mainstream practice, consumers may become more interested in the many aspects that contribute to the safe and sound use of Chinese herbs. It all begins with: 

  • Regulating Herb Quality
  • Prescriber Qualifications
  • Preparation & Dispensing
  • Resource on Interactions

REGULATING HERB QUALITY
The gold standard of herb quality is certification in Good Manufacturing Practice (cGMP). Indication of voluntary meeting this Australian standard of quality is printed on a product label, similar to the USDA certified-organic seal. The criteria for herbal quality according to the various GMP lab tests are:

  • Identity- the herb is the botanical the grower/distributor says it is
  • Safety- a safe herb is not purported as an unsafe herb
  • Purity- molds, fungi, heavy metals, pesticides etc. are absent
  • Efficacy- therapeutic compounds are present in sufficient quantity

Other verification and testing programs that companies voluntarily participate in include:

  • United States Pharmacopeia - Dietary Supplement Verification
  • NSF International - Dietary Supplement Certification Program
  • ConsumerLab.com – Seal of Approval

There are thousands of substances in the Chinese herbal formulary such as plants, resins, minerals, bone, shell etc. Substances that have been processed by, and then imported from other countries undergo rigorous testing by any reputable distributor before they are sold singly or processed into products. Chinese herbal products that are manufactured in the U.S. are done so under strict quality control by any reputable company. In either of these instances, GMP quality standards are met or exceeded.
 
Chinese Herbal Patent Medicines: The Clinical Desk Reference (Shya Publications, 2001) is a reference guide that lists patent products that are GMP certified, those found to contain certain contaminants*, and those yet untested. It includes patents that are made in, and those imported to the U.S.  This book is useful to weed out poor quality products, and/or identify reputable manufacturers/distributors.
 
Chinese herbal products can still slip through the “quality” crack when consumers order herbs online. This is the same as ordering pharmaceutical drugs from an unlicensed online pharmacy, without a prescription, and without seeing a provider first. The identity, purity, safety, and efficacy of the herbs are not ensured. Practitioners already know the reputable herb companies that usually, but not always, require proof of licensure in order to buy their products.
 
PRESCRIBER QUALIFICATION
Prescribers with a Masters Degree in Oriental Medicine receive a requisite number of hours in Chinese herbal theory, toxicology and clinical prescribing. Some state licensing boards require (1) more clinical hours, and/or (2) national certification/diplomat status in either Chinese Herbology (Dipl.C.H.) or Oriental Medicine  (Dipl. O.M.). Individual states vary. Other prescribers have mastered Chinese herbal medicine through an internship apprenticeship, or residency.
 
While a small number of Chinese herbal patents are sold in health food stores, it is best to consult with a provider before using one. This is because Chinese herbal medicine is a 5000 year old art, and also a modern science. Prescribing Chinese herbs requires extensive knowledge of herb properties according to Chinese medical theory:

  • thermal nature (cold, cool, neutral, warm, hot)
  • tropism (meridians entered)
  • flavor (sweet, sour, salty, pungent, bland)
  • movement (sinking, floating, upward, downward)
  • influence on qi, jing, shen, blood & fluids


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Herbal Medicines Prepared in Chinese Hospital
PREPARATION & DISPENSING
Chinese herbs are prepared as pills (patents), teas, powders, tinctures, liniments etc.. The form used depends on a combination of diagnosis, clinical judgment, convenience, and patient preference. The way herbs are prepared often determines their potency, therapeutic chemistry, and cost. Practicality is an issue when using Chinese herbs requires patient involvement (e.g. cooking the herbal tea themselves).
 

Practitioner may compound and dispense herbal prescriptions from their own on-site pharmacy. Practitioners also order prescriptions from off-site commercial pharmacy that comply with GMP herb quality criteria, FDA labeling laws, and the Health Information Portability and Accountability Act (HIPAA). Patients may pay more for herbs from off-site pharmacies. However, they are popular with practitioners because of less overhead compared to an on-site pharmacy; less time spent managing and stocking; and less waste of expired herbs that are not frequently used. These pharmacies also have a wider variety of products compared to what an individual practitioner could have on-hand.
 
RESOURCES ON DRUG-HERB INTERACTION
Drug-herb research is ongoing. Most known interactions are clinically insignificant. Some are synergistic (beneficial), or antagonistic (adverse). Others remain controversial. As with Western drug-drug interactions, there is much more information on drug-herb interaction in general than there was decades ago. Pharmacists and herbalists can now better advise on their concurrent use. If providers do not have access to formal consultation, there are now many other resources for evidenced-based information. 
 
Dr. John Chen Pharm.D., Ph.D., O.M.D., L.Ac. is an expert on Chinese herb quality, and lead author of two Chinese herbal pharmacopeias used in the U.S. He lectures, offers a clinical manual, and is available for medical consultation on drug-herb interaction. Other resources include:
 
  • American Herbal Pharmacopeia
  • Epocrates Alternative Medicine database
  • Natural Medicines Comprehensive Database
  • Natural Standards database
  • ChineseHerbInfo.com

 
* Marketing these products is prohibited in California.

References
[i] Reddy, S. (April 21, 2014). A Top Hospital Opens Up to Chinese Herbs as   Medicines. Wall Street Journal (online version). Retrieved from www.online.wsj.com.







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