Acupuncture & Risk. AATB Annual Spring Meeting Saturday, March 29, 2008 Savannah, Georgia

Transcription

1 Acupuncture & Risk AATB Annual Spring Meeting Saturday, March 29, 2008 Savannah, Georgia Scott A. Brubaker, CTBS Chief Policy Officer AATB McLean, Virginia

2 Acupuncture AATB to keep or remove it in Appendix II, listing 12? Decision also affects questioning for the UDHQ

3 1997

4 Reference #3 is a Memo from

5 Reference #3 from ? no body piercing reference?

6 Draft Guidance from 2004 shows acupuncture removed. Not in Final and criterion now focuses on knowledge that sterile procedures were not used and offers examples. AATB Standards, 12th edition, 2008: Phys Council voted no change until researched further ( ).

7 Related Meetings & Reports

8 BPAC Meeting March 14-15, 2002 Questions to the Committee & Results: 1. Does the committee recommend that donors should continue to be deferred based on a history of: a) tattooing: 13 yes, 2 no, 0 abstain b) skin/body piercing: 13 yes, 2 no, 0 abstain c) acupuncture: 0 yes, 15 no, 0 abstain 2. If yes to any of the above, does the committee recommend that blood donor deferral be modified by a determination that a tattoo, or skin/body piercing procedure was performed in a facility operating under state or local licensure, or trade association certification? Vote: 13 yes, 0 no, 0 abstain.

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11 Related Reports In 2000, a case-controlled study of 2,316 US blood donors who tested HCV positive concluded that acupuncture was not a risk factor. (REDS report) ARC Blood Services HCV NAT Interview Study, to , HCV Ab =, HCV NAT invited, 230 enrolled, 39 were true HCV NAT +, 139 false + controls - Collected additional samples and gave extensive interview questionnaire - No donor reported any body piercing or acupuncture - 4 reported tattooing: 3 cases, 1 control; 2 cases also IDU

12 Safety Record of Acupuncture Tierney Tully, M.S.O.M., Dipl. Ac. (NCCAOM) Executive Director AOMA presented that, in the US: - The current blood donor question and deferral implies risk that does not exist today, when receiving treatment from a licensed acupuncturist states plus the DC have passed statutes or regulations establishing standards of competency for licensure of acupuncture and Oriental medicine providers. 4 others have introduced legislation. - Licensing requires taking & passing course (Clean Needle Technique). Published a Clean Needle Technique Manual with help of CDC & more recently OSHA, and is in its 5th edition. - Extraordinary safety record.

13 Presented at PPTA Donor Suitability Workshop June 4, 2007 (Plasma Protein Therapeutics Association)

14 Acupuncture not indicated in list.

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21 2006 article offers some statistics: 1-yr prevalence of use in US is 1-2% of population # of US acupuncturists projected to quadruple by 2015 About 1/4 of all US & UK physicians endorse use of acupuncture or refer patients to an acupuncturist

22 Acupuncture - A critical analysis E. Ernst, Journal of Internal Medicine, 2006 Acupuncture has occasionally been associated with several serious adverse effects, in particular, trauma to internal organs (e.g., pneumothorax or cardiac tamponade) and infections, such as Hepatitis C or HIV. Several large prospective studies have shown that such adverse events are extreme rarities, provided acupuncture is carried out by well-trained practitioners. Found one case report of transmission of HIV to a 17-yr old male NEJM Correspondence; Vittecoq D, Mettetal JF, Rouzioux C, Bach JF. Acute HIV infection after acupuncture treatments, N Engl J Med,1989;320:

23 A few recent articles Is acupuncture a risk factor for hepatitis? Systematic review of epidemiological studies, Journal of Gastroenterology, 2003, Ernst E, Sherman KJ - Conclusion: A modest association between hepatitis C and acupuncture has been reported in some countries. This emphasizes the importance of exclusively using disposable acupuncture needles. 15 investigations reviewed; Most reports reviewed were from Asia

24 US articles - from the 1980 s A large outbreak of acupuncture-associated hepatitis B, American Journal of Epidemiology, 1988, Kent GP, Brondum J, et al - 35 patients in Rhode Island infected w/hbv in Linked a substantial increase of incidence due to # of needles received. Index case identified that led to transmissions. ID ed several mechanisms for needle contamination due to techniques. Outbreak of hepatitis B associated with acupuncture, Journal of Family Practice, 1986, Stryker WS, Gunn RA, Francis DP - Hepatitis B outbreak occurred in US in 1980 at a chiropractic clinic where 6 pts infected due to treating pts w/hepatitis and reusing needles that were not properly sterilized. Found similar articles from UK, Israel, Germany, India, China, and Brazil; some as recent as 2002

25 For AATB Standards, Appendix II, listing 12: 1. Should acupuncture be removed as a risk to consider? 2. Should our wording match FDA s in regard to using: in which sterile procedures were not used instead of in which shared instruments are known to have been used? AATB Standards, 12th edition, 2008:

26 If yes to either question, then need to formalize a recommendation from the Physicians Council to the Standards Committee that explains rationale.