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Taking Your Practice to the Next Level
June 26, 2018
© Copyright 2018 NCCAOM. Any use of these materials, including reproduction, modification,distribution or republication without the prior written consent of NCCAOM is strictly prohibited.
Chinese HerbalCompounding and Safety (CHCS)Certificate Of Qualification (COQ)
Maximizing Your Participation in the Webinar
Panelists
Bill Egloff, Crane Herb Pharmacy
APHA: Chair, Chinese Herbal Product Committee
Amy Sear
Dipl. O.M. (NCCAOM)®, A.P.
John Scott, DOM
Golden Flower Herbs
Kory Ward-Cook, CEO, NCCAOM
Ph.D., MT(ASCP), CAE
• Recognize the need for a Chinese Herbal Compounding and Safety (CHCS) Certificate of Qualification (COQ) program
• Familiarize participants with the CHCS COQ rationale and process
• Describe the difference between a national certification and a certificate program
• Provide an opportunity for ongoing dialogue about the requirements, timeline and resources for the CHCS COQ that is in development
Objectives of Today’s Webinar
• Why: – Need for greater standardization of protocols for compounding
Chinese herbal formulas
– Interest in self-regulation of compounding Chinese herbal formulas, before the FDA comes knocking on the door
• What: American Herbal Products Association (AHPA) Publications
✓ Good Herbal Compounding and Dispensing Practices✓ Guidance: Best TCHM Compounding and Dispensing Practice
• When: A needs assessment of NCCAOM Diplomates was conducted in 2017
How Did the CHCS Certificate Come About?
❖ John Scott, Golden Flower Herbs, Dipl. Ac. (NCCAOM)® - Chair
❖ Zonglan Xu, Dipl. O.M. (NCCAOM)® - NCCAOM Board Liaison
❖ Steve Kazmierczak, Ph.D., DABCC – NCCAOM Public Member
❖ Bill Egloff, Crane Herb Pharmacy; APHA: Chair, Chinese Herbal
Product Committee - Member
❖ Shellie Rosen, Dipl. O.M. (NCCAOM)® - Member
❖ Amy Sear, Dipl. O.M. (NCCAOM)® - Member
❖ Afua Bromley, Dipl. Ac. (NCCAOM)® - NCCAOM BOC Chair
❖ Kory Ward-Cook, Ph.D. - NCCAOM CEO
NCCAOM Chinese Herbal MedicineCompounding & Dispensing Safety Taskforce
• Spring – Summer 2017: The Taskforce developed a needs assessment
survey for the potential development of a certificate of qualification (COQ)
• Fall 2017: Stakeholder Survey Completed
– 58% Strongly Agreed or Agreed that a COQ should be offered
– 15% were neutral
– 25% had questions or concerns– See NCCAOM Spring 2018 Diplomate Newsletter
• February 2018: NCCAOM Board of Commissioners approved a motion
to move forward with development of the Chinese Herbal Compounding Safety COQ
CHCS Certificate Taskforce
Certification & Certificate of Qualification Comparison
Certification Certificate of Qualification
Focus
• Verify education and/or
training/experience obtained
elsewhere
• Assess Current KSAs
• Deliver education/training to
participants to achieve knowledge and
skills
• Assess attainment of those
knowledge/skills attained from the
program
Components
• Eligibility requirements
• Assessment of the candidate -
Based on a JA
• Recertification - MOC
• Pre-defined course or curriculum -
based on a pre-defined intended
learning outcomes
• Assessment of the learner achieving
the intended learning outcomes
Attributes
• Designation and associated
acronym granted
• Can be revoked if ongoing
requirements are not met or
disciplinary policies and
procedures warrant
• Usually no designation or acronym is
granted; if one is granted, should state
or imply that the individual is not
certified or licensed
• Cannot be revoked
• 1980’s Jin Bu Huan & PC SPES: Banned
• 1992 Belgian Slimming Pill: Kidney Failures
• 1994 DSHEA (Dietary Supplement Health & Education Act)
• 2004 Ma Huang: Banned
• 2004 FDA Allergen Warnings on Labels
• 2007 FDA “Enforcement Discretion” for Custom Prescriptions
• 2016 APHA White Paper: Good Herbal Compounding and Dispensing Practices
• 2017 TCHM: Best Compounding & Dispensing Practices
Regulatory Timeline
Bill Egloff, Crane Herb Pharmacy
APHA: Chair, Chinese Herbal Product
Committee
• Herb Safety and Adulteration
• WHO: ICD-11 Traditional Medicine Diagnostic Codes
• Self-regulation is the Best Policy
• Cleveland Clinic Chinese Herb Practice
Why a CHCS Certificate? Why Now?
Bill Egloff, Crane Herb Pharmacy
APHA: Chair, Chinese Herbal Product
Committee
• FDA: Enforcement Discretion
• Education & Training
– AOM Institutions Inconsistent and Non-compliant
• Public Safety
• Professional Integrity and Reputation
• Unwarranted Government Oversight
• Communicate Chinese Herbal Medicine Confidence
• Self-regulation is the Best Policy
• Professional Liability Insurance
• Forms & Templates Included in the Training
Why a CHCS Certificate? Why Now?
John Scott, DOM
ArticlesAcupuncture Today
June 2018
Resources• Best Practices
• Definition of Terms
• Medical Record Keeping
• Forms
• Tracking Software
www.herbalgram.org
AHPA is Taking the Lead:
A Proactive Approach to Herbal SafetyAugust 2017 (Vol. 18, Issue 08) by Shellie Rosen, DOM, Lac.
http://www.acupuncturetoday.com/digital/index.php?i=714#17
John Scott, DOM
• “Best Practices”
• Cleanliness
• Labeling and Instructions
• Staff and Personnel
• Equipment and Areas
• Adverse Event Reporting
• Reducing Cross Contamination
Practical and Helpful
Amy Sear
Dipl. O.M. (NCCAOM)®, A.P.
• Increase safety
• Provide resources for staff and employees involved in Compounding and Dispensing
• Better prepared for an inspection by the FDA, local health departments, or state regulatory boards
• Not about herb drug interactions
• Not about herbal strategies or prescribing
Practical and Helpful
Amy Sear
Dipl. O.M. (NCCAOM)®, A.P.
• Will cover FDA guidelines and requirements that were new in 2010
• These are a natural and positive extension of the growth of our industry and the increased utilization of herbs and supplements by the mainstream public
• “Compounding”, “Dispensing”, “Manufacturing”
Practical and Helpful
Amy Sear
Dipl. O.M. (NCCAOM)®, A.P.
You
Manufacturers
(Your Sources)
HerbDietary
SupplementDrug
Amy Sear
Dipl. O.M. (NCCAOM)®, A.P.
Who can get the CHCS Certificate?
Herbal Practitioners
Oriental Medicine Practitioners
Is it Mandatory? NO
Strictly Voluntary Educational Program
Is it for NCCAOM Diplomates only? NO
Open to all CH and OM practitioners
Coming in 2019!
Follow-up
NCCAOM Website• Recording of the
CHCS COQ Webinar• Responses to your questions• Ability to submit additional
questions
The NCCAOM PDA Certificate for one point will
be emailed to each participant within two weeks of the webinar.
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