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.