ACCME at the International Pharmaceutical Compliance Summit Philadelphia March 2005

ACCME at the International Pharmaceutical

Compliance Summit

PhiladelphiaMarch 2005

No financial relationships with any commercial interests

No financial relationships with any commercial interests

Murray Kopelow, MD, MSC, FRCPC

ACCME’s Mission

ACCME’s Mission

…the identification, development, and promotion of standards for quality continuing medical education utilized by physicians in their maintenance of competence…

…the identification, development, and promotion of standards for quality continuing medical education utilized by physicians in their maintenance of competence…

…to assure physicians, the public, and the CME community that CME programs meet the ACCME's criteria for compliance with the Essential Areas.

…to assure physicians, the public, and the CME community that CME programs meet the ACCME's criteria for compliance with the Essential Areas.

ACCME’s Responsibility

ACCME’s Responsibility

1982

Continuing Professional Development

Continuing Medical Education

• Provider accreditation by ACCME; • Activity Accreditation by AAFP• Credit systems by membership organizations

(ex: AMA, AAFP)

Achieving Certification

MedicalStudent

Resident Licensed CredentialedSpecialist Practice

(Maintenance of Certification(Requirements by members of ABMS)

(Accreditation

UnderGraduate

MedicalEducation

by LCME)

Graduate

MedicalEducation

(Accreditationby ACGME)

Achieving Licensure Maintenance of Licensure ( Requirements by members of FSMB )

Size of Enterprise - 2003

ACCME Accredited

State Medical Society Accredited

62%70%

38% 30%

0%

20%

40%

60%

80%

100%

Activities

~ 140,000Hours

~ 1.3 million Physician Registrants

~ 8.5 million

53%

47%

Funding of CME

$0

$200

$400

$600

$800

$1,000

$1,200

$1,400

$1,600

$1,800

$2,000

1998 1999 2000 2001 2002 2003

in M

illion

s

Commercial Support Advertising and Exhibits Other Income

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1998 1999 2000 2001 2002 2003

Commercial Support Advertising and Exhibits Other IncomeCommercial Support Advertising & Exhibits Other Income

Quality and Safety as a NEED

Quality and Safety as an OUTCOME

#1‘Mission critical’ that CME be…

Linked to quality and safety

Effective in improving practice

Based on valid content

Independent of commercial interests

‘Mission critical’ that CME be…

Linked to quality and safety Effective in improving practice Based on valid content Independent of commercial interests



The literature is clear…

Continuing education is effective in assisting professionals to modify and improve their practice

Umble and Cervero, 1996

Robertson Umble Cervero 2003

Our challenge is to overcome…

Overuse Under use Misuse

…in clinical care

Grol, JAMA, 286,20,2001

Via interventions that are … Predisposing

(Prepare for change)

Enabling(Link new to what learner already doing, in practice)

Reinforcing (Via reminders and feedback)

Cantillon and Jones, BMJ, 318:127, 1999



Content Validity True New or Important Free of commercial

bias

Credibility or Face Validity

Credentials Independent Transparency

Validity of CME

2002 ACCME Action

2002 ACCME Action



Content Validity True New or Important Free of commercial

bias

Credibility or Face Validity

Credentials Independent Transparency

Standards for Commercial Support are a key part of ACCME’s overall strategy to ensure validity of CME…

Standards for Commercial Support are a key part of ACCME’s overall strategy to ensure validity of CME…

PromotionEducation

1992 Goal

“Second wave…” Independence Industry’s Profession’s

AdvaMed® Code on I nteractions with Healthcare Professionals

“…to facilitate Members’ethical interactions with those…that purchase, lease, recommend, use…prescribe.”

PhRMA® Code on Interactions with Healthcare Professionals

“…focuses on our interactions with healthcare professionals that relate to the marketing of our products.”

Independence Industry’s Profession’s





2005 Goal

“ In my view, the ACCME 2004 Updated Standards for Commercial Support were necessary to remind CME providers and commercial supporters alike, that CME is to enhance physicians’ ability to care for patients and that accredited providers have sole responsibility / accountability for certifying that CME is independent from commercial interests.”

Fred WilsonCategory Manager CME

P&G PharmaceuticalsOctober 30, 2004

“ In my view, the ACCME 2004 Updated Standards for Commercial Support were necessary to remind CME providers and commercial supporters alike, that CME is to enhance physicians’ ability to care for patients and that accredited providers have sole responsibility / accountability for certifying that CME is independent from commercial interests.”

Fred WilsonCategory Manager CME

P&G PharmaceuticalsOctober 30, 2004

Standard 1: Independence

• CME decisions free of the control of commercial interest

• Commercial interest is not joint sponsor

Identification of CME needs; Determination of educational

objectives; Selection and presentation of

content; Selection of all persons and

organizations that will be in a position to control the content of the CME;

Selection of educational methods; Evaluation of the activity.

Identification of CME needs; Determination of educational

objectives; Selection and presentation of

content; Selection of all persons and

organizations that will be in a position to control the content of the CME;

Selection of educational methods; Evaluation of the activity.

The Standards for Commercial SupportStandards to Ensure Independence in CME Activities

STANDARD 1: Independence

A CME provider must ensure that the following decisions were made free of the control of a commercial interest. …

STANDARD 2: Resolution of Personal Conflicts of Interest

The provider must be able to show that everyone who is in a position to control …

An individual who refuses to disclose .. will be disqualified …

The provider must have implemented a mechanism to identify and resolve …

STANDARD 3: Appropriate Use of Commercial Support

Written agreement documenting terms of support

Expenditures for an individual providing CME

Expenditures for learners

Accountability

STANDARD 4. Appropriate Management of Associated Commercial Promotion

Arrangements for commercial exhibits or advertisements …

A provider cannot use a commercial interest as the agent providing a CME activity to learners…

STANDARD 5. Content and Format without Commercial Bias

The content or format of a CME activity … must promote improvements or quality in healthcare …

Presentations must give a balanced view of therapeutic options. …

STANDARD 6.Disclosures Relevant to Potential Commercial Bias

Relevant financial relationships of those with control over CME content

Commercial support for the CME activity.

Timing of disclosure

…a checklist…a checklist

“ Codes of conduct promulgated by the CME industry may provide a useful starting point for manufacturers when reviewing their CME arrangements.”

DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General

OIG Compliance Program Guidance for Pharmaceutical Manufacturers Federal Register / Vol. 68, No. 86 / Monday, May 5, 2003

“ Codes of conduct promulgated by the CME industry may provide a useful starting point for manufacturers when reviewing their CME arrangements.”

DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General

OIG Compliance Program Guidance for Pharmaceutical Manufacturers Federal Register / Vol. 68, No. 86 / Monday, May 5, 2003

Independence

Industry’s Profession’s





Everyone discloses to Provider

Continue with persons who disclose

Implement a mechanism**i.e. Manage COI by inserting safeguards

against bias.

Standard 2: Resolution of Personal COI


CME decisions free of the control of commercial interest

Commercial interest is not joint sponsor


CME decisions free of the control of commercial interest

Commercial interest is not joint sponsor




against bias.





against bias.


STANDARD 2: Resolution of Personal Conflicts of interest The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners.


The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both

A financial relationship with a commercial interest

andand The opportunity to affect the

content of CME about the products or services of that commercial interest.

How do these circumstances create a conflict of interest?

The potential for increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME – an incentive to insert commercial bias.

How do these circumstances create a conflict of interest?

The potential for increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME – an incentive to insert commercial bias.



Any amount…within the past 12 months…

Types of Relationships Salary Royalty Intellectual property rights Consulting fee Honoraria Ownership interest

(excluding diversified mutual funds)

Other financial benefit

The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both

A financial relationship with a commercial interest

andand The opportunity to affect the

content of CME about the products or services of that commercial interest.

ResolvingResolving the conflict means making sure that the content of the activity is aligned with the interests of the public.

Alter the relationship … so

that the individual no longer has the

financial relationship

Insert safeguards against bias … when the content is relevant

to the commercial interest

ResolvingResolving the conflict means making sure that the content of the activity is aligned with the interests of the public.

Alter the relationship … so

that the individual no longer has the

financial relationship

Insert safeguards against bias … when the content is relevant

to the commercial interest

“It is not the intent of the ACCME to block participation in CME events by all physicians who receive any remuneration from a pharmaceutical or medical device company; and

It is not the intent of the ACCME to adopt a policy whereby conflicts of interest can only be addressed by excluding physicians from participating as planners or teachers in CME activities that might be related to their conflicts of interest.”

Murray Kopelow MD CEO ACCMEAlliance for CME Annual Meeting

January 2004

… must promote improvements or quality in healthcare …

… balanced view ….

ACCME Element 2.4 Measuring Educational

Effectiveness Criteria for Exemplary

Compliance

“ Educational activities are evaluated consistently for effectiveness in meeting identified educational needs, as measured by practice application and/or health status improvement.”

ACCME Element 2.4 Measuring Educational

Effectiveness Criteria for Exemplary

Compliance

“ Educational activities are evaluated consistently for effectiveness in meeting identified educational needs, as measured by practice application and/or health status improvement.”

Standard 5: Content and Format without Commercial Bias

Individuals’ disclosure to learners (including no relationships) prior to activity

Disclosure of commercial support

No use of trade names or product group message in disclosure

Standard 6: Disclosure

In making decisions about implementing the SCS…

“CME providers must be guided by what is in the best interest of the public.”

“…always deferring to Independence

from commercial interests Transparency and CME separate from

product promotion”

…as basic and guiding principles.”

Thank you

Documents

ACCME at the International Pharmaceutical Compliance Summit Philadelphia March 2005