accme at the international pharmaceutical compliance summit philadelphia march 2005
TRANSCRIPT
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
‘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
‘Mission critical’ that CME be…
Linked to quality and safety Effective in improving practice Based on valid content Independent of commercial interests
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
‘Mission critical’ that CME be…
Linked to quality and safety Effective in improving practice Based on valid content Independent of commercial interests
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
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.”
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
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.”
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
Standard 1: Independence
CME decisions free of the control of commercial interest
Commercial interest is not joint sponsor
Standard 1: Independence
CME decisions free of the control of commercial interest
Commercial interest is not joint sponsor
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
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
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.
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.
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.
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.
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