"Conflict of Interest Curriculum" slide set

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Conflict of Interest
Curriculum
Eric Jackson, PharmD
University of Connecticut School of Medicine
Department of Family Medicine
Disclosure
I currently have no relationships of any kind
with any company whose products or
services in any way relate to the practice of
medicine, medical education or research.
Importance of Topic
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Our Institution’s COI Policy applies to both
GME and UME
Implementation of the ACA and need for
faculty to comply with Open Payments
(Physician Payments Sunshine Act)
Need to address the so-called “Hidden
Curriculum”
Topics to Cover
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Resources for crafting & implementing strong
COI policies & curricula at medical schools &
academic medical centers
Open Payments Program (PPSA)
University of Connecticut SOM
Conflict of Interest Policy
 Conflict of Interest Curriculum
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AMSA PharmFree (Just Medicine) Initiative
“Hidden” Curriculum
RESOURCES
Crafting and Implementing Strong
COI Policies
The Prescription Project
Advancing Medical Practice and Policy
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Launched by the Pew Charitable Trusts in 2007.
Led by Community Catalyst in partnership with the
Institute on Medicine as a Profession.
Promotes policy change among:
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Academic Medical Centers
Professional Medical Societies
Public and Private payers
Seeks to
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Eliminate COI created by industry marketing and
Expand the use of evidence-based medicine
Policy Guide for Academic Medical
Centers and Medical Schools*
Conflict of Interest Toolkit
Competencies
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Accept the fact that marketing by pharmaceutical and
medical device manufacturers is designed to influence
physician behavior
Recognize when marketing is occurring, even in the guise
of education
Acknowledge one’s own COI when unavoidable
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Effective Teaching Methods
Teaching Opportunities
*March
2013/Conflict-of-Interest Curricula/Community Catalyst
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COI Curriculum Toolkit - continued
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The general competencies can be taught in
specific domains including practices related to:
Small gifts
 Pharmaceutical samples
 CME
 Speakers bureaus
 Ghostwriting and ‘honorary’ authorship
 Purchasing/vendor relationships
 Consulting & research contracts with pharmaceutical
& medical device companies
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Attitudes About Gifts
“That stuff doesn’t influence me at all. I don’t even
remember the name of the drug on my pen.”
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85% of medical students in one study believed it
improper for politicians to accept a gift.
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Only 46% thought it improper for them to accept gifts
of similar value from a drug company.
Palmisano P et al. J Med Edu 1980;55:453-5.
US Pharmaceutical Facts - 2001
Source: www.nofreelunch.org
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The “research-based” drug industry spent > $15.5
billion on promotion - more than it spent on R&D
22% employed in R&D vs. 39% in marketing
60 million “details” made by 83,000 drug reps
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1,300 reps added by Astra-Zeneca for Nexium
> $10,000 per year is spent by the pharmaceutical
industry on each US physician.
Nearly one PR for every 11 practicing MDs.
How Does Pharma Market Its Drugs &
How Much Does it Spend?
CME vs. Pharmaceutical Marketing
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“Medical education is a powerful tool that can
deliver your message to key audiences and get
those audiences to take action that benefits your
product.”
Spokesman for a Medical Education and Communication
Company (MECC)
COI Curriculum Toolkit - continued
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Effective Teaching Methods
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Lecturing - least effective/most often used (84%)
Small group discussions using case-based examples more
likely to be effective.
Teaching Opportunities
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Early on emphasizes importance by the faculty
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Orientation
Courses on Ethics and “Doctoring’
Just before students begin their 3rd year clerkships
In 4th year after students finish residency interviews but
before match results are known
Residency Training
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“No Free Lunch” & supervised encounters with MSR’s
Open Payments
Open Payments website: go.cms.gov/openpayments
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Will create greater transparency around the financial
relationships of manufacturers, physicians, and teaching
hospitals
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Makes no assumptions nor draws conclusions about
information being collected & reported by industry
Provides an opportunity for providers & institutions to check
the accuracy of info reported about them
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Access to preliminary data begins in August 2014
Release dates:
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Aggregate data - September 30, 2014
Detailed data on individuals - January 31, 2015
UConn SOM
Conflict of Interest Policy*
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Purpose: to define parameters of appropriate
interactions between students & faculty with
industry representatives.
Liaison Committee on Medical Education
requires affiliation agreements with voluntary
physicians.
Adherence to this policy is expected in all
educational settings.
*Included
in Academic Policies and Procedures Manual – Updated 7/3/13
COI Policy Statement
Any interaction between members involved with
the undergraduate medical education program
and industry representatives which are or could
be perceived as COI’s must be disclosed and
appropriately managed
Scope of Policy
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Gifts & Meals
Consulting Relationships
Industry Sponsored
Speakers
Disclosure
Pharmaceutical Samples
Purchasing &
Formularies
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Industry Sales Reps
Attendance at IndustrySponsored Lectures &
Meetings
Industry Support for
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Scholarships
Funds for Trainees
Disclosure requirement
in SOM Curriculum
UConn SOM
Conflict Of Interest Curriculum
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COI covered in
Orientation
 Human Development & Health
 PCM 1
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Student Professional Competency*
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Ability to identify potential COI’s arising from
The influence of marketing & advertising
 Financial & organizational arrangements
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*Included under ‘Integrity’ in the Code of Professionalism for Medical Students
Orientation
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Planned for next year
One hour session using team-based learning to
assess initial understanding, provide some
learning materials, have students work as a team
through a typical case that they may encounter
as a first year student, and then to end with a
post-test.
Goal: provide a brief introduction to COI issues
before students begin SCP.
Human Development & Health
Year 1: Health Law & Ethics
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First session (2 hours):
Introduction & Overview of HLE
 Doctors, Patients & Society
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One Goal:
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Recognize legal & ethical issues as part of dynamic
relationships between doctor-patient and doctor-society
Assigned Reading for first session
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ACP Ethics Manual: Ann Intern Med 2012;156:73-104.
ACP Ethics Manual, 6th Edition
Physician-Industry Relations & Gifts
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Determining Appropriateness
What is the purpose of the industry offer?
What would my patients or the public think about this
arrangement?
What would my colleagues think about this
arrangement?
What would I think if my own physician accepted this
offer?
How would I feel if the relationship was disclosed
through the media? “Sunshine Test”
Human Development & Health
Year 2: Pharmaceutical Law & Policy
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Part 1: Regulation of drug development, intellectual
property & costs of pharmaceuticals
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Deals with intellectual property and drug approval processes
Drug licensing & approval process aims to insure safety &
efficacy while protecting the interests (patents) of developers.
Part 2: Industry-provider Relationships & COI’s
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Health industry behaviors that create COI’s
Understand the effects of industry marketing on physician
education & practice and
Marketing’s relationship to medical professionalism
*
Both parts are required for top score on Curriculum in AMSA Scorecard
PCM 1
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Group discussion using scenarios to get students
thinking about the complexities of clinicianpharmaceutical industry interactions.
Most students interact with Pharm reps from the
moment they start having clinical encounters & have
seen the gifts (big & small) reps leave at clinical sites.
One scenario has a student reporting to his SCP on a
Tuesday afternoon just in time for lunch provided by
a rep detailing his new BP lowering med “Tekturna”
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Pharm Rep Lunch Scenario
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Should the student
Politely decline lunch & listen to the talk?
 Enjoy the food & listen to the talk?
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Subsequent discussion with preceptor about
Validity of info provided about the medication
 Relevance of info to a specific patient encountered
 Pros & Cons of using samples
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Revitalizing Professionalism
AMSA’s PharmFree Initiative
Revitalizing Professionalism
AMSA’s
“Just Medicine” Initiative
AMSA Just Medicine Campaign
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Established in 2002 to advocate for
Evidence-based rather than marketing-based
prescribing practice
Global access to essential medicines
Removal of conflicts of interest in medicine
Name changed to “Just Medicine” as it
addresses much more than COIs.
Just Medicine Scorecard
(AMSA & The Pew Charitable Trusts)
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First released in 2007, revised in 2008
Letter grade assigned to COI Policies at AMC’s
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Schools adopting ‘strong’ policies (A or B)
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Based on implementation of recommendations in the
AAMC Report on Industry Funding of Medical Education
to mitigate/eliminate COI’s.
30% in 2009
72% in 2013 !!
We received a ‘B’ on the 2013 Scorecard
AMSA Scorecard 2013
UConn SOM Commentary
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Policy significantly improved & is fairly strong
overall
Model domains:
Gifts & Meals
 Purchasing & Formularies
 Industry Support for Scholarships/Funds for
trainees
 Medical School Curriculum*
 Policies specify an oversight mechanism
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AMSA Scorecard 2013
UConn SOM Commentary
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Recommendations for improvement:
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Address consulting relationships
Policy seems mainly aimed at trainee interactions with
industry
 Does not address consulting relationships
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Address explicit policies regarding off-site education
supported by industry.
Rather than asking trainees to pay attention to who funds
the offsite event,
 Just prohibit attendance at all industry-supported events
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Scorecard Grade Looks Good
But What About the “Hidden Curriculum”?
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During the clinical years of medical school,
students often see concerning interactions,
opinions, & expectations when it comes to
attending/resident/student interactions &
relationships with industry.
The AMSA Scorecard project was born from
these concerns when a few med students
thought, ‘I wonder if medical schools have
specific COI policies”.
Hidden Curriculum
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Trainees tend to do as we do, not as we say.
Actions speak louder than words
COI Curriculum should be reflected in all of our
academic & clinical activities
Just Medicine Fellow
Comment on the Scorecard
“My hope is that pre-med applicants
look at the Scorecard to gauge the
values and interests of the medical
schools they apply to.”
In Conclusion
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Our Institutional COI Policy is strong
The Medical School COI Curriculum is ‘fairly
strong’ and is improving
AMSA’s Just Medicine Campaign & Scorecard
came primarily from concerns about experiences
during clinical rotations.
Questions or Comments?
ejackson2@stfranciscare.org
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