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Conflict of Interest Curriculum

Conflict of Interest Curriculum. Eric Jackson, PharmD University of Connecticut School of Medicine Department of Family Medicine. Disclosure.

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Conflict of Interest Curriculum

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  1. Conflict of Interest Curriculum Eric Jackson, PharmD University of Connecticut School of Medicine Department of Family Medicine

  2. 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.

  3. Importance of Topic • 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”

  4. Topics to Cover • 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 • AMSA PharmFree (Just Medicine) Initiative • “Hidden” Curriculum

  5. RESOURCES Crafting and Implementing Strong COI Policies

  6. The Prescription Project Advancing Medical Practice and Policy • 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: • Academic Medical Centers • Professional Medical Societies • Public and Private payers • Seeks to • Eliminate COI created by industry marketing and • Expand the use of evidence-based medicine

  7. Policy Guide for Academic Medical Centers and Medical Schools* Conflict of Interest Toolkit • Competencies • 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 • Effective Teaching Methods • Teaching Opportunities *March 2013/Conflict-of-Interest Curricula/Community Catalyst

  8. COI Curriculum Toolkit - continued • 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

  9. Attitudes About Gifts “That stuff doesn’t influence me at all. I don’t even remember the name of the drug on my pen.” • 85% of medical students in one study believed it improper for politicians to accept a gift. • 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.

  10. US Pharmaceutical Facts - 2001Source: www.nofreelunch.org • 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 • 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.

  11. How Does Pharma Market Its Drugs & How Much Does it Spend?

  12. CME vs. Pharmaceutical Marketing • “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)

  13. COI Curriculum Toolkit - continued • Effective Teaching Methods • Lecturing - least effective/most often used (84%) • Small group discussions using case-based examples more likely to be effective. • Teaching Opportunities • Early on emphasizes importance by the faculty • 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 • “No Free Lunch” & supervised encounters with MSR’s

  14. Open PaymentsOpen Payments website: go.cms.gov/openpayments • Will create greater transparency around the financial relationships of manufacturers, physicians, and teaching hospitals • 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 • Access to preliminary data begins in August 2014 • Release dates: • Aggregate data - September 30, 2014 • Detailed data on individuals - January 31, 2015

  15. UConn SOMConflict of Interest Policy* • 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

  16. 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

  17. Gifts & Meals Consulting Relationships Industry Sponsored Speakers Disclosure Pharmaceutical Samples Purchasing & Formularies Industry Sales Reps Attendance at Industry-Sponsored Lectures & Meetings Industry Support for Scholarships Funds for Trainees Disclosure requirement in SOM Curriculum Scope of Policy

  18. UConn SOMConflict Of Interest Curriculum • COI covered in • Orientation • Human Development & Health • PCM 1 • Student Professional Competency* • Ability to identify potential COI’s arising from • The influence of marketing & advertising • Financial & organizational arrangements *Included under ‘Integrity’ in the Code of Professionalism for Medical Students

  19. Orientation 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.

  20. Human Development & HealthYear 1: Health Law & Ethics • First session (2 hours): • Introduction & Overview of HLE • Doctors, Patients & Society • One Goal: • Recognize legal & ethical issues as part of dynamic relationships between doctor-patient and doctor-society • Assigned Reading for first session • ACP Ethics Manual: Ann Intern Med 2012;156:73-104.

  21. ACP Ethics Manual, 6th EditionPhysician-Industry Relations & Gifts 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”

  22. Human Development & HealthYear 2: Pharmaceutical Law & Policy • Part 1: Regulation of drug development, intellectual property & costs of pharmaceuticals • 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 • Health industry behaviors that create COI’s • Understandthe 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

  23. PCM 1 • Group discussion using scenarios to get students thinking about the complexities of clinician-pharmaceutical 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”

  24. Pharm Rep Lunch Scenario • Should the student • Politely decline lunch & listen to the talk? • Enjoy the food & listen to the talk? • 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

  25. Revitalizing ProfessionalismAMSA’s PharmFree Initiative

  26. Revitalizing ProfessionalismAMSA’s “Just Medicine” Initiative

  27. AMSA Just Medicine Campaign 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.

  28. Just Medicine Scorecard(AMSA & The Pew Charitable Trusts) • First released in 2007, revised in 2008 • Letter grade assigned to COI Policies at AMC’s • Based on implementation of recommendations in the AAMC Report on Industry Funding of Medical Education to mitigate/eliminate COI’s. • Schools adopting ‘strong’ policies (A or B) • 30% in 2009 • 72% in 2013 !! • We received a ‘B’ on the 2013 Scorecard

  29. AMSA Scorecard 2013UConn SOM Commentary • 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

  30. AMSA Scorecard 2013UConn SOM Commentary • Recommendations for improvement: • Address consulting relationships • Policy seems mainly aimed at trainee interactions with industry • Does not address consulting relationships • 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

  31. Scorecard Grade Looks GoodBut What About the “Hidden Curriculum”? • 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”.

  32. Hidden Curriculum • 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

  33. Just Medicine FellowComment 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.”

  34. In Conclusion • 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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