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 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) 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” 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 Resources for crafting & implementing strong COI policies & curricula at medical schools & academic medical centers Open Payments Program (PPSA) Open Payments Program (PPSA) University of Connecticut SOM University of Connecticut SOM Conflict of Interest Policy Conflict of Interest Policy Conflict of Interest Curriculum Conflict of Interest Curriculum AMSA PharmFree (Just Medicine) Initiative AMSA PharmFree (Just Medicine) Initiative “Hidden” Curriculum “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. Launched by the Pew Charitable Trusts in 2007. Led by Community Catalyst in partnership with the Institute on Medicine as a Profession. Led by Community Catalyst in partnership with the Institute on Medicine as a Profession. Promotes policy change among: Promotes policy change among: Academic Medical Centers Academic Medical Centers Professional Medical Societies Professional Medical Societies Public and Private payers Public and Private payers Seeks to Seeks to Eliminate COI created by industry marketing and Eliminate COI created by industry marketing and Expand the use of evidence-based medicine Expand the use of evidence-based medicine

7. Policy Guide for Academic Medical Centers and Medical Schools * Conflict of Interest Toolkit Competencies Competencies Accept the fact that marketing by pharmaceutical and medical device manufacturers is designed to influence physician behavior 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 Recognize when marketing is occurring, even in the guise of education Acknowledge one’s own COI when unavoidable Acknowledge one’s own COI when unavoidable Effective Teaching Methods Effective Teaching Methods Teaching Opportunities 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: The general competencies can be taught in specific domains including practices related to: Small gifts Small gifts Pharmaceutical samples Pharmaceutical samples CME CME Speakers bureaus Speakers bureaus Ghostwriting and ‘honorary’ authorship Ghostwriting and ‘honorary’ authorship Purchasing/vendor relationships Purchasing/vendor relationships Consulting & research contracts with pharmaceutical & medical device companies 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. 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. 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 - 2001 Source: www.nofreelunch.org The “research-based” drug industry spent > $15.5 billion on promotion - more than it spent on R&D 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 22% employed in R&D vs. 39% in marketing 60 million “details” made by 83,000 drug reps 60 million “details” made by 83,000 drug reps 1,300 reps added by Astra-Zeneca for Nexium 1,300 reps added by Astra-Zeneca for Nexium > $10,000 per year is spent by the pharmaceutical industry on each US physician. > $10,000 per year is spent by the pharmaceutical industry on each US physician. Nearly one PR for every 11 practicing MDs. 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.” “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 Effective Teaching Methods Lecturing - least effective/most often used (84%) Lecturing - least effective/most often used (84%) Small group discussions using case-based examples more likely to be effective. Small group discussions using case-based examples more likely to be effective. Teaching Opportunities Teaching Opportunities Early on emphasizes importance by the faculty Early on emphasizes importance by the faculty Orientation Orientation Courses on Ethics and “Doctoring’ Courses on Ethics and “Doctoring’ Just before students begin their 3 rd year clerkships Just before students begin their 3 rd year clerkships In 4 th year after students finish residency interviews but before match results are known In 4 th year after students finish residency interviews but before match results are known Residency Training Residency Training “No Free Lunch” & supervised encounters with MSR’s “No Free Lunch” & supervised encounters with MSR’s

14. Open Payments Open Payments website: go.cms.gov/openpayments Will create greater transparency around the financial relationships of manufacturers, physicians, and teaching hospitals 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 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 Provides an opportunity for providers & institutions to check the accuracy of info reported about them Access to preliminary data begins in August 2014 Access to preliminary data begins in August 2014 Release dates: Release dates: Aggregate data - September 30, 2014 Aggregate data - September 30, 2014 Detailed data on individuals - January 31, 2015 Detailed data on individuals - January 31, 2015

15. UConn SOM Conflict of Interest Policy* Purpose: to define parameters of appropriate interactions between students & faculty with industry representatives. Purpose: to define parameters of appropriate interactions between students & faculty with industry representatives. Liaison Committee on Medical Education requires affiliation agreements with voluntary physicians. Liaison Committee on Medical Education requires affiliation agreements with voluntary physicians. Adherence to this policy is expected in all educational settings. 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. Scope of Policy Gifts & Meals Gifts & Meals Consulting Relationships Consulting Relationships Industry Sponsored Speakers Industry Sponsored Speakers Disclosure Disclosure Pharmaceutical Samples Pharmaceutical Samples Purchasing & Formularies Purchasing & Formularies Industry Sales Reps Attendance at Industry- Sponsored Lectures & Meetings Industry Support for Scholarships Funds for Trainees Disclosure requirement in SOM Curriculum

18. UConn SOM Conflict Of Interest Curriculum COI covered in COI covered in Orientation Orientation Human Development & Health Human Development & Health PCM 1 PCM 1 Student Professional Competency * Student Professional Competency * Ability to identify potential COI’s arising from Ability to identify potential COI’s arising from The influence of marketing & advertising The influence of marketing & advertising Financial & organizational arrangements 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. 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. Goal: provide a brief introduction to COI issues before students begin SCP.

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

21. ACP Ethics Manual, 6 th Edition Physician-Industry Relations & Gifts Determining Appropriateness What is the purpose of the industry offer? What is the purpose of the industry offer? What would my patients or the public think about this arrangement? What would my patients or the public think about this arrangement? What would my colleagues think about this arrangement? What would my colleagues think about this arrangement? What would I think if my own physician accepted this offer? 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” How would I feel if the relationship was disclosed through the media? “Sunshine Test”

22. Human Development & Health Year 2: Pharmaceutical Law & Policy Part 1: Regulation of drug development, intellectual property & costs of pharmaceuticals Part 1: Regulation of drug development, intellectual property & costs of pharmaceuticals Deals with intellectual property and drug approval processes Deals with intellectual property and drug approval processes Drug licensing & approval process aims to insure safety & efficacy while protecting the interests (patents) of developers. Drug licensing & approval process aims to insure safety & efficacy while protecting the interests (patents) of developers. Part 2: Industry-provider Relationships & COI’s Part 2: Industry-provider Relationships & COI’s Health industry behaviors that create COI’s Health industry behaviors that create COI’s Understand the effects of industry marketing on physician education & practice and Understand the effects of industry marketing on physician education & practice and Marketing’s relationship to medical professionalism 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. 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. 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 Should the student Politely decline lunch & listen to the talk? Politely decline lunch & listen to the talk? Enjoy the food & listen to the talk? Enjoy the food & listen to the talk? Subsequent discussion with preceptor about Subsequent discussion with preceptor about Validity of info provided about the medication Validity of info provided about the medication Relevance of info to a specific patient encountered Relevance of info to a specific patient encountered Pros & Cons of using samples Pros & Cons of using samples

25. Revitalizing Professionalism AMSA’s PharmFree Initiative

26. Revitalizing Professionalism AMSA’s “Just Medicine” Initiative

27. AMSA Just Medicine Campaign Established in 2002 to advocate for Evidence-based rather than marketing-based prescribing practice Evidence-based rather than marketing-based prescribing practice Global access to essential medicines Global access to essential medicines Removal of conflicts of interest in medicine Removal of conflicts of interest in medicine Name changed to “Just Medicine” as it addresses much more than COIs. 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 First released in 2007, revised in 2008 Letter grade assigned to COI Policies at AMC’s 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. 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) Schools adopting ‘strong’ policies (A or B) 30% in 2009 30% in 2009 72% in 2013 !! 72% in 2013 !! We received a ‘B’ on the 2013 Scorecard We received a ‘B’ on the 2013 Scorecard

30. AMSA Scorecard 2013 UConn SOM Commentary Policy significantly improved & is fairly strong overall Policy significantly improved & is fairly strong overall Model domains: Model domains: Gifts & Meals Gifts & Meals Purchasing & Formularies Purchasing & Formularies Industry Support for Scholarships/Funds for trainees Industry Support for Scholarships/Funds for trainees Medical School Curriculum* Medical School Curriculum* Policies specify an oversight mechanism Policies specify an oversight mechanism

31. AMSA Scorecard 2013 UConn SOM Commentary Recommendations for improvement: Recommendations for improvement: Address consulting relationships Address consulting relationships Policy seems mainly aimed at trainee interactions with industry Policy seems mainly aimed at trainee interactions with industry Does not address consulting relationships Does not address consulting relationships Address explicit policies regarding off-site education supported by industry. Address explicit policies regarding off-site education supported by industry. Rather than asking trainees to pay attention to who funds the offsite event, Rather than asking trainees to pay attention to who funds the offsite event, Just prohibit attendance at all industry-supported events Just prohibit attendance at all industry-supported events

32. Scorecard Grade Looks Good But 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. 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”. The AMSA Scorecard project was born from these concerns when a few med students thought, ‘I wonder if medical schools have specific COI policies”.

33. Hidden Curriculum Trainees tend to do as we do, not as we say. Trainees tend to do as we do, not as we say. Actions speak louder than words Actions speak louder than words COI Curriculum should be reflected in all of our academic & clinical activities COI Curriculum should be reflected in all of our academic & clinical activities

34. 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.”

35. In Conclusion Our Institutional COI Policy is strong Our Institutional COI Policy is strong The Medical School COI Curriculum is ‘fairly strong’ and is improving 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. AMSA’s Just Medicine Campaign & Scorecard came primarily from concerns about experiences during clinical rotations. Questions or Comments? ejackson2@stfranciscare.org