1. Conflicts of Interest and Transparency Issues Susan Cantrell Vice President, Resources Development

2. Focus of Today’s Discussion Review some of the recent developments related to potential conflicts of interest that are of concern to associations Discuss implications of and potential mechanisms for minimizing conflicts of interest in continuing pharmacy education

3. Institute of Medicine A conflict of interest is a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. http://iom.edu/CMS/3740/47464/65721.aspx

4. Primary interest = goal of the profession Providing optimal care for patients Ensuring medication safety Advocating public health Secondary interests Earning income Teaching Publishing Volunteering in professional associations Conducting research Pursuing personal interests

5. According to IOM…. All professionals have secondary interests Secondary interests become problematic if they distort or undermine judgments related to an individual’s primary interest.

6. Accreditation Council for Continuing Medical Education When an individual’s interests are aligned with those of a commercial interest, the interests of the individual are in ‘conflict’ with the interests of the public. The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both a financial relationship with a commercial interest and the opportunity to affect the content of CME about the products or services of that commercial interest. http://tinyurl.com/accme-coi

7. Commercial Interest Any entity producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests. A commercial interest is not eligible for ACCME accreditation.

8. Potential Impact of COI in Practice Education – introduction of commercial bias Research – misrepresentation, suppression of data Practice – compromises professional judgment, erodes public trust

9. COI Implications to Associations Board of directors, policy-making bodies Committees Staff CPE faculty, planners

10. Recent Developments Pharma and medical device company fines, settlements for improper payments (http://www.oig.hhs.gov/fraud/cia/cia_list.asp)http://www.oig.hhs.gov/fraud/cia/cia_list.asp Investigations by Senator Grassley High-profile individuals’ failure to disclose industry payments Institute of Medicine Report – Conflicts of Interest in Medical Research, Education, and Practice Physician Payment Sunshine provisions in House and Senate health care bills State laws on gifts and disclosure of physician payments

11. Pharma Public Disclosure Sites CompanyDisclosure Site Amgen http://www.amgen.com/citizenship/donation_list_overview.html Pfizer https://www.pfizer.com/responsibility/grants_payments/support_medical _patient_organizations.jsp GSK http://us.gsk.com/html/responsibility/grants-sponsorship.html Ortho McNeil http://www.ortho-mcneil.com/ortho- mcneil/medicaleducation_transparency.html?siteName=Ortho-McNeil Pricara http://www.pricara.com/pricara/pages/medicaleducation_transparency.js p?siteName=Pricara Ortho McNeil Neurologics https://www.ortho-mcneilneurologics.com/ourgiving_transparency.html Lilly http://www.lillygrantoffice.com/Pages/grant_registry.aspx Merck http://www.merck.com/corporate-responsibility/business-ethics- transparency/ethics-financial-support-third-parties/home.html

12. http://www.ashp.org/DocLibrary/AboutUs/NomElecAppoint/Accepting_Corporate_Support.pdf

14. White House Healthcare Plan Sunshine Provisions Title VI. Transparency and Program Integrity Enhancing Choices with Full Disclosure of Physician Financial Interests To prevent conflicts of interests and insure full transparency and information for patients, the Act requires all drug companies, device, and medical supply manufacturers to fully disclose and report any gifts they make or financial arrangements they have with doctors, a physician practice or group.

15. Conflicts of Interest and Continuing Pharmacy Education

16. Commercial Support for CME, 2008 (millions) Source: ACCME Annual Report Data, 2008

17. Commercial Bias vs. Professional Opinion Commercial Bias: Information presented in a manner that attempts to sway participants’ opinions in favor of a particular commercial product for the express purpose of furthering a commercial entity’s business; a deliberate intent to mislead. Professional opinion: A belief held by an individual based on his or her experience in the practice of health care; no intent to mislead but rather to share knowledge formed from personal experience. Cornish JK, Leist JC. Journal of Continuing Education in the Health Professions. 2006; 26:161-7.

18. ACPE SCS 5.2(a) The provider obtains a signed statement that lists relevant faculty (and others with potential to influence content) conflicts of interest that have the potential to influence an activity.

19. SCS 5.2(b) The provider has policies and procedures to ensure that if an individual refuses to disclose conflicts of interest, they are disqualified from any involvement with the CE activity.

20. SCS 5.2(c) The provider has a mechanism to resolve conflicts of interest and documents the resolution prior to delivery of the educational activity.

21. What is a Relevant Financial Relationship? Relationships in which the individual benefits by receiving salary, royalty, intellectual property rights, consulting fees, honoraria, ownership interest, or other financial benefit. Relationships occurring within the past 12 months. ACCME considers relationships of the person involved in a CME activity to include financial relationships of a spouse or partner.

22. How Can Conflict of Interest Be Managed by the provider? Disclosure of relevant financial relationships to provider. Resolution of conflicts of interest. Disclosure of relevant financial relationships to learners. Assessment of learners’ perception of commercial bias in the activity.

23. Who Has to Disclose? All individuals who are engaged in the planning of a CPE activity, including: Activity chairs Planning committee members Faculty/speakers Authors Moderators Editors Staff

24. How Must Disclosure Information Be Provided? Consult ACPE regarding language in rubric. Completion of Faculty Disclosure Form Orally to staff member, who documents the information in the activity file In writing, with documentation included in file On-line speaker database management system

25. What Information Must Be Provided? Name of commercial interest with whom the relationship exists Nature of relationship (e.g., employee, consultant, research grant recipient, speakers bureau, stockholder) Lack of any relevant relationships Existing relationship or one in which the individual has divested himself or herself

26. Identification and Resolution of COI Who determines that a conflict exists? Staff CPE Committee Peer Review Group Internal External

27. Disclosure Form Received? YesNo Disclosure Information Obtained Another Way Prior to Activity? YesNo Has Control Over Content Discussing Healthcare Products and Services? YesNo Has Financial Relationship(s) With Manufacturers or Service Providers Relative to Product and Services Discussed? YesNo Relationship(s) Disclosed to Participants Conflict of Interest Identified Yes No Conflict Resolved? Yes No Through: Self-Identification, Peer Review, Committee Review, or Other Process Ineligible to Plan/Present Ineligibility Communicated to Faculty Member Eligible to Plan/Present with Restrictions Restrictions Communicated to Faculty Member Eligible to Plan/Present without Restrictions Restrictions? YesNo Resolving Conflict of Interest Decision Tree Participants Evaluate Potential Presence of Bias

28. Potential Mechanisms to Resolve Conflicts of Interest Resolving COIs is the responsibility of the provider, not the person who has the conflict. Planner/Teacher Direction and Restrictions Communication of Standards for Content Development and Presentation Oversight, Peer Review Disqualification Others

29. Faculty Restrictions/Directions Refrain from providing clinical recommendations regarding products or services of a commercial entity Restricted subject matter Specified levels of evidence Divest of the financial interest

30. Disclosure to Learners The following information must be disclosed prior to the delivery of the activity: Name of individual Name of commercial interest(s) and nature of relationship(s) No relevant relationships

31. Participant Evaluation of Bias Perception of Commercial Bias Statements/Recommendations supported by adequate evidence Others Need to have a threshold for investigating complaints of bias and taking measures to prevent it in the future

32. Documentation in Activity File Need to document the mechanism used to resolve COI Document any action taken (e.g., peer review, restrictions on presentation)

33. Sample Bias Question Please indicate the extent to which you agree or disagree with the following statement: “Faculty statements and therapeutic recommendations in this activity were based on supported evidence or professional opinion and did not evidence commercial bias.” If you answered strongly disagree or disagree to question 8, what commercial bias did you perceive in this activity?

34. What Our Participants Are Saying Why the discussion of (drug) at end? Was this best place for it? The actual numbers of side effects were not really given, only characterized as more reactions or less reactions. Too much focus on (drug) but no discussion of risks and AE’s and how it fits in with other therapy. First presenter dismissed the effectiveness of (drug) in the metastatic setting. Presenter should not put personal opinion of regimens into presentation.

35. Summary Increased scrutiny of industry relationships is driving the move to examine COIs and increase transparency CPE providers must have policies and procedures in place and must document Associations should consider developing clear policies on acceptance of support (recommended by IOM) Watch for state legislative actions and changes in hospital/medical school policies