UCDHS Vendor Relations Policy Development & Implementation

1. UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin, MD - Chief Medical Officer Timothy Albertson, MD,MHP, PhD - Professor/Division Chief Garen Wintemute, MD,MHP – Professor, Emergency Medicine

2. Our Goals for Sharing • Vendor Policy Development • Vendor Policy Implementation • Bumps in the Road • Where we are today • Best Practices – Campus Sharing & Q/A

3. Starting Points • JAMA Article, P&T Committee (sub), Pharma Code • Systemwide start • Medical Staff, P&T - whose decision was it to extend the definition of “vendor” to include all, rather then just health care vendors. • Policy Rollout • Industry Relations Committee (IRC) development

4. UCDHS Vendor Relations • Background on Development • JAMA Article • Pharma Code • Dr. Wintemute’s interest/guts to move forward • His foresight for soliciting Dr. Albertson for assistance as the Chair of the P&T Committee • P&T appoints a sub-committee for recommendations

5. P&T Sub-Committee • Important acknowledgement that ownership of the recommendations being made were done through a Medical Staff Committee • Vendor relations would apply to “all” vendors, not only health care related • Recognizing existing policies that covered COI, financial interest, preceptorships and manufacturer relations • Appointment of Dr. Albertson to the newly formed UCOP committee to develop systemwide vendor policy

6. UCOP Vendor Committee • Early draft of the UCOP policy was used to initiate the UCDHS Vendor Policy. • P&T subcommittee recommendation to the Dean who codified the policy. • Presentation to Governing Body • UCDHS Vendor Relations Policy approved • Recognition that the success of this policy would require transparency and buy-in from the bottom-up.

7. Policy Implementation Rollout • CMO/CCO, Allan Siefkin, MD committed to education • Peer Pressure – Evolutionary change from the bottom • Transparency and light on the subject

8. Rollout CMO/CCO Plan • Six months prior to policy implementation the campaign began • Periodic Email Notifications • Education • Focus Groups • Medical Staff • Department Managers, Department CAO’s, Nursing • Individual Department Faculty/Resident Meetings • Marketing & Fundraising personnel • Early version of FAQ’s developed and distributed

9. Important Notes • Transparency • Peer pressure – Evolutionary change • Concerns about implications for clinical research and the need to maintain industry relationships to further science and funding

10. System Developments/Components • P&T Committee • Products and Standardization Committee • Value Analysis Committee • Medical Staff Committee • Collaborative committee with the hospital • Emphasis on supply purchasing for the OR

11. Concerns about the Vendor Relations Policy from Faculty, Residents and Staff • Food - need to budget or obtain unrestricted funds • Samples – Most had been removed due to stricter Joint Commission requirements • Additional need for samples imposed a need for policy requiring Pharmacy to receive and distribute • Recognized Pharma Patient Assistance Programs • No distribution to any individual

12. Supporting Mission • Care – Research • Important reminder for faculty related to: • speakers’ bureaus • compensation plan • consulting/outside professional activities

13. Recognized Need • Based on the number of questions to various sources throughout the institution • Need to coordinate • Need to provide direct source • Establish formal committee to address questions about Vendor Policy implementation • Ability for physicians to “plug-in”

14. Dean’s Recommendation • Industry Relations • Committee Charge: • This committee is advisory to the Vice Chancellor of Human Health Sciences and reports to the UCDHS Executive Compliance Committee to draft directives and review health system policy; provide resources and direction to faculty and administration; review annual faculty conflict of interest disclosure statements; review teaching, and professional service arrangements or proposals; and field questions and inquiries related to conflict of commitment, conflict of interest and vendor relations for faculty and staff. • Conduct substantive review of issues presented. • Recommend changes or restrictions in the project and/or recommend changes to manage, reduce or eliminate potential conflicts of interest. • Recommendation whether the grant, contract, or gift should be accepted. • The committee will meet monthly and may conduct business outside of regularly scheduled meetings when the Chair of the Committee deems necessary.

15. Best for Last - Interactive Sharing • Open Sharing