1. The Prescription Project: Ending Conflicts of Interest; Promoting Evidence-Based Prescribing Marcia Hams, Director of Prescription Policy Initiatives The Prescription Project National State Attorneys General Program Columbia Law School, 5/10/07

2. The Prescription Project is a collaboration of Community Catalyst and The Institute on Medicine as a Profession Funded by Pew Charitable Trusts

3. 3 Community Catalyst is a national non-profit advocacy organization established in 1997 to increase consumer participation in shaping the U.S. health care system to ensure quality, affordable health care for all. It works in numerous states with state and local organizations as well as other national organizations. Community Catalyst Community Catalyst

4. 4 The Institute on Medicine as a Profession seeks to shape a world inside and outside of medicine that is responsive to the ideals of professionalism. IMAP supports research on the past, present, and future roles of professionalism in guiding individual and collective behavior. It aims to make professionalism relevant to physicians, leaders of medical organizations, policy analysts, public officials, and consumers. IMAP’s programmatic agenda is carried out through the Center on Medicine as a Profession of Columbia University. Institute on Medicine as a Profession Institute on Medicine as a Profession

5. 5 www.prescriptionproject.org

6. 6 Out of control industry marketing Industry influence in government Quality of care compromised Pharmaceutical costs out of control Consumers can’t afford their drugs The Problem

7. 7 Industry spends $12B/year on drug marketing to MDs ($13,000/MD) 90,000 sales reps (1 for every 5 MDs) Gifts, lunches, trips, educational grants, entertainment, free samples Rx Marketing to Doctors

8. 8 Even small gifts create obligation and influence prescribing decisions Free samples create loyalty to brand Newest, least tested, drugs promoted and often prescribed Impact of marketing on prescribing

9. 9 Marketing is 30% of cost of drugs Only 10-15% spent on R&D Expensive me-too drugs over prescribed Generics under prescribed; cost 30-80% less than brand names 17% of cost increases due to switches to more expensive drugs Impact on costs Impact on costs

10. 10 Prescription Project Goals Reduce conflicts of interest created by the pharmaceutical industry’s marketing practices in the medical profession and among payers Increase reliance on evidence-based prescribing among providers and purchasers

11. 11 Prescription Project Strategy Advance practical public and private policy solutions to meet these goals among: –academic medical centers –medical professional societies –public and private purchasers –providers –policy makers/regulators –consumers and advocates

12. 12 Drivers of Prescription Reform Consumers want access & affordability Media and public opinion Public and private payers seek to preserve programs and benefits States seek to sustain expansions of coverage/benefits MDs and other providers who seek to reestablish trust in medicine The Quality Movement

13. 13 Reducing Conflicts of Interest: Self-Regulation Academic Medical Centers Professional Medical Societies (which also publish Clinical Practice Guidelines) Hospitals and group practices

14. 14 Journal of the American Medical Association January 25, 2006 (2006; 295: 429-433)

15. 15 Recommendations to Academic Medical Centers for Controlling Conflicts of Interest ActivityRegulation Gifts, meals directly to physician from industry Eliminate Provision of free samples, other patient-use products Vouchers, other indirect distribution system Speakers ’ Bureaus and Ghostwriting Eliminate Payment for physician and trainee travel Contributions to a conflict- free central facility

16. 16 Recommendations to Academic Medical Centers for Controlling Conflicts of Interest ActivityRegulation Direct support for CMEContributions to a conflict- free central facility Consulting, speaking honoraria, and research contracts Transparency; Specify terms of service and be available for public inspection Formulary and other purchasing decisions Decision-makers must be conflict free

17. 17 Conflicts of Interest: Public Policy Solutions Vermont statute (2002): Disclosure. Reports by AG on amounts to MDs (by specialty, not name) Minnesota statute (1993): $50 limit for gifts but many exemptions; disclosures published by Board of Pharmacy Maine (2003): disclosure of expenses>$25 West Virginia (2004): Broad disclosure but no individual MD names

18. 18 Evidence-based prescribing Expand reliance on evidence-based systematic reviews Expand use of generics Implement academic/counter detailing Prohibit sale of prescriber data for industry marketing

19. 19 Promote evidence-based reviews to shape prescribing: public sector Promote evidence-based reviews to shape prescribing: public sector Expand use of Drug Effectiveness Review Project to shape Preferred Drug Lists; now in13 states Statutory requirements to use EBM as basis for public purchasing (WA ’05; proposed in VT and MA ‘07)

20. 20 Promote evidence-based reviews to shape prescribing: private sector Promote evidence-based reviews to shape prescribing: private sector Create standards for accountability Minnesota Coalition utilizing DERP based CRBestBuyDrugs Health plan/insurer/employer interest Public/Private partnerships: Puget Sound Health Alliance

21. 21 Academic/Counter Detailing Public Programs & Payers Academic/Counter Detailing Public Programs & Payers Pennsylvania senior Rx PACE program (rigorous evaluation underway) West Virginia and Vermont New legislation proposed in Proposed in VT, ME and MA. New Hampshire interested.

22. 22 Academic Detailing/MD Education Private Payers Academic Detailing/MD Education Private Payers Kaiser, Health Partners in-house Potential for employer interest Minnesota Coalition/payers using CRBest BuyDrugs for MD education Proposed ME and MA bills allows for private plans to subscribe to public initiative

23. 23 Academic Detailing: Evaluation and Best Practices Show Me the Evidence: Best practices for using educational visits to promote evidence-based prescribing  A two-year evaluation program from May 2004 to April 2006  By the Canadian Academic Detailing Collaboration and Drug Policy Futures

24. 24 Programs Evaluated in the U.S. and Canada Kaiser Permanente, Colorado; Brigham and Women’s Hospital, Harvard Medical School; Accessible Intelligent Medication Strategies, West Virginia; Veterans Administration, Greater Los Angeles B.C. Community Drug Utilization Program; Alberta Drug Utilization Program; RxFiles Academic Detailing Program, Saskatchewan; Prescription Information Services of Manitoba; Dalhousie Academic Detailing Service, Nova Scotia

25. 25 Evaluation conclusions (1) Academic detailing is working  Effectively influences prescribing practices  Randomized controlled trials show improvements in the performance of health professionals receiving visits from academic detailers Success is dependent on the credibility of the program and the detailers

26. 26 Evaluation conclusions (2) Well-produced printed materials and handouts are useful to physicians Costs to provide academic detailing services vary widely and depend on a number of factors An evidence-based approach to medicine is increasingly important to physicians Academic detailing programs should be more thoroughly evaluated to strengthen programs

27. 27 Maine LD 839 Will establish an academic detailing program Targets prescribers and dispensers participating in publicly funded health programs

28. 28 Maine LD 839 cont. Requires investigation of partnership with VT and NY; and a review of Pennsylvania’s program Program design phase will include all stakeholders, including the MaineCare Advisory Committee and the MaineCare Drug Utilization Review Committee

29. 29 Maine LD 839: Funding Maine LD 839: Funding Pharmaceutical manufacturer payments to the State Tobacco Manufacturers Act General Fund Savings the program itself generates

30. 30 Vermont S.115: Comprehensive Rx Legislation Will establish a preferred drug list based on Evidence Based Medicine and a prior authorization system for state programs Bans the sale of prescriber information unless the physician explicitly “opts-in” Requires PBM transparency and establishes required practices

31. 31 Vermont S.115 cont. Establishes an annual $1,000 manufacturer fee for each pharmaceutical company selling prescription drugs to state programs Establishes a pharmacy discount plan for certain seniors and individuals below a specified income threshold Prohibits “unconscionable pricing”

32. 32 Vermont S.115 cont. Establishes an evidence-based prescription drug education program for state program health care professionals  There may be collaboration with other states in establishing the program  Includes establishment of a pilot program to provide generic drug samples

33. 33 Massachusetts Cost/Quality bill: Rx sections Establishes Evidence Based Medicine as basis for MassHealth Preferred Drug List Establishes joint purchasing consortium for all state agencies that adopt this PDL Establishes academic detailing Prohibits sale of prescriber data for pharmaceutical marketing Establishes clinical trials registry

34. 34 Academic Detailing Funding Academic Detailing Funding Start-up funding is difficult, particularly for small Medicaid programs, despite expected future savings Medicaid state funds matched by federal funds Potential for use of settlement funds in pharmaceutical cases?

35. 35 Contact Us: The Prescription Project 30 Winter St. 10 th Floor Boston, MA 02108 www.prescriptionproject.org Main Office (Boston): 617-275-2853 New York Office: 212-305-4184