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 ProgramColumbia Law School, 5/10/07

The Prescription Project is a collaboration of

Community Catalyst andThe Institute on Medicine as a

Profession Funded by Pew Charitable Trusts

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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 CatalystCommunity Catalyst

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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 Institute on Medicine

as a Profession as a Profession

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www.prescriptionproject.org

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• 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 ProblemThe Problem

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• 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 Rx Marketing to DoctorsDoctors

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• 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 Impact of marketing on prescribing on prescribing

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• 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

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Prescription Project GoalsPrescription 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

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Prescription Project StrategyPrescription 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

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Drivers of Prescription ReformDrivers 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

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Reducing Conflicts of Interest:Reducing Conflicts of Interest:Self-RegulationSelf-Regulation

• Academic Medical Centers• Professional Medical Societies

(which also publish Clinical Practice Guidelines)

• Hospitals and group practices

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Journal of the American Medical Association January 25, 2006

(2006; 295: 429-433)

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Recommendations to Academic Recommendations to Academic Medical Centers for Controlling Medical Centers for Controlling

Conflicts of InterestConflicts of InterestActivity Regulation

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

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Recommendations to Academic Recommendations to Academic Medical Centers for Controlling Medical Centers for Controlling

Conflicts of InterestConflicts of InterestActivity Regulation

Direct support for CME Contributions 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

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Conflicts of Interest: Conflicts of Interest: Public Policy Solutions 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

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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

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Promote evidence-based Promote evidence-based reviews to shape reviews to shape

prescribing: public sectorprescribing: 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)

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Promote evidence-based Promote evidence-based reviews to shape prescribing: reviews to shape prescribing:

private sectorprivate sector • Create standards for accountability

• Minnesota Coalition utilizing DERP based CRBestBuyDrugs

• Health plan/insurer/employer interest

• Public/Private partnerships: Puget Sound Health Alliance

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Academic/Counter Detailing Academic/Counter Detailing Public Programs & PayersPublic 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.

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Academic Detailing/MD Academic Detailing/MD Education Private PayersEducation 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

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Academic Detailing: Academic Detailing: Evaluation and Best PracticesEvaluation 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 2006By the Canadian Academic Detailing

Collaboration and Drug Policy Futures

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Programs Evaluated in the Programs Evaluated in the U.S. and CanadaU.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

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Evaluation conclusionsEvaluation conclusions (1) (1)

• Academic detailing is workingEffectively influences prescribing practicesRandomized 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

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Evaluation conclusionsEvaluation conclusions (2) (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

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Maine LD 839Maine LD 839

• Will establish an academic detailing program

• Targets prescribers and dispensers participating in publicly funded health programs

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Maine LD 839Maine LD 839 cont. 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

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Maine LD 839Maine LD 839: Funding: Funding

• Pharmaceutical manufacturer payments to the State

• Tobacco Manufacturers Act

• General Fund

• Savings the program itself generates

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Vermont S.115: Vermont S.115: Comprehensive Rx LegislationComprehensive 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

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Vermont S.115 Vermont S.115 cont.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”

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Vermont S.115Vermont S.115 cont. 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 programIncludes establishment of a pilot program to

provide generic drug samples

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Massachusetts Massachusetts Cost/Quality bill: Rx sections 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

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Academic Detailing FundingAcademic 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?

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Contact Us:Contact Us:

The Prescription Project 30 Winter St. 10th Floor

Boston, MA 02108www.prescriptionproject.org

Main Office (Boston): 617-275-2853 New York Office: 212-305-4184