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The KP Med-SMART Isotretinoin Risk Management and Monitoring Program

Richard A. Wagner, Pharm.D. T. Craig Cheetham, Pharm.D., M.S. Kaiser Permanente California February 26, 2004. The KP Med-SMART Isotretinoin Risk Management and Monitoring Program. KP Med-SMART Isotretinoin Program.

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The KP Med-SMART Isotretinoin Risk Management and Monitoring Program

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  1. Richard A. Wagner, Pharm.D. T. Craig Cheetham, Pharm.D., M.S. Kaiser Permanente California February 26, 2004 The KP Med-SMART Isotretinoin Risk Management and Monitoring Program

  2. KP Med-SMART Isotretinoin Program The strategic goals of the isotretinoin risk management and monitoring program The What: • No one should begin isotretinoin therapy if pregnant • No pregnancies should occur while a patient is on isotretinoin therapy The How: • Linkage of dispensing of isotretinoin for female patients to verification of a negative pregnancy test result • Development of a centralized female patient registry with prescription level detail and associated prescriber and pharmacy performance reporting • Development of written operational policies and procedures • Guidelines for the appropriate use of isotretinoin developed and monitored by dermatologists

  3. KP Med-SMART Isotretinoin Program • Kaiser Permanente California is comprised of two regions with a total of 6.1 million California members • Integrated health care delivery system from a financial, operational technological, and cultural standpoint • Kaiser Foundation Hospitals and Kaiser Foundation Health Plan, Inc., are non-profit, community benefit organizations • Two independent Permanente Medical Groups with 8,000 physicians • 29 hospital based medical centers throughout the state • Over 200 outpatient medical offices with over 250 outpatient pharmacies • Over 5,000 pharmacy employees, including over 2,000 pharmacists • 42 million prescriptions provided yearly, including over 24 thousand isotretinoin prescriptions • Deployment of an automated medical record will start in California in 2004 • Extensive experience with care management patient registries

  4. KP Med-SMART Isotretinoin Program • Descriptive Statistics - Female (South) • Dates: January 2002 through November 2003 • Age at first isotretinoin prescription: mean = 25.3 years • Distribution is 49% females • Unique patients:South 2,376 North 2,253 • Prescriptions: South 9,484 North 10,232 • Diagnosis: acne related: 86.3%; cancer diagnosis = 0.5% • Prior isotretinoin (6 months): no = 95%, yes = 5% • Total number of isotretinoin prescriptions: mean = 4, • range 1 - 16 • Day supply per prescription: mean = 31 days • Total days of therapy per patient: mean = 124 days • Previous prior acne therapies (6 months): 64% Tretinoin Topical: 23% Topical Antibiotic: 28% Oral Antibiotic: 47%

  5. KP Med-SMART Isotretinoin Program Med-SMART is a KP web-based application within the KP intranet (not accessible to the public) • Med-SMART acts as a centralized patient (female) registry based on the provision of a isotretinoin prescription from a KP pharmacy (index prescription) • Automatically links pharmacy, laboratory, and patient demographic data; refreshed weekly • Allows for transactional inputting of data to accommodate the “yellow” sticker, other stickers, and non-KP providers • Compares medical center performance over time and between medical centers; data is current • Download data into Excel format for custom local reporting • Security and limited access to protect confidential patient and provider information

  6. KP Med-SMART Isotretinoin Program

  7. KP Med-SMART Isotretinoin Program “Health care organizations are complex adaptive systems.” A collection of individual agents who have the freedom to act in ways that are not always totally predictable, and whose actions are interconnected such that one agent’s actions change the context for other agents.-- Paul E. Plsek Simple Complicated Complex

  8. Contrasting Issues in Diffusion of Innovation

  9. Rules for Disseminating Innovations in Health Care • Find sound innovations • Find and support innovators • Invest in early adopters • Make early adopter activity observable • Trust and enable reinvention • Create slack for change • Lead by example • --Berwick, JAMA 2003;289:1969

  10. KP Med-SMART Isotretinoin Program Why Does this Work? • Physician/Pharmacist buy-in and commitment: leadership support • Cultural alignment • Clinical Guidelines for Appropriate Use • Operational Policies and Procedures can be localized (reinvention) • Technology and Data: readily available and real time • Performance Monitoring and Reporting: regional, medical center, pharmacy, specialty, prescriber, patient level • Exception process with documentation: common sense needs to prevail • Quality issues are reviewed locally through existing structures and processes (peer review)

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