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Keystone

Written Patient Information

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Keystone

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    1. Keystone / Action Plan Compliance

    2. Written Patient Information 1970s to Present Required by FDA for oral contraceptives and certain hormones (1970) FDA Proposed Rule - Patient Package Insert (PPI) (1979) Withdrawn (1982) MedGuide Proposal (1995-1996) Public Law 104-180 (1996)

    3. PL 104-180: Development of the Action Plan Criteria The Action Plan For the Provision of Useful Prescription Medicine Information (Keystone Guidelines) Development of Keystone Criteria and Useful CMI

    4. CMI Evaluation Survey 2001 Significant variability in CMI quality Key information missing from some drug monographs

    5. CMI Evaluation Current Status Survey 2007: With a few exceptions, the format of CMI currently being distributed has not significantly changed since the last survey in 2001 Clinical Content Issues Format Issues

    6. CMI Evaluation - Survey 2007 FDA Survey Criteria for Action Plan Compliant CMI Format Content Distribution

    7. BARRIERS TO A SUCCESSFUL 2007 SURVEY Customer Perception of Increased Costs Workflow Concerns Rx Label / Form Changes Current Lack of Regulatory Enforcement Mindset / Attitude

    8. SURVEY 2007: Consequences Of Non-Compliance Regulatory / Financial Further unfunded Congressional / FDA mandates Potential loss of database providers as a source of efficiently updated clinical information Burden for obtaining Up-To-Date CMI could shift to system vendors / pharmacies

    9. SURVEY 2007: Consequences Of Non-Compliance Regulatory / Financial A Medication Guide for Every Drug? Loss of Financial Control

    10. SURVEY 2007: Consequences Of Non-Compliance Legal Liability Regulatory / Governmental Civil Liability

    11. SURVEY 2007: Benefits of Success Preserve Your Bottom Line $$ Avoid further UNPREDICTABLE Congressional / Regulatory action Reduce Legal Pitfalls Associated with Non-Compliance Retain Database Provider Relationships for Operational / Quality Control

    12. SURVEY 2007: Benefits of Success Electronic MedGuide Distribution Preserve Patient Safety

    13. OVERCOMING THE BARRIERS: Current Status Action Plan Compliant CMI for Content and Format Workflow Solutions

    14. OVERCOMING THE BARRIERS: What Else Must Be Done? We Must ALL Work Together to Facilitate Action Plan Compliance and the Success of the 2007 Survey Database Providers Pharmacy Label Vendors Professional Associations Including ASAP, NACDS, NCPA, NCPIE Chains / Self Programmers Pharmacy Software Vendors Independent / Small Chain Pharmacies

    15. Thank You !

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