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Keystone Initiative for Prescription Medicine Information Enhancement

Join the effort to improve written information on prescription medicines for low-literate patients. Propose a three-function process, tackle barriers, engage FDA for oversight and education. Support other FDA initiatives to enhance patient understanding. Let's make a difference together.

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Keystone Initiative for Prescription Medicine Information Enhancement

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Presentation Transcript

  1. NCPIE CMI Initiative • Goals • Letter of the Law • Fulfill promise of the Keystone process • Spirit of the Law • Provide useful information for low literate patients

  2. Question 1 • What is the private sector doing to improve the usefulness of written information regarding prescription medicines? • Much has already been done • We propose a three-function process represented by the three Committees

  3. Process • Each Committee provides essential processes, each must coordinate with the others Criteria Education Implementation

  4. Question 2 • What barriers exist, how can they be overcome? • 95% success rate is a very high standard • Logistics/resources in small pharmacies • Lack of technological support • How to apply Keystone criteria for certain medicines? • Additional evolving barriers

  5. Question 3 • What role should FDA have? • Primary • Oversight and evaluation to determine if Keystone goals are met • Additional • Work with private sector to aid process • Criteria – how will FDA interpret/apply Keystone criteria • Education – share views of success and ramifications of not meeting goals • Implementation - how will FDA evaluate success?

  6. Question 4 • What other FDA initiatives are needed? • Usefulness of information for Low Literacy patients • Additional interventions are needed • Research program to learn how to influence behavior • Regulatory Role • Medication Guides • Coordinate with risk management initiatives

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