|(Bethesda, MD) -- The National Council on Patient Information and Education (NCPIE), a broad-based coalition of organizations committed to improving communication about the appropriate use of medicines, today presented to the U.S. Food and Drug Administration a comprehensive plan to ensure that consumers receive useful information about prescription medicines.
"NCPIE has stepped forward to serve as catalyst and convener to stimulate voluntary, private sector efforts to ensure that goals of Public Law 104-180 are met," said Linda Golodner, NCPIE Chairperson and President of the National Consumers League. Enacted in 1996, this law resulted in the Action Plan for the Provision of Useful Prescription Medicine Information (Action Plan). NCPIE served on the committee that drafted this Action Plan, approved in 1997 by then-Secretary of HHS, Donna Shalala.
The law set a 75% target for distribution of "useful" CMI accompanying prescriptions in 2000, and a 95% target for 2006. The FDA's initial assessment of progress toward meeting the year 2000 goal - conducted in 2002 - found that while the distribution rate of medicine leaflets at community pharmacies was 89%, the usefulness of such leaflets varied and some were deemed lacking. Today's public meeting gives the FDA an opportunity to learn about NCPIE's own Action Plan for meeting the 2006 goal.
Golodner noted, "This allows private sector stakeholders (including CMI producers, pharmacy system integrators, organizations representing pharmacists and pharmacy-owners) to publicly pledge their commitment to producing and distributing useful CMI with prescriptions. We encourage all organizations - particularly consumer and patient groups - to participate in this CMI Initiative coordinated by NCPIE."
Formed in early 2003, the NCPIE CMI Initiative features three committees (Criteria, Education, and Implementation) to ensure a practical, comprehensive approach to meeting the 2006 goals. It also calls on the FDA to be a full participant in the multi-year collaborative process. At the heart of the CMI Initiative is a mutual commitment by producers of CMI, and the nation's pharmacists and pharmacies, to integrate specific Action Plan criteria for useful prescription medicine information into the CMI product development and distribution process.
The Criteria Committee "will develop CMI prototypes that can serve as model leaflets and benchmarks for private sector efforts," said David Blair, R.Ph., founder of Medical Care and Outcomes, (Indianapolis). "Consumer research also plays an important role in successful broad application of the original Action Plan criteria," he said.
Speaking on behalf of the Education Committee, Susan Winckler, R.Ph., JD, said, "Making written information useful is one challenge; encouraging consumers to actually use it is another." Winckler serves as Vice President for Policy & Communications and Staff Counsel, American Pharmacists Association (Washington, DC). The Education Committee is developing action plans publicizing the criteria, the significance of implementing them, and the adaptations the private sector must undertake to meet the 2006 CMI goals.
The Implementation Committee will coordinate the work of NCPIE's Criteria and Education Committees, and provide directional feedback along the CMI road map. This committee will also plan and manage consumer and survey research, including exploring options to ensure that low-literate individuals also benefit from useful CMI.
"With this process in place," said NCPIE's Executive Vice President, W. Ray Bullman, M.A.M., "we will now develop timelines, budgets, and detailed program plans to meet the Year 2006 CMI goal. As for the long-term contribution of the CMI Initiative, what is 'useful' will ultimately be determined based on the ability of CMI to influence safer, more appropriate medicine use by all consumers," he said.
The National Council on Patient Information and Education, formed in 1982, is a non-profit coalition of over 130 organizations that share a commitment to improving communication about the appropriate use of medicines. NCPIE hosts the annual "Talk About Prescriptions" Month, and sponsors the "Be MedWise" campaign promoting wise use of non-prescription medicines. To learn more about the Council, visit http://www.talkaboutrx.org or http://www.bemedwise.org.
National Consumers League, Washington, DC: (202) 835-3323
American Pharmacists Assn., Washington, DC: (202) 628-4410
Medical Care & Outcomes, Indianapolis, IN: (317) 616-4530
W. Ray Bullman, Bethesda, MD: (301) 340-3940, ext. 14; firstname.lastname@example.org
N. Lee Rucker, Bethesda, MD: (301) 340-3940, ext. 12; email@example.com