December 18, 1998: William Ray Bullman, National Council on Patient Information and Education

The National Council on Patient Information and Education (NCPIE) is a non-profit coalition of over 250 organizations representing health care professionals, consumers and patients, voluntary health agencies, the pharmaceutical industry, and managed care. The Food and Drug Administration (FDA) is a founding member and maintains non-voting/liaison status on NCPIE's Board of Directors. NCPIE's mission is to stimulate and improve communication between consumers and health care professionals about the appropriate use of medicines.

This letter responds to the call for ideas and study topics for AHCPR's new demonstration program for grants to establish Centers for Education and Research on Therapeutics (CERTs). We also invited NCPIE's board of directors to submit comments to us and to AHCPR directly. I am pleased to provide the following suggestions for initial areas of emphasis for your consideration.

1. Development of a research agenda to assess the quality of written drug information conveyed with prescription medicines.

According to the FDA's most recent (1996) survey of consumers 67 percent reported receiving printed information with new prescription medicines. This reflects a more than four-fold increase in the provision of written information to consumers since NCPIE was formed in 1982. Currently, third party information vendors produce most product-specific patient information (distributed at retail pharmacies), not the pharmaceutical manufacturer.

The FDA has documented significant variability in the content of such printed information. Such variability creates a situation whereby consumers receive different information/guidance on drug-product printouts obtained at different pharmacies for the same medication.

In August 1996, Congress enacted legislation (Public Law 104-180, section 601 of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act), calling on the Secretary of the Department of Health and Human Services (HHS) to convene a steering committee of private sector stakeholder organizations to develop a long-range comprehensive plan to improve the quality (usefulness) of written medicine information. NCPIE was pleased to serve on this steering committee.

In January 1997, HHS accepted the committee's private sector Action Plan for the Provision of Useful Prescription Medicine Information. The Action Plan includes specific criteria for written drug information to improve the quality and usefulness of the information to patients and their caregivers. Pursuant to P.L. 104-180, the Action Plan also includes voluntary benchmarks (goals) to stimulate broader distribution of such useful written information to 75% of individuals receiving new prescriptions by the year 2000 and to 95% by the year 2006. The legislation also requires the Secretary of HHS to review the status of private sector initiatives designed to achieve the goals of the Action Plan.

I recommend that regular assessments of the content, quality, and impact (effectiveness) of written drug information vis-à-vis criteria outlined in the Action Plan be designed and conducted by CERTs. Currently, the FDA is charged with undertaking this assessment. Transferring this assessment function to a CERT will ensure that broader stakeholder involvement and greater academic rigor be brought to the development of the assessment methodology and analysis of findings. To stimulate quality improvement more broadly in the marketplace, CERTs should also be charged with providing feedback, technical assistance, and guidance to the producers of drug-specific information. Those medicine information materials that meet established quality standards for usefulness could then be designated with a distinctive seal or icon as having been favorably reviewed by a CERT ("CERTIFIED").

2. Commission and support psychosocial/behavioral research to assess consumers' medicine-taking knowledge, attitudes, and skills, and to better understand consumers' preferences for medicine information.

In the mid-1980s NCPIE coined the phrase, "America's Other Drug Problem," to characterize the scope and persistency of prescription medication misuse. A decade later, researchers estimated that drug-related morbidity and mortality in the U.S. cost $76 billion annually, which is about the same amount spent on outpatient prescriptions (Johnson, J., Bootman, J., "Drug Related Morbidity and Mortality in Nursing Facilities," Archives of Internal Medicine, Vol. 155, Oct. 9, 1995, pp. 1949-1956). Estimates of medication noncompliance range from 30-50 percent of the nearly 2.8 billion prescriptions dispensed annually.

I therefore suggest that psychosocial/behavioral research to improve medication use and compliance promotion be adopted as an integral element of the CERT's charter (mission). Stimulation of high-quality research and dissemination of findings by such a credible, neutral party is imperative to stimulating improvements in medicine use through positive behavior change. CERTs should also be required to organize broad-based stakeholder advisory panels to participate in the design of such research and the interpretation of research findings.

Thank you for the opportunity to comment.

William Ray Bullman
Executive Vice President
National Council on Patient Information and Education
wrbullman@erols.com

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