July 8, 2002

Ms. Kimberly Littleton Topper

Center for Drug Evaluation and Research

Food and Drug Administration, HFD-21

5600 Fishers Lane

Rockville, MD 20857

RE: Drug Safety and Risk Management Advisory Committee, July 17, 2002

Dear Ms. Topper:

On behalf of the National Council on Patient Information and Education (NCPIE), this letter is in response to your request for comments on ways to improve the usefulness of consumer medication information (CMI) distributed with prescriptions filled at pharmacies. We would appreciate the opportunity to present our comments orally at the FDA Drug Safety and Risk Management Advisory Committee scheduled for July 17, 2002 at the Holiday Inn, Gaithersburg, MD. As defined in the agenda for this meeting, our comments will help identify and define "scientific methods to assess and monitor whether effective communication of key information to patients is occurring." However, the following comments do not necessarily represent the opinion of all members of our coalition.

NCPIE is a non-profit coalition of over 135 members committed to improving health professional/patient communication about the appropriate use of medicines. As such, NCPIE served on the Keystone Committee (along with many of our coalition members) in 1996 to develop the Action Plan for the Provision of Useful Prescription Medicine Information.

Historical Perspective: Public Policy Initiatives to Improve CMI

A brief review of initiatives to improve consumer medication information is important to appreciate the historical perspective in which the Drug Safety and Risk Management Advisory Committee will make its recommendations.

Page 2 of 4

July 8, 2002

Significance of this Public Policy Foundation

The consensus among medicine information stakeholders is that CMI is most effective when it involves written information supplemented by oral counseling. For two decades, various state, federal, and voluntary initiatives have supported this two-pronged approach, as outlined above. The July 17, 2002 hearing may focus primarily on improving written CMI. However, it is only with the full commitment of all health care professionals to actually "Talk About Prescriptions" (as NCPIE calls its national observance each Oct.) that patients will understand the possible risks, use their medicines safely, and realize their medicinesí full benefits through enhanced CMI.

Page 3 of 4

July 8, 2002

Outlining a Research Agenda to Improve CMI

Over the years, NCPIE has served as a catalyst by identifying areas for future medicine communication research. Specifically, please refer to our April 27, 2000 letter to FDA about research in the next phase of evaluation of written medicine leaflets. Today, we recommend a CMI research agenda that includes the following issues:

  1. How much information is too much? For those prescription medicines that require Medication Guides, do we know their effect on patient understanding of possible risks? Do we know the extent to which the Medication Guides contribute to appropriate use? Do we know how Medication Guides have affected patient adherence and health outcomes?
  2. What effect does a simplified format for CMI have on safe medicine practices? For example, what post-marketing research is being done on the new "Drug Facts" label now required on most non-prescription medicines?
  3. Focusing, for example, on the five or six prescription medicines most commonly used by persons aged 65 and older (in order, Prilosec, Norvasc, K-Dur 20, Lanoxin, Lipitor, and Celebrex, per http://www.familiesusa.org, June 24, 2002), research could be conducted to examine: (a) different formats for, and quantity of information conveyed on, pharmacy-distributed leaflets; (b) different types of follow-up contact (from physicians, pharmacists, nurses, physician assistants, etc.) within various time frames of starting a new prescription; (c) medicines that are selected for extensive DTC campaigns vs. those that are not: does the supplemental manufacturer-provided information that may reach patients for whom these medicines are prescribed have any effect on their adherence, understanding of risks vs. benefits, and/or safe medicine use?
  4. Advice to "use one pharmacy for all of your medicines, and complete the patient profile form" are common, non-controversial suggestions to promote safe medicine use. What percent of patients aged 65 and older have such forms on file at their local pharmacy? Are these patients asked each time they come in for a new prescription to fill out and/or update their form? Are patients routinely asked about non-prescription medicines and dietary supplements they may be using, so that this information can be added to their profile?
  5. Much attention has been focused on adoption of computerized physician-order entry systems, primarily in hospitals, as one way to reduce medication errors. While the advent of "PDA" technology (e.g., Palms) has made this an option for ambulatory settings as well, implementation to date is extremely limited. In 2000, Susanna Bedell, M.D., cited discrepancies of up to 75% in reported versus recorded medications (http://archinte.ama-assn.org/issues/v160n14/abs/ioi90676.html ). Bedellís research was conducted in physiciansí offices. What if community pharmacies sent a copy of a "high-risk" patientís profile form to each of their prescribing physicians?

Page 4 of 4

July 8, 2002

5. (continued) To what degree could such technologically-enhanced pharmacist-prescriber communication improve CMI overall?

NCPIE remains committed to ensuring that consumers receive useful information about their prescription medicines. We forward to working with FDA and other committed stakeholders to improve the quality of both oral and written consumer medicine information. I look forward to presenting these comments personally on July 17. Please contact me at (301) 656-8565, ext. 12, should you have any questions.



Wm. Ray Bullman, M.A.M.
Executive Vice President
E-mail: wrbullman@erols.com


cc: Linda Golodner, NCPIE Chair and President, National Consumers League