2003N-0575 - Agency Information Collection Activities; Proposed Collection; Comment Request; 2004 National Tracking Survey of Prescription Drugs Information Provided to Patients
FDA Comment Number : EC1
Submitter : Mr. William Bullman Date & Time: 03/30/2004 05:03:59
Organization : Nat'l Council on Patient Information
Category : Association
Issue Areas/Comments
(The following comments do not necessarily reflect those of our entire membership.)

This survey is of great interest to the National Council on Patient Information and Education (NCPIE) for two reasons: (1) since our founding in 1982, our mission has been to improve health professional-patient communication about the safe, appropriate use of medicines; and (2) we are presently coordinating the private sector Consumer Medicine Information (CMI) Initiative to meet targets for the distribution of useful CMI that accompanies prescriptions, per P.L. 104-180.

The Federal Register announcement (Vol. 69, No. 17, Jan. 27, 2004) invites comments on four items. Our comments address primarily items (1) and (3).

Query #1 - Whether information collection is necessary, and will have practical utility:

The FDA National Tracking Survey is very important and should be continued. Its future practical utility will be assured if new questions are added periodically to capture the rapidly-changing environment of patient information, to more specifically support related objectives in Healthy People 2010 (Objectives 17-3, 17-4, and 17-5), to gauge the implementation of the OBRA-90 pharmacist offer-to-counsel mandate, to establish /track older adults' receipt of prescription information before and post-implementation of the Medicare Prescription Drug Improvement and Modernization Act of 2003, and if frequent/broad dissemination of the data are incorporated into all FDA consumer education campaigns about risk management of prescription medicines.

Query #3 - Ways to enhance the quality, utility, and clarity of information collected:

1. Questions #5 and #9 ask about prescriptions filled at a pharmacy. Yet, mail-order pharmacy accounted for 13% of Rx sales in `03, and is the fastest-growing retail distribution channel, (Drug Topics, Mail-order Growth Continued in 2003, 03/22/04). Many insurance plans include a mail- order component, and on-line pharmacies are also attracting many consumers. FDA?s 2004 survey should reflect this trend.

2. Question #16 and #30 (Did you talk about..) should include queries re: other Rx medicines you are taking and other OTC medicines you are taking. This addition would help address HP 2010 objective #17-3.

3. Questions #23 and #38 refer to (a) brochures or pamphlets, (b) instruction sheets, (c) stickers, and (d) other type of written information. These subcategories should be listed by frequency, e.g., (a) stickers, (b) instruction sheets, (c) brochures, and (d) other.

4. There are many sub-questions that could be asked of interviewees who say that they received instruction sheets. Responses to questions such as the following could be very practical for the FDA when planning its 2007 assessment of CMI usefulness:

a. When you received this instruction sheet, did someone offer to go over it with you? [clerk, pharmacist; toll-free telephone number to call to speak with pharmacist, etc.]

b. Did you save it or throw it away? (If saved) Did you read it?

c. (If yes) Did you find it useful?

d. If you are still taking the medicine this information sheet came with, have you re-read the instruction sheet?

5. Question #45h. asks interviewees, thinking back over the past three months, Did anyone at the pharmacy ask you if you would like to talk with the pharmacist? This question should be asked much closer to the beginning if the interview, and should not be based on a three-month recall.

FDA is encouraged to over sample adults age 65+ and to coordinate with CMS to develop questions about older adults? preferences for / use of prescription medicine information from prescribers and pharmacists. This survey affords an ideal opportunity to establish a baseline for receipt, preferences for, and use of prescription drug information by older adults prior to implementation of the Medicare Rx Drug Improvement & Modernization Act of 2003.