[Federal Register Volume 68, Number 133 (Friday, July 11, 2003)]
[Notices]
[Pages 41384-41385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17574]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0017]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Impact of Risk Management Programs on the 
Practice of Pharmacy

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
11, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Impact of Risk Management Programs on the Practice of Pharmacy

    FDA is requesting OMB approval for the reporting and recordkeeping 
requirements contained in the survey entitled ``Impact of Risk 
Management Programs on the Practice of Pharmacy.''
    Risk management (RM) programs are reviewed by divisions in the 
Center for Drug Evaluation and Research (CDER) as part of the new drug 
application (NDA) review process as well as during the postmarketing 
period. In an effort to address safety risks associated with drug 
therapy, several RM programs have been implemented (for example, for 
clozapine, thalidomide, and bosentan). Many RM programs require 
pharmacists to actively intervene and implement actions that deviate 
from their normal work procedures. Currently, the impact of RM programs 
on the practice of pharmacy in terms of pharmacists' compliance, 
knowledge, burden, and barriers is not known.
    The survey is a small investigator-initiated research project to 
improve science safety review within CDER. The research is intended to 
help FDA safety evaluators of drug adverse events understand the larger 
context of RM programs and how they are perceived and implemented by 
pharmacists. The study is independent from the Prescription Drug User 
Fee Act III guidance that is currently under development on RM.
    The descriptive survey will be sent to a representative sampling of 
pharmacists in the United States. Approximately 5,000 pharmacists will 
be chosen at random from listings of licensed pharmacists obtained from 
participating U.S. State Boards of Pharmacy. Because the number of 
licensed pharmacists in each State varies and the number of respondents 
from each State cannot be predicted, either a simple random or a 
stratified sample design will be used, depending on whether there is a 
sufficient number of participating pharmacists to evaluate regional 
differences. The geographic regions will be classified by location in 
one of the four geographic regions of the United States corresponding 
to those used by the U.S. Bureau of Census (northeast, midwest, south, 
and west).
    The survey will be conducted via first-class mail. The survey will 
be mailed with a cover letter to randomly chosen pharmacists along with 
a preaddressed, stamped return envelope. To ensure anonymity and 
confidentiality, no premarkings or numbering systems will be recorded 
on the survey or return envelope.
    From the sample size of approximately 5,000 pharmacists, the 
desirable response rate is approximately 75 to 85 percent. If needed, 
actions will be taken to increase the response rate, such as resending 
the survey approximately 2 weeks after the initial mailing.
    In the Federal Register of February 12, 2003 (68 FR 7124), FDA 
published a notice requesting comments on FDA's burden estimates to 
conduct a descriptive survey of pharmacists to evaluate pharmacists' 
knowledge of RM programs, identify barriers to compliance, and assess 
the impact of these programs on the practice of pharmacy. FDA received 
one comment. A summary of the comment and FDA's responses are in the 
following paragraphs.
    Concerning the issue of sampling methodology, the comment said that 
the primary focus of the survey should be on community pharmacists who 
are most likely to dispense medications associated with RM programs.
    FDA believes that RM programs may affect pharmacists in all 
practice settings; during drug dispensing, answering drug information 
questions, and/or monitoring drug therapy. For this reason, the primary 
focus of the survey is not on community pharmacists. However, FDA will 
analyze responses according to pharmacy practice settings (for example, 
retail, hospital, and long-term care).
    The comment said that the sampling frame should be stratified to 
obtain an equal distribution of pharmacists working in chain versus 
independent pharmacies.
    FDA notes that the primary objective of the survey is not to 
compare the responses between chain and independent pharmacies. In 
addition, because the sampling frame does not include the setting 
information in which the pharmacist works, the agency cannot stratify 
the sampling frame. However, the survey contains a question regarding 
the practice setting of surveyed pharmacists and FDA intends to analyze 
this data.
    The comment said that the survey should be accompanied by an 
explanation or incentive that provides a compelling reason for a 
pharmacist to complete it.

[[Page 41385]]

    FDA believes that the cover letter that will accompany the survey 
will accomplish this suggestion because the cover letter will explain 
what the survey is about and that it is intended to gain insight from a 
pharmacist's point of view. The comment said that the sampling size 
should be reduced.
    The survey's sample size was selected by FDA based on a 
consideration of response rate and cost. FDA is also concerned about 
the possibility that a large number of pharmacists in the sample may 
not have encountered RM programs. The agency believes that in a sample 
size of 5,000, sufficient responses may be received to gain some 
insight about pharmacists' experiences in dispensing drugs.
    Concerning the enhancement of response rates, the comment said that 
a cover letter explaining why it is important for selected respondents 
to participate would result in a greater likelihood that sample 
pharmacists will participate. The letter should include an offer to 
send a report of the results directly to the respondent and assurance 
that the responses will be kept confidential.
    FDA notes that a cover letter will be included with the survey 
explaining why the selected respondents should participate. The letter 
will state that the surveys are not marked and that the respondents are 
not identifiable. FDA intends to post the results of the survey on 
FDA's Web site at: www.fda.gov.
    The comment suggested that disclosures be included on the outside 
envelope that will make the survey mailing ``stand out'' from the 
clutter of other mailings.
    FDA intends to include FDA's logo on the outside envelope along 
with a stamped message (for example, ``Important'').
    The comment said that a more comprehensive followup plan would 
result in greater participation.
    FDA plans to send two mailings of the same survey to the selected 
pharmacists. A reminder postcard will be sent between these two 
mailings to inform the pharmacists that the second mailing will be 
arriving soon. The reminder postcard will also state that if the survey 
has already been completed and returned to FDA, the second mailing 
should be disregarded.
    Concerning the enhancement of the quality, utility, and clarity of 
the information, the comment said that the survey should be revised to 
include questions about what educational programs might be helpful in 
facilitating compliance with RM programs.
    FDA agrees that educating patients and health care professionals 
about drug risks is an important component of RM programs. The survey 
contains questions about existing communication tools (for example, 
medication guides, dear health professional letters, drug educational 
material), barriers to compliance, and the ways to improve this 
communication.
    The comment said that question number 20 of the survey should be 
revised to measure barriers to compliance through the inclusion of: (1) 
A new section heading and introductory sentence or two to clarify the 
scope of the queries, and (2) a change to the format that would allow 
indication of the severity of the problem.
    FDA has added self-explanatory section headings to the survey. 
Because the agency would consider the identification of any barrier to 
compliance significant, categorizing the severity of the problem would 
be unnecessary.
    The comment said that the survey should include questions that 
examine the impact on the practice of pharmacy of any of the three 
different RM components examined (use of special prescription stickers, 
dear health care professional/pharmacist letters, labeling/patient 
information/medication guides), because this is the stated goal of the 
research.
    FDA has added a question to the survey specifically addressing the 
impact of RM programs on the practice of pharmacy. In addition, the 
format of the question is open-ended so that the response would not be 
restricted in any way.
    FDA estimates that it will take each pharmacist approximately 20 
minutes to respond to the survey and return it to FDA.
    The burden of this collection of information is estimated as 
follows:

                                Table 1.--Estimated One-Time Reporting Burden\1\
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                                       Annual Frequency     Total Annual        Hours per
        Number of Respondents            Per Response        Responses           Response         Total Hours
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5,000                                              1              5,000                   .33           1,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: July 3, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-17574 Filed 7-10-03; 8:45 am]
BILLING CODE 4160-01-S