[Federal Register: July 11, 2003 (Volume 68, Number 133)]
[Notices]
[Page 41384-41385]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy03-69]
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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