[Federal Register Volume 76, Number 48 (Friday, March 11, 2011)]
[Notices]
[Pages 13410-13411]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5397]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
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SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``Pilot Test of the Proposed Pharmacy Survey on Patient Safety
Culture.'' In accordance with the Paperwork Reduction Act, 44 U.S.C.
3501-3521, A1-IRQ invites the public to comment on this proposed
information collection.
DATES: Comments on this notice must be received by May 10, 2011.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Pilot Test of the Proposed Pharmacy Survey on Patient Safety Culture
As the baby boomer population ages, the general U.S. population
continues to grow, and as drug therapies for the treatment of chronic
diseases become more efficacious, the expected increase in the number
of prescriptions and demand for pharmaceutical products is likely to
increase the potential for medication errors in community/retail
pharmacies. In 2007, there were about 56,000 community/retail
pharmacies, including about 22,000 traditional chain pharmacy
companies, nearly 17,000 independent drug stores, about 9,300
supermarket pharmacies, and about 7,700 mass merchant pharmacies.
Numerous reports substantiate the presence of medication errors in
pharmacies. For example, one national observational study of
prescription dispensing accuracy and safety in 50 pharmacies in the
U.S. found a rate of about 4 errors per day in a pharmacy filling 250
prescriptions daily. This error rate translates to an estimated 51.5
million errors occurring during the filling of 3 billion prescriptions
each year.
Given the widespread impact of pharmacies on patient safety, the
new Pharmacy Survey on Patient Safety Culture (Pharmacy SOPS) will
measure pharmacy staff perceptions about what is important in their
organization and what attitudes and behaviors related to patient safety
are supported, rewarded, and expected. The survey will help community/
retail pharmacies to identify and discuss strengths and weaknesses of
patient safety culture within their individual pharmacies. They can
then use that knowledge to develop appropriate action plans to improve
their practices and their culture of patient safety. This survey is
designed for use in community/retail pharmacies, which includes chain
drugstores (e.g., Walgreens and CVS), supermarket pharmacies,
independently owned pharmacies, and mass merchant pharmacies (e.g.,
Wal-Mart, Costco, Target), not for use in hospital pharmacies.
This research has the following goals:
(1) Cognitively test and modify as necessary the Pharmacy Survey on
Patient Safety Culture Questionnaire;
(2) Pretest and modify the questionnaire as necessary;
(3) Make the final questionnaire available to the public.
This study is being conducted by AHRQ through its contractor,
Westat, pursuant to AHRQ's statutory authority to conduct and support
research on healthcare and on systems for the delivery of such care,
including activities with respect to the quality, effectiveness,
efficiency, appropriateness and value of healthcare services and with
respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1)
and (2).
Method of Collection
To achieve the goals of this study the following activities and
data collections will be implemented:
(1) Cognitive interviews--Two rounds of interviews will be
conducted by telephone with 10 respondents each. The purpose of these
interviews is to refine the questionnaire's items and composites. Each
round will be conducted with a mix of pharmacists and non-pharmacist
staff working in community/retail pharmacies throughout the U.S. The
same interview guide will be used for each round.
(2) Pretest--The draft questionnaire will be pretested with all
pharmacy staff in approximately 60 community/retail pharmacies. The
purpose of the pretest is to collect data for an assessment of the
reliability and construct validity of the survey's items and
composites, allowing for their further refinement.
(3) Pharmacy background questionnaire--This questionnaire will be
completed by the pharmacy manager in each of the 60 pretest sites to
provide background characteristics of the pharmacy, such as pharmacy
type (independently owned or chain), type of chain (traditional
drugstore, supermarkets, mass merchant), average number of
prescriptions filled weekly, average number of hours the pharmacy is
open on weekdays, etc.
(4) Dissemination activities--The final questionnaire will be made
available to the public through the AHRQ Web site. This activity does
not impose a burden on the public and is therefore not included in the
burden estimates in Exhibit 1.
The information collected will be used to test and improve the
draft survey items in the Pharmacy Survey on Patient Safety Culture
Questionnaire. Psychometric analysis will be conducted on the pilot
data to examine item nonresponse, item response variability, factor
structure, reliability, and construct validity of the items included in
the survey. Because the survey items are being developed to measure
specific aspects of patient safety culture in the pharmacy setting, the
factor structure of the survey items will be evaluated through
multilevel confirmatory factor analysis. On the basis of the data
analyses, items or factors may be dropped.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
pharmacies' time to participate in this research. Cognitive interviews
will be conducted with staff at 20 pharmacies (approximately 10
pharmacists and 10 nonpharmacist staff) and will take about one hour
and 30 minutes to complete. 627 staff from 60 pharmacies will
participate in the pretest (an average of 10.45 staff from each
pharmacy). The pretest questionnaire (the Pharmacy Survey on Patient
Safety Culture)
[[Page 13411]]
requires 15 minutes to complete. The pharmacy background questionnaire
will be completed by the manager at each of the 60 pharmacies
participating in the pretest and takes 10 minutes to complete. The
total annualized burden is estimated to be 197 hours.
Exhibit 2 shows the estimated annualized cost burden associated
with the pharmacies' time to participate in this research. The total
cost burden is estimated to be $4,948 annually.
Exhibit 1--Estimated Annualized Burden Hours
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Number of
Form name/activity Number of responses per Hours per Total turden
pharmacies pharmacy response hours
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Cognitive interviews............................ 20 1 1.5 30
Pretest......................................... 60 10.45 15/60 157
Pharmacy background questionnaire............... 60 1 10/60 10
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Total....................................... 140 na na 197
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Exhibit 2--Estimated annualized cost burden
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Number of Total burden Average hourly Total cost
Form name/activity pharmacies hours wage rate* burden
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Cognitive interviews............................ 20 30 $32.28 $968
Pretest......................................... 60 157 22.08 3,467
Pharmacy background questionnaire............... 60 10 51.27 513
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Total....................................... 140 197 na 4,948
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*Based upon the mean of the average hourly wages for Pharmacists (29-1051; $51.27), Pharmacy Technicians (29-
2052; $13.92), and Pharmacy Aides (31-9095; $10.74), National Compensation Survey: Occupational wages in the
United States May 2009, ``U.S. Department of Labor, Bureau of Labor Statistics.'' The hourly wage for the
cognitive interviews is a weighted average for 10 pharmacists, 8 pharmacy technicians and 2 pharmacy aides;
the hourly wage for the pretest is a weighted average for 157 pharmacists, 235 pharmacy technicians and 235
pharmacy aides.
Estimated Annual Costs to the Federal Government
Exhibit 3 shows the estimated total and annualized cost for this
project. Although data collection will last for less than one year, the
entire project will take about 3 years. The total cost for this project
is approximately $320,818.
Exhibit 3--Estimated Total and Annualized Cost
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Cost component Total cost Annualized cost
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Project Development............... $65,340 $21,780
Data Collection Activities........ 62,831 20,944
Data Processing and Analysis...... 11,004 3,368
Publication of Results............ 15,767 5,256
Project Management................ 7,496 2,498
Overhead.......................... 158,380 5,293
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Total......................... 320,818 106,939
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Request for Comments
In accordance with the Paperwork Reduction Act, comments on AHRQ's
information collection are requested with regard to any of the
following: (a) Whether the proposed collection of information is
necessary for the proper performance of AHRQ healthcare research and
healthcare information dissemination functions, including whether the
information will have practical utility; (b) the accuracy of AHRQ's
estimate of burden (including hours and costs) of the proposed
collection(s) of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information upon the
respondents, including the use of automated collection techniques or
other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: March 2, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-5397 Filed 3-10-11; 8:45 am]
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