[Federal Register Volume 76, Number 48 (Friday, March 11, 2011)]
[Notices]
[Pages 13410-13411]
From the Federal Register Online via the Government Publishing 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 
[email protected].
    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 
[email protected].

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
                                                 ---------------------------------------------------------------
    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
                                                 ---------------------------------------------------------------
    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
                                   -------------------------------------
    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]
BILLING CODE 4160-90-M