13410 Federal Register / Vol. 76, No. 48 / Friday, March 11, 2011 / Notices 

Dated: March 8, 2011. 

Jeffrey Abrams, 

Associate Director, Cancer Therapy 

Evaluation Program, Division of Cancer 

Treatment and Diagnosis, National Cancer 

Institute. 

[FR Doc. 2011–5609 Filed 3–10–11; 8:45 am] 

BILLING CODE 4140–01–P 

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. 

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 email 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) 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 48 / Friday, March 11, 2011 / Notices 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

Form name/activity Number of 

pharmacies 

Number of responses per 

pharmacy 

Hours per response Total turden 

hours 

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 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name/activity Number of 

pharmacies 

Total burden 

hours 

Average hourly wage rate* Total cost burden 

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

*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

Cost component Total cost Annualized cost 

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 

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 


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