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Agency Information Collection Activities: Proposed Collection; Comment Request

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Agency for Healthcare Research and Quality, HHS.




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: “Assessing Organizational Responses to AHRQ's Health Literacy Pharmacy Tools.” In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invitesthe public to comment on this proposed information collection.


Comments on this notice must be received by March 30, 2009.


Written comments should be submitted to: Doris Lefkowitz, Reports clearance Officer, AHRQ, by e-mail at

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.

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Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by e-mail at

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Proposed Project: Assessing Organizational Responses to AHRQ's Health Literacy Pharmacy Tools

According to the 2003 National Assessment of Adult Literacy, only 12 percent of adults have proficient health literacy-the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. Limited health literacy often leads to medication errors. For example, one study found that a majority of adults with low health literacy did not understand instructions to “take medication on an empty stomach.” Overall, it is estimated that low health literacy costs the U.S. health care system $50 billion to $73 billion per year. Pharmacies can serve as an important source of medication information for people with limited health literacy, but relatively few pharmacies have implemented health literacy practices (Praska et al., 2005).Start Printed Page 5163

Recognizing that pharmacies may need outside knowledge and assistance to improve their health literacy practices, AHRQ, through a previous task order, supported the creation of the following four health literacy tools for pharmacy settings, which have been validated in institutional pharmacy settings.

1. Is Our Pharmacy Meeting Patients' Needs? A Pharmacy Health Literacy Assessment Tool User's Guide (Jacobson et al., 2007)

2. Strategies to Improve Communication between Staff and Patients: Training Program for Pharmacy Staff (Kripalini & Jacobson, 2007).

3. How to Create a Pill Card (Jacobson et al., 2008).

4. Telephone Reminders: A Tool to Help Refill Medications on Time (Jacobson et al., 2008)

AHRQ now proposes to distribute these tools to a more diverse set of pharmacies and to conduct in-depth case studies to enhance our understanding about the conditions that may facilitate or impede the adoption of the tools in these settings. AHRQ would use insights gained to develop materials (promotional implementation guides) that could assist interested pharmacies in putting the tools into practice and anticipating and overcoming obstacles to doing so.

The pharmacy health literacy tools will be disseminated through an AHRQ Web site, which will also provide technical assistance to pharmacies that wish to implement the tools. A description of the tools and site will be distributed to pharmacists through national pharmacy organizations' trade publications and a direct mailing to chain pharmacy headquarters. We anticipate that we would be able to reach as many as 60,000 individual pharmacists across the country through these channels.

This project is being conducted 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 health care services; quality measurement and improvement; and health care costs, productivity, organization, and market forces. 42 U.S.C. 299a(a)(1), (2), and (6).

Method of Collection

Case Studies

Through its contractor, AHRQ proposes to conduct 7 in-depth case studies to assess pharmacies' experiences with implementation of one or more of these four health literacy tools, using interviews, site visits, review of documents and a survey of pharmacy staff from case study pharmacies. In addition, AHRQ will conduct 2 more limited studies of pharmacies that were aware of the tools but chose not to implement them.

A 2-day site visit with be conducted with each of the 7 sites that implement at least one of the tools. Each site visit will include a walk-through of the pharmacy site to see the physical layout, an interview with the key informant or contact person, and individual interviews with up to eight additional pharmacy employees, including the pharmacy manager, staff pharmacists, pharmacy technicians, and pharmacy clerks.

Therefore, up to 63 interviews will be completed across the 7 sites that implement one or more of the tools. In addition, up to 12 pharmacy staff at each of the 7 implementation sites will complete the tool's Pharmacy Staff Survey contained in the Pharmacy Health Literacy Assessment Tool.

For each of the two pharmacies which do not implement the tools, interviews will be conducted with up to 2 informants per site. The content of this interview will be similar, but not identical, to the interviews with staff at the implementing sites.

Web Site Visitors' Survey

For pharmacists and other visitors to the AHRQ Web site, we will conduct a voluntary survey regarding health literacy in general, and feedback regarding AHRQ's health literacy tools. The Web site visitors' survey will be available on-line.

Estimated Annual Respondent Burden

Exhibit I shows the estimated annualized burden hours for the respondents' time to participate in this case study. The staff interview at the implementation sites will be completed with up to 9 pharmacy staff members from each of the 7 pharmacies that implement all or part of the health literacy tools. Staff interviews at the two nonimplementation sites will be completed with up to 2 individuals per pharmacy. The staff interviews are estimated to last 1 hour. The pharmacy staff survey will be completed by up to 12 staff from the 7 implementation pharmacies and is estimated to take approximately 20 minutes. Lastly, the Web site visitor's survey will be completed by about 150 respondents and is estimated to take up to 12 minutes to complete. The total burden hours for all data collections is estimated to be 125 hours.

Exhibit 2 shows the estimated annualized cost burden for the respondents' time to provide the requested data. The estimated total cost burden is about $3,791.

Exhibit 1—Estimated Annualized Burden Hours

Form NameNumber of respondentsNumber of responses per respondentHours per responseTotal burden hours
Staff interview-implementing sites79163
Staff interview-non-implementing sites2214
Pharmacy staff survey71220/6028
Web site visitors survey150112/6030

Exhibit 2—Estimated Annualized Cost Burden

Form NameNumber of respondentsTotal burden hoursAverage hourly wage rate*Total cost burden
Staff interview-implementing sites763$30.33$1,911
Staff interview-non-implementing sites2430.33121
Pharmacy staff survey72830.33849
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Web site visitors survey1503030.33910
* The average hourly wage rate of $30.33 was calculated based on the following mean hourly wage rates: pharmacists—$47.58; pharmacy manager [medical & health services manager category]—$50.34; pharmacy tecimicians—$13.25; and pharmacy aides $10.15. The mean hourly wage rates for these occupations were obtained from the Bureau of Labor & Statistics on “Occupational Employment and Wages, May 2007,” found at: http//​OES/​current/​oes291051.htm.

Estimated Annual Costs to the Government

The total cost of this contract to the government is $400,000. The project extends over three fiscal years. Exhibit 3 shows a breakdown of the total cost as well as the annualized cost.

Exhibit 3

Cost componentTotal costAnnualized cost
Project Development$54,822$18,274
Data Collection Activities111,50937,170
Data Processing and Analysis129,08943,030
Publication of Results63,73621,245
Project Management40,84513,615

Request for Comments

In accordance with the above cited legislation, comments on the AHRQ information collection proposal are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of functions of AHRQ, 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 of information; (c) ways to enhance the quality, utility, and clarity on the information to be collected; and (d) ways to minimize the burden of the collection of information on 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 request for OMB approval of the proposed information collection. All comments will become a matter of public record.

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Dated: January 16, 2009.

Carolyn M. Clancy,


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[FR Doc. E9-1751 Filed 1-28-09; 8:45 am]