PRESCRIPTION 

DRUG LABELS

Actions Needed to 

Increase Awareness 

of Best Practices for 

Accessible Labels for 

Individuals Who Are 

Blind or Visually 

Impaired

Report to Congressional Addressees

December 2016

GAO-17-115

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-17-115, a report to 

congressional addressees

December 2016

PRESCRIPTION DRUG LABELS

Actions Needed to Increase Awareness of Best 

Practices for Accessible Labels for Individuals Who 

are Blind or Visually Impaired

What GAO Found

GAO found that some pharmacies can provide accessible prescription drug 

labels, which include labels in audible, braille, and large print formats and are 

affixed to prescription drug containers. 

• Mail order pharmacies: Four pharmacy benefit managers (PBMs) used by 

large insurers that GAO contacted reported that they can provide accessible 

labels through their mail order pharmacies.

• Retail pharmacies: Six of the 9 largest chain pharmacy companies and 8 of 

the 18 selected individual retail pharmacy locations GAO contacted also 

reported that they can provide accessible labels through their store-based 

retail pharmacies.

The percent of prescriptions dispensed with accessible labels was generally 

low—less than one percent of all prescriptions dispensed—according to some 

PBMs and chain pharmacy companies that GAO contacted. With regard to best 

practices, a working group convened by the U.S. Access Board—a federal 

agency that promotes accessibility for individuals with disabilities—developed 

and published 34 best practices for accessible labels. Four PBMs, six chain 

pharmacy companies, and eight individual retail pharmacy locations GAO 

contacted reported that they have generally implemented most of the 34 best 

practices for accessible labels. However, stakeholders GAO contacted said that 

individuals who are blind or visually impaired continue to face barriers accessing 

drug label information, including identifying pharmacies that can provide 

accessible labels.

Stakeholders GAO contacted identified four key challenges that pharmacies 

faced in providing accessible labels or implementing the best practices: (1) lack 

of awareness of the best practices; (2) low demand and high costs for providing 

accessible labels; (3) technical challenges for providing these labels; and (4) an 

absence of requirements to implement the best practices. Many stakeholders 

identified greater dissemination of the best practices as a step, among others, 

that could help address some of these challenges.

The National Council on Disability (NCD)—the federal agency responsible for 

conducting an informational campaign on the best practices, as required by the 

Food and Drug Administration Safety and Innovation Act (FDASIA)—has 

conducted limited campaign activities. Primarily in 2013 and 2014, NCD used its

website and social media to disseminate an agency statement and press 

releases on the best practices. However, most stakeholders GAO spoke with 

said they had no communication with NCD about its campaign, and some said 

they were unaware of the best practices. Agency officials provided GAO with an 

original plan for conducting campaign activities through 2014, but most activities 

were not conducted. During the course of our review, NCD developed a 

corrective action plan for conducting future campaign activities. However, neither 

plan assigned responsibilities for conducting these activities nor does the agency 

have plans to evaluate them, which is inconsistent with federal internal control 

standards. Without assigning responsibilities and developing an evaluation plan, 

NCD will be unable to adjust its action plan and assess whether the information 

on the best practices is effectively reaching its target audience.

View GAO-17-115. For more information, 

contact John Dicken at (202) 512-7114 

or dickenj@gao.gov

Why GAO Did This Study

About 7.4 million Americans are blind 

or visually impaired and may face 

difficulty reading prescription drug 

container labels. FDASIA required the 

U.S. Access Board to develop best 

practices for accessible labels and 

NCD to conduct an informational 

campaign on these best practices.

FDASIA also included a provision for 

GAO to review pharmacies’ 

implementation of these best practices. 

This report examines: the extent to 

which pharmacies can and do provide 

accessible labels and implement the 

best practices; pharmacy challenges; 

and the extent to which NCD 

conducted its informational campaign, 

among others.

GAO collected information from 55 

stakeholders, including 4 PBMs used 

by large insurers; 9 of the largest chain 

pharmacy companies; 18 randomly 

selected individual retail pharmacy 

locations in 4 states with varying levels 

of visually impaired residents; and 24 

others, such as state regulating bodies 

and advocacy and industry groups. 

GAO sent a web-based questionnaire 

to PBMs, chain pharmacy companies, 

and individual retail pharmacy 

locations. GAO also interviewed 

stakeholders and reviewed state 

regulations and documents from NCD.

What GAO Recommends

NCD should assign responsibility for 

conducting campaign activities and 

evaluate these activities. NCD neither 

agreed nor disagreed with the 

recommendation but indicated that it is 

taking steps to address this issue.
Page i GAO-17-115 Accessible Prescription Drug Container Labels

Letter 1

Background 7

Some Pharmacies Can Provide Accessible Labels but Dispensed 

Few of Them and Have Implemented Most of the U.S. Access 

Board’s Best Practices 11

Stakeholders Reported That Individuals Who Are Blind or Visually 

Impaired Continue to Face Barriers Accessing Prescription 

Label Information 20

Stakeholders Identified Pharmacy Challenges and Steps for 

Providing Accessible Labels or Implementing the U.S. Access 

Board’s Best Practices 22

NCD Has Conducted Limited Campaign Activities, but Has Not 

Assigned Responsibilities for Future Activities Nor Evaluated Its 

Activities 26

Conclusions 28

Recommendation for Executive Action 29

Agency Comments and Our Evaluation 29

Appendix I Description of Web-Based Questionnaire 30

Appendix II Comments from the U.S. Access Board 33

Appendix III Comments from the National Council on Disability 34

Appendix IV GAO Contact and Staff Acknowledgments 35

Tables

Table 1: Number of Selected Pharmacy Benefit Mangers (PBM), 

Chain Pharmacy Companies, and Individual Retail 

Pharmacy Locations That Reported They Can Provide 

Accessible Labels through Their Pharmacies, as of March 

31, 2016 12

Table 2: Four Selected Pharmacy Benefit Managers (PBM) Can 

Provide Accessible Labels through Their Mail Order 

Pharmacies, as of March 31, 2016 13

Contents
Page ii GAO-17-115 Accessible Prescription Drug Container Labels

Table 3: Six of Nine Selected Chain Pharmacy Companies Can 

Provide Accessible Labels through Their Retail 

Pharmacies, as of March 31, 2016 14

Table 4: All-Format Best Practices Implemented by Selected 

Pharmacy Benefit Managers (PBM), Chain Pharmacy 

Companies, and Individual Retail Pharmacy Locations 

That Can Provide Accessible Labels through Their 

Pharmacies, as of March 31, 2016 16

Table 5: Audible Format-Specific Best Practices Implemented by 

Selected Pharmacy Benefit Managers (PBM), Chain 

Pharmacy Companies, and Individual Retail Pharmacy 

Locations That Can Provide Audible Labels through Their 

Pharmacies, as of March 31, 2016 18

Table 6: Braille Format-Specific Best Practices Implemented by 

Selected Pharmacy Benefit Managers (PBM), Chain 

Pharmacy Companies, and Individual Retail Pharmacy 

Locations That Can Provide Braille Labels through Their 

Pharmacies, as of March 31, 2016 18

Table 7: Large Print Format-Specific Best Practices Implemented 

by Selected Pharmacy Benefit Managers (PBM), Chain 

Pharmacy Companies, and Individual Retail Pharmacy 

Locations That Can Provide Large Print Labels through 

Their Pharmacies, as of March 31, 2016 19

Table 8: National Council on Disability’s (NCD) Informational 

Campaign Activities after Publication of the U.S. Access 

Board’s Best Practices 27

Figure

Figure 1: Examples of Accessible Prescription Drug Container 

Labels 10
Page iii GAO-17-115 Accessible Prescription Drug Container Labels

Abbreviations

FDASIA Food and Drug Administration Safety and 

Innovation Act

NCD National Council on Disability

PBM pharmacy benefit manager

PSAO pharmacy services administrative organization

RFID Radio Frequency Identification

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

copyrighted images or other material, permission from the copyright holder may be 

necessary if you wish to reproduce this material separately.
Page 1 GAO-17-115 Accessible Prescription Drug Container Labels

441 G St. N.W.

Washington, DC 20548

December 9, 2016

The Honorable Lamar Alexander

Chairman

The Honorable Patty Murray

Ranking Member

Committee on Health, Education, Labor & Pensions

United States Senate

The Honorable Fred Upton

Chairman

The Honorable Frank Pallone

Ranking Member

Committee on Energy and Commerce

House of Representatives

The Honorable Edward J. Markey

United States Senate

As of 2014, according to an analysis of U.S. Census Bureau survey data, 

about 7.4 million Americans were blind or visually impaired—individuals 

who have serious difficulty seeing even when wearing glasses.1 These 

individuals may be unable to read or have difficulty independently reading 

a standard print prescription drug container label—a document prepared 

by the pharmacist filling a prescription, typically affixed to a medication 

bottle, and containing information about and for using a medication. 

Individuals are more likely to experience vision loss as they age. Also, as 

of 2014, according to the analysis of U.S. Census Bureau survey data, 

over 3 million Americans that were blind or visually impaired were aged 

65 and older and this number is likely to increase with an aging 

 1

Yang Tan Institute on Employment and Disability, Cornell University, 2014 Disability 

Status Report: United States, (Ithaca, N.Y.: 2016). Another analysis estimated that as 

many as 21 million Americans 18 years or older were blind or had trouble seeing even 

when wearing glasses or contacts in 2012. See Department of Health and Human 

Services, Centers for Disease Control and Prevention, Summary Health Statistics for U.S. 

Adults: National Health Interview Study, 2012, DHHS Publication No. 2014-1588

(Hyattsville, Md.: February 2014).

Letter
Page 2 GAO-17-115 Accessible Prescription Drug Container Labels

population.2 Older individuals are more likely to be prescribed multiple 

medications and may experience physical and cognitive conditions that 

increase the need for safe, consistent, reliable, and independent access 

to prescription drug container label information. Individuals whose vision 

precludes them from reading standard print prescription drug container 

labels may be at risk of taking the wrong medication or incorrectly 

following instructions found on the labels of their medications, thus 

endangering their health and safety.

The Food and Drug Administration Safety and Innovation Act (FDASIA) 

authorized the U.S. Access Board, a federal agency that promotes 

accessibility for people with disabilities, to convene a stakeholder working 

group to develop best practices for making information on prescription 

drug container labels accessible to individuals who are blind or visually 

impaired (henceforth referred to as the best practices).3 The working 

group published its report on the U.S. Access Board’s website in July 

2013, which included information on delivering prescription drug container 

label information through audible, braille, and large print labels—

collectively referred to as accessible labels—and the best practices for 

formatting these labels.4 These best practices are voluntary and offer 

guidance to pharmacies on how to provide accessible labels to individuals 

who are blind or visually impaired.5 Further, these best practices are 

 2

Yang Tan Institute on Employment and Disability, 2014 Disability Status Report: United 

States. Another analysis estimated that over 5 million Americans 65 or older were blind or 

had trouble seeing even when wearing glasses or contacts in 2012. See Department of 

Health and Human Services, Centers for Disease Control and Prevention, Summary 

Health Statistics for U.S. Adults. The number of Americans aged 65 and older increased 

about 28 percent from 36.2 million in 2004 to 46.2 million in 2014, and the number of 

Americans aged 65 years and older is projected to more than double to 98 million by 

2060. See Administration on Aging, Administration for Community Living, Department of 

Health and Human Services, A Profile of Older Americans: 2015 (Washington, D.C.: 

2015).

3

Pub. L. No. 112-144, § 904(a)(3), 126 Stat. 993, 1090 (2012).

4

U.S. Access Board Working Group on Accessible Prescription Drug Container Labels, 

Best Practices for Making Prescription Drug Container Label Information Accessible to 

Persons Who are Blind or Visually-Impaired or Who are Elderly (Washington, D.C.: July 

10, 2013), accessed November 23, 2015, http://www.access-board.gov/guidelines-andstandards/health-care/about-prescription-drug-container-labels/working-grouprecommendations.

5

FDASIA provides that the best practices are not to be construed to limit or condition any 

right, obligation, or remedy available under the Americans with Disabilities Act of 1990 or 

any other federal or state law requiring effective communication, barrier removal, or 

nondiscrimination on the basis of disability. 
Page 3 GAO-17-115 Accessible Prescription Drug Container Labels

consistent with certain practices included in agreements between some 

companies that operate pharmacies and advocacy groups representing 

individuals who are blind or visually impaired.6 FDASIA also required the 

National Council on Disability (NCD)—a federal agency that advises the 

President, Congress, and other federal agencies on policies and practices 

affecting people with disabilities—to conduct a campaign to inform and 

educate individuals with disabilities, pharmacists, and the public about the 

best practices after they were published.7

FDASIA also included a provision for us to review pharmacies’ 

implementation of the best practices and examine barriers that individuals 

who are blind or visually impaired continue to face in accessing 

information on prescription drug container labels. We briefed your staff on 

our preliminary findings in September 2016. This report contains 

information shared during that briefing and examines:

1. the extent to which pharmacies can and do provide accessible 

prescription drug container labels to individuals who are blind or 

visually impaired and have implemented the best practices;

2. barriers that individuals who are blind or visually impaired face in 

accessing prescription drug container label information after 

publication of the best practices, as identified by stakeholders;

3. challenges that affect pharmacies’ provision of accessible labels or 

implementation of the best practices and steps that could address 

these challenges, as identified by stakeholders; and

4. the extent to which NCD has conducted its informational campaign on 

the best practices.

To examine our first three research objectives, we collected and analyzed 

information from 55 stakeholders. Our review included mail order 

pharmacies, which dispense prescriptions from a central location and 

deliver prescriptions directly to customers, and retail pharmacies with 

store-based locations, which are generally accessible to the public on a 

walk-in basis. Retail pharmacies included both chain pharmacies (those 

with four or more locations under common ownership) and independent 

 6

For example, an agreement effective from February 1, 2016 through June 30, 2016 

required one company to make audible prescription drug container labels available upon 

request. Such agreements may vary in terms of the companies participating, activities 

specifically required, geographic scope, and duration. 

7

Pub. L. No. 112-144, § 904(a)(5), 126 Stat. 1091. 
Page 4 GAO-17-115 Accessible Prescription Drug Container Labels

pharmacies (those with three or fewer retail locations under common 

ownership). We collected information from the following stakeholders:

• Four pharmacy benefit managers (PBM) that manage prescription 

drug benefits for the four largest private insurers that sponsor 

Medicare Part D plans based on enrollment as of March 2016.8 PBMs 

may operate mail order pharmacies and assemble networks of retail 

pharmacies.9

• Nine of the ten largest chain pharmacy companies based on the 

number of retail pharmacy locations as of March 2016.10 Chain 

pharmacy companies include traditional pharmacy companies, 

supermarkets, and mass merchandizers.

• Three of the largest pharmacy services administrative organizations 

(PSAO) based on the number of independent pharmacies in their 

retail pharmacy network as of 2011.11 PSAOs provide administrative 

services for networks of retail pharmacies and generally represent 

independent pharmacies.

• Four state pharmacy regulating bodies (e.g., state boards of 

pharmacy) that oversee the practice of pharmacy in California, 

 8

Medicare Part D provides voluntary, outpatient prescription drug coverage for Medicare, 

the federally financed health insurance program for eligible individuals 65 years and older, 

certain individuals with disabilities, and individuals with end-stage renal disease; and is 

administered by the Centers for Medicare & Medicaid Services. Based on data from the 

Centers for Medicare & Medicaid Services, these four Medicare Part D sponsors’ health 

plans represented about 60 percent of total Medicare Part D enrollment as of March 2016, 

which were the most recent available data at the time we began collecting data. 

9

Our four selected PBMs had about 60,000 or more pharmacies in their retail pharmacy 

networks. 

10Based on data from the National Council for Prescription Drug Programs—a nonprofit 

that develops pharmacy industry standards and maintains data on pharmacies—the 

number of retail pharmacies operated by these chain pharmacy companies ranged from 

about 480 to over 9,700 pharmacies. We used National Council for Prescription Drug 

Programs data to select chain pharmacy companies as of March 2016, which were the 

most recent available data at the time we began collecting data. We compared this list of 

pharmacies to data from the National Association of Chain Drug Stores—which represents 

companies that operate chain pharmacies—on their members as of March 2016 and 

reconciled any differences between these two lists.

11The number of retail pharmacies that these three PSAOs represented ranged from 

about 1,900 to about 4,100 pharmacies in 2011. We used data we previously reported to 

select PSAOs and used market research from 2016 to verify that these PSAOs continue 

to be among the largest in terms of the number of independent pharmacies in their 

networks. See GAO, Prescription Drugs: The Number, Role and Ownership of Pharmacy 

Service Administrative Organizations, GAO-13-176 (Washington, D.C.: Jan. 29, 2013).
Page 5 GAO-17-115 Accessible Prescription Drug Container Labels

Florida, Illinois, and Massachusetts. We selected states that were 

geographically diverse, that had varying levels of visually impaired 

residents as of 2013, and based on other stakeholders’ 

recommendations.12

• Eighteen randomly selected individual retail pharmacy locations—

including chain and independent pharmacies that were licensed in 

California, Florida, Illinois, and Massachusetts—the four states for 

which we interviewed the state pharmacy regulating bodies.13

• Seventeen other stakeholders, including the U.S. Access Board and 

NCD; pharmacy accreditation or standard-setting organizations; 

advocacy groups for individuals who are blind or visually impaired; 

industry groups that represent pharmacies, pharmacists, or 

physicians; and vendors that develop and sell technologies that 

produce accessible labels. We selected these organizations because 

of their participation in the U.S. Access Board working group, because 

of other stakeholders’ recommendations, or because they may affect 

pharmacies’ prescription drug container labeling practices.

To collect information from stakeholders, we conducted interviews with 

most of these stakeholders; administered a web-based questionnaire to 

the selected PBMs, chain pharmacy companies, and individual retail 

pharmacy locations; and reviewed key documents. We analyzed 

questionnaire responses from the 4 PBMs, 7 of the 9 chain pharmacy 

companies, and the 18 individual retail pharmacy locations. These 

responses included information on the extent to which mail order and 

retail pharmacies can provide accessible labels and implemented specific 

 12The number of visually impaired individuals residing in these four states ranged from 

about 137,000 residents in Massachusetts to about 791,000 residents in California. 

Collectively, visually impaired residents in these four states represented about 23 percent 

of the total number of visually impaired individuals in the United States as of 2013. This 

was the most recent analysis on the visually impaired from the Employment and Disability 

Institute, which annually produces disability statistics, at the time we began collecting 

data. See Employment and Disability Institute, Cornell University, 2013 Disability Status 

Report: United States (Ithaca, N.Y.: 2014); and, for example, Employment and Disability 

Institute, Cornell University, 2013 Disability Status Report: Massachusetts, (Ithaca, N.Y.: 

2014) and Employment and Disability Institute, Cornell University, 2013 Disability Status 

Report: California (Ithaca, N.Y.: 2014).

13We obtained a listing of active retail pharmacies licensed in each of the four states as of 

May or June 2016 and sent a web-based questionnaire to 38 randomly selected individual 

chain and independent pharmacy locations in metropolitan and non-metropolitan areas. Of 

these 38 pharmacies, 18 submitted responses, including 10 chain and 8 independent 

pharmacies. 
Page 6 GAO-17-115 Accessible Prescription Drug Container Labels

best practices as of March 2016, when we began data collection.14 (See 

app. I for more information on the web-based questionnaire that we 

administered to PBMs, chain pharmacy companies, and individual retail 

pharmacy locations.) We also reviewed documents that we collected from 

stakeholders—including state pharmacy regulations; company pharmacy 

policies; and pharmacy standards—as well as relevant peer-reviewed 

articles published within the past 5 years and other key reports.

To examine the extent to which NCD has conducted its informational 

campaign on the best practices, we collected information on steps NCD 

has taken to conduct its campaign, including steps to plan and document 

campaign activities, the agency’s progress in conducting these activities, 

and steps taken to assess the effectiveness of the campaign. To collect 

this information, we reviewed NCD documents—such as a brochure and 

press releases—and interviewed agency officials. Additionally, we 

interviewed some of the stakeholders previously mentioned about their 

communication with NCD about its campaign.

Our findings on the extent to which pharmacies have provided accessible 

labels and implemented the best practices are not generalizable to all 

pharmacies. For example, our review included mail order and retail 

pharmacies in the commercial market; therefore, our findings may not be 

applicable to other types of pharmacies, such as those operated by 

federal health systems, including through the Department of Veterans 

Affairs.15 Further, our findings on individual retail pharmacy locations are 

limited to a small random sample in the four selected states. Additionally, 

our findings on barriers that individuals who are blind or visually impaired 

face in accessing information on prescription drug container labels, 

pharmacy challenges for providing accessible labels or implementing the 

best practices, and steps that could address these challenges represent 

the views of the pharmacies and other stakeholders from which we 

collected information and cannot be generalized.

 14Of the nine selected chain pharmacy companies, two declined to provide responses to 

our web-based questionnaire. However, we collected information from both companies 

that did not respond to our web-based questionnaire on the accessible labels their retail 

pharmacies can provide, with one of these companies also providing information on the 

specific best practices it implemented for these labels. 

15According to agency officials, the Department of Veterans Affairs can provide audible 

labels at all of its medical center pharmacies; however, we did not assess the extent to 

which these medical center pharmacies have implemented the best practices.
Page 7 GAO-17-115 Accessible Prescription Drug Container Labels

We took several steps to ensure that the data used to produce this report 

were sufficiently reliable. We reviewed relevant documents to learn about 

their sources, including methods for collecting and checking data and 

limitations of the data, and compared these data to other published 

sources to the extent possible. Also, we spoke with officials who were 

knowledgeable about these data. We determined that all data sources 

that we used were sufficiently reliable for our purposes.

We conducted this performance audit from November 2015 to December 

2016 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

As of July 2014, about 60,000 community retail pharmacies in the United 

States dispensed prescription drugs of which approximately 66 percent 

were chain retail pharmacies and the remaining 34 percent were 

independent pharmacies, according to an industry study.16 In 2015, retail 

pharmacies dispensed about 4 billion prescriptions, while mail order 

pharmacies dispensed over 200 million prescriptions, according to one 

study.17

Pharmacies’ prescription drug container labeling practices may be 

affected by several types of entities:

• PBMs that help many third-party payers—such as health plans—

manage their prescription drug benefits by operating mail order 

pharmacies, assembling retail pharmacy networks that include both 

chain and independent pharmacies, and providing other services. 

PBMs issue corporate policies that govern their mail order pharmacy 

operations and enter into contracts with retail pharmacies in their 

networks that set forth the terms and conditions for dispensing 

prescriptions to health plan enrollees.

 16National Association of Chain Drug Stores, “Community Retail Pharmacy Outlets by 

Location,” Chain Drug Review (New York, N.Y.: Oct. 26, 2015). 

17IMS Institute for Healthcare Informatics, Medicines Use and Spending in the U.S.: A 

review of 2015 and Outlook to 2020 (Parsippany, N.J.: April. 2016). 

Background

Entities That May Affect 

Pharmacies’ Labeling 

Practices
Page 8 GAO-17-115 Accessible Prescription Drug Container Labels

• Chain pharmacy companies that operate chain retail pharmacies 

with four or more locations. These companies issue corporate policies 

that govern their retail pharmacy operations.

• PSAOs that provide a broad range of administrative services to 

networks of retail pharmacies, including contract negotiation with 

third-party payers. To establish these networks, PSAOs enter into 

contracts with retail pharmacies—generally independent 

pharmacies—that set forth the duties and obligations of the PSAO 

and each pharmacy.

• State pharmacy regulating bodies that oversee the practice of 

pharmacy through activities such as licensing pharmacies and issuing 

regulations. According to the National Association of Boards of 

Pharmacy, which represents state boards of pharmacy, as of 

February 2016, only one state—Massachusetts—requires pharmacies 

to provide large-print labels to individuals who are visually impaired 

and elderly upon request.18

• Pharmacy accreditation organizations that certify pharmacies meet 

a predetermined set of standards for pharmacy care or functions, 

which may include elements for providing services to individuals who 

are blind or visually impaired.19

Other entities may also develop or disseminate guidance on prescription 

drug container labels that may affect pharmacies’ labeling practices. For 

example, standard-setting organizations may develop prescription drug 

container labeling standards and entities, such as state pharmacy 

regulating bodies, can incorporate these standards into their pharmacy 

labeling requirements.20 Industry groups representing pharmacies or 

pharmacists and advocacy groups for individuals who are blind or visually 

impaired also may develop guidance, including prescription drug 

container labeling guidance, or use tools, such as newsletters or website 

postings, to disseminate guidance or other information to their members.

 18Mass. Gen. Laws ch. 94C, § 21 (2016). 

19For example, URAC developed accreditation standards intended to address pharmacy 

communications with populations who have physical impairments, including visual 

impairments. 

20For example, in 2012, the U.S. Pharmacopeial Convention initially published standards 

for patient-centered prescription drug container labels to promote patient understanding, 

and these standards were updated in 2016. See U.S. Pharmacopeial Convention, 

Prescription Container Labeling, First Supplement to USP 39-NF 34 (Rockville, Md.: 

August 2016). 
Page 9 GAO-17-115 Accessible Prescription Drug Container Labels

Accessible labels can make information on prescription drug container 

labels more easily available to individuals who are blind or visually 

impaired. Pharmacies can purchase hardware and software from private 

technology vendors to produce labels in audible, braille, and large print 

formats. Audible labels allow individuals to hear prescription drug 

container label information. Technologies for audible labels include talking 

pill bottles that allow pharmacists to create a voice or digital recording of 

label information and tags that can be encoded with label information, 

affixed to prescription drug containers, and are read out by a separate 

device. Braille labels allow individuals who are blind or visually impaired 

to read prescription drug container label information by touch, and large 

print labels enhance the size of label text for easier viewing. Pharmacists 

can produce hard copy braille or large print labels and affix them to the 

prescription drug container. See figure 1 for examples of accessible 

labels.

Accessible Labels
Page 10 GAO-17-115 Accessible Prescription Drug Container Labels

Figure 1: Examples of Accessible Prescription Drug Container Labels

Note: We analyzed vendor-reported information on their technologies for prescription drug container 

labels in audible, braille, and large print formats. Other technology vendors also have other 

technologies available for producing prescription drug container labels in accessible formats. Braille is 

a system of one to six raised dots arranged in cells to represent letters, words, numbers, or symbols.

In 2012, the U.S. Access Board convened an 18-member working group 

to develop best practices to make prescription drug container label 

information accessible to individuals who are blind or visually impaired. 

This working group included representatives from mail order pharmacies; 

chain pharmacy companies; advocacy groups for individuals who are 

blind or visually impaired; and industry groups representing pharmacies 

and pharmacists. The working group’s July 2013 report identified 34 best 

practices. These best practices offer guidance to pharmacists on how to 

deliver and provide accessible labels and their adoption is voluntary. The 

Best Practices Related to 

Accessible Labels
Page 11 GAO-17-115 Accessible Prescription Drug Container Labels

best practices include those that promote access to prescription drug 

container label information in all accessible labels formats as well as 

those specific to audible, braille, and large print formats. For example, 

one best practice that applies to all accessible label formats is for 

pharmacies to not impose an extra fee to individuals to cover the cost of 

providing accessible labels or equipment dedicated for prescription drug 

container label access.

The mail order pharmacies operated by the 4 PBMs, some retail 

pharmacies operated by the 9 chain pharmacy companies, and some of 

the 18 individual chain and independent retail pharmacy locations that we 

contacted for this review said they can provide accessible labels as of 

March 31, 2016.21 For example, officials from the 4 PBMs reported their 

mail order pharmacies generally can provide accessible labels, including 

audible, braille, and large print labels. Similarly, officials from 6 of the 9 

nine chain pharmacy companies reported their retail pharmacies can 

provide accessible labels. Additionally, officials from 8 of the 18 randomly 

selected individual chain and independent retail pharmacy locations 

reported they can provide accessible labels. Of the 8 individual retail 

pharmacy locations that reported that they can provide accessible labels, 

officials from more chain pharmacies—7 pharmacies—reported being 

 21After March 31, 2016, officials from one PBM told us they can provide large print labels 

through its mail order pharmacies. Further, officials from three chain pharmacy companies 

told us that they are considering providing accessible labels through their retail 

pharmacies. 

Some Pharmacies 

Can Provide 

Accessible Labels but 

Dispensed Few of 

Them and Have 

Implemented Most of 

the U.S. Access 

Board’s Best 

Practices

Mail Order Pharmacies 

and Some Retail 

Pharmacies Can Provide 

Accessible Labels
Page 12 GAO-17-115 Accessible Prescription Drug Container Labels

able to provide accessible labels than independent pharmacies—1 

pharmacy.

22 Furthermore, officials from the PBMs more often reported 

that their mail order pharmacies can provide audible and braille labels, 

while officials from the chain pharmacy companies and individual retail 

pharmacy locations more often reported that their retail pharmacies can 

provide audible labels. (See table 1.)

Table 1: Number of Selected Pharmacy Benefit Mangers (PBM), Chain Pharmacy 

Companies, and Individual Retail Pharmacy Locations That Reported They Can 

Provide Accessible Labels through Their Pharmacies, as of March 31, 2016

Accessible label 

formats

PBMs

(n=4)

Chain pharmacy 

companies

(n=9)

Individual retail 

pharmacy 

locations

(n=18)

At least one format 4 6 8

Audible 4 5 6

Braille 4 2 2

Large print 2a 2 6

Source: GAO analysis of information provided by selected PBMs, chain pharmacy companies, and individual retail pharmacy locations. 

| GAO-17-115

Note: We collected information from 4 PBMs on the operation of their mail order pharmacies, 9 chain 

pharmacy companies on the operation of their retail pharmacies, and 18 individual retail pharmacy 

locations that included both chain and independent pharmacies.

a

Officials from one PBM told us they began providing large print labels through their mail order 

pharmacies after March 31, 2016.

The four PBMs that can provide accessible labels through their mail order 

pharmacies dispensed prescriptions with these labels from a central 

location and delivered them directly to customers. These PBMs used the 

same technologies to provide audible and braille labels, but differed in 

how they can provide large print labels through their mail order 

pharmacies. See table 2 for more information on how these PBMs can 

provide accessible labels through their mail order pharmacies.

 22Of the 18 individual retail pharmacy locations that responded to our questionnaire, 10 

were chain pharmacies and 8 were independent pharmacies.
Page 13 GAO-17-115 Accessible Prescription Drug Container Labels

Table 2: Four Selected Pharmacy Benefit Managers (PBM) Can Provide Accessible Labels through Their Mail Order 

Pharmacies, as of March 31, 2016

Four PBMs’ mail order pharmacies dispense prescriptions with accessible labels from a central location and deliver them directly to 

the customer. Pharmacies provide these labels to individuals upon request or if pharmacy staff identify an individual as someone who 

could benefit from accessible labels. These labels include audible labels that digitally record prescription drug container label 

information that can be scanned and audibly read by a separate device; and braille labels that are a clear tape, embossed with braille, 

and affixed over the original standard print prescription drug container label.

Additionally, two of these PBMs’ mail order pharmacies can also provide large print labels in a booklet format that is affixed to the drug 

container. The other two PBM’s mail order pharmacies cannot provide large print labels. However, one of these PBM’s mail order 

pharmacies can make other accommodations by providing prescription drug container label information in large print on a piece of 

paper that is not affixed to the drug container.a

Source: GAO analysis of information provided by four PBMs. | GAO-17-115

Note:

a

Officials from the other PBM told us they began providing large print labels through their mail order 

pharmacies after March 31, 2016.

The six chain pharmacy companies that can provide accessible labels 

through their retail pharmacies varied in terms of the accessible label 

formats they can provide, the number of retail locations that can provide 

them, and timeframes for providing prescriptions with these labels. For 

example, officials from one chain pharmacy company reported to us their 

retail locations can provide accessible labels in all formats, while others 

reported to us their retail locations can provide accessible labels in one or 

two formats. Also, officials from five companies reported to us that they 

can provide accessible labels in all retail locations, while officials from one 

company reported they can provide accessible labels in one retail 

location. Further, some of these companies can provide prescriptions with 

accessible labels available with same-day pickup, while others delivered 

them directly to customers. Officials from the three chain pharmacy 

companies that cannot provide accessible labels reported that they can 

make other accommodations, such as providing information on a 

separate piece of paper in large print. See table 3 for more information on 

how selected chain pharmacy companies can provide accessible labels.
Page 14 GAO-17-115 Accessible Prescription Drug Container Labels

Table 3: Six of Nine Selected Chain Pharmacy Companies Can Provide Accessible Labels through Their Retail Pharmacies, as 

of March 31, 2016

Five chain pharmacy 

companies can provide 

accessible labels at all of 

their retail locations

• One company’s retail pharmacies can provide audible, braille, and large print labels upon request. 

Retail locations can provide two types of audible labels. One audible label allows pharmacy staff to 

voice record prescription drug container label information that can be played back at a later time by 

pushing a button and prescriptions with these labels are available for same-day pickup. Additionally, 

retail locations can provide another type of audible label that digitally records prescription drug 

container label information that can be scanned and audibly read by a separate device; braille labels 

that are a clear tape, embossed with braille, and affixed over the original standard print prescription 

drug container label; and large print labels in a booklet format. These labels are generated at a 

central location, delivered to retail pharmacies, and prescriptions with these labels are not available 

for same-day pickup.

• One company’s retail pharmacies can provide audible labels and braille labels upon request. Retail 

pharmacies can provide audible labels that digitally record prescription drug container label 

information that can be scanned and audibly read by a separate device. Prescriptions with audible 

labels are available for same-day pickup at some retail locations; other retail locations can provide 

prescriptions with these labels through the company’s mail order pharmacy and deliver them directly 

to customers.a Also, all retail locations can provide braille labels that are a clear tape, embossed with 

braille, and affixed over the original standard print prescription drug container label through the 

company’s mail order pharmacy.b

• Two companies can provide audible labels upon request.

• One company’s retail pharmacies can provide audible through its mail order pharmacy 

and deliver the prescriptions directly to the customers. Retail locations can provide 

audible labels that digitally record prescription drug container label information that can 

be scanned and audibly read by a separate device.b

• The other company’s retail pharmacies can provide audible labels that allow pharmacy 

staff to voice record prescription drug container label information that can be played 

back at a later time by pushing a button. Prescriptions with these labels are available for 

same-day pickup.b

• One company’s retail pharmacies’ standard print prescription drug container label is a large print 

label that includes information in an enhanced font size.

One chain pharmacy 

company can provide 

accessible labels in one 

of its retail locations

One company can provide audible labels that digitally record prescription drug container label information 

that can be scanned and audibly read by a separate device at one of its retail locations upon request. 

Further, officials stated that their company may consider providing these labels at additional locations. 

When an individual requests an audible label at a retail location that cannot provide these labels, the 

company refers the individual to another nearby retail location that can provide the labels or, if there are 

no nearby retail locations that can provide such labels, it will consider providing audible labels at that 

location in the future. 

Three chain pharmacy 

companies cannot 

provide accessible labels, 

but their retail locations 

can make other 

accommodations

All three companies’ retail pharmacies can provide prescription drug container label information in large 

print on a piece of paper that is not affixed to the drug container. 

Source: GAO analysis of information provided by nine chain pharmacy companies. | GAO-17-115

Notes:

a

When a retail location that provides audible labels through the company’s mail order pharmacy 

receives a request for such labels, the company will begin the process of implementing technology in 

that retail location to make prescriptions with audible labels available for same-day pickup.

b

While retail pharmacies cannot provide large print labels, they can provide prescription drug 

container label information in large print on a piece of paper that is not affixed to the drug container.
Page 15 GAO-17-115 Accessible Prescription Drug Container Labels

Officials from the four PBMs and three of the six chain pharmacy 

companies that can provide accessible labels through their pharmacies 

reported that the percent of prescriptions dispensed with such labels was 

generally low—less than 1 percent. For example, officials from one PBM 

stated their mail order pharmacy dispensed an average of about 21,000 

prescriptions with accessible labels out of about 11.5 million total 

prescriptions dispensed each month during the first quarter of calendar 

year 2016. Officials from another PBM stated that they dispensed about 

1,200 prescriptions with accessible labels out of about 3 million total 

prescriptions dispensed each month during the first quarter of 2016. 

Similarly, officials from one chain pharmacy company stated that their 

retail pharmacy locations dispensed an average of about 240 

prescriptions with accessible labels out of about 6.5 million total 

prescriptions dispensed each month during the first quarter of 2016. 

Officials from the three remaining chain pharmacy companies could not 

provide us with the percent of prescriptions dispensed with accessible 

labels. However, officials from one of these companies stated that one of 

their retail locations dispensed prescriptions with accessible labels to 6 to 

10 individuals who are blind or visually impaired each month and 

dispensed between 3,200 and 5,600 total prescriptions each month 

during the first quarter of 2016.

Officials from the four PBMs, six chain pharmacy companies, and eight 

individual retail pharmacy locations that we contacted and that can 

provide accessible labels reported that their mail order and retail 

pharmacies have generally implemented most of the 34 best practices for 

these labels. Of these 34 best practices, 14 apply to all accessible labels 

(henceforth referred to as all-format best practices), 3 apply to audible 

labels, 7 apply to braille labels, and 10 apply to large print labels.

Officials from the four PBMs, four of the six chain pharmacy companies, 

and eight individual retail pharmacy locations generally reported that their 

mail order and retail pharmacies have implemented most of the 14 allformat best practices for accessible labels.23 These all-format best 

practices include specific recommendations to promote access to 

prescription drug container label information in all available formats—

including audible, braille, and large print labels—and include practices 

 23Two chain pharmacy companies that can provide accessible labels did not provide us 

with information on the all-format best practices implemented in their retail pharmacies.

Mail Order and Retail 

Pharmacies Dispensed 

Few Prescriptions with 

Accessible Labels

Mail Order and Retail 

Pharmacies Reported 

Implementing Most of the 

Best Practices for 

Accessible Labels

All-Format Best Practices
Page 16 GAO-17-115 Accessible Prescription Drug Container Labels

such as pharmacists encouraging patients and their representatives to 

communicate their needs to the pharmacist. All selected PBMs, chain 

pharmacy companies, and individual retail pharmacy locations that 

provide accessible labels implemented practices such as making 

prescription drug container labels available in various accessible formats, 

as well as using the same quality control processes for prescription drug 

container labels in accessible formats as print prescription drug container 

labels. See table 4 for further detail on all-format best practices 

implemented in pharmacies by selected PBMs, chain pharmacy 

companies, and individual retail pharmacy locations.

Table 4: All-Format Best Practices Implemented by Selected Pharmacy Benefit Managers (PBM), Chain Pharmacy Companies, 

and Individual Retail Pharmacy Locations That Can Provide Accessible Labels through Their Pharmacies, as of March 31, 

2016

All-format best practices

PBMs

(n=4)

Chain pharmacy 

companies

(n=4)

Individual retail 

pharmacy locations

(n=8)

1. Encouraging patients and patient representatives to 

communicate their needs to pharmacists.

●●●● ●●●● ●●●●●●●△ 

2. Following universal patient-centered prescription drug 

container label standards for the format, appearance, 

content, and language of prescription medication 

instructions to promote patient understanding.

●●●● ●●●● ●●●●●●○△

3. Making available options for accessible prescription drug 

container labels in audible, braille, and large print formats 

via methods using, for example, hard copy, dedicated 

devices, and computers or smart devices.

●●●● ●●●● ●●●●●●●●

4. Explaining the accessible format options available for 

prescription drug container labels to the patient, and 

providing the prescription drug container label in the format 

selected by the patient.

●●●● ●●●● ●●●●●●●○

5. Ensuring that duplicate prescription drug container labels 

in accessible formats preserve the integrity of the print 

prescription drug container label.

●●●● ●●●● ●●●●●●○○

6. Subjecting prescription drug container labels in accessible 

formats to the same quality control processes used for print 

prescription drug container labels to ensure accuracy and 

patient safety.

●●●● ●●●● ●●●●●●●●

7. Maintaining patient privacy in accordance with the Health 

Insurance Portability and Accountability Act rules when 

preparing prescription drug container labels in accessible 

formats.

●●●● ●●●● ●●●●●●●○

8. Making arrangements in advance to provide prescription 

drug container labels in accessible formats.

●●●● ●●●● ●●●●●●○○
Page 17 GAO-17-115 Accessible Prescription Drug Container Labels

All-format best practices

PBMs

(n=4)

Chain pharmacy 

companies

(n=4)

Individual retail 

pharmacy locations

(n=8)

9. Providing prescription medication with an accessible 

prescription drug container label format in the same time 

frame as a prescription would be provided to patients 

without visual impairments.

●●●● ●●○○ ●●●●●○○○

10. Providing accessible prescription drug container labels 

and any dedicated equipment free of charge to individuals 

requesting them.

●●●● ●●●● ●●●●●●●○

11. Ensuring the durability of accessible label formats until 

the expiration date specified on the prescription drug 

container label.

●●●● ●●●● ●●●●●●●○

12. Selecting a container that best supports the type of 

accessible label provided.

●●●● ●●●● ●●●●●●●○

13. Ensuring all required information contained on the print 

prescription drug container label is provided on the 

accessible label in the same sequence as the print label.

●●●○ ●●●○ ●●●●●●●○

14. Including information on warning labels added to the 

container at the pharmacist’s discretion in an accessible 

format on the prescription drug container label.

●●○○ ●●○○ ●●●●●●●○

Legend: ●=implemented; ○=not implemented; △=no answer

Source: GAO analysis of information provided by four PBMs, four chain pharmacy companies, and eight individual retail pharmacy locations. | GAO-17-115

Note: Two additional chain pharmacy companies that can provide accessible labels did not provide us 

with information on the all-format best practices implemented in their retail pharmacies. Some of the 

language for the best practices in this table was modified from the U.S. Access Board’s report for 

purposes of conducting our web-based questionnaire. See U.S. Access Board Working Group on 

Accessible Prescription Drug Container Labels, Best Practices for Making Prescription Drug 

Container Label Information Accessible to Persons Who are Blind or Visually-Impaired or Who are 

Elderly (Washington, D.C.: July 10, 2013).

Officials from the four PBMs, five of the six chain pharmacy companies, 

and eight individual retail pharmacy locations told us that their mail order 

and retail pharmacies implemented most of the applicable format-specific 

best practices for audible, braille, and large print labels.24 These formatspecific best practices include specific recommendations on how to 

provide these labels and some of these practices only apply under certain 

circumstances. For example, six of the seven format-specific best 

practices for braille prescription drug container labels only apply to hard 

copy braille labels. The most commonly implemented applicable formatspecific best practices across the PBMs, chain pharmacy companies, and 

individual retail pharmacy locations included speaking in a clear voice 

when recording an audible label, using transparent materials when 

embossing braille labels, and printing text in the highest possible contrast 

 24One chain pharmacy company that can provide accessible labels did not provide us with 

information on the format-specific best practices implemented in its retail pharmacies.

Format-Specific Best Practices
Page 18 GAO-17-115 Accessible Prescription Drug Container Labels

for large print labels. See tables 5 through 7 for further detail on the 

audible, braille, and large print format-specific best practices implemented 

by PBMs, chain pharmacy companies, and individual retail pharmacy 

locations.

Audible Format-Specific Best Practices

Table 5: Audible Format-Specific Best Practices Implemented by Selected Pharmacy Benefit Managers (PBM), Chain 

Pharmacy Companies, and Individual Retail Pharmacy Locations That Can Provide Audible Labels through Their Pharmacies, 

as of March 31, 2016

Audible format-specific best practices

PBMs

(n=4)

Chain pharmacy 

companies

(n=4)

Individual retail 

pharmacy locations

(n=6)

1. Offering to show patients how to operate the audible label. ●●●○ ●●●● ●●●●●○

2. For dedicated equipment provided to the patient, selecting 

devices that provide independent, easy to use, start/stop 

operation, with volume control, and ear bud access for privacy.

●●●● ●●●○ ●●○○○□

3. If using a voice recorder, ensuring the label information is 

spoken in a clear voice in a setting that minimizes background 

noise and maintains patient privacy.

□□□□ ●●□□ ●●●□□□

Legend: ●=implemented; ○=not implemented; □=not applicable

Source: GAO analysis of information provided by four PBMs, four chain pharmacy companies, and six individual retail pharmacy locations. | GAO-17-115

Note: One additional chain pharmacy company that can provide audible labels did not provide 

information on the audible format-specific best practices implemented in retail pharmacies. For two 

audible format-specific best practices (numbers 2 and 3), respondents had the option to select “not 

applicable” if a particular practice did not apply. Some of the language for the best practices in this 

table was modified from the U.S. Access Board’s report for purposes of conducting our web-based 

questionnaire. See U.S. Access Board Working Group on Accessible Prescription Drug Container 

Labels, Best Practices for Making Prescription Drug Container Label Information Accessible to 

Persons Who are Blind or Visually-Impaired or Who are Elderly (Washington, D.C.: July 10, 2013).

Braille Format-Specific Best Practices

Table 6: Braille Format-Specific Best Practices Implemented by Selected Pharmacy Benefit Managers (PBM), Chain Pharmacy 

Companies, and Individual Retail Pharmacy Locations That Can Provide Braille Labels through Their Pharmacies, as of March 

31, 2016

Braille format-specific best practices

PBMs

(n=4)

Chain pharmacy 

companies

(n=2)

Individual retail 

pharmacy 

locations

(n=2)

1. For patients with electronic braille equipment, providing 

electronic delivery methods.

●●●□ ○○ ●□

2. For pharmacies with low demand for hard copy braille, 

partnering with other pharmacies that have the capacity to provide 

hard copy braille prescription drug container labels.

□□□□ ●○ ●●
Page 19 GAO-17-115 Accessible Prescription Drug Container Labels

Braille format-specific best practices

PBMs

(n=4)

Chain pharmacy 

companies

(n=2)

Individual retail 

pharmacy 

locations

(n=2)

3. For pharmacies with high demand for hard copy braille, having 

an onsite hard copy braille embosser in pharmacies.

●●●□ ●○ □□

4. When embossing braille labels, using contracted (grade 2) 

braille.

●●●○ ●○ ●□

5. When embossing braille labels, using transparent materials in 

order to preserve the legibility of print prescription drug container 

labels.

●●●● ●● ●□

6. When embossing braille labels, affixing braille labels to the 

prescription drug container with strong adhesive.

●●●● ●● ●□

7. When embossing braille labels, not folding labels. ●●●● ●● ●□

Legend: ●=implemented; ○=not implemented; □=not applicable

Source: GAO analysis of information provided by four PBMs, two chain pharmacy companies, and two individual retail pharmacy locations. | GAO-17-115

Note: Grade 2 braille is a space-saving braille system where dots are arranged in cells to represent 

words or contractions. For all braille format-specific best practices, respondents had the option to 

select “not applicable” if a particular practice did not apply. Some of the language for the best 

practices in this table was modified from the U.S. Access Board’s report for purposes of conducting 

our web-based questionnaire. See U.S. Access Board Working Group on Accessible Prescription 

Drug Container Labels, Best Practices for Making Prescription Drug Container Label Information 

Accessible to Persons Who are Blind or Visually-Impaired or Who are Elderly (Washington, D.C.: July 

10, 2013).

Large Print Format-Specific Best Practices

Table 7: Large Print Format-Specific Best Practices Implemented by Selected Pharmacy Benefit Managers (PBM), Chain 

Pharmacy Companies, and Individual Retail Pharmacy Locations That Can Provide Large Print Labels through Their 

Pharmacies, as of March 31, 2016

Large print format-specific best practices

PBMsa

(n=2)

Chain pharmacy 

companies

(n=2)

Individual retail 

pharmacy locations

(n=6)

1. Printing labels in 18-point bold font. ●● ●○ ●●●●●●

2. Printing labels in a non-condensed, san-serif font. ●● ●● ●●●●●●

3. Printing labels using 1.5 line spacing. ●● ●○ ●●●●●○

4. Printing labels using sentence case capitalization, with a 

capitalized first letter followed by lower-case letters.

●● ●○ ●●●○○○

5. Printing labels exclusively in horizontal text. ●● ●○ ●●●●●○

6. Printing labels using the highest possible contrast between 

text and background color.

●● ●● ●●●●●●

7. Printing labels on non-glossy paper or other material that is 

durable and easy to manipulate.

●● ●● ●●●●●●
Page 20 GAO-17-115 Accessible Prescription Drug Container Labels

Large print format-specific best practices

PBMsa

(n=2)

Chain pharmacy 

companies

(n=2)

Individual retail 

pharmacy locations

(n=6)

8. Securely affixing labels to the prescription drug container. ●● ●● ●●●●●△

9. When labels are printed on both sides, printing labels on 

material that does not allow print bleed-through. ●● ●□ ●●●□□□

10. When protective tape is used, covering labels in tape that is 

non-glossy and transparent.

●□ ●□ ○□□□□□

Legend: ●=implemented; ○=not implemented; □=not applicable; △=no answer

Source: GAO analysis of information provided by two PBMs, two chain pharmacy companies, and seven individual retail pharmacy locations. | GAO-17-115

Note: For two large print format-specific best practices (numbers 9 and 10), respondents had the 

option to select “not applicable” if a particular practice did not apply. Some of the language for the 

best practices in this table was modified from the U.S. Access Board’s report for purposes of 

conducting our web-based questionnaire. See U.S. Access Board Working Group on Accessible 

Prescription Drug Container Labels, Best Practices for Making Prescription Drug Container Label 

Information Accessible to Persons Who are Blind or Visually-Impaired or Who are Elderly

(Washington, D.C.: July 10, 2013).

a

Officials from one additional PBM told us they began providing large print labels through their mail 

order pharmacies after March 31, 2016. This company’s mail order pharmacies have implemented 

most of the applicable large-print format specific best practices for these labels.

Stakeholders we contacted most often identified three key barriers that 

individuals who are blind or visually impaired continue to face in 

accessing prescription drug container label information even after the 

publication of the best practices in 2013.25 Some of these stakeholders 

told us that the best practices have reduced some barriers to accessing 

prescription drug container label information for individuals who are blind 

or visually impaired by increasing pharmacies’ awareness of these 

barriers or encouraging more pharmacies to provide accessible labels. 

However, other stakeholders told us that the types of barriers that 

individuals who are blind or visually impaired face have not changed.

Inability to identify medications independently. Stakeholders told us 

that individuals who are blind or visually impaired continue to face barriers 

identifying medications independently. Without accessible labels, 

individuals who are blind or visually impaired will need to rely on a 

pharmacist or caregiver to help them identify medications. For example, 

 25We analyzed information collected through interviews and questionnaire responses from 

selected stakeholders, including 4 PBMs; 9 chain pharmacy companies; 4 states; 18 

randomly selected individual retail pharmacy locations; and 17 other stakeholders. These 

17 other stakeholders included federal agencies; accreditation and standard setting 

organizations; advocacy groups for individuals who are blind or visually impaired; industry 

groups representing pharmacies, pharmacists, or physicians; and technology vendors. We 

defined key barriers as those cited by at least 10 stakeholders.

Stakeholders 

Reported That 

Individuals Who Are 

Blind or Visually 

Impaired Continue to 

Face Barriers 

Accessing 

Prescription Label 

Information
Page 21 GAO-17-115 Accessible Prescription Drug Container Labels

some stakeholders said that pharmacists may offer medication 

counseling, such as allowing individuals who are blind or visually impaired 

to feel the size, shape, and weight of their medication and answering 

questions about dosage or side effects. Pharmacists may also place 

rubber bands on some prescription drug containers or use differently 

sized containers to help individuals who are blind or visually impaired 

identify different medications by their containers. However, according to 

some stakeholders, these alternative methods may not be reliable; for 

example, a rubber band may be removed from a prescription drug 

container or caregivers may not understand medication directions. 

Further, stakeholders stated that if accessible labels are not securely

affixed to the prescription drug containers, then they can fall off and get 

mixed up, which could increase individuals’ risk for medication errors.

Inability to identify pharmacies that can provide accessible labels.

Stakeholders told us that individuals who are blind or visually impaired 

generally do not know which pharmacies can provide accessible labels. 

Many stakeholders stated that the inability to identify pharmacies that can 

provide these labels stems from limited or no efforts to advertise 

accessible labels in pharmacies and no centralized database that 

provides information on pharmacies that can provide these labels. While 

officials from the four selected PBMs reported taking steps to inform 

individuals who are blind or visually impaired about the accessible labels 

that their mail order pharmacies can provide—such as two PBMs 

reporting training customer service representatives to ask specific 

questions to identify individuals who could benefit from prescriptions with 

accessible labels and help them identify the accessible label that would 

best fit their needs—other selected stakeholders that operate pharmacies 

told us that they do not advertise the accessible labels their pharmacies 

can provide. Specifically, officials from 2 of our 9 selected chain 

pharmacy companies and 4 of 18 individual retail pharmacy locations that 

submitted questionnaire responses reported to us that they generally do 

not advertise the accessible labels their pharmacy can provide, or that 

customers need to ask pharmacists about these labels in order to have 

them included on the prescription containers. Officials from an advocacy 

group also reported that individuals who are blind or visually impaired 

continue to be unable to identify pharmacies that can provide accessible 

labels because there is no centralized database that provides information 

on which pharmacies can provide such labels. Officials from the two 

technology vendors told us that they compiled information on retail 

pharmacies that can provide accessible labels sold by their companies; 

however, their databases are limited to locations that can provide their 
Page 22 GAO-17-115 Accessible Prescription Drug Container Labels

specific products and do not include retail pharmacy locations that can 

provide accessible labels made by other technology vendors.

Inability to obtain prescriptions with accessible labels on the same 

day as requested. Stakeholders told us that individuals who are blind or 

visually impaired may be unable to obtain prescriptions with accessible 

labels on the same day as requested. For example, officials from two 

chain pharmacy companies stated that individuals who are blind or 

visually impaired can work with retail pharmacy staff to order prescriptions 

with accessible labels through mail order pharmacies and have these 

accessible prescriptions sent directly to these individuals at a later date. 

Further, officials from these chain pharmacy companies reported that it 

may take up to 72 hours from the time an individual requests a 

prescription with an accessible label to the time the individual receives 

that prescription. Officials from one advocacy group raised concerns that 

this delay in obtaining prescriptions through the mail order pharmacy is 

unreasonable for certain time-sensitive prescriptions that must be 

dispensed immediately, such as antibiotics to treat an infection.

Stakeholders most often identified four key challenges that pharmacies 

had in providing accessible labels or implementing the best practices and 

identified steps that could address some of these challenges.26

Lack of awareness of the best practices. Stakeholders identified lack 

of awareness of the best practices by pharmacies and others as a key 

challenge:

• Pharmacies (including pharmacists and pharmacy staff). Federal 

agencies, advocacy groups, technology vendors, and an accreditation 

organization told us that pharmacies were not aware of the best 

practices. Further, officials from 7 of 18 individual retail pharmacy 

locations stated that they first learned about the best practices when 

we contacted them. Additionally, some stakeholders told us that 

 26We analyzed information collected through interviews and questionnaire responses from 

selected stakeholders, including 4 PBMs; 9 chain pharmacy companies; 3 PSAOs; 4 

states; 18 randomly selected individual retail pharmacy locations; and 17 other 

stakeholders. These 17 other stakeholders included federal agencies; accreditation and 

standard setting organizations; advocacy groups for individuals who are blind or visually 

impaired; industry groups representing pharmacies, pharmacists, or physicians; and 

technology vendors. We defined key challenges as those cited by at least 10 

stakeholders.

Stakeholders 

Identified Pharmacy 

Challenges and Steps 

for Providing 

Accessible Labels or 

Implementing the 

U.S. Access Board’s 

Best Practices
Page 23 GAO-17-115 Accessible Prescription Drug Container Labels

individuals who are blind or visually impaired are generally unaware of 

the best practices and, as a result, may not request accessible labels 

at their pharmacies.

• Other stakeholders. Other stakeholders that could affect 

pharmacies’ labeling practices or provide medical services to 

individuals who are blind or visually impaired were unaware of the 

best practices. For example, the four states and an industry group 

representing physicians told us that they were unaware of the best 

practices prior to our contact with them. After our outreach, one state 

published an article about the best practices in its newsletter and 

discussed these practices with pharmacists, pharmacy staff, and the 

public at two public meetings in May and July 2016.

Of those stakeholders who identified this challenge, many stated that 

greater dissemination of information on the best practices could increase 

awareness of the best practices.27 Additionally, NCD officials told us that 

they would continue to disseminate information on the best practices as 

long as stakeholders remained unaware of them.

Low demand and high costs for providing accessible labels. Another 

challenge that stakeholders identified is that pharmacies had low demand 

and incurred high costs to provide accessible labels. Officials from five 

chain pharmacy companies and four individual retail pharmacy locations 

told us that they have had relatively few or no customer requests for 

accessible labels.28 Some stakeholders reported that the demand for 

these labels does not justify the costs to provide accessible labels. These 

costs include staff costs—such as training or the time needed to produce 

these labels—as well as the costs associated with the technology 

required to produce the labels—such as purchasing software, printers, or 

labels. Two stakeholders told us that the initial costs to purchase this 

technology may range from a few hundred to a few thousand dollars for 

each individual retail pharmacy location. Further, these pharmacy 

locations may incur ongoing costs, such as annual fees of up to a few 

hundred dollars to cover technical assistance and other services or fees 

 27We found that some stakeholders have taken steps to disseminate information on the 

best practices. For example, officials from an industry group representing pharmacists 

published an article about the best practices in its member newsletter. Additionally, 

officials from an advocacy group for individuals who are blind or visually impaired stated 

that it informed its members about the best practices at a national convention. 

28This is consistent with our finding that prescriptions with accessible labels accounted for 

less than one percent of all prescriptions dispensed across pharmacies operated by the 

four selected PBMs and three of the seven chain pharmacy companies. 
Page 24 GAO-17-115 Accessible Prescription Drug Container Labels

of up to a few dollars to purchase additional accessible labels. 

Additionally, many stakeholders stated that it may be costly for larger 

chain pharmacy companies to implement technology and train staff in 

many locations, while smaller independent pharmacies may have 

difficulty absorbing the costs of purchasing the new technology they need 

to produce accessible labels.

Of those stakeholders who identified this challenge, some stated that 

financial support for pharmacies, such as third-party reimbursement, 

could address high costs that pharmacies incur to provide accessible 

labels that meet the best practices. These stakeholders stated that there 

is currently no direct financial support for providing these labels and these 

labels are provided free of charge to customers.29 Officials from four chain 

pharmacy companies told us that pharmacies may be willing to provide 

accessible labels that meet the best practices if third parties, such as 

health plans, were willing to reimburse or share in the costs of producing 

these labels. Additionally, officials from one industry group representing 

pharmacists stated that pharmacies may be more willing to provide 

accessible labels that meet the best practices if grant money were 

available to cover costs for producing these labels.

Technical challenges for providing accessible labels. Stakeholders 

identified some technical challenges for providing accessible labels that 

meet the best practices. For example, officials from one state and four 

chain pharmacy companies told us that pharmacies face challenges fitting 

all the required prescription label information in large print formats on 

small prescription drug containers.30 Officials from one technology vendor 

stated that printing the large print labels in a booklet form, which can then 

be affixed to the prescription drug container, could address this challenge. 

Additionally, officials from a chain pharmacy company, a state regulating 

body, and a federal agency told us that pharmacists typically cannot 

independently verify information on braille labels to ensure their 

 29Officials from the Centers for Medicare & Medicaid Services and the Department of 

Veterans Affairs confirmed that they do not provide additional reimbursement to retail 

pharmacies for dispensing prescriptions with accessible labels.

30One of the all-format best practices states that all required information contained on the 

print prescription drug container labels should be provided on the accessible labels in the 

same sequence as the print label.
Page 25 GAO-17-115 Accessible Prescription Drug Container Labels

accuracy.31 Specifically, three stakeholders expressed concern that 

pharmacists who cannot read braille cannot determine if the braille 

translation is accurate and therefore must rely on the accuracy of the 

braille technology to translate prescription label information to braille.

Absence of requirements to implement the best practices.

Stakeholders told us that some pharmacies are not implementing the best 

practices, given an absence of requirements to do so by applicable 

corporate policies, contracts, state regulations, or accreditation standards.

• Corporate pharmacy policies. Officials from all four PBMs and four 

of the nine chain pharmacy companies told us that they incorporated 

some, but not all, of the best practices into their corporate policies that 

pharmacies must follow. However, officials from three chain pharmacy 

companies told us that their corporate policies do not include any of 

the best practices and their retail pharmacies cannot offer any 

services for individuals who are blind or visually impaired other than 

what has been approved at the corporate level.32

• Contracts with retail pharmacies. Officials from all four PBMs and 

all three PSAOs told us that their contracts with retail pharmacies in 

their networks do not require pharmacies to implement the best 

practices.

• Pharmacy accreditation standards. Officials from two accreditation 

organizations told us that their pharmacy standards do not incorporate 

the best practices. Pharmacies must comply with standards for the 

accreditation processes they choose to undergo. Two accreditation 

organizations reported that they have standards that address services 

for individuals with disabilities, but these standards are not specific to 

drug labeling for the visually impaired and do not incorporate the best 

practices.

• State regulations. Officials from all four states told us that their 

state’s regulations do not incorporate the best practices. They also 

stated that they did not have any plans to update their current 

regulations to incorporate the best practices; however, officials from 

one state told us that they may consider doing so in the future. 

 31One of the all-format best practices states that accessible labels should be subjected to 

the same quality control processes used for print labels to ensure accuracy and patient 

safety. 

32We did not receive information about corporate pharmacy policies from two of the nine 

chain pharmacy companies. 
Page 26 GAO-17-115 Accessible Prescription Drug Container Labels

Massachusetts does have a law requiring the provision of large print 

labels to the visually impaired and elderly upon request, but the font 

size requirement differs from that of the best practices.33

Of those stakeholders who identified this challenge, most stakeholders 

told us that more pharmacies may implement the best practices if 

corporate pharmacy policies or pharmacy accreditation standards 

incorporated them. For example, officials from three chain pharmacy 

companies, one advocacy group, one industry group, and one technology 

vendor told us that pharmacies could implement the best practices if 

corporate pharmacy policies included them. Further, officials from two 

individual retail pharmacy locations stated that they require corporate 

approval to implement any technologies to produce accessible labels that 

meet the best practices. Additionally, officials from one PBM and one 

technology vendor told us that more pharmacies would implement the 

best practices if pharmacy accreditation standards incorporated them.

We found that NCD conducted limited campaign activities from July 2013 

through August 2016 to inform and educate pharmacies (including 

pharmacists and pharmacy staff), individuals who are blind or visually 

impaired, and the public about the best practices. For example, prior to 

the publication of the U.S. Access Board working group’s report, NCD 

sent emails to members of the working group to solicit ideas on how the 

agency could coordinate with working group members to disseminate 

information on the best practices once they were published. From July 

2013 through February 2016, NCD issued an agency statement and two 

press releases through its website, listserv, and online social media about 

the best practices and pharmacies’ agreements with advocacy groups to 

provide accessible labels; hosted a conference call with three advocacy 

groups to discuss how they could conduct outreach as part of NCD’s 

campaign; and published a blog post on accessible labels.34 However, the 

agency did not conduct any campaign activities in 2015. From June 

through August 2016, NCD developed a brochure on some of the best 

practices, disseminated the brochure through its website, and coordinated 

with the U.S. Access Board, one industry group representing 

 33See Mass. Gen. Laws ch. 94C, § 21 (2016). 

34NCD officials stated that the agency’s listserv has about 3,000 subscribers, such as 

members of advocacy groups for individuals who are blind or visually impaired. They 

tracked the number of likes on their Facebook posts or number of retweets on their Twitter 

posts. 

NCD Has Conducted 

Limited Campaign 

Activities, but Has Not 

Assigned 

Responsibilities for 

Future Activities Nor 

Evaluated Its 

Activities
Page 27 GAO-17-115 Accessible Prescription Drug Container Labels

pharmacists, and one chain pharmacy company to disseminate this 

brochure. See table 8 for a timeline of NCD’s campaign activities.

Table 8: National Council on Disability’s (NCD) Informational Campaign Activities after Publication of the U.S. Access Board’s 

Best Practices

2013 July: Issued agency statement about publication of best practices and disseminated statement via its website, its listserv, 

and social media, such as Facebook.

November: Held conference call with three advocacy groups to discuss outreach for campaign.

2014 March: Issued a press release about the best practices and a pharmacy’s agreement with advocacy groups to provide 

accessible labels and disseminated press release via its website, its listserv, and social media. Also, published blog post 

on accessible labels from the perspective of an individual who is blind.a

2015 No reported campaign activities.

2016 February: Issued a press release about the best practices and a pharmacy’s agreement with advocacy groups to provide 

accessible labels and disseminated press releases via its website, its listserv, and social media.

June-August: Developed brochure on best practices, disseminated brochure via website, and coordinated with the U.S. 

Access Board, one industry group, and one chain pharmacy company to also disseminate brochure.

Source: GAO analysis of NCD campaign activities. | GAO-17-115

Note:

The U.S. Access Board working group published its report on the best practices on July 10, 2013. 

See U.S. Access Board Working Group on Accessible Prescription Drug Container Labels, Best 

Practices for Making Prescription Drug Container Label Information Accessible to Persons Who are 

Blind or Visually-Impaired or Who are Elderly (Washington, D.C.: July 10, 2013).

a

The blog post was published on Disability.Blog, the blog for Disability.gov, a federal website for 

information on disability programs and services. 

Most of the selected stakeholders we spoke with—including PBMs, chain 

pharmacy companies, states, and advocacy groups—have not had any 

communication with NCD about its campaign, and, as previously 

discussed, some were unaware of the best practices. When we first 

interviewed NCD officials in February 2016, they could not provide us with 

a fully developed and documented plan for conducting and evaluating the 

agency’s campaign nor did they do so in subsequent follow-up we had 

with them through August 2016. However, in September 2016 during a 

meeting to review NCD’s campaign activities, officials told us they had 

developed a plan in December 2013 for conducting campaign activities 

that were to occur throughout 2014. These activities consisted of 

developing a virtual toolkit for stakeholders to use for planning their own 

outreach, according to documentation NCD provided. However, we 

determined that NDC did not conduct most of these activities. 

Subsequent to our September 2016 meeting, officials provided us with a 

corrective action plan with timeframes for conducting future campaign 

activities through fiscal year 2017, including some of the activities that 

NCD did not conduct in 2014. The development of this corrective action 

plan is a positive step to conduct campaign activities. However, neither 

the original plan nor the corrective action plan assigned responsibilities 
Page 28 GAO-17-115 Accessible Prescription Drug Container Labels

for campaign activities. This is inconsistent with federal internal control 

standards, which indicate that an agency should assign responsibilities to 

achieve its objectives. Given that most of the activities NDC originally 

planned for 2014 never occurred, this lack of specificity regarding 

responsibilities is concerning because it does not provide assurance that 

the agency will conduct future campaign activities as planned. Further, 

officials could not provide us any plans for how they will evaluate the 

agency’s campaign activities. NCD officials stated that the agency has not 

evaluated nor has any plans to evaluate its campaign activities, other 

than tracking the number of likes or retweets on its social media posts. 

Federal internal control standards indicate that an agency should design 

and execute a plan to evaluate its activities, document evaluation results, 

and identify corrective actions to address identified deficiencies.35 In the 

absence of a formal evaluation plan, NCD officials will be unable to 

determine the effectiveness of their campaign activities and make 

adjustments, as needed.

The U.S. Access Board published best practices to make information on 

prescription drug container labels accessible to the about 7.4 million 

Americans who are blind or visually impaired. However, there continues 

to be a lack of awareness among a variety of stakeholders that these best 

practices exist. NCD, the agency charged with conducting a campaign to 

inform and educate stakeholders of these practices, has not had an 

effective plan to conduct its campaign and, consequently, conducted 

limited activities from July 2013 through August 2016. For example, the 

agency did not conduct most of its planned campaign activities in 2014 

and conducted no activities in 2015. Although NCD now has a corrective

action plan for activities it intends to conduct through fiscal year 2017, it 

has not assigned responsibilities for these activities and has not 

developed an evaluation strategy for its activities, which is inconsistent 

with federal internal control standards. Without ensuring these elements 

are in place, NCD will be unable to adjust its corrective action plan and 

assess whether the information it is providing on the best practices are 

effectively reaching its target audience.

 35See GAO, Standards for Internal Control in the Federal Government, GAO-14-704G 

(Washington, D.C.: September 2014). Internal control is a process effected by an entity’s 

oversight body, management, and other personnel that provides reasonable assurance 

that the objectives of an entity will be achieved.

Conclusions
Page 29 GAO-17-115 Accessible Prescription Drug Container Labels

The Executive Director of NCD should assign responsibilities for 

conducting future campaign activities and develop an evaluation plan for 

its activities.

We provided a draft of this report to the U.S. Access Board and NCD for 

comment. Both agencies provided written comments, which we have 

reprinted in appendixes II and III, respectively. The U.S. Access Board 

said that it found our report to be complete and accurate. In its written 

comments, NCD did not specifically state whether it agreed with our 

recommendation, but signaled its intention to revise its corrective action 

plan for conducting campaign activities through fiscal year 2017. NCD 

stated that it has reassessed its plan and is taking action to ensure 

ongoing compliance with federal internal control standards. NCD also 

provided technical comments, which we incorporated as appropriate. 

We are sending copies of this report to the appropriate congressional 

committees, the Executive Director of the U.S. Access Board, the 

Executive Director of the National Council on Disability, and other 

interested parties. In addition, the report is available at no charge on the 

GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact 

me at (202) 512-7114 or dickenj@gao.gov. Contact points for our Offices 

of Congressional Relations and Public Affairs may be found on the last 

page of this report. GAO staff who made key contributions to this report 

are listed in appendix IV.

John E. Dicken

Director, Health Care

Recommendation for 

Executive Action

Agency Comments 

and Our Evaluation
Appendix I: Description of Web-Based 

Questionnaire

Page 30 GAO-17-115 Accessible Prescription Drug Container Labels

We developed a web-based questionnaire that included questions on

1. the extent to which pharmacies can provide accessible labels and 

have implemented the specific U.S. Access Board’s best practices for 

making information on prescription drug container labels accessible to 

individuals who are blind or visually impaired (henceforth referred to 

as best practices);

2. barriers that individuals who are blind or visually impaired face in 

accessing information on prescription drug container labels; and

3. factors that affect pharmacies’ implementation of the best practices 

and steps that could address any implementation challenges.

We sent this questionnaire to pharmacy benefit managers (PBM) that 

operate mail order pharmacies that centrally fill prescriptions and send 

them directly to individuals; chain pharmacy companies that operate retail 

pharmacies in traditional pharmacies locations, supermarkets, and mass 

merchandise stores; and individual retail pharmacy locations—including 

chain pharmacies (those with four or more locations under common 

ownership) and independent pharmacies (those with three or fewer retail 

locations under common ownership):

• Four PBMs that manage prescription drug benefits for the four largest 

private insurers that sponsor Medicare Part D plans as of March 

2016.1 To select PBMs, we analyzed Medicare Part D contract and 

enrollment data as of March 2016 from the Centers for Medicare & 

Medicaid Services, which were the most recent available data at the 

time began our work. Using these data, we identified the four private 

insurers that sponsor Medicare Part D plans with the largest 

percentage of Medicare Part D enrollment as of March 2016—

representing a total of about 60 percent of Medicare Part D 

enrollees—and selected the four PBMs that managed the prescription 

drug benefits for these private insurers.

• Nine of the 10 largest chain pharmacy companies as of March 2016. 

To select these companies, we obtained data from the National 

 1

Medicare Part D provides voluntary, outpatient prescription drug coverage for Medicare, 

the federally financed health insurance program for eligible individuals 65 years and older, 

certain individuals with disabilities, and individuals with end-stage renal disease; and is 

administered by the Centers for Medicare & Medicaid Services. PBMs are companies that 

help third-party payers—such as private insurers—manage their prescription drug benefits 

by operating mail order pharmacies, assembling retail pharmacy networks that include 

both chain and independent pharmacies, and providing other services.

Appendix I: Description of Web-Based 

Questionnaire
Appendix I: Description of Web-Based 

Questionnaire

Page 31 GAO-17-115 Accessible Prescription Drug Container Labels

Council of Prescription Drug Programs on the 16 chain pharmacy 

companies with the most retail pharmacy locations as of March 2016, 

which were the most recent available data at the time we began our 

data collection.2 We compared this list of pharmacies to data from the 

National Association of Chain Drug Stores on their members as of 

March 2016 and reconciled any differences between these two lists of 

data.3 We contacted the 10 largest chain pharmacy companies based 

on their number of retail pharmacy locations, which ranged from about 

480 to over 9,700, and 9 agreed to participate in our study.

• Thirty-eight individual retail pharmacy locations that included both 

chain and independent pharmacies in metropolitan and nonmetropolitan areas in the four states for which we interviewed the 

state pharmacy regulating bodies—California, Florida, Illinois, and 

Massachusetts. To make our selection, we obtained data as of May 

and June 2016 on the active licensed retail pharmacies in each of the 

four states—including pharmacy name, the county in which the 

pharmacies were located, and pharmacy license number.4 Then, 

using the U.S. Department of Agriculture’s 2013 Rural-Urban 

Continuum Codes data, which classifies counties by their population 

size and degree of urbanization, we coded pharmacies by the county 

in which they were located.5 We used the coded data to create two 

randomized lists—one for pharmacies in metropolitan counties and a 

second for pharmacies in non-metropolitan counties—to use for 

 2

The National Council for Prescription Drug Programs is a nonprofit organization that 

develops pharmacy industry standards and maintains data on pharmacies. 

3

The National Association of Chain Drug Stores is an industry group that represents 

companies that operate chain pharmacies. 

4

We excluded pharmacies that were located out of state or did not have a county name 

listed in the original data file we obtained from the state pharmacy regulating body. 

5

The Rural-Urban Continuum Codes are a classification scheme that distinguishes 

metropolitan counties by the population size of their metropolitan area and nonmetropolitan counties by degree of urbanization and adjacency to a metropolitan area. 

Each county in the U.S. is assigned a code that ranges from one (meaning that the county 

is in a metropolitan area with a population of one million people or more) to nine (meaning 

that the county is rural, has a urban population of less than 2,500 people, and is not 

adjacent to a metropolitan area).
Appendix I: Description of Web-Based 

Questionnaire

Page 32 GAO-17-115 Accessible Prescription Drug Container Labels

selection.6 Using these lists, we targeted two independent and two 

chain pharmacies from metropolitan counties, since most pharmacies 

were located in metropolitan areas, and one independent and one 

chain from non-metropolitan counties.

During the development of our questionnaire, we pretested it with two 

randomly selected individual retail pharmacy locations (one chain and

one independent pharmacy) to ensure that our questions and response 

choices were clear, appropriate, and answerable. We then made changes 

to the content of the questionnaire based on feedback obtained from the 

pretests.

We administered the web-based questionnaire from July 2016 through 

September 1, 2016 and received responses from the 4 selected PBMs, 7 

of the 9 selected chain pharmacy companies, and 18 of 38 randomly 

selected individual retail pharmacy locations. The 18 individual retail 

pharmacy locations represented 10 chain and 8 independent pharmacies 

in both metropolitan and non-metropolitan areas in all four of our selected 

states.

 6

We defined metropolitan counties as those coded with Rural-Urban Continuum Codes 

one through three and non-metropolitan counties as those coded with Rural-Urban 

Continuum Codes four through nine. Data on retail pharmacies located in Florida did not 

contain data on the county, but rather zip codes, in which pharmacies are located. We 

used a crosswalk from the Centers for Medicare & Medicaid Services that allowed us to 

match zip codes to counties to identify counties in which the pharmacies were located.
Appendix II: Comments from the U.S. Access 

Board

Page 33 GAO-17-115 Accessible Prescription Drug Container Labels

Appendix II: Comments from the U.S. 

Access Board
Appendix III: Comments from the National 

Council on Disability

Page 34 GAO-17-115 Accessible Prescription Drug Container Labels

Appendix III: Comments from the National 

Council on Disability
Appendix IV: GAO Contact and Staff 

Acknowledgments

Page 35 GAO-17-115 Accessible Prescription Drug Container Labels

John E. Dicken (202) 512-7114 or dickenj@gao.gov

In addition to the contact named above, individuals making key 

contributions to this report include Rashmi Agarwal, Assistant Director; 

Kristin Ekelund, Analyst-in-Charge; Melissa Duong; and John Lalomio. 

Also contributing were George Bogart, Carolyn Fitzgerald, Laurie Pachter, 

and Vikki Porter.

Appendix IV: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments

(100454)
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