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. In 2015, retail pharmacies dispensed about 4 billion prescriptions, while mail order pharmacies dispensed over 200 million prescriptions, according to one study. 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. 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. 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. 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. 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. 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. 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 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. 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 able to provide accessible labels than independent pharmacies—1 pharmacy. 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.) 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. 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. 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 all- format best practices for accessible labels. 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 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. 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. These format- specific 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 format- specific 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 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. 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. 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, 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 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. 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 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. 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. 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 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. 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. 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 accuracy. 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. 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. 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. 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. 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 pharmacists, and one chain pharmacy company to disseminate this brochure. See table 8 for a timeline of NCD’s campaign activities. 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 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. 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. 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. 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. 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 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. 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. 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 non- metropolitan 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. 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. 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 selection. 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. 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.

Summary: 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. 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. 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.