Prescription Drug Labels: Actions Needed to Increase Awareness of Best Practices for Accessible Labels for Individuals Who are Blind or Visually Impaired
Published: 2016-12-09T00:00:00

Fast Facts:
Over 7 million Americans are blind or visually impaired and may have trouble reading the labels on prescription drug containers. We found that some pharmacies can provide accessible labels in audible, braille, and large print formats but dispensed very few prescriptions with these labels.
We also found that the National Council on Disability has conducted limited activities to inform pharmacies and the public about best practices for accessible prescription drug labeling. We recommended that NCD assign responsibility for conducting these activities, and evaluate its efforts to raise awareness of these best practices.

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.
section_title: What GAO Recommends
paragraphs: 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.

section_title: Letter
paragraphs: 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. 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  population. 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). 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. These best practices are voluntary and offer  guidance to pharmacies on how to provide accessible labels to individuals  who are blind or visually impaired. Further, these best practices are  consistent with certain practices included in agreements between some  companies that operate pharmacies and advocacy groups representing  individuals who are blind or visually impaired. 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.
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  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. PBMs  may operate mail order pharmacies and assemble networks of retail  pharmacies.
Nine of the ten largest chain pharmacy companies based on the  number of retail pharmacy locations as of March 2016. 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. 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,  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.
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.
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  best practices as of March 2016, when we began data collection. (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. 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.
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.
subsections: section_title: Background
paragraphs: 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.
subsections: section_title: Entities That May Affect Pharmacies’ Labeling Practices
paragraphs: 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.
section_title: Accessible Labels
paragraphs: 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.
section_title: Best Practices Related to Accessible Labels
paragraphs: 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.
section_title: Some Pharmacies Can Provide Accessible Labels but Dispensed Few of Them and Have Implemented Most of the U.S. Access Board’s Best Practices
subsections: section_title: Mail Order Pharmacies and Some Retail Pharmacies Can Provide Accessible Labels
paragraphs: 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.
section_title: Mail Order and Retail Pharmacies Dispensed Few Prescriptions with Accessible Labels
paragraphs: 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.
section_title: Mail Order and Retail Pharmacies Reported Implementing Most of the Best Practices for Accessible Labels
paragraphs: 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.
subsections: section_title: All-Format Best Practices
paragraphs: 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.
section_title: Stakeholders Reported That Individuals Who Are Blind or Visually Impaired Continue to Face Barriers Accessing Prescription Label Information
paragraphs: 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.
section_title: Stakeholders Identified Pharmacy Challenges and Steps for Providing Accessible Labels or Implementing the U.S. Access Board’s Best Practices
paragraphs: 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.
section_title: NCD Has Conducted Limited Campaign Activities, but Has Not Assigned Responsibilities for Future Activities Nor Evaluated Its Activities
paragraphs: 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendation for Executive Action
paragraphs: The Executive Director of NCD should assign responsibilities for  conducting future campaign activities and develop an evaluation plan for  its activities.
section_title: Agency Comments and Our Evaluation
paragraphs: 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.
section_title: Appendix I: Description of Web-Based Questionnaire
paragraphs: 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.
section_title: Appendix II: Comments from the U.S. Access Board
section_title: Appendix III: Comments from the National Council on Disability
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: 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.