Some Pharmacies Can Provide Accessible Labels but Dispensed Few of Them and Have Implemented Most of the U.S. Access Board’s Best Practices

		Mail Order Pharmacies and Some Retail Pharmacies Can Provide Accessible Labels

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. Additionally, officials from 8 of the 18 randomly  selected individual chain and independent retail pharmacy locations  reported they can provide accessible labels. Mail Order and Retail Pharmacies Dispensed Few Prescriptions with 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. Mail Order and Retail Pharmacies Reported Implementing Most of the Best Practices for Accessible Labels

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. 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 Identified Pharmacy Challenges and Steps for Providing Accessible Labels or Implementing the U.S. Access Board’s Best Practices

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. Other stakeholders. 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. Low demand and high costs for providing accessible labels. Absence of requirements to implement the best practices. State regulations. NCD Has Conducted Limited Campaign Activities, but Has Not Assigned Responsibilities for Future Activities Nor Evaluated Its Activities

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. However, the  agency did not conduct any campaign activities in 2015. 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. 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. However, there continues  to be a lack of awareness among a variety of stakeholders that these best  practices exist. 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. Recommendation for Executive Action

The Executive Director of NCD should assign responsibilities for  conducting future campaign activities and develop an evaluation plan for  its activities. Appendix I: Description of Web-Based Questionnaire

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.
Why GAO Did This Study

About 7.4 million Americans are blind or visually impaired and may face difficulty reading prescription drug container labels. FDASIA required the U.S. Access Board to develop best practices for accessible labels and NCD to conduct an informational campaign on these best practices.
FDASIA also included a provision for GAO to review pharmacies' implementation of these best practices. This report examines: the extent to which pharmacies can and do provide accessible labels and implement the best practices; pharmacy challenges; and the extent to which NCD conducted its informational campaign, among others.
GAO collected information from 55 stakeholders, including 4 PBMs used by large insurers; 9 of the largest chain pharmacy companies; 18 randomly selected individual retail pharmacy locations in 4 states with varying levels of visually impaired residents; and 24 others, such as state regulating bodies and advocacy and industry groups. GAO sent a web-based questionnaire to PBMs, chain pharmacy companies, and individual retail pharmacy locations. GAO also interviewed stakeholders and reviewed state regulations and documents from NCD.

What GAO Found

GAO found that some pharmacies can provide accessible prescription drug labels, which include labels in audible, braille, and large print formats and are affixed to prescription drug containers.
Mail order pharmacies: Four pharmacy benefit managers (PBMs) used by large insurers that GAO contacted reported that they can provide accessible labels through their mail order pharmacies.
Retail pharmacies: Six of the 9 largest chain pharmacy companies and 8 of the 18 selected individual retail pharmacy locations GAO contacted also reported that they can provide accessible labels through their store-based retail pharmacies.
The percent of prescriptions dispensed with accessible labels was generally low—less than one percent of all prescriptions dispensed—according to some PBMs and chain pharmacy companies that GAO contacted. With regard to best practices, a working group convened by the U.S. Access Board—a federal agency that promotes accessibility for individuals with disabilities—developed and published 34 best practices for accessible labels. Four PBMs, six chain pharmacy companies, and eight individual retail pharmacy locations GAO contacted reported that they have generally implemented most of the 34 best practices for accessible labels. However, stakeholders GAO contacted said that individuals who are blind or visually impaired continue to face barriers accessing drug label information, including identifying pharmacies that can provide accessible labels.
Stakeholders GAO contacted identified four key challenges that pharmacies faced in providing accessible labels or implementing the best practices: (1) lack of awareness of the best practices; (2) low demand and high costs for providing accessible labels; (3) technical challenges for providing these labels; and (4) an absence of requirements to implement the best practices. Many stakeholders identified greater dissemination of the best practices as a step, among others, that could help address some of these challenges.
The National Council on Disability (NCD)—the federal agency responsible for conducting an informational campaign on the best practices, as required by the Food and Drug Administration Safety and Innovation Act (FDASIA)—has conducted limited campaign activities. Primarily in 2013 and 2014, NCD used its website and social media to disseminate an agency statement and press releases on the best practices. However, most stakeholders GAO spoke with said they had no communication with NCD about its campaign, and some said they were unaware of the best practices. Agency officials provided GAO with an original plan for conducting campaign activities through 2014, but most activities were not conducted. During the course of our review, NCD developed a corrective action plan for conducting future campaign activities. However, neither plan assigned responsibilities for conducting these activities nor does the agency have plans to evaluate them, which is inconsistent with federal internal control standards. Without assigning responsibilities and developing an evaluation plan, NCD will be unable to adjust its action plan and assess whether the information on the best practices is effectively reaching its target audience.

What GAO Recommends

NCD should assign responsibility for conducting campaign activities and evaluate these activities. NCD neither agreed nor disagreed with the recommendation but indicated that it is taking steps to address this issue.