Access Board Issues Report on Best Practices for Access to Prescription Drug Label Information by Melanie Brunson
On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (P.L. 112-144, 126 Stat. 993). One provision of this act authorized the U.S. Access Board to convene a stakeholder working group to develop best practices for making information on prescription drug container labels accessible to people who are blind or visually impaired or who are elderly. The intent was that these best practices would be used voluntarily by pharmacies to ensure that blind and visually impaired individuals have safe, consistent, reliable, and independent access to the information on prescription drug container labels.
The working group was organized and met several times beginning in January of this year. ACB, the Council of Citizens with Low Vision (CCLVI) and the American Foundation for the Blind (AFB) were among the advocacy organizations who participated in the working group. There were equal numbers of representatives from disability organizations and the pharmaceutical industry. The group issued its report in July 2013. Soon, the National Council on Disability will conduct an informational and educational campaign in cooperation with the stakeholder working group to inform the public, including people with disabilities and pharmacists, of the best practices contained in the group's report. The Government Accountability Office will undertake a review beginning 18 months after the date of this report to assess the extent to which pharmacies are following the best practices and to what extent barriers to information on prescription drug container labels remain.
In the meantime, the next step is up to us, the consumers of prescription drugs, who need access to the information on the containers in which we receive those drugs. We need to go to the pharmacies that fill our prescriptions, let them know about these best practices, and ask them to implement them in their pharmacy in order to give us access to the information we need. In order to give you, the readers of this article, the tools you need to do this, I will provide a summary of the best practices section of the Access Board's report.
Some of the best practices noted in the report are simple practices that can benefit any pharmacy patron, regardless of disability. For instance, pharmacists are urged to advertise a local or, when possible, a toll-free telephone number to promote communication between patients and pharmacists. If pharmacy web sites and applications (apps) are made available to patients, they should also ensure web site and app accessibility. When a pharmacist observes a patient or patient representative having reading difficulty, she/he should offer education and counseling in a setting that maintains patient privacy.
The following is a list of additional best practices that are suggested in order to give people with disabilities and people who are elderly increased independent access to information about their medications:
- Make available options for accessible prescription drug container labels in audible, braille, and large print formats via methods using, for example, hard copy, dedicated devices, and computers or smart devices. Note: remember that this is not mandatory, and all pharmacies will not be able to make all options available, but the best practice is for pharmacies to work with patients to make available by these, or other mutually acceptable methods, an alternative form of access to the information on a traditional container label.
- Explain to the patient the available accessible prescription drug container label format options, and provide the prescription drug container label in the format option selected by the patient.
- Ensure that duplicate accessible labels preserve the integrity of the print prescription drug container label. This is important so that both the patient and the pharmacist can identify what's in the container and verify the accuracy of the information about it.
- Subject accessible prescription drug container labels to the same quality control processes used for print labels to ensure accuracy and patient safety.
- Maintain patient privacy in accordance with the Health Insurance Portability and Accountability Act (HIPAA) rules when preparing accessible prescription drug container labels, e.g., record audible labels in a location where patient information cannot be overheard by unauthorized persons.
- In advance, make arrangements to provide accessible prescription drug container labels. For example, maintain a sufficient inventory of supplies necessary to support timely provision of prescription drug container labels in accessible label formats.
- Provide prescription medication with an accessible prescription drug label within the time frame the same prescription would be provided to patients without visual impairments.
- Do not impose a surcharge or extra fee to an individual to cover the cost of providing an accessible drug container label and equipment dedicated for prescription drug container label access.
- Ensure the durability of accessible label format options until the expiration date specified on the prescription drug container label.
- Select a container that best supports the type of accessible label provided.
- For all accessible label formats, including audible formats, ensure that all required information contained on the print prescription drug container label is provided on the accessible label in the same sequence as the print label.
- Include in accessible prescription drug container labels the information on warning labels added to the container at the pharmacist's discretion.
The report also includes best practices specifically related to each of the possible accessible formats that are listed above. Space does not allow us to include that much detail here, but anyone interested in reading the entire report can find it online at www.acb.org/node/1427.
Whether you read the entire report or not, all of us who use prescription medications should begin spreading the word about these best practices, particularly to those pharmacies from which we purchase those medications. When the Government Accountability Office begins its investigation of the effectiveness of these practices, it would be very unfortunate if they discover that the biggest problem was that not enough people requested label information in accessible formats. Pharmacies will need some time to implement these practices, but I urge you to join me in starting that process by talking to our own pharmacies about the specific accessible formats that would be helpful to us, so they will have a reason to find a way to provide it. We will keep you posted on further developments, and as always, if you have questions, feel free to contact the ACB national office.