Introduction
Understanding prescription labels and medical discharge
instructions is critical for patient safety and adherence. However, many
patients face accessibility challenges in reading or comprehending this
information due to visual impairments, language barriers, dyslexia, mild
cognitive issues, or low health literacy. These challenges can lead to
medication errors, poor compliance, and adverse health outcomes psnet.ahrq.gov pmc.ncbi.nlm.nih.gov. In response, healthcare providers and
policymakers have begun implementing regulations, best practices, and
technological solutions to make medical information more accessible. Below, we
explore the key challenges for each group and the efforts to improve
accessibility, along with examples from pharmacies, hospitals, and clinics.
Challenges for Patients with Visual Impairments
Vision impairments including low vision or blindness – make
it difficult or impossible to read standard print on pill bottles and discharge
papers. Pharmacy labels are typically small and printed text, and hospital
discharge instructions are often only provided on paper. Patients report they
“rarely obtain written information – ranging from discharge instructions to
labels on medication bottles – in accessible formats”, leaving them
ill-informed and at risk of serious errors
psnet.ahrq.gov. A legally blind patient, for example, may
not know which medication is which or how to take it, risking taking the wrong
drug or dose ncd.gov. Despite the Americans with Disabilities Act (ADA)
requiring effective communication, these patients often do not receive braille,
large-print, or audio alternatives by default
psnet.ahrq.gov.
Solutions and Best Practices for Visual Impairments
Healthcare providers are encouraged – and in some cases
required – to provide information in the patient’s preferred accessible format.
Staff should offer discharge instructions and labels in large print, Braille,
or audio form as needed psnet.ahrq.gov. The ADA’s effective communication rules
mandate that blind individuals be given auxiliary aids such as large-print or
Braille documents, electronic texts (for screen readers), or audio recordings
of printed material ada.gov. Hospitals and clinics meet this by printing
large-font paperwork or using braille embossing services upon request.
Talking Labels: Audible
prescription labels have emerged as a best practice. These use a device or
smartphone app to read out label information. For instance, many U.S.
pharmacies offer “talking” prescription labels (like ScriptTalk or CVS’s
Spoken Rx), which use RFID tags or QR codes on the bottle that can be
scanned to play a recorded speech or digital voice of the instructions newswire.ca cvshealth.com. Such innovations enable blind or
low-vision patients to independently hear medication names, doses, and
directions cvshealth.com.
Braille: Some pharmacies
provide Braille labels affixed to medication bottles. While a quick and
easy to read solution for those who read it, Braille only helps a small
portion of those who are blind. Many
with vision loss have never learned Braille, either from the lack of
opportunity, age, or physical limitations like neuropathy.
Large Print Labels: Large
print, sometimes called Jumbo print, is usually considered to be a font
size of 18 point or larger. For
those with minimal vision loss, this is a great accommodation that can
often still fit on the prescription label or be provided through a mobile
app with font options.
Other Audible formats:
patient discharge information can also be provided through other audible
formats such as a digital flash drive, voice recording, email or app that
can speak aloudIn-Person Counseling:
Pharmacies and hospital staff also play a role by verbally reviewing
instructions with visually impaired patients (and confirming understanding
through teach-back). However, verbal counseling alone is not
sufficient – it should supplement, not replace, accessible written or
recorded materials psnet.ahrq.gov. Best practice is to ask patients about
their vision needs and not assume they can read standard print psnet.ahrq.gov.
Training hospital staff to routinely ask about vision needs and provide materials accordingly is now emphasized to prevent hospital readmissions. For example, one patient safety case noted the failure to recognize a patient’s blindness during discharge – the patient went home with unreadable instructions and was later re-admitted psnet.ahrq.gov.
Patients Facing Language Barriers
Many patients and caregivers in the U.S. have limited
English proficiency (LEP) or disabilities that effect their ability to read.
Prescription labels and discharge papers are typically in printed English,
which poses a serious safety risk for those cannot read English well.
Misinterpreting medication instructions due to language barriers can lead to
incorrect dosing or omission of doses. Studies have found, for example, that
Hispanic parents with limited English and low literacy were more than twice as
likely to make dosing errors for children’s liquid medications pharmacytimes.com. Relying on family or friends to
translate instructions is not ideal, as nuances can be lost or mistranslated pharmacytimes.com. Thus,
language barriers can leave patients without a clear understanding of how to
take their medications or manage their post-visit care. Relying on others can also impinge on
people’s HIPPA rights and limit their freedom to make independent informed
health care decisions.
Patients Needing Language Access
Several states have enacted laws to ensure bilingual or
multi-language prescription labels. New York was early adopter, requiring chain
pharmacies to provide translations of labels in certain languages upon request
or proactively for common languages in their communities pharmacytimes.com. California law, for instance,
established that patients with limited English skills can obtain translated
directions for use on the prescription container or a supplemental sheet pharmacy.ca.gov. Pharmacies in California must, on request,
include translated directions (using Board-provided translations for
standardized sig codes) in addition to English on the labelpharmacy.ca.gov. Oregon expanded this approach with a 2020
law (SB 698) requiring pharmacies to print prescription labels in one of 14
languages (including Spanish, Russian, Chinese, Vietnamese, Somali, and
others) alongside English at the patient’s request pharmacytimes.com. This more than doubled the number of
languages covered compared to California’s 5 and New York’s 6 pharmacytimes.com. Such dual-language labels help ensure
patients can read instructions in their preferred language while still allowing
emergency personnel or other caregivers to see the English version.
Translated Discharge Instructions:
Hospitals and clinics are expected to provide written discharge
instructions in the patient’s primary language whenever possible. Many
U.S. hospitals use pre-translated templates for common discharge
instructions (e.g. care for specific conditions, medication lists) or have
on-demand translation services. In a survey of children’s hospitals, 74%
reported translating at least some discharge instructions, primarily using
pre-translated documents or interpreter services pmc.ncbi.nlm.nih.gov. However, this means over a
quarter of hospitals still do not routinely provide written translations,
often citing barriers like lack of resources for less common languages or
the fast turnaround needed at discharge
pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov. To address this, some hospitals
employ bilingual staff or professional medical interpreters who can orally
translate instructions at discharge and help produce a written summary in
the patient’s language.
Interpreter Services:
Federal law (Title VI of the Civil Rights Act) requires any healthcare
provider receiving federal funds to offer meaningful access to LEP
patients. This usually means free interpreter services for explaining
instructions, either in person or via phone/video. But interpretation is
not enough if the patient goes home with only English paperwork. Best
practice combines interpreter-assisted counseling with giving a translated
written summary, so patients and families can refer back in their own
language.
Plain Language and Pictograms:
Using universally understandable formats benefits those with language
barriers. Plain language – avoiding medical jargon and using simple
wording – helps both non-native English readers and those with low
literacy. For example, saying “for high blood pressure” instead of “for
hypertension” on a label is clearer. The United States Pharmacopeia (USP)
has developed standard medication pictograms (simple icons) to convey
common instructions (such as time of day, with food, do not drive, etc.).
Pharmacists can add these pictograms to labels or handouts to reinforce
instructions in a visual way. This is especially helpful for patients who
cannot read the text well
pharmacytimes.com. Studies indicate that pictographic
instructions, when used alongside text, improve comprehension and
adherence among low-literacy and ESL (English as Second Language) patients pharmacytimes.com.
Many pharmacy chains now support multi-language label
printing via their software. For instance, Walgreens and CVS have
Spanish-language labels nationwide, and others support Chinese, Korean,
Vietnamese, etc. In states like New York, large chain pharmacies are required
to post signage informing patients of free translation services for
prescription information pharmacytimes.com. In clinical settings, hospital systems
like Kaiser Permanente have created patient education libraries with materials
in multiple languages, and some emergency departments use discharge instruction
sheets available in Spanish, Chinese, Arabic, and more. Despite these efforts,
compliance varies: a 2019 study found that while most children’s hospitals had
a language access policy, only 11 of 31 surveyed had a formal process to
consistently translate discharge instructions, showing a gap between policy
and practice pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov.
Patients with Dyslexia or Print Disabilities
Individuals with dyslexia or other print disabilities (such
as certain learning disabilities) can see text but struggle to decode and
understand written language. Dense blocks of medical text, unfamiliar
terminology, or cluttered label layouts can be overwhelming. A prescription
label printed in ALL CAPS or a discharge packet full of complex sentences may
be extremely difficult for someone with dyslexia to read accurately. They may
mix up similar-looking drug names or misconstrue dosage instructions, even if
the content is in their native language. This demographic benefits from many of
the same accessibility measures as visually impaired patients, even though the
nature of the impairment differs.
Clear Typography: One
simple but important practice is using readable fonts and formatting.
Regulatory guidelines and experts recommend sans-serif fonts (which
are cleaner for many readers) and adequate font size (minimum 12-point on
labels) for critical information
law.cornell.edu. By law in California, for example,
the main elements of a prescription label (patient name, drug
name/strength, directions, etc.) must be in at least 12-point sans-serif
type and grouped in a “patient-centered” area of the labellaw.cornell.edu. This kind of design, along with
avoiding ALL CAPS text, helps not only older patients but also those with
dyslexia who find mixed-case, larger text easier to parse. Some dyslexic
individuals prefer specialized fonts (like OpenDyslexic) that
weight the letters to reduce flipping or swapping, though such fonts are
not standard in healthcare yet. Ensuring labels and instructions have high
contrast and clear spacing also improves readability.
Plain Language & Chunking:
Writing instructions in plain language (short, simple sentences and
familiar words) is crucial. For a dyslexic reader, simpler sentences
reduce cognitive load. Instead of “administer two tablets orally twice
daily,” a label might say “Take 2 tablets each morning and 2 tablets each
evening.” Research shows that using explicit timing words (morning,
evening) instead of numeric or medical terms improves understanding for
those with limited literacy
pmc.ncbi.nlm.nih.gov. Breaking information into bullet
points or step-by-step lists (rather than long paragraphs) on discharge
paperwork can help all patients, especially those with learning
differences, process each instruction one at a time.
Audio Support: Many tools
that assist visually impaired users (like text-to-speech screen readers or
talking labels) also aid those with dyslexia. A patient with dyslexia
might use their smartphone to scan a printed discharge instruction and
have it read aloud. Recognizing this, pharmacies offering talking pill
bottles or smartphone-readable RFID labels are implicitly also serving
patients who are “print disabled” but not blind law.lis.virginia.gov law.lis.virginia.gov. The term “print disabled” can
include dyslexia, and some accessibility laws (like a new Virginia law in
2024) explicitly cover blind, visually impaired, or otherwise print
disabled individuals in requiring pharmacies to provide accessible
labels on request law.lis.virginia.gov. That means a pharmacy in
Virginia must accommodate a dyslexic patient by, for example, providing an
audible label or an enlarged-print label at no extra cost law.lis.virginia.gov.
Digital Access: Providing
discharge instructions through patient portals or email in addition to
print can help those with reading difficulties. Electronic documents can
be zoomed in or run through text-to-speech or dyslexia-friendly settings
by the patient. Ensuring that the digital format is accessible (i.e. not a
hard-to-read scanned image) is key. Some healthcare providers also create
video summaries of instructions or use interactive apps for care
instructions, which can benefit patients who struggle with text.
On the hospital side, while there’s less publicized activity
specific to dyslexia, the general trend of adopting plain language and offering
to review instructions verbally helps. Continued education of healthcare staff
on learning differences is gradually improving the sensitivity to these needs.
Patients with Mild Cognitive Impairment or Low
Literacy
Patients with mild cognitive issues (such as early dementia,
brain injury, or simply age-related memory decline) and those with low general
literacy face overlapping challenges. They may be able to read the words but
not fully grasp the meaning, especially if the instructions are complex. They
might also struggle to remember multiple steps or new medical terms. Medical
jargon, acronyms, and detailed medication schedules can confuse these patients
easily. For instance, an older adult with mild cognitive impairment might not
recall whether to take a medication before or after meals if the
discharge papers are not clear or if too much information is given at once.
Similarly, a person with limited education might misinterpret “take two tablets
twice daily” – a well-documented problem, as nearly half of patients in one
study misunderstood common label instructions, and low literacy was a major
predictor of errors pmc.ncbi.nlm.nih.gov. Clinics often encourage patients to
bring a family member or friend to help review written instructions,
effectively acknowledging that some patients may need an extra set of eyes or
ears on the information.
Plain Language & Health Literacy:
As with dyslexia, using plain, everyday language is one of the most
effective strategies. The goal is to ensure the materials are written at
an accessible reading level (often recommended at a 6th- to 8th-grade
reading level for general medical information). This means avoiding
technical terms or explaining them in simple words (e.g., say “heart
doctor” instead of “cardiologist” on paperwork, or “high blood pressure”
instead of “hypertension”). The CDC and health literacy experts estimate
nearly 9 out of 10 adults have trouble understanding medical info when
it’s full of technical language
medibubble.com. Simplifying vocabulary and sentence
structure improves comprehension for everyone – including those with
cognitive impairments.
Organized and Highlighted Information:
Structuring information in a clear, logical order is important. On prescription
labels, critical information is now often “clustered” and draw
attention law.cornell.edu. This kind of standardized layout
helps patients find the most important information quickly. Likewise,
discharge instructions can be formatted with headings like “Medications,”
“Follow-up Appointments,” “When to Seek Help” – so that patients or
caregivers can easily find and review each category.
Teach-Back Method: In both
pharmacy and clinical settings, providers use the “teach-back” technique
to ensure understanding. After explaining the medication regimen or care
instructions, the provider asks the patient (or their caregiver) to repeat
it back in their own words. This method is proven to catch
misunderstandings and reinforce memorymedibubble.com. For instance, a nurse might say, “I
know we covered a lot. Can you tell me how you will take your new
medication for diabetes each day?” – giving the patient a chance to
articulate the plan and the nurse a chance to correct any errors. This
approach addresses cognitive and memory issues by reinforcing learning and
clarifying confusion before the patient leaves.
Visual Aids: The use of
visual aids can be very helpful for those who have trouble processing
written or spoken instructions. Simple charts showing a medication
schedule, or pictograms (as mentioned earlier) indicating morning, noon,
evening, and bedtime doses, can transform a daunting list of instructions
into an easy-to-follow daily routine. For discharge instructions, some
hospitals include infographics – for example, an illustrated wound care
guide with step-by-step pictures. Such visuals can transcend language and
literacy barriers and serve as memory prompts.
Involving Caregivers: For
patients with cognitive impairment, it’s often vital to involve a family
member or caregiver in the discharge education process (with the patient’s
consent). Written instructions might include a note like “A copy of
these instructions has been given to your daughter, who was present during
the discussion.” Caregivers can help reinforce and manage the
instructions at home, ensuring that the patient isn’t solely relying on
their own memory.
Many hospitals have health literacy programs aimed at
rewriting patient handouts and discharge templates in plainer language. For
instance, some emergency departments found that 78% of patients had
comprehension deficits in at least one area of their discharge instructions pmc.ncbi.nlm.nih.gov; in response, they initiated projects
to simplify and clarify those instructions. UT Southwestern’s Clements
University Hospital ED systematically reviewed and standardized discharge
instructions, yielding improvements in patient understanding pmc.ncbi.nlm.nih.gov. In primary care clinics, providers
often print after-visit summaries that are truncated to essential points, and
these can be paired with phone call follow-ups for those known to have memory
issues. Community pharmacists sometimes use Medication Guides with icons or
color-coding – for example, placing a colored sticker on a bottle cap to
indicate “nighttime” or using pill organizers – to help patients with complex
regimens. All these practices recognize that making information easy to read
and remember is as important as the medical information itself.
Summary of Technological Solutions and Innovations
Technology is playing a transformative role in overcoming
accessibility barriers in healthcare. A variety of assistive technologies and
innovative practices are being implemented across pharmacies and health
systems:
Labeling and Packaging
Talking Prescription Devices:
These include digital voice recorders attached to pill bottles or smart
caps that play recorded instructions. For instance, devices like Talking
Rx Pill Bottles allow pharmacists to record a 60-second instruction
summary that patients can replay.
These are intended for patients with low literacy or memory issues, as
well as those with vision loss.
While still not widespread, some healthcare organizations piloted talking
bottles for improved adherence
as early as 2009. washington.edu. Walgreens also offers a voice recorder
called Talking Pill Reminder. walgreensbootallance.com
RFID and QR Code Labels:
As mentioned earlier, RFID-tagged labels (like ScriptTalk and Spoken Rx)
are now available at major pharmacy chains
newswire.ca cvshealth.com. Patients can either use a dedicated
prescription reader device (often provided free by pharmacies or through
advocacy programs) or a mobile app to scan the tag. The device/app then
speaks out all the label information (drug, dose, patient name, directions,
refill info, etc.). This technology has been a game-changer for blind
patients. It’s now offered by national chains (CVS, Walmart, Walgreens,
Rite Aid, etc.) and mail-order pharmacies, often thanks to collaborations
with companies like En-Vision America’s ScripTalk. According to a 2016 GAO
report, several large PBMs (pharmacy benefit managers) also provide
audible labels for mail-order clients upon request gao.gov.
Innovative Packaging:
Accessibility is also considered in packaging design. There are color-coded
systems for families (each family member’s prescriptions get a distinct
color label or cap) to avoid mix-ups. Some blister pack systems have
printed days/times and Braille on them to aid those with visual or
cognitive impairments in following complex regimens. Pharmacies and
healthcare startups are looking at how universal design can be applied to
medication packaging so that it’s intuitive for all users (for example,
using tactile symbols or raised markings to distinguish different
medicines by touch).
Apps and Software
Mobile Health (mHealth) Apps:
Beyond pharmacy-specific solutions, there are apps that help patients
manage medications in accessible ways. Some apps can display medication
instructions in large font or read them aloud using text-to-speech. Others
allow the user to set reminder alarms with voice prompts (“Time to take 2
pills of your heart medicine”). For language needs, translation apps or
multilingual pill identifier apps can assist. Hospitals sometimes leverage
their patient portal apps to send discharge instructions that include
videos or audio clips explaining key instructions (for example, a
wound-care tutorial video in the patient’s language). These multimedia
approaches can reinforce understanding much more effectively than text
alone.
Natural Language Generation:
On the back-end, some hospitals are using software that can automatically
generate patient instructions in plainer language. These systems take the
clinician’s discharge notes (often full of jargon or shorthand) and
translate them into more patient-friendly wording and multiple languages.
While still evolving, this kind of technology can standardize
high-quality, easy-to-understand instructions for common conditions.
Telehealth and Remote Communication:
For follow-up after discharge, telehealth calls (with video) can be used
to go over instructions again, with interpreters or adaptive technologies
as needed. This isn’t a direct “technology on the label” solution, but
it’s a tech-enabled service that ensures the information was received and
understood, thereby addressing any accessibility issues after the fact.
Dispensers
- Electronic Medication Dispensers:
While not part of the label or instruction sheet per se, some patients use
“smart” pill dispensers or pill organizer apps that tie into their
instructions. These devices can be pre-loaded with the medication regimen
and then beep, flash, or even voice prompt the patient when it’s time to
take a dose. They often come with companion materials that the caregiver
or pharmacist sets up according to the discharge instructions. For someone
with cognitive impairment, this kind of technology, in conjunction with simplified
written instructions, greatly improves adherence.
Examples from Healthcare Settings
Concrete examples illustrate how pharmacies, hospitals, and
clinics are putting these practices into action in a variety of settings.
Pharmacy
Though there has been substantial progress in the retail
pharmacy sector, in practice, if you walk into a major pharmacy chain today and
identify yourself as having a vision or reading impairment, the staff may or
may not be aware of the official corporate policy to provide accessible labels.
Patients must still advocate for the
services they need since a culture of accessibility is not yet the standard.
Hospital
Hospitals have focused heavily on language services and
readability of discharge instructions. For instance, the Children’s Hospital of
Philadelphia (CHOP) and others in the Children’s Hospital Association
participated in research to improve translated discharge instructions pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov. Many hospitals now employ translation
teams or subscribe to translation vendors so they can hand patients discharge
papers in Spanish, Chinese, Portuguese, etc. immediately upon release. Some,
like Boston Medical Center, have developed pictogram-enriched instructions for
low-literacy populations (particularly for common issues like how to take
antibiotics or care for a wound). In terms of disability access, major hospital
systems (e.g., Mayo Clinic, Cleveland Clinic) have patient education centers
that provide materials in alternative formats—if a patient who is blind is
scheduled for surgery, these centers can produce the consent forms and post-op
instructions in Braille or audio in advance. Compliance with ADA is taken
seriously; for example, if a Deaf patient is in recovery, the hospital will
ensure a sign-language interpreter or at least a video relay interpreting
device is present to go over discharge plans. Another example: Vanderbilt
University Medical Center piloted giving patients “accessible discharge
toolkits” which included large-print medication schedules and a recorded CD of
discharge instructions for those who needed them. While not yet universal, such
examples demonstrate growing awareness. Importantly, The Joint Commission’s
emphasis on addressing health literacy and communication needs has spurred many
hospitals to incorporate teach-back and to have pharmacists or nurses do
medication counseling at bedside with any necessary aids before the patient
leaves.
Clinic and Community
In smaller clinics or primary care offices, the scale is
different but the principles remain. A community health clinic serving a
diverse population might have bilingual health coaches who call patients a day
or two after a visit to go over any lab results and ensure they understood the
medication changes in their after-visit summary. Federally Qualified Health
Centers (FQHCs), which serve many non-English-speaking and low-income patients,
receive federal support to provide interpreters and translated written
materials. For example, a clinic in a predominantly Spanish-speaking
neighborhood will typically have Spanish prescription labels and Spanish
discharge handouts for common conditions on hand. Many clinics also utilize
easy-to-read pamphlets (5th-grade level, often with visuals) for patient
education, sourced from organizations like the Centers for Disease Control
(CDC) or American Medical Association, which produce simplified educational
materials on managing diabetes, asthma, etc. These supplement the doctor’s
typed instructions with more accessible explanations.
One innovative clinic approach is the use of “health
literacy navigators.” These are staff or volunteers who meet with high-risk
patients (for instance, an older person on multiple meds with low literacy)
after the appointment to literally walk through each instruction, set up
pillboxes, mark refill dates on a calendar, and ensure the patient knows how to
carry out the advice. This hands-on approach acknowledges that just handing
someone a piece of paper, even if well-written, isn’t always enough.
Across these examples, the common thread is an increasing
proactive approach: rather than waiting for patients to say they are confused
(which many won’t until a mistake happens), health providers are trying to
anticipate and design for comprehension and accessibility. Pharmacies post
signs that interpretation is available and that prescription readers exist;
hospitals ask about preferred language and format at intake (some intake forms
now have a question like “Do you need any assistance to help you read health
information, such as large print?”); clinics simplify and clarify their written
communications for everyone by default.
U.S. Regulations and Standards Supporting
Accessibility
A number of laws, regulations, and standards in the U.S.
address the need for accessible medical information, creating obligations or
guidelines for pharmacies and healthcare providers to accommodate patients’
needs. Below are key regulations and best-practice standards that drive
improvements in accessibility:
Federal Laws, Regulations and Guidelines
Americans with Disabilities Act
(ADA) – The ADA (Title III for public accommodations like
pharmacies and hospitals, and Section 504 of the Rehabilitation Act for
federally funded providers) requires “effective communication” with
individuals who have disabilities. This means healthcare providers must provide
auxiliary aids and services to ensure communication is as clear as it is for
non-disabled patients ada.gov. For a blind patient, that could mean providing
braille or audio versions of printed materials; for a Deaf patient, a sign
language interpreter or captioning. The ADA explicitly mentions providing
information in alternate formats (large print, Braille, electronic text, audio)
for those with vision impairments
ada.gov. In practice, this forms the legal basis for
patients to request accessible prescription labels or discharge documents as a
reasonable accommodation.
Civil Rights Act – Title VI Title
VI prohibits discrimination based on national origin, which the Department of
Health and Human Services interprets as requiring language access services for
LEP individuals in healthcare.
Affordable Care Act Section 1557
–ACA Section 1557 reinforces that any healthcare entity receiving federal funds
must provide “meaningful access” for patients with limited English
proficiency pharmacytimes.com. This includes offering interpreters and
translated written materials. While these federal rules don’t prescribe exact
label formats, they set a clear expectation that critical health information
(like medication instructions) be conveyed in a language the patient
understands pharmacytimes.com. Providers risk civil rights violations
if they consistently fail to communicate instructions in the patient’s
language.
U.S. Access Board Best Practices
(2013): As required by an FDA Safety law in 2012, the U.S. Access
Board (a federal agency on accessibility) convened a working group that issued
34 best practices for making prescription drug container labels accessible gao.gov. These best practices – published in July 2013 –
are not regulations but guidelines. They cover approaches like Braille
labeling, large font size, high-contrast print, tactile cues on bottles, and
audible devices nabp.pharmacy. The working group included advocates for the
blind and industry reps, aiming for consensus on feasible solutions nabp.pharmacy. Pharmacies are encouraged to implement
these; a 2016 GAO report found that while many large chains had implemented
most of the 34 best practices, awareness of these guidelines among smaller
pharmacies and patients was still low
gao.gov gao.gov. The National Council on Disability was tasked to
promote these best practices, reflecting their importance at the policy level gao.gov.
The Centers for Medicare &
Medicaid Services (CMS) conditions of participation require
hospitals to ensure patients understand their discharge plan. While not
prescriptive about format, these standards compel hospitals to, for example, provide
interpreters, use teach-back, and give written instructions that the patient
can comprehend. Non-compliance can affect a hospital’s accreditation or
funding.
State Laws
States have been at the forefront of label accessibility
requirements. State statutes help to maintain consistent enforcement despite an
often changing federal regulator landscape.
California’s “Patient-Centered”
Prescription Label Law: Requires pharmacies to use a
patient-centered layout with the aforementioned 12-point font minimum for main
information law.cornell.edu. It also mandates translating directions
for use into Chinese, Korean, Russian, Spanish, or Vietnamese upon request,
using standardized phrases the Board of Pharmacy provides pharmacy.ca.gov.
Nevada, Oregon, and Others:
Nevada (2017) and Oregon (2019) passed laws specifically requiring accessible
prescription labeling. Oregon’s law, as noted, guarantees labels in 14
languages upon request pharmacytimes.com.
Virginia’s Accessible Labels Law
(2024): Recently, Virginia became one of the first states to
explicitly require pharmacies to notify patients who are blind or
print-disabled about the availability of accessible labels, and to provide
such labels (audible, large print, or other suitable formats) at no extra cost
on request law.lis.virginia.gov. This law also mentions the labels
should meet best-practice standards of the U.S. Access Board and be compatible
with “prescription reader” devices. Such state-level actions are
gradually filling the gap in enforceable standards for accessible prescription
information.
Local Ordinances
- New York City Regulation: Large chain pharmacies in NYC must provide translation of prescription labels and materials in the city’s most common languages (such as Spanish, Chinese, Russian, Italian, French, and Polish).
Industry Standards
USP Standards and Health Literacy Initiatives: The U.S. Pharmacopeia Convention (USP) has issued recommendations for prescription labels to improve patient understanding. USP advocates for standardized language (e.g., using numeric times like “8 AM” rather than “twice daily”), a universal medication schedule (morning, noon, evening, bedtime) format, and the inclusion of purpose on labels when possible. Many of these align with state rules like California’s. In terms of general patient communication, federal initiatives like Healthy People 2030 and the National Action Plan to Improve Health Literacy call for making all health information clear and accessible – including a specific objective to “standardize prescription drug labels” to enhance comprehension health.gov.
The Joint Commission: Accreditation bodies also push for accessibility. The Joint Commission (which accredits hospitals) has standards for patient education and communication – hospitals must identify patient communication needs (including language or sensory impairments) and provide appropriate resources.
In summary, the regulatory landscape in the U.S. is
gradually aligning behind the principle that clear, accessible medication
instructions are a right, not a privilege. Whether through civil rights law,
disability accommodation, or state pharmacy regulations, there is growing
accountability for pharmacies, clinics, and hospitals to meet the needs of
those who can’t easily read standard print or English. The combination of tech
and policy – like requiring compatibility with such devices (as Virginia does)
– ensures that innovative solutions actually reach the patients who need them,
rather than remaining optional add-ons. Importantly, these tools often benefit
multiple groups: a talking label helps a blind person, but also a dyslexic or
an elderly person with low literacy; a multilingual app helps LEP patients but
also any patient who prefers listening over reading. An advocacy initiative
called Stay Safe RX tracks public policy and legislation regarding accessible
prescriptions. staysaferx.org.
Global Standards and Influences
Global policies and standards have helped inform and
motivate U.S. accessibility efforts by providing models of what can be done:
Braille on Packaging (European Union):
Perhaps the most striking difference is that in the EU, Braille on
medication packaging is mandatory. Since 2006, all medicine packages in
the EU must include the drug name (and often dosage) in Braille on the
outer packaging mt-g.com. This requirement, part of EU Directive
2004/27/EC, was aimed at ensuring that blind or low-vision individuals can
identify their medications. While this applies to manufacturer packaging
(not the pharmacy label with patient instructions), it sets a precedent
for accessibility. The U.S. has no equivalent federal requirement
for Braille on medication packaging or labels cclhealthcare.com. However, advocacy groups often
point to the EU example to argue for similar mandates in America. Some
U.S. pharmacies voluntarily add Braille (for example, identifying the
medication name on the cap in Braille) for patients who request it, but
it’s not widespread. The EU’s stance demonstrates that industry-wide
accommodation is feasible and has likely encouraged U.S. regulators to
consider more assertive measures.
Accessible Information Standard (United
Kingdom): In 2016, England’s National Health Service (NHS)
implemented the Accessible Information Standard (AIS), which legally
requires all NHS healthcare providers to identify and meet the
communication needs of patients with disabilities or sensory loss. This
means UK hospitals and clinics must ask patients if they need information
in alternative formats (like Braille, easy-read, large print, audio) or
communication support, record that, and provide it for all communications
including discharge instructions. The impact has been that UK providers
are more routinely offering, for example, appointment letters in large
print or emailing patients with visual impairments instead of paper.
According to a review, many UK patients still reported gaps in getting
accessible information (e.g., not receiving alternative formats for
discharge instructions despite AIS), but the standard at least creates
accountability signhealth.org.uk. This comprehensive policy has
influenced discussions in the U.S. – American disability advocates often
cite the NHS AIS as a model for what a health system-wide approach to
communication equity could look like. While the U.S. relies on ADA’s more
general provisions, the idea of a specific healthcare information
accessibility standard is gaining traction, inspired by the UK’s example.
“Easy Read” Materials (New Zealand):
Several countries have championed “Easy Read” health materials for people
with intellectual disabilities. For instance, New Zealand’s Ministry of
Health and various European health services produce simplified,
illustrated versions of health information (like hospital discharge guides
with pictograms and very basic text). These ensure that even those with
significant cognitive disabilities can understand their care instructions
as much as possible. The concept of Easy Read has influenced some U.S.
providers, especially in mental health and disability services, to create
analogous materials. While not mainstream in all U.S. hospitals, there are
pockets where, say, a cancer center might provide an easy-read chemo guide
alongside the standard one, based on materials from international
partners.
Canadian Pharmacy Initiatives:
In Canada, though the healthcare system differs, pharmacy chains have also
embraced accessibility, sometimes outpacing the U.S. A recent example is
the national rollout of audible prescription labels across Empire
Company’s grocery pharmacies (Sobeys, Safeway, etc.) in 2020, making
Canada’s first coast-to-coast talking label program newswire.ca Canadian advocacy by groups like the CNIB
(Canadian National Institute for the Blind) led to widespread availability
of ScriptTalk labels in pharmacies, with leaders noting it helps prevent
“accidental overdoses and other serious medication errors” that can occur
when print is inaccessible. This Canadian success story provides evidence
that large-scale implementation is practical and beneficial, which in turn
encourages U.S. pharmacies to follow suit to stay on par with
international peers.
International Health Literacy Efforts:
Organizations like the World Health Organization (WHO) and Joint
Commission International promote health literacy as a patient safety
priority worldwide. The WHO’s “Medication Without Harm” campaign, part of
the Global Patient Safety Challenge, emphasizes clear communication to
avoid medication errors. This global focus adds momentum to U.S.
initiatives. When other countries demonstrate improved outcomes by, for
example, using pictograms on medication labels in communities with low
literacy (studies in South Africa and India have shown pictogram use
reducing errors), those findings make their way into U.S. policy
discussions and researchpharmacytimes.com.
United Nations Convention on the Rights
of Persons with Disabilities (CRPD): Although the U.S. has
signed but not ratified this treaty, the CRPD has influenced global norms
by asserting that people with disabilities have the right to access
information and communications on an equal basis (Article 9) and the right
to the highest attainable standard of health without discrimination
(Article 25). This global human rights framework reinforces the idea that
providing health information in accessible formats is not just a courtesy,
but a right. U.S. disability advocates often invoke this principle, and it
likely underlies some of the federal advisory actions like the US Access
Board’s best practices and the National Council on Disability’s campaigns.
access-board.gov
In conclusion, global standards and examples have provided
both inspiration and justification for improving accessibility in the U.S.
While the U.S. healthcare system has unique challenges (such as fragmentation
among providers and payers), it is gradually absorbing these international
lessons. The trend is toward a more inclusive approach where accessible
communication is embedded in healthcare quality standards. What remains is
continued effort to implement known solutions uniformly so that no patient – whether
in a small rural clinic or a big city hospital – is left in the dark about
their own care due to an avoidable communication barrier.
Conclusion
Accessible prescription labels and discharge instructions
are essential for patient safety, yet achieving this accessibility requires
addressing a spectrum of needs. The U.S. has made meaningful progress by
recognizing the challenges faced by visually impaired individuals, those with
language barriers, learning differences like dyslexia, cognitive impairments,
and low literacy. Regulations, from the ADA to state-specific laws, are pushing
healthcare providers to offer information in alternative formats and multiple
languages, and best practice guidelines urge the use of clear language, larger
print, and supportive tools like pictograms. Technology is bridging many gaps –
turning text into voice, hard copy into digital – and innovative programs in
pharmacies and hospitals are demonstrating that these solutions are not only
feasible but highly beneficial. There is also a clear influence from global
standards: as other countries implement bold accessibility measures, they set
benchmarks that the U.S. can strive toward or even surpass.
Still, challenges remain. Awareness of available
accommodations is not universal – many patients and even some providers do not
know what is possible or required, which means accommodations might go
unrequested or unoffered. The 2016 GAO report on prescription labels noted that
usage of accessible labels was under 1% of prescriptions, partly due to lack of
awareness and the fact that these measures are often optional rather
than standard gao.gov. Continued efforts are needed to normalize
accessible practices as a routine part of healthcare. This includes training
healthcare staff, investing in translation and assistive technologies, and
engaging patients in the design of communications.
Ultimately, the goal is a healthcare environment where every
patient – regardless of visual ability, language, or literacy – receives
instructions they can understand and act upon. The examples and initiatives
highlighted show that this is achievable. Improved accessibility leads to
better adherence to medication regimens, lower rates of readmissions and
errors, and a more equitable healthcare system. As regulations tighten and
technology advances, we can expect accessible prescription labeling and patient
instructions to become ever more standard. The continued convergence of policy,
practice, and technology will ensure that this principle is put into practice,
so that critical health information truly reaches everyone who needs it.
