Health Liter acy: Implications for
Pharmacy Pr actice
Michael J. Miller, BSPharm, M.S., DrPH; and Kara L. Jacobson, MPH, CHES
Reviewed by Oralia V. Bazaldua, Pharm.D., FCCP, BCPS; and Emilie L. Karpiuk, Pharm.D., BCPS, BCOP
Learning Objectives
1. Distinguish among domains of literacy.
2. Estimate the prevalence of limited health literacy
(LHL).
3. Summarize health consequences associated with LHL.
4. Assess health literacy implications for managing drug
use.
5. Demonstrate methods for identifying patients with
LHL.
6. Design a program that promotes clear health
communication.
Background and Context
for Health Literacy in
Pharmacy Practice
Regardless of practice setting, most pharmacists have
encountered patients who have misunderstood medical or
prescription information or misinterpreted prescription
instructions and have not taken their drugs correctly.
The consequences vary greatly, but misunderstandings
and misinterpretations ultimately result in drug errors
and substandard quality of care. In the hospital setting,
pharmacists use verbal and written communication to
perform drug histories at admission, at the time of discharge
counseling, and in the drug reconciliation process. With
each prescription dispensed in a community pharmacy,
pharmacists use both written and verbal communication
to inform and verify understanding of instructions to
patients. Although the instructions and information may
appear obvious to the pharmacist, they are often confusing
to the average patient and even more so to the patient with
limited health literacy (LHL). Thus, the simple translation
of complicated written health-related information into plain
language remains a fundamental step in improving health
care communication.
Health literacy is currently and commonly defined by
leading experts as “the degree to which individuals have
Pharmacotherapy Self-Assessment Program, 6th Edition
the ability to obtain, process, and understand basic health
information and services needed to make appropriate health
decisions.” In an increasingly complex health care system
that relies heavily on patient self-management, LHL has
potentially serious health consequences. The Institute of
Medicine report “Health Literacy: A Prescription to End
Confusion” provided a comprehensive summary of health
literacy research and recognized the challenges of applying
health literacy principles in practice. The Institute of
Medicine concluded that:
• Health literacy is a multidimensional phenomenon
involving reading, writing, numeric, listening, and
speaking skills.
• Health literacy is influenced by society, cultural
beliefs, and educational and health systems.
• LHL is a widely prevalent problem and has the
potential to significantly contribute to health care
disparities.
The Institute of Medicine report and findings from
other nationally recognized organizations and initiatives
underscore the importance of health literacy to health care
providers. Healthy People 2010 includes the improvement of
health literacy for people with LHL skills as an objective. In
addition, the National Quality Forum has listed the teach-
back method, a health communication and literacy strategy,
as one of the top patient safety practices for reducing medical
errors.
In 2007, the Joint Commission report “What Did the
Doctor Say? Improving Health Literacy to Protect Patient
Safety” recommended the following:
• Make effective communication an organizational
priority to protect the safety of patients.
• Address patients’ communication needs across the
continuum of care.
• Pursue policy changes that promote improved
practitioner-patient communication.
Given the national attention directed to health literacy, it
is imperative that pharmacists understand the context of the
problem, its definition and measurement, and key actions
15 Health Literacy: Implications for Pharmacy Practice

Abbreviations in
This Chapter
AHL Adequate health literacy
FHL Functional health literacy
LHL Limited health literacy
NAAL National Assessment of Adult Literacy
NVS Newest Vital Sign
NVS-E Newest Vital Sign-English version
NVS-S Newest Vital Sign-Spanish version
REALM Rapid Estimate of Adult
Literacy in Medicine
S-TOFHLA Short Test of Functional Health
Literacy in Adults
TOFHLA Test of Functional Health
Literacy in Adults
that can be taken to improve their patients’ understanding of
health instructions.
LHL and Its Prevalence
General Functional Literacy
Historically, general literacy was defined as the ability
to read and write; it was typically measured through self-
report and later by educational attainment through school
enrollment statistics and successful completion of school-
based, standardized reading tests. The reliability and
validity of both methods of assessment were influenced by
the accuracy of self-reporting and variations in the timing
and quality of education.
Since then, the definition of general literacy has evolved
into the concept of functional literacy, in that a person must
demonstrate not only the ability to read, but also the ability
to comprehend and appropriately act on the information to
adequately function in society. General functional literacy
is considered a continuum of increasingly complex skills
rather than a simple binary classification of literate and
illiterate. General functional literacy is composed of three
sets of knowledge and skills:
1. Prose literacy (i.e., the ability to understand and
use information from texts such as editorials, news
stories, poems, and fiction).
2. Document literacy (i.e., the ability to locate and
use information contained in materials such as
job applications, payroll forms, transportation
schedules, maps, tables, and graphs).
3. Quantitative literacy (i.e., the ability to apply
arithmetic operations, either alone or sequentially,
using numbers embedded in printed materials).
The first National Adult Literacy Survey in 1992 divided
general functional literacy skills into five skill levels
representing differing degrees of information-processing
ability across the literacy continuum. For example,
individuals with the lowest level of general functional prose
literacy skills can typically identify one piece of information
Health Literacy: Implications for Pharmacy Practice
in a short article, whereas those at the highest level of general
functional prose literacy skills can summarize, compare,
and contrast a variety of information in a lengthy article.
The 1992 National Adult Literacy Survey estimated
that 40–44 million Americans performed at the lowest
level of functional literacy, with an additional 50 million at
the second lowest level of functional literacy. Individuals
with low levels of literacy were older, less educated, low-
income, members of ethnic or racial minorities and held
lower-paying jobs. Although the survey did not address
the domain of health, it is easy to see how the domains of
general functional literacy are relevant to the health care
environment. For example, a patient may need prose skills
to read a drug guide and identify information about his or
her therapy. Document skills are often necessary to review
and select health benefits, as well as to complete insurance
enrollment and reimbursement forms. Finally, quantitative
literacy skills are readily apparent when a patient is required
to calculate and measure the correct dose of a drug. Of
interest, the profile of those with low to moderate general
functional literacy paralleled the profile of population
subgroups that have come to be associated with higher risk
for poor health status, worse medical care outcomes, and
decreased access to medical care.
Functional Health Literacy
Early studies of health literacy focused on the readability
of health care–related documents. Typically, consent forms,
patient package information leaflets for drugs, discharge
instructions, and disease-specific treatment and prevention
materials were written at a level higher than the sixth grade
level of readability recommended for the average adult.
Although readability of information is essential, it became
clear that the ability to synthesize and apply complex health-
related information was critical if a patient was to partner
in successful disease prevention and management. In 1999,
the American Medical Association recognized and defined
functional health literacy (FHL) as the ability to perform
basic reading and numeric tasks required to function in the
health care environment. This definition was a precursor to
the definition of FHL commonly accepted today.
The definition, measurement, and reporting of health
literacy has been inconsistent in the literature. This makes it
difficult to use standard terminology; reports of the range of
health literacy skill depend on the method of measurement.
To simplify the discussion in this chapter, LHL is used
to describe the lowest levels of health literacy, including
inadequate or marginal health literacy; below basic or basic
health literacy; or estimated reading below the ninth grade
level. Adequate health literacy (AHL) is used to describe
proficiency at the highest levels. Under circumstances in
which unique measures are used and explicit distinctions
must be made, the appropriate category of health literacy
proficiency unique to the type of measurement will be
used.
Prevalence in Select Subgroups
In 1995 and 1999, two large studies were conducted
to describe the magnitude of FHL in at-risk population
subgroups. In a sample of predominantly indigent and
minority patients at two urban public hospitals, 35% of
English-speaking and 62% of Spanish-speaking patients had
16 Pharmacotherapy Self-Assessment Program, 6th Edition
Table 2-1. Health Literacy Proficiency Levels from the 2003 National Assessment of Adult Literacy
Literacy Proficiency Level Example
Below basic Based on a short set of instructions, identify what is permissible to drink before a medical test
Basic Based on information in a clearly written pamphlet, give two reasons why a person with no symptoms
of a specific disease should be tested for the disease
Intermediate Based on information on the prescription drug label that relates the timing of a drug to eating,
determine what time a person can take a prescription drug
Proficient Using a table that shows how the employee’s monthly cost varies depending on income and family size,
calculate an employee’s share of health insurance costs for 1 year
Information from Kutner M, Greenberg E, Jin Y, Paulsen C. The Health Literacy of America’s Adults: Results from the 2003 National Assessment of
Adult Literacy (NCES 2006-483). U.S. Department of Education. Washington, DC: National Center for Education Statistics, 2006. Available at nces.ed.
gov/pubsearch/pubsinfo.asp?pubid=2006483. Accessed August 19, 2008.

LHL. There were higher proportions (80% or more) in the
elderly. Specifically, a majority of patients with LHL could
not correctly interpret written information on how to take a
drug on an empty stomach, determine financial eligibility, or
ascertain how many pills of a prescription should be taken.
A majority also did not understand the instructions for a
radiograph procedure, the rights and responsibilities section
of a Medicaid application, or a standard consent document.
A follow-up study of Medicare-managed care health plan
enrollees echoed the results of the study in public hospitals,
finding that 34% of English-speaking and 54% of Spanish-
speaking participants had LHL. Collectively, these studies
have served as the basis for describing the magnitude of the
problem of LHL and identifying many factors associated
with the problem.
National Prevalence
Building on the 1992 National Adult Literacy Survey,
the 2003 National Assessment of Adult Literacy (NAAL)
included general as well as health-related literacy tasks
divided into four levels of competence: below basic, basic,
intermediate, and proficient. Health literacy tasks included
clinical, prevention, and navigation of health care system
activities. Examples of health literacy–related tasks and their
corresponding proficiency levels are described in Table 2-1.
The NAAL reported that 14% of adult Americans had below
basic health literacy skills and 22% demonstrated basic
health literacy skills, translating to about 78 million people
with only basic health literacy skills or less. Those at high
risk of LHL had less than a high school education; spoke
a language other than English before starting school; lived
below the poverty level; were of male sex; or were black,
Hispanic, American Indian, Alaska Native, or multiracial.
Among those 65 years and older, the prevalences of below
basic and basic health literacy increased to 29% and 30%,
respectively, corroborating the findings of earlier studies of
Medicare-managed care enrollees.
Health Consequences
Associated with LHL
Several studies have described the relationship between
measures of health literacy and disease knowledge, health
status, and aspects of health services use. Many of these
studies have been summarized in comprehensive reports
by the Institute of Medicine and the Agency for Healthcare
Research and Quality. The following discussion primarily
focuses on FHL and key processes and consequences of
care that may be of particular relevance to a pharmacist.
In aggregate, these studies suggest that FHL is a likely
mediating factor for optimal patient care and health status.
Disease Knowledge
A patient’s knowledge of his or her disease and its
management provides the fundamental background for
successful adherence to a prescribed treatment plan.
Limited health literacy has been associated with suboptimal
knowledge of disease. Patients with hypertension or
diabetes who have AHL had significantly higher mean
knowledge scores of their disease when compared with
those with LHL. Medicare enrollees with one of four
chronic diseases (i.e., asthma, congestive heart failure,
diabetes, or hypertension) and LHL were significantly less
knowledgeable about their disease than those with AHL.
Adult patients with asthma and LHL were less likely to
understand the adverse consequences associated with
asthma exacerbations, warning signs, and monitoring. In a
diverse, low-income sample, adult patients with LHL treated
at an anticoagulation clinic had higher odds of incorrectly
answering four warfarin-related knowledge questions and
three of four warfarin-related numeracy questions. These
knowledge deficits underscore the importance of reviewing
and verifying patients’ understanding of their medication
instructions at each encounter.
Health Status and Health Services Use
Limited health literacy has been associated with health
status and health service use. Among patients who used
emergency care and walk-in medical clinics for nonurgent
medical problems at two public hospitals, those with LHL
were significantly more likely to report poor health status
compared with those having AHL. Although LHL was not
significantly related to the use of ambulatory care in any
patient subgroup, patients at one public hospital with LHL
were more likely to report being hospitalized during the
previous year compared with those with AHL.
Another study of patients presenting to an emergency
department of an urban public hospital found that patients
with LHL were more likely to be hospitalized than those
with AHL. The relationship between LHL and hospital

Pharmacotherapy Self-Assessment Program, 6th Edition 17 Health Literacy: Implications for Pharmacy Practice
admission was even stronger in patients who had a prior
hospitalization. Further study demonstrated that Medicare-
managed care plan enrollees with LHL were more likely to
be hospitalized than those with AHL.
Limited health literacy has also been associated with poor
health outcomes. In a cross-sectional sample of English- and
Spanish-speaking patients attending public health clinics,
patients with diabetes and LHL were significantly more
likely to have poor glycemic control and retinopathy than
those with diabetes and AHL. In a sample of adult patients
with asthma, LHL was associated with lower scores on the
asthma quality-of-life questionnaire and on the physical
component of the Medical Outcomes Study Short Form 36,
as well as increased emergency department use, during a
2-year period. However, this association was seen in bivariate
analyses of study data but not in multivariable analyses.
Preventive Health Care Use
Patients must also recognize and understand the value
of preventive care services in the absence of obvious
symptoms. Among Medicare-managed care enrollees,
individuals with LHL had higher odds of never receiving
an influenza or pneumococcal vaccination compared with
those with AHL. Women with LHL also had higher odds
of not receiving a mammogram within the previous 2 years
and of never having a Papanicolaou smear than individuals
with AHL. Special approaches may be required to inform
and motivate those with LHL to seek preventive services.
Mortality
Given the relationships between LHL and knowledge
of disease, health status, use of acute care, and prevention
activities, it is natural to question the relationship between
LHL and mortality. Among the Medicare-managed care
elderly, mortality rates were found to be significantly higher
among those with LHL compared with those with FHL after
controlling for numerous explanatory variables related to
background demographics, comorbidities, health status, and
daily living impairment. Compared with those with AHL,
cardiovascular-specific mortality was significantly higher
among those with LHL. No differences were found for
cancer-specific mortality among health literacy subgroups.
This study confirmed earlier research that found individuals
aged 70–79 years with an estimated reading level of eighth
grade or below had an almost 2-fold increase in mortality
compared with those reading at the ninth grade level or
higher even after adjusting for factors commonly associated
with increased mortality.
Medical Expenditures
Information describing the relationship between health
literacy and health care expenditures is limited. Limited
health literacy would be expected to lead to an inefficient
mix of health services use and subsequent higher costs. It is
routinely cited that excess annual costs associated with LHL
are in the range of U.S. $106 billion to U.S. $238 billion
using estimates from the 2003 NAAL. However, these
estimates have not been subject to rigorous peer review and
are based on numerous assumptions.
The most rigorous study of medical expenditures
and FHL was performed in a large sample of Medicare-
managed beneficiaries. There was no difference in inpatient,
Health Literacy: Implications for Pharmacy Practice
outpatient, and pharmacy costs between those estimated to
have LHL when compared with those who had AHL after
controlling for sex, age, income, schooling, smoking, alcohol
consumption, physical and mental status, and chronic
conditions. However, those with LHL had significantly
higher emergency room costs compared with those with
AHL. The relationship between marginal health literacy
and costs was less clear, suggesting lower outpatient costs
and higher emergency department costs.
Health Literacy Concerns
for Managing Drug Use
Pharmacists rely on the written word and verbal
counseling to convey instructions and clinical information.
This communication often occurs in busy practice settings
that are not conducive to encouraging pharmacist-patient
dialogue. Adherence to a prescribed drug regimen requires
a patient, at a minimum, to read an instruction, comprehend
its meaning, and act on it successfully. Many points during
the pharmacist-patient exchange of information may be
hindered by LHL.
Drug Labels and Guides
In the ambulatory setting, the drug label is the universal
standard for communicating instructions for taking the drug.
A recent study to evaluate drug labeling format and content
highlighted significant variations that may adversely affect
the patient with limited literacy skills. Label variations
included small and nonstandardized font size, highlighted
text more relevant to the pharmacist than the patient, and
awkward placement of warning and special instruction
stickers.
Auxiliary labels are intended to provide useful
information; however, a majority of patients attending a
primary care clinic at a public hospital and with estimated
reading levels at or below the sixth grade incorrectly
interpreted seven of eight prescription drug warning labels.
Auxiliary labels with multiple-step instructions posed the
greatest challenge for most patients (92% or more, depending
on the label), as did labels with higher reading difficulty and
confusing icons. Differences in label color influenced label
interpretation and decreased message clarity; conflicting
messages were also cited as problems. Specific examples of
challenges in understanding auxiliary labels are provided in
Table 2-2.
The process of successfully taking a prescription
explicitly meets the definition of FHL (i.e., the ability to
read, comprehend, and act). In a study at three primary care
clinics serving mostly indigent populations, patients were
tested on their understanding of five drug label instructions
and were asked to demonstrate dosage instructions for
one of the drugs. Overall, the proportion of patients who
misunderstood at least one of the drug instructions was
46.3%; this ranged from 37.7% in patients reading at the ninth
grade level to 62.7% of patients reading at the sixth grade
level and below. Understanding indicated by answering
the question “How would you take this medicine?” varied
by drug instruction and ranged from 67.1% to 91.1%.
Most incorrect interpretations were dosage errors (51.8%),
18 Pharmacotherapy Self-Assessment Program, 6th Edition
Table 2-2. Challenges in Understanding Auxiliary Drug Labels
Challenge Definition
Instructions Multiple-step instructions are more difficult to “Do not take dairy products, antacids, or iron preparations within 1
interpret
Reading Higher Lexilea scores are associated with
difficulty decreased comprehension; Lexile scores are
an indicator of reading difficulty and range vs.
from 0 to 2000
Icons Pictures on labels can be misinterpreted
Label color Patients often attribute label color to
instructions
Clarity Even messages with low Lexile scores can be
misunderstood
a
The Lexile Framework for Reading. Durham, NC: MetaMetrics. Available at www.metametricsinc.com/DesktopDefault.aspx?view=mm&tabindex=2&ta
bid=96. Accessed August 7, 2008.
followed by dosing frequency (28.2%) and duration of use
(11.1%). Although 70.7% of patients reading at the sixth
grade level and below could correctly state the instructions
for a guaifenesin prescription (i.e., reading), only 34.7%
could correctly demonstrate the correct number of pills
to be taken daily (i.e., comprehension). This discrepancy
illustrates the need to require patients not only to state back
the instructions after counseling but also to demonstrate
exactly what they plan to do (i.e., the teach-back method).
As expected, patients taking more drugs were more likely
to misunderstand their prescription instructions. For further
clarification, the authors recommended explicit language
when describing dosing intervals (e.g., use “Take one tablet
in the morning and one at 5 PM” instead of “twice daily”).
In addition, they suggested standardized organization of
labels and simplified text including use of numbers instead
of their text equivalent (e.g., “5” instead of “five”), as well as
avoidance of medical jargon (e.g., antibiotic, decongestant)
and vague words (e.g., “5 mL” together with an appropriate
measuring device instead of “teaspoonful”).
Health care materials are often written at a level of
readability beyond the capacity of those with LHL. In
a recent study, 40 U.S. Food and Drug Administration
(FDA)–approved medication guides intended for consumers
were estimated to be written at an 11th to 12th grade reading
level, exceeding the recommended reading level of sixth to
eighth grade. In a study of 251 patients, only 23% of patients
reviewed the FDA medication guides or accompanying
patient information materials. This proportion was even
lower among patients with limited literacy, calling into
question the value of the medication guides as currently
written, especially in the population with limited literacy.
Written drug information often accompanies the
dispensing of prescription drugs. Researchers performing
a systematic review of the literature concluded that there
is a disconnect in the quality of written patient information
leaflets and perceived value by the audience for which they
are intended. No substantial evidence exists that written
patient information, in its current format, improves patient
Pharmacotherapy Self-Assessment Program, 6th Edition
Example
hour of this medication” (has several steps in the instruction)
“Take with food” (Lexile score not assigned, but at the level of a
beginning reader [i.e., less than first grade])
“You should avoid prolonged or excessive exposure to direct or
artificial sunlight while taking this medication” (Lexile score =
1300 [12th grade reading level])
A label that states “Refrigerate, shake well; discard after (date)” but
only has a picture of a refrigerator does not convey the whole
message
Red may be interpreted as danger; yellow may be interpreted as
caution; green may be interpreted as a recommendation
“For external use only” (Lexile score = 100; however, message was
difficult to interpret for respondents in a recent study)
satisfaction or adherence. Furthermore, patients prefer
simplified information tailored to their circumstance.
Verbal Communication
Baseline data from Healthy People 2010 reported that,
in 1998, only 14% of patients received verbal counseling
from pharmacists on the appropriate use and potential
risks of drugs. Furthermore, only 24% of patients received
counseling from their prescribers.
Although not specifically studied in the pharmacist-
patient dyad, LHL has been associated with decreased
clarity in physician discussions about care of patients with
diabetes. This communication gap may be widened by the
stigma associated with LHL. One study related that 40%
of patients with LHL who admitted having trouble reading
also admitted shame. Moreover, three-fourths of patients
did not discuss their reading difficulty with their health
care providers, more than two-thirds did not discuss their
reading difficulty with their spouse, and more than half did
not tell their children about their reading problem. LHL may
also serve as a barrier to provider-patient communication
if important health care messages are communicated in a
complex way and patients are reluctant to ask questions
because result of shame.
Pharmacy Preparedness
Pharmacists must consider how prepared they are to assist
their patients who have limited literacy. Despite alarming
evidence about the large proportion of the population at risk
of LHL, recent data suggest that pharmacies make little
effort to identify the literacy-related needs of their patients.
For example, only 2 (7%) of 30 pharmacies contacted in the
Atlanta area made such attempts. Although most pharmacies
(73%) reported the availability of verbal counseling and
written instructions, only 27% provided adherence aids
such as packaging or organizing aids, 17% provided refill
services, and 13% provided graphic or multimedia aids that
could help patients with low literacy skills. Recognizing the
need for further development, the Institute of Medicine has
19 Health Literacy: Implications for Pharmacy Practice
recommended that health professions schools incorporate
health literacy content into the curricula.
In a recent survey, a majority of physicians, nurses,
and pharmacists reported using simple language, handing
out print materials, speaking more slowly, and reading
instructions aloud as communication techniques. Techniques
reported by only a minority of participants were the use of
the teach-back method, underlining key points in a pamphlet,
and using telephone follow-up to assess understanding.
Environmental Barriers
Whether it is a pharmacy or clinical setting, the patient
care environment should invite or encourage questions.
However, physical environments can often serve as a barrier
to comprehension of health information for someone with
limited literacy skills. In the community setting, the physical
environment must be clearly marked for prescription drop-
off, pickup, and counseling to ensure easy navigation. An
easily accessible location for discharge counseling in the
hospital setting would be useful. A lack of privacy may
ultimately discourage questions by the patient with LHL
skills because of fear of exacerbating shame. Physical layouts
sometimes make the pharmacist inaccessible, leaving the
patient to interact with a telephone operator, receptionist,
clerk, technician, or student intern before gaining access to
a pharmacist. The perception of pharmacist inaccessibility
may further discourage questions. Requiring patients to sign
forms without explaining the purpose of the process does
not promote a pharmacist-patient dialogue. Finally, the pace
of activity caused by a large prescription volume or number
of appointments in many patient care settings reduces the
opportunity for pharmacist-patient interaction.
Drug Adherence
Drug adherence is a complex process in which patients
use verbal, written, and numeric information to manage
their prescribed treatment. Misunderstanding health care
provider instructions undermines the integrity of successful
drug adherence. Studies exploring the relationship between
LHL and suboptimal drug adherence have been conducted
in select population subgroups and produced varied results.
Patients with human immunodeficiency virus (HIV)
and LHL were more likely to be nonadherent to their anti-
retroviral drug regimen. In multivariate analyses, patients
who scored lower than 86% on a health-related reading
comprehension test were 3.9 times more likely to be
nonadherent to their anti-retroviral drugs in the previous
2 days compared with those who scored 86% or greater.
In contrast, bivariate analyses of a longitudinal study of
patients who were HIV positive were unable to demonstrate
a relationship between health literacy and drug adherence to
anti-retroviral therapy at 48 weeks.
In a study of refill adherence to cardiovascular-related
drugs, Medicare managed care enrollees with LHL had
higher odds of low adherence than those with AHL in
bivariate analyses. However, this relationship was not
significant in multivariable analysis. In another study, health
literacy was not associated with self-reported drug adherence
or time within the therapeutic international normalized ratio
in patients undergoing anticoagulation with warfarin.
Finally, a recent study revealed that health literacy may
adversely affect the drug reconciliation process. Patients with
Health Literacy: Implications for Pharmacy Practice
hypertension and inadequate FHL were significantly more
likely than patients with marginal or adequate FHL to report
no antihypertensive drugs in common with their medical
record (64.9% vs. 37.8%). Additional studies are necessary
to fully understand the relationship between LHL and drug
adherence and factors that modify this relationship.
Methods for Identifying
Patients with LHL
Pharmacists should be alert for cues that a patient may
have LHL. With this knowledge, pharmacists can work to
meet their needs and ensure that these patients can access
and understand important health information, which may
lead to improved health outcomes.
Signs of Limited Literacy Skills
Patients are practiced in masking the signs of LHL to avoid
the stigma, and it often is impossible to tell by appearances
who may be affected. In a study at a general internal
medicine clinic where 40.7% (74 of 182) of patients tested
positive for LHL, medical residents did not suspect a literacy
problem in 90% of the patients evaluated. Of those thought
to have AHL, 36% tested positive for LHL. Patients with
LHL interpret words literally, read slowly, skip uncommon
words, lack an adequate frame of reference, depend on visual
cues, have a short attention span, and hide their inabilities.
To avoid stigma, they may offer excuses such as “I forgot
my glasses,” “I need to take the papers home for my spouse
to look over,” or “I do not have time to fill out these papers
or read this information.” A universal precautions approach
should be considered in which information is simplified
for everyone independent of the perceived health literacy.
By simplifying information for all and assuming that most
patients may have difficulty understanding the information,
communications can be improved. For those recognized to
have LHL skills, further tailoring communication strategies
and materials to their needs fosters a more effective learning
environment.
Health Literacy Testing Tools
Debate exists whether patients should be screened
or tested for health literacy level in the practice setting.
Although identifying patients at risk of limited literacy may
assist with intervention, the notion of testing may further
exacerbate the shame associated with it. A recent study
demonstrated that literacy testing in physician practices did
not change patient satisfaction. Another study discovered
that patients demonstrating limited literacy through testing
were likely to be ashamed of being identified and having it
documented in their medical record.
Rather than testing patients at individual encounters, an
alternative is to use screening tools to study a representative
sample of patients in the practice environment to establish
a general health literacy level of the practice population
and identify the factors that may be associated with LHL
in that setting. The Institute of Medicine acknowledges that
the measurement of health literacy is quite varied and has
recommended standardization. The ideal approach depends
on the individual practice environment and the relationship
20 Pharmacotherapy Self-Assessment Program, 6th Edition
between the pharmacist and his or her patients. Methods for
screening include word recognition tests, comprehension
tests, the Newest Vital Sign (NVS) tool, and one-item
screening questions that have been validated against either
general literacy or health literacy tests.
The Rapid Estimate of Adult Literacy in Medicine
(REALM), a word recognition test, was the first practical
instrument to measure individual patient ability to read
medical terms in the health care setting. With the REALM,
patients are asked to read a list of 66 increasingly difficult
medical terms. The number of correctly pronounced words
is subsequently related to approximate grade levels of
reading (i.e., 0–18: third grade and below; 19–44: fourth to
sixth grade; 45–60: seventh and eighth grade; 61–66: ninth
grade and above). The test is simple, brief (administered
in 2–3 minutes), and useful for profiling reading skills and
helping target teaching methods.
Comprehension tests such as the Test of Functional
Health Literacy in Adults (TOFHLA) and the Short Test
of Functional Health Literacy in Adults (S-TOFHLA)
were designed to provide a broader assessment of FHL
that addresses dimensions of reading comprehension
and quantitative literacy. The TOFHLA uses three prose
passages to assess reading comprehension: (1) instructions
for the preparation for an upper gastrointestinal series; (2)
the patient rights and responsibilities section of a Medicaid
application form; and (3) a standard hospital consent
form. The S-TOFHLA uses only the first two passages.
In addition, hospital forms and prescription bottles are
used to assess patient ability to comprehend quantitative
tasks such as instructions for taking a drug; appointment
schedules; and blood pressure and glucose monitoring, as
well as interpreting instructions for financial assistance.
The number and type of quantitative tasks vary with the
version of the TOFHLA used. A version even shorter than
the S-TOFHLA can be used; this version includes only the
reading comprehension component. In contrast with the
REALM, both long and shortened versions of the TOFHLA
have been demonstrated to be reliable and valid measures
of FHL. Although the TOFHLA and S-TOFHLA are the
primary instruments for measuring reading comprehension
and quantitative (i.e., numeracy) skills, time (22 minutes
for the TOFHLA, 12 minutes for the S-TOFHLA, and 7
minutes for the reading comprehension–only component of
the S-TOFHLA), and complexity with administration have
limited their use in health care research environments.
The NVS is a simple and quick (3 minutes) health literacy
screening tool that requires users to read a standard nutrition
label from a carton of ice cream and answer a series of six
questions. The NVS was successfully validated against
the TOFHLA; therefore, performance on the NVS can be
mapped to levels of FHL. As with the TOFHLA, there are
English (NVS-E) and Spanish (NVS-S) versions of the
NVS. Currently, there is limited experience with the NVS
in the published literature.
One-Item Screening Measures
To further simplify measurement of health literacy in
the busy practice environment, efforts have been made to
identify nonoffensive screening questions that avoid the
perception of literacy testing. One study evaluated a series
of questions as potential predictors of FHL as measured by
Pharmacotherapy Self-Assessment Program, 6th Edition
the S-TOFHLA. Three questions emerged from the analysis
as best:
• How often do you have problems learning about
your medical condition because of difficulty
understanding written information?
• How confident are you filling out medical forms by
yourself?
• How often do you have someone help you read
hospital materials?
In a follow-up study of these three questions, “How
confident are you filling out medical forms by yourself?”
was identified as the best predictor of LHL skills when
validated against the REALM. On the five-item response
set (ranging from “not at all” to “extremely”), the midpoint
response “somewhat” appeared to be the most accurate
for both the initial and follow-up validation studies. Two
subsequent validation studies have confirmed this question
as a useful predictor of LHL.
Using a one-item screening question at individual
encounters is simple and less intrusive and may be a
practical alternative to more complex measures such as the
TOFHLA or S-TOFHLA, although validation studies were
conducted in small samples and used narrow population
subgroups, thus limiting their generalizability. There is
limited evidence describing the use of one-item screening
measures in the published literature.
Design a Program That
Promotes Clear Health
Communication
Conduct an Organizational Assessment
It is important to look beyond the individual encounters
between a pharmacist and a patient. The Agency for
Healthcare Research and Quality released a guide titled
“Is Our Pharmacy Meeting Patients’ Needs? A Pharmacy
Health Literacy Assessment Tool User’s Guide” that is
publicly available (publication no. 07-0051; available at
www.ahrq.gov/qual/pharmlit). A health literacy assessment
will:
• Raise pharmacy staff awareness of health literacy
issues.
• Detect barriers that may prevent individuals
with limited literacy skills from accessing,
comprehending, and using health information and
services provided by the organization.
• Identify opportunities for improvement.
Conducting an organizational assessment may also
provide a baseline measurement before implementing
an organizational change or intervention. A follow-up
assessment allows evaluation of the intervention’s influence
on accessibility of the organization to individuals with
LHL.
The audit tool is made up of three parts that, taken together,
address nine key elements of an organizational health
21 Health Literacy: Implications for Pharmacy Practice
literacy intervention: (1) management, (2) measurement, (3)
workforce, (4) care process, (5) physical environment, (6)
technology, (7) paperwork and written communications, (8)
culture, and (9) alignment. The first part of the audit tool is
a survey to be completed by pharmacy staff; the second is
an audit tour guide to be completed by objective, trained
auditors; and the third is a guide for focus groups with
pharmacy patients. The three complementary components
provide a comprehensive audit to assess congruence among
patient, provider, and organization.
Review Communication Methods
The information and services provided by pharmacies
typically include written materials such as bottle labels,
prescription information inserts, signs about the Health
Insurance Portability and Accountability Act, and patient
education materials. In addition to written materials, verbal
instruction on drug use is expected of pharmacists. People
with LHL can learn from health materials and communication
strategies as long as these are designed and presented with
consideration of the reading and comprehension skills,
levels of knowledge and experiences, cultural beliefs and
practices, and communication expectations of the intended
audience. Therefore, it is essential to solicit feedback from
the intended audience before broad implementation.
The more senses involved in the learning process, the
greater the likelihood that the patient will understand and
remember information. Audiences with limited literacy
need simple, basic information that is conveyed in an
appropriate format. This section provides information on
how to promote clear health communication for written,
visual, and oral communications with patients. The type of
communication strategy should be aligned with the practice
setting and individual needs. For example, a hospital
environment may be more conducive to showing a videotape
because the patient is a captive audience. A busy outpatient
clinic or pharmacy may require more streamlined options.
Newer technologies (e.g., Internet, pod casts) require further
exploration.
Written Materials
Most of the health information delivered to patients is in
the form of complex print media (e.g., insurance and consent
forms, drug directions, health brochures and pamphlets, test
results). The inability to read and understand these materials
limits access to care and the ability to make informed
decisions. Printed materials should be used to reinforce
verbal communication.
Studies suggest that audiences of all reading capabilities
prefer and better understand information that is presented in
a simple, concise, and clear manner. Printed materials such
as postcards, fact sheets, brochures, and booklets should be
created in an easy-to-read format. Some characteristics of
easy-to-read materials include short, simple sentences; large
font size (12 points or greater); sufficient white space; and
sixth grade level or below readability. Various document
readability tests (e.g., Simplified Measure of Gobbledygoop
[SMOG], Flesch-Kincaid, Fry, Gunning Fog, Lexile) are
available. Advice should be solicited before using readability
tests because each one has its own formula and instructions
for use in assessing the complexity of the written word.
Health Literacy: Implications for Pharmacy Practice
Bulleted lists are preferred to lengthy paragraphs.
Highlighting or circling key information is very helpful.
Complex graphs or charts should be avoided because they
often require integration of many pieces of information.
Visual Materials
Visual materials help people remember information they
hear. One study demonstrated that subjects who listened to
medical instructions accompanied by a simple line drawing
(or pictograph) remembered 85% of what they heard. In
contrast, those who did not use a pictograph remembered
only 14% of the instructions. Using visual materials can help
teach about something that cannot be easily perceived (e.g.,
cholesterol in the blood vessels), can illustrate a specific
point, and can demonstrate steps to follow to complete a
task. In addition, visual materials are an effective way to
present real-life circumstances.
When working with visual materials, it is important
that they are relevant to the topic and audience. The visual
item should reflect the culture, age, and background of the
audience. For example, people shown in the materials should
look like they could be family or friends of the patient, and
objects shown should be familiar. In addition, the visual
materials should be simple, recognizable, and clear. Action-
oriented visual materials that show correct patient actions
result in the greatest benefit. Images showing incorrect
actions should be avoided. Photographs should depict real-
life events, showing people and conveying emotions. Simple
line drawings work well for showing step-by-step procedures
such as drawing blood. Examples of visual patient teaching
methods are described in Table 2-3.
Table 2-3. Visual Teaching Methods
Pictographs—Simple line drawings of an idea or action drawn
in front of the patient so the images can be explained; they
are an effective way to convey complex information or
actions in a quick, inexpensive, and meaningful way
Posters—Combine illustrations, drawings, or photographs with
a limited amount of text; they are generally used to raise
awareness of a particular health concern or to provide
limited amounts of information; posters can be used as a
stand-alone source of information and can be placed in a
variety of settings
Flip charts—A series of posters put together in sequence to tell
a story or provide step-by-step instructions; they are
generally used by a person giving a presentation
Talk boards—Posters without any words; they can be used alone
or in a series and may include photographs or drawings
showing an action or behavior or showing an everyday scene
or situation; talk boards are used to promote a group
discussion on a health issue or concern
Models—Real objects that are three-dimensional, real-life, or
to-scale teaching aids; using real objects or models makes
concepts and ideas easier to understand; models can be used
to demonstrate a procedure and allow the patient to practice
the procedure
Fotonovelas—Stories told with pictures and dialogue in a format
similar to a comic book; the stories present real-life
situations and have entertaining and educational plots;
fotonovelas are most effective in population subgroups
familiar with the technique (e.g., Hispanic immigrants)
22 Pharmacotherapy Self-Assessment Program, 6th Edition
Verbal Communications
A key component of the environment is the verbal
interaction between patients and pharmacy staff; this
includes people responsible for providing instructions
for locating and navigating the pharmacy, as well as
pharmacists responsible for offering drug counseling. The
National Quality Forum indicates that patients with LHL
skills often do not follow drug use instructions because
providers have not clearly communicated the directions.
The Forum also identifies poor communication between
providers and patients as one of the unintentional causes
of poor adherence, and it highlights provider-patient
communication as a priority area for improving patient
drug adherence. Discussing health topics with patients
orally presents many challenges. Verbal instructions are
often complex, delivered rapidly, and easily forgotten in
stressful circumstances. Language barriers also present
comprehension problems. Asking patients to demonstrate
their understanding of what has been communicated to
them using the teach-back method is often suggested as a
simple way to verify patient understanding. Techniques for
effective verbal communication are described in Table 2-4.
Ask Me 3 is a no-cost program developed by the
Partnership for Clear Health Communication; it can be
implemented in the pharmacy setting to empower patients
to ask questions and promote understanding about their
prescribed drugs. The Ask Me 3 program encourages
patients to ask three essential questions during every health
care encounter: (1) What is my main problem? (2) What do
I need to do? (3) Why is it important for me to do this? The
program also encourages every health care provider to offer
answers to these three questions and ensure understanding,
and it encourages organizations to create an environment
to facilitate this communication. An effective health care
communication process is made possible by aligning these
questions and answers for both patients and providers. The
Ask Me 3 program educational materials (www.npsf.org/
askme3/PCHC/download.php) are available in both English
and Spanish to use as part of a program to improve health
care communication. Although not specifically tested in the
pharmacy environment, simple programs such as Ask Me
3 may serve as a starting point for promoting clear health
communication in any pharmacy environment.
Train Staff
The Agency for Healthcare Research and Quality
publication “Strategies to Improve Communication
Between Pharmacy Staff and Patients: A Training Program
for Pharmacy Staff” is available at www.ahrq.gov/qual/
pharmlit/pharmtrain.htm. This program is designed to
introduce pharmacists to the problem of LHL in patient
populations and to identify the implications of this problem
for the delivery of health care services. The program also
explains techniques to improve communication with
patients who may have LHL. The training can be conducted
in 2 hours. Materials provided include a slide set for the
initial presentation and handouts for use in the final section,
which is a role-play exercise in which the “pharmacist”
practices counseling the “patient” using the communication
techniques presented. An “observer” provides feedback
to the “pharmacist.” The program provides the necessary
background to serve as a catalyst for change.
Pharmacotherapy Self-Assessment Program, 6th Edition
Table 2-4. Effective Verbal Communication Techniques
Talk slowly—Slow down the pace of speech when talking with a
patient
Encourage questions—Patients should be encouraged to ask
questions and express concerns; have patients bring a list of
questions and concerns to each visit to help prompt
discussion; ask, “What questions do you have?” instead of
“Do you have any questions?”
Explain things in clear, plain language—Plain, nonmedical
language should be used; new terms should be defined;
words or expressions that are familiar to patients should be
used, such as painkiller instead of analgesic; jargon and
technical phrases should be avoided
Avoid complex numeric concepts and statistics—Many people
do not understand percentages; patients should understand
all the numbers given to them before they make any
treatment decision; instead of saying, “There is a 20%
chance that you will experience X outcome,” tell the patient
“20 people out of 100 will experience X outcome”
Use analogies and metaphors—Analogies should be selected to
relate complex concepts to things the patient already knows
(e.g., “arthritis is like a creaky hinge on a door”)
Limit information provided—Limit information to three or
fewer key messages per visit; reviewing and repeating each
point helps reinforce the messages; in addition, it is
important that other staff reinforce the key messages
Verify patient understanding—A teach-back or show-me
method allows the patient to demonstrate understanding and
verifies patient understanding
Avoid vague terms—Say “Take 1 hour before you eat breakfast”
instead of “Take on an empty stomach”
Implement Programmatic Change
The Commonwealth Fund has outlined five key literacy
practices that are particularly useful to primary care practices
treating underserved populations. These methods include (1)
use of a clinic team effort; (2) standardized communication
strategies that include the teach-back method, Ask Me 3
program, and motivational interviewing; (3) plain language
principles; (4) patient-provider partnerships; and (5) an
organizational commitment to health literacy principles.
An organizational audit, a review of current methods of
communication, and a staff training program should help
identify opportunities for pharmacies to implement change.
Conclusion
Successful delivery of optimal pharmacotherapy
requires patients to read, comprehend, and act on prescribed
treatment regimens. Health literacy is a mediating variable
in the health care process. Thus, the success of ensuring clear
health communication in the pharmacist-patient interaction
is dependent not only on the patient’s health literacy skills but
also on the methods of communication and the environment
in which it is provided. Although the ideal program or
intervention has not been identified, adopting changes that
are evidence-based and that have been endorsed by health
communication experts should be considered.
23 Health Literacy: Implications for Pharmacy Practice
Annotated Bibliography
1. Davis TC, Crouch MA, Long SW, Jackson RH, Bates P,
George RB, et al. Rapid assessment of literacy levels of adult
primary care patients. Fam Med 1991;23:433–5.
2. Davis TC, Long SW, Jackson RH, Mayeaux EJ, George
RB, Murphy PW, et al. Rapid Estimate of Adult Literacy
in Medicine: a shortened screening instrument. Fam Med
1993;25:391–5.
In the 1990s, assessment tools were developed to assess
the capacity of individuals to read and understand health
care–related material. The REALM was the first practical
instrument to measure individual patient ability to read
medical terms in the health care setting by asking patients to
read a list of increasingly difficult medical terms. The number
of correctly pronounced words is used to map a patient to
grade-equivalent reading levels. Grade levels are associated
with levels of competence in reading written materials. In
developing the REALM, one study used a longer version
(i.e., 125 words) and found 59% of 207 adult ambulatory
care patients scored below the ninth grade reading level.
In a subsequent study that used a shortened version of the
REALM (i.e., 66 words), 73% of 203 predominantly African
American, female patients scored below the ninth grade
level (number 2 above). In both studies, the REALM and the
shortened version were highly correlated with accepted tests
of word recognition and reading. Strengths of the REALM
include its ability to identify individuals at low levels of
reading ability; its negligible training requirement; and its
ease of administration (requiring less than 3 minutes). Note
that the REALM is a word recognition test, not a test of
FHL.
3. Parker RM, Baker DW, Williams MV, Nurss JR. The Test
of Functional Health Literacy in Adults: a new instrument
for measuring patients’ literacy skills. J Gen Intern Med
1995;10:537–41.
4. Baker DW, Williams MV, Parker RM, Gazmararian JA,
Nurss J. Development of a brief test to measure functional
literacy. Patient Educ Couns 1999;38:33–42.
The TOFHLA and the shortened version S-TOFHLA
were designed to provide a broader assessment of FHL
that addresses dimensions of reading comprehension and
quantitative literacy. The TOFHLA uses three prose passages
to assess reading comprehension: (1) instructions for
preparation for an upper gastrointestinal series; (2) the patient
rights and responsibilities section of a Medicaid application
form; and (3) a standard hospital consent form. In addition, an
assortment of hospital forms and prescription bottles are used
to assess patient ability to comprehend tasks such as drug-
taking instructions, appointment schedules, blood pressure
and glucose monitoring, and obtaining financial assistance.
For reading comprehension, patients are required to complete
passages in which words have been randomly deleted.
Grounded in Gestalt psychological theory, comprehension
is measured by the cloze procedure (i.e., the patient’s ability
to successfully fill in the missing words). The principles
behind the cloze procedure include word association and total
language context. That is, if one understands the complete
passage, one can complete the individual parts of the passage
through word association, redundancy, and understanding
the whole passage. With respect to the assessment of
quantitative ability, the patient is required to read and react
Health Literacy: Implications for Pharmacy Practice
to a given set of instructions and determine when to take the
next dose of drug, when to appear for the next physician visit,
or determine whether a blood pressure or glucose reading
is normal or abnormal. The TOFHLA and S-TOFHLA are
highly correlated with the REALM, which measures only
the patient’s ability to correctly read and pronounce medical
terms, and have been demonstrated to be reliable and valid
measures of FHL. The TOFHLA and S-TOFHLA are the
primary instruments by which reading comprehension and
numeracy skills are measured in the health care research
environment.
5. Williams MV, Parker RM, Baker DW, Parikh NS, Pitkin K,
Coates WC, et al. Inadequate functional health literacy among
patients at two public hospitals. JAMA 1995;274:1677–82.
This study was the first to assess FHL in a sample of 2659
patients seeking care in two urban public hospitals. The
TOFHLA was used to measure reading and comprehension
of health care information. Overall, 29.1% and 13.7% of
patients had inadequate or marginal FHL, respectively. The
proportions of patients with inadequate and marginal FHL
were higher in the Spanish-speaking subgroup. Particularly
relevant in this study was that 41.6% of patients overall were
unable to comprehend taking drugs on an empty stomach, 26%
were unable to understand information regarding when a next
appointment was scheduled, and 59.5% could not understand
a standard informed consent document. These proportions
of patients were higher in the inadequate FHL subgroup.
Researchers found that age was inversely associated with
FHL, whereas education was directly associated with FHL.
This study is important because it was the first to assess
patient ability in a wide range of literacy tasks, including
basic tasks such as reading labels on prescription bottles,
understanding appointment slips, and completing financial
eligibility requirements. Data collected from this study have
been used to study the relationship between FHL and a variety
of measures of health status and health services use.
6. Gazmararian JA, Baker DW, Williams MV, Parker RM, Scott
TL, Green DC, et al. Health literacy among Medicare enrollees
in a managed care organization. JAMA 1999;281:545–51.
This study measured the prevalence of inadequate,
marginal, and adequate FHL among Medicare enrollees in a
managed care organization. In-person interviews with 3260
Medicare enrollees were conducted to measure FHL. Results
showed that 33.9% of English-speaking and 53.9% of Spanish-
speaking participants had inadequate or marginal FHL. In
addition, 27% of the respondents with inadequate literacy did
not know the date of their next appointment, 48% to 54% did
not understand basic prescription instructions (depending on
the task), and 68% could not interpret blood glucose values
for commonly used diabetes tests. The researchers also found
that study location, race, language, age, years of school
completed, occupation, and cognitive impairment were
significantly associated with inadequate or marginal literacy.
This study underscores the need for clinician awareness
regarding FHL in members of the senior population, many of
whom often have complex illnesses. Data collected from this
study have been used to study the relationship between FHL
and a variety of measures of health status, health services
use, cost, and mortality in the senior population.
7. Parikh NS, Parker RM, Nurss JR, Baker DW, Williams MV.
Shame and health literacy: the unspoken connection. Patient
Educ Couns 1996;27:33–9.
24 Pharmacotherapy Self-Assessment Program, 6th Edition
 The relationship between shame and limited FHL was
assessed in this study. Patients in a large public hospital in
Atlanta were interviewed. Of the 202 patients interviewed,
42.6% had inadequate or marginal FHL. Researchers found
that patients with LHL were more likely to be male, have
less than a high school education, and be older than 60 years.
About 40% of patients with LHL who had trouble reading
admitted to shame. Of the patients with LHL, more than half
never told their spouses or children. These findings suggest
changes in the health care delivery system should be made
to accommodate patients with LHL. To avoid stigma, these
changes should be made available to everyone because
patients may not ask for help on their own. The authors
suggest that hospital personnel and staff be informed about
the problems of patients with LHL and create a shame-free
environment.
8. Doak CC, Doak LG, Root JH. Teaching Patients with Low
Literacy Skills, 2nd ed. Philadelphia: JB Lippincott, 1996.
Available at www.hsph.harvard.edu/healthliteracy/doak.
html. Accessed August 1, 2008.
This seminal reference provides a wide range of practical
tools that a health care provider can use to maximize patient
education. The authors introduce the idea of literacy and how
it is related to health care. The authors then shift to more
practical applications by introducing guidelines that offer a
framework for designing health instructions that are easily
understood by patients. Reading tests that can be used to
help select appropriate teaching methods for specific patient
populations are reviewed. Because the health care environment
relies heavily on written instructions, the authors provide
a checklist of attributes that define easy-to-read materials.
Because comprehension results in understanding the meaning
of instructions, the authors suggest obtaining advice from
members of the targeted culture during planning; producing
materials in the language of the targeted population; using
practitioner panels to develop health materials; and assessing
the suitability of finished materials using the learner
verification and revision process. Once a target audience is
defined, writing instructions for patients involves deciding
on a format and testing for quality assurance. Guidelines
are provided for effective use of visuals and creating visuals
that are understandable as well as beneficial for patients. The
authors stress that interaction between the patient and health
care providers using these visual and written materials is vital
to understanding. The authors describe the use of audiotaped
instructions, television, and interactive multimedia, which
can enhance teaching effectiveness and increase a patient’s
ability to learn. Teaching tips provide practitioners with steps
that make instructions understandable and acceptable. Finally,
the authors describe learner verification and revision as an
interview procedure using specific steps to judge whether the
health instructions used for a population are suitable.
9. Andrus MR, Roth MT. Health literacy: a review.
Pharmacotherapy 2002;22:282–302.
This is a comprehensive literature review of health literacy
from a pharmacist’s perspective. The authors define health
literacy and provide a brief overview of some assessment
tools. Limited literacy encompasses all populations, medical
conditions, classes, and age groups. The authors indicate
that reading materials targeting patient populations are
written at higher reading levels than the mean reading level
of the patients. Cultural literacy plays a large part in health
literacy. Challenges such as language barriers and nonverbal
cues affect communication between health care providers
and patients. Shame regarding reading difficulties creates a
Pharmacotherapy Self-Assessment Program, 6th Edition
barrier to improved health outcomes. Consequences of LHL
include poorer health status, lack of medical care knowledge,
decreased comprehension of medical information, lack
of use of preventive services, poorer self-reported health,
increased hospitalizations, and increased health care costs.
To address these problems, the authors suggest improving
patient education materials by creating simple, easy-to-read
materials with instructional graphics. Through the use of
lower reading levels, patients with inadequate literacy as well
as those with adequate literacy can improve comprehension.
Increased use of nonwritten information (e.g., television,
radio, talking with friends and family) may enhance patient
knowledge. In conjunction with these suggestions, health
care providers must interact with patients by asking them
to demonstrate their understanding of a concept. Among
their recommendations, the authors suggest research should
focus on the consequences of LHL. They also recommend
promotion of health literacy by acknowledging limited
literacy as a barrier to treatment, making other organizations
and communities aware of the extent of limited literacy, and
developing programs to train clinicians. The article also
provides a list of useful resources.
10. Schillinger D, Piette J, Grumbach K, Wang F, Wilson C,
Daher C, et al. Closing the loop: physician communication
with diabetic patients who have low health literacy. Arch
Intern Med 2003;163:83–90.
To measure patient recall, comprehension, and adherence
of new concepts during outpatient encounters, researchers
used direct observation and audiotapes during visits with
patients with diabetes. They also examined whether there was
an association between physicians’ application of interactive
communication and patients’ glycemic control using clinical
databases. Researchers found that physicians assessed
recall and comprehension of a concept in 20% of 61 visits
and for 12% of 124 concepts. Patients with a physician who
assessed recall were more likely to have hemoglobin A1C
concentrations below the mean. Researchers also found that
good glycemic control was independently associated with
higher health literacy levels and physician application of the
interactive communication strategy. These findings suggest
that communication can improve by assessing patient recall
and comprehension of new concepts, thereby giving patients
an opportunity to express what is unclear to them.
11. Howard DH, Gazmararian JA, Parker RM. The impact of low
health literacy on the medical costs of Medicare managed
care enrollees. Am J Med 2005;118:371–7.
This study combined data from the Medicare-managed care
health literacy study (number 6 above) and administrative
claims from a health insurer to assess the relationship between
FHL and health care use and costs in a sample of 3260 seniors.
Background demographics and health literacy were linked with
administrative claims data. Multivariate regression models
were used to estimate the relationship between FHL, health
care use, and health care costs. Background characteristics
included age, sex, race/ethnicity, income, education, smoking
and drinking status, and comorbid conditions. Functional
health literacy was measured by the S-TOFHLA. Health
care use and costs were categorized as overall, inpatient,
outpatient, emergency department, and pharmacy. About
one-third of the sample had LHL. In adjusted analyses, the
probability of inpatient and emergency department use was
significantly higher for those with inadequate FHL compared
with those with adequate FHL (p<0.05); no difference in
use was noted between the marginal and adequate FHL
subgroups. In adjusted analyses, emergency department
25 Health Literacy: Implications for Pharmacy Practice
 costs (mean difference, U.S. $108) were significantly higher
for those with inadequate FHL compared with those with
adequate FHL subgroups. In adjusted analyses, outpatient
costs were lower (mean difference, U.S. $350) and emergency
department costs were higher (mean difference, U.S. $80)
for those with marginal compared with AHL (p<0.05). The
results suggest, at minimum, an inefficient mix of health care
use, although overall costs did not significantly differ.
12. Praska JL, Kripalani S, Seright AL, Jacobson TA. Identifying
and assisting low-literacy patients with drug use: a survey of
community pharmacies. Ann Pharmacother 2005;39:1441–5.
The authors of this study used a telephone-based survey
of Atlanta-area pharmacies to determine the frequency that
pharmacies identify and assist patients with limited literacy.
They also provided recommendations to help improve
pharmacists’ recognition of LHL and strategies to improve
adherence. Of the 30 pharmacies surveyed, only two reported
attempting to identify literacy-related needs among patients.
Most pharmacies reported limited availability of adherence
aids such as special packaging, refill services, and multimedia.
The findings of this study suggest that pharmacies rarely take
steps to identify patients with limited literacy. The authors
offer techniques for pharmacists to help patients with limited
literacy while minimizing patient discomfort (e.g., handing
a patient an educational brochure upside down to see if the
patient turns it the correct way, asking the patient if the print
is large enough to read).
13. Davis TC, Wolf MS, Bass PF 3rd, Thompson JA, Tilson
HH, Neuberger M, et al. Literacy and misunderstanding
prescription drug labels. Ann Intern Med 2006;145:887–94.
The authors performed a cross-sectional study of patients
receiving care from three primary care clinics (serving
primarily indigent community populations) to examine their
abilities to understand and demonstrate instructions found
on prescription drug labels. All patients participating in the
study were shown prescription container labels and asked
for their interpretation. A research assistant administered
a literacy assessment and also noted whether the patient
examined the auxiliary labels on the bottle. Results indicated
that almost half of patients misunderstood one or more label
instructions, and most incorrect responses reflected an
error in dosage (e.g., tablespoon vs. teaspoon). In addition,
the more drugs patients took, the more likely they were to
misunderstand labels. The authors suggest this may be caused
by complexity and confusion from managing many different
instructions. The authors also found that patients, although
able to correctly read and state the labels, were not necessarily
able to demonstrate the correct amount to take. Rates of
misunderstanding that could lead to drug errors were higher
among patients with LHL. Mistakes were most common when
instructions had several components with varying numeric
information. Auxiliary labels were ignored by most patients,
especially those with LHL. As with other studies, this study
had several limitations. The study investigated understanding
of the primary prescription label only. It did not study the
patients’ actual prescription drug–taking behaviors; patients
in the study were socioeconomically disadvantaged and
mostly women. The authors suggest that the text and format
of prescription labels be redesigned and standardized. They
suggest that less complex and more explicit dosing instructions
will improve patient understanding and that more research is
needed to evaluate instructional formats.
14. Wolf MS, Davis TC, Shrank W, Rapp DN, Bass PF, Connor
UM, et al. To err is human: patient misinterpretations of
Health Literacy: Implications for Pharmacy Practice
prescription drug label instructions. Patient Educ Couns
2007;67:293–300.
To examine the cause of patients’ misunderstanding of
common dosing instructions on drug container labels, the
authors of this study conducted face-to-face interviews that
included a literacy assessment. Patients (n=395) read and
demonstrated their understanding of dosing instructions.
Physician raters reviewed patient responses and determined
the level of understanding. Incorrect responses were coded
and reviewed for themes using qualitative methods. Results
showed rates of misunderstanding ranged from 8% to 33%,
and patients with LHL had higher rates of misunderstanding.
Common causes of misunderstanding were label language,
complexity of instructions, implicit versus explicit dosage
intervals, presence of distracters, label familiarity, and
attentiveness to label instructions. The study’s findings show
that although LHL is associated with misunderstanding, the
instructions may also be vague and difficult to understand
because of inconsistencies in prescription writing. The
authors suggest that prescription drug labels explicitly state
dosing intervals, minimize distracters, and use clear, simple
language.
15. Barrett SE, Puryear JS, Westpheling K. Health literacy practices
in primary care settings: examples from the field [monograph
on the Internet]. January 2008. The Commonwealth Fund.
Available at www.commonwealthfund.org/usr_doc/Barrett_
hltliteracypracticesprimarycaresettingsexamplesfield_1093.
pdf?section=4039. Accessed August 1, 2008.
This two-phase study sought to identify promising
practices to promote clear health communication for those
working in primary care clinics providing care to underserved
populations. In the first phase, a national sample of primary
care physicians and facilities identified by the Association
of Clinicians for the Underserved was asked to report health
literacy practices used in their environment through an
online survey. Results were tabulated, and five diverse sites
were selected for a more intensive qualitative analysis in
phase two. The five practices were identified by their total
team effort, from administrative staff to clinician; use of
standardized communication tools such as the teach-back
method, Ask Me 3 program, and motivational interviewing;
use of plain language materials; provider-patient partnerships
involving goal setting; and organizational commitment to
health literacy initiatives. This article provides practical
health literacy strategies and real-world examples that are
readily translated into other practice settings.
16. Schwartzberg JG, Cowett A, VanGeest J, Wolf MS.
Communication techniques for patients with low health
literacy: a survey of physicians, nurses, and pharmacists. Am
J Health Behav 2007;31(suppl 1):S96–104.
In this study, self-administered questionnaires were sent
to 356 physicians, pharmacists, and nurses. The health
care professionals were asked to identify communication
techniques used in the previous week from a list, to write in
any other techniques used that were not listed; and to identify
the perceived effectiveness of the techniques. Communication
techniques reported by the 307 respondents included using
simple language (94.7%); handing out printed materials to
the patient (70.3%); speaking more slowly (67.3%); reading
aloud instructions (59.1%); writing out instructions (44.5%);
presenting only two or three concepts at a time and checking
for understanding (44.1%); asking patients how they would
follow the method at home (40.4%); asking if the patient
would like a family member to be included in the discussion
26 Pharmacotherapy Self-Assessment Program, 6th Edition
 (39.5%); asking patients to repeat information or use of the
teach-back technique (39.5%); underlining key points in
patient information handouts (38.0%); having the patient
follow up with office staff to review instructions (23.6%);
drawing pictures (15.1%); following up with a telephone call to
check understanding/compliance (12.4%); and using models
to explain (10.4%). Although more than 70% of respondents
reported each of these techniques to be effective, they are
not always used. Compared with nurses and pharmacists,
physicians were more likely to report presenting two or three
concepts at a time and checking for understanding (p<0.02),
having the patient follow up with office staff to review
instructions (p<0.001), and drawing pictures (p<0.001).
Routinely reading aloud instructions was most likely to be
reported by pharmacists (p<0.003). Nurses were more likely
to report handing out printed materials to patients (p<0.002),
writing out instructions (p<0.001), asking patients how
they would follow the method at home (p<0.001), using the
teach-back technique (p<0.001), underlining key points in
patient information handouts (p<0.015), and following up
with a telephone call to check understanding and compliance
(p<0.001). Although the small sample size limits the
application of results, the study results are a cause for concern
because currently accepted communication techniques are
underused and although pharmacists are in the position to
use many of these communication techniques, they appear
to do so less routinely than their colleagues in medicine and
nursing.
17. Paache-Orlow MK, Wolf MS. Evidence does not support
clinical screening of literacy. J Gen Intern Med 2008;23:100–
2.
This article discusses the risks and benefits of screening
for LHL. The techniques and accuracy of the REALM,
S-TOFHLA, NVS, and screening questions are discussed. The
authors indicate that no studies have been done to demonstrate
accuracy in a clinical setting. Because most patient education
techniques benefit patients at all literacy levels, the potential
stigmatization, alienation, and misclassification of those at
risk of LHL must be balanced against the potential benefits of
identifying at-risk patients. Therefore, clear communication
and confirmation of understanding should not be reserved
for patients with LHL. The authors do not recommend using
clinical health literacy screenings.
18. Bass PF 3rd, Wilson JF, Griffith CH, Barnett DR. Residents’
ability to identify patients with poor literacy skills. Acad Med
2002;77:1039–41.
The goal of this study was to determine whether residents
in a general internal medicine clinic could identify patients
with limited literacy based on interactions during a clinic
visit. Health literacy was formally assessed in 182 clinic
patients using the REALM-R. In addition, medical residents
were asked whether the patients had a literacy problem
subsequent to their visit. Patients were classified as having
inadequate or adequate health literacy as measured by both
the REALM-R and medical residents’ perception. Data were
cross-tabulated to assess agreement between the two methods
of assessment. Of the 74 patients with inadequate health
literacy as measured by the REALM-R, residents were only
able to identify 20% of them correctly. These results suggest
that AHL is overestimated by medical providers. The authors
recommend that literacy awareness and teaching skills be
taught in medical schools and residency programs.
Pharmacotherapy Self-Assessment Program, 6th Edition
19. Weiss BD, Mays MZ, Martz W, Castro KM, DeWalt DA,
Pignone MP, et al. Quick assessment of literacy in primary
care: the Newest Vital Sign. Ann Fam Med 2005;3:514–22.
The NVS was developed as a more practical alternative
to the TOFHLA in busy primary care settings and as an
option for assessing FHL in Spanish-speaking patients. Both
English-speaking and Spanish-speaking patients older than
18 years were recruited from primary care clinics. The 500
participants were asked questions about five different types of
instruction (i.e., instructions from a prescription for headache
medicine, a consent form for coronary angiography, self-care
instructions for heart failure, an ice cream container nutrition
label, and instructions for an asthma drug that included a
tapering steroid dosage). A total of 21 questions were asked.
The final short form was selected to be the nutrition label
from the ice cream container accompanied by six questions
(read aloud by the interviewer). The average time the English
version of the NVS (NVS-E) took to administer was 2.9
minutes. The internal consistency and criterion validity (when
correlated with the TOFHLA) of the NVS-E were acceptable
(Cronbach α = 0.76; r=0.59; p<0.001). Answering less than
two of six questions correctly on the NVS-E had a sensitivity
of 72% and specificity of 87% for predicting LHL when
validated against the TOFHLA. The Spanish version (the
NVS-S) took longer to administer (average of 3.9 minutes),
and the internal consistency and validity were slightly lower
(Cronbach α = 0.69; r=0.49; p<0.001). A score of less than
2 on the NVS-S had a sensitivity of 77% and specificity of
57% for detecting patients with limited literacy. Patients who
could correctly answer four or more questions on the NVS-E
were likely to have AHL, whereas patients who answered less
than two questions correctly had greater than a 50% chance
of having LHL.
20. Wallace LS, Rogers ES, Roskos SE, Holiday DB, Weiss BD.
Brief report: screening items to identify patients with LHL
skills. J Gen Intern Med 2006:21:874–7.
This follow-up report to the original validation study
published in 2004 evaluated the accuracy of identifying
patients with LHL using one-item screening questions. In
contrast with the original validation that used the S-TOFHLA,
the REALM was used as the gold standard. The three
screening questions evaluated were as follows: (1) How often
do you have problems learning about your medical condition
because of difficulty understanding written information?
(2) How often do you have someone help you read hospital
materials? (3) How confident are you filling out medical
forms by yourself? The five-category response set included
(1) extremely, (2) quite a bit, (3) somewhat, (4) a little bit,
or (5) not at all. Diagnostic properties, individually and
in paired combinations of two or all three questions, were
analyzed. The third question, “How confident are you filling
out medical forms by yourself?”, was significantly more
accurate than the other two questions (p<0.01). Screening
accuracy did not improve significantly by adding the
additional questions (p>0.10). Consistent with earlier studies,
patients who answered “somewhat” to the third question had
the best balance between sensitivity and specificity, although
the cutoff point chosen may be dependent on whether the user
wants to emphasize sensitivity or specificity. The one-item
question shows potential as a practical screening tool to assist
in identifying at-risk patients. Further studies are needed to
assess its performance in larger and more diverse samples.
27 Health Literacy: Implications for Pharmacy Practice
Health Literacy: Implications for Pharmacy Practice 28 Pharmacotherapy Self-Assessment Program, 6th Edition
Self-Assessment Questions
Questions 21–31 pertain to the following case. D. She has functional health literacy (FHL) skills.
A pediatrician is working in an integrated health system
that serves a large geographic area with demographic 24. Which one of the following is the type of literacy skill
characteristics similar to the national population. The best defined by E.B.’s mother’s ability to determine the
pediatrician prescribes amoxicillin 400 mg/5 mL to E.B., possible adverse reactions of E.B.’s antibiotic using the
a 4 year old with a history of asthma, with instructions to patient drug guide?
take 5 mL twice daily for 10 days. The pharmacist fills the A. Quantitative (numeracy).
prescription as written and places an auxiliary label on B. Prose.
the prescription bottle that reads “Refrigerate-Shake Well, C. Readability.
Discard after 1/30/2009.” The pharmacy dispenses the D. Document.
prescription to E.B.’s mother, together with an oral syringe
and a written patient drug guide as a reference. At the time 25. Which of the following is the best estimate of the
of pickup, the pharmacy technician asks E.B.’s mother to proportion of adults in E.B.’s health system that would
sign a log indicating that she obtained the drug and whether not be expected to collectively identify the drug name,
she would like to speak with a pharmacist. E.B.’s mother the dosing instructions, and at least two key adverse
states that she forgot her glasses. She does not sign the log reactions in the drug guide?
and verbally declines counseling. She indicates that she will
A. One-eighth.
read the drug guide at home. E.B.’s mother is 26 years old, is
B. One-fourth.
multiracial, and has completed high school. The pharmacist
C. One-third.
is removed from sight behind the counter and is not easily
D. One-half.
identifiable. The environment is busy and lacks a private
area for counseling.
26. Which of the following could be used to measure E.B.’s
mother’s ability to comprehend appointment slips and
21. Which of one of the following statements is the most
instructions on prescription bottles?
accurate predictor of E.B.’s mother’s health literacy?
A. Rapid Estimate of Adult Literacy in Medicine
A. Her age is a predictor for limited health literacy
(REALM).
(LHL).
B. Short TOFHLA (S-TOFHLA).
B. Her multiracial background may predispose
C. Newest Vital Sign (NVS).
her to problems reading and acting on health
D. One-item Health Literacy Screening Questions.
information.
C. She has completed high school, so it is likely that
she will not struggle in understanding her child’s
27. If E.B.’s mother were identified as having LHL through
drug instructions.
testing, which one of the following would be the most
D. Because she is a woman, she is more likely than a
likely consequence?
man to have LHL.
A. E.B.’s mother would likely have limited asthma
22. Which of the following is the best practical strategy for disease knowledge.
quickly determining whether E.B.’s mother can read B. E.B.’s mother would likely call the pharmacy with
and comprehend the prescription instructions and drug questions about drug scheduling.
guide in a busy practice setting? C. E.B. would likely have poor asthma drug refill
adherence.
A. Ask for her highest grade level of education.
D. E.B.’s mother would likely follow up by scheduling
B. Ask her to complete the Test of Functional Health
an outpatient visit.
Literacy in Adults (TOFHLA).
C. Ask her if she can read and write.
28. If E.B.’s mother has limited reading skills, which one of
D. Ask her how confident she is in completing medical
the following is she most likely able to do?
forms by herself.
A. Discard any remaining drug after 1/30/2009.
23. By stating that she forgot her glasses and that she will B. Demonstrate how to measure E.B.’s drug.
read the drug guide at home, which one of the following C. Shake the amoxicillin suspension before pouring
is most likely for E.B.’s mother? out a dose.
D. Restate the drug instructions on the prescription
A. She will rely on the patient drug guide for
label.
information.
B. She may be able to restate the instructions but will
29. Which one of the following is the best action for the
not be able to measure the dose.
pharmacist to take to encourage E.B.’s mother to discuss
C. She will ask the pharmacist if she has questions
the amoxicillin prescription?
about how to measure 5 mL.

Pharmacotherapy Self-Assessment Program, 6th Edition 29 Health Literacy: Implications for Pharmacy Practice
 A. Ask her “Do you have any questions?” when she
picks up the prescription.
B. Help her implement the principles of the Ask Me 3
program.
C. Ask her to complete the TOFHLA while she is
waiting for the amoxicillin prescription to be
filled.
D. Ask her “Have you ever had this prescription for
your child before?”
30. Which of the following is most likely to optimize E.B.’s
mother’s understanding of the prescription label?
A. Use “teaspoonful” instead of “5 mL.”
B. Use “in the morning and in the evening” instead of
“twice daily.”
C. Spell out “ten” instead of “10.”
D. Include the drug indication together with dose,
frequency, and duration on the label.
31. The pharmacist states to E.B.’s mother, “This is
E.B.’s antibiotic” while showing her the 5-mL
mark on a medication syringe. Which one of the
following statements is the clearest and simplest oral
communication of the dosing instructions?
A. He needs to take 5 mL twice daily.
B. He needs to take 5 mL when he wakes up and
before he goes to bed.
C. He needs to take it twice daily.
D. He needs to take it as prescribed on the bottle
label.
Questions 32–37 pertain to the following case.
T.G. is a 70-year-old white woman with a high school
education. T.G. scores less than 44 on the REALM. She
received a diagnosis of severe poison ivy dermatitis on more
than 25% of her body. Her primary care physician prescribed
54 tablets of prednisone 10 mg with the instructions, “Take
60 mg for 4 days, then decrease the daily dose by 10 mg
every 2 days until gone.”
32. If time is limited, which of the following is the best
screening tool to estimate T.G.’s FHL at the time of
initial enrollment in the pharmacy system?
A. Ask T.G. to complete the NVS.
B. Ask T.G., “How often do you have someone help
you read hospital materials?”
C. Ask T.G. to complete the S-TOFHLA.
D. Ask T.G. to complete the Simplified Measure of
Gobbledygoop (SMOG).
33. Which one of the following visual aids would be most
helpful for the pharmacist to use in counseling T.G.
about her complex prednisone dosing instructions?
A. Fotonovela.
B. Patient drug insert.
C. Flip chart.
D. Pictograph.
34. Which of the following would be most effective to
ensure T.G.’s understanding of her dosing instructions?
Health Literacy: Implications for Pharmacy Practice
A. Expect T.G. to initiate questions.
B. Ask T.G., “Do you have questions?”
C. Limit teaching to the dosing instructions and
adverse effects of treatment.
D. Have T.G. repeat instructions only once to avoid
confusion.
35. To facilitate understanding of the lengthy and complex
prednisone dosing instructions, the pharmacist prepares
a separate patient handout. Which one of the following
is the best characteristic of an easy-to-read handout for
T.G.?
A. Large print font (minimum of 12 point).
B. Paragraph format.
C. Bar chart to assist with dosing schedule.
D. Use of graphs to display information.
36. Which of the following pieces of auxiliary or prescription
label information is most likely to be understood by
T.G.?
A. Take as prescribed; talk to your doctor before
making changes to your dosing regimen.
B. Take this drug with a small glass of milk.
C. Take this drug with breakfast.
D. This drug may cause insomnia.
37. Which one of the following is an integral component of
the Ask Me 3 program?
A. The pharmacist should ask T.G., “Do you
understand?”
B. The pharmacist should describe to T.G. the result
of not following the taper instructions properly.
C. The pharmacist should ask T.G., “Do you think you
can take your medicine correctly?”
D. The pharmacist should provide a written handout
describing T.G.’s medical problem.
38. Which of the following best describes the essence of an
effective teach-back session?
A. It is a quick way at the end of a pharmacy visit for
the provider to remind the patient when and how to
take her drug.
B. It provides an opportunity for the patient to describe
what medicine she will take, why she will take it,
and when she will take it.
C. It allows the pharmacist a chance to answer
questions about the adverse reactions of her drugs.
D. It reminds the patient of when her medicines need
to be refilled.
39. A pharmacy audit that uses the Agency for Healthcare
Research and Quality guide titled “Is Our Pharmacy
Meeting Patients’ Needs? A Pharmacy Health Literacy
Assessment Tool User’s Guide” best assesses which one
of the following?
A. Whether the pharmacy has implemented the Ask
Me 3 health literacy program.
B. Whether the pharmacy is navigable by all patients
and over-the-counter drugs are easy to find.
30 Pharmacotherapy Self-Assessment Program, 6th Edition
 C. Whether the health literacy level of individual
patients has been measured and is adequate.
D. Whether health literacy principles are aligned
among pharmacy physical environment, staff, and
patients.

40. Which of the following best describes how to correctly

include health literacy communication principles in a
drug review with a patient?
A. A patient brings all medicines to the pharmacy and
the pharmacist writes down the medicine names
and dosage information from the bottles.
B. A patient is given several prescription bottles and
medical instructions and uses the information
on the bottles and instructions to answer several
questions.
C. A patient is given a list of drug names and is asked
to read aloud as many names as possible.
D. A patient brings all medicines to the pharmacist
and explains to the pharmacist the name of each
medicine, why it is taken, and how it is taken.

Pharmacotherapy Self-Assessment Program, 6th Edition 31 Health Literacy: Implications for Pharmacy Practice
Health Literacy: Implications for Pharmacy Practice 32 Pharmacotherapy Self-Assessment Program, 6th Edition