http://accesspharmacy.mhmedical.com/content.aspx?bookid=1861&secti... Pharmacotherapy: A Pathophysiologic Approach, 10e > Chapter e1: Health Literacy and Medication Use Oralia V. Bazaldua; DeWayne A. Davidson; Ashley Zurek; Sunil Kripalani INTRODUCTION KEY CONCEPTS Limited health literacy is common and must be considered when providing medication management services. Some groups of people are at higher risk for having limited literacy skills, but in general, you cannot tell by looking. Patients with limited health literacy are more likely to misunderstand medication instructions and have difficulty demonstrating the correct dosing regimen. Limited health literacy is associated with increased healthcare costs and worse health outcomes, including increased mortality. Despite numerous efforts to improve safe medication practices, current strategies have been inadequate, and this may have a larger impact in patients with limited literacy. Most printed materials are written at higher comprehension levels than most adults can read. The United States Pharmacopeia has set new standards for prescription medication labeling to minimize patient confusion. Several instruments exist to measure health literacy, but some experts advocate “universal precautions” under which all patients are assumed to benefit from plain language and clear communication. Obtaining a complete medication history and providing medication counseling are vital components in the medication management of patients with limited health literacy. Every day, thousands of patients are not taking their medications correctly. Some take too much. 1 of 50 22/12/2016 07:06 ﻡ http://accesspharmacy.mhmedical.com/content.aspx?bookid=1861&secti... Others take too little. Some use a tablespoon instead of a teaspoon. Parents pour an oral antibiotic suspension in their child’s ear instead of giving it by mouth because it was prescribed for an ear infection. Others are in the emergency department because they did not know how to use their asthma inhaler. It is not a deliberate revolt against the doctor’s orders but rather a likely and an unfortunate result of a hidden risk factor—limited health literacy. Literacy, at the basic level, is simply the ability to read and write. When these skills are applied to a health context, it is called health literacy, but health literacy is more than just reading and writing. Health literacy, as defined by the Institute of Medicine (IOM), is “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.” A growing body of evidence associates low health literacy with less understanding, worse outcomes, and increased cost. These poor outcomes have led this topic to receive national attention. Health literacy has been made “a priority area for national action” by the IOM1,2 and Healthy People 2020.3 As a result, federal policy initiatives promoting health literacy continue to be highlighted in Healthy People 2020, the Patient Protection and Affordable Care Act of 2010, and the Plain Writing Act of 2010.4 A National Action Plan to Improve Health Literacy (Table e1-1) has also been developed by the Department of Health and Human Services (HHS).5 Likewise, the Agency for Healthcare Research and Quality (AHRQ),6,7 the National Institutes of Health (NIH),8 and Centers for Disease Control and Prevention (CDC)9 have each dedicated websites to this topic and have provided funding to support studies and interventions that are specifically relevant to health literacy. Additionally, state and private sector organizations, such as America’s Health Insurance Plans (AHIP) and the American College of Physicians (ACP) Foundation, have led efforts to improve health literacy following the IOM’s call to action.10 Indeed, health literacy should be a national priority for the medical community as its consequences are far-reaching and cross-cutting. TABLE e1-1  Goals of the National Action Plan to Improve Health Literacy5 Develop and disseminate health and safety information that is: accurate Goal 1 accessible actionable Promote changes in the healthcare system that improve: health information Goal informed decision-making 2 communication access to health services 2 of 50 22/12/2016 07:06 ﻡ http://accesspharmacy.mhmedical.com/content.aspx?bookid=1861&secti... Goal Incorporate accurate, standards-based, and developmentally appropriate health and science 3 information and curricula in child care and education through the university level Support and expand local efforts to provide: adult education Goal 4 English language instruction culturally and linguistically appropriate health information services in the community Goal Build partnerships, develop guidance, and change policies 5 Goal Increase basic research and the development, implementation, and evaluation of practices 6 and interventions to improve health literacy Goal Increase the dissemination and use of evidence-based health literacy practices and 7 interventions More than one of every three American adults has difficulty understanding and acting on health information.11 Patients with limited health literacy have less knowledge about how to manage their disease;12 they misunderstand dosing instructions and warning labels on medication containers;13,14 they are less likely to read or even look at medication guides;15 their ability for medication management is limited as these persons are less able to identify or distinguish their medications from one another;16,17 and they are less able to use a metered-dose inhaler (MDI) properly.18 Limited health literacy skills have also been documented in caregivers of seniors19 and in parents of children.20 There is no question that limited health literacy is associated with adverse health outcomes21 including an increased mortality rate22 and increased healthcare costs.23 Current strategies for safe medication use have not been effective for the general population and are likely less useful for persons with limited health literacy. All health professionals need to acknowledge that limited health literacy is common and may be a barrier to improving health outcomes in their patients. They need to implement strategies for clear communication in order to enhance appropriate medication management. This chapter will review what is known about health literacy and present the evidence available as it relates to medication use. Clinical Controversy… Is there a shared meaning of health literacy? While the IOM has provided a concise definition of health literacy, some argue that the field of health literacy has become so dynamic that experts in the field do not have a shared meaning for this term. PREVALENCE According to the National Assessment of Adult Literacy (NAAL), 36% of Americans have limited health literacy skills, meaning that out of four levels, they function at the lowest two.11 The NAAL 3 of 50 22/12/2016 07:06 ﻡ http://accesspharmacy.mhmedical.com/content.aspx?bookid=1861&secti... survey was administered randomly to 19,000 adults (greater than or equal to 16 years of age) across the United States and final results were reported in four skill levels: below basic, basic, intermediate, and proficient. Fourteen percent of Americans had health literacy skills that were considered below basic, 22% were at the basic level, 52% were at intermediate, and only 12% were considered proficient (Fig. e1-1). The below basic level is substantially below that which is necessary to function within the healthcare setting. Individuals in the basic level have skills to perform simple everyday literacy activities. They can read, understand, and use information in short and “simple” documents. Intermediate literacy levels include skills necessary to perform moderately challenging literacy activities. (Note that the NAAL considered interpreting prescription drug labels an intermediate level task.) Individuals in the proficient level would have the least difficulty navigating the healthcare system. This group can analyze, integrate, and synthesize complex information. Approximately 3% of people surveyed were excluded from the analysis due to language barriers or cognitive disabilities. Thus, if you add this 3% to the 36% of people that measured at the two lowest levels and consider the estimated American population of 2020, approximately 130 million Americans have limited health literacy.11,24 FIGURE e1-1 Percent of adults in each health literacy level. Percentages are from Kutner et al.11 The values in parentheses estimate the number of American adults (greater than or equal to 15 years of age) in each literacy level, based on 2015 population projections,(from http://www.census.gov/population /projections/data/national/2012/summarytables.html). 4 of 50 22/12/2016 07:06 ﻡ http://accesspharmacy.mhmedical.com/content.aspx?bookid=1861&secti... GROUPS AT HIGH RISK It is generally not possible to tell if someone has limited health literacy simply by looking at or talking to them. Many persons with limited health literacy learn to hide it very well and many are known to keep this secret to themselves. In one study, two-thirds of persons surveyed (68%) admitted to not telling their spouse about their reading difficulties and more than one-half had not told their children.25 In a study of internal medicine residents and students, few of them recognized low literacy as a potential factor in patient nonadherence and hospital readmission.26 It is important to note that health literacy is a context-dependent skill, meaning that people who function well in one environment may still struggle when presented with healthcare tasks. Thus, even people with adequate education levels may find it difficult to navigate the healthcare system due to lack of familiarity with the context. While it is important to remember that people of all ages, nationalities, and income groups are at risk for limited health literacy, there are some groups that are at particularly high risk that should be mentioned (Table e1-2).11 This information can help assess the potential risk of limited health literacy in the patient population being served. TABLE e1-2  Groups at High Risk of Limited Health Literacy Age 65 or older Minorities 5 of 50 22/12/2016 07:06 ﻡ http://accesspharmacy.mhmedical.com/content.aspx?bookid=1861&secti... Spoke another language prior to formal education Have less than a high school diploma Live at or below the poverty line Rate their overall health as poor Have Medicaid, Medicare, or no insurance Data from reference 11. As the Latino population in the United States continues to increase to over 28% as it is projected by 2060,24 this group and those with limited English proficiency (LEP) are at a high risk for limited health literacy and inappropriate medication management. Not only do they have lower health literacy scores than the overall population,11 but more than one-half of Latinos are known to have LEP.27 Unfortunately, most pharmacies in the United States are not equipped with appropriate translation or interpreter services. In a telephone survey of 764 pharmacies, nearly 57% reported limited or no translation services available.28 In fact, 45% of pharmacies admit to not being satisfied with their ability to communicate with patients that have LEP. In 2012, the United States Pharmacopeia (USP) set new standards for prescription container labeling and recommends that whenever possible, directions be provided in the patient’s preferred language as well as English to minimize the risk of misinterpretation.29 Practices that serve Latinos or patients with LEP should be cognizant of their high risk and employ strategies for providing clear communication about appropriate medication management. Children What happens when adults with limited literacy become parents? Not surprisingly, a systematic review of the literature concludes that child and parent literacy seem to be associated with important health outcomes.30 Similar to data found in adults, children with limited literacy had worse health behaviors. If their parents had limited literacy skills, these children had worse health outcomes. In a study of 1,500 parents, Medicaid-insured parents had less education than those with commercial insurance and were more likely to request unnecessary antibiotics for their children.31 In asthmatic children, limited parental health literacy is associated with a greater incidence of emergency department visits, hospitalizations, missed school days, and greater use of rescue medications.32 In another study, caregivers with low health literacy were more likely to report use of a nonstandardized dosing instrument.33 While interventions in general are lacking, there are more that target improvement in knowledge than outcomes. One intervention using pictograms, brief counseling and the teach-back method improved the likelihood of parents correctly dosing medicines and adhere to the regimen.34 Similarly, parents with low health literacy were less likely to make a dosing error with infant acetaminophen after receiving text-plus-pictogram instructions compared to text only recipients.35 As in the adult 6 of 50 22/12/2016 07:06 ﻡ http://accesspharmacy.mhmedical.com/content.aspx?bookid=1861&secti... population, effective interventions that improve outcomes and minimize health disparities are needed. CONSEQUENCES Table e1-3 provides a comprehensive list of studies to date evaluating health literacy and medication use. In particular, it provides a summary of the studies evaluating the effect of health literacy on medication knowledge and understanding, medication management, and medication adherence. One study evaluated the effect of health literacy on adverse drug events and found no association.36 TABLE e1-3  Studies Evaluating Limited Health Literacy and Medication Use Citation and Literacy Results Measurement   Knowledge Decreased understanding of how to take medicines: Take on empty stomach → 65% incorrect Williams et al.37 (TOFHLA) How many pills to take → 70% incorrect How many refills left → 42% incorrect Decreased understanding of instructions on prescription labels: Davis et al.13 (REALM) Two times more likely to misunderstand Increased misinterpretation of drug warning labels: Davis et al.14 (REALM) Three to four times more likely to misinterpret Decreased understanding of mechanisms and side effects: Warfarin works by thinning blood → 30% incorrect Fang et al.38 (S-TOFHLA) Bleeding/bruising most common → 51% side effect incorrect Decreased awareness of weight-based dosing among caregivers of children: Yin et al.33 (TOFHLA) 88.6% unaware Decreased medication knowledge including name, dose, indication, and side effects: Marks et al.39 (REALM) 80% had medication knowledge score (MKS) below the median 7 of 50 22/12/2016 07:06 ﻡ http://accesspharmacy.mhmedical.com/content.aspx?bookid=1861&secti... Citation and Literacy Results Measurement Mosher et al.36 (REALM) Decreased medication knowledge (name/indication):   Health literacy level % correct of names Indications 32.2 61.8 Low 54.6 77.4   Marginal 60.8 81.4 Adequate P < 0.001 P < 0.001   Medication Management Decreased ability for proper use of metered-dose inhaler (MDI): Williams et al.18 (REALM) 88% with limited literacy had poor the MDI technique, compared with 48% of those with higher literacy levels Decreased ability to demonstrate correct dosing: Davis et al.14 (REALM) 65% could not demonstrate, “Take two tablets by mouth twice daily” Decreased ability to name their medications: Persell et al.17 (S-TOFHLA) 40.5% of those with limited health literacy vs 68.3% of other patients Decreased ability to identify all of their medications: Kripalani et al.16 (REALM) 10-18 times the odds of being unable to identify   Adherence   Decreased adherence Increased nonadherence to antiretroviral therapies: Kalichman et al.40 (WRAT-3) (TOFHLA) Three to four times more likely to be nonadherent in last 2 days Decreased adherence to antiretroviral medications: Graham et al.41 (REALM) 40% of those with limited health literacy vs 64% of other patients Increased likelihood to be nonadherent with antiretroviral therapies: Wolf et al.42 3.3 times more likely to be nonadherent 8 of 50 22/12/2016 07:06 ﻡ http://accesspharmacy.mhmedical.com/content.aspx?bookid=1861&secti... Citation and Literacy Results Measurement Decreased adherence to medication refills: Kripalani et al.43 (REALM) Two times more likely to be nonadherent Decreased medication taking adherence: Noureldin et al.44 54.2% of those with inadequate health literacy vs 69.4% of other (S-TOFHLA) patients More likely to have unintentional nonadherence after hospital discharge Lindquist et al.45 (S-TOFHLA) 47.7% (inadequate HL) vs 20.5% (adequate HL), p = 0.002 Patients with diabetes had more time without sufficient pill supply to Bauer et al.46 [3-item newly prescribed antidepressants: screener] 41% vs 36%, p< 0.01 Nonadherent patients more likely to report inadequate health literacy: Karter et al.47 [single question] 51% vs 30% Health literacy was associated with medication adherence: Osborn et al.48 (REALM) r = 0.12, p < 0.02   Increased adherence Increased adherence to daily multivitamins by infant caregivers: Hironaka et al.49 Two times as likely to report high adherence   No effect on adherence Health literacy is not independently associated with adherence: Gatti et al.50 (REALM) 52.4% vs 50.1% (difference not significant) Low health literacy not associated with lower odds of adherence: Paasche-Orlow et al.51 (REALM) Adjusted odds ratio = 1.93 (not significant) Mosher et al.36 (REALM) Health literacy is not associated with medication adherence:   Health literacy level % of medications taken (p = 0.14) 84   Low 9 of 50 22/12/2016 07:06 ﻡ