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For more than a decade, the Food and Drug Administration (FDA) has required ‘medication guides’ (med guides) be issued to consumers for prescription medications viewed to possess “serious and significant public health concerns.1,2” These industry-developed, FDA-approved print materials are distributed by pharmacies at the time of medication dispensing with the intent that they be read by patients prior to taking a prescribed drug. They provide specific dosing administration instructions that could prevent serious adverse effects associated with taking the medication, warn individuals about significant health risks that could affect one’s decision to take the medication, and underscore the importance of taking the prescribed medication to the patient’s health, and the need for proper adherence.

Med guides have become an essential part of risk evaluation and mitigation strategies (REMS).3–6 REMS are FDA-required, detailed pharmaceutical company plans for directly communicating the safe use of and risks associated with a certain drug to both prescribers and consumers. Prior investigations have repeatedly found that physicians and pharmacists miss opportunities to counsel patients on appropriate use of prescribed medicines,7–10 so med guides remain a frontline and often sole channel for conveying risk information to patients.

There has been increasing criticism of the efficacy of med guides to help patients, as a limited number of studies have suggested that there are problems with their format, clarity of content, and manner in which they are disseminated.11–13 Despite a 1996 Department of Health & Human Services memorandum that established readability standards for health materials,14 we found in our earlier research that the majority of med guides are too complex and written at a reading grade level not suitable for the majority of patients to comprehend.12 Consequently, only one in four patients reported attending to these materials.12 Shrank and colleagues also found that a required med guide was never distributed along with a prescription in observed prescription fills at pharmacies nationwide.15 Few studies to date have assessed patients’ ability to comprehend information contained in med guides, especially those with limited literacy. As the FDA is now aggressively investigating potential improvements and expansion of the med guides program,16–19 evidence we can provide detailing individuals’ comprehension of the information could serve as a valuable baseline for later program evaluations. We therefore sought to document the prevalence of misunderstanding med guides and provide a systematic evaluation of their current content and format. We conducted two complementary investigations: 1) a readability and suitability assessment of med guides, and 2) comprehension testing among primary care adult patients. We hypothesized that med guides would have an unacceptable level of reading difficulty and accessibility, and patients’ comprehension would be low; those with limited literacy would be at greatest risk for not being able to read and understand the materials successfully.

Adapted version of the Suitability Assessment of Materials (SAM) instrument20 to assess the suitability of med guides for use among lower literate adults. The SAM is the most commonly used tool for evaluating the appropriateness of written health care information and instructions for use among lower literate adults. Trained raters analyzed materials across 22 factors in six categories that may impact readability and ease-of-use (content, literacy demand, graphics, layout and typography, learning simulation/motivation, cultural appropriateness). Cultural appropriateness was not rated as med guides were created for general audiences. Since none had cover graphics, that factor was also dropped. The specific factors we evaluated are identified in the Figure 1. The original scoring method was to classify, by factor, whether the document was ‘not suitable’, ‘suitable’, or ‘superior’. We modified this rating to reflect whether the document met the minimal criteria (suitable vs. not suitable). Two trained reviewers independently rated each med guide. Inter-rater reliability was calculated based on individual item ratings, and found to be high (K = 0.78). A third reviewer was used in cases of discordance. Overall suitability of a document was determined based on whether the document was classified as ‘suitable’ on 70 % or more of the categories.

To determine the length and readability of med guides, we used the Professional Lexile Analyzer, which measures the level of difficulty and complexity of written passages.21 This process was previously used by the study team on med guides and prescription instructions.12,22 Lexile scores have previously been found to be independently associated with patient medication comprehension. Scores ranging from below zero to 2000 were recorded for each document. Grade levels were then estimated based on Lexile scores for ‘typical readers’ in that grade.

Procedure Participants were guided through an untimed, ‘open book’ assessment of their comprehension of the three med guides. They were first shown the med guide for Ritalin and instructed to look it over for two minutes, after which the interviewer began asking questions. Participants were explicitly told they could take their time in answering and refer to the med guide as needed while responding. Verbatim responses were recorded and coded as correct or incorrect based on a preset list of acceptable options per question (developed by the study team). This process was repeated for the other two med guides (Morphine Sulfate and Aranesp, respectively). Interviewers then asked a brief set of questions regarding prior experience with the medication, including whether they or a family member were currently taking or had ever taken the medication being discussed. Demographic and socioeconomic information was also collected. As prior studies have shown that low literacy impacts comprehension of written medication information, we administered the Rapid Estimate of Adult Literacy in Medicine (REALM).24 This is the most common measure in health literacy research.

Analysis Frequencies and/or means and standard deviations were calculated for each patient characteristic. REALM scores were categorized as inadequate, marginal, or adequate based on known thresholds. Chi-square and/or student t tests were used to examine the association between literacy and each of the patient variables. The primary outcome was the mean total comprehension score (range: 0–99) across all three med guides. We used ANOVA models to compare mean total scores across literacy levels, and per med guide content subcategory. A Generalized linear model was used for multivariable regression analysis examining predictors of comprehension of med guide content. Analyses were performed using STATA version 10 (College Station, TX).

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The Online appendix presents item performance for each of the med guides examined. Mean comprehension total score and subcategory scores are detailed in Table 2, also by literacy level. In general, patients had a hard time comprehending the med guides, with a mean total score of 52.7 (SD = 22.6). This was also true for each subcategory score. Participants with lower literacy consistently demonstrated poorer understanding of all med guides content, with increasing, gradient trends noted in total and subcategory comprehension scores across low, marginal, and adequate literacy levels.

In multivariable analysis controlling for all demographic and socioeconomic variables, including literacy and prior experience with med guides, low and marginal literacy were independently associated with a poorer comprehension of med guides (β = –14.3, 95 % CI –18.0 – –10.6, p < 0.001; low: β = –23.7, 95 % CI –28.3 – –19.0, p < 0.001, Table 3). Other risk factors included older age, black race, and less education. Interactions with age, literacy, and other variables were tested and none were significant.

Available med guides fall below the threshold of acceptable standards for patient print materials set by both professional societies and the federal government. Despite a nearly eight-fold increase in the past five years in the number of drugs required by the FDA to have a med guide (from 40 in 2006 to 305 as of September 2011),25 little to no improvement has been made in their readability and accessibility. We confirmed the inadequacy of med guides in a representative sample of primary care patients, who had considerable difficulty comprehending basic information from print med guides even while viewing the material and given adequate time to respond. This is a serious concern, as med guides are frequently the only means that patients have for receiving critical information on how to safely use higher risk drugs. The extent to which patients across all literacy levels did not understand any aspect of the med guides demonstrates that they are too complex to be useful. This might explain why patients in prior studies reported not reviewing consumer medication information, and why the majority in our study had never heard of med guides.12,26–28

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Med guides have become an essential part of risk evaluation and mitigation strategies (REMS).3–6 REMS are FDA-required, detailed pharmaceutical company plans for directly communicating the safe use of and risks associated with a certain drug to both prescribers and consumers. Prior investigations have repeatedly found that physicians and pharmacists miss opportunities to counsel patients on appropriate use of prescribed medicines,7–10 so med guides remain a frontline and often sole channel for conveying risk information to patients.

There has been increasing criticism of the efficacy of med guides to help patients, as a limited number of studies have suggested that there are problems with their format, clarity of content, and manner in which they are disseminated.11–13 Despite a 1996 Department of Health & Human Services memorandum that established readability standards for health materials,14 we found in our earlier research that the majority of med guides are too complex and written at a reading grade level not suitable for the majority of patients to comprehend.12 Consequently, only one in four patients reported attending to these materials.12 Shrank and colleagues also found that a required med guide was never distributed along with a prescription in observed prescription fills at pharmacies nationwide.15 Few studies to date have assessed patients’ ability to comprehend information contained in med guides, especially those with limited literacy. As the FDA is now aggressively investigating potential improvements and expansion of the med guides program,16–19 evidence we can provide detailing individuals’ comprehension of the information could serve as a valuable baseline for later program evaluations. We therefore sought to document the prevalence of misunderstanding med guides and provide a systematic evaluation of their current content and format. We conducted two complementary investigations: 1) a readability and suitability assessment of med guides, and 2) comprehension testing among primary care adult patients. We hypothesized that med guides would have an unacceptable level of reading difficulty and accessibility, and patients’ comprehension would be low; those with limited literacy would be at greatest risk for not being able to read and understand the materials successfully.

Adapted version of the Suitability Assessment of Materials (SAM) instrument20 to assess the suitability of med guides for use among lower literate adults. The SAM is the most commonly used tool for evaluating the appropriateness of written health care information and instructions for use among lower literate adults. Trained raters analyzed materials across 22 factors in six categories that may impact readability and ease-of-use (content, literacy demand, graphics, layout and typography, learning simulation/motivation, cultural appropriateness). Cultural appropriateness was not rated as med guides were created for general audiences. Since none had cover graphics, that factor was also dropped. The specific factors we evaluated are identified in the Figure 1. The original scoring method was to classify, by factor, whether the document was ‘not suitable’, ‘suitable’, or ‘superior’. We modified this rating to reflect whether the document met the minimal criteria (suitable vs. not suitable). Two trained reviewers independently rated each med guide. Inter-rater reliability was calculated based on individual item ratings, and found to be high (K = 0.78). A third reviewer was used in cases of discordance. Overall suitability of a document was determined based on whether the document was classified as ‘suitable’ on 70 % or more of the categories.

To determine the length and readability of med guides, we used the Professional Lexile Analyzer, which measures the level of difficulty and complexity of written passages.21 This process was previously used by the study team on med guides and prescription instructions.12,22 Lexile scores have previously been found to be independently associated with patient medication comprehension. Scores ranging from below zero to 2000 were recorded for each document. Grade levels were then estimated based on Lexile scores for ‘typical readers’ in that grade.

Procedure Participants were guided through an untimed, ‘open book’ assessment of their comprehension of the three med guides. They were first shown the med guide for Ritalin and instructed to look it over for two minutes, after which the interviewer began asking questions. Participants were explicitly told they could take their time in answering and refer to the med guide as needed while responding. Verbatim responses were recorded and coded as correct or incorrect based on a preset list of acceptable options per question (developed by the study team). This process was repeated for the other two med guides (Morphine Sulfate and Aranesp, respectively). Interviewers then asked a brief set of questions regarding prior experience with the medication, including whether they or a family member were currently taking or had ever taken the medication being discussed. Demographic and socioeconomic information was also collected. As prior studies have shown that low literacy impacts comprehension of written medication information, we administered the Rapid Estimate of Adult Literacy in Medicine (REALM).24 This is the most common measure in health literacy research.

Analysis Frequencies and/or means and standard deviations were calculated for each patient characteristic. REALM scores were categorized as inadequate, marginal, or adequate based on known thresholds. Chi-square and/or student t tests were used to examine the association between literacy and each of the patient variables. The primary outcome was the mean total comprehension score (range: 0–99) across all three med guides. We used ANOVA models to compare mean total scores across literacy levels, and per med guide content subcategory. A Generalized linear model was used for multivariable regression analysis examining predictors of comprehension of med guide content. Analyses were performed using STATA version 10 (College Station, TX).

The Online appendix presents item performance for each of the med guides examined. Mean comprehension total score and subcategory scores are detailed in Table 2, also by literacy level. In general, patients had a hard time comprehending the med guides, with a mean total score of 52.7 (SD = 22.6). This was also true for each subcategory score. Participants with lower literacy consistently demonstrated poorer understanding of all med guides content, with increasing, gradient trends noted in total and subcategory comprehension scores across low, marginal, and adequate literacy levels.

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In multivariable analysis controlling for all demographic and socioeconomic variables, including literacy and prior experience with med guides, low and marginal literacy were independently associated with a poorer comprehension of med guides (β = –14.3, 95 % CI –18.0 – –10.6, p < 0.001; low: β = –23.7, 95 % CI –28.3 – –19.0, p < 0.001, Table 3). Other risk factors included older age, black race, and less education. Interactions with age, literacy, and other variables were tested and none were significant.

Available med guides fall below the threshold of acceptable standards for patient print materials set by both professional societies and the federal government. Despite a nearly eight-fold increase in the past five years in the number of drugs required by the FDA to have a med guide (from 40 in 2006 to 305 as of September 2011),25 little to no improvement has been made in their readability and accessibility. We confirmed the inadequacy of med guides in a representative sample of primary care patients, who had considerable difficulty comprehending basic information from print med guides even while viewing the material and given adequate time to respond. This is a serious concern, as med guides are frequently the only means that patients have for receiving critical information on how to safely use higher risk drugs. The extent to which patients across all literacy levels did not understand any aspect of the med guides demonstrates that they are too complex to be useful. This might explain why patients in prior studies reported not reviewing consumer medication information, and why the majority in our study had never heard of med guides.12,26–28

The Plain Writing Act of 2010 mandates that federal agencies, including the FDA, communicate to the public in a clear, understandable manner free of unclarified jargon.29 What this new federal law does not state is how to determine whether this has been achieved. The Department of Health and Human Services and experts in health literacy are often inconsistent when defining a threshold for readability of print documentation. Some recommend an 8th grade level or below,14 while others have sought targets as low as below a 4th grade reading level.30 Adding to the confusion are more recent debates on the utility of reading formulas.17 Most experts agree that readability assessments are important within a more comprehensive evaluation of consumer materials. An operational set of standards for guiding government and industry in best practices for designing print materials like med guides, and thereby offering a means to assess these communications in the future, are urgently needed. The Agency for Healthcare Research and Quality (AHRQ) is now leading an effort to set these standards.31