Proceedings of a Workshop
Communicating Clearly About Medicines
Proceedings of a Workshop—in Brief
On November 17, 2016, the Roundtable on Health Literacy of the National Academies of Sciences, Engineering, and Medicine convened a workshop on communicating clearly about medicines. The workshop focused on the clarity of written information given to patients and consumers as printed or digital materials. The workshop was organized around presentations and panel discussions that explored the design of health-literate written materials and examples that illustrated implementation of research into the development of these materials. The day began with a panel of patients and caregivers who discussed their experiences with written materials. The purpose of the panel was to ground the day in the patient experience and ensure that the workshop remained focused on the consumer.
Communicating about medicines has been featured as a topic in previous workshops, noted Bernard Rosof of the Quality in Healthcare Advisory Group in his opening remarks.1 The reason for this is clear. “Medications, of course, are a vital component of health care and health care delivery, but when they are used incorrectly they can result in poor outcomes, injury, and often, death,” he remarked. “Research has shown that almost half of all patients misunderstand one or more of their dosage instructions and slightly more than half misunderstand one or more warning(s) related to their medications.” Rosof went on to explain that this should not be considered a failure of patients or their caregivers, but rather of those in the health care system who do not provide information clearly and check to make sure the information has been understood.
THE PATIENT EXPERIENCE
The first panel featured Bobbie Reed, the primary caregiver for her son who received a kidney transplant; Caleb Sexton, who has psoriatic disease; and Darvece Monson, who has chronic kidney disease and is on the transplant waiting list. The panel was moderated by Terri Ann Parnell, principal and founder of Health Literacy Partners, LLC. Parnell first asked the panelists to share what they had learned from their experiences with written communication about medicines. Reed answered that for her, the biggest challenge came when she suddenly found herself without support after her son’s kidney transplant. When he was on hemodialysis, she explained, they had access to a specialty pharmacy that helped them manage her son’s medications and could be a resource when they did not understand something. Once he had a transplant, Reed said, that changed and she was at the pharmacy every day picking up a new medication and attempting to manage everything by herself. To cope with this situation, she developed a spreadsheet to track her son’s medications, dosing instructions, and how many pills he had on hand. This was a tremendously helpful tool and the pharmacy embraced it, she said, but the responsibility for finding a way to manage fell to her, as it does to all patients and caregivers.
Sexton agreed that the burden falls on the patient. He said when he was diagnosed with a lifelong chronic illness that required multiple medications, he was given information about each medication, but none about how they might interact, how to coordinate them, or what resources he could use to help him with his questions. After 10 years he has learned all of these things, Sexton said, but had to figure it out himself. Monson also said that there should be better communication about toxicity, side effects, and adverse reactions to medications. She explained that when she was first diagnosed with kidney failure, she was put on 14 medications and experienced complications resulting from their interactions. She said it was her background as a nurse that allowed her to identify the problems and address them. None of the information she was given addressed the issue, said Monson, “It was not printed on the medication to look for this side effect.” Monson also noted that hemodialysis is a draining experience and that many patients are too tired to fully absorb the information given to them.
In response to a question about what providers should be asking patients, Sexton said people should consider keeping a journal to help them communicate to providers. At office visits, he said, patients are asked questions such as, “What has happened in the past 3 months?” Providing a meaningful response is very difficult without some kind of record. A journal can capture whether a patient is having dietary issues or is under a lot of stress, said Sexton. It can capture what is “outside the medical record” and identify issues that make taking medications difficult. Parnell also asked the panel for their ideas on what clinicians can do to enhance both oral and written communications. Reed said she believed patients should have multiple opportunities to gradually learn about their medications. During her experience caring for her son, she saw many transplant patients who were unprepared to manage their medications after their transplants and faced complications as a result. They had not been given the information before the transplant so they did not have time to prepare for the responsibility of managing things for themselves. Monson said the health care team should be proactive about partnering with patients and encouraging questions and talk about day-to-day experiences. For example, she said, she is much younger than the typical person with kidney failure. This means the drugs that are usually given to kidney failure patients have a different effect on her body. She was able to address this by developing a relationship with the pharmacist on her care team, she said, but her individuality was not considered when her doctors first prescribed her medications.
Finally, Parnell asked the panelists for one innovative solution to enhance medication communication. Reed and Monson agreed that one facet of communication about medications needs much more attention—cost. Reed said her son will lose Medicare coverage for his transplant medications after 36 months, but will need those medications for the rest of his life. This is a significant source of worry for her family. Monson said there are assistance programs from pharmaceutical companies, but often people do not know about them or are too intimidated to apply. Raising awareness about ways to deal with the cost of medications would help patients, she added. Sexton said he would suggest that care providers reframe their perspectives when thinking about long-term chronic conditions. Having a life-long medical condition is “a constant experience that has to be navigated,” he said, and physicians need to think about the impact of the diagnosis as something that affects every aspect of a person’s life. Better ways are needed to coordinate information and enable communication between patients and providers. Sexton said that he was hopeful that technology could offer tools to facilitate better communication. “Even if [the technology] is as simple as designing applications that allow you to just track your metabolism or your food diary, your sleep, or your stress levels and be able to connect that back to you doctor’s [electronic health record],” he said, these tools can help generate more individualized discussions about medications.
APPROACHES TO HEALTH-LITERATE MEDICATION INSTRUCTIONS
The second panel of the day featured presentations by William Shrank, chief medical officer of the University of Pittsburgh Medical Center Health Plan; Irene Chan, deputy director in the Division of Medication Error Prevention and Analysis at the Food and Drug Administration (FDA); and Edmond Israelski, technical advisor on human factors and retired director of human factors at AbbVie Inc.
Shrank opened the panel by presenting an overview of the current landscape of research on written communication. He said that 15 years ago when he was starting his career, health literacy was only just becoming a topic of discussion in health care. The progress that has been made between then and now in terms of awareness and building the evidence base is extraordinary, noted Shrank. As the focus of health care payment mechanisms shifts more and more from volume to value, predicted Shrank, health literacy will become an even more important tool for providers and payers. Given that medications are such an important part of health care and that medication errors are so pervasive, there is currently a great deal of attention on helping people to better understand their medications and how to
take them. Another important development over the past 15 years, said Shrank, is the number of tools and methods of communication that are available. Overall this is positive, noted Shrank, but providers, insurers, and pharmacists need to beware of information overload among consumers. The stakeholders in prescribing and managing medications need to ask themselves, “How do you build the right system, a comprehensive, thoughtful system that can really help patients take their meds?” Going forward, Shrank predicts that health literacy and health-literate strategies for communicating about medicines will become more common and deeply embedded into the health care system.
Chan, the second presenter on the panel, gave FDA’s perspective on the role of human factors engineering as a means of developing better written materials about medications. She explained that FDA’s goal for the design of medication labels and labeling information is that it translates into safe and effective use of the medication. Prevention of a harmful event is the key, said Chan, and human factors analysis, which examines the interactions between humans and elements of a system, is vital to that effort. Human factors engineering applies a process to system design, in this case labels and labeling, that decreases the risk in the system. Human factors studies are often smaller and completed more quickly than clinical studies, said Chan, and can uncover and help resolve issues before a drug is put on the market. She said FDA expects manufacturers to evaluate the entire user interface before putting the product on the market and to test the product with representative users in representative scenarios. FDA is also committed to the development of a new form of patient information called Patient Medication Information (PMI). This document would be designed following a human factors engineering process and testing, and would conform to guidelines developed using a human factors analysis. The PMI document would not, however, replace labeling for professionals and instructions for use, said Chan.
Of the many definitions of human-centered design, Israelski said, he favors one that defines it as the application of data on human capabilities and characteristics to the design and evaluation of systems and devices. This can include a broad array of things from drug labels and packaging to websites, he elaborated, adding that “anything that has a user interface where the human has to interact, get information, process it, and then act is fair game.” He also noted that there are a number of synonyms for human factors or human-centered design, such as ergonomics, usability engineering, and user experience design. The goal in every case, however, is to make products that are safe and easy to use. Human-centered design has been used to improve products that are complex, such as blood glucose meters, and simple, such as infant formula containers, said Israelski. Regulators in both the United States and Europe require human-centered design principles be followed for some products, he added.
The core method of human-centered design begins with a contextual inquiry that answers the questions of who is going to use the product, where they will use it, and to perform what task, explained Israelski. The next steps—risk analysis, user interface specification, and iterative design—develop a prototype based on the contextual analysis. The last step, said Israelski, is usability testing, which then feeds back into the iterative design phase. There is no technology that allows for a design that works for everyone. “Only through testing will you learn and iterate and make improvements,” he noted. Best practices for usability testing require that products be tested on representative users, said Israelski, which means that if the product will be used by people who are visually impaired, the testers must be similarly visually impaired. It is also important that the testing take place in a realistic use environment, he explained, that takes into account lighting, noise, and workflow. In conclusion, Israelski noted that there are a number of published standards for human factors analysis, such as those from the American National Standards Institute/Association for the Advancement of Medical Instrumentation, that detail the principles and methods of human-centered design and would be helpful for anyone who is interested in the topic.
TRANSLATING RESEARCH INTO PRACTICE
The third panel featured four case studies as examples of translating research into practice. The first presenter was Steve Sparks, health literacy director for Wisconsin Health Literacy. Second was Laurie Myers, global health literacy director at Merck Sharp & Dohme Corp. (Merck). Next, Brian Jack, professor and chair of the Department of Family Medicine at the Boston University School of Medicine, reviewed Project RED, an effort to reduce rates of readmission to the hospital by redesigning the discharge process. The last presenter was Charles Lee, president and founder of Polyglot Systems, Inc. He discussed approaches for providing medication information to limited English proficiency individuals.
Sparks opened his presentation by relating that whenever he talks about his work to improve pharmacy-generated medication labels in Wisconsin, he hears stories of medication errors that nearly led to disaster. In his opinion, those stories serve as reminders of how important this work is. His organization’s efforts to improve the labels produced and used by pharmacies began soon after the U.S. Pharmacopeia (USP) issued new patient-centered labeling guidelines in
2013. The first phase of the project involved interviewing pharmacists, pharmacy managers, and vendors who provide pharmacies with the software used to generate labels. They learned that most of those stakeholders were not aware of the new guidelines, said Sparks. There were some concerns about implementing the new guidelines such as space on the label and the costs of upgrading the software, but overall those interviewed were supportive of the new guidelines and thought the changes had the potential to be beneficial. Based on the knowledge gained from the interviews, Sparks’s organization, Wisconsin Health Literacy, applied for and received a grant from the Medical College of Wisconsin’s Advancing a Healthier Wisconsin Endowment to conduct a pilot program. This program would implement redesigned labels in 52 pharmacies, including those that serve low-income areas and rural areas. The goal of the pilot program is to implement the redesign of labels that meet the USP guidelines, then evaluate the effect of the new labels.
Patient focus groups are an important part of the pilot program, said Sparks. In redesigning the labels, it was necessary to bring in people who “typically may not have had a voice in a project such as this, but whose input is essential for the work that we’re doing,” he noted. The focus groups helped determine what information should and should not be included on the label and provided valuable insight into how pharmacies are viewed by their customers. Trust was an issue, noted Sparks, especially among low-income individuals, many of whom believed that poor people were given lower-quality drugs. In addition, implementing the pilot program highlighted the need to involve pharmacy teams in the effort to redesign labels. The adoption of redesigned labels was “smoother and faster,” he said, when the pharmacy teams were consulted about potential changes and processes. The group also learned that one of the challenges to redesigning medication labels is that sometimes outside systems must also change. For example, he said, adding the purpose of the medication to the label would require changes by providers and to the design of the electronic health record. The next phase of the project will focus on monitoring and evaluating the implementation of the new labels. Sparks said his organization looks forward to learning more and applying what they have learned to increase the adoption of redesigned medication labels across Wisconsin.
Myers gave the second panel presentation, in which she explained that she and her colleagues at Merck are including individuals with low health literacy in the development and testing of new patient labeling, which in this case means the information about the medication that is produced by the manufacturer. Myers stressed that it was important to include respondents with low health literacy in the testing phase and that this inclusion would not happen without careful planning. The efforts at Merck began with the realization that although individuals with a broad range of education levels were included in its research, few of those had low health literacy. This realization led to a revamping of its recruitment strategies that involved seeking respondents in different places than before, such as senior centers and literacy centers, and including health literacy assessments as a part of recruitment. The goal, said Myers, is to have 25 percent of participants be individuals with low health literacy. One important lesson they learned, she said, is that it is necessary to conduct in-person testing as well as online testing. In doing this, she noted, it is important to partner with a market research company that is skilled at working with those with low literacy and low health literacy and takes into account issues such as respect and dignity. They have also found that it is important to have the ability to conduct tests using a mobile application, said Myers. In the past, Merck required a desktop computer to participate in patient labeling research, but it discovered that this inadvertently excluded a number of potential low-income respondents.
Myers said patient labels designed using the new research and testing process have received a strong positive response from patients and caregivers. Merck’s assessments of the new labels show a high comprehension of the information presented by respondents with both adequate and limited health literacy, she said. In addition, participants in follow-up interviews indicated that health-literate labeling would make it more likely they would read the information and keep it to use later as a reference. In conclusion, Myers said it was important to take one project at a time and realize that what works for one area of product research may not work for others. But it is possible, she said, with careful planning and attention, to develop information about new products that is easily understood by people of all health literacy levels.
Jack presented on a project he and his colleagues developed with the Agency for Healthcare Research and Quality titled the Reengineered Discharge Program (Project RED). The goal of Project RED was to reduce the number of hospital readmissions by increasing patients’ understanding of their care after hospitalization and improving their ability to manage that care. Of the 11 mutually reinforcing components of Project RED, said Jack, medicine reconciliation is at the top of the list because it is the most important piece of a health-literate discharge program. Jack and his colleagues carefully designed the written discharge plan to follow health literacy best practices, he said, including lots of white space, large fonts, pictures, and icons. The medication component of the document is structured around four questions identified by focus groups as the most important, said Jack. Those four questions are (1) What time of day do I take this medicine? (2) Why am I taking this medicine? (3) How much do I take? and (4) How do I take this medicine?
Jack noted that the results of the clinical trial conducted to evaluate Project RED showed that fewer patients who received the intervention had to return to the hospital for any reason than those who received the standard hospital discharge procedure. He also noted that since the completion of the trial, the National Quality Forum has adopted Project RED as the standard for hospital discharge.
The final presentation of the panel was given by Lee, who began by noting that more than 30 million people in the United States do not speak English well. He went on to explain that this population is particularly vulnerable to medication errors and recalled that when he would give medication instruction sheets to patients, they would often indicate that they understood when they did not. Lee said he started Polyglot Systems in 2001 to address this issue by focusing on developing simple medication instructions, including individual instructions for use, a regimen summary, and 3- to 5-minute video demonstrations for how to use specific medications such as inhaled medications and eye drops. He began with 6 languages, said Lee, but now offers these materials in more than 20 languages. A big challenge, Lee said, has been working with FDA-approved medication information sheets in English. He had to “start with simplifying the English,” Lee said.
Developing the materials is both a science and an art, Lee explained. It is important that they are guided by health literacy research in terms of reading level, visual layouts, and font sizes, among other things. But materials written at the lowest grade reading level are not always better, he noted, because important nuance can be lost. Choosing the correct visual representations is important when dealing with people of different cultural backgrounds. A continuing challenge is label instructions, he said, such as “take one tablet per oral each day.” They are often ambiguous and require the patient to calculate the correct dose or contain words such as “gel cap” that do not translate into some languages. Pictograms can often help in these situations, but the images must be visually consistent with the dosing instrument given at the pharmacy. Lee concluded by noting that it is challenging for patients to understand medication instructions in any language.
THE FUTURE OF HEALTH-LITERATE DESIGN
The final panel of the day featured three presentations on the future of health-literate design. Daniel Morrow, chair of the Department of Educational Psychology at the University of Illinois at Urbana-Champaign, was the first presenter. His presentation focused on the migration of information about medicine into Web-based and digital states and the opportunity to increase patient understanding. Heather Rennie, managing counsel of the Regulatory Legal Group at Merck Sharp & Dohme Corp., spoke next, giving the legal and regulatory perspectives on designing health-literate materials. Finally, Michael Wolf, professor of medicine and learning sciences and associate division chief for research in the Division of General Internal Medicine at Northwestern University’s Feinberg School of Medicine, presented his views on the future of health literacy research and the development of written materials about medications.
Morrow began the first presentation of the panel by noting that traditionally, health information has been paper based. This is changing rapidly, however, and many patients are now getting their medication information from patient portals and other online sources. In addition, said Morrow, there are a number of electronic tools such as mobile phone applications. This switch from paper to digital sources has implications for designing materials that are more easily understood, explained Morrow. Reading is less linear when done online, and people are more likely to switch between documents and take advantage of multimedia approaches. Older people, in particular, are affected by the change from paper to digital because they may be less comfortable with getting information electronically and less able to process that information, Morrow said.
Morrow explained that he approached health literacy as a function of the skills that an individual brings to the situation and the demands of the self-care tasks required. As an example, aging is associated with reduced ability to process information. At the same time, older adults often have greater experience with health care, which gives them more resources to use in understanding information. In his work, Morrow said he is trying to learn how this interplay between processing capacity constraints and knowledge-based facilitation affects older adults’ understanding of health information. Morrow discussed an intervention in which he and his colleagues tried to reduce the demands on individuals while leveraging their preexisting knowledge to improve understanding. The intervention involved the redesign of Web-based information about hypertension. Morrow said test participants who were shown the information in the redesigned format and the original format remembered the redesigned passages more accurately. He concluded by saying that for older adults, the key aspect of the redesign was reorganizing the content to follow people’s expectations and systematically signaling how the information was going to be conveyed.
Rennie offered a lawyer’s perspective in her presentation on the legal considerations in applying health literacy to written communication. She began by saying that she believes there is a perception in the health literacy world that lawyers are an obstacle to producing health-literate materials. “I am here to tell you that is not the case, certainly not at Merck,” she said. Understanding how lawyers think and how that might be perceived as an obstacle to health literacy is important, however. She explained that it is a lawyer’s job to ensure that what is said will be found to mean precisely what is intended upon later scrutiny. Because of this, she said, lawyers tend to want to add words to make sure every possible interpretation has been covered. This can be challenging when the health literacy goal is to simplify. It is also important to remember, Rennie said, that prescription drug labeling from the manufacturer is primarily intended for health care professionals and not for patients or the general public. A number of materials fall under the guise of “patient labeling,” however, and the regulations governing these materials include health literacy principles, she said. All the materials, including promotional materials, must be consistent with the professional labeling of the product. This is why it is important to incorporate health literacy principles from the beginning of the labeling design and writing process and to include the legal team in this process as well, said Rennie. She concluded by saying that lawyers, regulators, and health care professionals can all work together to address these issues.
Wolf was the final presenter of the day. He began by acknowledging all of the work that brought the field of health literacy to this point. Because of this work, health literacy now has a sizable evidence base related to medication materials. Wolf also said that it was exciting to hear about projects happening at the state level and in pharmacies and to realize that a great deal of good is being done. However, a number of issues related to medication errors and misuse must be addressed, said Wolf. Those issues include reconciling medications, spacing out multiple doses per day, remembering to take medications, organizing and integrating complex prescription regimens, and solving problems with regard to medications, such as what to do if a dose is missed. Wolf discussed a recent review of interventions saying that in his view, the most important finding was that the best interventions were those that used multiple sources of information, such as verbal counseling supported by materials specific to that patient, and those that targeted system-level changes to ease navigation and access to information.
With regard to the evidence relating specifically to medication labeling, Wolf said the research shows that using plain language, although it is something that should be done, is not enough. For people who cannot read well, he said, any written materials are difficult to understand. Second, he said he is amazed there is still so much variability in the language used to provide information to people about medicines. The wide range of educational materials is a major obstacle toward developing evidence-based interventions to improve health literacy. In Wolf’s opinion, the field needs to move beyond setting standards for written materials and look to ways to develop, design, and disseminate digital tools and other multifaceted ways to communicate with patients. He concluded by saying that it is important to continue to test and evaluate interventions so the evidence base can continue to grow.◆◆◆
DISCLAIMER: This Proceedings of a Workshop—in Brief was prepared by Melissa G. French and Joe Alper as a factual summary of what occurred at the meeting. The statements made are those of the rapporteurs or individual meeting participants and do not necessarily represent the views of all meeting participants, the planning committee, or the National Academies of Sciences, Engineering, and Medicine.
The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop—in Brief rests with the rapporteurs and the institution.
REVIEWERS: To ensure that it meets institutional standards for quality and objectivity, this Proceedings of a Workshop—in Brief was reviewed by Jennifer Dillaha, Arkansas Department of Health, and Lee Zwanziger, Food and Drug Administration. Lauren Shern, National Academies of Sciences, Engineering, and Medicine, served as the review coordinator.
SPONSORS: This workshop was partially supported by AbbVie Inc.; the Aetna Foundation; the Agency for Healthcare Research and Quality (HHSP23337024); American Dental Association; Bristol-Myers Squibb; East Bay Community Foundation (Kaiser Permanente); Eli Lilly and Company; Health Literacy Missouri; Health Literacy Partners; Health Resources and Services Administration (HHSH25034011T); Humana; Institute for Healthcare Advancement; Merck Sharp & Dohme Corp.; National Institutes of Health (HHSN26300054); National Library of Medicine; Northwell Health; Office of Disease Prevention and Health Promotion (HHSP23337043); and UnitedHealth Group.
For additional information regarding the meeting, visit nationalacademies.org/healthliteracyRT.
Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2017. Communicating clearly about medicines: Proceedings of a workshop—in brief. Washington, DC: The National Academies Press. https://doi.org/10.17226/24785.
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Copyright 2017 by the National Academy of Sciences. All rights reserved.