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Reflections on the Day

Cindy Brach began the traditional Roundtable on Health Literacy practice of providing the members’ thoughts on the day’s presentations and discussions by noting that what she took away from the patient panel was the need for more shared decision making in medication decisions and understanding the lived experiences that must be incorporated in those decisions. Caleb Sexton expressed the need for empathy, Bobbie Reed spoke of her frustrations at having her ideas about her son’s medications summarily dismissed by her son’s physicians, and both Reed and Darvece Monson pointed to the importance of presenting information at the right time, when an individual is not at a cognitive low point and unable to absorb and understand information. These comments, she said, led her to wonder if there are options akin to nurse advice lines that could be an accountable place for patients and caregivers to go to get answers when they are ready to hear information or if they have questions they need answered after throwing away the materials the pharmacist handed them with their prescription.

Another message from the first panel that Brach highlighted was the importance of the care team and the need to make better use of all-care team members as sources of information. She raised the idea of requiring counseling at the time of dispensing, which is what Canada does, and wondered what roles team members could play that would result in patients and caregivers having a better understanding of their medication regimens. Brach’s final comment was that perhaps the roundtable could help get the message to electronic health record vendors and the companies that create

pharmacy labeling systems about the need to make information more accessible, understandable, and actionable.

Jane Grover said her main impression from the workshop was that there is an opportunity to not only integrate between the medical and dental worlds, but to bring health literacy into the world of dentistry. There is, she noted, an advisory committee on health literacy in dentistry, but dentistry is typically not team based. She pointed out that every patient has a mouth, and there is an opportunity to bring health literacy to oral health concepts into dentistry,

Lori Hall said that though she has been a roundtable member for 3 years, it was only since January 2016 that she was given the title of director of health literacy at Eli Lilly and Company. She credited her roundtable colleague Laurie Myers of Merck with blazing the trail for having dedicated health literacy teams in pharmaceutical companies. She then noted that the organization’s seriousness about health literacy started to change when she was given that official title, so she recommended that others doing health literacy work in pharmaceutical companies should advocate for a job title that has “health literacy” in it. For her, the impact of getting that title is that she has since received 139 unsolicited requests for input from every point along the drug development continuum at Merck. This is important, she said, because, “What I am hearing over and over again today is the further upstream we can apply health literacy in the research, clinical research, and the approval and commercialization of medications, all patients benefit.” She then invited all pharmaceutical companies to join this non-competitive effort. Kim Parson from Humana also supported the idea of introducing health literacy concepts as early in the research and development process as possible and noted the importance of bringing the consumers of medications into the design process as early as possible.

Jennifer Dillaha said it was clear to her how much work needs to be done to help people understand the information available to them on medication and other health-related topics. In particular, commenting on Heather Rennie’s remarks about the need to help patients and caregivers distinguish between factual and misleading, non-factual information, she said the field is going to need to work on that aspect of information gathering as an important piece of the health literacy skill set.

Wilma Alvarado-Little said she appreciated the comments of the day’s first panel because they highlighted the importance of empowering vulnerable populations and the need to meet patients where they are to address their concerns. “They are the experts about themselves and they are not given the voice in the room to be told it is okay to ask that question or to say something like, ‘This is too much information,’” said Alvarado-Little. She noted how she appreciates when her providers can acknowledge they

do not know the answer to one of her questions because that is actually a very sophisticated response and it means the provider is listening to her.

Myers said pharmaceutical companies need to address many things besides patient labeling in terms of health literacy. Clinical trials materials, for example, need to be understandable by people with low health literacy, and in particular, among individuals of underrepresented populations. Her concern is that while there are efforts to include patient perspectives in clinical trials, only the most articulate patients are part of that process today. Informed consent is another area that needs more attention from a health literacy perspective, as is the development of instructions of use for combination products. Myers also thought it is imperative to understand the met and unmet needs of patients who desire future products in terms of patient-reported outcomes and other quality measures. “Thinking about consumerism, how do we demonstrate the value of our products to patients? What are the quality measures that are important to them?” she asked.

Steven Rush from UnitedHealth Group said he had a mixed reaction to the workshop. On the one hand, as others had mentioned, he was disappointed to hear many of the same issues raised that he has been hearing for many years. At the same time, he did hear of some progress and is encouraged by the resources and approaches being brought to bear on the challenge of helping patients understand their medications. “Maybe they are not big changes, but there are changes, so that has been exciting,” said Rush. He noted that the concept of cognitive burden resonated with him because it makes real comments he hears from patients about having to think too much about their medications.

For Jay Duhig, the discussions at the workshop left him “incredibly hopeful.” Underlying that sense of optimism were the presentations by the members of the first panel, who were so articulate about their experiences and what is meaningful with regard to their care; the inclusion of the many stakeholders that need to be engaged in the effort to communicate more clearly about medications; and by the case studies of data-driven, outcome-driven interventions presented in the afternoon session.

Michael Villaire from the Institute for Healthcare Advancement agreed with the previous comments that the first panel was a highlight of the workshop and he thanked the panelists for sharing their stories and struggles. He commented that efforts to redesign systems are needed and are a critical part of what the health literacy community does. Medications, however, are still personal, taken by individuals, not systems, and not taken for a variety of personal reasons that need to be acknowledged and accepted. While systems-based approaches can address the large majority of issues, they will not fix every issue for every person. “That one-on-one interaction between individuals from the health care system and people who are trying to access the health care system is really the critical juncture, and, frankly, it is where

we spend the least amount of time in the entire health care system,” said Villaire. “My recommendation is to incentivize those interactions, extend that amount of time, use other providers, navigators, and educators, but to provide them when they are needed by the patient.” He also suggested that the pharmacy could provide a place where patients can receive help in a shame-free and cost-free environment.

Bernard Rosof noted that he is “not uncomfortable with hearing things over and over and over again until we get it right.” In fact, he added, “that is the principle of quality improvement and performance improvement, and that is to be transparent and say it again and again and again until you do get it right.” He then read an email with comments from Robert Logan, who wrote that in his opinion it would be good to embed a health literacy perspective as part of the future postmarketing surveillance initiatives. Logan noted that Will Shrank told the workshop that the U.S. Food and Drug Administration’s (FDA’s) postmarketing surveillance efforts are primarily epidemiological and overlook the social determinants of health that impact medication adherence, safety, and administration. He also recalled that in May 2017, he heard FDA Commissioner Robert Califf suggest that postmarketing surveillance efforts may be insufficiently multidimensional to address contemporary drug safety-related issues and may need to be expanded. “I envision an important role for the roundtable to gather evidence and provide guidance about how to embed a health literacy perspective as part of revamped postmarketing surveillance initiatives,” wrote Logan. “A health literacy perspective would enrich data collection for medication safety, efficacy, and administration.”

Linda Harris from the U.S. Department of Health and Human Services (HHS) started her comments by introducing Lee Zwanziger, the newly appointed co-chair of the HHS working group on health literacy. She said she appreciated that the workshop included presentations on user-centered design and Dan Morrow’s presentation on interdisciplinary skills. She noted the importance of including work on cognitive challenges affecting executive function, given the role that executive function plays in the ability to read and problem solve. “We need to be bringing that science into the way we are thinking about health literacy because it is so much more than just reading.”

Before adjourning the workshop, Rosof asked the workshop participants to take a moment and remember Margaret Loveland, who passed away on August 26, 2016. Loveland was a former member of the roundtable and long-time supporter of health literacy in her leadership role at Merck. “Always a valuable and loved member of the roundtable, her analytic input, her insights, and her ability to contribute to what we have accomplished over the past decade or so has been on everybody’s mind,” said Rosof.