Communicating Clearly About Medicines Proceedings of a Workshop (2017) / Chapter Skim
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5 Exploring the Future of Health-Literate Design
5 Exploring the Future of Health-Literate Design
Pages 67-84
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From page 67... ...
Heather Rennie, managing counsel in the Regulatory Legal Group at Merck Sharp & Dohme Corp., then provided a lawyer's perspective on health literacy and medication information. Next, Michael Wolf, professor of medicine and learning disease and associate division chief for research in the Division of General Internal Medicine at Northwestern University's Feinberg School of Medicine, provided his view of the future of health literacy research as applied to written medication communications.
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From page 68... ...
Today, that situation is evolving into one in which patients are getting their medication information via patient portals and other Web-based sources and are managing their medications with the help of electronic tools such as mobile phones or tablet apps. This new electronic ecology, as opposed to a written ecology, affords opportunities to increase patient access and comprehension while also constraining how individuals understand health information (Czaja et al., 2013; Taha et al., 2013, 2014)
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From page 69... ...
. This approach leads to a focus on processing capacity and working memory processing speed in relation to aging.
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From page 70... ...
Low health literacy also impairs an individual's ability to elaborate concepts with knowledge, which means that poorly organized text or complex or irrelevant graphics may undermine comprehension, particularly in digital environments, said Morrow. He concluded his presentation by discussing an intervention study in which he and his colleagues were trying to target particular comprehension processes and reduce demands on cognitive resources, thereby helping people leverage knowledge they have to improve comprehension.
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From page 71... ...
Reorganizing content may also support self-regulated learning experiences, he said in closing, by making the process of remembering key concepts more efficient, thus freeing cognitive resources to evaluate comprehension in the context of online environments. LEGAL CONSIDERATIONS IN APPLYING HEALTH LITERACY PRINCIPLES TO WRITTEN COMMUNICATION2 The health literacy world has the perception that lawyers are an obstacle to health literacy, said Heather Rennie as an introduction to her presentation.
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From page 72... ...
Current forms of patient labeling that are part of FDA-approved prescription drug labeling include package patient inserts, which are approved by FDA and are required only for certain classes of medicines; instructions for use, also approved by FDA and required for medicines with complicated dosing instructions; and medication guides, again approved by FDA and required under certain circumstances such as when a product has serious adverse events associated with its use or when adherence to directions is crucial to the product's effectiveness. The regulations governing prescription drug labeling encompass health literacy principles, said Rennie.
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From page 73... ...
Promotional materials intended for physicians, for example, have to be consistent with the physician prescribing information, while consumer-directed materials must be consistent with approved patient labeling. Promotional materials must be supported by substantial evidence, balance efficacy, and risk information; must include all material information; and must not be false or misleading.
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From page 74... ...
"I think it is still incumbent upon pharmaceutical companies to make sure patients understand the risks and benefits of the product, but certainly the learned intermediary doctrine places the onus on the prescribing physician because it is viewed that the prescribing physician is in the best place to have the discussion with the patient and to know their particular circumstances," said Rennie. From a legal perspective, health literacy must be considered in product labeling, and while legal considerations may present challenges, they are not insurmountable.
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From page 75... ...
Wolf then discussed the findings from a recent systematic review of interventions to improve medication information for low health literacy populations (Wali et al., 2016)
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From page 76... ...
The evidence generated so far on the effectiveness of various interventions on medication adherence and safe use has produced a few important takeaways, said Wolf. The first is that plain language in written prescription drug labeling alone has a limited ability to reduce disparities among individuals with low literacy.
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. "The disparity between the highest functioning literate patients and those with the lowest literacy skills does not shrink," Wolf explained.
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Moving beyond written information, Wolf mentioned a recent paper that reviewed 16 trials targeting medication adherence using mobile phone text reminders (Thakkar et al., 2016)
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From page 79... ...
Rennie replied that the testing and revision process happens before the sponsor submits labeling language to FDA. The testing and revision process is built into the time line that her company, and she supposed every other pharmaceutical company, develops for the drug approval process, and it starts well before FDA is ready to grant approval for a new medication.
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From page 80... ...
Rennie said she has observed over the past decade that there has been a move to put more information into patient medication guides and physician prescribing information. "That has had the effect of making patients overwhelmed, quite frankly," said Rennie.
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From page 81... ...
Jennifer Dillaha with the Arkansas Department of Health commented that the growing number of older adults who are not likely to improve their own health literacy skills places a burden on an increasing number of families to gain the skills needed to understand proper medication use. She asked Morrow if the Internet work his group has conducted could be applied to patient portals, which is where many family members and other caregivers will go to get the information they need.
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From page 82... ...
In some respects, he added, this type of system would provide patient decision support in the way that an EHR can provide clinical decision support to the physician. Catina O'Leary from Health Literacy Media noted that despite all of the good interventions that have been developed, nothing seems to disrupt the system in a way that enables those interventions to gain much of a foothold and then spread in the nation's health care systems.
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From page 83... ...
He noted that achieving the same status for health literacy would be helped by the ongoing work on health-literate organizations and how they function. Rennie added that one important area in which health literacy needs to become an integral part of the design process is in the social media world given the central role social media plays for younger adults when they look for information on what might be ailing them.
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