Communicating Clearly About Medicines Proceedings of a Workshop (2017) / Chapter Skim
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3 Approaches to Health-Literate Medication Instructions
3 Approaches to Health-Literate Medication Instructions
Pages 17-34
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From page 17... ...
Food and Drug Administration (FDA) , then spoke about designing labels and labeling for patients, and Edmond Israelski, technical advisor on human factors and retired director of human factors at AbbVie Inc., addressed the use of best practice human-centered design methods in the design of medication materials.
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From page 18... ...
As an example, he explained how CVS Health, a large retail pharmacy chain with a reputation for working with and focusing on consumers, allocates substantial resources to understand what words work in terms of patient communications, what messages work, what vehicles work, and how messages should be delivered. CVS Health also works with a remarkably deep set of analytics and predictive modeling, he added, to rapidly assess what is working or not working, and continually strive to understand how to get the right intervention to the right person.
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From page 19... ...
"We have a rich, robust consumer innovation arm and have acquired probably a dozen companies specifically to help us use different kinds of technology and different kinds of data to better target and deliver the right intervention to the right patient regarding their medications or their chronic disease management," explained Shrank. The focus of this work, which now involves more than 100 employees at the UPMC health plan, is on learning internally, improving continually, and running the business as well as possible, but with a "deep and profound commitment to understanding how we communicate with our patients best to deliver the very best care we can." One result from all of these efforts, said Shrank, is that patients may actually become overwhelmed with information.
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From page 20... ...
That kind of embedded approach would allow us to take into account all of the nuances, all of the different levers, all of the different approaches." As an example of this approach, Shrank cited the work Michael Wolf did on the Universal Medical Schedule, a methodology that simplifies medication instructions for patients and their caregivers. Wolf did some foundational work with Ruth Parker, Terry Davis, and to a lesser extent himself (Shrank et al., 2010)
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From page 21... ...
"Putting those concepts together -- medication error prevention and human factors -- we see they are interconnected," said Chan. "If we want to prevent medication errors, we have to be looking critically at human factors with the combined goal of ensuring that there is appropriate medication use and that we are optimizing human well-being." With human factors engineering, it is possible to apply a process to the design of a system, in this case labels and labeling, to ultimately decrease the risk in that system, she explained.
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From page 22... ...
Validation studies generate the data that can support the claim that the user interfaces, including the labels and labeling, provide effective information for end users that will lead to safe and effective use of a given drug. Chan noted that labels and labeling by themselves will not replace good product design.
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From page 23... ...
Going forward, said Chan, FDA is committed to the development of a new form of patient information, called Patient Medication Information, to help ensure patients receive essential information about prescription medications. FDA is proposing to amend medication guide regulations4 to require this new form of patient labeling, which fulfill the following: • Provide clear, concise written patient prescription drug product information.
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From page 24... ...
It would not replace labeling for professionals or the instructions for use, Chan explained in closing. HUMAN-CENTERED DESIGN5 Although there are many definitions of human factors or humancentered design, Israelski favors one that says it applies data on human capabilities and characteristics to the design and evaluation of systems and devices, which can include a broad array of things, including drug labels and packaging, medical devices, smartphone apps, device and drug combinations, and websites.
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From page 25... ...
Risk Analysis • Estimate hazards & risks User Interface Specification • Acceptance criteria • Quantified usability objectives Iterative Design • Rapid prototyping • Simulations Usability Testing • Formative (Early designs) • Summative at the end FIGURE 3-1 Human factors core methods.
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From page 26... ...
User interface specification follows risk analysis, and it can involve working on developing user-friendly navigation features for a smartphone app or the layout of instructional materials for a medical device, for example. This step involves creating detailed specifications for user interface and product design that leaves little room for creativity on the part of the development team, according to Israelski.
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From page 27... ...
"You have to maintain a good design history file that is auditable, and you have to do formal risk management," he said. FDA requires verification to demonstrate that design outputs meet design inputs and that user interfaces meet customer requirements.
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From page 28... ...
In addition, as Chan discussed, FDA has issued several guidance documents, including one released in February 2016 that elaborates on FDA's expectations for applying human factors to medical devices. DISCUSSION Bernard Rosof opened the discussion by asking the panelists if humancentered design will differentiate a product in the marketplace with the economic buyer and if there are metrics to determine that.
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From page 29... ...
Chan agreed that getting consumers more involved in the design of medication materials is a key aspect of getting patient-centered design widely adopted. Israelski recommended a book, Cost Justifying Usability, by Randolph Bias and Deborah Mayhew, that presents business cases showing how human factors can produce an economic return to the companies employing its methods.
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From page 30... ...
"I do hope that is something that could be expanded on." Chan, speaking from FDA's perspective, said the Center for Drug Evaluation and Research uses the FDA Adverse Event Reporting System, which receives millions of reports from manufacturers, as a major data source. It also relies on reports consumers and providers submit directly to the agency and from patient safety organizations such as the Institute for Safe Medication Practices.
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From page 31... ...
Elisabeth Walther from the Office of Medical Policy at FDA responded to a question about a proposed rule change that would require a one-page patient-centered medication information sheet to accompany all drugs dispensed or administered on an outpatient basis. She noted that this rule change has been included on the spring 2017 Unified Agenda, which lists the regulations FDA expects to publish within the next year.
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From page 32... ...
" asked Rosof. Shrank replied that there is a clearer sense of what needs to be done in the somewhat controlled environment of a hospital and there has been an extraordinary effort and success with regard to medication safety in that environment.
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From page 33... ...
Walther replied that FDA has in fact considered that issue when it developed the proposed new Patient Medication Information rule and has included flexibility in the rule that should enable EHR vendors to develop applications that could support better communication between the health care system and the patient at home. Israelski commented that a company such as AbbVie has to embrace the entire health care ecosystem and how its products fit into the patient journey.
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