Health Literacy Past, Present, and Future: Workshop Summary (2015) / Chapter Skim
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3 Health Literacy and Medications
3 Health Literacy and Medications
Pages 11-26
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From page 11... ...
Gerald McEvoy, assistant vice president of drug information at the American Society of Health-System Pharmacists, discussed the progress that has been made creating a standard and best practices for medication prescription labels. Theresa Michele, director of the Division of Non prescription Clinical Evaluations at FDA, then described the efforts that her agency has made in the health literacy area.
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From page 12... ...
Ten years ago, those Latin orders would often end up on the label on the pill bottle, though there were pharmacies and health care systems even then that were starting to change that practice and trying to figure out how to provide more consistent and easy-to-understand information for patients. As far as what constitutes label information that patients might receive, there is the actual container label, the Consumer Medication Information (CMI)
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From page 13... ...
Parker said one of the biggest lessons from the field of health literacy is that patients are actually experts on what they need in terms of drug information, and that partnering with them is important if the difficult challenge of making drug information understandable and actionable is going to be solved. Over the past decade, a framework for health literacy has been developed that puts health literacy at the intersection of skills and abilities with demands and complexities, Parker explained, and it was the paradigm shift that Koh described of aligning demands and complexities with skills and
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From page 14... ...
. Perhaps the most important shifts occurred when health literacy become framed as an issue of patient safety, and again when health literacy became linked with self-management as one of the priorities for Do not drink alcoholic beverages Michael Wolf Rx #: 1234567 9/8/2009 while taking this medicine 04/29/71 You have 11 refills Glyburide 5mg 180 pills Take for Diabetes Discard after 9/8/2010 Carry or wear medical identification stating you are Take: Provider: RUTH PARKER, MD taking this medicine Emory Medical Center 2 pills in the morning (414)
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From page 15... ...
HEALTH LITERACY AND MEDICATIONS 15 FIGURE 3-3 A simpler, more straightforward medication instruction sheet. SOURCE: Parker, 2014.
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From page 16... ...
Pharmacopeia (USP) , numerous professional medical societies, the Latino Coalition for a Healthy California, the National Consumers League, pharmaceutical manufacturers, and even the mass media.
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From page 17... ...
Two key findings noted in this white paper were that there was an inadequate understanding of the prescription container by patients that led to poor adherence, and that there were no universal standards for prescription labels. Other key findings in this white paper included • Evidence-based practices should guide label content and format.
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From page 18... ...
offered to have USP convene a neutral, multidisciplinary group to develop prescription container labeling standards, an offer that many workshop participants endorsed. This offer was followed by the USP Safe Medication Use Expert Committee authorizing an advisory panel to determine an optimal prescription label content and format in order to promote safe medication use by critically reviewing factors that promote or distract from patient understanding of prescription instructions and to create universal standards for label format, appearance, content, and language.
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From page 19... ...
Today, the standards are at what McEvoy characterized as at a high level, but he expects that over time they will become more specific in terms of how to standardize content and format as published evidence expands and strengthens. Currently, the standards stress that the prescription label be patient centered, that the information must be organized in a way that best reflects how most patients seek out and understand medication instructions, and that prescription container labeling should feature only the most important patient information needed for safe and effective understanding and use.
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From page 20... ...
NCPDP has since released a second white paper containing recommendations and guidance for standardizing dosing designations on prescription container labels of oral liquid medications (NCPDP, 2014)
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From page 21... ...
CDC, FDA, USP, and professional practice groups have all voiced support for these recommendations, as have several large national pharmacy chains. Pharmacy database producers are facilitating easy adoption by converting household units to milliliters, and schools of pharmacy are now being asked to advocate the recommendations, which McEvoy said have received widespread national press coverage.
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From page 22... ...
Another effort in the prescription drug area comes out of the FDA Safety and Innovation Act of 2012, and in particular Section 907, addressing issues related to demographic subgroups in clinical trials. The FDA Action Plan focuses on three key priorities, said Michele: quality in terms of improving the completeness and quality of demographic subgroup data collection, reporting, and analysis; participation with regard to identifying and breaking down barriers to subgroup enrollment in clinical trials; and
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From page 23... ...
In addition, OTC products have low potential for misuse and abuse and they have a safety margin such that the benefits of OTC availability outweigh any risks associated with the product. OTC drug candidates are tested to make sure they have these characteristics, typically using consumer studies.
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From page 24... ...
Michele responded that she could not say that anyone other than FDA is working on it, particularly with regard to meeting the needs of patients with low health literacy. Isham commented that the widespread availability of cell phones and other technologies may provide some opportunities for addressing some challenges
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From page 25... ...
Parker noted that a recent meeting of the IOM Roundtable on Promoting Health Equity and Eliminating Disparities was well attended by technologists; there are now nearly 700 apps available to help with medications. She also remarked that cell phones are particularly popular with some of the underserved populations that might have issues with low health literacy.
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From page 26... ...
She added that she has come to appreciate the fact that a regulatory agency such as FDA should not move too quickly with regard to issues such as these that are highly nuanced. As an example, McEvoy cited issues having to do with product branding, such as the decision of the maker of the cold product Sudafed to develop a formulation that did not include pseudoephedrine, which had been relegated to behind-the-counter status because of its potential use in making illicit drugs, and call it Sudafed PE.
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