The Safe Use Initiative and Health Literacy Workshop Summary (2010) / Chapter Skim
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3 Over-the-Counter Products
3 Over-the-Counter Products
Pages 11-18
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From page 11... ...
About the same time the Food and Drug Administration (FDA) launched its Safe Use Initiative, it also released a guidance for industry focused on dosage delivery devices for over-the-counter liquid drug products (FDA, 2009c)
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From page 12... ...
Problems included • No dosage delivery device included • Inconsistency between label and dosage delivery device • Superfluous markings on the device • Missing necessary markings on the device • arkings for units of measure that do not match what is on the M label • ormat of numeric text (decimals/fractions) does not match label F text • Inconsistency across products • Nonstandard abbreviation for milliliter (not mL)
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From page 13... ...
Feinberg School of Medicine northwestern University Health literacy is about helping patients and families understand their health and health care, translate knowledge to recommendations, and apply problem-solving skills to new situations, especially in the con text of OTC medications, since the consumer is making the decision to use a product, to take it home, and determine how to use it. A particular challenge occurs when the instructions for a specific medication change, because the consumer is accustomed to using the product in a particular way and probably does not check the instructions.
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From page 14... ...
This example illustrates how health literacy is important for helping patients and families understand their health and health care, translate knowledge to recommended actions, apply problem-solving skills to new situations, foster ongoing health learning opportunities, and instill health promotion attitudes. Individuals must make all kinds of decisions in the use of OTCs (Box 3-1)
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From page 15... ...
They also need proper dosing information such as how many pills to take at a time, how long to wait before they take the next dose, and the maximum daily dose. Because serious health risks have been documented with use of many OTCs, particularly analgesics, Wolf said, he and colleagues are undertaking four studies: a prevalence study to determine the rate of consumer misunderstanding of nonprescription analgesic medications, a follow-up study to determine why people misunderstand current labeling to inform better product language development, icon/message development to help consumers understand which products contain acetaminophen, and finally, a clinical trial testing labeling changes and whether they improve understanding.
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From page 16... ...
Lois Wessell, a family nurse practitioner with the Association of Clinicians for the Underserved, asked about instruction on pediatric medica tions based on age versus weight. In the populations she sees, mainly Latino immigrants, the obesity issue makes dosing difficult.
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From page 17... ...
said that agency's pharmacy health literacy center offers several tools, including the Health Literacy Universal Precautions Toolkit, 3 released in April 2010. The toolkit offers primary care providers and their practices a way to assess their services for health literacy considerations, raise awareness of the entire staff, and work on specific areas.
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From page 18... ...
Which are easier to read? Before considering who to invite to the table, Ruth Parker suggested stepping back and asking for clarity on what the task is.
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