The Safe Use Initiative and Health Literacy Workshop Summary (2010) / Chapter Skim
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2 FDA Safe Use Initiative
2 FDA Safe Use Initiative
Pages 3-10
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Janet Wood cock and her team at the FDA Center for Drug Evaluation and Research (CDER) unveiled the approach in a concept paper, FDA's Safe Use Initiative, Collaborating to Reduce Preventable Harm from Medications (FDA, 2009a)
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One way to do this is to monitor what happens in emergency rooms in the United States before an action is taken and how those mea sured events change after the action. Since launching the Safe Use Initiative in late 2009, the FDA has been holding listening sessions to obtain input from the public and professional groups about the kinds of issues the initiative should address.
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How, she asked, does health literacy specifically fit in with the Safe Use Initiative? Sharfstein responded that it is unlikely anyone would defend the kind of confusing information patients currently receive, and the FDA is pursuing some regulatory initiatives with respect to labeling.
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For populations with mental illness in residential outpatient rehabili tation, their mental health care needs to be coordinated with their medi cal care, said Carolyn Cocotas, Quality Corporate Compliance at F.E.G.S. Health and Human Services System, a nonprofit health, education, and human services organization.
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The labels are not regulated, and the FDA has said it is not in its bailiwick to regulate prescription labels as opposed to OTC labels. Sharf stein replied that the FDA has made recommendations to state pharmacy boards on labels, and if there are things that mislead patients they need to be fixed.
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Sue Johnson from the FDA added that the agency has regulatory authority with regard to properly labeling prescription medications. A strong coalition around this issue makes sense.
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program that coordinates care for more than 10,000 children with special health-care needs, all of whom have parents with low literacy or limited English proficiency. Can the FDA reduce confusion by serving as a warehouse for low literacy pointof-care tools for parents -- such as an easy-to-use personal health record and easy-to-understand health information for special needs children, Sanders asked?
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Bernard Dreyer from the New York University School of Medicine said that he is concerned that, other than the issue of vaccines in the United States, children are viewed as basically healthy with very few problems. We know in pediatrics that medication errors are generally the result of parent confusion about how to administer over-the-counter and prescription medications.
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