FDA Announces Safe Use Initiative, Proposes Changes in OTC Liquid Medication Dosing Devices
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The Food and Drug Administration (FDA) has unveiled the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use. In conjunction with that initiative, the FDA released a series of recommendations for dosage delivery devices that accompany over-the-counter (OTC) liquid medications.
The stated goal of the Safe Use Initiative is to reduce preventable harm by (1) identifying specific, preventable medication risks and (2) developing, implementing, and evaluating cross-sector interventions with partners who are committed to safe medication use. According to the FDA, many of these interventions may consist of both regulatory and non regulatory components, highlighting the need for collaborative action. A detailed description of the Safe Use Initiative is available online at http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188961.pdf.
In keeping with the goals of the Safe Use Initiative, the FDA has published draft guidance for companies that manufacture, market, or distribute OTC liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes, and spoons. Key recommendations in the draft guidance include:
• Dosage delivery devices should be included for all OTC liquid drug products.
• Devices should have calibrated markings that are the same as the units of measure specified in the labeled dosage directions.
• Devices should not bear extraneous or unnecessary markings (i.e., markings other than those needed for measuring the recommended doses).
• Devices should not be substantially larger than the largest dose described in the labeled dosage directions.
In addition, the FDA recommends that companies try to ensure that a dosage delivery device is used only with the intended product. One means of accomplishing this would be to devise a mechanism to secure the dosage delivery device to the drug product, such as creating an integrated dosing device. The complete draft guidance, which includes illustrations of dosing devices that would and would not meet the recommendations, is available online at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati....