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As part of its work to combat the opioid crisis, the agency is considering fixed-quantity, unit-of-use blister packaging for certain immediate-release opioid analgesics.
On May 30, 2019, FDA announced that it was opening a public docket to gather feedback on using fixed-quantity, unit-of-use blister packaging for certain immediate-release opioid analgesics. The agency is looking for comments on the potential public health impact of fixed-quantity blister packs and which specific products might be good candidates for such packaging.
The potential requirement is part of the agency’s work in connection with the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT Act), which promotes efforts to combat opioid addiction rates.
FDA stated in a press release that 5-, 10-, or 15-count unit-of-use blister package configurations of opioid pain medications as an option for doctors could help prescribers consider fewer pills to meet the needs of patients with acute pain. “Reducing the amount of unnecessary opioid pain medication prescribed will lead to fewer pills left in medicine cabinets that could be inappropriately accessed by family members or visitors, including children, and could potentially lower the rate of new opioid addiction,” the agency stated.
“The FDA’s efforts to address the opioid crisis must focus on encouraging ‘right size’ prescribing of opioid pain medication as well as reducing the number of people unnecessarily exposed to opioids, while ensuring appropriate access to address the medical needs of patients experiencing pain severe enough to warrant treatment with opioids,” FDA stated in the release.