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December 01, 2020 09:26pm
By Sara Karlovitch, Assistant Editor
The agency has opened a public docket to solicit feedback on the proposed requirement, which would necessitate certain immediate-release opioid analgesics be made available in fixed-quantity, unite-of-use blister packaging.
A special packaging requirement for prescription opioids is being weighed by FDA officials, and the agency is seeking feedback on the proposal.
The agency has opened a public docket to solicit feedback on the proposed requirement, which would necessitate certain immediate-release opioid analgesics be made available in fixed-quantity, unite-of-use blister packaging. This packaging could help prescribers consider more carefully the amount of opioid pain medications they prescribe, FDA officials said in a prepared statement.
By requiring fixed-quantity, unite-of-use blister packaging, the FDA aims to encourage “right size” prescribing of opioid pain medication, and reduce the number of people unnecessarily exposed to these prescription drugs. The proposed packaging requirement also is designed to ensure appropriate access to medications that address the medical needs of patients experiencing pain severe enough to warrant treatment with opioids.
Published studies have found that most patients used significantly fewer pills than they were prescribed for many minimally or less-invasive surgical procedures as well as some common acute pain conditions treated in the primary care setting, according to the FDA. Most of these patients appeared to use opioids for 1 to 3 days following surgery and took 15 or fewer pills. Patients reported that they usually retained unused pills in unsecure locations, providing opportunities for later misuse, abuse, accidental poisoning, overdose and development of addiction.
Available data suggests that if 5-, 10-, or 15-count unit-of-use blister package configurations of certain commonly-prescribed immediate-release opioid pain medications were made available, 1 or more of these options could be expected to meet the needs of many patients experiencing acute pain following a minimally or less-invasive medical procedure or other conditions commonly treated with opioid pain medications.
“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 FDA’s statement said. “Importantly, these fixed-quantity unit-of-use blister packages would just be one option, and prescribers could continue to write opioid analgesic prescriptions in quantities they deem appropriate for their patients.”
The agency is seeking comments about the potential public health impact of requiring fixed-quantity unit-of-use blister packages for certain opioid pain medications, including challenges associated with the proposal. FDA officials also are requesting feedback on which opioid or opioid-containing products would make good candidates for the blister packaging configurations, and numbers of pills that would be included.
The proposal is buoyed by the SUPPORT Act that allows the FDA to require special packaging for opioids and other drugs that pose risks for abuse and overdose.
Statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids [news release]. Silver Spring, MD; May 30, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/statement-fdas-request-information-requiring-fixed-quantity-blister-packaging-certain-opioid-pain. Accessed May 30, 2019.