FDA Seeking Public Input On Requirements For Blister Packaging Of Opioids
The US Food and Drug Administration (FDA) is opening a public docket to gain public input on the potential of requiring certain immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use, blister packaging.
The FDA is seeking public comments on the potential public health impact of making fixed-quantity unit-of-use blister packages of certain opioid pain medications available for the treatment of acute pain as well as potential challenges. The agency is also seeking feedback on which opioid or opioid-containing products are appropriate candidates for the blister packages as well as the number of pills to be included.
In making the proposal, the FDA says that studies have shown most patients used significantly fewer pills than prescribed for minimally or less-invasive surgical procedures or acute pain conditions, appearing to use opioids for only one to three days following surgery, taking 15 or fewer pills. Leftover pills were then retained in unsecure locations.
The FDA says that available data suggest that 5-, 10-, or 15-count unit-of-use blister package configurations of immediate-release opioid pain medications would meet the needs of patients following medical procedures or with other conditions commonly treated with opioid pain medications. The agency says that the availability of these new packaging configurations could help prescribers to more carefully consider the amount of opioid pain medication they prescribe. The agency says that these fixed-quantity unit-of-use blister packages could become the default option for many common acute pain conditions for which opioid pain medications are commonly prescribed, where the evidence shows that shorter durations are clinically appropriate.
It added that these fixed-quantity packages would be one option; however, prescribers would continue to write opioid analgesic prescriptions as they deem appropriate.