FDA requests comments on blister packaging for certain opioids
FDA is seeking feedback on a new rule that would require certain immediate-release opioids prescribed for the treatment of acute pain to be packaged in fixed quantity, unit-of-use blister packaging.
Specifically, FDA wants to know which opioid or opioid-containing products are appropriate candidates for such packaging. FDA is soliciting feedback through a public docket.
The new requirement is part of the SUPPORT Act law, which allows FDA to require special packaging for opioids and other drugs that have the potential for abuse or come with a risk of overdose.
Research cited by FDA indicates that most patients used substantially fewer opioids than they were prescribed for many common minimally or less-invasive surgical procedures and some common acute pain conditions treated in the primary care setting. "Patients reported that they usually retained unused pills in unsecure locations, providing opportunities for later misuse, abuse, accidental poisoning, overdose, and development of addiction,” noted FDA in a press statement.
Based on available data, the agency is suggesting 5-, 10-, or 15-count blister package configurations for certain commonly prescribed immediate-related opioid analgesics for acute pain. "The availability of these new packaging configurations could help prescribers to more carefully consider the amount of opioid pain medication they prescribe," FDA said. "These fixed-quantity unit-of-use blister packages could even 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."