FDA’s New Opioid Packaging Plan is Meant to Limit Overprescribing

Regulatory NewsRegulatory News
| 30 May 2019 | By Zachary Brennan 

As opioid-related overdoses killed almost 50,000 Americans in 2017, the US Food and Drug Administration (FDA) on Thursday began soliciting comments on a plan to require special packaging for certain types of opioids that might be overprescribed.

According to research cited by FDA, most patients use significantly fewer pills than they are prescribed after many common less-invasive surgical procedures as well as some common acute pain conditions treated in the primary care setting.

“Specifically, most of these patients appeared to use opioids for only one to three days following surgery and took 15 or fewer pills,” FDA said.

With those figures in mind, the agency is proposing to require opioid manufacturers to supply 5-, 10- and 15-count blister package configurations of certain immediate release (IR) opioid analgesics commonly used for treatment of acute pain.

The agency said it believes the utilization of these fixed-quantity unit-of-use blister package configurations “would substantially reduce the quantity of opioid analgesics dispensed per prescription compared to the status quo.”

But the new packages would not stop prescribers from continuing to write opioid prescriptions in quantities they deem appropriate for their patients.

“In short, FDA anticipates that the widespread availability of fixed-quantity unit-of-use blister packaging could play a significant role in reducing overprescribing that leads to unused opioid analgesics without impairing access to opioid analgesics for patients who need them,” the agency said.

In addition to the new package types, FDA said it is also developing evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain for the relevant therapeutic areas where such guidelines do not exist.

As far as feedback FDA is seeking related to this new proposal, the agency asks stakeholders to comment on the potential safety advantages of broadly available, fixed-quantity unit-of-use blister packages of opioid analgesics, the specific IR opioid analgesic drug products for which it may be appropriate to require that blister packaging and any possible negative impacts or unintended consequences of such mandatory blister packaging, among other topics.

The proposal follows an FDA advisory committee’s vote in favor of adding labeling language that recommends co-prescription of naloxone for all or some patients prescribed opioids.

Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments

FDA statement


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