FDA Wants Your Views on Opioid Blister Pack Rule

The Food and Drug Administration (FDA) announced May 30 that it has set up a public docket for comments on its proposal that immediate-release, solid-form, oral-dosage opioids be dispensed to outpatients in blister packs with fixed quantities.

The FDA believes that fixed-dosage blister packs of five, 10, and 15 pills “could reduce the amount of unused opioid analgesics, thereby reducing opportunities for misuse, abuse, inappropriate access, and overdose, and possibly reducing the development of new opioid addiction,” says the notice which announced that the comment docket is open. The blister pack rule would add to the existing FDA Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS).

FDA said in the May 30 announcement, “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.”

“Specifically, the agency would like 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.”

“We’d also like feedback on which specific opioid or opioid-containing products are good candidates for blister package configurations as well the number of pills to be included in the configuration. We are also interested in hearing about the potential challenges associated with the proposal,” the May 30 announcement said.

There is no formal proposal to read yet. The most detailed explanation of the FDA plan is in the agency’s prior, lengthy February 26 announcement.

To submit a comment online or to see alternative ways to submit, go to this web page to submit before the July 30 deadline.

In our previous story, we reported that FDA has cited studies saying that smaller total doses in initial outpatient prescriptions are associated with lower rates of long-term use. FDA is proposing blister packs of five, 10, and 15 pills.

The blister pack proposal is part of a broader FDA effort to create evidence-based guidelines for prescribing opioids. As we’ve previously noted, FDA and the Centers for Disease Control (CDC) seem to be competing to write evidence-based guidelines to replace the less flexible opioid prescribing guideline the CDC issued in 2016.