FDA May Require Opioids Be Packaged in ‘Blister Packs’

By Pat Anson, Editor

The Food and Drug Administration may soon require some opioid pain medications to be packaged in “blister packs” to limit the number of pills that can be prescribed and dispensed at one time.

“This is something we’ve been looking at for some time. And it is gaining some traction inside the agency as a potential solution to instigate different kinds of prescribing patterns around opioids. Something like this could move potentially quickly. We’re invested in it and taking a hard look at this,” FDA commissioner Scott Gottlieb told CNBC.

In May, Gottlieb appointed an Opioid Policy Steering Committee to study ways that the supply of opioids for short-term acute pain could be limited through packaging. Next month the FDA will hold a two-day public workshop with health experts and drug makers to discuss packaging options.

“One of the things that we can do is look at blister packs as an alternative to how opioids are dispensed. And perhaps package opioids in blister packs where it might come in a 2, 4, 6 or 8 day supply.  That would potentially encourage more doctors to prescribe smaller durations of use for patients,” said Gottlieb.


“This would be especially relevant to immediate release formulations of the drugs, which are the most widely prescribed formulations. And where most people form an addiction.”

Gottlieb said if doctors wanted to prescribe more opioids – such as a 30-day supply – the FDA could require that they “jump through additional hoops” such as a mandatory prescriber education course.

"We're at a point in this crisis that we're going to have to think of ideas and taking actions that are going to be more disruptive and are going to be uncomfortable to some parties," he said.

Several states have already adopted regulations that limit the supply of opioids for acute pain to seven days or less. CVS recently announced that its pharmacists would limit new opioid prescriptions to 7 days’ supply, starting in February for customers enrolled in its pharmacy benefit management program.