Blister packs

The Food and Drug Administration announced Thursday it is seeking comments on how to adopt packaging requirements that might help providers control the flow of opioid analgesics into healthcare and community settings.

The agency said in a posting in the Federal Registry that it is “encouraging healthcare providers to prescribe amounts that better reflect the quantity expected to meet the needs of the patient with acute pain. At the same time, we must help ensure appropriate access to opioid analgesics to address the medical needs of patients experiencing acute pain severe enough to require opioid analgesic treatment.”

The FDA says its data shows that adopting 5- , 10- , or 15-unit blister packs would provide appropriate options for “many patients experiencing acute pain following a minimally or less-invasive medical procedure or other conditions commonly treated with opioid pain medications.”

A 2018 law allows the FDA to require specific packaging and disposal systems for opioids and other drugs with a high risk of misuse. Accepting public comment on the issue is a first step toward turning the recommendation — widely supported by the pharmacy industry — into practice.

The agency said it also considering using mail-back pouches or other safe disposal options and encouraging drug makers to innovate on packaging.

According to published studies, the FDA said in a statement, most patients used significantly fewer pills than they were prescribed for many common minimally or less-invasive surgical procedures, as well as some common acute pain conditions. At home, patients may hold onto those pills in unsecure locations.

But nursing homes also have become a target for in-house thieves in recent years, both by those looking for a fix and those wanting to profit from their illegal resale. With opioids constantly in the news and their use under extreme scrutiny, physicians have been reluctant to write prescriptions or, in some cases, been confused by rules around their use in long-term care. Some patient advocates say that can lead to undertreatment.

Comments regarding Docket No. FDA-2019-N-1845 may be entered at https://www.regulations.gov.