FDA mulls fixed-quantity packaging stipulation for opioids

03-Jun-2019 - Last updated on 03-Jun-2019 at 14:04 GMT

(Image: Getty/Mycteria)

US FDA considers demanding opioid manufacturers to package treatments in 5-, 10-, or 15-count blisters to reduce the risk of harm.

According to research reviewed by the US Food and Drug Administration (FDA), most patients used opioid pain medication for up to three days and took 15 tablets or fewer.

Despite this, the FDA observed that patients are prescribed ‘significantly more’ opioid pills than are actually used, with excess tablets commonly stored in ‘unsecure locations’.

As a result, the agency is considering a recommendation that opioid medication for ‘minimally or less-invasive medical procedures’ be blister packaged in fixed doses of 5, 10, or 15.

The agency stated, “Reducing the amount of unnecessary opioid pain medication prescribed will lead to fewer pills left in medicine cabinets that could be inappropriately accessed by family members or visitors, including children, and could potentially lower the rate of new opioid addiction.”

This could potentially lower the rate of new opioid addiction because excess tablets not required for treatment provide the opportunity for ‘misuse, abuse, or overdose’.

Manufacturers of opioid treatments typically offer bottle packaging for solid-oral dose opioid treatments, with Purdue Pharma’s OxyContin (oxymorphone hydrochloride) and formerly its generic rival Endo Pharmaceuticals’ Opana ER offering packages containing 100 tablets.

In addition, the FDA noted that this fixed-quantity configuration could become the ‘default option’ when evidence shows that shorter durations of treatment with opioids are clinically appropriate.

The FDA is currently seeking feedback on these packaging requirements. The agency added that, under the Support Act, it can require special packaging for opioids and other drugs that are deemed to pose a risk of abuse or overdose.

Pre-empting this direction from the FDA, companies, including PCI Pharma Services, have begun investing in infrastructure for the increased demand for blister packaging.

The statement was issued by Norman Sharpless, acting commissioner for the FDA, who is following in his predecessor’s footsteps, with Scott Gottlieb having made addressing the US opioid epidemic a key priority of the agency.