Abuse-deterrent Formulations of Opioids

While discussing the abuse and misuse of opioid medications, the panelists consider abuse-deterrent formulations (ADFs) and how they have changed over the years through US Food and Drug Administration (FDA) regulations.

Although Charles Argoff, MD, calls ADFs “one step in helping to curve abuse and misuse and the devastating outcomes that can occur when the wrong person is using the medication at the wrong dose,” he also notes “there’s no requirement upon the payer right now to do what’s in the best interest of the person whose care they are paying for, and so I think there’s still a huge disconnect still out there between what is available.”

According to moderator Jeffrey A. Gudin, MD, another part of the problem is that “almost all of the opioids that we prescribe don’t have ADFs,” to which Joseph Pergolizzi, MD, adds that “95% of the extended-release opioids are generic and do not have ADF-type preparations, (and) 100% of the opioids that are covered by [the Centers for Medicare & Medicaid Services (CMS)] as first-line treatment are non-ADF.”

Even if health insurance companies and drug manufacturers attempted to resolve those issues, Christopher Gharibo, MD, says the process of eliminating or reducing the abuse and misuse of opioids has a “timeline in the form of decades” — especially since “swallowing whole pills at an amount greater than prescribed” is the most common form of opioid abuse, but “ADFs do nothing to mitigate that.”

Nevertheless, Pergolizzi says the ADF program is the first step towards helping patients, and Argoff says it may be easier to realize the risks and maximize the benefits over time, since “it will become more and more difficult for the payers to ignore the realities.”

“The fact that the FDA has released a blueprint and a white paper is a step in starting to put the screws in the payers,” Argoff notes. “If the standard of medical care across every medical practice situation is to use an abuse-deterrent approach … we will save a lot more lives.”