New IfPA Policy Brief Examines Abuse-deterrent Pain Medications

December 2, 2014

by Amanda Conschafter, blog editor

Abuse-deterrent formulations mark a valuable step toward curbing prescription pain pill abuse, suggests a new Institute for Patient Access policy brief. As “Abuse-Deterrent Opioid Formulations: Promising Technology, Unique Challenges,” explains, these formulations make opioid pain pills harder to crush or dissolve. Snorting or injecting these medications for recreational use thereby becomes more difficult – if not impossible. Authors David Charles, M.D. and Mary Ann Chapman, Ph.D. argue that these properties may effectively limit abuse for certain patient populations.

  • How Does Abuse-deterrence work?

“Abuse-Deterrent Opioid Formulations” delineates abuse-deterrence designs, such as physical barriers and aversion, whereby the pill produces unpleasant side effects when crushed. The brief also lays out the four levels of label claims that abuse-deterrent pain medications can make. These range from Level 1, acknowledging a physical or chemical barrier to abuse, to Level 4, asserting demonstrated abuse reduction.

  • Which Patients Benefit?

As the policy brief explains, “Physicians recognize that these formulations may have significant potential for certain patients, such as:

– Those who have struggled with addiction or substance abuse in the past

– Those who live with others who are current or recovering addicts

– Those who live with teens or young adults who may seek opioids for recreational use.”

  • What Policies Govern its Use and Cost?

Even as abuse-deterrent formulations help address prescription pain pill abuse, they also raise questions about policy. Can pharmacists substitute a traditional formulation in lieu of the abuse-deterrent pill? Should patients not at risk for abuse pay the higher price for abuse-deterrent formulations?

Drs. Charles and Chapman argue that cost parity should exist so that patients who benefit from abuse-deterrent formulations aren’t punished by higher prices. They also state that pharmacy substitution policy must prioritize the physician-patient relationship.

Questions of abuse-deterrent formulations’ use and usefulness gain importance as more formulations enter the market. Earlier this month the Food and Drug Administration approved an opioid pain pill with abuse-deterrent properties. Several weeks prior, the FDA held hearings that reiterated its commitment to abuse-deterrent technology as a tactic against prescription drug abuse.

Read “Abuse-Deterrent Opioid Formulations: Promising Technology, Unique Challenges” to learn more.

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