EVALUATION OF ABUSE-DETERRENT DRUG MECHANISMS

To encourage manufacturers to develop safe and efficacious abuse-deterrent formulations for drugs known to be abused and misused; further,

To promote research on the efficacy of abuse-deterrent mechanisms in preventing prescription drug abuse, and to support the reporting and dissemination of this information; further,

To advocate for legislation that would limit out-of-pocket expenditures for such formulations.

Rationale

The abuse of certain classes of prescription drugs, including narcotics and stimulants, has had a large impact on public health. One way the Food and Drug Administration (FDA) has sought to curb this activity is through the use of abuse-deterrent formulations (ADFs). ADFs are formulations that permit treatment of a patient’s medical condition but reduce the likelihood of diversion, misuse, and abuse, and related adverse outcomes through various mechanisms, such as hindering the extraction of active ingredients, limiting their bioavailability, preventing administration through alternative routes, or making abuse of the manipulated product less attractive or rewarding.

The FDA has been taking steps to incentivize and support the development of opioid formulations with progressively better abuse-deterrent properties. These steps include working with individual sponsors on promising abuse-deterrent technologies, developing appropriate testing methodologies for both innovator and generic products, and publishing guidance on the development and labeling of abuse-deterrent opioids.

Despite these efforts, prescription stimulants used to treat attention deficit hyperactivity disorder have become drugs of choice for young adults, with as many as 20% of college students using such drugs for nonmedical purposes. According to a 2011 study, benzodiazepines were involved in 30.6% of prescription drug-related overdose deaths. However, to date, the FDA has not provided guidance on ADFs for any controlled substance other than opioids.

Despite the groundswell of support for abuse-deterrent opioid formulations, there is not strong evidence that such formulations deter abuse. One study of 232,874 patients across 437 facilities found an increase in abuse prevalence of all opioids after introduction of an abuse-deterrent formulation. That study showed little success in deterring abuse, finding instead that patients had switched to alternative drugs. There may also be unintended consequences of preferring abuse-deterrent formulations to regular formulations, such as increased costs borne by patients who legitimately need the drugs.

There also is a need to demonstrate that these formulations are truly abuse deterrent as well. In April 2015, the FDA published an industry guidance document on Abuse-Deterrent Opioids – Evaluation and Labeling. The document explains the FDA’s “current thinking about the studies that should be conducted to demonstrate a given formulation has abuse-deterrent properties.”

Addressing the growing rate of prescription drug abuse will require a multifaceted strategy; no one tactic will solve the problem. While ASHP supports measures such as abuse-deterrent formulations and rescheduling to prevent abuse, more research is necessary to determine which tactics are the most effective at deterring abuse.