Abuse-deterrent formulations: transitioning the pharmaceutical market to improve public health and safety.
This article evaluates abuse-deterrent formulations (ADFs) as a method to reduce prescription drug abuse while ensuring access to vital medications for individuals with legitimate need; assesses the pros and cons of ADFs and the current state of ADF adoption in the market; and develops policy recommendations to transition the market to ADFs. Although abuse-deterrent technology is still in its nascent stages, ADFs have been proven to reduce prescription drug abuse and its consequences, and even an incremental reduction in abuse can have a significant impact on the nation by reducing the costly social, physical, mental, and public health problems resulting from abuse. Federal ADF policy does not reflect the urgency of the prescription drug abuse epidemic and does not go far enough toward changing the status quo. Policies must be implemented to encourage innovation and a market shift toward ADFs by ensuring any generic medication that references a branded ADF demonstrates that it does not have abuse-deterrent properties inferior to the branded ADF product. Policies must also require federal prescription drug benefit plans to cover ADFs to ensure consumers have access to such medications.
Director of Policy and Advocacy. Center for Lawful Access and Abuse Deterrence, 1000 Potomac Street NW, Suite 150-A, Washington, DC 20007, USA.
Kyle
K
Simon
DCBA Law & Policy, 1000 Potomac St., NW, Suite 150-A, Washington, DC 20007, USA.
Stacey L
SL
Worthy
DCBA Law & Policy, 1000 Potomac St., NW, Suite 150-A, Washington, DC 20007, USA.
Michael C
MC
Barnes
DCBA Law & Policy, 1000 Potomac St., NW, Suite 150-A, Washington, DC 20007, USA.
Benjamin
B
Tarbell
abuse-deterrent formulation; controlled substance; pharmaceuticals; prescription drug abuse; substance abuse; substance use disorders