USPHS: Opioid Drug Product Formulation Approaches to Deter Abuse

Description

Since Oxycontin's reformulation back in 2011, the Federal Drug Administration  (FDA) has approved several new opioid drug applications (NDAs) which contain abuse deterrent technologies. Various abuse deterrent approaches have been approved, including:  physical barriers, chemical barriers, and agonist/antagonist combinations. Given the current opioid overdose epidemic in the U.S., pharmacists should be aware of these new drug formulation technologies and how they may benefit the populations they serve.  

Pharmacist Learning Objectives

At the completion of this activity, participants will be able to:

  1. Explain the role of abuse deterrent technology in relation to the current Rx opioid epidemic.     
  2. List the types of studies required for determing abuse deterrence.   
  3. Describe labeling language used for AD products versus non-AD and how this can provide market exclusivity.     

 

     

Technician Learning Objectives

At the completion of this activity, participants will be able to:

  1. Explain the role of abuse deterrent technology in relation to the current Rx opioid epidemic.     
  2. List the types of studies required for determing abuse deterrence.   
  3. Describe labeling language used for AD products versus non-AD and how this can provide market exclusivity.     

     

 
 
 
Speakers:
Joshua
Joshua Hunt, PharmD, MPH
Senior Regulatory Reviewer
FDA/USPHS
 
Learning Level: Level 2
Track: Clinical Patient Care
Session Time Slot(s): 
Date: 
Monday, October 28
Time: 
4:30 PM - 5:00 PM
Room: 
Hilton Anatole Dallas - Cortez A
ACPE Pharmacist: 0202-0000-19-195-L01-P
CEUs Pharmacist: .05
ACPE Pharmacy Technician: 0202-0000-19-195-L01-T
CEUs Pharmacy Technician: .05
Activity Type:
Knowledge-based