TY - JOUR
KW - Analgesics, Opioid/administration & dosage/chemistry/therapeutic use
KW - Chemistry, Pharmaceutical
KW - Drug Compounding
KW - Humans
KW - Opioid-Related Disorders/epidemiology/prevention & control
KW - Prescription Drug Misuse/prevention & control
AU - Ya-Han Lee
AU - Daniel L. Brown
AU - Hsiang-Yin Chen
A1 - 
AB - BACKGROUND: Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse. OBJECTIVE: We aim to compare and contrast the characteristics and applications of current abuse-deterrent opioid products in clinical practice. METHODS: Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations. RESULTS: Increasing trends of opioid abuse and misuse have been reported globally. There are 5 types of abuse-deterrent opioid products: physical chemical barrier, combined agonist/antagonist, sequestered aversive agent, prodrug, and novel delivery system. The advantages and disadvantages of the 5 options are discussed in this review. A total of 9 products with abuse-deterrent labels have been approved by the Food and Drug Administration (FDA). The rates of abuse, diversion, and overdose deaths of these new products are also discussed. A framework for collecting in-time data on the efficacy, benefit and risk ratio, and cost-effectiveness of these new products is suggested to facilitate their optimal use. LIMITATIONS: The present review did not utilize systematic review standards or meta-analytic techniques, given the large heterogeneity of data and outcomes reviewed. CONCLUSIONS: ADFs provide an option for inhibiting the abuse or misuse of oral opioid products by hindering extraction of the active ingredient, preventing alternative routes of administration, or causing aversion. Their relatively high costs, uncertain insurance policies, and limited data on pharmacoeconomics warrant collaborative monitoring and assessment by government agencies, pharmaceutical manufacturers, and data analysis services to define their therapeutic role in the future. KEY WORDS: Opioid abuse, abuse-deterrent formulations, ADF, post-marketing, FDA guidance, cost impact, abuse liking, physician attitude, generic abuse-deterrent formulation, clinical application.
AD - Department of Clinical Pharmacy, School of Pharmacy, Taipei Medical University, Taipei, Taiwan.; College of Pharmacy, California Health Sciences University, Clovis, CA.; Department of Clinical Pharmacy, School of Pharmacy, Taipei Medical University, Taipei, Taiwan; Department of Pharmacy, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan.
BT - Pain physician
C5 - Opioids & Substance Use
CP - 7
CY - United States
IS - 7
JF - Pain physician
LA - eng
M1 - Journal Article
N2 - BACKGROUND: Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse. OBJECTIVE: We aim to compare and contrast the characteristics and applications of current abuse-deterrent opioid products in clinical practice. METHODS: Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations. RESULTS: Increasing trends of opioid abuse and misuse have been reported globally. There are 5 types of abuse-deterrent opioid products: physical chemical barrier, combined agonist/antagonist, sequestered aversive agent, prodrug, and novel delivery system. The advantages and disadvantages of the 5 options are discussed in this review. A total of 9 products with abuse-deterrent labels have been approved by the Food and Drug Administration (FDA). The rates of abuse, diversion, and overdose deaths of these new products are also discussed. A framework for collecting in-time data on the efficacy, benefit and risk ratio, and cost-effectiveness of these new products is suggested to facilitate their optimal use. LIMITATIONS: The present review did not utilize systematic review standards or meta-analytic techniques, given the large heterogeneity of data and outcomes reviewed. CONCLUSIONS: ADFs provide an option for inhibiting the abuse or misuse of oral opioid products by hindering extraction of the active ingredient, preventing alternative routes of administration, or causing aversion. Their relatively high costs, uncertain insurance policies, and limited data on pharmacoeconomics warrant collaborative monitoring and assessment by government agencies, pharmaceutical manufacturers, and data analysis services to define their therapeutic role in the future. KEY WORDS: Opioid abuse, abuse-deterrent formulations, ADF, post-marketing, FDA guidance, cost impact, abuse liking, physician attitude, generic abuse-deterrent formulation, clinical application.
PP - United States
PY - 2017
SN - 2150-1149; 1533-3159
SP - E1003
EP - E1023
EP - 
T1 - Current Impact and Application of Abuse-Deterrent Opioid Formulations in Clinical Practice
T2 - Pain physician
TI - Current Impact and Application of Abuse-Deterrent Opioid Formulations in Clinical Practice
U1 - Opioids & Substance Use
U2 - 29149148
VL - 20
VO - 2150-1149; 1533-3159
Y1 - 2017
Y2 - Nov
ER -