The Impact of Abuse Deterrent Technologies on Prescription Opioid Trends | Page 2
Published Online: October 11, 2013
Howard Oremland, RPh, MBA; Lauren G. Gallagher, MPH; John Schlie, PharmD; Dick Creager, MD, MPA; Anthony Palmieri, PharmD, MBA; Olga S. Matlin, PhD; and Steven M. Kymes, PhD
The purpose of abuse deterrent technologies is to reduce the social and medical burden associated with prescription drug abuse. In our analyses, we found that in the years following introduction of the abuse deterrent formulation, there has been a decline in utilization of Oxycontin among acute and chronic users of the medication. However, the evidence that this might be due to the abuse deterrent formulation is far from clear. The decline in use of opioid medications across other categories, noneof which included abuse deterrent formulations, may indicate that there are other market reasons for the shift away from Oxycontin. In addition, we examined changes in prescription preference for chronic Oxycontin users who purchased their medication through their pharmacy benefit plan. There we found no evidence of a negative impact on Oxycontin use among these chronic users following introduction of the abuse deterrent technology.
Previous studies of the impact of abuse deterrent formulation on opioid abuse reported mixed results.2,3 It has been argued that prescription opiate abuse is a complex health problem that requires a comprehensive, multifaceted solution, and thus resists a single solution.4 Indeed, many have noted that targeting abuse deterrent technology to a single medication alone is an ineffective strategy, as an effective restriction would require that all opiate formulations employ the technology.2,5-7 However, most recognize that in addition to the regulatory hurdles such a policy change would encounter, there would be substantially increased cost to individuals and global health budgets resulting from such a restriction.5,7,8
We found that across all categories of opioids, the rate of prescriptions dispensed fell by 8.3% for prescription drug benefit members between 2009 and 2012. It has been reported that between 2001 and 2012 the annual number of prescriptions written for opioids in the United States increased by 33%9; however, most of this increase occurred prior to 2005.10 Since 2009 sales of hydrocodone-acetaminophen combinations and oxycodone hydrochloide have been flat nationally11 while worldwide sales of branded Oxycontin have declined.12 It should be noted that our data only include sales of opioids to prescription drug benefit members using their pharmacy benefit. There remains a very large market of cash sales that cannot be captured in our data, and therefore the trends of purchasing and utilization of opioid medications obtained via cash transactions were not examined in this analysis.
In April 2013, the FDA approved updated labeling for the reformulated, abuse deterrent version of controlled release oxycodone hydrochloride indicating continued support of regulators for abuse deterrent technologies in both generic and branded medications.13 In Table 4,14-19 we detail the pipeline for abuse deterrent technologies for other opioid based analgesics. The pipeline includes a wide array of technologies with functionality that would limit the ability of abusers to tamper with the drug. The medications in development include traditional opioid treatments for moderate to severe pain that incorporate agonist/antagonist, aversion, and physical or chemical barrier technologies. Remoxy, an oxycodone controlled release product, appears to be a future candidate for FDA approval; however, Pfizer has not yet invested in further development.
Abuse deterrent formulations continue to evolve and find application across a range of therapeutic classes and interest from public policy makers. Prescription drug abuse shows no signs of abating as a social problem; therefore, there is a growing need for formulary policy makers to be aware of the clinical and economic impact of abuse deterrent technologies.
Author Affiliations: From the Division of Enterprise Analytics (LG, OSM, SMK), CVS Caremark, Northbrook, IL; Clinical Sales and Account Services (HO, JS, AP), CVS Caremark, Scottsdale AZ; and Medical Affairs (DC), CVS Caremark, Northbrook IL
Funding Source: None reported.
Author Disclosures and Disclaimers: The authors report no relationship or fi nancial interest with any entity that would pose a confl ict of interest with the subject matter of this article. The content is solely the responsibility of the authors and does not necessarily represent the official views of CVS Caremark. This document contains confi dential and proprietary information of CVS Caremark and cannot be reproduced, distributed, or printed without written permission from CVS Caremark. This document contains references to brand name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with CVS Caremark. The information contained in this communication is provided in summary form. It is not intended for use as the sole basis of clinical treatment, as a substitute for reading the original research, nor as a substitute for the knowledge, skill, and judgment of a medical provider. Plan member privacy is important to CVS Caremark. Our employees are trained regarding the appropriate way to handle members’ private health information. ©2013 Caremark. All rights reserved.
Address correspondence to: Steven M. Kymes, PhD, CVS Caremark, 2211 Sanders Rd, NBT 326, Northbrook, IL 60062. E-mail: Steven .Kymes@caremark.com.
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