Real-world misuse, abuse, and dependence of abuse-deterrent versus non-abuse-deterrent extended-release morphine in Medicaid non-cancer patients

ABSTRACT

Objective: Opioids with abuse-deterrent properties may reduce widespread abuse, misuse, and diversion of these products. This study aimed to quantify misuse, abuse, dependence, and health resource use of extended-release morphine sulfate with sequestered naltrexone hydrochloride (ER-MSN; EMBEDA®), compared with non-abuse-deterrent extended-release morphine (ERM) products in Medicaid non-cancer patients.

Methods: Administrative medical and pharmacy claims data were analyzed for 10 Medicaid states from 1 January 2015, to 30 June 2016. Patients were included if they received a prescription for ER-MSN or any oral, non-abuse-deterrent ERM. Index date was the date of first prescription for an ER-MSN or ERM. Abuse/dependence, non-fatal overdose, emergency department (ED) visits, and ED/inpatient readmissions were determined for each participant. An overall measure of misuse and abuse was also calculated. To account for differences in follow-up, all counts are expressed per 100 patient-years.

Results: There were 4,857 patients who received ER-MSN and 10,357 who received an ERM. The average age in the two cohorts was approximately 45 years old. From pre-index to follow-up, the number of patients per 100 patient-years with a diagnosis code indicating abuse or dependence increased by 0.91 (95% confidence interval [CI]: 0.85, 0.97) in the ER-MSN cohort and 2.23 (95% CI: 2.14, 2.32) in the ERM cohort. The number of patients per 100 patient-years with an opioid-related non-fatal overdose increased by 0.05 (95% CI: 0.04, 0.06) in the ER-MSN cohort compared with 0.11 (95% CI: 0.09, 0.13) in the ERM cohort. The opioid abuse overall composite score increased by 1.36 (95% CI: 1.24, 1.48) in the post-index period in the ER-MSN cohort compared to 3.21 (95% CI: 3.10, 3.32) in the ERM cohort.

Conclusion: Misuse, abuse, and dependence events were numerically lower in patients receiving ER-MSN compared with those receiving ERM products.

KEYWORDS:

• Abuse
• abuse-deterrent formulations
• addiction
• medicaid
• misuse
• morphine
• opioids
• opioids with abuse-deterrent properties
• overdose

Geolocation information

Provision of geolocation information is not possible due to the required confidentiality discussed in the Materials and Methods.

Data availability

Data are available on request due to privacy/ethical restrictions.

Declaration of interest

TJ Cicero receives research support from the National Institute on Drug Abuse, (T32-007261) and the RADARS® (Researched Misuse, Diversion and Addiction-Related Surveillance) System. TJ Cicero serves as a consultant on the Scientific Advisory Board of the RADARS® System and has no direct financial, commercial or other relationship with any of its subscribers. TJ Cicero is a paid consultant to Pfizer. RC Dart is an employee of Denver Health and Hospital Authority (DHHA) and Executive Director of the Researched Misuse, Diversion, and Addiction Related Surveillance (RADARS) System, a service provided by DHHA. Pfizer is one of many subscribers to RADARS System. RC Dart was not compensated for his participation in this manuscript. S Schnoll is an employee of Pinney Associates, Inc., which consults with numerous pharmaceutical companies including Pfizer. He does not receive payment directly from any of these companies. S Schnoll serves as a paid consultant to the RADARS System as a member of its Scientific Advisory Board. MJ Cattaneo, J Mardekian, CL Roland and PW Park are employees of, and have stock or stock options with, Pfizer. M Polson is an employee of and has stock in Magellan Health Services. M Mendoza is an employee of, and has stock options with Centrexion Therapeutics Corp; he also has stock with Pfizer, Inc. L Webster has been a paid consultant to and advisory board member for numerous pharmaceutical and biotech companies including Pfizer. Editorial support was utilized in the preparation of this manuscript, it was provided by Engage Scientific Solutions. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial relationships to disclose.

Additional information

Funding

This project was funded by Pfizer.