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Assessing the impact of the extended-release/long-acting opioid analgesics risk evaluation and mitigation strategies on opioid prescription volume

Victoria Divino, BA, M. Soledad Cepeda, MD, PhD, Paul Coplan, ScD, MBA, MPH, Jean-Yves Maziere, MD, PhD, Yingli Yuan, PhD, Rolin L. Wade, RPh, MS

Abstract


Objective: The Food and Drug Administration approved the extended-release/long-acting (ER/LA) opioid analgesics risk evaluation and mitigation strategies (REMS) in July 2012 to educate healthcare providers and patients about safe and appropriate opioid analgesic use. The authors evaluated the impact of the REMS on ER/LA opioid analgesic utilization, overall and stratified by patient characteristics and prescriber type associated with greater expected need for analgesia. Design: Retrospective repeated cross-sectional study. QuintilesIMS's National Prescription Audit™ and LifeLink™ patient-level longitudinal prescription databases measured prescription volumes, projected to national estimates.

Main Outcome Measures: Changes were assessed in ER/LA opioid analgesic prescriptions dispensed from the 2-year pre-REMS implementation (July 2010 to June 2012) to the 18-month post-REMS implementation (July 2013 to December 2014) periods (with 12-month transitional implementation period in between).

Results: Average quarterly ER/LA opioid prescription volume significantly decreased by 4.3 percent from Preimplementation to the Active Period (5.58 vs 5.34 million, p < 0.001). Differences in prescription volume change were observed between age, gender, and payer types. Prescription volume either significantly decreased or remained stable from Preimplementation to the Active Period among most provider specialties evaluated. The largest volume decreases were observed for dentists (–48.5 percent) and emergency medicine specialists (–25.5 percent) (both p < 0.001). The largest increases were observed for nurse practitioners (+33.7 percent) and physician assistants (+31.2 percent; both p < 0.001), whose overall prescribing of nonopioid medications also increased.

Conclusions: A significant decrease in dispensed ER/LA opioid prescriptions was observed following REMS implementation compared to Preimplementation. The impact on volume varied by patient characteristics and prescriber specialty. The REMS program, in conjunction with other healthcare policies and initiatives, likely influenced these observations.


Keywords


opioids, risk evaluation mitigation strategies, utilization, physician specialties, prescribing patterns

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References


Nelson LS, Perrone J: Curbing the opioid epidemic in the United States. JAMA. 2012; 308: 457-458.

Gudin JA: The changing landscape of opioid prescribing: Long-acting and extended-release opioid class-wide Risk Evaluation and Mitigation Strategy. Ther Clin Risk Manag. 2012; 8: 209-217.

Butler SF, Black RA, Cassidy TA, et al.: Abuse risks and routes of administration of different prescription opioid compounds and formulations. Harm Reduct J. 2011; 8: 29.

Governale L: Outpatient prescription opioid utilization in the US, years 2000–2009. FDA. 2010. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementADvisoryCommittee/UCM220950.pdf. Accessed July 18, 2016.

Centers for Disease Control and Prevention: Increases in drug and opioid overdose deaths—United States, 2000–2014. 2016. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm. Accessed July 18, 2016.

Centers for Disease Control and Prevention: Prescription opioid overdose data. 2016. Available at http://www.cdc.gov/drugoverdose/data/overdose.html. Accessed July 18, 2016.

FDA: Regulatory information: Food and Drug Administration Amendments Act (FDAAA) of 2007. 2015. Available at http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm. Accessed July 18, 2016.

FDA: Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioids. 2015. Available at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm. Accessed July 18, 2016.

ER/LA Opioid Analgesics REMS: 2017. Available at http://www.er-la-opioidrems.com/IwgUI/rems/home.action. Accessed March 10, 2017.

Silverstein FE, Faich G, Goldstein JL, et al.: Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: The CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA. 2000; 284: 1247-1255.

Ong CK, Lirk P, Tan CH, et al.: An evidence-based update on nonsteroidal anti-inflammatory drugs. Clin Med Res. 2007; 5: 19-34.

FDA: Introduction for the FDA blueprint for prescriber education for extended-release and long-acting opioid analgesics. 2014. Available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM361069.htm. Accessed July 18, 2016.

Ringwalt C, Gugelmann H, Garrettson M, et al.: Differential prescribing of opioid analgesics according to physician specialty for Medicaid patients with chronic noncancer pain diagnoses. Pain Res Manag. 2014; 19: 179-185.

Volkow ND, McLellan TA, Cotto JH, et al.: Characteristics of opioid prescriptions in 2009. JAMA. 2011; 305: 1299-1301.

Elliott VS: Sharp increase expected in number of nurse practitioners. American Medical News. Available at http://www.amednews.com/article/20120702/business/307029951/6/. Accessed April 29, 2015.

Auerbach DI: Will the NP workforce grow in the future?. New forecasts and implications for healthcare delivery. Med Care. 2012; 50: 606-610.

Hooker RS, Muchow AN: Supply of physician assistants: 2013-2026. JAAPA. 2014; 27: 39-45.

Proser M, Bysshe T, Weaver D, et al.: Community health centers at the crossroads: Growth and staffing needs. JAAPA. 2014; 28: 49-53.

Cepeda MS, Fife D, Kihm MA, et al.: Comparison of the risks of shopping behavior and opioid abuse between tapentadol and oxycodone and association of shopping behavior and opioid abuse. Clin J Pain. 2014; 30: 1051-1056.

Dart RC, Surratt HL, Cicero TJ, et al.: Trends in opioid analgesic abuse and mortality in the United States. N Engl J Med. 2015; 372: 241-248.

Levy B, Paulozzi L, Mack KA, et al.: Trends in opioid analgesic-prescribing rates by specialty, U.S., 2007-2012. Am J Prev Med. 2015; 49: 409-413.

Paulozzi LJ, Mack KA, Hockenberry JM: Variation among states in prescribing of opioid pain relievers and benzodiazepines—United States, 2012. J Safety Res. 2014; 51: 125-129.

McDonald DC, Carlson K, Izrael D: Geographic variation in opioid prescribing in the U.S. J Pain. 2012; 13: 988-999.

Franklin GM, Mai J, Turner J, et al.: Bending the prescription opioid dosing and mortality curves: Impact of the Washington State opioid dosing guideline. Am J Ind Med. 2012; 55: 325-331.

Surratt HL, O’Grady C, Kurtz SP, et al.: Reductions in prescription opioid diversion following recent legislative interventions in Florida. Pharmacoepidemiol Drug Saf. 2014; 23: 314-320.

Kreiner P, Nikitin R, Shields TP: Bureau of justice assistance prescription drug monitoring program performance measures report: January, 2009 through June 2012. U.S. Department of Justice, Bureau of Justice Assistance. Available at www.pdmpexcellence.org/sites/all/pdfs/BJA%20PDMP%20Performance%20Measures%20Report%20Jan%202009%20to%20June%202012%20FInal_with%20feedback.pdf. Accessed July 18, 2016.

Reifler LM, Droz D, Bailey JE, et al.: Do prescription monitoring programs impact state trends in opioid abuse/misuse? Pain Med. 2012; 13: 434-442.

Mercer Inc: State Medicaid interventions for preventing prescription drug abuse and overdose: A report for the National Association of Medicaid Directors. 2014. Available at http://medicaiddirectors.org/wp-content/uploads/2015/07/namd_rx_abuse_report_october_2014.pdf. Accessed July 18, 2016.

Ben-Joseph R, Chen CC, De AP, et al.: Consequences of patient access restrictions to branded oxycodone hydrochloride extended-release tablets on healthcare utilization and costs in US health plans. J Med Econ. 2014; 17: 708-718.

Alexander L, Mannion RO, Weingarten B, et al.: Development and impact of prescription opioid abuse deterrent formulation technologies. Drug Alcohol Depend. 2014; 138: 1-6.

Dowell D, Haegerich TM, Chou R: CDC guideline for prescribing opioids for chronic pain—United States, 2016. MMWR Recomm Rep. 2016; 65: 1-49.

FDA: FDA News Release. FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use. 2016. Available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518697.htm. Accessed March 10, 2017.

Cepeda MS, Coplan PM, Kopper NW, et al.: Opioid analgesics REMS: Overview of ongoing assessments of its progress and its impact on health outcomes. Pain Med. 2017; 18(1): 78-85.




DOI: http://dx.doi.org/10.5055/jom.2017.0383

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