• Grace Chai, Jing Xu, James Osterhout, Mark A Liberatore, Kathleen L Miller, Carolyn Wolff, Marisa Cruz, Peter Lurie, and Gerald Dal Pan.
• From the Division of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology (G.C.), Clinical Safety and Surveillance Staff, Immediate Office, Office of Generic Drugs (J.O.), Division of Anesthesia, Analgesia, and Addiction Products, Office of Drug Evaluation II, Office of New Drugs (M.A.L.), and Office of Surveillance and Epidemiology (G.D.P.), Center for Drug Evaluation and Research; and Office of Public Health Strategy and Analysis (J.X., M.C.), and Economics Staff, Office of Planning, Office of Policy, Planning, Legislation, and Analysis (K.L.M., C.W.), Office of the Commissioner, U.S. Food and Drug Administration, Silver Spring, Maryland. Current position: President, Center for Science in the Public Interest, Washington, D.C. (P.L.). LCDR Chai, CDR Osterhout, and LCDR Liberatore are commissioned officers in the United States Public Health Service (USPHS).
• Anesthesiology. 2018 May 1; 128 (5): 953-966.

BackgroundThe opioid epidemic, driven in part by increased prescribing, is a public health emergency. This study examines dispensed prescription patterns and approvals of new opioid analgesic products to investigate whether the introduction of these new drugs increases prescribing.MethodsPrescribing patterns based on dispensed prescription claims from the U.S. retail setting were assessed with new brand and generic opioid analgesic products approved in the United States from 1997 through 2015.ResultsFrom 1997 through 2015, the U.S. Food and Drug Administration (Silver Spring, Maryland) approved 263 opioid analgesic products, including 33 brand products. Dispensed prescriptions initially increased 80% from 145 million prescriptions in 1997 to a peak of 260 million prescriptions in 2012 before decreasing by 12% to 228 million prescriptions in 2015. Morphine milligram equivalents dispensed per prescription increased from 486 in 1997 to a peak of 950 in 2010, before decreasing to 905 in 2015. In 2015, generic products accounted for 96% (218/228 million prescriptions) of all opioid analgesic prescriptions dispensed. The remaining prescriptions were dispensed for brand products, of which nearly half were dispensed for one brand product (OxyContin, Purdue, USA).ConclusionsThere has been a dramatic increase in prescriptions dispensed for opioid analgesics since 1997 and an increasing number of opioid analgesic approvals; however, the number of prescriptions dispensed has declined since 2012 despite an increasing number of approvals. Examination of dispensed prescriptions shows a shifting and complex market where multiple factors likely influence prescribing; the approval of new products alone may not be sufficient to be a primary driver of increased prescribing.Visual AbstractAn online visual overview is available for this article at http://links.lww.com/ALN/B705.

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