New Opioid Analgesic Approvals and Outpatient Utilization of Opioid Analgesics in the United States, 1997 Through 2015

Grace Chai, Pharm.D.; Jing Xu, Ph.D., M.A.; James Osterhout, Ph.D.; Mark A. Liberatore, Pharm.D., R.A.C.; Kathleen L. Miller, Ph.D.; Carolyn Wolff, Ph.D.; Marisa Cruz, M.D.; Peter Lurie, M.D., M.P.H. and Gerald Dal Pan, M.D., M.H.S.


Anesthesiology. 2018;128(5):953-966. 

In This Article

Abstract and Introduction


Background: The 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.

Methods: Prescribing 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.

Results: From 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).

Conclusions: There 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.


DURING the past two decades, there has been a marked increase in outpatient utilization of opioid analgesics in the United States, paralleled by increases in abuse, misuse, and adverse outcomes, including addiction, overdose, and death.[1,2] In 2015, a reported 33,091 deaths were attributed to opioid overdose (prescription and illicit), an increase from 8,050 deaths in 1999.[3] Addressing the prescription opioid abuse epidemic is a national priority.[4,5]

While the increased prescribing of opioids is widely considered to have contributed to this public health emergency, the specific factors leading to increased prescribing are the subject of debate.[6] For example, with increasing acknowledgment that pain was often undertreated, Congress declared in 2000 that the upcoming decade would be the "Decade of Pain Control and Research."[7] Pain has also been considered the fifth vital sign since The Joint Commission, an organization that accredits and certifies healthcare organizations such as hospitals, included standards for pain assessment and treatment in 2001.[8]

During the last 20 yr, the U.S. Food and Drug Administration (Silver Spring, Maryland) has approved numerous new opioid analgesic products. However, most of these new products contain active moieties that have been used for decades in older products. In fact, only one new molecular entity opioid analgesic was approved during this period: tapentadol (2008). New product development of opioid analgesics has focused on new formulations of existing products, including, in some cases, the development of abuse-deterrent formulations.

In recent years, lawmakers, advocacy groups, and others have voiced concern that approvals of new opioid products are driving prescribing.[9–11] In theory, new products could drive prescribing by expanding the market with new innovator products, thus increasing product choice, or by increasing accessibility to less expensive products (e.g., generic products). Using nationally estimated prescription claims data and U.S. Food and Drug Administration resources, we examine patterns in prescriptions dispensed in the outpatient setting relative to new opioid product approvals to shed light on the relationship between prescribing patterns and product approvals.