Curbing the Opioid Epidemic in the United States

Abstract

HRONIC PAIN IS A MULTIDIMENSIONAL PROBLEM,WITH significant influence on the culture and economy of the United States. Although chronic pain associated with cancer is distinct from that associated with musculoskeletal or functional pain syndromes, common treatment strategies for both include the administration of opioids. Although it appears logical to prescribe potent analgesics to patients with chronic noncancer pain, the data to support the effectiveness of opioids for this indication are limited. 1 Prescription opioid analgesics have been used for decades for the outpatient treatment of acute medical, traumatic, and postoperative pain, as well as for chronic pain associated with malignancy and terminal disease. In the 1980s, a combination of factors, both patient-centered and business-oriented,ledtothebroaderuseofopioidsfortreatment of patients with chronic noncancer pain. This expanded use resulted in the dispensing of large quantities of opioids, of which a consequential, increasing minority was diverted to nonmedical uses, including inappropriate selfmedication and recreational abuse. Even used as prescribed, opioids are associated with significant morbidity and mortality. Reformulation of opioids as extended-release preparations to allow longer dosing intervals for patients in discomfort had the unintended consequence of making available large quantities of high-dose opioids and priming the epidemic of opioid misuse, abuse, addiction, and mortality. Sales of opioid analgesics, includingbothregular-andextended-release,increased4-foldbetween 1999 and 2010. 2 In 2008, more than 14000 deaths were related to the misuse of prescription medications, the vast majority of which were opioid analgesics. 2 Health care professionals, who may have prescribed analgesics to meet Joint Commissionanalgesia standards (and possibly to protect their patient satisfaction scores), 3 have become the primary supplier of the drugs fueling this epidemic. The US Food and Drug Administration (FDA) is tasked with ensuring that medications are effective and safe. However, the FDA is prevented from interfering with the “practice of medicine.” At the crossroads of these requirements is postmarketing, off-label prescribing, over which the FDA