Current status and evolving role of abuse-deterrent opioids in managing patients with chronic pain

Abstract

Opioids are widely used for the treatment of patients with chronic pain; yet, the increase in their abuse, misuse, and diversion is an ongoing focus of regulatory, governmental, and legal scrutiny. As a consequence, clinicians are faced with numerous challenges in an effort to use opioids in appropriate patients with pain while minimizing the potential for opioid abuse, misuse, and diversion. Policies and programs such as state prescription monitoring programs, which have been in existence for decades, are but one attempt to address some of the issues regarding the prescribing of opioids. Another is a risk evaluation and mitigation strategy for opioids under consideration by the US Food and Drug Administration. At the clinical level, a universal precautions and risk management package that includes risk assessment and patient monitoring is a recommended approach. This approach can also include the use of abuse-deterrent and abuse-resistant formulations designed to reduce the nonmedical use of opioids. Several of these opioid formulations have been approved or should soon be on the market for use in the United States; however, their role and other questions regarding their use remain unanswered. The authors offer their clinical perspective on several of these key questions.

The Epidemic of Prescription Opioid Abuse, the Subsequent Rising Prevalence of Heroin Use, and the Federal Response

“…8,15 Unprepared Prescribers Possibly as a result of the swift adoption of new standards and a relative lack of effective analgesics to treat chronic nonmalignant pain, primary care clinicians began prescribing opioids in greater amounts than ever before, arguably without adequate training. 16 In a 2000 survey of medical residency programs, only 56% of those surveyed required any training in substance abuse and those that did were minimal at best. Although improvements were noted in a 2008 followup survey, these were not uniform across programs.…”

“…13,16 The number of emergency department visits related to POs use increased from 59 to 121 per 100,000 emergency room visits between 2004 and 2008, with a 123% increase in those attributed to hydrocodone and 152% in those attributed to oxycodone. 16 By 2011, 49% of the 5.1 million visits to the emergency department attributed to drug-related emergencies were a result of drug misuse/abuse, with 134.8/100,000 of those involving PO analgesics (second only to the benzodiazepines). 40 Deaths from such unexpected events are also rising.…”

“…8 In 2010, President Obama took a strong stance against PO abuse, reflected in the National Drug Control Strategy report. 8,16,17 Outlining a 5-year plan for reducing opioid abuse, the president emphasized the need for interdepartmental collaboration among government, law enforcement, health care, and regulatory agencies. Proposed approaches to decreasing illegitimate use of POs included increasing drug tracking/monitoring, appropriate disposal, electronic interstate drug monitoring, standardization of screening/prescribing for PO therapy, and treatment/support for current abusers.…”

“…Nonsuicidal death resulting from opioid overdose evidenced a 175% increase between 2001 and 2006 (from 3,994 to 11,001 people). 16 By 2010, of the 38,329 deaths attributed to drug overdoses in the United States, three quarters of the 57.7% that involved psychotherapeutics were opioids. 41 According to the CDC, deaths related to opioid toxicity showed more than a 3-fold increase between 1999 and 2009, and in 2006, opioid deaths surpassed the number attributed to firearms and motor vehicles to become the second leading cause of death or injury among individuals aged 34 to 54.…”

A Clinical Ethics Approach to Opioid Treatment of Chronic Noncancer Pain

“…Progress in managing these potentially restrictive forces has required advocacy from patient groups, professional pain treatment organizations, and coalitions of these and other stakeholders [13]. As the twentieth and twenty-first centuries have unfolded, these limiting influences have combined with growing concerns about prescription opioid diversion and abuse [14,15], making clear the need for a solid, ethical foundation for opioid treatment of chronic nonmalignant pain.…”