medications, particularly benzodiazepines, also contributed to fatal overdoses. 6 In all, more than 136 Americans die every day from overdoses that involve a prescription or illicit opioid. Moreover, overdose deaths spiked during the COVID-19 pandemic, particularly deaths involving synthetic opioids. 7 These grim statistics illustrate how important it is to keep potential public health consequences in mind when prescribing any type of controlled substance, including opioids. The economic burden of opioid misuse reaches $78.5 billion a year in healthcare, lost productivity, addiction treatment, and criminal justice costs. 8 As of 2018, more than 2 million Americans had an opioid-use disorder (OUD) involving prescription or illicit opioids. Of people age 12 or older in 2019, there were: 4 • 1.6 million new individuals who misuse prescription pain relievers • 949,000 new individuals who misuse prescription sedative-hypnotics • 901,000 new individuals who misuse prescription stimulants Many people who misuse opioids are not receiving regular medical care or prescribed opioids. Indeed, most people who are prescribed opioids for pain treatment do not misuse their medications. However, roughly 21% to 29% of patients prescribed opioids for chronic pain do misuse them, and between 8% and 12% of them develop an OUD. 9 Furthermore, an estimated 4% to 6% of people who misuse prescription opioids transition to non-prescribed opioid and/or illicit opioid use. 10-12 Approximately 75% to 80% of people who use heroin misused prescription opioids first. 10,11 Health care practitioners (HCPs) play a key role in facilitating appropriate use of opioids and other sedating medications when prescribed for acute and chronic pain. Pain care is most effective when it combines multiple disciplines and utilizes a broad range of evidence-based pharmacologic and nonpharmacologic treatment options. 13,14
Opioids are associated with small improvements in pain and function versus placebo when used up to six months; however, evidence of longer-term effectiveness is limited, whereas increased harms from use beyond six months appear to be dose dependent. 4 Moreover, non-opioid options may bring equivalent or better patient outcomes with less risk: a comparative effectiveness review of evidence performed by the Agency for Healthcare Research and Quality found no difference in improvement in pain, function, mental health status, sleep, or depression when opioids versus non- opioid medications were used up to six months. 4 At the same time, there is a recently recognized potential for harm in suddenly discontinuing or rapidly tapering doses in patients who have been on long-term opioids or in forcing patients who have been stable on higher doses to reduce to a set threshold dose. 1,15-17 It is also critical that HCPs recognize and optimally manage OUD when present. Distressingly few people who need treatment for substance-use disorder (SUD) are able to access it, and far more people need treatment for OUD than receive it. In 2012, the treatment gap was nearly a million people, with about 80% of opioid treatment programs nationally operating at 80% capacity or greater. 18 Solutions will include more accessibility of OUD treatment, including greater access to medications to treat OUD, and measures to prevent prescription and illicit drug misuse from developing in the first place. 19 For acute pain and for some chronic pain, unresponsive to non-opioid therapies, opioids may form part of a customized treatment plan. A subset of patients may benefit from treatment with opioids long term, for example, during severe exacerbations of pain during the course of chronic conditions. 20 More than ever, HCPs are called on to optimize a range of available therapies and reserve opioids for when the benefits are expected to outweigh the risks and non-opioid options are inadequate. This educational activity is built on core messages of the U.S. Food and Drug Administration’s (FDA’s) Blueprint for the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). It provides guidance on safely prescribing opioid analgesics, including all extended-release and long-acting (ER/LA) and immediate-release/ short-acting (IR/SA) formulations. It is targeted to all HCPs who treat and monitor patients with pain, not prescribers alone. It stresses the importance of competence in considering and using a broad range of pharmacologic and nonpharmacologic therapeutic options for managing pain as well as in recognizing and managing OUD when indicated. The goal is to equip HCPs to recognize and manage any adverse events that may arise when a trial of potentially long-term opioids is part of a comprehensive treatment plan.
The Challenge of Treating Pain
The experience of pain brings great physical and emotional suffering as well as significant societal costs. Some 50 million U.S. adults live with chronic daily pain, and 19.6 million experience high-impact pain that interferes with daily life and work. 1 Pain is even more common in military veterans, particularly those who have served in recent conflicts: 66% reported pain in the previous three months, and 9% had the most severe pain. 2 The national cost of pain is estimated at between $560 billion and $635 billion annually. 1 Pain that is unremitting and without adequate treatment can lead to a multitude of problems for the person who suffers, including anxiety, depression, disability, unemployment, and lost income. 1 Certain populations are more vulnerable than others to developing more severe chronic pain and disability, including women, older adults, and individuals from minoritized racial and ethnic backgrounds, 3 who are also at risk for having their pain undertreated. 3 People who lack access to optimal pain care experience more complications in medical and psychiatric conditions. 1 Failure to give adequate care for pain from injury or surgery can prolong recovery times, leading to hospital readmissions and transition to chronic pain. 1 The challenge of managing acute and chronic pain is complicated by an ongoing public health crisis related to opioid overdose, a category that includes prescription opioids, heroin, and illicitly- produced fentanyl and its analogues. 4 Numerous families have endured tragedy in the form of opioid- related overdose deaths, which doubled from more than 21,000 in 2010 to more than 42,000 in 2016. 4 As of 2019, of the approximately 71,000 drug-related overdose deaths in the United States, close to 50,000 of them involved opioids, more than 14,000 of which involved prescription opioids (Figure 1). 5 Over the past decade, the fatalities have been strongly driven by a proliferation of illicitly-produced high-potency synthetic opioids, but prescription opioids and other sedating
Figure 1. National Drug Overdose Deaths Involving Prescription Opioids* Among All Ages, 1999-2019 5
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