Opioids are defined by the U.S. Food and Drug Administration (FDA) as “powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine, among others, and have both benefits as well as potentially serious risks.” When used properly, they can be effective at managing pain. When used improperly, they can lead to addiction, overdose, and even death.
According to the American Society of Addiction Medicine, drug overdose is the leading cause of accidental death in the US, with 52,404 lethal drug overdoses in 2016. Opioid addiction is driving this epidemic, with 20,101 overdose deaths related to prescription pain relievers, and 12,990 overdose deaths related to heroin in 2016.
In 2012, the FDA ordered a Risk Evaluation and Mitigation Strategy (REMS) for extended release and long-acting opioids as part of a multi-agency federal effort to address the growing problem of prescription drug abuse and misuse.
Before and after the REMS program went into effect, rates of opioid overdose or poisoning among those patients who were using extended release and long-acting opioids were stable or had decreased. Medicaid patients had more opioid overdoses than privately insured patients both before and after the REMS. However, because many programs are concurrently working to reduce opioid harm, alternative approaches are needed to formally assess the relation between the REMS and rates of opioid overdose*.
In March of 2016, the Centers for Disease Control and Prevention (CDC) released guidelines for prescribing opioids for chronic pain in an effort to improve communication between providers and patients about the risks and benefits of this therapy. More recently, in 2017 the U.S. Department of Health and Human Services declared a public health emergency and announced a "5-Point Strategy to Combat the Opioid Crisis". Countless others have launched additional efforts to combat the epidemic.
The FDA has since released a “Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention.”The timeline provides chronological information about FDA activities and significant events related to opioids, including abuse and misuse.
As these various efforts play out, it will be important to monitor the degree to which they succeed in the real world. Safety and Epidemiology research is providing insights into the effectiveness of these efforts.