The opioid crisis is an ever-changing public health menace. Individuals who start using opioids for legitimate medical reasons are at risk for becoming dependent when they mix opioids with other drugs or use opioids recreationally. Treatment can help those who become dependent, but it is costly and access to treatment is not reliably available in all parts of the country. Policies to curb prescribing may make opioids unobtainable for individuals who would benefit from them clinically. Policies to monitor opioid prescriptions have different outcomes in different places. Individuals who have become dependent on one type of drug may switch drug markets if their drug of first choice becomes less readily available.
Policies targeting one dimension of the crisis may have unintended consequences on other dimensions. Current research often treats opioid policies as if they were implemented in isolation, ignoring that many policies may be implemented at different times in a given area. Studies also fail to consider how the local environment influences the effects of policies.
The research summarized here describes RAND work on multiple dimensions of the crisis, including the health care consequences of opioid misuse; policy effects at federal, state, and local levels; treatment access, equity, and effectiveness; and harm reduction.
Expanding Alternatives for Managing Pain
Opioids are not the only option for managing pain. Non-pharmacologic approaches abound:
- high tech, such as electric nerve stimulation;
- more conventional, such as ultrasound or physical or occupational therapy;
- less conventional, such as acupuncture and mind-body techniques;
- over-the-counter medications, such as acetaminophen or nonsteroidal anti-inflammatory drugs;
- chiropractic care;
- psychotherapy; and
- corticosteroid injections, among others.
How Effective are Alternative Treatments?
Evidence of the effectiveness of these approaches varies across studies and the type of pain. So does their use by clinicians, a target audience for increasing use of non-opioids for pain management. For example, about 60 primary care providers participating in focus groups as part of a larger study felt they did not have sufficient access to non-opioid alternatives.
Perceived barriers included the distance that patients might have to travel for treatment and their out-of-pocket costs, and cultural issues such as providers’ belief that alternative approaches increased their workload and that patients would be resistant to alternative ways to manage pain.
Providers also thought they lacked the training and leadership needed to make this shift in prescribing practice. When a healthcare system promotes non-medication approaches to managing pain and provides access to these approaches, use of non-opioid options rises.
The opioid crisis is an ever changing public health menace.
Promoting Practice Guidelines
Photo by CatLane/Getty Images
Practice guidelines could help providers make decisions about opioid prescribing, but to date, there is scant evidence that guidelines reduce opioid use. For example, a recent study used data from a large national workers’ compensation insurer to explore whether dosage guidelines affected prescribing patterns for patients after an injury. In the study, the insurer identified patients who use of opioids was out of compliance with dosage guidelines; then a physician working for the insurer called the prescribing physician to discuss the patient’s treatment plan. But even this physician-to-physician counseling had no effect on the treating physician’s prescribing behavior.
Do Practice Guidelines Reduce Opioid Use?
The evidence base for practice guidelines related to opioid prescribing is not strong. In a recent study for the Department of Defense, RAND conducted a systematic review of the guidelines and empirical literature for preventing, identifying, and treating prescription drug use in both military and civilian settings to identify best practices. Most of the guidelines they identified noted the lack of strong research evidence for many of the current recommendations for preventing misuse of prescription opioids—for example screening exams or written treatment plans. To date, there is little evidence that practice guidelines, by themselves, are effective.
Improving Prescription Drug Monitoring Programs
A primary care physician may be the first but not the only provider to prescribe opioids for patients. For example, patients who are seeking opioids for non-medical reasons may “doctor shop” to obtain a supply larger than what any single physician might prescribe. Prescription drug monitoring programs are an important tool for preventing this kind of misuse. The programs are state-specific databases that track the prescribing and dispensing of controlled prescription medications. Physicians could use such information to inform their own prescription decisions, potentially preventing drug-related harms.
Do Prescription Drug Monitoring Programs Work?
Although all 50 states now have prescription drug monitoring programs, they vary substantially in their components (e.g., the scope of the drugs monitored) and implementation (e.g., the degree to which providers have access to program data, or how often data are collected). Some studies have found that these monitoring programs reduce drug-related mortality and ED visits. Others have found no effect. But states with more complete and timely opioid monitoring have achieved greater reductions in overdoses compared with states that have less comprehensive programs. What’s needed are studies to better understand which features of prescription drug monitoring programs can drive policy impact.
Decreasing High Risk Prescribing
Overprescribing is widely viewed as a major reason for the continuous rise in opioid mortality through 2010. Eliminating “high risk” prescribing could preemptively thin the ranks of individuals who could become dependent on opioids for which they have legitimate prescriptions.
Who Is at Risk for Inappropriate Prescribing?
Researchers examined claims data for Medicaid enrollees in four states to understand the prevalence of high risk prescribing and to identify individual and county level factors associated with it. The team used three measures of high-risk prescribing-- high dose prescriptions (using a dose level defined as high in the literature), overlapping opioid prescriptions (where more than 25 percent of days in a treatment episode have overlapping opioid prescriptions), and overlapping opioid and benzodiazepine prescriptions for at least five days during an episode. These measures of high-risk prescribing are linked to overdose deaths.
The team found that about 40% of opioid treatment episodes involved at least one measure of high-risk prescribing—most commonly high dose opioid prescribing. Individuals most likely to be associated with high risk prescribing were white, older, and residents of non-metropolitan counties. Enrollees who had a recent prior diagnosis of major depression were most likely to have higher rates of all types of high-risk prescribing. Indicators of high-risk prescribing varied considerably across states, suggesting that efforts to reduce high-risk prescribing will need to be state-specific.
An examination of potentially inappropriate prescribing (PIP) among Massachusetts residents between 2011 and 2015 established that more than 1 in 10 of individuals who received prescription opioids experienced at least one kind of PIP, and PIP became more common with increasing age. This study also demonstrates how an online state prescription monitoring program can help identify PIP in real time, raising the possibility of developing a clinical risk score, based on multiples types of PIP, that could be displayed in real time for providers as part of the online state prescription monitoring program.
Understanding Unanticipated Policy Consequences
Many prevention efforts have sought to reduce the risk of abusing opioids by disrupting their supply in some way. One such effort is the reformulation of OxyContin in 2010. In its original formulation, OxyContin could be crushed to deliver highly concentrated amounts of oxycodone that could be ingested, inhaled, or injected. Reformulation eliminated the opioid “rush” by making it difficult to crush or dissolve the pill, and the original reformulation was removed from the market.
But actions can have unintended consequences. When OxyContin became harder to get, addicts switched to other drugs, including heroin and fentanyl. RAND researchers explored the relationship between reformulation and the dramatic increase in heroin overdoses, which more than tripled between 2010 and 2014. They found that states with the highest initial rates of OxyContin misuse had the largest increase in heroin deaths, and the increases began immediately after the reformulation.
Disrupting the supply of opioids can have unintended consequences.
Researchers concluded that as much as 80% of the increase in heroin mortality in the years after 2010 may be due to the reformation. Each percentage point reduction in the rate of OxyContin misuse led to three more heroin deaths per 100,000.
Why Did Reformulation of OxyContin Increase Rates of Hepatitis C?
Researchers also found that the reformulation of OxyContin played a leading role in the rapid increase in hepatitis C infections in the United States. The hepatitis C virus is responsible for more deaths than any other infectious disease. The OxyContin reformulation, which led some users to switch to injectable heroin, may have exposed them to the hepatitis C virus. Hepatitis C infections increased three times faster in states that were most affected by the reformulation.
The unintended consequences of the reformulation, which was intended to reduce the supply of abuseable prescription drugs, suggests that such efforts need to be paired with policies that address the harms associated with switching to illicit drugs, including improving access to treatment and efforts to identify and treat diseases associated with injection drug use.
Expanding Access to Treatment
Many of the harms associated with opioid abuse can be mitigated by appropriate treatment. Medication assisted therapy, predominantly methadone and buprenorphine, is commonly accepted to be the most effective treatment for opioid use disorder. Buprenorphine has the additional advantage that it need not be administered in a methadone clinic. This flexibility is especially valuable in rural areas, where methadone clinics are scarce. But not everyone who needs treatment can get it.
In 2002, policymakers sought to increase access to treatment by allowing physicians to get a waiver from the Drug Enforcement Administration to prescribe buprenorphine. Initially, waivered physicians were limited to treating only 30 patients simultaneously. In 2006, the limit was raised to 100 and subsequently to 250 patients.
Increasing the number of physicians who could prescribe buprenorphine substantially increased potential access to treatment, especially in rural areas. Physicians with 100-patient waivers are largely responsible for the increased access and utilization.
Why Doesn't Waivering Physicians to Prescribe Buprenorphine Expand Access to Treatment?
Having more waivered physicians with 100 patient limits doesn’t necessarily translate into a lot more prescribing and many more patients for each new physician. Other research examined data from prescription drug monitoring programs in California, Maine, and Ohio between January 2010 and April 2015. Researchers analyzed the prescribing patterns of physicians, looking at the number of patients they treated monthly, how long a treatment episode lasted, and how close prescribers were to practicing near their patient limits.
Waivered physicians with 100-patient limits accounted for more than half of all treatment episodes. But nearly half of 30-patient waivered physicians did not prescribe any buprenorphine at all during the study period; 100-patient prescribers also had some months in which they did not prescribe any buprenorphine.
Overall, few physicians were practicing near their patient limits, so just increasing the number of waivered physicians and raising patient limits may not increase access to buprenorphine in any meaningful way.
It’s not clear why waivered physicians were not prescribing as much buprenorphine as they were allowed to do. Reasons might include lack of physician confidence in treating a complicated patient population, insufficient availability of counselors for patients receiving buprenorphine, low reimbursement rates, inadequate coordination and payment systems, and the potential stigma associated with treating these patients.
Analyzing the Equity of Expanded Treatment Access
Medicaid pays for more than one-third of treatments for opioid use disorder, so understanding how expansion efforts affect Medicaid enrollees is essential for assessing this approach. Researchers analyzed Medicaid claims data from 2002 to 2009 from 14 states representing about half of the U.S. population and about half of all 2009 Medicaid enrollees. They found that increased access to buprenorphine was indeed benefiting Medicaid enrollees, substantially increasing the number who were receiving medication assisted treatment.
Who Benefits from Expanded Coverage for Opioid Use Disorder Treatment
But the benefits were not the same everywhere. Enrollees living in urban counties with a low poverty rate and a low percentage of Hispanics or blacks were significantly more likely to receive buprenorphine than enrollees living in other counties. Unfortunately, this finding is consistent with many other studies highlighting an historical pattern of disparities in health care services for these vulnerable populations.
Assessing the Quality of Treatment for Opioid Use Disorders
In other clinical areas, quality of care can be measured by examining how well the care delivered meets recommended standards, as determined by clinical experts. Unfortunately, we do not currently have validated quality indicators for treating opioid use disorders.
How Good Is the Quality of Treatment for Opioid Use Disorders?
To assess the quality of care for opioid abuse, a RAND team used quality indicators developed by clinical experts, found in the scientific literature, or define by clearinghouses such as the National Quality Forum. Measures included treatment retention, treatment engagement, and psychosocial therapy and psychotherapy associated with substance abuse disorders. The team examined administrative records for nearly 340,000 veterans who were treated by the Veterans Health Administration for an opioid abuse disorder between October 2006 and September 2007. Their goal was to determine if the quality of care for opioid abuse these veterans received affected their mortality 12 and 14 months after treatment.
Results show unequivocally that quality of treatment for an opioid abuse disorder does matter. Overall, veterans whose care met the quality requirements had up to 25 percent lower mortality rates 12 and 14 months after treatment. These findings suggest that validating quality of care measures for substance abuse treatment, and applying those measures to ensure that quality care is being delivered, are essential in containing opioid abuse. Access to treatment is a necessary but not sufficient strategy for improving patient outcomes, and developing measures of quality for treatment should be a national priority. This study is one of the first to assess how quality of care affects patient outcomes.
Many of the harms associated with opioid abuse can be mitigated by appropriate treatment.
Understanding an Evolving Epidemic
The drug crisis and the risk of overdose continue to evolve. A recent study examined new opioid prescribing patterns in U.S. patients at increased risk of overdose.
Initial opioid prescriptions decreased from 2010 to 2015, suggesting that the recent increase in opioid-related deaths may be associated with factors other than physicians writing new opioid prescriptions—for example, an increase in the rate of death from synthetic opioids, such as fentanyl, and a steady increase in heroin-related opioid deaths and deaths from natural and semisynthetic opioids, such as oxycodone.
China is a major source of fentanyl entering the United States. China’s export-led economic strategy and lack of regulatory oversight have created favorable conditions for producing and exporting synthetic opioids and related chemicals. The entry of illicitly manufactured synthetic opioids to the U.S. drug market presents additional challenges for U.S. drug policy.
Can the Flow of Fentanyl from China Be Contained?
China's central government has promised to crack down on fentanyl manufacturers, but enforcement of such policies is typically done at the provincial level, where there is little infrastructure in place to regulate the drug and chemical industries.
Researchers say China's leaders recognize that they have a problem but are unlikely to contain the illicit production and distribution of fentanyl in the short term because enforcement mechanisms are lacking. And producers are quick to adapt, impeding the ability of Chinese law enforcement to stem the flow to global markets.
In recent testimony to Congress, researchers recommended actions at the federal level to address the problem.
- Most of U.S. drug policy data collection and analysis systems are inadequate to track arrival of these new and emerging drugs. Congress could reintroduce expanded data collection systems to improvement measurement and reduce lags in data.
- Congress could encourage federal authorities to use supply-side interventions strategically by working with Chinese counterparts to strengthen the country’s regulatory and interdiction capabilities.
- Congress could also encourage U.S. regulators to help their Chinese counterparts to improve joint monitoring and evaluation efforts of regulation violations.
Most important, “Congress could strengthen federal efforts aimed at reducing demand for illicit opioids. Reducing demand includes improving access to existing and proven therapies, such as methadone and buprenorphine. Congress could encourage expansion of pharmacological treatments covered by private and public insurance, subsidize the cost of medication treatments to those who cannot afford them, and reduce regulatory barriers to providing them. Congress could also direct federal health authorities, such as the FDA, to assess additional innovative and evidence-informed medication treatments.”
Photo by Brian Snyder/Reuters
The Centers for Disease Control and Prevention (CDC) recommends that clinicians consider offering naloxone to patients at increased risk for opioid overdose, including patients with concurrent benzodiazepine use. States have implemented many different kinds of laws intended to increase access to naloxone, but few studies have examined which laws are most effective.
Researchers examined state-level changes in both fatal and nonfatal overdoses from 2005 to 2016 across the 50 states and the District of Columbia after naloxone access laws were adopted. They looked at three kinds of laws: those that gave pharmacists direct authority to prescribe naloxone, those that gave them indirect authority, and other laws such as Good Samaritan laws.
What Kind of Naloxone Laws Work?
Naloxone access laws can save lives, but the details matter. States that adopted naloxone access laws giving direct prescription authority to pharmacists had significant decreases in fatal opioid-related deaths. Other types of naloxone access laws did not seem to affect opioid overdose rates.
Understanding the Ecology of Opioid Abuse
Opioid abuse is not just a clinical problem. It is influenced by social factors and availability of health care in a community. That influence is highlighted in a study of neonatal drug withdrawal, also known as neonatal abstinence syndrome (NAS), which infants can experience if they are exposed to an opioid before they are born. Like opioid overdoses and other opioid-related problems, NAS does not occur in a vacuum.
To better understand how social and economic factors might affect rates of NAS, a recent study examined more than 6,300,000 deliveries—about one-fourth of annual deliveries nationwide—in 580 counties across eight states: Florida, Kentucky, Massachusetts, Michigan, New York, North Carolina, Tennessee, and Washington.
How Might a Community Affect Opioid Use?
The researchers examined the supply of clinicians—including primary care and mental health care providers, as well as obstetricians—in each county. They investigated economic conditions, such as current and persistent unemployment and the percentage of residents living in poverty. Recognizing that the effects of these factors may vary by geographic location, they classified the counties as rural, urban, or rural adjacent to an urban county.
The team found that from 2009 to 2015, the average NAS rate per 1,000 hospital births in these counties rose from slightly more than six to more than 25 per 1,000 births. Over the same period, the ten-year moving average for the unemployment rate rose from 6.5 percent to nearly 14 percent in 2015, reflecting the impact of the 2008 recession.
Both the NAS rate and the unemployment rate varied substantially across counties. But NAS rates were often highest in remote rural counties. Higher rates were also associated with a shortage of mental health providers and high rates of long-term unemployment.
It is not yet clearly understood how economic conditions are linked to higher NAS rates. But social and economic support such as that provided by the USDA Community Facilities Direct Loan and Grant Program could potentially moderate some of the damaging effects of persistent unemployment.
To help decisionmakers gauge the potential effectiveness of policies designed to reduce NAS, the research team designed an interactive tool based on study findings. Federal, state, and local stakeholders can use the tool to explore how changing a county's economic conditions or the supply of mental health providers could affect the county's NAS rate.
Thinking About the Opioid Crisis as an Ecosystem
Faced with the challenge of confronting the opioid crisis, policy makers may be tempted to “solve” the problem by eliminating or severely limiting all opioid use. The reaction is understandable; however, eliminating all use would have undesirable consequences, including reducing access for people who benefit clinically from these drugs.
In many ways, it’s useful to think about the opioid epidemic as an ecosystem. Policies targeting one part of the system may affect other parts of the system that they weren’t intended to target. The effects of reformulating OxyContin is a classic example. Successfully confronting the opioid crisis will require anticipating how specific policy effects can ripple widely throughout the ecosystem.
Adopting this kind of comprehensive perspective can be challenging. Different actors often focus primarily on one population (e.g., providers focused on patients, criminal justice agencies on illicit and illegal opioids, substance abuse specialty providers on treatment population).
Policies and initiatives can target different dimensions of the system—e.g., efforts to minimize harm, expand treatment, reduce the risk of escalating to dependence, decrease the number of individuals unnecessarily exposed to opioids.
The opioid crisis may have been driven initially by widespread access to opioid analgesics such as OxyContin, but the crisis now appears to be fueled by heroin and fentanyl, purchased on the black market. If policies do not consider access to other illicit opioids—or at a minimum access to treatment to reduce the demand for opioids more generally—users may not reduce their use of opioids, but instead shift to illegal heroin and fentanyl markets, especially when these markets already exist in their area.
Decisionmakers need tools to help them pay attention to multiple parts of the ecosystem, at the same time. They also need reliable information to understand how policies interact and what effects of the interaction are likely to be.