Despite massive efforts to bring the opioid mortality epidemic under control, it continues to rage unabated. Overall, there were more than 70,000 drug overdose deaths in 2017, with roughly 66% involving an opioid, according to new projections from the Centers for Disease Control and Prevention (CDC). And the number of deaths continues to rise.
Overdose deaths have more than quadrupled over the past 20 years. Some 117 people die of an opioid overdose every day in the United States.
Medically prescribed opioids—with back pain being a leading indication—contribute to 30-40% of those deaths, according to various estimates. And prescription opioids, legitimate or diverted, are often the entree into heroin, fentanyl, and other illicit narcotics—which trigger the majority of opioid deaths.
The number of visits to emergency departments for opioid overdoses has also risen sharply—a likely signal of an impending further wave of opioid mortality. “From 2015 to 2016 opioid overdose deaths increased 27.7%, indicating a worsening of the opioid overdose epidemic...” according to a recent study by CDC researchers. (See Vivolo-Kantor et al., 2018.)
Even though medically prescribed opioids trigger a minority of opioid deaths, they are still a major primer and propellant for the larger epidemic. More than eight million Americans are currently on long-term opioid therapy. In excess of two million have diagnosable opioid use disorders, such as such as addiction, drug craving, and withdrawal problems. (See Hartney, 2018.) Medicine cabinets across the country are filled with unused prescription opioids, fueling continuing diversion and misuse.
Nora Volkow, MD, Director of the National Institute on Drug Abuse, recently gave a bleak characterization of the status of the opioid mortality epidemic in a keynote address to the National Institute of Health's Pain Consortium in May.
“We had hoped that the opioid overdose death rate was going down. Unfortunately, it has risen. Over the past two years [2015 and 2016], we have seen 22%-24% increases in opioid fatality rates in the US, despite a major effort to restrain these problems.”
“We have been unable to control this epidemic,” Volkow acknowledged. (See Volkow, 2018.)
Opioid Epidemic in a State of Continuous Flux
One of the problems in addressing this epidemic is that it is now in a state of continuous flux. The first wave of opioid overdose death reflected massive inappropriate use of opioids in medical settings in the early 1990s, according to Volkow.
As the medical establishment began to focus on overprescription of opioid in medical settings, the epidemic shifted sideways. “The overprescription of opioid medications led to misuse,” said Volkow. “Addiction to prescription opioids resulted in an epidemic of heroin use [beginning around 2010]. The third wave of this epidemic [beginning around 2013] involved the emergence of illicit versions of the opioid fentanyl with higher potency and greater profitability in the black market than heroin,” she explained. And many observers are expecting new and more deadly formulations of illicit opioids hitting the black market in coming months and years.
A Trillion Dollar Problem
The costs of this epidemic are truly staggering. The economic toll of the opioid crisis from 2001 to 2017 exceeded $1 trillion (in 2016 dollars), according to a recent report by health systems research firm Altarum. It will impose additional costs of $500 billion through 2020, if this epidemic cannot be reined in. (See Altarum, 2018.)
These costs affect multiple sectors of society, according to this health research firm; the private sector in lost productivity and health care costs; federal, state and local governments in lost tax revenue and spending on health care, social services, education, and criminal justice.
“The greatest cost comes from lost earnings and productivity from overdose deaths—estimated at $800,000 per person based on an average age of 41 among overdose victims. This figure is largely made up of lost wages of workers and productivity losses of employers, but it also weighs on government in the form of lost tax revenue. It has increased in recent years as the epidemic has transitioned away from older people to younger ones and from prescription opioids to illicit drugs,” according to the Altarum analysis.
Is the Level of Medical Opioid Use Falling?
What about the use of opioids in medical settings? Has the United States turned the corner? Is opioid prescription declining substantially? Are healthcare providers and patients turning to other treatments in place of opioids? The answers to these questions aren't completely clear.
A recent study suggested that the level of opioid prescription in medical settings has been declining for several years. And that healthcare systems may be starting to get a handle on this problem.
The IQVIA Institute for Human Data Science, a pharmacy and healthcare research organization, recently concluded that the volume of opioid prescriptions in medical settings in the United States is in steady decline. (See IQVIA, 2018.)
“In 2017, 23.3 billion fewer morphine milligram equivalents (MMEs) were dispensed to patients on a volume basis. Actual dispensed opioid prescriptions decreased 10.2 percent, while patients receiving high doses (at least 90 morphine milligram equivalents/day) declined by 16.1 percent. Factors driving this opioid prescription decline include major clinical guideline shifts, payer reimbursement controls, intensive medical education efforts by state/specialty medical societies, as well as regulatory and legislative restrictions,” according to a summary of the IQVIA analysis.
Some medical organizations have been quick to crow about these results. The American Medical Association Opioid Task Force portrayed this study as a major turnaround. “A 22 percent decrease in opioid prescriptions nationally between 2013 and 2017 reflects the fact that physicians and other healthcare professionals are increasingly judicious when prescribing opioids. It is notable that every state has experienced a decrease...” according to the Task Force.
However, one can argue that the IQVIA study doesn't provide a definitive portrait of the opioid crisis. It only offered information on opioid prescriptions dispensed at the cross-section of pharmacies that IQVIA tracks. And it provided no insights on patients who shift from medical opioids to heroin and fentanyl. So at best this is a limited snapshot of this crisis.
A Study of 48 Million Patients
And another large new study suggests that there has been no major reduction in opioid prescription use in key patient populations.
Emergency medicine specialist Molly Jeffery, MD, of the Mayo Clinic and colleagues reported recently on opioid use in a population of 48 million individuals from 2007 through 2016—based on a retrospective analysis of claims data. This included study subjects with commercial insurance, retirees 65 years or older with Medicare Advantage insurance, and disabled individuals younger than 65 years on Medicare with a permanent disability. (See Jeffery et al., 2018.)
“Opioid use was common, with annual use prevalence ranging from 14% among commercial beneficiaries to 52% among disabled Medicare beneficiaries,” according to Jeffery et al.
Jeffery et al. did find a decline in opioid use in the middle of this study period, but it did not last. “Our data suggest not much has changed in prescription opioid use [since then],” said Jeffery recently.
“Although opioid use prevalence and average dose of opioids leveled off after peaks in 2012-13, all three insurance coverage groups had a higher average dose of daily [morphine milligram equivalents] in 2017 than in 2007. In the two Medicare beneficiary groups, the prevalence of opioid use was higher in 2016 than 2007, which suggests that there may be opportunities to further optimize opioid prescribing practices to conform to guidelines,” according to Jeffery.
The prevalence of opioid use was particularly ominous among disabled Medicare beneficiaries. “We found very high prevalence of opioid use and opioid doses in disabled Medicare beneficiaries, most likely reflecting the high burden of illness in this population. Doctors and patients should consider whether long-term opioid use is improving the patient's ability to function, and if not, should consider other treatments either as an addition or replacement to opioid use. Evidence-based approaches are needed to improve both the safety of opioid use and patient outcomes including pain management and ability to function,” according to Jeffery et al.
So what is a good take-home message about opioid use in medical settings, according to Jeffery? “I think we need to look at this and say ‘This problem isn't solved yet,’” she said.
Pain specialist and coauthor Michael Hooten, MD, offered a similar observation. “Based on these historical trends, there remains an unmet patient need to better target the use of prescription opioids,” said Hooten in a statement accompanying the study.
In a separate interview recorded for the press at Mayoclinic.org, Hooten explained that the utilization of opioids has changed dramatically over recent decades, with positive and negative ramifications.
“I believe that in the past 20 years, the indication and the setting in which opioids are provided has changed dramatically,” said Hooten. People are able to get relief from severe pain, but they are also able to get prescriptions for opioids when less addictive options such as ibuprofen may work just as well.
“If they are predisposed to develop addiction, either neurobiologically or from a behavioral perspective, then all of a sudden, we are selecting the individuals who may go on to have long-term problems,” said Hooten.
Hooten said educating people about the dangers of opioid misuse may be an important step in managing this public health crisis. (See Sparks, 2018.)
Why is This Study Believable?
Why should researchers, patients, and healthcare providers believe this study rather than more optimistic previous reports, ones suggesting a steep decline in opioid use?
“The big issue here is that we have been able to look at opioid use on an individual level,” said Jeffery. “Prior studies have [mostly] used market-level data. What that means is that they know all the prescriptions that were filled by everybody. But they don't know much about the people that actually filled them”
“Because we have claims data for a large population, we were able to go in and say people of this age, people of this sex or gender, people of this race or ethnicity, what do their opioid prescription patterns look like? And it produced a distinctive picture of a worsening crisis,” she added.
Are the Two Studies Contradictory?
Jeffery said her new study does not necessarily contradict the conclusions of the IQVIA analysis. The two studies simply looked at different aspects of opioid use with differing research methods.
“Our study reported on the proportion of people using opioids at least once in a given time period. The IQVIA analysis reported on the number of prescriptions filled per 100 people. Suppose you had 100 people, 1 of whom filled 10 prescriptions, 5 of whom filled 1 prescription each, and 94 of whom filled 0, then our study reports that as 6% of people using any opioids, while the IQVIA report reports it as 15 prescriptions per 100 people,” Jeffery explained via email.
“In the next year, if one person filled 5 prescriptions, 5 filled 1 each, and 94 filled 0, we would report that as unchanged—still 6% using opioids—while the IQVIA report would state that there was a 33% decline in opioid use from 15 fills per 100 people to 10 fills per 100 people. Both measures are correct and both are important. They are just looking at different aspects of these problems,” said Jeffery.
“That's the major explanation for the difference. Another key difference is in the population included in the studies. Our study used insurance claims data. Our study population includes only people with commercial insurance (either through an employer or purchased on the individual market) and people with Medicare Advantage insurance, also known as Medicare part C. This is a group of people who qualify for Medicare insurance and have opted for a private insurance version of the product as opposed to the version provided directly by the government. We observed their fills only when they submitted them to insurance for payment,” she added.
“The IQVIA study included anyone who filled a prescription in one of the pharmacies they track, regardless of how they paid for their prescriptions. That included people who are uninsured, had Medicaid, VA, or Tricare, or have some other insurance but chose to pay cash (or were forced to pay cash because the medication wasn't covered by their insurer).”
How Might the Results of the Two Studies Be Combined?
A BackLetter editor asked Jeffery how the results of the two studies might be synthesized in an article.
“I think you could be comfortable suggesting the per capita number of prescriptions filled in the US has gone down somewhat, based either on the IQVIA report or the CDC report using the same data: https://www.cdc.gov/mmwr/volumes/66/wr/mm6626a4.htm.
“You could add that our BMJ study suggests that the overall proportion of people taking any opioids has not changed much. Putting those two data points together and assuming the slightly different populations show the same overall trends, this may suggest that roughly the same number of people are getting a smaller quantity of opioids and prescriptions,” Jeffrey said.
Disclosures: None declared.