The clinical term is respiratory depression.
“The patient … starts to breath very slow, or stops breathing altogether,” says Dr. Ingrid Binswanger, senior investigator for Kaiser Permanente Colorado’s Institute for Health Research in Denver.
Dosing can play a role, but a person needn’t take too much of an opioid, such as a prescription pain medication, to overdose, explains Robert Lubran, director of the Division of Pharmacologic Therapies at the Substance Abuse and Mental Health Services Administration, or SAMHSA. “Even a small dose of an opioid, and you’re drinking or you’re taking another medication — that can cause you to have this respiratory depression.”
The result can be devastating and final — taking one’s last breath away from them. “That is the mechanism by which patients essentially can overdose and die from opioid medications. That is a known adverse effect of those medications,” Binswanger says.
Earlier this month, Binswanger and Lubran were among the researchers and representatives from a who’s who of governmental health agencies, including the Centers for Disease Control and Prevention, the Health Resources and Services Administration and the National Institute on Drug Abuse, at a two-day meeting hosted by Food and Drug Administration to discuss expanding the use of a drug called naloxone to help curb prescription drug and heroin overdose deaths.
Naloxone is given by injection routinely to patients in hospitals to counteract the effects of opioid pain medications administered during surgery, for example, and it has been shown to counteract the respiratory depression that leads to overdose deaths as well when it’s administered by a health care worker, family member or another bystander to the individual who has taken opioids.
The White House noted earlier this year that its proposed fiscal year 2016 budget for SAMHSA includes $12 million to reduce opioid-related deaths and helps states purchase naloxone, provide education and equip first responders to use it to counteract overdoses. In March, Health and Human Services Secretary Sylvia M. Burwell announced an initiative to reduce prescription opioid- and heroin-related overdose, death and drug dependence that highlighted three priority areas, the second of which was increasing the use of naloxone.
Burwell also highlighted the need to educate and train physicians on making informed prescribing decisions and to expand the use of so-called medication-assisted treatment, combining medication with counseling and behavioral therapies to treat individuals who have substance abuse disorders.
The FDA hosted an initial meeting on naloxone in 2012, signaling the government’s openness to using the drug, and state and federal support has grown swiftly in recent years, making it an increasingly prominent part of the strategy to tackle opioid overdoses in the U.S.
But while the drug’s availability has increased somewhat, experts say it’s still infrequently prescribed, and used in a limited fashion when compared to the vastly growing population of people in the U.S. prescribed pain medication or using heroin recreationally.
In the years since the 2012 naloxone meeting, the FDA has approved an auto-injector product to administer naloxone, and more naloxone products are in the pipeline for ease of use. Its support across the political spectrum has also grown significantly.
“We now get questions from both sides of the aisle asking why naloxone is not more available or why it can’t be made available over the counter,” says Dr. Peter Lurie, the FDA’s associate commissioner for public health strategy and analysis, who organized both the 2012 and 2015 naloxone meetings.
“The agenda this time around … involved [discussing] a number of new methods of distribution, including ambulances, first responders — fire and so on — expanded pharmacy availability, and more focus on co-prescribing of naloxone along with opioids in a clinical setting,” Lurie says.
The spotlight on naloxone comes as the number of people dying from opioid overdose — a leading cause of preventable death in the U.S. — continues to climb, and the need for solutions grows ever more pressing.
“The nation is facing what has been a massive epidemic, first of prescription opioid use and now heroin use,” Lurie says. “The toll of both of these [in terms of overdose] can be reduced by the prompt administration of naloxone based on years of experience on ambulances and in emergency rooms and in other clinical settings.”
Along with mounting momentum on a federal level, roughly two-thirds of states have passed legislation aimed at making it easier for health providers to prescribe it or implementing programs to distribute the drug. Programs targeting heroin users have also made major strides, documenting more than 8,000 overdose reversals — or potential deaths from overdose-related respiratory depression averted by using naloxone in 2013, according to the latest CDC numbers. But even so, so-called co-prescribing, in which a doctor might prescribe naloxone alongside a prescription pain narcotic, remains low, government officials and researchers say.
Research led by Binswanger, published last month in the Journal of General Internal Medicine, found that barriers remain, including doctors’ concerns that talking about the risk of overdose might offend patients or that prescribing naloxone would engender more risk-taking behavior among patients.
“If you provide an antidote, or something that appears to decrease the risk … on a population basis sometimes people become more cavalier in their behavior,” says Dr. Daniel Carr, a professor of public health and community medicine, and director and co-founder of the Pain, Research Education & Policy program at Tufts University School of Medicine. Carr was not involved in the research published in the Journal of General Internal Medicine.
“It’s something like when filters were mandated for cigarettes to capture more carcinogens than unfiltered smoke would deliver to the body,” he says. “I think that created in some people a sense of protection or false safety that they could smoke more and didn’t have to worry about it because the new filters were there.”
Carr still supports the expansion of naloxone prescription generally, but he sees concerns by some providers regarding risk-taking behavior as warranted.
Binswanger, Lubran and Lurie all say there’s no evidence to support the notion that prescribing naloxone increases risk-taking behaviors, such as taking more of a drug. They say the upshot, however — that it could save a live — remains.
Still, robust debate continues about who should be prescribed naloxone among those taking prescription pain medication.
Some at the FDA meeting and in Binswanger’s study — a qualitative survey of a broad swath of health professionals, from physicians to pharmacists — suggested co-prescribing naloxone to all patients prescribed an opioid. There was also discussion of whether it could be made available over the counter in the future.
No decisions have been made, but the snowballing momentum for expanding naloxone’s use may help ensure those questions get answered soon. “At the top of the to-do list is to start to try and develop a consensus for guidelines on co-prescribing,” Lurie says.
But Lurie and others are quick to point out that the drug — no matter how effective it proves to be in addressing the opioid overdose epidemic — remains part of a larger effort that starts with education to prevent overdose deaths.
“We should not forget about the need to treat pain,” Carr says. Despite the stigmatization that has occurred as a result of the opioid overdose epidemic, clinicians say prescription pain narcotics still play an important role in this area.
But the sheer number of overdoses in the U.S. casts a long shadow. As such, experts add that it’s also important to look at alternative medications and methods of treating pain, such as physical therapy.
According to the CDC, 44 people die daily, on average, from prescription pain medication overdoses. What’s more, the agency reported this month that deaths from heroin-related overdoses increased nearly 300 percent between 2002 and 2013.
Certain patients, such as those with a history of drug abuse, do seem to be at higher risk for overdose, Lubran says. People who are taking medications for mental illness, particularly benzodiazepines, are also at greater risk, because of the way the drugs interact with opioids, he adds.
Higher doses of opioids, too, can increase the risk of their being misused or leading to overdose. “More research is suggesting some number around 100, 120 [milligrams] morphine equivalents, is a risk factor,” Lubran says, with the risk to patients measured in comparison to the widely used pain narcotic.
On the contrary, patients prescribed a painkiller or a relatively low dose for a short amount of time, such as for a single dental procedure, typically face a much lower risk of overdose.
“Indeed you can show that a large fraction of the prescriptions occur in people who get a small number of prescriptions in a year, like maybe only one,” Lurie says. “Those people are comparatively at quite low risk for overdose or death than people who are on the higher doses for longer periods of time, or have a history of drug abuse.”
For those prescribed painkillers who are unsure whether naloxone would also be beneficial, he says, it’s important to discuss options with their doctor.
Though availability of the drug varies, depending on factors such as location and the type of pharmacy used, experts say, naloxone is becoming an option for more patients concerned about opioid overdose risk.
Adds Lubran: “You’ve got an enormous number of people that are dying. We’re all trying to figure out here, what can we do to reduce the overdose situation, and this is part of the strategy.”
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