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Just two decades ago, a little more than 8,000 deaths in the U.S. could be traced to overdose by opioids. By 2017, the number had exploded, with 47,600 deaths involving prescription or illicit opioids, according to the Centers for Disease Control and Prevention — meaning the opioid crisis has overtaken deaths related to firearms, motor-vehicle injuries, alcohol-induced causes, and infant mortality.
Nearly a third of Americans know someone with an opioid addiction, and nearly a quarter said they knew someone who had overdosed, according to an April NPR/Ipsos poll of 1,510 adults.
Public attention is currently focused on a flurry of legal actions against drug-makers and distributors. But while important, these lawsuits promise to do only so much to change the whack-a-mole nature of the opioid epidemic.
“Product liability cases moving forward probably will have an effect on both the kinds of products that sellers of drugs put on the market and how they market them. At least, that’s what we hope,” says Mark Pauly, Wharton professor of health care management and senior fellow at Penn’s Leonard Davis Institute of Health Economics. “One of the problems with trying to deal with the issue by focusing on the pills is that there are alternatives to taking pills, which is heroin, and it’s cheap and easy to get, and fentanyl is also getting into that category. There is no easy solution.”
In fact, although deaths from opioids appear to have abated slightly in 2018, a recent RAND Corporation report sounds the alarm on the startling rise of fentanyl and synthetic opioids, a category that has unleashed a death rate that has grown ten-fold in five years to 30,000 in 2018.
“Cheap, accessible, and mass-produced synthetic opioids could very well displace heroin, generating important and hard-to-predict consequences,” the report states.
Opioid use disorder has been as stubborn as it has been destructive. But a number of public-policy shifts could, if adopted, dramatically alter the course of the crisis.
Doctors on the front lines say that relaxing some laws, changing the kinds of treatments for which payers reimburse and lifting the stigma around opioid addiction would go a long way in reducing deaths as well as future cases of persons with opioid use disorder.
These solutions are well worth fighting for. Much of what the public sees are the grim statistics, often failing to appreciate the value of effective substance use disorder treatment, says Margaret Lowenstein, a National Clinician Scholar at the Perelman School of Medicine and associate fellow at Penn’s Leonard Davis Institute.
“When you can help someone with effective treatment it can be pretty immediately life-changing for the patient,” she says. “It’s not perfect. People have their ups and downs, as they do with any chronic condition. But treatment allows people to do things like go back to work and see their kids and other things that are fundamental. I think if more people were able to see what effective treatment looks like, that would go a long way.”
“Product liability cases moving forward probably will have an effect on both the kinds of products that sellers of drugs put on the market and how they market them.” –Mark Pauly
Easing the Path to Critical Medication
But getting treatment comes with some formidable roadblocks, says Jeanmarie Perrone, director of the Division of Medical Toxicology at the Perelman School of Medicine, professor of emergency medicine and a Leonard Davis Institute senior fellow. Patients with substance use disorder or withdrawal coming into the emergency room can be stabilized with medication. “But often emergency housing facilities and rehab programs don’t allow them to be on medication,” says Perrone, “We need more mandates that say pathways to housing and inpatient treatment must use models that are evidence-based to keep patients safe for the duration. I hear that every day in some form or another. We don’t withhold insulin from diabetics, and this is absolutely just as critical to getting our patients safe.”
The reluctance of some rehab programs to use medication as part of the recovery process “is very deep,” and stems from the Alcoholics Anonymous “abstinence” model, Perrone says. “Some people are huge advocates for that model, but it stigmatizes the use of medication because, according to them, then you are not ‘clean.’ The challenge is that we are not succeeding in de-stigmatizing it to the level of conversation we have about insulin.”
Lowenstein says that the best evidence shows that buprenorphine should be used for long-term maintenance, as opposed to short term detoxification, similar to methadone maintenance. “There are a lot of misconceptions out there that long-term medications for opioid use disorder ‘replace one addiction for another,’ but opioid use disorder is a chronic disease and often requires long-term medication treatment to maintain recovery,” she says. “Unfortunately, medications carry stigma both inside and outside the medical profession, and this remains one of the many barriers to uptake. I think this contributes to reluctance about buprenorphine and other meds.”
Naloxone, sold under the brand name Narcan, is used to reverse the effects of opioids, and has become a commonly used tool to save lives in many cities. “But I still find a lot of groups that don’t know what I’m talking about in the suburbs,” says Perrone. “It’s still not well-known outside of our circle, so more free Narcan is good policy we know is working. But we need more of it.”
The hurdles to critical ongoing medication, though, are substantial, and could become more so.
“The emergency department is probably one of the most critical touch points for beginning to manage the approximately two million people in the U.S. who have an opioid use disorder, the majority of whom are not engaging in any kind of treatment,” says M. Kit Delgado, professor of emergency medicine at the Perelman School and a Leonard Davis Institute senior fellow. Often, incoming patients are “dopesick” — suffering from withdrawal — which is an agonizing combination of sensations and symptoms that includes agitation and anxiety, sweating and shivering, and muscle and bone pain. Buprenorphine is an effective answer.
“Just giving one dose of buprenorphine can completely alleviate the symptoms, and you can have a completely rational and normal conversation,” says Delgado, “to the point that I was working in triage not long ago, had a woman come in who was persistently vomiting and suffering from withdrawal, and after a quick dose of buprenorphine, within 45 minutes she gave me a hug, was connected to one of our recovery specialists via text-messaging, and discharged. She’s still engaged in treatment months later.”
“I think if more people were able to see what effective treatment looks like, that would go a long way.” –Margaret Lowenstein
The drug can be given in the emergency room. However, few doctors are authorized to send patients on their way with a prescription for buprenorphine. Under guidelines of the Drug Addiction Treatment Act of 2000, practitioners must complete an eight-hour course and submit to other requirements to receive a certificate from the DEA allowing them to prescribe it upon discharge. Less than 10% of physicians have this certification, with estimates as low as 2% in some states.
Says Delgado: “If I can take care of someone who has been sexually assaulted and prescribe HIV medication, or treat someone with diabetes or hypertension, or prescribe controlled medications to treat alcohol withdrawal, I don’t see any clinical, moral, ethical or legal reason for this requirement for buprenorphine in light of the current crisis. The irony is, any physician can prescribe opioid pain medications, but there are heavy restrictions on prescribing proven medications to treat opioid addiction.”
Pennsylvania is proposing even heavier restrictions, points out Michael Ashburn, director of pain medicine at the Penn Pain Medicine Center and a Leonard Davis Institute senior fellow. Legislation being considered by the Pennsylvania General Assembly would mandate that doctors prescribing buprenorphine obtain a special state license, with fees up to $500 a year, and would require that patients participate in a state-licensed addiction treatment program, which Ashburn notes are only a small part of programs available for people with addiction.
“It is an incredibly misguided bill,” says Ashburn, adding that it would “create additional barriers to access to buprenorphine treatment and very likely stop ongoing efforts to expand access to opioid addiction treatment in Pennsylvania in its tracks.”
Critics say that patients sometimes sell their buprenorphine pills. However, such diverted buprenorphine is being used to treat opioid withdrawal and not to get high, according to experts.
Until greater political momentum can completely remove the training requirements to prescribe buprenorphine, Delgado says, he would like to see a middle-ground approach that would allow any provider in a hospital setting to prescribe a three-day supply of buprenorphine. “That would allow us to bridge people from withdrawal to whatever resources exist in the community for treatment.”
In 1995, when France eliminated special licensing and expanded the number of doctors permitted to prescribe buprenorphine, the number of overdoses declined by nearly 80% in three years.
As for treatment facilities opposed to buprenorphine, Delgado thinks a policy that limits Medicaid, Medicare and private insurance payments to facilities that offer evidence-based treatment make sense. “It doesn’t have to be offered in every case, because not everyone wants it, but centers should offer it,” he says.
Limiting Opioids the Right Way
One recent attempt to curtail the opioid crisis has created some unintended consequences. The CDC determined that patients receiving over a certain amount of opioid medication per day were at a higher risk of addition, and so many patients were tapered to lower doses. “Now some studies have come out that look at abrupt tapering and find that people start having opioid withdrawal and overdose,” says Delgado. “I think that while it was well-intended, that overzealous interpretation is leading to more harm than good. There is a role for dialing people back slowly and consensually, but enforcing it with an insurance mandate or statutory limits has the potential to be harmful.”
“It’s still not well-known outside of our circle, so more free Narcan is good policy we know is working. But we need more of it.” –Jeanmarie Perrone
Delgado said he has had patients who have had their doses of opioids abruptly cut who subsequently overdosed on heroin in an effort to curb their pain. “When you get on very high doses [of opioids,] your perception of pain also goes up, so when opioid levels are lowered, your sensation of pain goes up,” he said. “They experience high levels of pain and high levels of withdrawal, so they are suffering, unfortunately, and sometimes they treat it with illicit opioids. You try to avoid getting there in the first place, but once they are, those patients have to be treated very carefully.”
Which is not to say that reducing opioid prescriptions — both in dose and duration — is a bad idea. Medicare, some insurance companies and 33 states have now imposed limits. Is it having any effect? A new study by Lowenstein, Delgado, Perrone and others took advantage of a new limit law in New Jersey to evaluate its impact, along with a health system electronic medical record (EMR) alert, on new opioid prescriptions, refill rates, and clinical encounters.
“Impact of a State Opioid Prescribing Limit and Electronic Medical Record Alert on Opioid Prescriptions: a Difference-in-Differences Analysis,” published in the Journal of General Internal Medicine, shows that the prescribing limit and EMR alert were associated with an approximately 22% greater decrease in opioid dose per new prescription in New Jersey compared with controls in Pennsylvania, suggesting the combination of prescribing limits and alerts as an effective strategy to influence prescriber behavior.
It is also the case that sometimes the benefits of putting fewer pills in medicine cabinets aren’t immediately apparent. “A lot of people are fixated on individual patients’ rate of prolonged use, but I think the true benefit of these laws for reducing excessive prescriptions for acute pain is reducing the amount of pills that can be diverted within families or communities,” said Delgado.
So found a study recently published in the Journal of the American Medical Association. Individuals who weren’t even the recipients of an opioid prescription were significantly more likely to overdose when they had a family member who did receive a prescription, according to “Association of Opioid Overdose With Opioid Prescriptions to Family Members,” which drew on data from a major U.S. insurance firm from 2004-2015.
Children were especially at risk, the study determined.
Settlements Offer Justice, but What Then?
In play at the moment are more than 2,500 lawsuits filed by state and local governments against drug-makers and distributors. These cases could yield billions of dollars to be used to put back together some of the communities and families that have been devastated by the crisis. In a so-called “bellwether case” that will set the tone for what’s to come, Johnson & Johnson on October 1 agreed to a $20.4 million settlement in opioid lawsuits by two counties in Ohio.
For any settlements to make a difference, “the destination of the money is one of the big questions,” said Robert I. Field, professor of law and professor of health management and policy at Drexel University and a Wharton lecturer in health care management, on a recent SiriusXM Knowledge@Wharton radio show segment. (Listen to the podcast at the top of this page.) “One of the disturbing aspects of the Johnson & Johnson verdict [in Oklahoma for $572 million] and the settlements that came before that is that the state is going to earmark a lot of it for research at the University of Oklahoma. Well, research is fine, but there is a more immediate, desperate need for treatment. The tobacco settlement is infamous for the way many states have used it — not for tobacco cessation, but for closing budget deficits and lowering taxes and things like that. So it’s going to be very important to watch where this money is earmarked.”
And the amount of money needed to combat the opioid crisis is considerable.
“Getting people into inpatient or outpatient treatment is a big endeavor. And then we need money for prevention. We need money for education. We need money to tell the next generation that opioid prescribing is not the answer to pain,” according to Perrone, who also appeared on the Knowledge@Wharton radio show. “And part of that, I think — one of the social benefits of having these litigations — is that there is education that comes out of this. People realize: ‘Wow, if this is a lawsuit because of negligence or false claims or fraud, then maybe I should be more skeptical if my doctor prescribes me an opioid and I don’t think I need it.’”
“The irony is, any physician can prescribe opioid pain medications, but there are heavy restrictions on prescribing proven medications to treat opioid addiction.” –M. Kit Delgado
Doctors could also be more skeptical about opioids, and many now are more so than they once were. But more doctors might take less risk if they knew something about the outcome of each patient’s story. To test that idea, a group of Southern California researchers conducted a randomized trial of 861 clinicians prescribing to 170 patients who subsequently suffered fatal overdoses. Clinicians in the intervention group were told of their patients’ deaths and sent a safe-prescribing injunction from their county’s medical examiner. Physicians in the control group were not.
The result was that milligram morphine equivalents in prescriptions subsequently filled by patients of the doctors informed of death dropped by nearly 10% after three months. “We also observed a significant reduction in high-dose prescribing in the intervention group compared with the control group,” wrote the authors of “Opioid Prescribing Decreases After Learning of a Patient’s Fatal Overdose,” published in Science in 2018.
“Forensic analysis is obviously too little, too late,” says Perrone, “but that is one of the places where we could use data, and we haven’t done that yet. So is there a policy where the medical examiner has to notify every clinician whose name is on a pill bottle after an overdose?”
Sharing data is particularly urgent given the nature of this epidemic: the fact that it keeps morphing, which makes it difficult to attack. The appearance of synthetics is a particularly disturbing development. For one thing, they kill on an unprecedented scale, and for another, it appears that the problem will get worse before getting better, according to the RAND report, “The Future of Fentanyl and Other Synthetic Opioids.”
Synthetics have so far spread unevenly across the U.S. And so what would happen if they started to saturate the rest of the country?
“The math is simple and distressing,” write the authors. “If the entire nation had a death rate of even half of what New England experienced in 2017, it would imply a substantial increase in deaths.”
Moreover, the report notes that fentanyl is not even the most potent synthetic opioid out there. In 2017, deaths in Ohio and British Columbia soared from carfentanil. Originally marketed as a tranquilizer for large animals such as elephants, it is a hundred times more potent than fentanyl.
“No one knows how the trajectories will actually evolve, but it would be prudent to prepare for the problem to get worse before it gets better and to anticipate that it will persist for the indefinite future, rather than flash and recede,” says the report.
Plus, Lowenstein says, it’s also important to understand how larger environmental factors have caused the opioid crisis to flourish with such alarming speed and stubbornness.
“In addition to opioids, we are seeing increases in other types of substance use like stimulants and alcohol,” she says, and it’s critical to ask why. “Policies to address opioids specifically are important, but some of the drivers of addiction are deeper. This crisis is also linked to much broader social determinants of health, trauma, mental illness, social isolation or lack of employment, and other larger forces right now. Opioids are impacting a lot of people, but these larger underlying issues go beyond opioids.”