CDC: Still Not Enough Naloxone   

By Pat Anson, PNN Editor

The Trump Administration is stepping up efforts to increase prescribing of naloxone, an overdose recovery drug credited with saving thousands of lives.

Although naloxone prescriptions have increased dramatically, a new CDC Vital Signs report estimates that nearly 9 million additional prescriptions could have been dispensed last year if every patient with a high-dose opioid prescription was offered naloxone.  Patients are considered “high risk” if they take an opioid dose of 50 morphine milligram equivalent (MME) or more per day.

Naloxone has been used for years by first responders and emergency medical providers to revive overdose victims. Current efforts are focused on expanding access to the drug by prescribing it directly to patients considered at risk of an overdose.

In 2018, CDC researchers say only one naloxone prescription was dispensed for every 70 high-dose opioid prescriptions nationwide. Naloxone “under-prescribing” was even more acute in rural counties, which are nearly three times more likely to be ranked low in naloxone dispensing than metropolitan counties.

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“It is clear from the data that there is still much needed education around the important role naloxone plays in reducing overdose deaths. The time is now to ensure all individuals who are prescribed high-dose opioids also receive naloxone as a potential life-saving intervention,” CDC Director Robert Redfield, MD, said in a statement.

Ironically, federal policies contribute to the under-prescribing. In 2018, most (71%) Medicare prescriptions for naloxone required a copay, compared to 42% for commercial insurance.

In January, the Food and Drug Administration encouraged drug makers to make naloxone available over-the-counter without a prescription. The FDA even developed an OTC label for Narcan, a naloxone nasal spray that sells for about $135. Seven months later, the FDA could not confirm to PNN that any company had submitted an application for an OTC version of naloxone.

Last year the Department of Health and Human Services released guidance urging doctors to “strongly consider” prescribing naloxone to patients on any dose of opioids when they also have respiratory conditions or obstructive sleep apnea, are co-prescribed benzodiazepines, have a mental health or substance abuse disorder, or a history of illegal drug use or prescription opioid misuse.

Many states are also taking steps to increase naloxone prescribing. California now requires doctors to “offer” naloxone prescriptions to pain patients deemed at high risk of an overdose. State law does not make the prescriptions mandatory, yet some patients say they were “blackmailed” by pharmacists who refused to fill their opioid scripts unless naloxone was also purchased. Patients around the country report similar experiences.   

Unintended Consequences

The drumbeat for naloxone comes at a time when sales are already booming. There were 556,000 naloxone prescriptions in 2018, twice as many as in 2017.

There’s no doubt naloxone saves lives, but some researchers say the drug has had little effect on the overdose crisis and may in fact be making it worse. In a recent study published by SSRN, two economics professors warned of “unintended consequences” if naloxone becomes more widely available.

“We expect these unintended consequences to occur through two channels. First, the reduced risk of death makes opioid abuse more appealing, leading some to increase their opioid use — or use more potent forms of the drug — when they have naloxone as a safety net. Some of those abusers may become criminally active to fund their increased drug use,” wrote Jennifer Doleac, PhD, Texas A&M University, and co-author Anita Mukherjee, PhD, University of Wisconsin.

“Furthermore, expanding naloxone access might not in fact reduce mortality. Though the risk of death per opioid use falls, an increase in the number or potency of uses means the expected effect on mortality is ambiguous.”

The researchers said there were anecdotal reports of “naloxone parties” where attendees used heroin and prescription opioids to get high knowing they could be revived. News reports have also quoted first responders who are frustrated that the same opioid abusers “are saved again and again by naloxone without getting treatment.”

The Prescription Opioid Crisis Is Over

By Roger Chriss, PNN Columnist

In a very real sense, the prescription opioid crisis is over. But it didn’t end and we didn’t win. Instead, it has evolved into a broader drug overdose crisis. Opioids are still a factor, but so is almost every other class of drug, whether prescribed or sourced on the street.

The main players in the crisis now are illicit fentanyl, cocaine and methamphetamine. The vast majority of fatal overdoses include a mixture of these drugs, with alcohol and cannabis often present, and assigning any one as the sole cause of death is becoming tricky.

Connecticut Magazine recently reported on rising fentanyl overdoses in that state. According to the Office of the Chief Medical Examiner, fentanyl deaths in Connecticut spiked from 14 in 2012 to 760 in 2018. Fentanyl was involved in 75% of all overdoses last year, often in combination with other drugs

Meanwhile, overdoses involving the most widely prescribed opioid — oxycodone — fell to just 62 deaths, the lowest in years. Only about 6% of the overdoses in Connecticut were linked to oxycodone.

Similar trends can be seen nationwide, mostly east of the Mississippi. Opioids still play a major role in drug deaths, with the CDC reporting that about 68% of 70,200 drug overdose deaths in 2017 involving an opioid. But more than half of these deaths involved fentanyl and other synthetic opioids obtained on the black market.

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According to the National Institute on Drug Abuse, overdoses involving prescription opioids or heroin have plateaued, while overdoses involving methamphetamine, cocaine and benzodiazepines have risen sharply.

In other words, deaths attributable to prescription opioids alone are in decline. Deaths attributable to fentanyl are spiking, and deaths involving most other drug class are rising rapidly. The CDC estimates that there are now more overdoses involving cocaine than prescription opioids or heroin.

Moreover, the crisis is evolving fast. At the American College of Medical Toxicology’s 2019 annual meeting, featured speaker Keith Humphreys, PhD, remarked that “Fentanyl was invented in the sixties. To get to 10,000 deaths took 50 years. To get to 20,000 took 12 months.”

In fact, provisional estimates from the CDC for 2018 suggest we have reached 30,000 fentanyl deaths. And state-level data show few signs of improvements for 2019.

Worryingly, methamphetamine use is resurgent. And cocaine is “making a deadly return.”  Illicit drugs are also being mixed together in novel ways, with “fentanyl speedballs” – a mixture of fentanyl with cocaine or meth – being one example.

Drug Strategies ‘Need to Evolve’

The over-emphasis on prescription opioids in the overdose crisis has led to an under-appreciation of these broader drug trends. Researchers are seeing a need for this to change.

“The rise in deaths involving cocaine and psychostimulants and the continuing evolution of the drug landscape indicate a need for a rapid, multifaceted, and broad approach that includes more timely and comprehensive surveillance efforts to inform tailored and effective prevention and response strategies,” CDC researchers reported last week. “Because some stimulant deaths are also increasing without opioid co-involvement, prevention and response strategies need to evolve accordingly.”   

It is now common to hear about the “biopsychosocial” model for treating chronic pain – understanding the complex interaction between human biology, psychology and social factors. This same model has a lot to offer substance use and drug policy.

Substance use and addiction involve a complex interplay of genetic and epigenetic factors combined with social and cultural determinants. Treatment must be more than just saying no or interdicting suppliers. At present, medication-assisted therapy for opioid use disorder remains hard to access. And other forms of addiction have no known pharmacological treatment.

Addressing the drug overdose crisis will require not only more and better treatment but also increased efforts at harm reduction, decriminalization of drug use, improvements in healthcare, and better public health surveillance and epidemiological monitoring. Further, the underlying social and cultural factors that make American culture so vulnerable to addiction must be addressed.

None of this is going to be easy. Current efforts are misdirected, making America feel helpless and look hapless. Novel and possibly disruptive options may prove useful, from treating addiction with psychedelics to reducing risks of drug use through safe injection sites and clean needle exchanges.

We are long past the prescription opioid phase of the crisis, and are now in what is variously being called a “stimulant phase” and a “poly-drug phase.” Recognition of the shape of the drug overdose crisis is an essential first step toward changing its grim trajectory.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Overdose Crisis Will Worsen, But Not Due to Rx Opioids

By Pat Anson, PNN Editor

The opioid crisis will “substantially worsen” in coming years and could result in the overdose deaths of over a million Americans by 2025, according to an eye-opening new study. Because most of the deaths will involve illicit opioids, researchers say limiting the supply of prescription opioids will have only a “modest” effect in reversing the trend.      

The study, published in JAMA Network Open, is based on mathematical models developed by a team of researchers at Harvard Medical School, Boston University School of Medicine, Pennsylvania State University and other academic institutions.

“Our study also highlights the changing nature of the epidemic. The opioid crisis is expected to worsen in the next decade owing to multiple factors,” said lead author Jagpreet Chhatwal, PhD, a researcher at Massachusetts General Hospital.

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“First, the number of individuals using illicit opioids is expected to increase substantially. Second, unlike historical trends where prescription opioid use has served as a path to heroin use, more people are directly initiating opioid use with illicit opioids. Third, there has been a rapid increase in illicit opioid lethality, likely mainly driven by the infiltration of the heroin supply with the highly potent synthetic opioid fentanyl.”

Under a “base-case” scenario, with the opioid crisis stabilizing by 2020, researchers project that over 700,000 Americans will die from opioid overdoses from 2016 to 2025. Nearly 80 percent of the deaths will involve fentanyl, heroin and other illicit opioids. Overdoses involving prescription opioids would decrease by about 10% during that period.

JAMA NETWORK OPEN

JAMA NETWORK OPEN

A “pessimistic” scenario developed by researchers is even more jaw dropping. If the opioid crisis does not stabilize until 2025, they project over 1.2 million Americans will die from overdoses. Over 88% of the deaths will involve illicit opioids.

In either scenario, efforts to reduce the misuse of opioid medication, such as limiting the dose and supply of prescription opioids, will only reduce the number of overdose deaths by 3 to 5 percent.

“State and local governments have instituted several interventions aimed at preventing individuals from exposure to prescription opioids, including a recently proposed goal to lower opioid prescriptions by one-third in the coming 3 years,” said Chhatwal.

“Our study does not devalue these efforts and it is possible that their effect could improve over time, which may ultimately yield a substantial benefit in the long term. However, given the large number of individuals who have already engaged in prescription opioid misuse or illicit opioid use, our study indicates that prevention efforts, in isolation, are unlikely to have the desired level of effect on opioid overdose deaths the near term.”

The researchers say a strong, multi-pronged approach is needed to reduce overdoses, including greater scrutiny of patients for signs of opioid use disorder (OUD).

"It could include implementation of screening for OUD in all relevant health care settings, improving access to medications for OUD such as methadone and buprenorphine, increasing OUD training programs at medical and nursing schools, improving access to harm-reduction services, and controlling the supply of illicit opioids,” they concluded.

Another recent study also predicts that reducing the supply of prescription opioids will have little effect on the overdose rate and could lead to increased use of heroin.   

Overdose Crisis Boosts Organ Donations

By Pat Anson, Editor

Drug overdose deaths have reached unprecedented levels in the United States, with over 63-thousand people dying in 2016 from overdoses involving antidepressants, illicit fentanyl, heroin, prescription opioids and other drugs.

Those deaths have led to an unexpected gift for thousands of Americans who needed organ transplants. Researchers at University of Utah Health and Brigham and Women's Hospital say there has been a steady increase in the number of organs available for transplantation – due in large part to the escalating overdose crisis. They documented an 11-fold increase in the proportion of organ donors who died of drug overdoses from 2000 to 2016.

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"We were surprised to learn that almost all of the increased transplant activity in the United States within the last five years is a result of the drug overdose crisis," said Mandeep Mehra, MD, medical director of the Heart and Vascular Center at Brigham and Women's Hospital and lead author of a research letter published in The New England Journal of Medicine.

Mehra and his colleagues examined transplantation records and found no significant change in the recipients' chance of survival when the organ donation came from an overdose victim. The survival rate of 2,360 patients after receiving a heart or lung transplant from donors who died from overdoses was no different than those who received organs from donors who died from gunshot wounds, asphyxiation, head injuries or stroke.

There has long been a stigma against using donated organs from overdose victims because the organs may be damaged due to reduced oxygen supply that may occur during an overdose. There are also fears the organs could be infected with HIV, hepatitis or other communicable diseases due to high rates of intravenous drug use by overdose victims. As a result, some organs harvested from overdose donors are discarded.

But researchers say those risks can be minimized with modern testing.

"I feel hopeful that doctors across the country will read this and feel confident that organs that pass the required tests are safe for transplant," said Josef Stehlik, MD, medical director of the Heart Transplant Program at University of Utah Health. "This awareness is especially important when organ procurement professionals have to decide on use of potential donors with this high-risk history."

The United Network for Organ Sharing requires organ recipients to be made aware of the circumstances of higher risk donations, so they can decide whether or not to accept it. There are nearly 115,000 Americans currently waiting for an organ donation, including many who have been on the waiting list for years.

"We must look to new ways to increase organ donor recovery by concentrating on greater use of marginal organs or by expanding the suitable donor pool by using new technologies to improve organ function before the transplant takes place," Mehra said.

A similar study recently published in the Annals of Internal Medicine also found an increase in the proportion of organ donors who died from an overdose. In 2000, only 1.1% of donors were overdose victims. By 2017, that grew to 13.4 percent.

"For people waiting on an organ transplant right now, I would like to think that our studies bring them hope that they could receive a transplant and have more donors that could help them," Dr. Christine Durand, a professor of medicine and oncology at Johns Hopkins University, told CNN. "We have an obligation to optimize the use of all organs donated. The donors, families and patients waiting deserve our best effort to use every gift of life we can."

Opioid Hysteria Leading to Patient Abandonment

By Pat Anson, Editor

As the overdose crisis has worsened, doctors are under increasing pressure from law enforcement, regulators and insurers to reduce or stop prescribing opioids.

A nurse practitioner in the Seattle area – who asked to remain anonymous -- recently told us that she was closing her pain clinic because she was afraid of losing her license and going to prison. 

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“This whole thing is making me literally sick to my stomach. I've cried a million tears for my patients already, and I'm just beginning,” she wrote.

“I will be carefully weaning them all down… or arranging transfer of care to anywhere the patient would like. What a joke that is. There is no one else prescribing effective doses of opioids for chronic pain patients.  If I am to be thrown in prison, it should be for that -- not for keeping them on therapy that enriches their lives."

Patient abandonment is a growing problem in the pain community. Patients safely prescribed opioids for years are being dropped by doctors – often without weaning or tapering -- after they fail a drug test, miss a pill count, or become disruptive during an appointment. Sometimes they’re dropped for no reason at all.

Such is the case of Chris Armstrong, a 50-year old Orlando, Florida man severely disabled by multiple sclerosis and trigeminal neuralgia, a chronic pain facial disorder sometimes called the “suicide disease.” For over six years, Armstrong’s pain was treated with relatively high doses of morphine and hydrocodone at Prospira’s National Pain Institute in Winter Park.

That came to abrupt ending in late December, when Armstrong’s 74-year old mother and caretaker was handed a brief letter during their last visit to the clinic.

"This letter is to inform you that I will no longer be your physician and will stop providing medical care to you,” wrote Cherian Sajan, MD. “I will continue to provide routine emergency and medical care to you over the next 30 days while you seek another physician.”  

No explanation was given for Armstrong’s dismissal. Dr. Sajan did not respond to a request for comment.

“To have the plug pulled just like that,“ says Chris. “There’s nothing in my record that I’ve ever done anything wrong. I was a model patient.”

“They discharged him and gave no reason,” Valerie Armstrong said.  “They gave us a name of another pain doctor which they scribbled on a piece of torn paper. We went to see him, but after a few visits, (that doctor) told my son he was discharging him as well, as he needs ‘long term care’ which they refuse to provide.”

At the National Pain Institute, Armstrong says he was prescribed 150 morphine equivalent units (MME) of opioid medication daily. The second doctor reduced that dose to 100 MME – still above the maximum dose of 90 MME recommended by the CDC.  

Chris has been unable to find a new doctor and believes he’s been red flagged as a patient who needs high doses of opioids. 

“I went to another one and he said he can’t do anything because his hands are tied because I’ve been ousted by another pain doctor,” he told PNN. “What am I going to do, if no one will see me because of that?”

CHRIS ARMSTRONG

CHRIS ARMSTRONG

“I have called every pain clinic in my area and no one will see my son because he has been discharged by the previous pain clinics,” says Valerie. “My son is bed-bound quadriplegic, only travels in a wheelchair and can barely talk or eat from trigeminal neuralgia pain. His health is extremely fragile, and he will surely die if he has to stop his pain medication abruptly. That happened once before and he went to the ER in an ambulance having seizures.”

Armstrong has only a few days left of his last prescriptions.

“We need help and we need it now. He only has a few days supply of his pills left and then I'm sure his body will give out from withdrawals,” says Valerie. “My son had never taken any kind of pain medication before going to the National Pain Institute six and a half years ago and now he is physically dependent on them. I have begged and pleaded with them to take him back and even called their corporate headquarters to no avail.”

There is often little recourse for patients like Chris Armstrong.  Malpractice and patient abandonment laws vary from state to state, but discharging a patient is generally considered legal, as long as it isn’t discriminatory.

Florida’s Board of Medicine says a “health care practitioner can terminate a patient relationship at any time, but the practitioner may not abandon a patient” and should provide “continuity of care” until a patient can find a new doctor. To fulfill that requirement, the Florida Medical Association recommends that patients be given adequate notice in writing, be provided with medical care for at least 30 days, and be offered assistance in locating another practitioner – which Armstrong’s previous doctors did.

“There not a lot of strength in the law here,” says Diane Hoffman, a professor of health law at the University of Maryland Carey School of Law. “That makes it very challenging for chronic pain patients. And for physicians, they are trying to find the right place to be. Physicians are very risk averse in terms of the law.”

If patients have a complaint about a doctor, Hoffman says they should contact their state medical board or their state’s consumer protection office.

If you have an experience with patient abandonment that you’d be willing to share, Hoffmann is collecting patient experiences on the issue. You can send your story to her at:  patientstories@law.umaryland.edu