Tag: Opioids

From “Opioid Epidemic” to “Stimulant Epidemic”

Speaking at the National Rx Abuse and Heroin Summit in Atlanta, John Eadie, coordinator for the National Threat Initiative, warned, “We’re now facing a very significant stimulant epidemic.” Abuse of prescription stimulants such as Adderal and Ritalin (used to treat Attention Deficit Disorders) as well as illicit stimulants, like cocaine and methamphetamine, are surging. “No one is paying attention to this,” Eadie said, because the focus has been on opioids.

Law enforcement has seized 15 kilograms of stimulants for every kilogram of heroin it has seized during the last 5 years. The Centers for Disease Control and Prevention reports that psychostimulant overdose deaths rose 30 percent in the past year. There is evidence to suggest stimulant abuse is now outpacing opioid abuse. And the Drug Enforcement Administration reports that cocaine use and availability are at their highest level in a decade.

I wrote here about the resurgence of methamphetamine abuse once meth labs, especially in Mexico, found a substitute for Sudafed after the federal and state governments made it more difficult to obtain. And Oregon health authorities reported overdose deaths from heroin dropped in 2016 to 107 while overdose deaths from methamphetamine rose to 141.

There are lessons to be learned from this news if anyone chooses to learn them. The obvious one is that the “War on Drugs,” America’s longest war, is unwinnable. This lesson was apparently not learned when the nation experimented with alcohol prohibition in the early 20thcentury. When a market exists for willing buyers and sellers, prohibition just drives that market underground. Waging a war on drugs is like playing a game of “Whac-a-mole.”

But the other lesson relates to current opioid policy. Policymakers seem stuck in what should, by now, be an obviously false narrative: that the opioid overdose crisis is a product of doctors prescribing opioids to their patients. And even after considerable reductions in the prescribing and manufacturing of opioids for patients has shifted non-medical users over to heroin and fentanyl—now the dominant causes of opioid deaths—policymakers can’t disabuse themselves of this false narrative. They continue to double down on restricting prescriptions of opioids and make many patients suffer in the process. 

The opioid overdose crisis has always primarily been the result of non-medical users seeking opioids in the illicit market—where the dose, purity, and even the actual identity of a substance can never be known with confidence. 

The resurgence of stimulant abuse and overdose should not be viewed in isolation. It should be integrated with the opioid issue. Both should be viewed in the broader context of substance abuse in the presence of drug prohibition. Sociocultural and psychosocial factors may ultimately explain why the use and abuse of mind altering drugs is on the rise across much of the developed world

As long as policymakers continue using supply-side interventions, hoping to win an unwinnable war, the problem will continue to grow.

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Why Doesn’t the Surgeon General Seek FDA Reclassification of Naloxone to OTC?

The Surgeon General issued an “Advisory on Naloxone and Opioid Overdose” today, drawing attention to the effectiveness of the opioid overdose antidote naloxone. The drug, approved for use since 1971, is an effective remedy that can be safely administered by lay personnel who receive basic instructions. The Advisory cites research demonstrating that community-based overdose education and naloxone distribution reduces overdose deaths, and points out that first responders in most states and communities are now equipped with the drug.

Because naloxone is available only by prescription, most states have developed workarounds to make it more available to patients and, in some cases, third parties who have proximity to medical and non-medical opioid users. This way, witnesses to an overdose can be capable of rescuing the victim. This usually involves a state authorizing pharmacists to prescribe the drug or, in many cases, the state health director, acting as the state’s physician, issuing a “standing order” to pharmacists to distribute it.

The Advisory lists a number of conditions and situations that might place a person at risk of opioid overdose and encourages such people, or people who know them, to avail themselves of naloxone. It supports efforts at wider distribution at the community level.

Unfortunately, because of the stigma that has developed in association with opioid use, many opioid patients are reluctant to speak to the pharmacist and request a naloxone prescription. In some states, the naloxone will not be prescribed to third parties who know an opioid user. Also, numerous instances have been reported where pharmacists are reluctant to prescribe the antidote, believing they are “enabling” a drug abuser.

Recognizing this obstacle to naloxone distribution, Australia made it available over-the-counter in 2016, making it as easy to purchase as cold remedies or antacids. This way medical and nonmedical opioid users can discreetly make a purchase and check out at the cash register without having to answer any questions or face scrutiny from a pharmacist. The drug has been over-the-counter in Italy for over 20 years.

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People Who Have Never Experienced Back Pain Have No Business Making Opioid Policy

Economist Steven Horwitz writes in USA Today about President Trump’s proposal to reduce legal opioid prescriptions by one third. Such a drastic reduction would inevitably harm people like Horwitz, who relates his experience with excruciating back pain and how opioids were essential to relieving his agony and helping his body heal:

People who wish to drastically limit access to opioids need to know the reality of this kind of pain. Getting out of bed took 10 minutes or more because even one small wrong movement while getting to a sitting position would cause severe back spasms, making me shudder with pain. Walking around my house required balancing myself on walls and door frames.

The pain from sitting down and standing up from the toilet required that I use a chair to hold my weight like one would use a walker. I had visions of being found in the bathroom, stuck on the toilet or even unable to get up off of the floor. Every little twist and turn of my body risked those spasms and shuddering.

Eventually I realized my mistake and got a prescription for opioids. The quality of my life quickly and dramatically improved, as within two or three days, the pain was reduced substantially and my mobility and mood were significantly better. I could walk comfortably and hug my kids again.

It’s important to understand that this kind of debilitating pain not only causes unnecessary suffering, it prevents patients from healing. It takes every bit of energy you have to fight it, and your body has little to nothing left to use to heal. Some medical professionals call pain “the fifth vital sign” because of the way in which it matters for a patient’s health. Opioids enabled me to relax, to sleep and to heal.

I too am one of the people Trump’s policy might harm.

I suffer from episodic back pain. Everything Horwitz describes I have experienced. If anything, I would say he understates the agony. In my experience, the pain can be more like torture—as if someone were deliberately trying to inflict as much pain as possible, for the purpose of breaking me emotionally and leaving me trembling in fear of its return.

Like Horwitz, I did not want to treat my back pain with opioids. I had previously used them to recover from knee surgery and I disliked the experience so much that after my second knee surgery, I refused them. Like Horwitz, I feared addiction. So I tried stretching. I tried physical therapy. I tried non-prescription analgesics.

Nothing worked until I broke down—until the pain broke me—and I tried opioids. They worked. They eliminated my pain and, as Horwitz says, that allowed me to heal. My pain could come back at any time, and so I too could be one of the people Trump’s policy would leave to suffer in excruciating pain. 

People who have never experienced back pain have no business making opioid policy.

Multiple Distinguished Health Care Practitioners Speak Out Against Misguided Opioid Policy

On March 30, Sally Satel, a psychiatrist specializing in substance abuse at Yale University School of Medicine, co-authored an article with addiction medicine specialist Stefan Kertesz of the University of Alabama Birmingham School of Medicine condemning the plans of the Center for Medicare and Medicaid Services to place limits on the amount of opioids Medicare patients can receive. The agency will decide in April if it will limit the number of opioids it will cover to 90 morphine milligram equivalents (MME) per day. Any opioids beyond that amount will not be paid for by Medicare. One year earlier, Dr. Kertesz made similar condemnations in a column for The Hill. While 90 MME is considered a high dose, they point out that many patients with chronic severe pain have required such doses or higher for prolonged periods of time to control their pain. Promoting the rapid reduction of opioid doses in such people will return many to a life of anguish and desperation.

CMS’s plan to limit opioid prescriptions mimics similar limitations put into effect in more than half of the states and is not evidence-based. These restrictions are rooted in the false narrative that the opioid overdose problem is mostly the result of doctors over-prescribing opioids to patients in pain, even though it is primarily the result of non-medical opioid users accessing drugs in the illicit market. Policymakers are implementing these restrictions based upon a flawed interpretation of opioid prescribing guidelines published by the Centers for Disease Control and Prevention in 2016.

Drs. Satel and Kertesz point out that research has yet to show a distinct correlation between the overdose rate and the dosages on which patients are maintained, and that the data show a majority of overdoses involve multiple drugs. (2016 data from New York City show 97 percent involved multiple drugs, and 46 percent of the time one of them was cocaine.)

Not only are the Medicare opioid reduction proposals without scientific foundation, but they run counter to the recommendations of CMS in its 2016 guidelines. As Dr. Kertesz stated in 2017:

“In its 7th recommendation, the CDC urged that care of patients already receiving opioids be based not on the number of milligrams, but on the balance of risks and benefits for that patient. That two major agencies have chosen to defy the CDC ignores lessons we should have learned from prior episodes in American medicine, where the appeal of management by easy numbers overwhelmed patient-centered considerations.”

In an effort to dissuade the agency, Dr. Kertesz sent a letter to CMS in early March signed by 220 health professionals, including eight who had official roles in formulating the 2016 CDC guidelines. The letter called attention to the flaws in the proposal and to its great potential to cause unintentional harm. CMS will render its verdict as early as today.

Until policymakers cast off their misguided notions about the forces behind the overdose crisis, patients will suffer needlessly and overdose rates will continue to climb. 

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CDC Researchers State Overdose Death Rates From Prescription Opioids Are Inaccurately High

In an article in the April 2018 issue of the American Journal of Public Health, four researchers at the Centers for Disease Control and Prevention’s Division of Unintentional Injury Prevention report that the CDC’s methods for tracking opioid overdose deaths have over-estimated the number of those deaths due to prescription opioids, as opposed to heroin, illicitly manufactured fentanyl, and other illicit variants of fentanyl. They called the prescription opioid overdose rate “significantly inflated.”

Fentanyl is a synthetic opioid categorized as a prescription opioid. But, in the outpatient setting, it is predominantly prescribed as a time-release transdermal patch, not suitable for nonmedical users. Occasionally, it is prescribed as a lozenge, a nasal spray, or a small film that can be placed within the corner of one’s mouth, usually to cancer patients in extreme pain. These forms of the drug don’t lend themselves to being converted into a form suitable for nonmedical users wishing to snort or inject the drug. The injectable form of fentanyl is almost exclusively used in the hospital setting, both as an anesthetic agent and to control severe pain in patients who are critically ill or in the postoperative recovery room. Over the past several years, the underground market has been flooded by illicitly manufactured fentanyl and its variants, often moved into the country in a powdered form through the mail.

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Hospitalized Patients Are Civilian Casualties in the Government’s War on Opioids

A recent story by Pauline Bartolone in the Los Angeles Times draws attention to some under-reported civilian casualties in the government’s war on opioids: hospitalized patients in severe pain, in need of painkillers. Hospitals across the country are facing shortages of injectable morphine, fentanyl, and Dilaudid (hydromorphone). As a result, trauma patients, post-surgical patients, and hospitalized cancer patients frequently go undertreated for excruciating pain.

Hospitals, including the ones in which I practice general surgery, are working hard to ameliorate the situation by asking medical staff to use prescription opioid pills such as oxycodone and OxyContin instead of injectables, when possible. But many patients are unable to take oral medication due to their acute illness or post-operative condition. In those cases, we are often asked to use injectable acetaminophen, muscle relaxants, or non-steroidal anti-inflammatory agents. But many times those drugs fail to give adequate relief to these patients—which is why they are not the first line of drugs we use.

The shortage is uneven across the country. Some hospitals are feeling the shortage worse than others. According to the American Society of Anesthesiologists, the shortage is so severe in some hospitals that elective surgeries—such as gallbladder and hernia operations—have been postponed.

Some hospitals have resorted to asking nursing staff to manually combine smaller-dose vials of morphine or other injectable opioids that remain in-stock as a replacement for the out-of-stock larger dose vials. Dose-equivalents of different IV opioids vary and are difficult to accurately calculate. This increases the risk of human error and places patients at risk for overdose, as was explained in a letter to the U.S. Drug Enforcement Administration by representatives of the American Hospital Association, American Society of Anesthesiologists, American Society of Clinical Oncology, American Society of Health-System Pharmacists, and the Institute for Safe Medication Practices. The letter asked the DEA to adjust its quota on the manufacture of opioids to help mitigate the shortage.

As part of the effort to address the opioid overdose crisis—which is really a fentanyl and heroin overdose crisis—the DEA, which sets national manufacturing quotas for opioids, ordered a 25 percent reduction in 2017 and another 20 percent reduction this year.

National shortages of drugs are not confined to injectable opioids. Over the years, various drugs in common use have gone on national “back-order” and health care practitioners have had to develop workarounds. The causes of these recurring shortages, not unique to the US, are complex and multifactorial.

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The War on Opioids Has Become a War on Patients

As Anne Fuqua recently pointed out in the Washington Post, non-medical drug users accessing heroin and fentanyl in the underground drug market are not the only victims in the opioid crisis. Many patients for whom prescriptions opioids are the only relief from a life sentence of torturing pain are also victims. That is because policymakers continue to base their strategies on the misguided and simplistic notion that the opioid overdose crisis impacting the US, Canada, and Europe, is tied to doctors prescribing opioids to their patients in pain.

Unfortunately, political leaders and the media operate in an echo chamber, reinforcing the notion that cutting back on doctors prescribing opioids is the key to reducing overdose deaths. As a result, all 50 states operate Prescription Drug Monitoring Programs that track the prescribing habits of doctors and intimidate them into curtailing the prescription of opioids. Yet multiple studies suggest that PDMPs have no effect on the opioid overdose rate and may be contributing to its increase by driving desperate pain patients to the dangers that await them in the black market.

Last month Arizona joined the list of 24 states that had put in place limits on the amount and dosage of opioids doctors may prescribe acute and postoperative pain patients. These actions are based on the amateur misinterpretation of the 2016 opioid guidelines put out by the Centers for Disease Control and Prevention and are not evidence-based.

And the Food and Drug Administration continues to promote the replacement of prescription opioids with abuse-deterrent formulations, despite an abundance of evidence showing this policy only serves to drive non-medical users to heroin and fentanyl while raising health care costs to health systems and patients.

As prescriptions continue to decrease, overdose deaths continue to increase. This is because as non-medical users get reduced access to usable diverted prescription opioids, they migrate to more dangerous fentanyl and heroin.

It is simplistic—and thus provides an easy target—for politicians and the media to latch on to the false narrative that greedy pharmaceutical companies teamed up with lazy, poorly-trained doctors, to hook innocent patients on opioids and condemn them to a life of drug addiction. But this has never been the case.

As Patrick Michaels pointed out about recrudescent opiophobia back in 2004, prescription opioids actually have a low addictive potential and when taken by patients under the guidance of a physician, have a very low overdose potential. Cochrane systematic studies in 2010 and 2012 both found an addiction rate of roughly 1 percent in chronic non-cancer pain patients. And a January 2018 study in BMJ by researchers at Harvard and Johns Hopkins examined 568,000 opioid naïve patients prescribed opioids for acute and postoperative pain from 2008 to 2016 and found a total “misuse” rate (all “misuse” diagnostic codes) of just 0.6 percent. And researchers at the University of North Carolina reported in 2016 on 2.2 million residents of the state who were prescribed opioids, where they found an overdose rate of 0.022 percent.

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