Tag: Fentanyl

Attorney General Sessions Proposes An Even More Destructive Opioid Policy

Speaking to a group of law enforcement officials in Raleigh, NC yesterday, Attorney General Jeff Sessions announced proposed rule changes to the way the Drug Enforcement Administration sets quotas on the manufacturing of opioids. The DEA now presumes to be able to divine the likelihood a particular type of prescription opioid will be diverted to the illegal market when setting production quotas. 

The Attorney General said, “Under this proposed new rule, if DEA believes that a company’s opioids are being diverted for misuse, then they will reduce the amount of opioids that company can make.”

The DEA ordered a 25 percent reduction in opioid production in 2017 and another 20 percent reduction for 2018. The tight quotas on opioid production contributed to the acute shortage of injectable opioids being felt in hospitals across the nation. It is not only making patients suffer needlessly but places them at increased risk for adverse drug reactions or overdose. Just the other day, after pleas from numerous medical professional associations, with the shortage reaching crisis levels, the DEA announced it will begin to relax this year’s quotas. But it may take months before things improve. 

The damage to hospitalized patients is an unintended consequence of central planning and should come as no surprise. DEA administrators had the fatal conceit of believing they could determine just how many opioids should be produced for what they call the “legitimate” pain control needs of the nation’s patients. Yet even after the DEA recognized that the quotas caused harm, with these new proposed regulations they are determined to get back up in the saddle and ride that horse again.

Despite the reduction in opioid supply and a 41 percent reduction in the prescription of high-dose opioids by health care practitioners since 2010—the year prescribing peaked—the overdose rate continues to soar, having increased 20 percent from 2015 to 2016. According to the National Survey on Drug Use and Health, nonmedical use of prescription opioids peaked in 2012, and total prescription opioid use in 2014 was less than in 2012. The evidence is that nonmedical users migrate to cheaper and easier to obtain heroin and fentanyl when diverted prescription opioids become less available. The overdose rate from fentanyl has increased at a clip of 88 percent per year since 2013, and the overdose rate from heroin increased 19 percent per year for the past 2 years after increasing at a rate of 33 percent per year from 2010-2014. Meanwhile, the overdose rate increase for prescription opioids has been unchanged at 3 percent per year since 2009.

The Attorney General and the DEA administrators seem unable to learn from their mistakes. They continue to view the opioid overdose crisis as a product of the number of pills produced or prescribed. They have been wrong about this from the get-go. It has always been the result of nonmedical users accessing drugs in a black market fueled by drug prohibition. The underground market responds quickly. It provides nonmedical users with cheaper and more dangerous and deadly drugs in response to prescription opioid restrictions. 

Not content with the damage they have already caused, regulators appear ready to double down on the supply-side approach to the overdose crisis. This means America’s hospitals can look forward to more and possibly greater shortages of vitally needed opioids, while first responders swell their emergency rooms with ever growing numbers of heroin and fentanyl overdoses.

New Study from American Action Forum Adds to the Argument Against Present Supply-Side Opioid Policy

On April 11 the Washington Post cited a new study from the American Action Forum that reinforces arguments I have made here and here, that despite a dramatic reduction in the opioid prescription rate—a 41 percent reduction in high-dose opioid prescriptions since prescriptions peaked in 2010—the overdose rate continues to climb, as nonmedical users have simply migrated to more dangerous substitutes like fentanyl and heroin while the supply of diverted prescription opioids suitable for abuse continues to come down.

I have a minor quibble with the study’s finding that “the annual growth rate of prescription opioid-involved overdose fatalities significantly slowed from 13.4 percent before 2010 to just 4.8 percent after.” In fact, the Center for Disease Control and Prevention end-of-2017 Data Brief No. 294 reported:

The rate of drug overdose deaths involving natural and semisynthetic opioids, which include drugs such as oxycodone and hydrocodone, increased from 1.0 [per 100,000] in 1999 to 4.4 in 2016. The rated increased on average by 13% per year from 1999-2009 and by 3% per year from 2009-2016. (Emphasis added)

As an aside, it is worth mentioning that four researchers working in the CDC’s Division of Unintentional Injury Prevention reported in the April 2018 American Journal of Public Health that the CDC’s method for tracking opioid overdose deaths have over-estimated the number due to prescription opioids, calling the rate “significantly inflated.” Many overdose deaths actually due to fentanyl are folded into the “prescription opioid” numbers since, technically, fentanyl is a prescription drug even though it is rarely prescribed outside of the hospital in a form suitable for abuse. 

The AAF report understates the significant role that the abuse-deterrent reformulation of OxyContin and other opioids have played in driving nonmedical users to heroin and fentanyl. The researchers “suggest” abuse-deterrent formulations “could be a major factor driving the rise in heroin fatalities.” But evidence of the connection is much more powerful and convincing, as I presented in the Cato Policy Analysis “Abuse-Deterrent Opioids and the Law of Unintended Consequences” in February of this year.

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Making the Case, Once Again, That the Opioid Crisis Is a Product of Drug Prohibition, Not Doctors Prescribing to Patients

Martha Bebinger reports for National Public Radio station WBUR about the rise in fentanyl-laced cocaine. She cites numerous accounts of college students using cocaine to stay awake while studying for exams, or while attending campus parties, and then falling into a deep sleep after the initial cocaine rush. Some don’t wake up. Others get revived by the opioid overdose antidote naloxone.

Massachusetts state police recorded a nearly three-fold increase in seizures of cocaine laced with fentanyl over the past year. And the Drug Enforcement Administration lists Massachusetts among the top three states in the US for seizures of cocaine/fentanyl combinations. The DEA says the mixture is popularly used for “speedballing.” The original recipe used heroin mixed with cocaine in order to minimize the negative effects of the “come-down” after the rush of cocaine. Cocaine mixed with heroin is very unpredictable and dangerous. When it is mixed with fentanyl—five times the potency of heroin—it is even more dangerous.

There is a debate among law enforcement as to whether the cocaine is accidentally laced with fentanyl by sloppy underground drug manufacturers, or whether the mixture is intentional. There have been several reports of cocaine users who were unaware that the cocaine they were snorting or smoking contained fentanyl.

Connecticut state health statisticians keep track of opioid overdoses that included cocaine. While the majority of the time the overdose is from the classic “speedball” combination of heroin and cocaine, they have noted a 420 percent increase in fentanyl/cocaine in the last 3 years. However, Massachusetts does not register drug combinations when it records “opioid overdoses,” so it is unknown just what percentage of the 1,977 estimated opioid overdose deaths in Massachusetts last year were in combination with cocaine or other drugs. New York City keeps detailed statistics. In 2016, cocaine was found in 46 percent of the city’s opioid deaths, heroin and fentanyl were involved in 72 percent of opioid overdose deaths, and 97 percent of all opioid overdose deaths involved multiple drugs.

Meanwhile, President Trump and most state and local policymakers remain stuck on the misguided notion that the way to stem the overdose rate is to clamp down on the number and dose of opioids that doctors can prescribe to their patients in pain, and to curtail opioid production by the nation’s pharmaceutical manufacturers. And while patients are made to suffer needlessly as doctors, fearing a visit from a DEA agent, are cutting them off from relief, the overdose rate continues to climb.

The overdose crisis has always primarily been a product of drug prohibition—not of doctors treating patients.

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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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Stop Calling it an Opioid Crisis—It’s a Heroin and Fentanyl Crisis

The National Center for Health Statistics reported last month that a record 63,600 deaths occurred in 2016 due to overdoses. Digging deeper into that number shows over 20,000 of those deaths were due to the powerful drug fentanyl, more than 15,000 were caused by heroin, and roughly 14,500 were caused by prescription opioids, although it has been known for years that, in most cases of prescription opioid deaths, the victims had multiple other potentiating drugs onboard. The rest of the deaths were due to methamphetamines, cocaine, benzodiazepines, and methadone.

Drugs Involved in U.S. Overdose Deaths* - Among the more than 64,000 drug overdose deaths estimated in 2016, the sharpest increase occurred among deaths related to fentanyl and fentanyl analogs (synthetic opioids) with over 20,000 overdose deaths. Source: CDC WONDER

* Provisional counts for 2016 are based on data available for analysis as of 8/2017.

In its end-of-year report, the National Center for Health Statistics noted deaths from fentanyl increased at a steady annual rate of 18% per year from 1999-2013 and then shot up 88% from 2013-2016.

Fentanyl is not routinely prescribed in the outpatient setting, and when it is, it most commonly is in the form of a skin patch for slow, transdermal release, unsuitable for abuse or nonmedical use. The evidence shows it is being smuggled into the country, often by mail, in powdered form from factories in China and elsewhere, where it is used to fill counterfeit prescription opioid capsules or to lace heroin to enhance its potency.

In the case of heroin, NCHS found the death rate steady from 1999-2005, then it increased 10% per year from 2005-2010, 33% per year from 2010-2014, and has been increasing at a rate of 19% per year since 2014.

Meanwhile, after increasing 13% annually from 1999-2009, the death rate increase from prescription opioids has remained steady at 3% per year since 2009.

For nearly a decade, policymakers have bought into the misguided narrative that the opioid overdose crisis is a result of careless doctors and greedy pharmaceutical companies getting patients hooked on prescription opioids and condemning them to the nightmarish world of drug addiction. As a result, the Drug Enforcement Administration has ordered decreases in prescription opioid production. There was a 25 % reduction in 2017 and a 20% reduction is ordered for 2018. States have set up monitoring programs that put doctors and patients under surveillance leading to a dramatic reduction in the prescription of opioids since 2010. In fact, high-dose prescribing fell 41% since 2010. The popular opioid OxyContin was replaced with an abuse-deterrent formulation in 2010 (that could not be crushed for snorting or dissolved for injecting), and, since then, several other such formulations have come online.

This focus on the supply and prescription of opioids makes many patients needlessly suffer in pain. Some, in desperation, turn to the illicit market to get relief, where they find heroin and heroin-laced fentanyl often cheaper and easier to get. Some resort to suicide.

Policymakers mistakenly focus on doctors treating their patients in pain. By intruding on the patient-doctor relationship they impede physician judgment and increase patient suffering. But another unintended consequence is that, by reducing the amount of prescription opioids that can be diverted to the illicit market, they have driven nonmedical users to heroin and fentanyl, which are cheaper and easier to obtain on the street than prescription opioids, and much more dangerous.

Data from the Centers for Disease Control and Prevention show that from 2006 to 2010 the opioid prescription rate tracked closely with the opioid overdose rate, at roughly 1 overdose for every 13,000 prescriptions. Then, after 2010, when the prescription rate dropped and it became more difficult to divert opioids for nonmedical use, the overdose rate began to climb as nonmedical users switched over to heroin and fentanyl. There is a dramatic negative correlation between prescription rate to overdose rate of -0.99 since 2010.

The overdose rate is not a product of doctors and patients abusing prescription opioids. It is a product of nonmedical users accessing the illicit market.

The problem will not get better—it will probably only get worse—as long as we continue to call this an “opioid crisis.” The title is too nonspecific. This is a crisis caused by drug prohibition—an unintended consequence of nonmedical drug users accessing the black market in drugs. Policymakers should stop harassing doctors and their patients and shift the focus to reforming overall drug policy. A good place to start would be to implement harm reduction measures, such as safe syringe programs, making Medication Assisted Treatments like methadone and suboxone more readily available, and making the opioid antidote naloxone available over-the-counter, so it can be easier for opioid users to obtain. Even better would be a sober reassessment of America’s longest war, the “War on Drugs.”

Renaming the problem a “heroin and fentanyl crisis” might be a way to trigger a refocus.

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