Tag: Opioids

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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Yet Another Study Points to The Potential of Cannabis for Reducing Opioid Use

The Minnesota Department of Health reported today that 42 percent of the more than 2,000 first-time medicinal marijuana users with intractable pain enrolled in its research study obtained significant pain relief. In announcing the results, the Minnesota Health Commissioner said, “We need additional and more rigorous study, but these results are clinically significant and promising for both pain treatment and reducing opioid dependence.”

The study found that 63 percent of the patients who were taking opioids for their chronic pain when they started taking cannabis were able to reduce or eliminate their opioid use after six months.  Some patients were also able to reduce their use of other pain medicines, as well as benzodiazepines.

This is not the first study to point to the potential of cannabis in reducing opioid use. A study reported in JAMA in 2014 by researchers looked at all 50 states from 1999-2010 and found opioid overdose rates approximately 25 percent lower in states with legalized medicinal marijuana during that time period. A RAND study published in the March 2018 Journal of Health Economics reveals similar findings. And researchers at the University of Michigan reported in 2016 64 percent of chronic pain patients were able to reduce their use of opioids. Researchers at the University of California at Berkeley reported last June that 97 percent of the chronic pain patients they studied were able to reduce their opioid use.

Opponents of cannabis, including Attorney General Sessions, believe it is a “gateway” drug to more potent and dangerous drugs. But this is not born out by the evidence. Since cannabis was legalized for recreational use in Colorado and Oregon, opioid overdose rates have actually come down, making a case that  cannabis is an “off-ramp,” not a “gateway.”

If anything, cannabis may have potential benefits as a substitute for opioids in the management of pain. And if the federal prohibition of cannabis is lifted then research can be more easily done, and we can find out if cannabis has a role to play in medication-assisted treatment for opioid addiction. If politicians in Washington want to do something constructive to address the opioid overdose problem, then lifting the federal ban and allowing states to go their own way would be a positive move.

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Politicians Cannot Stop Punishing Patients for the Unintended Consequences of Drug Prohibition

It seems no amount of evidence can make political leaders disabuse themselves of the misguided notion that the nation’s opioid overdose crisis is caused by doctors getting patients hooked on prescription opioids. A group of eight senators unveiled the CARA(Comprehensive Addiction and Recovery Act) 2.0 Act on February 27, targeting the opioid crisis. It would impose a 3-day limit on all opioid prescribing for patients in acute and outpatient postoperative pain.

But the movement to restrict prescriptions is not evidence-based, as prominent experts have pointed out. The politicians base their proposal on the 2016 opioid guidelines put out by the Centers for Disease Control and Prevention. The guidelines stated:

When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.

The guidelines pointed out that the above recommendations were based on “Type 4” evidence:

Type 4 evidence indicates that one has very little confidence in the effect estimate, and the true effect is likely to be substantially different from the estimate of the effect.

It further described Type 4 evidence as being based upon “clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations.”

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Arizona Governor, Legislature, Rush Through Flawed “Emergency” Opioid Legislation

Late on the night of January 25, the Arizona legislature unanimously approved “The Arizona Opioid Epidemic Act,” introduced at the urging of Governor Doug Ducey (R) just 3 days earlier. The Governor and legislature were in such a hurry that they took no time to request testimony from representatives of the medical profession or from any other experts that might have differing views about the best ways to approach the overdose crisis. The overdose crisis is such an “emergency” that there was no time for that. Yet, most of the Act’s provisions are not scheduled to take effect until 2019.

Among the harmful features of the Act are strict restrictions on the amount and dose of opioids doctors can prescribe to new and postoperative patients. Prescriptions may be for only 5 days, and the dosages are capped. Doctors wishing to exceed these limits must first consult a board-certified pain management specialist which, of course, might take several days. This policy is not evidence-based. It will cause injured patients and those recovering from surgery to suffer needless and agonizing pain. In December, the Arizona Medical Association and the Arizona Osteopathic Medical Association wrote the state Department of Health Services warning of harmful “unintended consequences” that may ensue from one-size-fits-all 5-day limits on prescriptions and dosages for patients in acute pain.

This policy is not just inhumane, it’s dangerous. Desperate patients might seek to get better relief for their undertreated pain by supplementing their prescriptions with alcohol and/or other drugs, or by obtaining drugs through the illegal market, increasing the risk of overdose or death.

Another provision requires all providers to use a state-approved E-prescription system to prescribe opioids, placing a burden on health care providers in remote and rural areas of the state, where broadband internet access is inadequate and where some practitioners lack technological sophistication in their practices.

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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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