pain

Toward a Healthy Relationship with Opioids

In the June 14th Wall Street Journal, Johns Hopkins University bioethicist Travis Rieder, in an excellent essay, shared with readers his battle with pain resulting from a devastating accident, the effectiveness of opioids in controlling the pain, and the hell he went through when he was too rapidly tapered off of the opioids to which he had become physically dependent. Like most patients requiring long term pain management with opioids, he developed a physical dependence, which is often mistakenly equated with addiction by policymakers and many in the media. 

The aggressive schedule launched me into withdrawal, and I learned viscerally, firsthand, what the absence of opioids can do to someone whose brain has become accustomed to them. Those symptoms include increased sensitivity to the very pain that the opioids counteract, as well as extreme flu-like symptoms, insomnia and crippling depression. I came to understand why people sometimes go back onto deadly dangerous drugs: because the alternative is such profound suffering that it makes you want to die.

I have criticized policymakers for their ham-handed approach based upon a misinterpretation and misapplication of the guidelines on pain management with opioids, released in 2016 by the Centers for Disease Control and Prevention, herehere, and here. As explained in an article I co-authored in the Journal of Pain Research in February 2019, this blunt reaction is based upon the false assumption that opioid-related overdose deaths from nonmedical use is primarily a result of doctors treating patients in pain.

In his essay, Dr. Rieder levels similar criticisms:

Perhaps the greatest challenge about them [opioids] today is to resist the urge to be simplistic or reactionary. America’s current crisis of overuse has led some prescribers to avoid the drugs completely, and it has led politicians to occasionally consider ham-fisted policy solutions, like limiting the lengths or dosages of prescriptions regardless of any individual patient’s needs. But when a medication has both risks and benefits, what we need isn’t one-size-fits-all policies but nuance. 

Dr. Rieder was one of dozens of scholars, academics, physicians, and pain experts who signed a letter to the Oregon Health Authority in March, authored by Stanford University Medical School Professor Sean Mackey, urging against the Authority’s plans to force a rapid tapering off of opioids on all of the chronic pain patients in Oregon’s Medicaid system. That letter, plus push-back from patient advocacy groups, caused the Oregon Health Authority to put its plans on hold. It should not be lost on readers of this blog post that such interventions in the practice of medicine and the delivery of health care  are part and parcel of a state-run health care system.

Better Late Than Never?

As I have written many times before, the opioid prescribing guidelines put forth by the Centers for Disease Control and prevention have been criticized for not being evidence-based. This has even caused the Food and Drug Administration to begin the process of developing its own set of guidelines.

The Law of Unintended Consequences Strikes Again

Late last week UPI news ran a report by E.J. Mundell with the headline, “Government efforts to curb opioid prescriptions might have backfired.” It cites two separate studies published online in JAMA Surgery on August 22 that examined two different restrictive opioid policies that fell victim to the Law of Unintended Consequences.

The first study, by researchers at the University of Michigan, evaluated the impact of the Drug Enforcement Administration’s 2014 rescheduling of hydrocodone (Vicodin) from Schedule III to Schedule II. Prescriptions for Schedule III narcotics may be phoned or faxed in by providers, but Schedule II narcotics require the patient to see the prescriber in person in order to obtain a prescription. The DEA’s goal was to reduce the number of Vicodin pills, popular with non-medical users, available for diversion to the black market.

The study looked at 21,955 post-surgical patients across 75 hospitals in Michigan between 2012 and 2015 and found that the number of hydrocodone pills prescribed after the 2014 schedule change increased by an average of seven 5mg tablets. The total Oral Morphine Equivalent of prescribed hydrocodone did not change significantly after the DEA made hydrocodone Schedule II. However, the refill rate decreased after the change. The study’s abstract concluded, “Changing hydrocodone from schedule III to schedule II was associated with an increase in the amount of opioids filled in the initial prescription following surgery.”

As a practicing general surgeon, my initial reaction to this study was: “Tell me something I don’t know.” Prior to the 2014 schedule change, I would often start off prescribing a small amount of hydrocodone to some of my post-op patients (depending upon the procedure and the patient’s medical history) with the knowledge that I can phone in a refill for those patients who were still in need of it for their pain after the initial supply ran out. Once it was rescheduled, I changed my prescribing habits. Not wanting any of my patients to run out after hours, over a weekend, or on a holiday—when the office is closed and their only recourse would be to go to an emergency room or urgent care center to get a prescription refill—I increased the amount I prescribe (based on my best estimate of the maximum amount of days any individual patient might need hydrocodone) to reduce the chances of them needing a refill. This results in some patients having leftover Vicodin pills in their medicine cabinet. On the other hand, fewer of those patients need refills.

Not surprisingly, many of my clinical peers have done the same thing. It’s not a surprise because most physicians place the interests of their patients ahead of the interests of regulators and bureaucrats. So the adjustment made in postoperative hydrocodone prescribing was basically a “no brainer.” 

Civilian Casualties Continue to Mount in Governments’ War on Opioids

I have written here and here about how patients have become the civilian casualties of the misguided policies addressing the opioid (now predominantly fentanyl and heroin) crisis. The policies have dramatically reduced opioid prescribing by health care practitioners and have pressured them into rapidly tapering or cutting off their chronic pain patients from the opioids that have allowed them to function. More and more reports appear in the press about patients becoming desperate because their doctors, often fearing they may lose their livelihoods if they are seen as “outliers” by surveillance agencies, under-treat their pain or abruptly cut them off of their pain treatment regimen.

story in the July 23, Louisville (KY) Courier Journal illustrates the harm this is causing in Kentucky. “Doctors say the federal raids on medical clinics lead to unintended consequences — patients thrust into painful withdrawals and left vulnerable to suicide or dangerous street drugs,” states the article.  Dr. Wayne Tuckerson, President of the Greater Louisville Medical Society, said, “[When investigators] go in with a sledgehammer and shut down a practice without consulting community physicians, suddenly we have patients thrown loose.” He went on to say, “Docs are very much afraid when it comes to writing pain medications…We don’t want patients to become addicted. And we don’t want to have our licenses — and therefore our livelihoods — at stake.” And if pharmacists in the area learn of a police raid or investigation of a medical practice—regardless of the outcome of that investigation—many of them refuse to fill legal prescriptions presented by patients of those practitioners.

Last week Oregon regulators announced plans for a “forced taper” of chronic pain patients in its Medicaid system. This contradicts and is much more draconian than the recommendations of the 2016 guidelines issued by the Centers for Disease Control and Prevention, which in turn have been criticized as not evidence-based. The Oregon Health Evidence Review Commission announced: 

 

The changes include a forced taper for all chronic pain patients on opioids (within a year), no exceptions. Opioids will be replaced with alternative treatments (cognitive behavior therapy (CBT), acupuncture, mindfulness, pain acceptance, aqua therapy, chiropractic adjustments, and treatment with non-opioid medications, such as NSAIDS, Acetaminophen).

 

This proposal has sparked an outcry from patients and patient advocacy groups in Oregon. While this policy proposal only applies to Medicaid patients, they fear it will soon become the standard adopted by all third-party payers in the state.

University of Alabama Medical School Associate Professor Stefan Kertesz, an addiction medicine specialist at the Birmingham VA Medical Center, tweeted in reaction to this proposal:

 

I cannot imagine a more violent rejection of the CDC Guideline on Prescribing Opioids of 2016 than the plan current before Oregon Medicaid : forced taper to 0 mg of all opioid receiving pain patients.

 

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.

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.

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.”

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