Americans now more likely to die from opioids than car crashes


​It marks a first for the U.S., where some 49,000 people died from opioids in 2018.

  • Each American has about a 1 in 7,569 chance of dying from an opioid overdose, according to a National Safety Council report. The probability of dying in a motor vehicle accident is 1 in 8,096.
  • The death rate for opioids is now six times higher than it was in 1999, with about 130 Americans dying every day from the drugs.
  • Narcan is a life-saving drug that can stop opioid overdoses in their tracks, however factors like stigma and cost are preventing this antidote from becoming more accessible.

For the first time in U.S. history, Americans are more likely to die from opioid overdoses than car accidents, according to a new report from the nonprofit National Safety Council.

Americans have a 1 in 7,569 chance of dying from an opioid overdose, while the probability of dying in a motor vehicle accident is 1 in 8,096. Those odds were calculated by dividing the total U.S. population by the total number of deaths for each cause in 2017, using data on preventable deaths from the National Center for Health Statistics.

“We’ve made significant strides in overall longevity in the United States, but we are dying from things typically called accidents at rates we haven’t seen in half a century,” Ken Kolosh, manager of statistics at the National Safety Council, said in a press release. “We cannot be complacent about 466 lives lost every day. This new analysis reinforces that we must consistently prioritize safety at work, at home and on the road to prevent these dire outcomes.”

The figures on opioid deaths are even more startling when presented in terms of lifetime odds, which are approximated by dividing the one-year odds of dying from a particular cause by the life expectancy of a person born in 2017 (78.6 years). Measured this way, Americans have a 1 in 96 probability of dying from an opioid overdose.

The lifetime odds of dying in a plane crash? 1 in 188,364.

“As human beings, we’re terrible at assessing our own risk,” Kolosh told National Public Radio. “We typically focus on the unusual or scary events … and assume that those are the riskiest.”

Opioids abuse and overdoses have been on the rise for years. In 2017, more than 49,000 people died of opioid overdoses, according to the National Institute on Drug Abuse. That’s about six times higher than the rate for 1999. Now, an average of 130 Americans die every day from an opioid overdose.

The increased availability of fentanyl, a powerful synthetic opioid, is partly responsible for the recent spike in opioid overdoses, the council said in the press release.

“The nation’s opioid crisis is fueling the Council’s grim probabilities, and that crisis is worsening with an influx of illicit fentanyl.”

​Can Narcan curb the opioid crisis?

There’s one life-saving drug that, if administered quickly and properly, can stop nearly all opioid overdoses in their tracks: naloxone, commonly known as Narcan. Patented in 1961, the drug works by preventing the brain’s receptors from bonding with opioids, eliminating their effects on the body. Narcan can’t stop the addiction, but it can stop an overdose.

In 2018, U.S. Surgeon General Jerome Adams issued an advisory calling for more people to carry and learn how to administer Narcan, which is already carried by many EMTs and police officers.

“The call to action is to recognize if you’re at risk,” Adams told NPR. “And if you or a loved one are at risk, keep within reach, know how to use naloxone … We should think of naloxone like an EpiPen or CPR. Unfortunately, over half of the overdoses that are occurring are occurring in homes, so we want everyone to be armed to respond.”

Some believe making Narcan more accessible is the key to curbing the opioid crisis. That’s why most U.S. states have recently implemented a so-called standing order that allows people to get Narcan from a pharmacist without having to visit a doctor. Still, several factors seem to be preventing Narcan from being as ubiquitous as advocates like Adams might hope.

One problem is stigma. A 2017 study published in the Journal of the American Pharmacists’ Association showed how both pharmacists and addicts report being uncomfortable engaging in face-to-face discussions about the need for Narcan. The researchers argued that this stigma might be reduced through policies that call for pharmacies to universally offer Narcan to patients obtaining opioid prescriptions.

Another component of the stigma surrounding Narcan is an argument that says increasing the drug’s accessibility actually enables addicts. The idea is that addicts are more willing to take risks, and take increasingly dangerous drugs like fentanyl, when they know they have a life-saving drug in their pocket. Proponents of this idea might argue that Narcan “subsidizes recklessness,” but others say denying medical patients a lifesaving drug isn’t the answer.

“I understand the frustration,” Police Chief Thomas Synan Jr. of Newtown, Ohio, told The Associated Press. “I understand the feeling that someone is doing something to themselves, so why do the rest of us have to pay? But our job is to save lives, period.”

But perhaps the biggest obstacle to increasing the accessibility of Narcan is the price. As STAT points out, a life-saving dose of Narcan cost just $1 a decade ago, but now “costs $150 for the nasal spray, a 150-fold increase,” while a “naloxone auto-injector, approved in 2016, costs $4,500.”

As Stephen Wood wrote for Harvard Law School’s Bill of Health, these price increases came “when the opioid epidemic was at its peak, and they came without any explanation.” If the prices don’t drop, it’s unlikely that efforts like standing orders and community distribution programs will be effective.

Ultimately, Wood argued, it’s all about the money for pharmaceutical companies.

“Naloxone has gone from a $21 million dollar a year industry prior to 2014, to a booming $274 million dollar take per year since 2015. There is no doubt: pharmaceutical companies are making money off the opioid epidemic. Additionally, those who need this drug the most, often don’t have access to it. They are the under- or uninsured, so waving a co-pay is moot.

There are plenty of opportunities to reduce costs. Several authorities have asked for induction of federal law 28 U.S.C. section 1498, which would allow the United States to contract with a manufacturer to act on their behalf to create a less costly product. However, this still puts the onus of the cost on the tax payer. The pharmaceutical industry brought us the opioids that sparked this epidemic, heavily marketing oxycontin and oxycodone, which retail at around $1.25 a pill. What could possibly justify the antidote costing upwards of 3,600 percent more? There is no justification for this and policy makers need to draw their attention to this scamming of the general public in a time of crisis.”

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Are Opioids Beneficial for Chronic Back and Osteoarthritis Pain?


Although most clinical guidelines recommend against opioids for patients with chronic back and musculoskeletal pain, opioids still are prescribed frequently for these conditions. In this randomized trial, conducted in the Minneapolis Veterans Affairs system, researchers randomized 240 patients (mean age, 58; mostly men) with moderate-to-severe chronic back pain or hip or knee osteoarthritis pain to flexible opioid or nonopioid regimens. Patients who were receiving long-term opioid therapy were excluded, as were those with substance abuse disorders or poor prognoses.

Opioid regimens started with immediate-release morphine or oxycodone or hydrocodone/acetaminophen and progressed to sustained-action morphine or oxycodone or transdermal fentanyl, all titrated to 100-mg morphine-equivalents, as needed. Nonopioid regimens started with acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) and progressed to tricyclic antidepressants, gabapentinoids, topical analgesics, serotonin-norepinephrine reuptake inhibitors, and tramadol as needed. Patients pursued nonpharmacologic treatments as desired. Both groups were monitored in-person monthly until stable; subsequently, patients were monitored every 1 to 3 months (usually by telephone).

At 12 months, improvement in pain-related function was similar between the two groups. Pain intensity was significantly lower in the nonopioid group than in the opioid group, although this improvement was of borderline clinical significance. The opioid group had significantly more medication-related symptoms; adverse events did not differ between groups.

Comment

This nonblinded trial mimics real-life practice with its patient heterogeneity and wide range of medication choices. No benefit, and some potential harm, seems to be associated with use of opioids in patients with chronic back or osteoarthritis pain. Note, however, that several of the medications used by patients in this study’s control group — including acetaminophen, NSAIDs, and gabapentinoids — also are ineffective or minimally effective in patients with chronic low back pain

Opioids: A Crisis Decades In the Making


In 1980, Jane Porter and Hershel Jick published in a prominent medical journal the results of their study of pain among hospital patients.

These simple words about patients who took opioids would be used — and misused – for decades:

“We conclude,” the doctors wrote in a letter to the editor, “that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.”

Nearly four decades later, Jick said he regrets that he and Porter ever published their work. But they are hardly to blame for what would come.

Pain, Pills, and Death

An estimated 100 million Americans live with long-term pain. For decades, medicine’s overwhelming response has been prescription opioids like hydrocodone and fentanyl. Retail pharmacies dispensed more than 214 million opioid prescriptions in 2016. That’s more than 66 prescriptions for every 100 people and more prescriptions than any other country in the world.

In 2015, a reported 2 million Americans ages 12 and older were addicted to prescription pain relievers. In 2015 and 2016, nearly 117,000 Americans died from opioid overdoses. That’s more than the number of U.S. soldiers killed in the Korean, Vietnam, Iraq, and Afghanistan wars combined.

The numbers are so massive, they’re hard to comprehend. They have led dozens of cities and states, joined by the U.S. Justice Department, to sue opioid manufacturers and distributors as the federal government tightens regulations on opioid prescribing and calls the epidemic a public health emergency.

And it started with the mistaken idea that opioids were not addictive.

There’s plenty of blame to go around, from companies that used questionable marketing to make opioids the go-to for pain treatment, to the doctors who failed to change their habits even as patients’ bodies piled up, to the insurance companies that may not cover alternatives to opioids.

Because the drugs are so addictive, some patients, too, played a role in the crisis. Lax regulation and tracking allowed some to “doctor shop”: If one doctor refused to prescribe opioids, there’s another just down the street who might.

War on Pain

In their 1980 study, Jick and Porter wanted to find out whether hospital patients who received narcotics for acute pain for a short time became addicted to them. They reviewed the medical records of about 39,000 hospital patients. Nearly 12,000 of them received opioids while they were in the hospital. Four developed addiction to them. They reported their findings in a letter to the editor in the New England Journal of Medicine.

The patients that Porter and Jick observed “weren’t being treated with chronic opioid therapy for chronic pain, so the observation had no bearing at all on the risk of developing addiction” with chronic use, says Daniel Tobin, MD, medical director of Adult Primary Care at Yale-New Haven Hospital in New Haven, CT. He focuses on long-term pain management and opioid safety. “But this letter to the editor became doctrine.”

A study found that Porter and Jick’s five-sentence letter was cited 608 times in support of opioids. In 80% of those citations, the authors did not note that the patients received the drugs in the hospital.

A 1986 study in the journal Pain, which observed 38 patients, concluded again that opioid addiction was extremely rare.

“If we were talking about (blood pressure) medication, doctors would want rigorous evidence from long-term trials. We were ready to use opioids more freely before we had that data. I’d say physicians should take some of the responsibility,” says William Becker, MD, a core investigator in the Pain Research, Informatics, Multimorbidities & Education (PRIME) Center of Innovation at the VA Connecticut Healthcare System in West Haven, CT.

The ‘Fifth Vital Sign’

Around the same time, the medical community started paying more attention to the treatment of pain.

In the 1980s, the HIV epidemic called the medical profession’s attention to the under treatment of pain. “It triggered a worldwide outcry about the underutilization of opioids in the treatment of pain and how doctors needed to do a better job of treating chronic pain,” says Walter Ling, MD, a psychiatrist and founding director of the Integrated Substance Abuse Programs at the University of California-Los Angeles.

In 1996, increasing concern about untreated pain led the American Pain Society, a group of health care professionals and scientists that promote changes in public policy and medical practice to reduce pain-related suffering, to declare pain the “fifth vital sign.” That suggests it’s just as important for health care professionals to evaluate and address pain in every patient visit as it is to address the four common vital signs: temperature, pulse, breathing rate, and blood pressure.

While patients’ perception about their own pain is important, there is no test or instrument to verify it.

“Of course, pain is not a vital sign. There’s no objective test for it,” Tobin says. “We only have patients’ self-reports.”

That same year, Purdue Pharma released a new opioid prescription medication called OxyContin. In the 1998 OxyContin promotional video “I Got My Life Back,” targeted at doctors, a doctor explains that opioid painkillers are the best pain medicine available, they have few if any side effects, and fewer than 1% of people who use them get addicted.

OxyContin, originally sold in 80 milligram tablets, was appropriate, its label said, “for the management of moderate to severe pain where use of an opioid analgesic is appropriate for more than a few days.”

“The drug companies were ‘educating’ the doctors,” Ling says. “But there’s a very thin line between educating doctors and promoting your product.”

At the same time, drug reps were everywhere. They traveled from clinic to clinic, promoting their drugs while offering doctors gifts such as travel and lodging at expensive medical conferences in exchange for a visit to their booth. “They were literally throwing money at us,” says Joji Suzuki, MD, a psychiatrist who specializes in substance abuse at Brigham and Women’s Hospital in Boston. “These were the Wild West days when drug reps had free rein.”

Other Options Cheaper, Safer

Opioid painkillers aren’t the only pain medications available. They were just more aggressively marketed. Studies have shown that over-the-counter ibuprofen or a combination of ibuprofen and acetaminophen may treat pain better than opioids. Topical creams, certain antidepressants called SNRIs, and nerve pain medications such as gabapentin can ease chronic pain in some people, too. Other therapies, like yoga, acupuncture, physical therapy, and exercise, have also shown benefit for some.

While opioid manufacturers were “educating” doctors, American medical schools offered little or no training in the management of long-term pain. In 2010, only 1 in 5 American medical schools had any formal instruction on the topic. Among those, some schools required fewer than 5 hours of instruction. “In the absence of adequate education, pharmaceutical manufacturers stepped into the void with the message that long-term opioids were unquestionably safe and effective,” Becker says.

In 2003, the FDA warned the company its advertisements and promotional materials, which claimed OxyContin was less addictive than other opioids, were breaking federal law.

“The combination in these advertisements of suggesting such a broad use of this drug to treat pain without disclosing the potential for abuse with the drug and the serious, potentially fatal risks associated with its use, is especially egregious and alarming in its potential impact on the public health,” the agency wrote.

In 2007, the company agreed to pay $634 million to settle criminal and civil charges over its “long-term illegal scheme to promote, market and sell OxyContin,” according to an FDA press release issued at the time.

Today, Purdue Pharma publicly supports state and federal programs to fight the opioid epidemic, including encouraging prescribers to consult prescription-drug-monitoring program databases and repeating the CDC’s call to shorten the duration of first opioid prescriptions. The drug company distributed the CDC’s guidelines to prescribers and pharmacists when they were first released.

“Our industry and our company have and will continue to take meaningful action to reduce opioid abuse,” the company says in a statement. The company says it supports efforts to limit the length of first prescriptions of opioids and vows to continue research into new, non-opioid pain medications.

But the horse was already out of the barn before the FDA’s warning to Purdue Pharma in 2003.

Both the Veterans Administration and the Joint Commission, the independent organization that accredits American hospitals, had also declared pain the fifth vital sign. Health care professionals took notice when, soon after, a doctor was fined $1.5 million for under treatment of pain in an 85-year-old patient who died of lung cancer. “Under treatment of pain became a form of malpractice, of medical abuse,” Ling says.

By 2006, the Centers for Medicare and Medicaid Services launched a patient-satisfaction survey that would affect how much reimbursement hospitals got. Among other questions, the survey asked patients whether their pain was well managed.

“It behoved hospitals to push opioids as much as they could to keep patients happy,” Becker says.

A Way Forward?

Though opioid prescribing is still high, it peaked in 2010 and has continued to fall. In 2014, there was a steeper decline in opioid prescriptions after new laws took effect that required patients to see their doctor every time they wanted a refill of certain painkillers, Jones says.

The requirement made it a little harder for people to get opioids, and it may have raised doctors’ awareness of how much of the medication their patients were taking.

As of October 2017, in response to comments from doctors, the U.S. Department of Health and Human Services no longer considers hospitals’ pain management scores on patient satisfaction surveys in its reimbursement decisions for Medicare and Medicaid patients. The agency also plans to take another look at pain management survey questions and may revise them, says Jones.

These policy changes are intended to cut prescribing but not end access to the drugs altogether. “There are patients who do benefit from opioids,” says Daniel Tobin, MD, medical director of adult primary care at Yale-New Haven Hospital in New Haven, CT. He focuses on long-term pain management and opioid safety. “For those patients who benefit without evidence of harm, you don’t need to just take it all away. I would hate to see the pendulum swing too far.”

But there is some evidence that the proverbial pendulum has already begun to swing too far, according to a recent article in The New England Journal of Medicine. “The increase in opioid-related mortality fueled by injudicious prescribing and increasing illicit use of both prescription and illegal opioids has led some clinicians to simplify their lives by discontinuing prescribing of opioid analgesics,” the authors of the article write.

The authors say that halting opioid prescribing altogether would cause patients to suffer and could push some to seek out illegal opioids, like heroin, on the street.

“We need to find a middle ground,” says Tobin, “where we’re being deliberate and careful about prescribing.”

medicine cabinet

Beyond Opioids: The Future of Pain Management


Cindi Scheib wanted to die.

A three-day weekend spent jumping and dancing on Labor Day 2014 had left her with a neck injury – specifically the cervical spine – that was possibly an exacerbation of an unrecognized mountain biking injury earlier that year. To make matters worse, her doctor performed the surgery to fix the injury on the wrong part of her spine.

Cindi Scheib

Now 54, Scheib has lived with constant neck pain and other unusual sensations throughout her body ever since. These sensations, including electrical shocks down her spine, buzzing, vibrating, burning sensations, ringing in her ears and sensitivity to normal noises, had gotten so bad, she said, that “I wanted to go to bed and not wake up tomorrow. This life was so bad, so horrible, that I couldn’t imagine how I was going to live the rest of whatever life I had,” says the Harrisburg, PA, nurse.

Today, the pain may be worse than it was in 2014, but Scheib is better. She says that’s because she stepped off the well-trodden path of lifelong prescription painkillers and took the less traveled road of pain management — a combination of pharmaceutical and non-pharmaceutical treatments that gave Scheib her life back.

Like Scheib, an estimated 100 million Americans live with long-term pain. Since the 1990s, physicians’ go-to treatment for constant pain has been prescription opioids, such as oxycodone or hydrocodone. Though the evidence that opioids work for long-term pain is lacking, Americans get more prescriptions for them than the citizens of any other country in the world. The prescribing epidemic has led to a national crisis of opioid misuse, overdose, and death. Now, as policymakers and health care providers work to stem the tide of addiction and abuse, patients and some prescribers worry that the changes will take pain medications out of the hands of people who truly need them.

New Drugs

Access to painkilling medications that can’t cause addiction, abuse, and overdose would make life easier for prescribers and could save the lives of patients.

Development of such drugs has been slow-going, in part because scientists don’t completely know how chronic pain works. They believe the body has multiple pathways to chronic pain, and that means multiple targets for painkillers. But researchers don’t have proven ways to identify which pathway is causing the pain in each person.

Drugmakers may have zeroed in on a target for chronic back pain and osteoarthritis pain. The FDA recently fast-tracked the drug tanezumab for approval. Federal regulators had previously halted work on tanezumab and other drugs like it over concerns about side effects.

The non-opioid blocks the production of nerve growth factor, a substance that’s needed for certain types of pain to happen. Several other anti-nerve growth factor drugs are in clinical trials.

Opioids address pain in a different way. They look like chemicals that the body produces naturally to regulate pleasure, pain, and emotions. So, when you take an opioid, the drug attaches to parts of nerve cells called opioid receptors, where they can block pain. But they also cause the pleasurable feelings that make people want more opioids. And they slow breathing, which is why overdoses can kill.

A team of researchers at Wake Forest University and the University of Bath in the U.K. is exploring a new kind of opioid that could relieve pain without affecting breathing or raising the chance for abuse. The new drug, only called by its chemical compound name BU08028, relieved pain in rhesus macaque monkeys. When they had the opportunity to take as much of the drug as they wanted, they didn’t abuse it. When taken off the drug, they didn’t show signs of painful withdrawal.

Although in early development, safely and successfully using the drug in this type of monkey is a key step on the path toward human clinical trials.

A second drug, also in early development, could harness the pain-relieving effects of opioids while bypassing the negative effects. The drug eased pain in mice. It’s still a long way from human testing.

New Approaches

The bottom line is that opioids should not be the first thing doctors try in patients who have chronic pain. The CDC’s latest guideline for opioid prescribing, released in 2016, notes that most proof of how well opioids work is based on short-term pain. It directs doctors to try nondrug treatments, such as physical therapy and talk therapy, as well as non-opioid treatments first. If those aren’t enough, before adding opioids, doctors should work with patients to set realistic goals for easing pain, with an emphasis on making the body work better rather than eliminating pain.

The U.S. Department of Health and Human Services, too, released a “National Pain Strategy” in 2016 that emphasized many of the same points. The HHS document also called for an approach to treatment that would include mental health, social and work concerns of the patient, and alternative therapies.

“We need to teach our patients that you may never be able to get rid of the pain completely,” says Joji Suzuki, MD, a psychiatrist who specializes in substance abuse at Brigham and Women’s Hospital in Boston. “So how do you cope with it? How do you restore function?”

Exercise, physical therapy, and talk therapy have proven benefits in the areas of function, or making the body work better, and coping. Health care providers ought to approach long-term pain with a combination of those treatments, says Ellen Edens, MD, a psychiatrist who treats veterans with chronic pain and long-term opioid use in the VA Connecticut Healthcare System.

“It’s not clear [in clinical trials] that opiates actually improve function in the long run,” she says. “In fact, there’s some evidence that people on chronic opiates lose function over the long run.” Loss of function is due in part to the side effects of these drugs, which include nausea, vomiting, and constipation. While they might ease pain, the side effects can keep a person from getting on with their life. What’s more, most people typically need to increase the dosage over time to keep getting the same level of pain relief.

HHS has compiled a report for doctors to use when treating long-term pain that summarizes the research behind many nondrug treatments and how they work.

“An opiate might bring your pain score down from an 8 to a 6.5, but if we add physical therapy, we can bring you down to a 6,” Edens says. “Ibuprofen might bring you down to 5.75. Then we’re going to get you therapy for your depression and your mood. Then acupuncture will bring you down to 5.25 and so on.”

It was a varied approach that got Cindi Scheib her life back.

She learned about a pain rehab program in her area that put many methods into one treatment plan. There, 2 years after that fateful Labor Day weekend, she had physical therapy, talk therapy, swim therapy, meditation training, hypnosis, yoga, and biofeedback — a treatment that uses electronic monitoring of seemingly involuntary bodily functions (such as pain) to teach a person to control it.

Health insurance plans might soon include more nondrug ways to treat chronic pain.

“I think we’re seeing some shifts within the private insurance sector in how we are paying for pain care,” says Christopher Jones, PharmD, a pharmacist and director of the National Mental Health and Substance Use Policy Laboratory at the Substance Abuse and Mental Health Services Administration. The Department of Health and Human Services is researching insurance coverage policies on treatment of long-term pain. “That’s an important step in trying to start the conversation on changing coverage policies.”

Coverage is one barrier to a varied, nondrug way to treat chronic pain. Time is another. Some people won’t want to invest the time in what might appear to be a slower approach. Still, it’s what worked for Scheib. “Everything started to gel,” she says. “I realized that my brain is adaptive. I could keep sending it the message that life is horrible and I’m dying, or I could start sending it good messages. It’s literally mind over matter.”

Scheib hasn’t gotten rid of her pain. “Actually, it’s probably worse now,” she says, matter-of-factly. But her body works better now. In spades. Incredibly, she hikes, bikes, scuba dives, and rappels down waterfalls. She attributes much of her improvement to changing her expectations.

Too often, says Suzuki, patients have unrealistic beliefs about pain. “There’s this automatic expectation that pain should be completely eliminated.”

That’s what’s changed for Scheib. “Before, I had an expectation of a perfect life, but now, I’m reprogramming my brain. I have a realistic expectation to accept and adapt. The most powerful tool in my toolbox is my ability to be positive and hopeful.”

Women Do Well Without Opioids after Gyn Surgery


An 89% drop in opioid use with restrictive prescribing protocol

The amount of opioids prescribed after gynecologic surgery declined by almost 90% with few complaints from patients after implementation of a restrictive prescription protocol, as reported here at the Society of Gynecologic Oncology (SGO) meeting.

Over a 6-month period, the total opioid pill count declined by 89% as compared with historical prescribing practices. The total included a 73% reduction the number of pills dispensed after open surgery and 97% after minimally invasive procedures.

Patients undergoing ambulatory/minimally invasive procedures and with no history of chronic pain received only prescription-strength ibuprofen or acetaminophen at discharge. Those with a history of opioid exposure or chronic pain, received a 3-day supply (12 pills) of hydrocodone-acetaminophen (Norco) or oxycodone-acetaminophen (Percocet).

Patients undergoing open surgery received either nonopioid pain medication or a 3-day opioid prescription at discharge. If a patient used an opioid for pain in the previous 24 hours, then a 3-day supply consisting of 24 pills (two every 6 hours) was prescribed.

More than 90% of patients went home without an opioid prescription after minimally invasive procedures, and fewer than 5% of patients expressed dissatisfaction with their doctors’ prescribing practices under the restrictive prescribing protocol, said Jaron D. Mark, MD, of the Roswell Park Comprehensive Cancer Center in Buffalo, New York.

“We were quite surprised by how few inquiries and requests for medication we got from our patients,” said Mark. “We expected that we would be able to reduce use of opioids without detrimental consequences, but the extent to which our hypothesis was supported by these results was really striking.”

Principal investigator Emese Zsiros, MD, PhD, also of Roswell Park, said the key factor in reducing opioid use after gynecologic surgery was setting appropriate expectations about pain management in advance of surgery — for clinicians and patients.

A second study reported at SGO documented overprescribing of opioids for minimally invasive hysterectomy. Patients routinely went home with an opioid prescription, but almost a third used none of the pills. The vast majority of patients used only a portion of the prescription, reported Erica Weston, MD, of Johns Hopkins Hospital in Baltimore.

Data, Planning, Caution

Taken together, the two studies showed that most patients undergoing gynecologic surgery — open or minimally invasive — require little or no opioid medication, said invited discussant Sean C. Dowdy, MD, of the Mayo Clinic in Rochester, Minnesota. Availability and use of nonopioid alternatives and preoperative education of patients are critical elements in a strategy to reduce opioid use.

Dowdy called for the development of procedure-specific guidelines for opioid use, which he helped develop at Mayo and will describe in detail at an upcoming meeting. Noting the lack of guidance in the medical literature, Dowdy and colleagues reviewed historical data encompassing 2,500 patients, 25 procedures, and 10 subspecialties. They then performed a survey of outpatient opioid prescribing practices covering a similar number of patients, procedures, and subspecialties.

After reviewing the data, surgeons at Mayo implemented a restrictive prescribing protocol similar to the one described by Mark. Dowdy said they expect to cut opioid use by 1.5 million pills a year.

However, he cautioned against allowing the prescription pendulum to swing too far in the direction of restrictive practices.

“There is no question that our current state is overprescribing, but we need to be very careful not to overcompensate and move to a state of underprescribing,” said Dowdy. “These guidelines apply to acute, postsurgical pain. They do not apply to management of chronic pain and certainly not apply to patients in the palliative-care setting.

‘Ultra-Restrictive’

Prior to implementing the restrictive protocol, Mark and colleagues surveyed U.S. gynecologic surgeons about their opioid prescribing practices. For patients undergoing minimally invasive procedures, half the surgeons prescribed 15-20 opioid tablets at discharge, and another 28% wrote prescriptions for 21 to 40 pills. For patients undergoing open surgery, two thirds of surgeons prescribed 21-40 opioid tablets and discharge, and 13% prescribed more than 40 tablets.

The restrictive protocol was evaluated from June 2017 through January 2018 and included 337 patients. Investigators compared the results with a control group of 626 patients who underwent similar procedures in prior years.

Overall, the average number of opioid tablets prescribed at discharge declined from 31.7 to 3.5, an 89% reduction. The total reduction included a 73% decline in average pill count for patients who had open surgery (43.6 vs 11.6, P<0.001) and a 97% decrease among patients undergoing minimally invasive procedures (28.1 vs 0.9, P<0.001). The proportion of patients discharged with no opioid prescription after minimally invasive procedures increased from 19.6% to 92.6% (P<0.001).

The average number of opioid tablets prescribed for patients with no prior opioid use declined from 31.7 to 3.1 (P<0.001) and from 31.6 to 6.2 among opioid-dependent patients (P<0.001).

The proportion of patients requesting refills within 30 days after surgery did not change significantly. Mean postoperative pain scores were virtually identical before and after implementation of the restrictive prescribing protocol (P=0.34).

Unused Pills

Weston reported findings from a prospective cohort study involving 114 women who underwent minimally invasive hysterectomy. The patients received an average of 3 opioid doses while in the hospital, and all were discharged with opioid prescriptions, averaging 30 pills per prescription. Weston said 25 patients used no opioid medication during hospitalization.

The women were surveyed regarding opioid use at follow-up visits 1-2 weeks after surgery and again at 4-6 weeks. At the first follow-up, 45 patients (36.9%) reported no opioid use since discharge, and the median number of pills used across the entire cohort was nine. At the end of follow-up, 37 patients (32.5%) had used no opioids, and the median number of pills since discharge was 11 for all 114 patients.

“We found that 90% of the patients used 30 or fewer opioid tablets,” said Weston. “The strongest predictor of opioid use after discharge was opioid use during the inpatient stay.”

How Necessary Are Opioids for Chronic Pain?


The continued ravages of the opioid epidemic have prompted researchers to reconsider whether opioids are an appropriate treatment strategy for chronic non-cancer pain. In this 150-Second Analysis, F. Perry Wilson MD, MSCE, looks at a trial appearing Tuesday in JAMA that compared opioid to non-opioid therapy in patients with chronic knee and back pain and found virtually no data to support using opioids in this setting.

When two treatment modalities are being compared, I can usually find something positive to say about both of them.

But today we have this study, appearing in the Journal of the American Medical Association, comparing opioid to non-opioid regimens for chronic back or knee pain and I am hard-pressed to find a single data point that argues FOR the use of opioids in this setting.

240 Veterans Affairs patients with moderate to severe chronic knee or back pain were randomized to one of the two treatment strategies, each of which had three tiers. Take a look:

The opioid group first tier was characterized by short-acting pain killers, then escalated to longer acting agents, and finally capped out with transdermal fentanyl.

The non-opioid regimen was a bit more clever, in my opinion. Tier 1 was acetaminophen and NSAIDs. Providers could then escalate to other oral meds (I particularly like the underused amitriptyline appearing in this tier) and topicals, and finally capped out with tramadol.

Now, I know what you’re thinking. Isn’t tramadol an opioid? I asked lead author Dr. Erin Krebs that very question. She reminded me that this trial started in 2010: “This was before all the concerns about opioid overdose and addiction and back then a big concern was is it ethical to deprive patients of opioids if they fail all these non-opioid medications.”

Times have certainly changed. But regardless, only 13 patients in the non-opioid group ever required escalation all the way to tramadol.

And the results did not look good for opioids. The primary outcome was pain-related function which improved substantially in both groups but did not differ between the groups. Raw pain scores ended up being a bit better in the non-opioid arm.

Adverse events, as you might expect, were significantly higher in the opioid group, but fortunately no opioid abuse was detected.

One common criticism you hear about opioid trials is that researchers simply didn’t give enough – if they had titrated up more aggressively, patients would have better pain control. While the investigators limited the total morphine equivalents to 100 mg per day, Dr. Krebs told me very few patients bumped into that ceiling.

“The vast majority of folks stopped before 50, and it wasn’t because we had a limit there. It’s because simply that seemed to be the best dose for them.”

Are opioids dead for chronic back or knee pain? I think they are on life support. But the real key to this study was the careful titration of non-opioid pain medication in that group. Most of us try Tylenol and Advil and then give up. With close monitoring, patient feedback, and a willingness to try multiple interconnected agents including tricyclics, physicians may find that treating chronic pain is not so painful after all.

Sports Medicine Can Do Without Opioids


Beating Back an Epidemic

The problem of opioid addiction now affects us all. For me, the biggest shock came when one of my patients, former National Football League quarterback Erik Kramer, tried to commit suicide after his 18-year-old son, a high school quarterback, died of a heroin overdose.[1]

It’s a vivid illustration of the way the ripples from drug abuse are becoming a tsunami that destroys not only the addicted but everyone around them. As sports physicians, we must do our part to beat back the waves, beginning with our approach to controlling patients’ pain.

The magnitude and complexity of the problem makes it truly daunting. In the year ending July 2017, a total of 66,972 people died of drug overdoses in the United States, a 14.4% increase over the previous year. That includes more than 115 deaths from opioids per day.[2]

These overdoses are killing Americans at a faster rate than the AIDS epidemic at its height. They are killing more than the number that die from traffic accidents or suicides. More have died from opioids than were killed in the entire Vietnam War.[3]

Paving the Road to Devastation

To understand how we can stop this epidemic, it helps to know how we got here. In the 1990s, drug makers convinced doctors’ associations and government policy makers that new formulations of opioids such as OxyContin would not addict patients, and that they were essential to control pain. Prescriptions soared.

But patients did become addicted. One study found that 8.2% of patients who took opioids for the first time after total knee arthroplasty were still using them 6 months later,[4] despite weak evidence that the drugs are effective for chronic pain management.[5] Not only does abuse of these prescriptions kill thousands, but for many people, these medications serve as a bridge to illegal drugs.[6]

The amount of opioids prescribed in the United States peaked in 2010, but doctors still wrote 70 opioid prescriptions for every 100 people in 2015, three times more than in 1995 and four times more than in Europe.[7]

Protecting, Then Empowering, Patients

For the clinician, the phenomenon poses a complicated challenge. We cannot ignore our patients’ pain. But we usually can’t tell which patients are at risk for addiction. We also usually don’t know when they are suffering from other mental health problems.

To play our part in addressing this national problem, sports physicians must start by recognizing the magnitude of it. I’d like to see addiction come out of the closet. It should be a medical diagnosis like any other, so that patients can freely discuss whether they have struggled with it in the past, gone through rehabilitation, or are still misusing drugs.

As it stands, most people can’t get coverage for addiction treatment, and rehabilitation programs are relegated to the margins of medicine. As physicians, we must attend to the psychological, emotional, and addictive aspects of our patients’ lives, even when the healthcare system does not.

Sometimes we can make a difference in surprising ways. When I was in medical school at Washington University in St. Louis, Missouri, I trained to run a marathon. Every day I ran to the hospital. One day I passed my patient who was at the hospital for mental illness, and he asked me why I was running. I told him it made me feel good.

“Would it make me feel good?” he asked.

“I bet it would,” I answered. And after getting permission from his head physician, I took him for a run. He could barely run a quarter mile, but he came back saying how good it made him feel. So the next day we ran again, and the next day after that.

I believe that exercise empowers people to discover that solutions are within them. It would be naive to think that running is all that the average patient needs to recover from addiction. But in combination with behavioral modification and addiction medications such as methadone, it can provide powerful benefits.

Identifying High-Risk Patients

I’ve found it essential in my practice to develop relationships with rehabilitation programs to which I can refer my patients. I’ve referred some to in-patient 30-day detoxification followed by outpatient rehabilitation. Other patients come to me already enrolled in rehabilitation programs.

In Malibu, there are several programs that attract patients from around the world. They come to me with sports medicine problems while they’re in town. It’s very important to be aware of the complexity of these patients and work closely with their other physicians to coordinate the medical management with the addiction therapy, especially to know which drugs to prescribe and which ones to avoid.

I’ve also treated patients who injured their knees because a drug abuse problem led to a car crash. These patients may be enmeshed in legal problems and enrolled in rehabilitation but are continuing to abuse drugs and are unable to comply with my advice for recovering from surgery.

These very complex patients require careful management. I spend a lot of time on communication when treating them, trying to preempt problems. To provide such patients with the best possible care, I have worked closely with rehabilitation programs, such as Beit T’Shuvah in Culver City, California. With runners enrolled there, I’ve talked about the principles of my book, The Win Within, which shows readers how to modify their own behavior.

Non-opioid Pain Management

The second step we can take to prevent opioid abuse is to address our patients’ pain carefully and systematically so that they can manage without opioids. My goal is always to create for my surgery patients an experience that is devoid of pain. I follow the motto “No pain is your gain,” because it’s not just the best approach for my patients’ health; it’s the best possible way to promote my practice.

A lot of surgeons routinely send patients home with prescriptions for 30 hydrocodone/acetaminophen or oxycodone tablets. I’ve moved away from prescribing those drugs, along with codeine and most of the other opioids, because of my concern about addiction.

Instead, I rely on preemptive blocks and long-acting liposomal local anesthetics. Typically, I inject ketorolac into the area around the joint before, during, and after the surgery. After surgery, I prescribe a variety of acetaminophen and nonsteroidal anti-inflammatories. I recommend ice, compression, and sometimes electrical stimulation. Only when these measures fail do I prescribe tramadol, a synthetic opioid. It does have some addiction potential, but much less than hydrocodone, codeine, or oxycodone.[8]

I also have a discussion upfront with the patient about my strategy to create a pain-free experience for them. When patients ask for opioids, I tell them I’m very effective at pain management and that my surgical technique aims to avoid causing pain in the first place.

That works about 98% of the time. Over the years, a handful of patients have tried to manipulate me for opioid prescriptions. For this reason, I pay close attention to the reports I get from central databases that track patients’ prescriptions from one pharmacy to another.

The most dramatic report I ever received concerned not a patient but another physician, who got the license and Drug Enforcement Agency numbers of several of his colleagues. I got a report saying that I’d written about 30 prescriptions for him in 1 year. Several of us spoke to him, and he entered a rehabilitation program.

Success in managing patients’ pain requires careful monitoring. I ask patients to score their pain on a 1-10 visual analogue scale. Not only does this help me analyze the situation of an individual patient, but it allows me to evaluate my success across my practice by averaging the scores of dozens of patients. And by participating in the Arthrex Surgical Outcomes System, I can compare my results with those of other physicians. I challenge all physicians to take on this level of pain management.

No Easy Fixes

Although I feel confident in my approach, I also think surgeons’ options are limited until our healthcare system finds a better approach to mental illness. Many people become addicted to opioids not because they got prescriptions after surgery, but because it’s the only way they know to douse the flames burning inside their heads.

So the problem is going to require attention from politicians as well as doctors. The purple ribbons that some members of Congress wore at the State of the Union Address in January provided a reminder of the problem, but we need much more than that. As I write this, we don’t even have an administrator for the Drug Enforcement Agency.

All of us must work together to develop comprehensive solutions of prevention and caring to bring an end to this crisis.

Compounds in herbal supplement kratom are opioids, FDA says


On Tuesday, USDA Commissioner Scott Gottlieb warned the public about the dangers of the herbal supplement kratom saying “There is no evidence to indicate that kratom is safe or effective for any medical use.”1
The leaves of the kratom plant, which is native to Malaysia, are traditionally crushed and then made into a tea to treat pain or heroin/morphine dependence (by reducing withdrawal cravings). And according to its 3 to 5 million U.S. users, it’s a game changer and a life saver.

PUBLIC COMMENTS AND SCIENTIFIC REVIEW

However, the DEA and FDA aren’t so sure. Thankfully, since requesting public comment about Kratom and calling for a scientific review by the FDA, the agency hasn’t taken any further steps to make its use illegal. But the plant is still listed as a “drug of concern”. (You’ve got to wonder if they are doing that because it hurts their bottom line.)

“To better understand the plant, the FDA conducted computer modeling that predicted that many of the chemical compounds found in kratom bind to the same receptors as narcotic drugs such as oxycodone and hydrocodone.

But researchers who study the plant, including Scott Hemby, say the agency is making too broad of a statement. Hemby chairs the Department of Basic Pharmaceutical Sciences at High Point University in North Carolina and has been researching the abuse liability or ‘addictiveness’ of kratom.”2

While the model indicates that kratom compounds might affect the body just like opioids, which Hemby has seen in his research, he says that they do not bind to opioid receptors the same way the chemicals in heroin or oxycodone do, “Just because it binds, it doesn’t mean it has the same efficacy.”3 Instead, the compounds in kratom “sit on different parts of the receptor and fit differently than the chemicals in heroin and oxycodone.”4 And that means kratom use doesn’t lead to overdose fatalities the way opioids do. (But you know Scott Gottlieb, science is hard.)

IS IT REALLY THAT DANGEROUS?

In 2010 the CDC reported just 26 calls to poison control centers about kratom, it 2015 that number had gone up to 263. But the FDA is now blaming the plant for 44 deaths, another issue Hemby takes with the agency- because there was no proof from toxicology or autopsy reports. And he’s not alone, Christopher McCurdy, a medicinal chemist at the University of Florida, has analyzed samples of kratom from emergency room patients and found that very often they aren’t even what they claim to be.5
If the FDA continues to paint with such a broad brush, it could potentially put serious regulations on kratom’s study and use and that could be devastating to many people.
We’ve been watching this story since 2016 and will continue to do so. If the FDA really just wants to protect people they need to make the drug available for proper “intact animal models and humans”6 rather than simply write it off.

FDA and Opioids: Too Much Regulation or Not Enough?


Agency’s call for public input on the health emergency yields conflicting views

 If the FDA is looking for a streamlined approach to respond to the opioid crisis, it didn’t come from a public meeting of the agency’s Opioid Policy Steering Committee.

At the meeting Tuesday, academics, physicians, patients, advocates, and industry officials shared sometimes conflicting recommendations on how the FDA can best handle the problem.

Advocates generally fell into two camps: pain patients and their supporters, concerned that opioids are being over-regulated and becoming harder to access, and people who have lost loved ones to addiction and overdoses, and would like to see stronger restrictions on such products.

Meanwhile, healthcare experts stressed addiction and overdose prevention, better provider education and awareness efforts, and the elimination of “doctor-shopping.”

In September 2017, the FDA issued a request for comment, which said the national crisis is one that requires “action by federal agencies that may in some instances be unprecedented.” The notice solicited public input to help the agency determine what it should leverage to respond to the crisis.

President Trump declared the opioid epidemic a public health emergency a month later. Approximately 64,000 people died from opioid overdoses in 2016.

The FDA notice included a handful of direct questions for stakeholders, such as:

  • How can the agency use the available public health data to influence opioid related regulatory decisions?
  • What changes can the agency make with regard to “dispensing and packaging” to encourage proper prescribing practices?
  • Should mandatory education be required for clinicians who prescribe opioids?

At the recent meeting, agency officials also discussed whether to specify dose limits, the creation of a nationwide prescription history database, and how to assess the impact of prescription drug monitoring programs (PDMP).

With regard to provider education, “there is no evidence, in the published literature, that mandatory education increases knowledge or changes behavior and practice,” pointed out Norman Kahn, MD, of the Conjoint Committee on Continuing Education. “If the goal is to count the number of people who complete the education, then of course we should make it mandatory.”

“If … the goal is to make people learn and change the behavior and practice, that doesn’t happen with mandatory education. That happens with voluntary education,” he stressed.

Kahn said he has discussed the idea of an “adaptive learning” approach with the Centers for Medicare and Medicaid Services. He said he has hopes that such an approach might count as an improvement program under the Merit-Based Incentive Payment System (MIPS).

Another concern is the language used to describe opioids, stated Diana Zuckerman, PhD, of the National Center for Health Research. She said “abuse deterrent” may mean different things to doctors, patients, and family members.

 She urged the FDA to include education on the meaning of “abuse deterrent” within its Risk Evaluation and Mitigation Strategies (REMS) because “too often it’s misinterpreted to mean it’s not as addictive.”

But Zuckerman also questioned the value of REMS itself, claiming that the “vast majority” of physicians don’t even know REMS exists. Following the implementation of REMS, one prescriber-based survey found 48% of respondents said they did not change their prescribing habits, she noted. Also, while 49% said they made use of the patient counseling documents, that means roughly half did not, she added.

On the advocates’ side, Richard Lawhern, PhD, co-founder of the Alliance for the Treatment of Intractable Pain, urged the FDA to “stand down” from additional regulations on opioids.

He said that the agency is chasing the wrong crisis, as more regulation “is going to make the real crisis worse,” by driving patients into the realm of heroin and/or other illegal street drugs. He also urged the FDA to “remove and rewrite” its practice standards regarding opioids, and he dismissed the Centers for Disease Control and Prevention’s revised guidelines as “nonsense.”

Emily Walden, of Louisville, Kentucky, called on the FDA to remove the highest dose opioids from the market and “immediately delay any new approvals.” Her 22-year-old son died because of an opioid addiction, she said.

She also pressed the agency to end its use of enriched enrollment in clinical trial design. The FDA describes the method as a way to “increase the likelihood that data collected during a clinical trial will demonstrate that an effective drug is effective.”

Other topics discussed at the meeting included the need to increase e-prescribing, improve PDMP, and integrate both into electronic health records (EHR) systems.

Robert Heary, MD, of the American Association of Neurological Surgeons, suggested providers complete a short (less than 5 minutes), standardized form, with each opioid prescription, to explain why the prescription is medically justified. If a national PDMP were established, data from those forms could feed into it and be cross-checked at the pharmacy.

He noted that having a connected PDMP would prevent doctor-shopping across state lines.

Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research called it a “bold proposal,” but questioned how much of a burden these additional measures would be for providers.

Patrice Harris, MD, an American Medical Association trustee and chair of the AMA’s Opioid Task Force expressed skepticism about the capacity of today’s EHRs. Recommendations on e-prescribing “overstate and overestimate the current capabilities of today’s electronic systems,” she said, adding that e-prescribing “in its current state” may not be suited to “explain medical necessity.”

While physicians may prefer e-prescribing, the pin numbers, passwords, and authentication processes can be “onerous” and may take time away from direct patient care, she added.

Drug may help surgical patients stop opioids sooner


Drug may help surgical patients stop opioids sooner

(HealthDay)—Opioid painkillers after surgery can be the first step toward addiction for some patients. But a common drug might cut the amount of narcotics that patients need, a new study finds.

When  received a non- medication called gabapentin before and after surgery, the need for continued opioid painkillers was reduced by 24 percent, said researchers at Stanford University School of Medicine.

The finding comes amid an  in the United States. Since 1999, overdose deaths have quadrupled, in large part due to abuse of prescription painkillers such as OxyContin (oxycodone) or heroin.

“Our country is facing an opioid crisis, and a lot of people are exposed to opioids after surgery,” said researcher Dr. Sean Mackey, chief of the division of .

More than 51 million Americans undergo surgery each year, according to background notes in the study. Most are given opioid painkillers afterward, and up to 13 percent become habitual users.

“There are some people who are vulnerable to the addictive proprieties of these drugs,” Mackey said. “We would prefer to find ways of not having people get into problems with opioids.”

Gabapentin (brand names: Neurontin, Gralise) is used to help prevent seizures and ease nerve  from shingles. It’s available as a generic, so it is inexpensive and covered by most drug plans.

Now, it appears to reduce the time patients feel they need opioid relief by a “modest” amount, the researchers said.

“This means that people are less likely to become addicted to opioids and less likely to have the side effects of an opioid,” Mackey said.

Those side effects can include sedation, nausea and constipation.

Surprisingly, the drug had no effect on how long it took for post-operative pain to subside, Mackey said. But it did effect how long patients needed opioids.

For the study, Mackey and his colleagues randomly assigned 410 surgical patients to receive gabapentin or a placebo before surgery and for three days afterward. Patients were followed for up to two years.

Procedures included chest surgery, knee replacements, and hand and breast surgery, to name a few. The study found that gabapentin seemed to help regardless of the type of operation.

It’s not clear how gabapentin might reduce the need for opioids, Mackey said. Perhaps it’s changing brain chemistry after surgery, he said.

“It’s probably having pain-relieving properties along with the opioid, and you don’t need so many opioids because the effects of the gabapentin are long-lasting,” he said.

Gabapentin is considered nonaddictive.

Mackey said more work needs to be done to determine which patients would benefit most from gabapentin, at what dose and for how long.

It’s also possible that gabapentin might benefit patients with pain from trauma. Given in the emergency room, it might help reduce the need for opioids, and thus help to prevent addiction in that setting, he said.

The findings were published online Dec. 13 in the journal JAMA Surgery.

Dr. Michael Ashburn is director of pain medicine at the Penn Pain Medicine Center in Philadelphia. He said this study may have important implications.

“This and other studies have reported that the duration of opioid administration may impact whether or not patients transition to chronic opioids after surgery,” said Ashburn, co-author of an accompanying journal editorial.

Although gabapentin doesn’t seem to reduce the length of time it takes for pain to cease after surgery, it “may allow for opioids to be discontinued more quickly following surgery,” Ashburn said.

Giving  after surgery is already part of clinical practice at Lenox Hill Hospital in New York City, said Dr. Kiran Patel.

“I am constantly looking for ways to reduce opioid requirements and to get patients off opioids so they don’t transition to chronic opioid use,” said Patel, an anesthesiologist and pain management specialist at the hospital.

There are ways to manage pain aside from opioids and anti-inflammatories after , she noted. “Incorporating them with the right patients, we might be able to reduce their overall use of opioids,” she said.