Study: Prescription Drug Databases Overestimate Opioid Misuse

By Pat Anson, PNN Editor

Prescription drug monitoring has long been seen as the gold standard for tracking the opioid crisis. Patients who fill an opioid prescription for more than three months are considered long-term users with a higher risk of misuse, addiction and overdose. Many pharmacy chains assign a “risk score” to these patients and their doctors could even get a warning letter from the government.

But in a small study of emergency room patients, Canadian researchers found the risk of opioid misuse by long-term users is small and one out of five patients who fill opioid prescriptions don’t even use them. Their findings suggest that prescription databases alone are a poor way to measure opioid misuse.

“The rate of long‐term opioid use reported by filled prescription database studies should not be used as a surrogate for opioid misuse,” said lead author Raoul Daoust, MD, a professor and researcher in the Department of Family Medicine and Emergency Medicine at the University of Montreal.

Daoust and his colleagues surveyed 524 patients who were discharged from a hospital emergency department (ED) with an opioid prescription for acute pain. Instead of just relying on a database to track their prescriptions, the researchers asked the patients about their opioid use.

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Three months after discharge, only 47 patients – about 9 percent – said they were still using opioids. Of those, 72% said they used opioids to treat their initial pain and 19% were using the drugs to treat a new pain condition.

The remaining four patients said they used opioids for another reason, suggesting possible misuse. That’s less than one percent (0.8%) of the original 524 patients.

“Within the limit of our study, our results suggest that the risk of long‐term opioid use for reasons other than pain is low for ED discharged patients with an opioid prescription treating an acute pain condition,” Daoust reported in the journal Academic Emergency Medicine.

Daoust’s findings are controversial because they throw into question the widely accepted theory that all opioid prescribing is risky, whether it’s for chronic or acute pain. The methodology used in his study was questioned by one critic.

"Emergency physicians should not be reassured by the authors' findings. The lack of a denominator, poor response rate (56%), and applied definition of misuse are significant limitations,” said Gail D'Onofrio, MD, a professor of emergency medicine and chair in the department of emergency medicine at Yale University.

D'Onofrio cites a 2017 CDC study, which found that the probability of long-term opioid use increases sharply after the first few days of treatment.

“Transitions from acute to long-term therapy can begin to occur quickly: the chances of chronic use begin to increase after the third day supplied and rise rapidly thereafter,” CDC researchers warned.

But that analysis is based solely on the number of opioid prescriptions – not actual opioid use. And Daoust found that studies like that are a poor way to measure risk.

“These studies used filled prescriptions databases that could overestimate opioid use since not all patients filling an opioid prescription consumed them. As a case in point, in this study, 21% of patients who filled their opioid prescription after the initial ED visit did not consume them,” Daoust reported.

What is the risk of long-term opioid use after an emergency room visit? In a large 2017 study by the Mayo Clinic, only about 1 percent of ER patients given an opioid prescription progressed to long term use – similar to what Daoust found.

"Our paper lays to rest the notion that emergency physicians are handing out opioids like candy," said lead author Molly Moore Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Most opioid prescriptions written in the emergency department are for shorter duration, written for lower daily doses and less likely to be for long-acting formulations."

A 2018 study also questioned the value of prescription drug monitoring programs (PDMPs) which have long been promoted as critical tools in the fight against opioid abuse. The study found little evidence that PDMPs are reducing overdoses and that they may lead to unintended consequences such as patients turning to street drugs for pain relief.

Chronic Fatigue Patients Often Feel Disbelieved in ERs

By Pat Anson, PNN Editor

Patients suffering from chronic fatigue syndrome (CFS) often feel disrespected and disbelieved in hospital emergency rooms, according to a new survey by researchers at Georgetown University Medical Center.

CFS is a complex and poorly understood disorder characterized by extreme fatigue, chronic pain, impaired memory and insomnia. Because many of the symptoms of CFS overlap with other conditions -- including fibromyalgia, depression, and inflammation – a correct diagnosis is often difficult.

In the first study of its kind, Georgetown researchers surveyed 282 CFS patients about their experiences in emergency departments. Two-thirds said they would not go to an ED because they believed they wouldn't be taken seriously or because they had a previous unsatisfactory experience. Only a third said they received appropriate treatment in the ED.

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"The high proportion of patients who were basically told 'It is all in your head' by ED staff indicates that there is much misunderstanding and misgivings about the diagnosis of CFS,” said allergist and immunologist James Baraniuk, MD, senior investigator of the study published in the journal Open Access Emergency Medicine.

“These patients should feel they are respected and that they can receive thorough care when they feel sick enough to go to an ED."

The survey found that only 59 percent of the CFS patients had gone to an ED. In that group, 42 percent were dismissed as having psychosomatic complaints. Asked to collectively rate their ED caregivers' knowledge of chronic fatigue, patients gave them a score of 3.6 on a 10-point scale.

Baraniuk says more training is needed for ED staff and physicians to better understand the disorder.

"An already-available CFS Symptom Severity Questionnaire can be used in the ED to assist with the diagnosis of CFS, and to differentiate exacerbations of CFS symptoms from medical emergencies such as heart attacks or infections," Baraniuk says.

The number one reason for going to the ED was orthostatic intolerance, which occurs when a person feels faint when standing or sitting upright because not enough blood is reaching the brain and heart. The symptoms only improve when a person lies down.

"This condition is something that can be readily addressed by ED caregivers. There is a real need for physician education that will improve their efficiency in identifying and treating CFS and in distinguishing CFS symptoms from other diseases in the exam room," he said.

In 2015, an independent panel convened by the National Institutes of Health called for major changes in the way the healthcare system treats people suffering from chronic fatigue – which is also known as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

“Both society and the medical profession have contributed to ME/CFS patients feeling disrespected and rejected. They are often treated with skepticism, uncertainty, and apprehension and labeled as deconditioned or having a primary psychological disorder,” the panel reported in its final report.

About one million Americans suffer from chronic fatigue, most of them women. There are no pathogens linked to CFS, no diagnostic tests and no known cures.

CDC: Emergency Room Overdoses Up Sharply

By Pat Anson, Editor

Emergency room visits for opioid overdoses have soared by 30 percent in 16 states, according to a new Vital Signs report by the Centers for Disease Control and Prevention. The CDC called the report a “wake-up call to the fast-moving opioid overdose epidemic.”

Between July 2016 and September 2017, there were over 142,000 suspected opioid overdoses treated in hospital emergency rooms in the 16 states. Overdoses increased for men and women in all age groups, in all regions of the country, and in rural and urban areas.

The new report does not specify how many patients died or if the overdoses involved prescription opioids or illegal opioids like heroin and illicit fentanyl. A previous report by the CDC indicated that over half the nation’s fatal overdoses are now linked to fentanyl, a synthetic opioid increasingly available on the black market.

“Long before we receive data from death certificates, emergency department data can point to alarming increases in opioid overdoses,” said CDC Acting Director Anne Schuchat, MD. “This fast-moving epidemic affects both men and women, and people of every age. It does not respect state or county lines and is still increasing in every region in the United States.”

Ten of the 16 states studied had significant increases in emergency room overdoses, with the number of overdoses in Wisconsin up by an alarming 109 percent.  Opioid overdoses in Delaware also doubled.

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Midwestern states saw the biggest increase overall, with a 70% increase in overdoses, followed by the West (40%), Northeast (21%), Southwest (20%) and Southeast states (14%).

Overdoses declined by 15% in Kentucky, and by smaller amounts in Massachusetts, New Hampshire and Rhode Island. Schuchat said the decline could be related to the increased availability of drugs like naloxone, which can rapidly reverse the effects of an opioid overdose.

Failure of Opioid Guidelines Ignored  

The Vital Signs report did not examine the apparent failure of the CDC’s opioid prescribing guidelines to have any impact on the overdose rate. The agency's controversial guidelines were not even discussed during a 30-minute briefing Schuchat had with reporters today.

Since the CDC guidelines were released in March 2016, many pain patients say their opioid doses have been reduced or eliminated, and the quality of their pain care has deteriorated. Some patients abandoned by doctors are having trouble finding new ones willing to treat them.

A recent report from the Massachusetts Department of Public Health found that prescription opioids were involved in only about 15% of the fatal overdoses in 2017, while fentanyl was involved in 83 percent of the opioid deaths in that state.

ER Safety Tips for Ehlers-Danlos Syndrome Patients

By Ellen Lenox Smith, Columnist

People living with Ehlers-Danlos Syndrome (EDS) are often afraid to go to a hospital emergency room, due to a lack of understanding in the ER staff on how to safely care for them. I myself recently had another negative experience, one that almost killed me.

In the process of being admitted, after passing out over and over due to low blood pressure, things went terribly wrong. While being transferred from the ambulance to the hospital stretcher, my hip was dislocated. This dislocation was unintentional, but avoidable, as it was a direct result of the rough manner in which the transfer was managed.

On top of this, they gave me no IV fluids for several hours, which should have been the first thing done to help elevate my blood pressure. Complicating matters even further, no food was brought to my room that I could safely eat and metabolize for the two days I was there.

And then, when a nurse thought I had stopped breathing, she compressed my chest to stimulate my heart, even though I was wearing two medical bracelets warning I shouldn’t be given chest compressions. Three months later, I am still paying for these mistakes.

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As a result of my traumatizing and life threatening experience, I sent a letter to the hospital in the hopes of never having another EDS patient experience what I did. I was shocked to receive a call that resulted in the hospital taking me up on my offer to meet with their doctors and nurses to help them understand how to properly handle us.

To prepare for this meeting, I asked other EDS patients to submit suggestions to enhance my program. I hope that this list will be helpful to both patients and hospital staff.

How to Treat Ehlers-Danlos Patients

  • Consider having a generic EDS protocol for staff to get a quick understanding of this condition with new patients.
  • Put notes or a bulletin board or patient chart to share information and keep the patient safe from shift to shift.
  • Be cautious, for EDS is an “invisible condition” so remember to do no harm. Understand that touching and moving us can create more problems, so listen to the patient. Tread lightly using chest compressions, because our ribs sublux, dislocate and break easily. Allow EDS patients to position themselves safely before any procedure.
  • Subluxations are a real thing. Don't just take a quick x-ray and tell us, "It's nothing, you're fine.” When a joint feels wrong, there's an injury worth finding some relief for.
  • Because we bruise easily, don’t rush to judgement with EDS children before reporting abuse.
  • If someone arrives with an ID warning bracelet, please read and respect what is says!
  • If a patient has low blood pressure, elevate their bed to a 30% angle. Hook up IV fluids quickly and approve the patient’s BP medication in time for their next dose. Consider using a PICC line if the IV does not hold.
  • Many EDS patients are drug reactive, so respect if a DNA drug test has been done or listen to what medications have not worked in past. Pain relief is difficult to achieve with EDS so please believe the person.
  • Some of us use compounded medications that need to be accepted in place of what you have in stock in the pharmacy. Some also use supplements, so please respect the use of them. Many are using the Cusack Protocol supplement routine.
  • If a patient is using cannabis for pain control, consider allowing CBD use in the hospital in an oil, tincture, topical or pill form.
  • Many of us are food reactive, so send your dietician to the room to meet the patient and create a safe meal plan.
  • If a patient sleeps with CPAP or BPAP mask, be sure that it gets brought in and worn during sleep.
  • Have on staff a physical therapist that can use manual energy techniques for re-alignment or allow an EDS manual therapist on the floor.
  • If there is a need to draw blood, use a butterfly or small pediatric needle.
  • If there is a need for intubation, be careful with movement of the neck and use small equipment. If an EDS patient presents with a neck fusion, do intubation using the fiber optic glidescope.
  • If stitches are needed, try to using natural products over synthetic.
  • Many of us have wound healing issues, so please be careful with the choice of tape and its removal. Some of us have skin that is fragile and easily tears.
  • All types of EDS are at increased risk for scary vascular events. Any sudden or severe chest or abdominal pain needs a scan to rule out an aneurysm or another serious condition.

If surgery is needed, be sure to have your anesthesiologist do a pre-op interview before any procedures. Be careful about joint positioning and manipulation when performing anesthesia. Yes, that "jaw thrust maneuver" may make intubation easier or more comfortable, but it's not worth the months of rehab from a dislocated jaw.

Please reassure your orthopedic residents that we'd prefer to avoid surgery, too. Having them share their fears out loud that they don't want to operate on EDS patients because “that'll just make things worse" may be true, but it's not helpful. Nobody wants to feel like an untouchable leper. Instead, please focus on what you can do to help. It might be as simple as helping to reposition the joint to a more neutral spot, and then bracing or splinting it there to give things a rest before starting physical therapy

Ehlers-Danlos can be a very painful, isolating and heartbreaking condition to live with. We would love to come to a hospital for emergency help and not be afraid to be sent home in worse shape. Let’s all work to educate the medical field and improve the future for us all coping with this condition. May this list be a start for you!

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Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis. Ellen and her husband Stuart are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition.

For more information about medical marijuana, visit their website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Heroin Overdoses in ER's Surpass Rx Opioid Overdoses

By Pat Anson, Editor

The number of patients admitted and discharged from U.S. hospitals for abuse of opioid pain medication has declined significantly this decade, while the abuse of heroin and illicit fentanyl has surged, according to a new study that documents the shifting nature of the nation’s overdose crisis.

Researchers at Stanford University analyzed national trends in hospital inpatient and emergency department (ED) discharges for opioid abuse, dependence and poisoning from 1997 to 2014, the last year data was available.

They found that hospital admissions for overdoses from pain medication started falling in 2010, the same year that opioid prescriptions began declining.

At the same time, hospital discharge rates for heroin poisoning increased at an annual rate of over 31 percent. By 2014, heroin overdoses exceeded those from prescription opioids in emergency rooms by almost a 2 to 1 margin.

“After 2008, ED discharge rates for heroin poisoning increased more sharply than the rates for any opioid poisoning -- signaling that the scope of heroin harm is worse than previously suggested -- while discharges for prescription opioid poisoning recently began to decline in both the ED and inpatient settings,” researchers reported in the journal Health Affairs.

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“While these changes could be the result of national and local policies aimed at reducing the prescribing of opioids, the expanded availability of heroin and new lethal illicit drugs, such as nonpharmaceutical fentanyl, could mean that they are being used instead of prescription opioids.”

The findings add evidence to recent public health concerns that people misusing or addicted to prescription opioids are switching to heroin and synthetic opioids such as fentanyl because they are cheaper and easier to get.

"This suggests that the expanded availability of lethal illicit drugs are being used to replace prescription opioids in some cases," said Tina Hernandez-Boussard, PhD, associate professor of medicine, of biomedical data sciences and of surgery at Stanford University School of Medicine.

source: health affairs

source: health affairs

The Centers for Disease Control and Prevention has been reluctant to admit that efforts to reduce opioid prescribing could be backfiring, although their own statistics indicate otherwise.  Deaths involving heroin and synthetic opioids overtook overdoses linked to prescription opioids in 2016, the same year the CDC released its opioid prescribing guidelines.

As PNN has reported,  the CDC last week launched a public awareness campaign to combat the abuse of prescription opioids, a marketing effort driven by surveys and focus groups that completely ignores the scourge of heroin and illicit fentanyl.

“The campaign does not include messages about heroin. Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging. Heroin is a related topic that also needs formative research and message testing,” the CDC explained.

The Stanford study found that discharge rates for prescription opioid poisonings declined annually by about 5 percent from 2010 to 2014, while discharge rates for heroin poisoning increased at an annual rate of 31.4 percent from 2008 to 2014. The trend has likely worsened since 2014, as heroin and illicit fentanyl are even more widely available on the black market.

"I'm cautiously optimistic that prescribing clinicians are positively reacting to the opioid crisis and therefore prescription opioids are contributing less to the overall drug epidemic," Hernandez-Boussard said. "That's the good news. The bad news is that although prescription opioid use decreased, heroin and methadone greatly increased.”

Anna Lembke, MD, an associate professor of psychiatry at Stanford and a board member of Physicians for Responsible Opioid Prescribing (PROP), says she has no doubt many people addicted to prescription opioids have switched to using heroin or illicit fentanyl.

"My patients have told me that's exactly what they did," said Lembke. "Heroin was cheaper and easier to get."

ER Patients Less Likely to Use Opioids Long Term

By Pat Anson, Editor

Patients who are prescribed opioid pain medication for the first time in hospital emergency rooms are less likely to become long term opioid users than patients in other settings, according to a large new study by researchers at the Mayo Clinic.

"Our paper lays to rest the notion that emergency physicians are handing out opioids like candy," said lead author Molly Moore Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Most opioid prescriptions written in the emergency department are for shorter duration, written for lower daily doses and less likely to be for long-acting formulations."

Jeffrey and her colleagues analyzed data for 5.2 million opioid prescriptions filled in emergency rooms from 2009 to 2015.

They found that only 1.1% percent of “opioid naïve” patients with private insurance progressed to long term opioid use. That compares to 2% of patients in non-emergency settings. Long term use was defined as someone getting 10 or more refills or more than a 120 day supply of opioids in a year.

About 3 percent of Medicare beneficiaries used opioids long term after getting them in an ER, with disabled Medicare patients the most likely ER patients to progress to long term use (13.4%).

Only 3.3% of opioid doses for privately insured patients in the ER exceeded 90mg morphine equivalent units (what the CDC considers a high daily dose). That compares to 7.2% of doses in non-emergency settings.  The duration of prescriptions was also lower for ER patients.

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"Less than 5 percent of opioid prescriptions from the ER exceeded 7 days, which is much lower than the percentage in non-emergency settings. Further research should explore how we can replicate the success of opioid prescribing in emergency departments in other medical settings," said Jeffery, whose study is published online in the Annals of Emergency Medicine.

The use of opioid medication in hospital emergency rooms has become a contentious issue for both patients and physicians, with many patients complaining that they are profiled and labeled as drug seekers when they seek treatment at an ER for pain.

“I refuse to go to the ER for pain. Unless I feel I'm absolutely dying, I will not go. It isn't worth being made to feel like I'm only ‘putting on a show’ or I'm a junkie just trying to get high,” one pain sufferer told us.

In a survey of over 1,250 pain patients last year by PNN and the International Pain Foundation, 80 percent said they had felt labeled as an addict or drug seeker by hospital staff. Asked if doctors were reluctant to prescribe opioid medication while they were hospitalized, over two-thirds said it happens often or sometimes. To see the complete survey results, click here.

“I had a doctor in an emergency room situation one time during an episode I was having, who actually stood in the open doorway of my room, I was still in the ER, and yelled at me as loud as he could, that he wasn't giving me any pain medicine,” said one patient.

Some hospitals, such as Temple University Hospital in Philadelphia, have adopted guidelines that discourage opioid prescribing to ER patients. The voluntary policy quickly won broad support from Temple’s physicians.

In a survey by the hospital, only 13% of Temple’s ER doctors thought patients with legitimate reasons for opioids were denied appropriate care. A large majority – 84% of the doctors -- did not believe patients were denied appropriate pain relief.

“Emergency physicians have identified themselves as targets for patients who seek opioids for nonmedical purposes, yet it can be difficult for clinicians to distinguish drug seeking behavior from legitimate need,” said Daniel del Portal, MD, Assistant Professor of Clinical Emergency Medicine at the Lewis Katz School of Medicine at Temple University.

Study Finds Racial Disparity in ER Opioid Prescriptions

By Pat Anson, Editor

Black patients who visit hospital emergency rooms with back and abdominal pain are significantly less likely to receive opioid prescriptions than white patients, according to a large new study published in PLOS ONE

The study, led by researchers at Boston University Medical Center, looked at data involving over 36 million emergency room visits in the U.S. from 2007 to 2011. No previous studies have examined racial disparities involving opioid prescriptions in ER settings.

The researchers found that opioids were prescribed for blacks at about half the rate for whites for vague “non-definitive conditions” that do not have an easy diagnosis -- such as back and abdominal pain.

No racial prescribing differences were found for ER visits involving fractures, kidney stones or toothaches – which are easier to diagnose.

The authors concluded that ER doctors may be relying on subjective cues such as race when deciding whether to prescribe opioids.

“These disparities may reflect inherent biases that health care providers hold unknowingly, leading to differential treatment of patients based on their race,” wrote co-authors Yu-Yu Tien of the University of Iowa College of Pharmacy and Renee Y. Hsia of the University of California at San Francisco.

“Healthcare providers carry inherent human biases, which can impact their prescription practices, especially in situations that do not lend themselves well to objective decisions. Racial-ethnic minority patients, especially non-Hispanic blacks presenting with vague conditions often associated with drug-seeking behavior, may be more likely to be judged as ‘a drug-seeker’ relative to a non-Hispanic white patient, presenting with similar pain-related complains.”

The authors noted that a recent study in JAMA found that prescription opioid abuse and addiction were actually more likely among whites than Hispanics and non-Hispanic blacks.

“In light of this, our findings raises a perplexing question as to whether it is non-Hispanic blacks who are being under-prescribed, or is it non-Hispanic whites who are being over-prescribed. Paradoxically, then, while non-Hispanic blacks do not benefit from bias, they might be inadvertently benefitting by receiving fewer opioid medications and prescriptions,” they wrote.

In their analysis of emergency room visits, the researchers also found that uninsured patients and those on Medicaid were less likely to receive an opioid for “non-definitive conditions” than those with private insurance.

A small study at the University of Virginia also found signs of racial bias involving pain care in a survey of white medical students. Researchers asked 222 medical students and residents a series of hypothetical questions about treating pain in mock medical cases involving white and black patients suffering pain from a kidney stone or leg fracture.  

Many of the students and residents were found to hold false beliefs, such as believing that black people's skin is thicker and that their blood coagulates faster than whites.  Half of those surveyed endorsed at least one false belief; and those who did were more likely to report lower pain ratings for black patients and were less accurate in their treatment recommendations for blacks.