AMA: Patients Being Harmed by Rx Opioid Crackdown

By Pat Anson, PNN Editor

Patients are being harmed by the crackdown on opioid pain medication and increasingly “burdensome” requirements for prior authorization, according to the president of the American Medical Association.

“The pendulum swung too far when pain was designated a vital sign, and now we are in danger of it swinging back so far that patients are being harmed. We need to use our expertise in patient care to change the dialogue to appropriate pain control,” said Barbara McAneny, MD, at a weekend meeting of the AMA. 

McAneny, who is a practicing oncologist in Gallup, New Mexico, shared the story of a patient with advanced prostate cancer who was in severe pain.  

“Metastatic prostate cancer in your bones hurts, and one day he called me to say that his pain regimen wasn’t holding him. So, I increased the dosage of his opioids from two per day to three and of course he ran out early,” McAneny said. “So, I called his primary care physician who agreed to write a prescription for his very large amount of time-release morphine.” 

When the patient tried to get his prescription filled, the pharmacist called the insurer for prior authorization and was denied. The pharmacist also checked the prescription drug monitoring program (PDMP) and found that the patient had multiple prescriptions written by McAneny and other doctors.  

BARBARA MCANENY, MD (AMA PHOTO)

“The pharmacist suspected my patient was a drug seeker and did not alert me that his prescription was denied. My patient, a very proud man, felt shamed and didn’t know what to do. So, he went home to be as tough as he felt he could be. That worked for about three days and then he tried to kill himself,” said McAneny.  

“Fortunately, his family found him in time, and the emergency medicine physician was able to save his life. He spent a week in the hospital and finally we got his pain back under control, on the exact regimen I had prescribed him as an outpatient.”  

Ironically, the insurer paid for the patient’s ambulance and hospital bills without any prior authorization. And the CDC’s “voluntary” opioid guidelines — which have been widely adopted by insurers — don’t even apply to cancer patients.

“Like you, I share the nation’s concern that more than 100 people a day die of an overdose. But my patient nearly died of an under-dose. This story illustrates the problems we all confront every day in our current dysfunctional health care system,” McAneny said. “The health plan does not have the chart, doesn’t know the patient, and basically countermanded my orders without even telling me using the prior authorization process. How have we let health plans determine the course of care? They call this quality? 

“My patient suffered, in part, because of the crackdown on opioids… When I visited my patient in the hospital as he was recovering from his suicide attempt, I apologized for not knowing his medication was denied. I felt I had failed him.”

McAneny cited a 2017 AMA survey, which found over 90% of doctors believed prior authorization led to delays in treatment and had a negative impact on patient outcomes. Nearly a third of doctors had to wait at least 3 business days for a prior authorization decision to be made.  

New prior authorization rules to be adopted by Medicare on January 1 could lead to delays in treatment for millions of elderly and disabled pain patients on high doses of opioids. Prescriptions over 200mg MME (morphine equivalent daily doses) will trigger a “hard edit” safety alert requiring pharmacists to consult with the prescribing physician before filling a prescription. Insurers will also be given greater authority to identify beneficiaries at high risk of addiction and to require they use “only selected prescribers or pharmacies.”

FDA Approves Controversial New Opioid

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved a controversial new opioid drug intended to relieve moderate to severe pain in wounded soldiers and trauma patients. 

Dsuvia is a tablet form of the potent opioid sufentanil. It was developed by AcelRx Pharmaceuticals and the Department of Defense – in part to treat battlefield wounds – but became embroiled in the national hysteria over opioid drugs and addiction.

Dsuvia was developed to fulfill an unmet need in military and civilian hospitals, where patients in acute pain are usually treated with opioids intravenously or with a pill.

Each Dsuvia tablet comes in a single dose plastic applicator. The tablet is taken sublingually under the tongue, where it quickly dissolves and is absorbed into the body.

“There is currently no way available to rapidly treat your pain without sticking you with a needle,” said Dr. Pamela Palmer, an anesthesiologist who co-founded AcelRx and is Chief Medical Officer.

ACELRX image

“If you broke your femur and are obese or elderly or on a blood thinner, that can be very painful with a lot of bruising. If you take a pill, you have to swallow it with water and wait for it to kick in, which could take up to an hour. Right now, that’s all that’s available. For the first time, we’ve developed a small tablet that goes under the tongue and dissolves in about six minutes.”

“The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds,” said FDA commissioner Scott Gottlieb, MD.

Dsuvia’s efficacy and safety were tested in two placebo-controlled studies with over 200 patients. The company said the drug was well-tolerated and effective across a range of patient ages and body sizes.

But because Dsuvia is so potent – it’s 10 times stronger than fentanyl – it drew the ire of critics who believe diversion is inevitable.

“We know from looking at other potent opioids that have been put on the market in the last four years that once these drugs get past the FDA, there’s very little, if any, control over them, no matter what the sponsor says prior to the time they come on the market,” Raeford Brown, MD, told ABC News.

Brown is chairman of the FDA advisory committee that voted 10-3 to recommend approval of Dsuvia.  Brown was not present for the vote, but called on the FDA to ignore the panel’s recommendation and stop the approval of “this dangerously unnecessary opioid medication."

“It doesn’t seem reasonable to place another potent opioid on the market at this time, especially when we’re currently still writing 200 million prescriptions for opioids a year,” said Brown.

Politicians also weighed in.

“An opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused and a thousand times more likely to kill,” said Sen. Ed Markey (D) Massachusetts. “It makes no sense to approve an opioid painkiller that has no benefits over similar medications and against the advice of experts.”

The FDA is requiring that Dsuvia not be dispensed for home use, should only be administered by a healthcare provider, and should not be used for more than 72 hours. Palmer says extra precautions would also be taken by distributors, wholesalers and hospitals to prevent theft and diversion.

“I’m not saying that drugs delivered to hospitals never get stolen or abused, but that’s a tiny sliver” of the opioid problem, she said.

Overdoses Soar in 2 States Despite Fewer Rx Opioids

By Pat Anson, PNN Editor

New studies from two of the states hardest hit by the opioid crisis – Massachusetts and Pennsylvania -- are throwing a damper on recent speculation that drug overdoses may have peaked.  

Researchers at Boston Medical Center released a startling study that found nearly 5 percent of people over the age of 11 in Massachusetts have an opioid use disorder.

The Drug Enforcement Administration also admitted in a Joint Intelligence Report that reducing the supply of prescription opioids in Pennsylvania failed to reduce the state’s soaring overdose rate and may have even increased demand for counterfeit painkillers. Pennsylvania had 5,456 fatal overdoses in 2017, a 65% increase from 2015.  

“Implementation of legislation influencing prescription opioid prescribing has resulted in a decrease in availability; however, a corresponding decrease in demand is less certain,” the DEA report found.

“Practitioners may be offering non-opioid alternatives to pain management to their patients, but this is most likely due to increased scrutiny of prescribing habits, as well as legislated changes, not due to requests from patients seeking non-opioid products.”

Prescription opioids were involved in only 20% of Pennsylvania’s overdoses. Most of the deaths involve a combination of illicit drugs such fentanyl, heroin, cocaine and counterfeit medication.

“The increasing presence of counterfeit opioid CPDs (controlled prescription drugs) in Pennsylvania is an indicator of strong demand for opioid CPDs in the illicit market. Traffickers use substances such as heroin, fentanyl, and tramadol to create tablets that look like the opioid CPDs most commonly purchased on the street (e.g., oxycodone 30 milligram tablets). The tablets are often exact replicas with the shape, coloring, and markings consistent with authentic prescription medications,” the report found.

The DEA said heroin and fentanyl could be found in 97% of Pennsylvania’s counties and called the city of Philadelphia a “wholesale market” for illicit drugs from China and Mexico.

Opioid Use Disorder in Massachusetts

Illicit fentanyl is also blamed for a soaring number of fatal overdoses in Massachusetts, where researchers used a new method to estimate how many people have opioid use disorder (OUD).  

Instead of relying on insurance claims for addiction treatment, researchers used a database that links information from 16 state agencies on other forms of healthcare use. Researchers were then able to identify patients who have OUD and estimate those who have the disorder but aren't seeking treatment. Individuals with substance use disorders are often less likely to seek medical care or be insured. Many are also reluctant to admit they have a drug problem.  

"There are many people with opioid use disorder who do not encounter the health care system, which we know is a barrier to understanding the true impact of the opioid epidemic," said Joshua Barocas, MD, an infectious disease physician at Boston Medical Center, who was lead author of the study published in the American Journal of Public Health.

Barocas and his colleagues found the prevalence of opioid use disorder in Massachusetts rose from 2.72% in 2011 to 4.6% in 2015. People between the ages of 11 and 25 experienced the greatest increase in OUD – a demographic much younger than a typical chronic pain sufferer, who is usually middle aged.

In 2012, Massachusetts was one of the first states where insurers and healthcare providers took steps to reduce the supply of prescription opioids – measures that have yet to have any meaningful impact on the state’s overdose rate.  

MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

Massachusetts was also one of the first states to use toxicology screens from coroners and medical examiners to get a more accurate assessment of the drugs involved in overdoses.

According to the most recent report from the first quarter of 2018, nearly 90% of Massachusetts overdoses involve fentanyl, 43% percent involve cocaine, 42% involve benzodiazepines and 34% involve heroin. Prescription opioids were involved in only about 20% of the Massachusetts overdoses, the same rate as Pennsylvania.

Preliminary estimates released by the CDC last week show a modest 2.3% nationwide decline in opioid overdoses from September 2017 to March 2018. Over 48,000 people died from opioid overdoses during that period, with most of those deaths involving illicit fentanyl, heroin and other street drugs.

What Will Support Act Mean for Pain Patients?

By Pat Anson, PNN Editor

President Trump this week signed into law the Support for Patients and Communities Act, a comprehensive and mostly bipartisan legislation that combined over 70 bills passed by Congress aimed at fighting the opioid epidemic.

"Together we are going to end the scourge of drug addiction,” Trump said at a bill-signing ceremony at the White House. “Or at least make an extremely big dent in this terrible, terrible problem.”

While most of the Support Act is aimed at slowing the flow of illicit drugs and subsidizing the $35 billion dollar addiction treatment industry, there are some key elements that will affect millions of Americans who take opioids for chronic or acute pain.

Most are designed to limit access to opioid medication and further reduce the supply, which has nearly been cut in half since 2016.

The new law authorizes the Food and Drug Administration to require that some opioids be dispensed in so-called “blister packs” to limit the number of pills that can be prescribed and dispensed at one time. That type of packaging would primarily be for patients with short-term, acute pain who need only a few days’ supply. But it could also lead to a standardization of doses and make refills more difficult for patients who are slow to recover from surgery or trauma.

“The doses dispensed in the packs could be designed to align with evidence-based recommendations on what the proper dosing should be for common indications. These packs could then become the default option for more post procedure uses and could discourage physicians from prescribing long durations of use in situations where the evidence shows that short durations are clinically appropriate,” said FDA commissioner Scott Gottlieb, MD, in a statement.

“Ultimately, this approach could reduce the overall number of drugs in circulation and potentially lower the rate of new opioid addiction. It could also address the problem of excess supply, leading to fewer pills left in medicine cabinets that could be inappropriately accessed by family members, including children.”

The Support Act also gives the FDA the authority to require that opioids be dispensed with a mail-back pouch or other safe disposal options. The goal again is to get unused medications out of medicine cabinets where they could be stolen or diverted.

The new law also supports an effort recently launched by Gottlieb to develop opioid guidelines for acute pain. The guidelines won’t replace or change the CDC’s controversial guideline for chronic pain, but they will be developed with more transparency. Gottlieb has instructed the National Academies of Sciences, Engineering, and Medicine to hold a series of public meetings and to seek input from "a broad range of stakeholders" from different medical specialties. The CDC guideline was initially developed with no public hearings and with little input from pain management experts.

The Support Act also gives more authority to the FDA to require longer post-market studies on the safety and efficacy of drugs. Current evidence on the long-term use of all pain medication – not just opioids – is extremely limited. That has led to exaggerated claims from opioid critics that there is “no evidence” that opioids are safe or effective long term. Those same critics often call for greater use of non-opioid medications, such as gabapentin and pregabalin, when there is little long term evidence to support their use either.

The Support Act also calls on other federal agencies to enact measures to prevent the diversion and abuse of opioids and other controlled substances:

• All prescriptions for controlled substances covered under Medicare Part D or Medicare Advantage must be transmitted electronically starting Jan. 1, 2021.

• The Department of Health and Human Services (HHS) will develop guidelines for pharmacists to decline to fill prescriptions they think may be fraudulent or questionable.

• Medicaid programs will be required to have “safety edits” in place for opioid refills and to monitor the concurrent use of opioids with potentially risky drugs such as benzodiazepines.

• A web portal will be created to allow communication between HHS, CMS and Medicare Advantage insurers to share information about providers under investigation for inappropriate prescribing of opioids.

• HHS will develop guidelines to allow the inclusion of opioid addiction history in patient electronic health records.

One pain management expert cautioned that some provisions of the Support Act put too much of an emphasis on opioid medication.

“Excessive focus on reducing opioid supply in the legislation can lead to more harm than good. We cannot continue to ignore the needs of people in pain at the expense of preventing illicit drug use,” Lynn Webster, MD, past president of the American Academy of Pain Medicine told Pain Medicine News.

“We have seen draconian steps by the VA (Department of Veterans Affairs) and other payors to force opioid reduction in patients who have been stable and functional for years. This is cruel and simply not right. My hope is that the act is implemented with compassion for people with addiction and pain, but that they allow science and not prejudices and politics to inform policy.”

Sessions: Opioid Prescriptions at 18-Year Low

By Pat Anson, PNN Editor

Opioid prescriptions in the United States fell by 12 percent in the first eight months of 2018 and will decline even further in coming years, according to Attorney General Jeff Sessions.

“We now have the lowest opioid prescription rates in 18 years.  And we’re going to bring them a lot lower,” Sessions said in prepared remarks at the National Opioid Summit in Washington, DC.

Opioid prescriptions have indeed been falling for many years, but the trend appears to be accelerating as many doctors lower doses, write fewer prescriptions, or simply discharge and refuse to treat chronic pain patients.

Sessions pledged to continue fighting “the deadliest drug crisis in American history” by reducing opioid prescriptions by another third over the next three years. That’s in addition to a 44% reduction in opioid production that the DEA began in 2016.

Sessions also promised to step up efforts against healthcare professionals alleged to have overprescribed opioids. He said the Trump Administration has charged 226 doctors and 221 medical personnel with “opioid-related crimes.”

“These numbers will continue to rise,” Sessions predicted, because of new federal prosecutors and a data analytics team focused on tracking opioid prescriptions.

ATTORNEY GENERAL JEFF SESSIONS

“This team follows the numbers—like which doctors are writing opioid prescriptions at a rate that far exceeds their peers; how many of a doctor's patients have died within 60 days of an opioid prescription; and pharmacies that are dispensing disproportionately large amounts of opioids,” Sessions said.

“They will help us find the doctors, pharmacists, and other medical professionals who are flooding our streets with drugs—and put them behind bars.”

At no point in his speech did Sessions discuss the impact the opioid crackdown was having on millions of chronic pain patients, who are increasingly bedridden or disabled due to lack of access to effective pain care. Earlier this year, Sessions suggested they should “tough it out” by taking aspirin.

While opioid prescriptions have fallen dramatically in recent years, they’ve yet to have much of an impact on the nation’s overdose rate.  Preliminary estimates released by the CDC this week show a modest 2.3% decline in opioid overdose deaths from September 2017 to March 2018. Over 48,000 people died from opioid overdoses during that period, with most of those deaths involving illicit fentanyl, heroin and other opioid street drugs, not prescription opioids.

Sessions said the Justice Department was taking “unprecedented action” against fentanyl traffickers at home and abroad, including the recent indictments of three Chinese nationals and dozens of Mexican drug traffickers.

“China could do more to stop these drugs from coming here.  Frankly, they’re not doing enough.  They must do more,” he said.

Prenatal Use of Acetaminophen Linked to Early Puberty

By Pat Anson, PNN Editor

The daughters of women who took acetaminophen during pregnancy tend to start puberty early, according to a new study by Danish researchers.  

The study is the latest indication that prenatal use of acetaminophen – more commonly known as paracetamol outside the U.S. -- can have long term effects on children.

Researchers at Aarhus University studied health data on about 100,000 Danish women who provided detailed information about their use of acetaminophen during pregnancy.

Nearly 16,000 children born to those mothers between 2000 and 2003 were followed from the age of eleven and throughout puberty, with surveys every six months about different aspects of their development.

The study, published in the American Journal of Epidemiology, found that girls on average entered puberty between one-and-a-half and three months earlier if their mothers took the over-the-counter pain reliever for more than 12 weeks during pregnancy.

"We found a 'dose-response' correlation. That is to say, the more weeks with paracetamol during pregnancy, the earlier puberty in girls, but not in boys," says lead author Andreas Ernst, a PhD student from the Department of Public Health at Aarhus University.

"While entering puberty one-and-a-half to three months earlier may seem unimportant, when taken together with the frequent use of paracetamol during pregnancy, our findings ought to make people take notice. Our results are certainly not the decisive factor that should change current practice, but the perception of paracetamol as 'the safe and harmless choice' during pregnancy ought to be challenged."

Early puberty development increases the risk of serious diseases in adulthood, such as obesity, diabetes, cardiovascular diseases and testicular and breast cancer.

The use of acetaminophen (paracetamol) has been increasing worldwide and studies have found that over half of pregnant women in the U.S. and European Union use the pain reliever at least once during their pregnancy. It is the active ingredient in Tylenol, Excedrin, and hundreds of pain medications.

Previous research has shown that prenatal use of acetaminophen is associated with slow language development, autism and attention deficit problems in young children.

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. The FDA label for products containing acetaminophen warns about the risk of liver damage and other side effects but does not specifically warn pregnant women about using the pain reliever. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

In its 2016 opioid prescribing guidelines, the CDC recommends acetaminophen as an alternative to opioid pain medication. The guideline only briefly mentions that acetaminophen is involved in hundreds of overdose deaths annually and can cause liver problems.

The CDC guideline does warn pregnant women -- at length -- that opioids can cause birth defects, poor fetal growth, still births and neonatal opioid withdrawal syndrome.

Patients at Ohio Hospital Have Surgery Without Opioids

By Pat Anson, PNN Editor

Would you want to go through a major surgery without the use of opioid pain medication?

Patients at an Ohio hospital are getting acetaminophen, gabapentin and nonsteroidal anti-inflammatory drugs (NSAIDs) to manage their pain before and after colorectal operations – and their surgeons say the treatment results in better patient outcomes.

“Over 75 percent of our elective colorectal patients underwent surgery without requiring narcotic analgesics postoperatively, including after discharge,” says Sophia Horattas, MD, of Cleveland Clinic Akron General Hospital.  “During this time period our patient satisfaction scores improved as well as patients' perceptions of pain control.”

All eight general surgeons at Akron General adopted the non-opioid treatment protocol in 2016, applying it to patients who had elective colon operations. Prior to surgery, the patients were all educated about pain management, non-opioid analgesics, and the risks associated with opioids.

Researchers evaluated 155 of the patients and presented their findings this week at the American College of Surgeons Clinical Congress in Boston.

Overall, 83 percent (128) of the patients did not need opioid medication after their operations. Among those who did, use of opioids before surgery was often an indicator that they would want them again. Nine of the 15 patients who had prior experience with opioids used them again after surgery.

Among the remaining 140 patients who did not use opioids before surgery, 85 percent (119) did not need opioid medication for pain relief.

The researchers found that patients who used opioid painkillers typically spent more time in the hospital; an average of 2.7 days vs. 2.3 days for the non-narcotic group.

“Patient education played a large role in protocol compliance, and patient satisfaction improved as they were able to avoid prolonged fasting, achieve improved pain control without the side effects of narcotic analgesia, and be discharged home earlier,” said Horrattas.

For pre-emptive analgesia before surgery, patients received one dose of acetaminophen, gabapentin, and the NSAID celecoxib (Celebrex).  In the operating room, patients received a nerve block and underwent anesthesia with the non-opioid pain relievers ketamine and lidocaine.   

Surgeons at Akron General have since adopted the non-opioid protocol for other major abdominal operations, such as bariatric procedures, gynecological and genital/urinary tract procedures, and liver and gall bladder operations.

“One of the great things about our protocol is its reproducibility.  Once we developed our program, we found that it could be standardized across departments with consistently reproducible results,” said Horattas.

Akron General’s protocol is similar to guidelines adopted by the American Pain Society (APS) for postoperative pain care. The APS also encourages the use of non-opioid medications such as acetaminophen, NSAIDs, gabapentin (Neurotin) and pregabalin (Lyrica).  

Akron General gets below average ratings for patient satisifaction from Hospital Compare, a Medicare survey that asks patients about their experiences during a recent hospital stay. The hospital received only two of a possible five stars, which places it in the bottom third of hospitals nationwide. Only 68% of Akron General’s patients said they would definitely recommend the hospital.

According to Healthgrades, 3 percent of the patients died after a colorectal surgery at Akron General, which is slightly below the national average for that procedure.

Opioid Addiction Rare After Surgery

In recent years, many hospitals have shifted away from routinely giving patients opioids during and after major surgeries -- even though it is rare for patients to become chronic opioid users.

A large Canadian study found that only 0.4% of elderly patients that were prescribed opioids while recovering from a heart, lung, colon, prostate or hysterectomy operation were still using them a year after their surgeries.

Another large study published this year in the British Medical Journal found similar results. Only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Long-term opioid use after dental surgeries is also rare. A recent study published in JAMA found that only 1.3% of teens and young adults who were given opioids after wisdom teeth removal were still being prescribed opioids months after their initial prescription.

The vast majority of patients still prefer opioids and perceive them as the most effective form of pain relief after surgery. In a recent survey of over 500 adults who were scheduled to have surgery, researchers at Thomas Jefferson University Hospital in Philadelphia found that 77% expected opioids, 37% expected acetaminophen, and 18% expected a NSAID for pain relief.

"Patients often assume they will receive opioids for pain, believing they are superior, and therefore may pressure physicians to prescribe them after surgery," said lead author Nirmal Shah, DO, an anesthesia resident at Thomas Jefferson University Hospital.

"But research shows opioids often aren't necessarily more effective. Clearly, we need to provide more education to bridge that gap and help patients understand that there are many options for pain relief after surgery, including other pain medications such as acetaminophen and ibuprofen."

Should Roseanne Have Died From an Opioid Overdose?

By Pat Anson, PNN Editor

Roseanne Barr is the latest victim of America's opioid crisis. Or to be more precise, Roseanne Conner is.

The fictional matriarch of ABC’s cancelled “Roseanne” show was killed off in the opening episode of “The Conners” Tuesday night, with her family struggling to come to terms with her death. What was initially thought to be a fatal heart attack turns out to be an accidental overdose of prescription opioids.

TV audiences had last seen Roseanne Conner hiding her addiction to opioid painkillers while waiting for long-delayed and costly knee surgery. But that storyline ended when Roseanne Barr was fired by ABC for a racist tweet and the network had to come up with a way to explain her absence.

“We firmly decided against anything cowardly or far-fetched, anything that would make the fierce matriarch of the Conners seem pathetic or debased,” Executive Producer Bruce Helford explained in The Hollywood Reporter.

“I wanted a respectful sendoff for her, too: one that was relevant and could inspire discussion for the greater good about the American working class, whose authentic problems are often ignored by broadcast television.”

ABC

"I AIN'T DEAD BITCHES," Barr tweeted after watching the show. She followed up with a longer joint statement with her spiritual advisor, Rabbi Shmuley Boteach.

“We regret that ABC chose to cancel 'Roseanne' by killing off the Roseanne Conner character,” the statement said. "That it was done through an opioid overdose lent an unnecessary grim and morbid dimension to an otherwise happy family show.”

It was also a bit of a cliché. The popular perception that most opioid overdoses are due to prescription painkillers is now largely a myth.  According to the Centers for Disease Control and Prevention, nearly 49,000 Americans died from opioid overdoses in 2017, but over half of them were due to illicit fentanyl and heroin, not prescription opioids.

A more accurate way to depict Roseanne’s death would have been through an overdose of heroin or counterfeit painkillers laced with fentanyl. That’s how thousands of Americans are dying. Roseanne Conner could have even been driven to suicide by untreated pain. Imagine what an eye-opening show that would have been.

Instead, the Conner family discovers that Roseanne was hiding painkillers all over the house and sharing them with a group of friends, all of them struggling with pain and addiction. The show makes it appear like opioid medication is easy to obtain, something real pain patients know is no longer true.

The only thing missing from the hackneyed script was someone saying, “If only Roseanne had tried yoga and taken Tylenol, she’d still be alive!”

Executive producer Bruce Rasmussen told Variety last week they thought carefully about how to end Roseanne's character. "You don't want to be flip about how you do this," said Rasmussen.

But that’s exactly how it came across to some PNN readers.

“The media can't seem to get the other side of the story out, nor can they print the truth about exactly how many deaths are the result of PRESCRIPTION opiates,” wrote Stephen Johnston.  “Now millions of folks will be watching as more gas is poured onto the fire. That same fire that's burning up what's left of people like myself and millions of others for whom opiate pain medications are the only relief from whatever traumatic accident or terrible malady has befallen them.”

“It was bad enough when they made pain meds a focus of the rebooted show when the first episode of the show's return aired. Now we have the added stigma, as intractable pain people, of them choosing to have Roseanne die from opioid misuse,” said Jack.

“Don't give the writers, actors, producer, the network hacks, etc., anything that isn't OTC when they have occasion to need pain relief — chronic or acute. Tylenol 3's would be much too generous, as many of us don't even get those.”

You can watch the first episode of “The Conners” by clicking here.

Cutting Rx Opioid Supply Is Not Stopping Diversion

By Roger Chriss, PNN Columnist

Drug diversion is an increasingly important factor in the opioid overdose crisis. A new report from Protenus found that 18.7 million pills, valued at around $164 million, were lost due to drug diversion in the United States during the first half of 2018. This represents a vast increase over 2017, when 20.9 million pills were diverted during the entire year.

As we’ve described previously, drug diversion in the supply chain is a vast, complex and old phenomenon. And it is rapidly worsening.

According to the textbook, “Prescription Drug Diversion and Pain,” drug thefts from hospitals “have increased significantly within the past decade as street prices have climbed sharply for diverted prescription opioids and benzodiazepines.”

In other words, the steep cuts in opioid production that began in 2017 aren’t working. And Attorney General Jeff Sessions was wrong when he said, "The more a drug is diverted, the more its production should be limited." A tightening supply has actually resulted in more diversion.

Drug diversion can be broadly divided into three categories: clinical diversion, personal diversion and industrial diversion. The first, according to Protenus, is drug diversion by healthcare workers. The second is the sale or transfer by a patient who received a legitimate prescription to a third party. And the third is everything else, from diversion by employees at manufacturing facilities to theft in distribution centers or pharmacies.

Personal diversion has gotten substantial attention in recent years. Prescription drug monitoring databases, pain agreements, and urine drug testing are all intended to help prevent such diversion.

Clinical drug diversion is a long-standing problem in healthcare that has garnered more interest recently. The bipartisan opioid bill recently passed by Congress includes a provision that allows hospice workers to destroy opioid medication that has expired or is no longer needed by a patient. The National Institutes of Health has also awarded a grant to further expand efforts to detect opioid and other drug theft in hospital systems.

Industrial diversion is less well known, but appears to be a longstanding problem. In the book “Dopesick,” journalist Beth Macy writes that as early as 2001 the DEA was investigating lax security standards at Purdue Pharma manufacturing plants after the arrest of two Purdue employees accused of trying to steal thousands of pills.

Between 2009 and 2012, over 63,000 thefts of opioids and other controlled substances were reported to the DEA. Pharmacies (66%) and hospitals (19%) accounted for the vast majority of those drug thefts.

And in 2007, an audit of CMS Medicare Part D payments identified 228,000 prescription payments with invalid prescriber identifications for Schedule II drugs.

In other words, tens of thousands of drug thefts and hundreds of thousands of fraudulent prescriptions are occurring annually, leading to millions of prescription pills entering the illegal market. This may help explain how OxyContin entered the black market so quickly and completely.

As Beth Macy writes: “The town pharmacist on the other line was incredulous: “Man, we only got it a month or two ago. And you’re telling me it’s already on the street?””

The National Association of Drug Diversion Investigators and the DEA Diversion Control Division are attempting to address industrial diversion. But available evidence suggests there is much more work needed to secure the entire prescription drug supply chain.

As the opioid overdose crisis continues to evolve toward poly-drug substance abuse, drug diversion will play an increasingly significant role in the illegal supply of prescription pharmaceuticals unless the entire supply chain is secured. This will require far more than the easy tasks of checking a prescription database or legislating pill counts. The hard part of reducing drug diversion remains to be done.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

Is Walmart Blacklisting Doctors?

By Pat Anson, PNN Editor

Carolyn Eastin has been a nurse practitioner in Arizona for nearly a decade. She is the only licensed prescriber at a busy pain clinic in Scottsdale, where many patients are on high doses of opioid medication.

Eastin says she was “mortified” by a letter last month from Walmart’s corporate headquarters that said the retail giant’s Walmart and Sam’s Club pharmacies would no longer fill her prescriptions for opioids.

“In reviewing your controlled substance prescribing patterns and other factors, we have determined that we will no longer be able to continue filling your controlled substance prescriptions,” the letter states. “We regret any inconvenience this may cause you or your patients.”

“It was very humiliating. I was upset about it,” says Eastin. “We’ve already had patients who can’t get prescriptions there.”

The unsigned Walmart letter has all the appearances of a form letter. It makes no mention of any complaints against Eastin, whether any of her patients have overdosed, or if her prescribing is medically inappropriate.

Eastin writes prescriptions for nearly 500 chronic pain patients at the Absolute Rehabilitation and Pain Medicine clinic. Most are on high doses of opioids, at levels well above those recommended by the CDC in its 2016 opioid guideline. Eastin believes she was red flagged by Walmart after a prescription database search and is now on a “blacklist” of prescribers.

“I’m the only one who writes prescriptions here. So I would have higher numbers than the average nurse practitioner,” she told PNN. “I’m not doing anything wrong. I’m tapering my patients. I’m trying to do my part to bring people into compliance.”

Does Walmart blacklist doctors who prescribe high doses of opioids? Is Walmart practicing medicine without a license? We posed those questions to Walmart and received a one sentence reply.

“Walmart does not comment on our patients or their prescribers,” wrote Erin Hulliberger, Walmart Corporate Communications in an email.

Corresponding Responsibility

What Walmart is doing isn’t illegal. Under federal law, pharmacists have a “corresponding responsibility” when filling medications -- a legal right to refuse to fill prescriptions they consider unusual or improper. Most pharmacists will call the prescribing doctor to double-check before turning away a patient, but in some cases there’s a “hard edit” – pharmacy jargon for when a company database tells a pharmacist not fill a prescription.

“It may be appropriate for a pharmacy to not fill a prescription because of a dangerous dose or even an inappropriate drug,” says Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine.

“However, if they are refusing to fill a prescription because the doctor has met some arbitrary dosage threshold by the company without understanding the circumstances, it would be inappropriate and potentially harmful to the patient.”   

A former Walmart pharmacist told PNN the company closely monitors prescriptions and doctors at every store.

“They had assembled prescription numbers for every doctor who had filled prescriptions at my store. They knew the exact number of medications ordered and sold down to the tablet. They knew what drugs the doctors wrote for and what percentage of the total each drug they wrote for," said the pharmacist, who asked to remain anonymous.

Walmart recently began using Narxcare, a private healthcare database developed by Appriss Health, which analyzes the prescriptions and medical claims of millions of Americans. Every patient evaluated by NarxCare is assigned a “risk score” based on the past two years of their prescription drug use, medical claims, electronic health records and even their criminal history.

Is Walmart using Narxcare data to blacklist doctors? A spokesman for Appriss denies it.

“No, we do not provide provider risk scores to Walmart, or anyone else,” said David Griffin, Vice President of market and communication for Appriss Health.

Prescription Data Mining

The data mining of opioid prescriptions has become increasingly common in healthcare and law enforcement. Doctors, pharmacies, insurers, and federal and state regulators are all using prescription drug databases to look for signs of opioid “overprescribing.”

In addition to Walmart, the Absolute clinic has drawn the attention of the Arizona Medical Board. Last year the clinic’s owner, Dr. Steve Fanto, signed an agreement with the medical board to stop practicing medicine after he was accused of overprescribing Subsys, a potent fentanyl spray.  

Although Fanto is no longer involved in the day-to-day management of the Absolute clinic, it remains under scrutiny. Last December, the clinic was raided by DEA agents, although no charges were ever filed as a result of that investigation. The clinic has also received over a hundred letters from insurer United Healthcare warning about the high dose prescriptions Carolyn Eastin is writing.

“It’s a bullying technique,” says Jessica Webb, the office manager at Absolute. “We’re afraid if we don’t taper down, the insurance companies will file a complaint on Carolyn. If Carolyn’s license is revoked, we’ll have to shut down. She’s the only reason we’re still open.”

Caught in the middle of this tug of war are Absolute’s patients – who could be faced with the difficult task of finding new doctors if the clinic closes. Their painful medical conditions -- and the human suffering that comes with them – appear to be non-factors in Walmart’s decision not to fill Eastin’s prescriptions.

“I can’t tell you the number of patients that made the comment to me, ‘I might as well die. I don’t have any other options but to take my own life because I can’t live without this medication,’” Eastin said. “It’s very difficult to look these people in the eye every single day and say, ‘I want to help you but I’m going to take more away from you.’”

‘I Hope It Doesn’t Harm Patients’

Pain management experts say its unethical to use data mining alone to judge whether a prescription should be filled.

“It appears that Walmart is trying to reduce their risk of being charged with criminal conduct and paying more fines. It is hard to know. But whatever their reason I hope it doesn't harm patients,” said Webster.  

“Without further explanation about the basis for their decision, and without information about any previous interventions attempted by Walmart, this seems remarkably punitive and capricious,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“I would hope that companies that review prescriber records would attempt a series of less drastic interventions with the prescriber before reaching this point. There may be issues of concern, but the appropriate step is to discuss those with the prescriber and try to reach an understanding about what is going on, and about what needs to happen to ensure that everyone is prescribing and dispensing safely. I’d be interested to hear from Walmart about whether they have such a graduated policy and if not, why not.”

Carolyn Eastin says there’s only so much she can do. Abruptly tapering patients or cutting them off from opioids could cause more harm than good.

“We’re trying to follow the CDC guidelines. We’re trying to comply with the insurance letters asking for tapers,” she says.  “I’m doing my part to taper my patients. But these things have to be done delicately. We just can’t go, ‘Okay, give me all your meds.’”  

“We’ve pushed them to get physical therapy and cognitive behavioral therapy, and patients are having good results with that,” says Jessica Webb. “But we have some patients, if I had to take their meds away, I couldn’t go to sleep at night. They’re that sick.”   

Doctors Urge CDC to Clarify Rx Opioid Guideline

(Editor’s Note: Five healthcare professionals recently began circulating an open letter to the CDC asking it to make a “bold clarification” of its controversial 2016 opioid guideline.

They believe many chronic pain patients have suffered under the guideline, because it has led to widespread tapering and discontinuation of opioids. They invited other healthcare professionals to co-sign the letter. To date, well over 200 have.

To see a list of signatories, click here. If you are a healthcare professional and also wish to sign the letter, click here.)  

Authors: Health Professionals for Patients in Pain

Any professional who cares for patients, including physicians, pharmacists, nurses, psychologists and social workers, is invited to sign on to this letter, as are any professional organizations that wish to endorse formally. 

I. In 2016, the Centers for Disease Control and Prevention, CDC, issued a Guideline for Prescribing Opioids for Chronic Pain for primary care physicians. Its laudable goals were to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy. The Guideline reflected the work of appointed experts who achieved consensus on the matter of opioid use in chronic pain. 

Among its recommendations are that opioids should rarely be a first option for chronic pain, that clinicians must carefully weigh the risks and benefits of maintaining opioids in patients already on them, and that established or transferring patients should be offered the opportunity to re-evaluate their continued use at high dosages (i.e., > 90 MME, morphine milligram equivalents).  

In light of evidence that prescribed dose may pose risks for adverse patient events, clinicians and patients may choose to consider dose reductions, when they can be accomplished without adverse effect, and with possible benefit, according to some trial data.  

Nonetheless, it is imperative that healthcare professionals and administrators realize that the Guideline does not endorse mandated involuntary dose reduction or discontinuation, as data to support the efficacy and safety of this practice are lacking.  

II. Within a year of Guideline publication, there was evidence of widespread misapplication of some of the Guideline recommendations. Notably, many doctors and regulators incorrectly believed that the CDC established a threshold of 90 MME as a de facto daily dose limit. Soon, clinicians prescribing higher doses, pharmacists dispensing them, and patients taking them came under suspicion.  

Actions that followed included payer-imposed payment barriers, pharmacy chain demands for the medical chart, or explicit taper plans as a precondition for filling prescriptions, high-stakes metrics imposed by quality agencies, and legal or professional risks for physicians, often based on invocation of the CDC’s authority. Taken in combination, these actions have led many health care providers to perceive a significant category of vulnerable patients as institutional and professional liabilities to be contained or eliminated, rather than as people needing care.  

III. Adverse experiences for these patients are documented predominantly in anecdotal form, but they are concerning. Patients with chronic pain, who are stable and, arguably, benefiting from long-term opioids, face draconian and often rapid involuntary dose reductions. Often, alternative pain care options are not offered, not covered by insurers, or not accessible. Others are pushed to undergo addiction treatment or invasive procedures (such as spinal injections), regardless of whether clinically appropriate.  

Consequently, patients have endured not only unnecessary suffering, but some have turned to suicide or illicit substance use. Others have experienced preventable hospitalizations or medical deterioration in part because insurers, regulators and other parties have deployed the 90 MME threshold as a both a professional standard and a threshold for professional suspicion. Under such pressure, care decisions are not always based on the best interests of the patient. 

lV. Action is Required: The 2016 Guideline specifically states, “the CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted”. The CDC has a moral imperative to uphold its avowed goals and to protect patients.  

Therefore, we call upon the CDC to take action: 

1. We urge the CDC to follow through with its commitment to evaluate impact by consulting directly with a wide range of patients and caregivers, and by engaging epidemiologic experts to investigate reported suicides, increases in illicit opioid use and, to the extent possible, expressions of suicidal ideation following involuntary opioid taper or discontinuation. 

2. We urge the CDC to issue a bold clarification about the 2016 Guideline – what it says and what it does not say, particularly on the matters of opioid taper and discontinuation.  

Signatories here represent their own views, and do not purport to reflect formal positions of their employing agencies, governmental or otherwise.

For questions regarding the letter, please contact Stefan G. Kertesz, MD, Professor of Medicine at University of Alabama at Birmingham School of Medicine (skertesz@uabmc.edu).

The information in this letter 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.

Medicaid Expansion Did Not Fuel Opioid Crisis

By Pat Anson, PNN Editor

A new study is debunking claims that increased access to healthcare and pain management helped to fuel the opioid crisis. If anything, the opposite appears to be the case.

The study, published in the Journal of General Internal Medicine, found that early Medicaid expansions in Arizona, Maine and New York may have led to lower overdose rates in those states.

"These findings suggest that Medicaid expansions were unlikely to have contributed to the subsequent rise in drug overdose deaths, and may even have been protective," said lead author Atheendar Venkataramani, MD, PhD, an assistant professor of Medical Ethics and Health Policy at the Perelman School of Medicine at the University of Pennsylvania.

Venkataramani and co-author Paula Chatterjee, MD, looked at state-level data on drug overdoses from 1999 to 2008, comparing overdose mortality rates in the three Medicaid-expansion states to those in other states.

By 2008, Arizona, Maine and New York had about 7 fewer overdose deaths per 100,000 people compared to the other 47 states.

The differences were even greater when the three states were only compared to adjacent states: They had 17 fewer deaths per 100,000 people.

Overall, the study suggests that drug overdose deaths were nearly 20 percent lower in the early expansion states.

"The results should provide reassurance to policymakers who are concerned that state Medicaid expansions, including the recent expansions implemented as part of the Affordable Care Act, promote rises in drug overdose mortality," said Venkataramani.

The Affordable Care Act (ACA) – widely known as Obamacare – greatly expanded Medicaid coverage for millions of poor Americans, starting in 2014. But some critics have claimed the ACA made the opioid crisis worse by giving patients easier access to opioids.

“The Medicaid expansion may be fueling the opioid epidemic in communities across the country,” Wisconsin Sen. Ron Johnson (R) wrote in a 2017 letter to the Health and Human Services inspector general. “Because opioids are so available and inexpensive through Medicaid, it appears that the program has created a perverse incentive for people to use opioids, sell them for large profits and stay hooked.”

The Penn Medicine study wasn't designed to determine why Medicaid expansion appeared to lower overdose death rates in New York, Arizona and Maine. But it does suggest that better access to healthcare was a factor.

“Improving people’s access to health care could have a number of effects. It may be that people had better access to substance use disorder treatment or better access to mental health or pain management. Or it may be that providing health insurance reduced the risk of financial ruin, which helped downward socioeconomic spirals that could lead to substance use disorder,” Venkataramani wrote in an email to PNN.

“If Medicaid expansions did increase access to opioids, then the effect of doing so was far outweighed by other forces that actually reduced mortality rates from drug use order. The mechanisms again are not known because of data limitations in this study, but access to regular health care, access to substance use disorder treatment, and improved socioeconomic circumstances all may have contributed to the slower growth in drug overdose mortality in Medicaid expansion states.”

The Affordable Care Act expanded Medicaid coverage to about 12 million Americans in the 31 states and the District of Columbia that opted to receive it. A recent study found that opioid prescriptions decreased slightly in those states, while prescriptions for addiction treatment drugs like Suboxone rose significantly.

Tennessee’s ‘Absolutely Crazy’ Opioid Law

By Pat Anson, PNN Editor, and Blake Farmer, Nashville Public Radio

Since the CDC released its opioid guideline in 2016, over 30 states have passed legislation that limit opioid prescriptions in some way. Most limit the supply to a few days for initial opioid prescriptions and some set limits on the doses that doctors can prescribe.

Which state has the toughest opioid regulations?

“Tennessee is just absolutely crazy,” says Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

Twillman is referring to a strict and complicated state law that took effect in July that restricts how long Tennessee doctors can prescribe opioids to patients.

“Depending on what you document and depending on your judgement of what’s going on with the patient, you’re either limited to a 3-day supply, a 10-day supply, a 21-day supply or a 30-day supply of an opioid,” Twillman told PNN.

“You wonder how in the world they’re ever going to police this. If it’s a particularly severe case you could do a 21-day supply, but if it’s a rare case then you can do a 30-day supply. What is the difference?”

Tennessee also limits the dose that doctors prescribe, under a complicated formula that lowers the allowable dose the longer a prescription lasts. In other words, you may get more pills but the dose will be smaller.

Any “significant deviation” from Tennessee’s opioid law could result in disciplinary action for a doctor not showing “sound medical judgment.” First offenders could be banned from prescribing opioids for five years.

“They’ve left us saying make your own best judgement and document the reason for it and cross your fingers and hope you’re going to be okay,” says Twillman.

Some doctors have decided not to take that risk. Many primary care providers in Tennessee have stopped prescribing opioids and are referring patients to the state’s dwindling supply of pain clinics, where waiting lists are long and there’s no guarantee a new patient will even be able to get treatment.

Insurers Drop OxyContin

But it’s not just legislation that limits how pain patients are being treated in Tennessee. Insurance companies are refusing to pay for some opioids.

The largest insurer in Tennessee recently announced it will no longer cover prescriptions for OxyContin, what was once a blockbuster pain reliever. It’s the latest insurance company to turn against OxyContin, whose maker, Purdue Pharma, faces dozens of lawsuits related to its high-pressure sales tactics around the country and contribution to the opioid crisis. Last fall, Cigna and Florida Blue both dropped coverage of the drug.

Top officials at BlueCross BlueShield of Tennessee (BCBST) say newer abuse-deterrent opioids work better than OxyContin, and starting in January, the insurer covering 3.5 million Tennesseans will only pay for opioids made by other pharmaceutical companies.

“We felt it was time to move to those products and remove Oxycontin from the formulary, which does still continue to have a higher street value,” said Natalie Tate, the insurer’s vice president of pharmacy.

OxyContin was reformulated in 2010 to make the drug harder to misuse — but it’s still possible to crush or liquefy in order to snort or inject it.

The latest long-acting opioids that BlueCross BlueShield of Tennessee is going to start covering — Xtampza and Morphabond — are still more difficult to misuse, according to the company and some pharmaceutical experts.

Practicing pain physicians in Tennessee — who regularly battle with insurance companies —  approve of the change, though they said OxyContin was already falling out of favor. And they argue trading one opioid for slightly safer ones doesn’t address a larger gripe that physicians have with insurers over paying for other, non-addictive types of treatment.

“We will have denials and prior authorizations on a muscle relaxer, and we will have no issue getting an opioid through the insurance company,” said Dr. Stephanie Vanterpool, an anesthesiologist at the University of Tennessee and the president-elect of the Tennessee Pain Society.

“The physicians or the doctor’s offices jump through hoops to get the better medication for the patients,” said Vanterpool. “And when I say better medication, I mean the medication that’s treating the cause of the pain, not just the medication that’s covering up the pain.”

Not to say OxyContin won’t be sorely missed by some patients.

“There are plenty of people who benefit from that drug,” said Terri Lewis, a patient advocate and rehabilitation specialist from Cookeville, Tenn.

Lewis is suspicious of BCBST’s motives since the insurer may be blamed for its role in the opioid crisis. Embattled Purdue Pharma could also be a convenient scapegoat.

“Maybe this is a good decision,” Lewis said. “But it smells like a political decision.”

This would be just the latest decision inserting politics into a nuanced medical problem that affects millions of pain patients.

John Venable of Kingsport, Tenn., was shown the door by his pain clinic in July after more than a decade on oxycodone — a generic, short-acting version of OxyContin.

“I just felt like I was in a hopeless state, like, ‘there is no help for John,'” he recalled.

At their worst, he said his headaches get so debilitating “that death would be a relief.” Despite his dread, he’s noticed something surprising over the last few months without opioids — his crippling headaches haven’t gotten that much worse, if at all.

“It very well might be a blessing in disguise,” Venable said.

The retired builder and one-time pastor said he prays that those losing OxyContin also will get to use the moment as an opportunity, though he knows many can’t cut ties with opioids. And he worries some will turn to more dangerous drugs off the street or even contemplate ending their own lives.

Experts point out that the number of opioid prescriptions has already been falling around the country. And in Tennessee, BCBS has experienced a 26 percent drop in opioid prescription claims over three years.

But restricting legal access to opioids hasn’t turned back the rise in overdose deaths, which hit a record in Tennessee and nationwide last year.

This story is part of a partnership that includes Nashville Public Radio, NPR and Kaiser Health News.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Lyrica Not Effective for Treating Traumatic Nerve Pain

By Pat Anson, Editor

Pregabalin is not effective in relieving chronic pain caused by traumatic nerve injury, but it may be useful as an analgesic in treating pain after surgery, according to a new study published in the Journal of Neurology.

The placebo-controlled study followed 539 patients in North America, Europe, Africa and Asia for three months. About half had nerve pain after surgery, while the rest had nerve pain after an accident or trauma.

Researchers found that pregabalin was not an effective pain reliever for the patients with traumatic nerve injuries, but the drug did provide better pain relief than placebo for the surgery patients.

"While these finding show that pregabalin is not effective in controlling the long-term pain for traumatic injury, it may provide relief for patients (that) experience post-surgical pain," said lead author John Markman, MD, director of the Translational Pain Research Program in the University of Rochester Department of Neurosurgery.

"The possibility that there was pain relief for those patients who had a hernia repair, or breast surgery for cancer, or a joint replacement lays the groundwork for future studies in these post-surgical syndromes where there is so much need for non-opioid treatments."

Pregabalin, which is sold by Pfizer under the brand name Lyrica, is FDA-approved for the treatment of chronic pain associated with shingles, spinal cord injury, fibromyalgia, and diabetic peripheral neuropathy.

It is also commonly prescribed as an "off label" treatment for other types of chronic pain and as an alternative to opioid medication.

A major challenge for doctors is that biological changes in nerves and other tissues while healing from surgery or trauma vary from one patient to the next. There is also no diagnostic method that allows doctors to identify which patients will respond to a particular type of pain treatment.

"Given the rising rates of surgery and shrinking reliance on opioids, it is critical that we understand how to study new drugs that work differently in patients like the ones included in this study," Markman added.

While critics often say there is little or no evidence to support the long-term use of opioids, the same is true for other types of pain medication, including pregabalin. Nevertheless, in its guideline for opioids, the Centers for Disease Control and Prevention recommends pregabalin and its chemical cousin gabapentin as alternatives for treating chronic pain – without even mentioning their side effects or potential for abuse.

Pregabalin and gabapentin belong to a class of nerve medication called gabapentinoids, which were originally developed to treat epilepsy, not pain. In recent, deaths involving gabapentinoids have increased in the UK, Australia and Canada, where some addicts have learned the drugs can heighten the euphoric effect of heroin and other opioids.

The use of pregabalin and gabapentin has tripled in the U.S. over the past decade, but health officials have only recently started looking into their misuse and abuse. While gabapentin has a warning label cautioning users who take the drug with opioids, there is no similar warning for pregabalin.

Overdose Crisis Began 40 Years Ago

By Pat Anson, PNN Editor

The overdose crisis in the United States began long before a spike in opioid prescribing and is likely to last for many more years, according to a new study published in Science magazine.

Researchers at the University of Pittsburgh Graduate School of Public Health looked at nearly 600,000 poisoning deaths in the U.S. from 1979 to 2016 and found a steadily rising number of overdoses caused by “subepidemics” of different drugs, including heroin, cocaine, illicit fentanyl, methamphetamine and prescription opioids. As each subepidemic rose and fell, the drug fueling it was replaced by another substance that can be abused.

“The epidemic of drug overdoses in the United States has been inexorably tracking along an exponential growth curve since at least 1979, well before the surge in opioid prescribing in the mid-1990s,” said senior author Donald Burke, MD, Pitt Public Health dean and UPMC-Jonas Salk Chair of Global Health. 

“Although there have been transient periods of minor acceleration or deceleration, the overall drug overdose mortality rate has regularly returned to the exponential growth curve. This historical pattern of predictable growth for at least 38 years strongly suggests that the epidemic will continue along this path for several more years.”

Burke and his colleagues say the type of drug and the demographics of those who die from overdoses has fluctuated over the years. When the use of one drug waned, another drug replaced it, attracting new populations from different geographic regions.

When plotted on a map, certain drugs dominate different areas. Almost every region in the country is a hot spot for overdose deaths from one or more drugs. Heroin and cocaine primarily impact urban populations, while prescription opioids and methamphetamine skew a bit more rural. Cocaine increased death rates for black men, while heroin raised the death rates for younger whites and older blacks.

To be successful, researchers say overdose prevention efforts must extend beyond control of individual drugs. The current subepidemic of drug deaths caused by illegal and legal opioids will likely to be replaced by something else.

“The recent historical variability with which some specific drugs have waxed and waned makes predictions about the future role of specific drugs far more uncertain. Indeed, it is possible that in the future, the drug overdose epidemic may be driven by a new or heretofore obscure psychoactive substance,” Burke warned. 

Click on the video below to see a chart of the different subepidemics and how they align to form an exponential growth curve:

Technological factors fueling the epidemic include enhanced communication methods (smartphones and the Internet), faster supply chains (FedEx and UPS) and underground drug manufacturing that increased the supply of drugs while lowering their cost. Socioeconomic factors such as unemployment, lost social connections and lack of healthcare may also be creating a climate of despair that leads to drug abuse. 

“Understanding the forces that are holding multiple subepidemics together into a smooth exponential trajectory may be important in revealing the root causes of the epidemic, and thisunderstanding may be crucial to implementation of prevention and intervention strategies,” Burke said. 

“Evidence-based public health responses have contained past epidemics. If we understand and address these root causes at the same time that we take on the opioid crisis, we should be able to curb the epidemic for good."