Poorly Rated Hospital May Become Model for Pain Care

By Pat Anson, Editor

A New Jersey hospital that has been widely praised for significantly reducing the use of opioid pain medication in its emergency room continues to receive poor ratings from Hospital Compare, a Medicare website that tracks the quality of care in the nation’s hospitals.

The one star overall rating for St. Joseph’s Regional Medical Center in Paterson, New Jersey puts it in the bottom 6 percent of hospitals nationwide.

Despite the poor rating and complaints from patients about poor pain care, St. Joseph’s anti-opioid initiative – known as ALTO (Alternatives to Opioids) -- is being held up as a national model for combatting opioid abuse. ALTO requires emergency room doctors to first consider non-opioid treatments, such as NSAIDs, ibuprofen and nerve block injections, for patients suffering pain from accidents, trauma and chronic conditions.

“We launched ALTO two years ago to offer a real solution to a rapidly growing opioid epidemic,” said Mark Rosenberg, DO, Chair of Emergency Medicine at St. Joseph’s, who was recently named to a federal task force charged with developing "best practices" in pain management for federal agencies.

"I’m very proud to report that we have reduced opioid prescriptions by 82 percent here in the St. Joseph’s Emergency Department. We are stopping addiction before it starts.”

St. Joseph’s has drawn congressional attention for its opioid policy. Last month, New Jersey Senators Robert Menendez and Cory Booker and Rep. Bill Pascrell – all Democrats – introduced legislation in Congress that would create a nationwide pilot project based on the ALTO program.

“The opioid crisis in our country is staggering and epic in its evil,” Sen. Booker said at a news conference. “The work being done here at St. Joseph’s Medical Center is innovative, it is inspiring, and it is shining light against the darkness.”

SEN. CORY BOOKER SPEAKS AT APRIL, 2018 NEWS CONFERENCE

“The ALTO program here at St. Joe’s is at the forefront of innovative thinking and new approaches to treating pain -- to fighting opioid addiction,” said Sen. Menendez.  “We want to see every hospital and provider across New Jersey and across this nation follow St. Joe’s lead, and our bill provides the necessary federal resources to help make it possible.” 

The Alternatives to Opioids in the Emergency Department Act is one of dozens of bills being considered in Congress to combat opioid addiction and overdoses. It would provide $30 million in funding to other hospitals to build their own ALTO programs. After a three-year demonstration project, the Secretary of Health and Human Services would submit a report to Congress on the results and issue recommendations for broader implementation.

St. Joseph's One Star Rating

In patient satisfaction surveys and other quality measures, St. Joseph’s consistently ranks poorly. It is one of 260 hospitals in the country given a one-star rating by Hospital Compare. Over 3,400 hospitals were ranked higher, getting two to five stars.

To be fair, St. Joseph’s is a teaching hospital in a low-income neighborhood and has one of the busiest emergency rooms in the country. The American Hospital Association believes Hospital Compare unfairly penalizes teaching hospitals and those that serve low-income areas, where many people lack access to insurance and medical care.

Hospital Compare evaluates hospitals on 7 major quality measures. St. Joseph’s is rated below the national average on safety, readmission, patient experience, timeliness of care and efficient use of medical imaging. The hospital was rated as average for mortality and effectiveness of care.

ST. JOSEPH'S REGIONAL MEDICAL CENTER

The quality of pain care is difficult to assess at St. Joseph’s because Medicare dropped all pain questions from its patient satisfaction survey last year – largely due to political pressure and unproven claims that the questions encouraged doctors to prescribe more opioids.

One pain quality measure that still exists is the average amount of a time a patient with a broken bone had to wait before getting pain medication in St. Joseph’s ER. It is 51 minutes, slightly longer than the national average of 49 minutes.

HospitalInspections.org, a website maintained by the Association of Healthcare Journalists, also found deficiencies in St. Joseph’s emergency room. An October 2017 report faulted the ER for failing to stabilize several patients or provide them with a screening exam or pain assessment. Some patients left the hospital in frustration after waiting for hours without being treated.  

One patient who fell down a flight of steps suffered injuries to her face and arm when she landed on concrete. She waited in St. Joseph’s emergency room for over seven hours before leaving without treatment. There was no record of her getting Tylenol or Motrin while waiting, which is hospital policy.

Another patient suffering from abdominal pain after a Caesarean section waited over five and a half hours in the ER before leaving. There was no record of her getting Tylenol or Motrin either.

Delays in Getting Pain Treatment

St. Joseph’s emergency room gets mixed reviews on Yelp, with many patients complaining of delays in getting treatment.

“This is by far the worst hospital in the state of NJ, my little cousin and I came here because she was in excruciating pain and the waiting room was EMPTY, they literally took over an hour to check her temp and register her,” wrote one reviewer, who even posted a photo of the empty waiting room. 

“Arrived at St Joe's due to vomiting, stomach pain and headache all night. After waiting 50 minutes to get vital signs taken I start vomiting in the lobby,” wrote another patient who eventually left. “I just got frustrated and asked to be discharged and went to primary doctor. Needless to say, I had a gallbladder infection and severe dehydration all diagnosed by primary doctor. 6 hours in the ER for nothing.”

ST. JOSEPH'S EMPTY WAITING ROOM

“St. Josephs isn't in the best part of town, but the care here, especially for children is excellent. During a scare with our 1 month old, the emergency room staff were excellent and comforting,” wrote one father.

“The nurses and doctors were nice to me, but they moved like snails,” wrote a pregnant woman who went to the ER because she was cramping and bleeding. “The pain was unbearable, and it took them until I threw up on the floor for them to move a little faster. And I was there for 3 hours before I was finally told I was unfortunately miscarrying.”  

Granted, these may be just isolated cases in a busy hospital that treats over 60,000 patients a year. But before Congress passes legislation holding up any hospital as a national model for how pain should be treated, they might want to start asking St. Joseph's patients what they think.

The widespread belief that giving opioids in the ER often leads to addiction is a myth anyway. A recent large study of opioid prescriptions filled in emergency rooms found that only 1.1% of patients progressed to long term opioid use. That compares to 2% of patients given opioids in other hospital settings.  

Reducing Supply of Opioids Will Not Stop Drug Diversion

By Roger Chriss, Columnist

Drug diversion is a massive problem. It plagues the entire drug supply chain, from manufacturer through wholesaler and distributor, to drug stores and dispensaries, all the way to consumers. It is particularly important for opioid pain medications because of the ongoing opioid crisis.

It is well established that the non-medical use of pharmaceutical drugs is an increasing public health concern. Most pharmaceutical drugs used non-medically are obtained from family and friends. There is little to no organized crime involved. And importantly, doctor shopping is rare.

An under-appreciated issue here is scale. According to the DEA, less than 1 percent of legally prescribed opioids are diverted. The sharing or selling of individual prescription pills is small compared to the impact of diversion higher up in the supply chain. For instance, Effingham Health systems just agreed to pay a $4.1 million settlement as a result of a DEA investigation into reports that tens of thousands of oxycodone tablets were believed to have been diverted for four years.

Similar reports about large-scale diversion abound. The Associated Press reported incidents of diversion at about 1,200 VA facilities rose from 272 in 2009 to 2,926 in 2015.

And in 2013 Walgreens was charged $80 million for poor record-keeping and dispensing violations that let millions of doses of controlled substances to enter the black market.

In 2007, the Drug Enforcement Administration estimated that prescription drug diversion in the United States was a $25 billion-a-year industry. About one of every four thefts of methadone and OxyContin were attributed by the DEA to employee pilferage at pharmacies, hospitals and other healthcare facilities.

More recently, a 2017 survey by Porter Research, 96 percent of healthcare workers said drug diversion occurs frequently in healthcare. And 65 percent believe most diversion goes undetected.

Pill mills are even worse. In the book “American Pain,” journalist John Temple describes the impact of Florida pill mills on the east coast a decade ago.

“Florida pumped millions upon millions of doses of those narcotics—oxycodone, mostly—northward, not through a major criminal organization like the cartels of Mexico, but via thousands of individuals who streamed up and down Interstate 75 or flew from Tri-Sate Airport in Huntington, West Virginia, to Miami International, on a flight nicknamed the Oxy Express,” Temple wrote.

And none of this is remotely new. In the book “Dark Paradise,” historian David Courtwright explains: “Diversion from maintenance programs posed a real danger, given that perhaps half of all licitly manufactured barbiturates and amphetamines ended up on the black market.”

So the claim by Attorney General Jeff Sessions that "It’s a common sense idea: the more a drug is diverted, the more its production should be limited” is both simplistic and misguided.

Sessions is assuming that limiting production will reduce diversion. But economic theory suggests the opposite may be true. Reducing supply leads to scarcity, which generally increases value. This in turn may create stronger incentives to divert more opioids into the black market.

Moreover, there is no evidence that people who divert medication are aware of and responding to DEA production quotas. Instead, the consensus is that people divert what they need and think they can get away with. In other words, diversion is an exercise in what economists call the “Tragedy of the Commons,” in which individuals each use a collective resource for their own benefit without regard for the effects on others.

And Sessions’ idea implies that reducing production won’t have any effect on medical practice. But there is an abundance of evidence to the contrary. There is an ongoing shortage of injectable opioids at hospitals around the country. And despite claims to the contrary, opioid analgesics cannot always be replaced or substituted with other pain relievers.

Thus, more intelligent and nuanced approaches are needed. For instance, the NIH is sponsoring research to use advanced data analytics to detect drug theft and diversion in hospitals. Similar efforts at wholesalers, distributors, pharmacies and dispensaries are worth considering.

So while diversion is a major problem, it is neither new nor limited to individual consumers with prescriptions for opioids or other medications that have a street value or abuse potential. The seemingly obvious response of reducing supply could easily backfire. Instead, securing the entire supply chain, from manufacturer through distributor to point-of-sale to consumers, is a vital step in making sure that only the intended recipients of pharmaceutical drugs have access to them.

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.

What Every Patient Should Know About NarxCare

By Rochelle Odell, Columnist

Walmart and Sam’s Club recently announced that by the end of August their pharmacists will start using NarxCare, a prescription tracking tool that analyzes real-time data about opioids and other controlled substances from Prescription Drug Monitoring Programs (PDMP’s).

Recent studies question the value of PDMP’s, but 49 states have implemented them so that physicians, pharmacists and insurers can see a patient's medication history. Granted, there is a need for monitoring the select few who doctor shop and/or abuse their medications, albeit that number is only in the 2 percent range.

What is NarxCare? Appriss Health developed NarxCare as a “robust analytics tool” to help “care teams” (doctors, pharmacists, etc.) identify patients with substance use disorders. Each patient is evaluated and given a “risk score” based on their prescription drug history. According to Appriss, a patient is much more willing to discuss their substance abuse issues once they are red flagged as a possible abuser.

“NarxCare automatically analyzes PDMP data and a patient’s health history and provides patient risk scores and an interactive visualization of usage patterns to help identify potential risk factors,” the company says on its website.

“NarxCare aids care teams in clinical decision making, provides support to help prevent or manage substance use disorder, and empowers states with the comprehensive platform they need to take to the next step in the battle against prescription drug addiction."

Sounds great doesn't it? Except prescription drugs are not the problem and never really have been. Illicit drug use has, is, and will continue to be the main cause of the addiction and overdose crisis. 

Even the name NarxCare has a negative connotation. “Narx” stands for narcotics. And in today's environment, narcotics is a very negative word. NarxCare makes me feel like a narcotics police officer is just around the corner.

Each patient evaluated by NarxCare gets a “Narx Report” that includes their NarxScores, Overdose Risk Score, Rx Graph, PDMP Data and my favorite, the Red Flags. The scores are based on the past two years of a patient’s prescription history, as well as their medical claims, electronic health records and even their criminal history.

Ohio, Michigan, Indiana, Iowa, and several other states are using NarxCare to supplement their own PDMPs. And Walmart isn’t the only big retail company to adopt it. Kroger, Ralphs, Kmart, CVS, Rite Aid and Walgreens are already using NarxCare. There’s a good chance your prescriptions are already being tracked by NarxCare and you don’t even know it.

But NarxCare doesn’t just analyze opioid prescriptions. It also tracks other controlled substances, such as antidepressants, sedatives and stimulants. If a patient is on any combination of those drugs, their risk scores and their chances of being red flagged will be higher – even if they’ve been safely taking the medications for years.

There are several other ways a patient can be red flagged, such as having multiple doctors or pharmacies. But what if you moved and changed physicians? What if you had the same physician for many years and he/she retired or moved away? What if your pharmacy refused to fill your prescription and you had to go pharmacy hunting every month? What if you had dental surgery and your dentist placed you on a short-term pain medication?

Unfortunately, the NarxCare scores do not reflect any of that. How can raw data on prescription medications be an indicator of abuse? I believe there is some merit in tracking and weeding out the rare abuser, but NarxCare doesn't factor in all the “what if’s” that can happen to law-abiding and responsible patients. 

As pain patients, we need to be acutely aware of the negative impact this analytics tool can have. Many of us have already been required to sign pain contracts, take drugs tests, and undergo pill counts. In 2019, Medicare will adopt policies making it even harder for patients to get high doses of opioid medication. Some insurers are already doing it. We're already being policed enough as it is.

I intend to ask my physician, pharmacist and case manager if they utilize NarxCare. So should you. If they say yes, ask them why. Ask your doctor if they believe you are at risk for substance use disorder. Why is their judgement and treatment of you being second guessed by anyone?

Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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.

FDA Uncovers Errors in Opioid Database

By Pat Anson, Editor

The U.S. Food and Drug Administration has identified potentially serious errors in a database of opioid sales maintained by IQVIA - a private company that provides data to the federal government on the volume of drugs sold by manufacturers and wholesalers to pharmacies and hospitals.

The FDA said the errors “raise serious questions” about the reliability of IQVIA’s database, which is used by the Drug Enforcement Administration to set opioid production quotas for drug makers. In the last two years, the DEA has reduced opioid production quotas by as much as 45 percent, claiming there was less demand for opioids and that the market was oversupplied with them.

“When we discover irregularities or inconsistencies in the data we use, we take such deficiencies very seriously,” the FDA said in a statement. "The FDA uses these data to assist the DEA in determining the medical and research needs for Schedule I and II controlled substances in the U.S. for the upcoming year."

The FDA believes the error was caused when IQVIA incorrectly converted into kilograms the amount of prescription fentanyl contained in transdermal skin patches and other fentanyl products. As a result, FDA researchers believe the company overestimated the amount of fentanyl sold in the U.S. in the last five years by over 20 percent.

“This error caused IQVIA to overestimate the total amount of fentanyl distributed into the marketplace,” the FDA said. “As a result of this work, we identified additional data quality issues related to several other controlled substances with similar weight-based conversion factors, including oxymorphone and hydrocodone. These additional errors raise serious concerns about systemic issues with IQVIA’s data and quality control procedures.”

Fentanyl is a potent synthetic opioid that is used to treat severe chronic pain and acute pain in patients recovering from surgery and trauma. There is currently a nationwide shortage of intravenous fentanyl and other opioids that has forced some hospitals to postpone surgeries or use other pain medications that are less effective.   

FDA Commissioner Scott Gottlieb, MD, called on IQVIA to immediately hire an independent, third party auditor to conduct a review of its database. Gottlieb said he would brief members of Congress about the data issues and their potential impact on public health.

IQVIA was formed in 2016 after the merger of IMS Health and Quintiles, two prominent healthcare research firms. The company released a statement saying it identified the problems in its opioid database last month and notified customers.  

“Recently, we made a correction to a kilogram conversion measurement in the United States IQVIA National Sales Perspective (NSP) market research service affecting reported measurements for transdermal patches in the opioid market,” the company said. “IQVIA’s internal processes had already identified the measurement conversion issue prior to the FDA’s notification. We notified our clients about this measurement conversion issue in April of this year. Ongoing steps have been undertaken to correct this measurement conversion issue.

“We stand behind our data methodologies. We value our long-standing relationship with the FDA. We take the FDA’s concerns seriously and will continue working with the FDA to resolve these concerns to its satisfaction.”

If confirmed, the database errors would be the second admission by federal agencies this year that their analysis of opioid prescriptions relied on faulty data. In March, four researchers in the CDC’s ironically named Division of Unintentional Injury Prevention acknowledged that many overdoses involving illicit fentanyl and other synthetic black market opioids were erroneously counted as prescription drug deaths.

Overdose Crisis Boosts Organ Donations

By Pat Anson, Editor

Drug overdose deaths have reached unprecedented levels in the United States, with over 63-thousand people dying in 2016 from overdoses involving antidepressants, illicit fentanyl, heroin, prescription opioids and other drugs.

Those deaths have led to an unexpected gift for thousands of Americans who needed organ transplants. Researchers at University of Utah Health and Brigham and Women's Hospital say there has been a steady increase in the number of organs available for transplantation – due in large part to the escalating overdose crisis. They documented an 11-fold increase in the proportion of organ donors who died of drug overdoses from 2000 to 2016.

"We were surprised to learn that almost all of the increased transplant activity in the United States within the last five years is a result of the drug overdose crisis," said Mandeep Mehra, MD, medical director of the Heart and Vascular Center at Brigham and Women's Hospital and lead author of a research letter published in The New England Journal of Medicine.

Mehra and his colleagues examined transplantation records and found no significant change in the recipients' chance of survival when the organ donation came from an overdose victim. The survival rate of 2,360 patients after receiving a heart or lung transplant from donors who died from overdoses was no different than those who received organs from donors who died from gunshot wounds, asphyxiation, head injuries or stroke.

There has long been a stigma against using donated organs from overdose victims because the organs may be damaged due to reduced oxygen supply that may occur during an overdose. There are also fears the organs could be infected with HIV, hepatitis or other communicable diseases due to high rates of intravenous drug use by overdose victims. As a result, some organs harvested from overdose donors are discarded.

But researchers say those risks can be minimized with modern testing.

"I feel hopeful that doctors across the country will read this and feel confident that organs that pass the required tests are safe for transplant," said Josef Stehlik, MD, medical director of the Heart Transplant Program at University of Utah Health. "This awareness is especially important when organ procurement professionals have to decide on use of potential donors with this high-risk history."

The United Network for Organ Sharing requires organ recipients to be made aware of the circumstances of higher risk donations, so they can decide whether or not to accept it. There are nearly 115,000 Americans currently waiting for an organ donation, including many who have been on the waiting list for years.

"We must look to new ways to increase organ donor recovery by concentrating on greater use of marginal organs or by expanding the suitable donor pool by using new technologies to improve organ function before the transplant takes place," Mehra said.

A similar study recently published in the Annals of Internal Medicine also found an increase in the proportion of organ donors who died from an overdose. In 2000, only 1.1% of donors were overdose victims. By 2017, that grew to 13.4 percent.

"For people waiting on an organ transplant right now, I would like to think that our studies bring them hope that they could receive a transplant and have more donors that could help them," Dr. Christine Durand, a professor of medicine and oncology at Johns Hopkins University, told CNN. "We have an obligation to optimize the use of all organs donated. The donors, families and patients waiting deserve our best effort to use every gift of life we can."

FDA Commissioner Listening to Chronic Pain Patients

By Pat Anson, Editor

Chronic pain sufferers have long complained that they rarely get a seat at the table when important decisions are being made about opioid medication.

Last year President Trump’s opioid commission held five public hearings without ever inviting a patient, patient advocate or pain management physician to testify.  The Centers for Disease Control and Prevention also ignored the pain community in 2015 when it secretly drafted its opioid prescribing guideline, relying instead on the advice of addiction treatment specialists and anti-opioid activists.

Now there is a hopeful sign that at least one federal agency is starting to listen to patients about the worsening quality of pain care in the U.S.

The Food and Drug Administration is seeking comments from patients only on the challenges they face finding treatment and on the effectiveness of opioids and other types of pain medication. Patients are invited to submit their comments by mail or in the Federal Register, and to attend a public meeting on July 9. Click here for more details.

The meeting is the latest in a series of step ordered by FDA Commissioner Scott Gottlieb, MD, to get more public input on how to deal with the opioid crisis.  In January, dozens of pain patients and their advocates expressed their concerns to the FDA’s Opioid Policy Steering Committee.

“We’ve heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life,” Gottlieb wrote in an online blog.

“We’re focused on striking the right balance between reducing the rate of new addiction while providing appropriate access to those who need these medicines. In some medical circumstances, opioids are the only drugs that work for some patients. This might include patients with metastatic cancer or severe adhesive arachnoiditis.”

SCOTT GOTTLIEB, MD

Gottlieb also signaled that the FDA is considering the development of prescribing guidelines for specific chronic pain conditions – not the one-size-fits-all approach taken by the CDC.

“We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs,” he wrote.

“In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.”

Although Gottlieb has angered some in the pain community with his crackdowns on kratom and stem cell clinics, he does appear to have a sympathetic ear for pain sufferers. In 2012, a full five years before becoming FDA commissioner, Gottlieb warned that heavy-handed enforcement actions by the DEA were interfering with patient care.  

“This approach is burdening a lot of innocent patients, including those with legitimate prescriptions who may be profiled at the pharmacy counter and turned away. Others have in effect lost access to care, because their doctors became too wary to prescribe what their patients need,” Gottlieb wrote in a prophetic column published in The Wall Street Journal.

To leave a public comment for the FDA in the Federal Register, click here. Comments will be accepted until September 10, 2018.

Critics Say DEA Plan Could Worsen Opioid Shortages

By Pat Anson, Editor

Pain sufferers and patient advocates are overwhelming opposed to plans by the U.S. Drug Enforcement Administration to further restrict the supply of opioid medication to punish drug makers that allow too many of their painkillers to be diverted and abused. Health organizations also caution that the proposal could worsen an acute shortage of pain medication in the nation’s hospitals.

Over 1,500 people left public comments in the Federal Register on the DEA’s plan to change the rules governing opioid production quotas. Under the proposal, the DEA could arbitrarily reduce the amount of opioids a company can make -- even if it has no direct role in the diversion or abuse.

"It’s a common sense idea: the more a drug is diverted, the more its production should be limited," said Attorney General Jeff Sessions. 

But critics say the plan will not prevent opioid abuse and will likely harm patients.

“The DEA has no business deciding how much valid medicine can be produced. The doctors prescribing the medicine should dictate the amount. The DEA is going to cause a crisis,” wrote Tina Liles.

“Reducing opiate medication has done nothing to help the rate of overdose deaths in this country because opioid prescriptions are not the issue in this country it is illicit fentanyl and heroin,” said Nicole Garage.

“Limiting access to the only medication that helps to control severe, intractable pain will not stop the crisis; those who abuse or sell drugs illegally have not stopped due to current quotas and will not stop with any new quota reductions,” said James Loranc.

“The logic (behind) this DEA proposal is completely untested, unproven, and unsupportable. The shortages being seen in hospitals and by pain patients will only get worse with further DEA cutbacks, leading to more mistakes, waste, and higher costs, not to mention additional pain,” said Valerie Padgett Hawk, Director of a Coalition of 50 State Pain Advocacy Groups.  

Hospitals Rationing Opioids

The shortages mainly involve injectable opioids such as morphine, hydromorphone and fentanyl, which are used to treat acute pain in patients recovering from surgery or trauma. Hospitals have been forced to ration opioids or use other pain medications that are not as effective.

“With limited availability of some opioids, operations may have to be postponed or cancelled.  In some cases, this could prove life‐threatening to the patient,” wrote Janis Orlowski, MD, Chief Health Care Officer for the Association of American Medical Colleges. “We urge the DEA to remember that opioids are also an important part of treatment regimens for controlling acute and chronic pain in a variety of patients – including trauma, postoperative and patients with advanced stage cancer – and any limits on quotas should not negatively impact access for patients that have a legitimate and critical need for these medications.”  

“Please, I beg you, don't do this. My dear friend Sarah takes painkillers for her rheumatoid arthritis. Even with the medication it's terrible; without it, I have no doubt she'll kill herself. Her mental health is already fragile,” wrote Kelsey Hazzard. “This regulation will destroy her.”  

“For the love of God let the doctors and pharmacists handle prescribing and filling prescriptions and allow the patients and doctors to worry about how much opioid pain medication they need to take. This is none of the DEA’s concern!” wrote Brandon Tull, a disabled police officer who shared the tragic story of Jennifer Adams, a Montana pain patient who recently committed suicide.

“That suicide will probably be the first in a long line if you continue this attack upon innocent chronic pain sufferers!”

The public comment period on the DEA proposal ended May 4th. The public was given only 15 days to comment in the Federal Register on the rule change. Public comment periods are usually between 30 and 60 days long, with some taking up to 180 days. Agencies are allowed to use shorter comment periods "when that can be justified."

"This shortened period for public comment is necessary as an element in addressing the largest drug crisis in the nation's history," the DEA said.

The DEA has already made substantial cuts in opioid production quotas, reducing them by 25% in 2017, followed by a 20% cut in 2018. This year’s cuts were ordered despite warnings from drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

Under the proposed rules, the DEA would be required to consult with states, Food and Drug Administration, Centers for Disease Control and Prevention, and the Department of Health and Human Services before setting opioid quotas. The rule change was triggered by a lawsuit filed against the DEA by West Virginia, alleging that the current quota system “unlawfully conflates market demand for dangerous narcotics” with the legitimate needs of pain patients.    

Although overdose deaths from heroin, illicit fentanyl and other street drugs now surpass those from pain medication, the DEA claims prescription opioids are gateway drugs to long-term substance abuse.

“(Opioid) users may be initiated into a life of substance abuse and dependency after first obtaining these drugs from their health care providers or without cost from the family medicine cabinet or from friends. Once ensnared, dependency on potent and dangerous street drugs may ensue,” the DEA said.

According to the National Institutes of Health (NIH), only about 5 percent of patients taking opioids as directed for a year end up with an addiction problem. And the DEA itself estimates that less than 1% of legally prescribed opioids are diverted.

Rx Drug Monitoring Not Reducing Opioid Abuse

By Pat Anson, Editor

Prescription drug monitoring programs (PDMPs) have long been promoted as a critical tool in the fight against opioid abuse and overdoses. PDMP’s in 49 states and the District of Columbia allow physicians and pharmacists to consult a prescription drug database to see if patients might be “doctor shopping” or selling their opioid medication.

But a new study has found little evidence that PDMPs are working and that they may in fact be driving some patients to the black market for cheaper drugs such as heroin.

Researchers at Columbia University's Mailman School of Public Health and University of California, Davis, analyzed 17 studies that looked at the effectiveness of PDMPs. Their findings are published online in the Annals of Internal Medicine.

“Evidence that PDMP implementation either increases or decreases nonfatal or fatal overdoses is largely insufficient, as is evidence regarding positive associations between specific administrative features and successful programs. Some evidence showed unintended consequences,” wrote lead author David Fink, MPH, a doctoral candidate in epidemiology at the Mailman School of Public Health.

What were those unintended consequences? Three studies that looked at heroin related overdoses found a “statistically significant” increase in heroin deaths after PDMPs were implemented.

"This suggested to us that heroin substitution may have increased after PDMP-inspired restrictions on opioid prescribing," says Silvia Martins, MD, a professor of epidemiology at Mailman and co-senior author. "We therefore caution that programs aimed at reducing prescription opioids should also address the supply and demand of illicit opioids."

Researchers believe that efforts to reduce doctor shopping and the diversion of prescription opioids may have backfired.

“A reduction in black market prescription opioids, although generally viewed as positive, also may generate unanticipated outcomes. For example, an ethnographic study of high-risk users in Philadelphia and San Francisco found that key drivers of the progression from prescription opioid to heroin use are the rising cost of the ‘pill habit’ and heroin’s easy availability and comparatively lower cost,” Fink said.

Heroin overdoses also rose after Purdue Pharma introduced a new and more expensive abuse deterrent formulation of OxyContin in 2010. According to one study, each death that was prevented by OxyContin's reformulation “was replaced with a heroin death.”

Fink and his colleagues say more studies are needed to examine the true effectiveness of PDMPs, which can vary widely from state to state.

Doctor Shopping Rare

Missouri is the lone state that has not adopted a statewide PDMP and one family physician would like to keep it that way.

In an unpublished study, John Lilly, DO, claims that PDMPs are not working because doctor shopping is rare to begin with. In 2016, doctor shopping was responsible for only 1.7% of all misused opioid prescriptions. The rest are stolen, borrowed or bought on the black market, or misused by the patients they were prescribed to.

“The prescription drug monitoring programs will never catch the remaining 98.3 percent of the problem. That is why the death rate has not decreased despite 49 states having an operational PDMP,” Lilly wrote.  “There is now an alternative to prescription drugs that is easier to obtain and more powerful. Illicit fentanyl is now the preferred opioid and the PDMPs have absolutely no effect on its rapid rise. I would not be surprised if prescription opioid deaths start to fall, not due to the effectiveness of the PDMPs, but due to market competition from illicit fentanyl.”

If PDMP's were effective, Lilly says states that have them would see a decline in opioid overdoses. But in 2016, West Virginia had the highest opioid death rate in country -- over three times higher than Missouri's -- which ranked 25th.

Missouri’s Governor ordered the creation of a statewide PDMP last year, but the state legislature has so far resisted efforts to fund it. Critics say it doesn’t give doctors the necessary tools to prevent overprescribing, but allows law enforcement to track and prosecute physicians and pharmacists.  A spokesman for the Missouri State Medical Association called the program a “witch hunt against physicians.”

Walmart to Limit Rx Opioids for Acute Pain

By Pat Anson, Editor

Walmart has announced plans to restrict opioid prescriptions for short-term acute pain to no more than a 7-day supply.

The new policy, which is similar to one already adopted by CVS, will begin “within the next 60 days” and be implemented at all Walmart and Sam’s Club pharmacies in the United States and Puerto Rico.

“We are taking action in the fight against the nation’s opioid epidemic,” Marybeth Hays, executive vice president of Health & Wellness and Consumables for Walmart U.S. said in a statement.

“We are proud to implement these policies and initiatives as we work to create solutions that address this critical issue facing the patients and communities we serve.”

In addition to the 7-day limit on opioids for acute pain, Walmart and Sam’s Club pharmacists will also limit the dose to no more than 50 morphine milligram equivalent (MME) units per day. The company said its policy was “in alignment” with the Centers for Disease Control and Prevention’s opioid guidelines.

However, those 2016 guidelines are voluntary and only intended for primary care physicians who are treating chronic pain. They say nothing at all about pharmacists being required to limit the dose or duration of opioid prescriptions for acute pain:

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

Several states have already adopted policies that limit opioid prescriptions for acute pain to seven days or less. Walmart said when state law limits prescriptions to less than seven days, Walmart and Sam’s Club pharmacists will follow state law.

The company’s pharmacists will also be trained and required to counsel patients about the CDC’s guidelines, while “focusing on using the lowest effective dose for pain management for the shortest time possible.”

In 2020, Walmart and Sam’s Club will also require e-prescriptions for controlled substances such as opioids. The company said e-prescriptions are less prone to errors, cannot be altered or copied, and are electronically trackable.

By the end of August 2018, Walmart and Sam’s Club pharmacists will also have access to a controlled substance tracking system called NarxCare. NarxCare analyzes a prescription database to provide pharmacists with a patient’s “risk score” for potential drug abuse.

Study Finds Opioid Medication Effective for Chronic Pain

By Pat Anson, Editor

Opioids have been used for thousands of years to provide relief from pain. But are they an effective treatment? Are they worth the risk of addiction? And do they improve quality of life?

Millions of chronic pain patients who use prescription opioids so that they can work, sleep, bathe and do simple household chores would quickly answer “Yes” to those questions.

But that’s a radical concept in an age of anti-opioid hysteria and propaganda. Prominent anti-opioid activists insist that “opioids are ineffective or can worsen both the pain and the long-term outcome." And the CDC's opioid prescribing guideline tells us there is “insufficient evidence to determine long-term benefits of opioid therapy for chronic pain.”  

Except now there’s a review that says opioids are effective and the evidence was there all along.

Researchers at Brown University and Tufts University School of Medicine analyzed 15 clinical studies performed for the Food and Drug Administration that looked at the effectiveness of opioids in treating chronic non-cancer pain. Their findings were just published in the Journal of Pain Research.

“The recent claims that opioids lack efficacy for chronic pain have created controversy among physicians, prescribers, regulators, scientists, and the general public,” wrote lead author Nathaniel Katz, MD, president of Analgesic Solutions and a professor of anesthesia at Tufts University.

“This review was, therefore, performed in order to gather together the key evidence to facilitate understanding opioid efficacy within the paradigm of FDA studies required for approval, and to perform a meta-analysis in order to quantify opioid efficacy for chronic pain.”

‘Ample Evidence’ Opioids Work

The authors are careful to note that they did not try to study or minimize the risks of opioids but were simply trying to reach “an accurate assessment of their benefits.” The 15 placebo controlled studies they reviewed evaluated the effectiveness of hydrocodone, oxycodone, tramadol and other opioids for up to 3 months.

What did they find?

“There is an ample evidence base supporting the efficacy of opioid analgesics for at least 3 months’ duration,” Katz wrote. “This evidence base is at least as large as that for any other class of analgesics, and analysis of responders demonstrates clinically meaningful improvements.”

Nearly two-thirds of the patients (63%) who participated in the 15 studies demonstrated “a clinically meaningful response” to opioids as a treatment for chronic pain. Their physical function only improved marginally, and researchers say there was no positive or negative effect on the patients’ mood. Interestingly, adverse effects were similar in the patients who took opioids and those who were given placebos.  

In short, the authors found no reason to abandon opioids as a treatment for chronic pain.

“While the effectiveness of existing treatments for chronic pain leaves plenty of room for improvement, and considering that only a small minority of patients do not experience clinically meaningful treatment response, discarding all analgesics approved for chronic pain contradicts numerous treatment guidelines, international treatment guidelines, widespread patients experience, and the FDA approval process,” they wrote.   

Critics will no doubt question why the authors only reviewed studies that lasted 3 months or less. The answer is that high quality, placebo controlled studies longer than that simply don’t exist. Long term safety and efficacy studies are not required for a drug to get FDA approval -- which is why many anti-opioid activists and the CDC claim there is “no evidence” or "insufficient evidence" that opioids work long-term. It's also a misleading statement, because non-opioid pain medications and alternative treatments are not studied for long periods either.   

“The reason for the 3 months isn't because there aren't good studies that go beyond 3 months but that 3 months is the period of time the FDA requires for efficacy studies.  It is the regulatory standard for assessing long-term efficacy of placebo-controlled studies in chronic pain conditions,” explains pain management expert Lynn Webster, MD, who is vice president of Scientific Affairs at PRA Health Sciences. 

Webster says there are technical and ethical reasons researchers do not conduct longer studies of analgesics.

“It is very difficult to conduct longer studies that are placebo controlled because of the number of dropouts in the placebo arm and the ethical concerns of denying patients access to treatment," he told PNN. "It is true there aren't placebo-controlled studies longer than 3 months but there are extended open label studies that are 12 months.  As the article states, these extension studies show the efficacy (of opioids) is maintained.”  

Katz and his colleagues have worked as consultants to Endo, Pfizer, Purdue Pharma and other opioid makers, which they disclose in their article. Funding for the study was provided by Analgesic Solutions and several pharmaceutical companies.

Broader Public Health Campaign Needed for Drug Crisis

By Pat Anson, Editor

Overdose deaths in the United States involving illicit fentanyl and other synthetic opioids have surpassed those linked to prescription opioids, according to new research published in JAMA.  Researchers say drugs used to treat depression and anxiety are also involved in more overdoses than opioid pain medication.

The study by researchers at the Substance Abuse and Mental Health Services Administration (SAMHSA) mirrors a similar report released by the CDC in March. The findings further demonstrate how federal and state efforts to combat the overdose crisis are wrongly focused on prescription pain medication as the primary cause of the overdose crisis.

“These findings underscore the rapidly increasing involvement of synthetic opioids in the drug overdose epidemic and in recent increases in overdose deaths involving illicit and psychotherapeutic drugs," wrote lead author Christopher Jones, PharmD, SAMHSA.

“Lack of awareness about synthetic opioid potency, variability, availability, and increasing adulteration of the illicit drug supply poses substantial risks to individual and public health. Widespread public health messaging is needed.”

Over 19,400 overdoses were linked to synthetic opioids in 2016, while 17,087 deaths involved opioid pain medication.

Synthetic opioids such as fentanyl are far more potent than other opioids such as oxycodone. Fentanyl is prescribed legally for severe pain, but illicit fentanyl has become a scourge on the black market, where it is often mixed with heroin and cocaine or used in the manufacture of counterfeit medication. It is assumed that illicit fentanyl and its chemical cousins account for the vast majority of deaths caused by synthetic opioids.  

Another key finding of the SAMHSA study is that psychotherapeutic drugs used to treat depression, anxiety and other mental disorders are now involved in more overdoses than any other class of medication. They include antidepressants, benzodiazepines, anti-psychotics, barbiturates and attention deficit hyperactive disorder (ADHD) drugs such as Adderall.

DRUGS INVOLVED IN 2016 OVERDOSES

Over 25,000 overdoses in 2016 involved psychotherapeutic drugs.

That compares to nearly 13,900 deaths linked to the medications in 2010, an increase of 45 percent.

"I think what you're seeing in the data in the last couple of years is that the illicit drug supply has become substantially more dangerous than it has been, and there's this level of unpredictability and lack of awareness of what are exactly the substances that people are using that are contributing to the overdose risk," Jones told Medscape.

That lack of awareness is due in part to poorly designed public health messaging. For example, last year the CDC launched a public relations campaign in 14 states that focused exclusively on warning of the risks associated with prescription opioids. Fentanyl, heroin and other drugs commonly involved in overdoses are not addressed in the Rx Awareness campaign because the CDC didn't want to risk “diluting” its primary message.

“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,” the CDC said.  

SAMHSA researchers say nearly 80 percent of the synthetic opioid overdoses in 2016 involved multiple drugs, indicating that many of the decedents are abusing a wide variety of substances. The most commonly involved drugs were another opioid (48%), heroin (48%), cocaine (22%), prescription opioids (21%), benzodiazepines (17%), alcohol (11%), psychostimulants (5%) and antidepressants (5%).

About 20 percent of the death certificates did not specify the type of drug involved, so the number of reported overdoses are likely underestimated.

Death of Pain Patient Blamed on DEA Raid

By Pat Anson, Editor

The Montana pain community is in mourning over the tragic death of Jennifer Adams, a 41-year old Helena woman who suffered from intractable chronic pain. The Lewis and Clark County coroner has not yet released a cause of death, but friends say Adams died from a self-inflicted gunshot wound April 25.

Adams, a former police officer and mother of an 11-year old boy, lived with severe back pain from Reflex Sympathetic Dystrophy (RSD) and arachnoiditis, two painful and incurable diseases in her spine.

Friends say in her final months Adams suffered from extreme anxiety – fearing that her relatively high dose of opioid pain medication would be reduced or stopped by doctors.

“Jennifer had horrible anxiety that was eating her alive,” says Kate Lamport, a close friend who also has arachnoiditis. “She hadn’t lost her meds. But the fear of it drove her crazy. Every day she was so afraid.

“She was beautiful, inside and out. Her little boy was her everything. And I know she felt like the walls were just closing around her.”

Adams was a patient of Dr. Forest Tennant, a prominent California pain physician, whose home and office were raided last November by agents with the Drug Enforcement Administration. A DEA search warrant alleged that Tennant must be running a drug trafficking organization because many of his patients came from out-of-state and were on high doses of opioid medication.

JENNIFER ADAMS

Tennant, who has not been charged with a crime and denies any wrongdoing, recently announced plans to retire and close his clinic, in part because of the DEA investigation. Tennant is a revered figure in the pain community because of his willingness to see patients like Adams who have intractable pain from rare diseases like arachnoiditis.

“She’s a patient I saw in consultation. She was on a very good (pain) regimen, had a very good nurse practitioner and had good support,” said Tennant. “It’s a tragic situation. She was a lovely person. She was ill, no question about it.”

Several of Adams’ friends and fellow patients told PNN that the DEA raid frightened her. Like many others in the pain community, Adams feared losing access to opioid medication because many doctors have cut back on prescribing or stopped treating pain altogether.  

KATE LAMPORT AND JENNIFER ADAMS

“There’s more (suicides) coming. I don’t know how many people I’ve talked to that have a backup plan. We are the unintended consequences of the DEA’s actions,” said Lamport.

“Every day you get online and there’s another chronic pain patient that took their life. There’s another 20 that lost their medication. And she knew she couldn’t be a mom or work without it. And she didn’t want to be a burden. She was very prideful.”

“Before the raid she was very positive, keep fighting, that type of attitude. And the last couple of months she hasn't really been talking to anyone really consistently like she was,” said Heather Ramsdell. “I would characterize her mood as somber and scared with what's going on in this world and with her pain progressing, worrying about care.”

“She did not deserve to die. It’s just ridiculous. An entirely preventable loss of life. I think she was just totally freaked out over what was happening,” said Gary Snook. “We’re not drug addicts. We’re just sick people.”

“I think that Jennifer is collateral damage in that heinous DEA raid on Dr. Tennant,” says Dr. Mark Ibsen, a Helena physician who used to treat Adams. “We have a way to prevent these suicides and we’re completely ignoring it. Treating the patients in pain would prevent these suicides.”

Tennant does not believe Adams’ death is connected to the DEA raid.

“People who want to make that claim, that’s just simply false,” Tennant told PNN. “I think she was upset by the raid, like a lot of people, but I don’t believe you can make any assumption that there’s any connection.

“People have a lot of complaints about the government, but I think in this case and I want to make it abundantly clear, there is no connection to her pain care, her practitioners, or the DEA. This appears to be an independent, random event in a state that’s got a very, very high suicide rate.”

Adams’ last appointment with Tennant was in January. He said she was responding well to treatment and did not have a return appointment.

‘Disgusted’ by DEA Search Warrant

PNN has obtained a copy of an email that Adams sent to one of Tennant’s lawyers. Adams wrote that she was “truly disgusted” by the DEA raid and the allegations made against Tennant. Her patient records were among those seized by DEA agents. The search warrant claimed patients must be selling their opioid medication and funneling the profits back to Tennant. 

“My intention was and is to let you know a bit about myself and let you know that I am truly disgusted after reading the search warrant. I am NOT a drug dealer! I am not part of a drug cartel. I do not provide kickbacks to Dr. Tennant and I do not share my prescriptions. This whole situation has turned my life upside down once again,” Adams wrote. 

“It needs to stop. Legally speaking, someone has got to put an end to this obscene attack on patients with intractable pain, in particular; Adhesive Arachnoiditis.”

Adams said she developed adhesive arachnoiditis – a chronic inflammation of spinal nerves that causes them to stick together – after a failed back surgery and dozens of failed epidural injections. She also suffered a stroke during the birth of her son because of a botched epidural.

Before her career in law enforcement was cut short by chronic pain, Adams was a police officer in Helena and the first female deputy in Rosebud County, Montana.  She graduated third in her class at the Montana Law Enforcement Academy.

She was proud of her career and felt the DEA raid unfairly stigmatized her and other Tennant patients. 

“I also have had all my accomplishments stained!” she wrote. “I have had to fight day after day to survive the devastation of this ever-changing disease! Please do not dismiss me.”

Donations to a college trust fund for Jennifer's son, Joshua "Tuff" Adams, can be made to First Interstate Bank, 3401 N. Montana Avenue, Helena, MT 59602. You can also call the bank at (406) 457-7171.

Is Addiction or Untreated Pain Causing Patient Suicides?

By Pat Anson, Editor

A new op/ed in The New England Journal of Medicine focuses on an aspect of the overdose crisis that’s rarely discussed – how opioids are a “silent contributor” to the nation’s rising suicide rate. But critics say the article misses the mark on why a growing number of pain patients are having suicidal thoughts and taking their own lives.

Most people already know that drug overdoses are soaring in the United States, but few recognize that suicides are at their highest level in nearly 30 years. In 2016, more Americans died from suicides (44,965) than from opioid overdoses (42,249).

“The significant increases in both opioid-overdose deaths and suicide rates in our country have contributed to reduced life expectancy for Americans. These two epidemics are intermingled, and solutions to address the opioid crisis require that we tailor interventions to preventing opioid-overdose deaths due to suicidal intent,” wrote co-authors Maria Oquendo, MD, and Nora Volkow, MD.

Volkow is the longtime director of the National Institute on Drug Abuse, while Oquendo is a Professor of Psychiatry at the Perelman School of Medicine at the University of Pennsylvania and past president of the American Psychiatric Association.

Volkow and Oquendo believe many suicides are misreported as “undetermined” or accidental drug overdoses, and that “the true proportion of suicides among opioid-overdose deaths is somewhere between 20% and 30%, but it could be even higher.”

They also engage in a familiar pattern of demonizing opioid pain medication, citing studies showing that patients with “opioid use disorder” (OUD) from prescription opioids are more likely to have suicidal thoughts and “whose motivation to live might be eroded by addiction.” 

“Notably, two populations that are more likely than others to receive opioid prescriptions — patients with chronic pain and those with mood disorders — are also at greater risk for suicide,” they wrote.

That may all be true. The suicide rate among chronic pain patients is probably increasing. But what’s puzzling is that Volkow and Oquendo never acknowledge the role that the federal government has played in contributing to that trend. Anecdotal evidence is building that suicides started climbing after the CDC released its 2016 opioid prescribing guidelines and pain medication became harder to get. 

"Over the last year, I have received wave after wave of reports of traumatized patients, with outcomes that include suicidal ideation, medical deterioration, rupture of the primary care relationship, overdose to licit or illicit substances, and often enough, suicide,” Stefan Kertesz, MD, a professor of medicine at the University of Alabama at Birmingham School of Medicine, recently told PNN.

Those suicides -- such as those of Bryan Spece and Jay Lawrence -- are rarely reported by the mainstream media or even acknowledged by government bureaucrats like Volkow, who was an early supporter of the CDC guidelines.

In a survey of over 3,100 pain patients on the one-year anniversary of the guidelines, over 40 percent told PNN they had considered suicide because their pain was poorly treated. Many patients feel the healthcare system has turned its back on them.

“Even though I can barely function my doctor wants to stop my meds completely. With no hope, suicide seems like the best and only choice to get relief from the pain. I never thought doctors would be so uncaring, along with the government,” wrote one patient.

“I never thought I would even consider suicide, but death looks good when every move you make is painful, 24 hours a day, 7 days a week. The guidelines are not fair to me, my husband, and my children. No one can judge anyone else's pain level,” said another patient.

“I frequently contemplate suicide. I lay in bed on many nights crying because there is no comfortable positions and the spasms are relentless,” said a disabled nurse in Maine who is no longer able to obtain opioids.

“In the past year, six chronic patients I know who were no longer able to get their pain medication have committed suicide. I personally have researched the quickest and surest way of ending my own life. And no, it doesn’t include opioids,” wrote another patient.

“I nearly committee suicide last summer and again last November because of undertreated pain,” said one woman. “It is ridiculous beyond belief when my neighbor’s dog gets prescribed pain meds for a torn claw and I get treated like a criminal for having a chronic pain condition.”

Undertreated Pain

Patient advocates say these suicidal thoughts are often not the result of addiction or OUD, but because chronic pain is increasingly untreated or undertreated.

“The diagnosis of OUD is overwhelmingly made by physicians who are untrained in making the diagnosis,” says Stephen Nadeau, MD, a Professor of Neurology and Clinical Health Psychology at the University of Florida College of Medicine. “Most patients in chronic pain are under-dosed and/or suffer from inadequately treated depression. We don’t know the exact figures on prevalence of under-dosing but we do have studies that suggest that depression is detected only 20% of the time.”

“There is emerging data to suggest that increasing numbers of opioid overdose-related deaths may be a consequence of undertreatment of both pain and depression.  But the dominant public narrative is demanding even less treatment of pain when opioids are the chosen therapy,” says Red Lawhern, PhD, co-founder of the Alliance for the Treatment of Intractable Pain, a patient advocacy group.    

Lawhern believes many suicides can be attributed to the “epidemic of despair” first documented by Princeton researchers Anne Case and Angus Deaton.  They believe that the reduced life expectancy of Americans is not just due to substance abuse, but linked to unemployment, poor finances, lack of education, divorce, depression and loss of social connections – issues that Volkow and Oquendo fail to address.

“Their article is seriously deficient for failure to mention that both substance abuse and suicide generally are closely associated with depression and isolation -- both of which are consequences of economic hard times.  It is simply wrong to imply that opioid use disorder (itself an incorrect term) is the ‘cause’ of suicide, when both are driven jointly by socio-economic factors,” Lawhern wrote in an email.

What can be done to prevent suicides in the pain community? Volkow and Oquendo say more doctors should be trained to recognize the warning signs of suicide and patients should be screened for suicide risk and then referred for addiction treatment. Nowhere do they suggest better pain management.   

Counterfeit Pill Problem ‘Getting Worse by the Day’

By Pat Anson, Editor

Counterfeit painkillers and fake medications made with illicit fentanyl have killed Americans in at least 22 states, according to a new report by the Partnership for Safe Medicines (PSM) a coalition of pharmacy and healthcare organizations. Counterfeit pills laced with fentanyl have now been found from coast to coast in 43 states.

“This updated report shows that the illegally-imported fentanyl problem is getting worse by the day,” said Dr. Marvin Shepherd, chairman of the PSM Board.

Fentanyl is 100 times more potent than morphine. It is prescribed legally for severe pain, but illicit fentanyl has become a scourge on the black market, where it is typically mixed with heroin or cocaine. Rogue manufacturers also press it into counterfeit prescription pills such as Vicodin, Percocet and Xanax.

Unsuspecting buyers – including pain sufferers looking for relief -- often have no idea what they’re getting.

According to a recent CDC report, drug deaths involving fentanyl (19,413) surpassed overdoses linked to prescription opioids (17,087) in 2016.

COUNTERFEIT PERCOCET

“The annual count of overdose deaths from prescription opioids has remained constant since 2011, but deaths from fentanyl poisoning have spiked since then. As fentanyl-laced pills mimicking legitimate medication have flooded the illicit drugs supply, prescription drug users have been poisoned by the counterfeits,” the PSM report found. 

“The tally of deaths because of counterfeit pills made with fentanyl is probably undercounted because lab protocols lagged behind this shift and weren’t testing for fentanyl.”

The pills are difficult to trace, as Minnesota prosecutors admitted last week when they announced that no criminal charges would be filed in the accidental overdose death of Prince. The music icon died two years ago after taking counterfeit painkillers that were “an exact imitation” of Vicodin.

“Prince thought he was taking Vicodin and not fentanyl,” said Carver County Attorney Mark Metz, adding that dozens of counterfeit pills were found in Prince’s home, many of them stored in aspirin bottles.

Investigators were unable to determine how or where Prince obtained the fake pills, but they are readily available online for anyone who cares to look. According to one report, there are as many as 35,000 online pharmacies operating worldwide. Many do not require a prescription and are selling counterfeit medications. Their customers include some pain patients who are no longer able to obtain opioids legally from doctors and are looking for other sources.

‘Criminals Are Pretty Smart’

“They’re looking, maybe innocuously, for medicine online. They’re searching for ‘fentanyl online’ or ‘Percocet buy.’  Not because they want to buy medicine on the Internet, but rather they just want to find medicine,” says Libby Baney, Executive Director of the Alliance for Safe Online Pharmacies, an industry supported non-profit.

“The criminals are pretty smart. They know that there’s a market out there and they know they can offer these medicines to patients for good reasons, bad reasons or otherwise that are looking for those medicines. And they are going to get duped because they are very likely buying from a website that is selling it illegally.”

The National Association of Boards of Pharmacy recently evaluated 100 websites selling medications and found that almost all were operating illegally and selling drugs without a prescription. Over half (54%) were selling controlled substances and 40% were offering drugs that are frequently counterfeited with fentanyl.

The marketing and selling of counterfeit medicine goes beyond just online pharmacies. Drug dealers are increasingly using Facebook, Twitter and message boards to reach customers. PNN recently received this sales pitch from one dealer:

"We have pharmaceutical drugs for your health illness especially for Chronic Pain, Anxiety, Depression, Panic Disorder. ADHD, Xanax Bars, Narcolepsy pills, Antidepressants, Antipsychotics, Benzodiazepines, Narcotics, Opiates, weight loss/fat burner. We do overnight secure shipping."

Warning unsuspecting buyers about the easy availability of these drugs poses a dilemma for law enforcement and policy makers.

“We have ethical tension around all of this. On the one hand, we certainly don’t want to be educating people that you can buy controlled substances or prescription drugs on the Internet without a prescription, counterfeit or otherwise. That’s just dangerous. But we also don’t want to be in a position of not warning them or not making a policy response to the fact that this currently exists,” Baney told PNN.

It is relatively easy to tell the difference between a legitimate online pharmacy and an illegal one. The URL’s for websites that end with “.Pharmacy” (not .com or .net) are certified by the National Association of Boards of Pharmacy and are in compliance with laws and practice standards. You can also visit buysaferx.pharmacy to verify whether a website is legitimate.

Do 80% of Heroin Users Really Start With a Prescription?

By Roger Chriss, Columnist

U.S. Attorney General Jeff Sessions recently announced a new plan by the DEA to further tighten production quotas for opioid pain medication as a step in the fight against opioid abuse and addiction.

The proposal appears in the Federal Register with the following explanation:

“Users may be initiated into a life of substance abuse and dependency after first obtaining these drugs from their health care providers…. Once ensnared, dependency on potent and dangerous street drugs may ensue. About 80% of heroin users first misused prescription opioids. Thus, it may be inferred that current users of heroin and fentanyl largely entered the gateway as part of the populations who previously misused prescription opioids."

This is not a new claim by the DEA. In its 360 Strategy: Diversion Control, the DEA plainly states, “The connection between prescription opioid abuse and heroin use is clear, with 80% of new heroin abusers starting their opioid addiction by misusing prescription medications.”

Where does the 80% figure come from?

The DEA cites the National Institute on Drug Abuse (NIDA) as its source, while NIDA in turn references a 2013 study by the Substance Abuse and Mental Health Administration (SAMHSA).

SAMHSA pooled a decade's worth of data from the National Survey on Drug Use and Health and found that “four out of five recent heroin initiates (79.5 percent) previously used NMPR (nonmedical use of pain relievers)."

But the SAMHSA study did not examine how many of those heroin users had a valid prescription for opioids, so the DEA claim about users "first obtaining these drugs from their health care providers" is untrue. SAMHSA also notes that "the literature on transition from NMPR to heroin use is relatively sparse" and that the "vast majority" of people who abuse opioid medication never actually progress to heroin.

The abuse of opioid medication by heroin users also varies considerably by time, region and demographics -- so must users don't fit neatly into the 80% claim. A review article in The New England Journal of Medicine reports that prior nonmedical use of opioid medication was found in 50% of young adult heroin users in Ohio, in 86% of heroin users in New York and Los Angeles, and in 40%, 39%, and 70% of heroin users in San Diego, Seattle, and New York respectively.

Conversely, studies on the medical use of opioid analgesics show very low rates of opioid addiction. A review in the journal Addiction concluded that “The available evidence suggests that opioid analgesics for chronic pain conditions are not associated with a major risk for developing dependence.”

A 2016 article in The New England Journal of Medicine by Dr. Nora Volkow, Director of NIDA, also explains that “addiction occurs in only a small percentage of persons who are exposed to opioids—even among those with preexisting vulnerabilities.”

‘Opiophobia’ Returns

But despite this well-established information, the 80% statistic is being used to set policy and justify a supply-side approach to the opioid addiction crisis. States are citing the number as they pass new legislation to restrict opioid prescribing, health insurers are using it as they enact new policies to limit medical opioid use, and doctors are telling patients it’s one of the reasons they won’t prescribe opioids.

According to one addiction treatment specialist, the goal of the DEA quota reductions should be to take opioid prescribing back to levels where they stood two decades ago.

“We‘re back down to 2006 levels, but the goal should be to get us back down to 1995 levels. So this means many Americans are still going to be addicted until prescribing becomes more cautious,” Andrew Kolodny, MD, founder of Physicians for Responsible Opioid Prescribing (PROP), told STAT.  

But this assumes that pre-1995 opioid prescribing levels were adequate. According to Jeffrey Singer, MD, a Senior Fellow at the CATO Institute, that would be a mistake.

“It must be remembered that numerous studies throughout the 1970s, 1980s, and 1990s documented that patients were being undertreated for pain because of an irrational fear of opioids,” Singer wrote. “Policymakers need to disabuse themselves of the notion that the prescription of opioids to patients by doctors is at the heart of the problem. That notion has made too many patients suffer needlessly as the old ‘opiophobia’ of the 1970s and 1980s has returned.”

Moreover, it assumes that opioids have no clinical benefit. But they are medically very useful, not only in the acute and surgical setting, but also for a variety of chronic pain conditions, such as neuropathy and restless leg syndrome.

The 80% statistic is misleading and encourages faulty assumptions about the overdose crisis and medical care. It is shifting resources away from the public health interventions that would most likely help in the crisis and removes a valid medical treatment for people with a wide range of ailments.

To read and comment on the DEA’s quota proposal, click here. All comments must be received by May 4, 2018.

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.