Opioid Guidelines Leave Some Surgery Patients in Pain

By Pat Anson, PNN Editor

In recent years, many U.S. hospitals have adopted policies that reduce or eliminate the use of opioids during and after surgery.

Patients at Houston Methodist Hospital, for example, are getting acetaminophen (Tylenol) for post-operative pain after hernia repairs and other minimally invasive surgeries. And dozens of hospitals in Michigan have adopted guidelines for post-operative pain that have significantly reduced the use of opioids.

But a new study presented at the annual meeting of the American College of Surgeons suggests that policies that discourage the use of opioids for post-operative pain may be neglecting patients that need opioids for better pain control.

“The key findings of our study are that we were able to successfully reduce how many opioids we were prescribing for patients after operations using evidence-based guidelines,” said lead author Cornelius Thiels, DO, a surgical oncology fellow at Memorial Sloan Kettering Cancer Center and a researcher at the Mayo Clinic.

“However, the other finding of our research is that there’s still additional room to improve in terms of making sure all patients after surgery have their pain well controlled.”

The researchers evaluated 138 patients who had one of 12 elective surgeries after the Mayo Clinic adopted guidelines in 2018 that call for “multimodal pain control,” a combination of opioids with non-opioid pain relievers such as ibuprofen, naproxen and acetaminophen. Those patients were compared with 603 patients who had the same procedures before the guidelines, when opioids were used more widely.

While most patients in the post-guideline group were satisfied with their pain control after discharge, a significant number were not.

In telephone surveys conducted about four weeks after discharge, the percentage of patients in the post-guideline group who were dissatisfied with their pain control was more than double that of the pre-guideline group (9.4% vs. 4.2%). The percentage who said they were not prescribed enough pain medication was also higher (12.5% vs. 4.9%).

“There is a small subset of patients who we’re not optimally managing yet, and this study confirmed that this is a small number,” Thiels said. “However, I think that’s a critically important subset of patients.”

Thiel says about half of patients need opioid medication after major surgeries, and doctors need to do a better job identifying who they are.

“Our goal is to give them the exact right amount so that we limit the number of un-used opioids in our community while also making sure we don’t reduce it down too far and then leave them in pain,” he said. “The right answer may be more non-opioid based pain medications, better patient education and setting of expectations, or in some cases patients may actually require slightly more opioid medications, and that is OK.”  

Opioid addiction is actually rare after surgery.  A large 2016 Canadian study found only 0.4% of older adults were still taking opioids a year after major elective surgery.  Another large study in the British Medical Journal found only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or had a non-fatal overdose.

Pre-Existing Conditions Deserve Affordable Treatment

By Dr. Lynn Webster, PNN Columnist

The National Institutes of Health reports that about 10 percent of Americans experience a substance use disorder (SUD) at some point in their lives. Most of those who suffer from an SUD receive no treatment.

About twice as many Americans – 20 percent -- have chronic pain. Many of them also cannot find adequate treatment or even a provider willing to treat them. 

Making treatment accessible for both of these conditions -- which are defined as pre-existing for insurance purposes -- is always a topic of concern. These days, it is of paramount concern that access to treatment is available. And it requires us to take action.

We’re All at Risk for Pain and Drug Abuse

Poverty and hopelessness are risk factors for drug abuse, even though not everyone who is economically challenged develops an SUD. Unfortunately, prevention and treatment programs for SUDs are less available to those who cannot pay for them and who most need them.

Anyone can suffer from chronic pain, but even those with resources may not have access to adequate pain management.

My concern is more than theoretical. It is personal. I have friends, former patients and family members who suffer from SUDs. If the Affordable Care Act (ACA) — widely known as Obamacare — ends and we lose coverage of pre-existing conditions, I fear they will be abandoned in exactly the same way as people in pain have been abandoned ever since the CDC issued its 2016 opioid prescribing guideline.

In recent years, I have received hundreds of emails and calls from people in pain. Their medications have been tapered and they don't know where to turn for help. Untreated chronic pain, as well as untreated SUDs, can result in ruinous consequences: disability, destitution, isolation, poverty and suicide.

We need to help healthcare providers find more effective ways to treat their patients. The Centers of Excellence in Pain Education (CoEPEs) program was created to teach healthcare professionals about pain and its treatment. Since this is something most doctors do not study adequately during medical school, it's important to have continuing medical education opportunities to learn about the stigma associated with pain treatment and substance abuse disorders.

Abolishing ACA Could Have Devastating Consequences

The current administration has appealed to the Supreme Court to abolish the ACA. President Trump has said that Obamacare "must fall." Given the fact that we're in the middle of a pandemic and millions of people are unemployed and may have lost access to employer-sponsored healthcare, the timing seems terrible.  

But even without a pandemic, reversing the ACA would be devastating for millions of Americans who have an SUD or chronic pain. President Trump signed an executive order on September 24 that claims to protect people with pre-existing conditions. However, experts dispute whether his executive order can actually do what it promises.

Regardless, eliminating the ACA will likely allow insurance companies to charge higher rates for people with pre-existing conditions. This would essentially render treatment for chronic pain and SUD unaffordable for many people, leading to an increase of the terrible consequences mentioned above. And, of course, SUDs and chronic pain are only two of the pre-existing conditions that would no longer be protected. 

It is time for everyone to understand the consequences that losing the ACA may have for their community, family, friends and themselves. There is still time to be heard, but you have to act quickly. Click here to find your federal, state, and local elected officials and express your views.  

Let us also send healing thoughts and prayers to President Trump, the First Lady and everyone else infected with COVID-19.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find Lynn on Twitter: @LynnRWebsterMD. 

FDA Requires Stronger Warning Labels for Benzodiazepines

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is ordering drug manufacturers to update warning labels for benzodiazepines to strongly caution patients and providers about the risk of abuse, addiction, dependence and withdrawal. The agency said current warning labels are inadequate about the risks associated with anti-anxiety medications such as Xanax and Valium, even when they are taken as prescribed.

Benzodiazepines are generally used to treat anxiety, insomnia, seizures and social phobia, and they were once commonly prescribed to chronic pain patients to reduce anxiety and help them sleep. In recent years, many pain patients were taken off the drugs because they are considered risky when taken with opioid medication.

“While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol and illicit drugs,” said FDA Commissioner Stephen Hahn, MD. “We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction and dependence.”

In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed by U.S. pharmacies, with alprazolam (Xanax) being the most common, followed by clonazepam (Klonopin) and lorazepam (Ativan).

The FDA said it reviewed post-marketing databases and its Adverse Events Reporting System, and found that benzodiazepines were often prescribed for long periods. In 2018, about half of patients prescribed the drugs received them for two months or more, even though most benzodiazepines are only recommended for short-term use. Physical dependence can occur after taking benzodiazepines for several days or weeks, according to the FDA.

“They are also widely abused and misused, often together with alcohol, prescription opioids, and illicit drugs, which worsen the risks of serious problems. We also found that some patients have had serious withdrawal reactions after benzodiazepines were stopped suddenly or the dose was reduced too quickly. Some patients experienced withdrawal symptoms lasting many months,” the agency said.

The FDA previously warned about the risks of combining benzodiazepines with opioids in 2016. Opioids and benzodiazepines are both central nervous system depressants that can cause sleepiness, respiratory depression, coma and death. In 2016, the number of emergency department visits due to non-medical use of benzodiazepines was higher than the number of ER visits for non-medical use of prescription opioids.

Fatal overdoses involving benzodiazepines increased from 1,298 deaths in 2010 to 11,537 deaths in 2017. The vast majority of those overdoses also involved other substances.

My Pain Doctor Abandoned Me, But I'm Not Going Away Quietly

By CindyLee Calaluca, Guest Columnist

Recently I was terminated by my pain management physician without notice and with no plan for continued care. Why? I complained to the physician that I did not appreciate getting no call back when I repeatedly contacted his practice — over an 8-day period — to report that my chronic pain now had a severe acute component to it.

The acute problem is caused by a severe deep vein thrombosis, extending from the groin to the toes in my left leg – the result of a surgical wound from a toe amputation tearing open from severe swelling. Additionally, an old pressure ulcer had abscessed. The acute pain I am experiencing is because of an overlap with my poorly controlled chronic pain, thanks to the CDC guideline for prescribing opioid medication.

All I can do now, because of the pain, is lay in bed and force myself to sleep to cope with the pain. I am totally incapacitated and unable to do daily activities independently. I am 70 years old, a widow, and my only living relative is a 69-year-old brother who lives 2,000 miles from me.

The physician responded to me inappropriately. He told me he gets 3,000 phone calls a day and saw no reason to respond me, because there was nothing he was going to do about my pain. Furthermore, he had an arrogant demeanor and feels he isn't required to call me. I get an appointment once a month with him and that's where his responsibility for my care ends, he said.

Naturally, that opened the door wide open to abandonment and neglect of a patient. His practice has no after-hour or weekend coverage beyond an answering service.

Before he walked out on me, he insulted my career experience, called me uneducated, and said I didn't know what I was talking about regarding health care or laws.

It is a shame that in his superiority complex, he forgot, if he ever knew, my career or educational background. You see, I am an adult and geriatric nurse practitioner who holds a doctorate in nursing practice with 55 years of clinical experience, along with 20 years of simultaneous healthcare administration. That physician is about to find out how "uneducated, stupid and wrong" I actually am.

That's the story behind my being abandoned and put in my place for complaining. I tried to be nice and have an adult conversation with this man. What a shame his child showed up!

I completely understand the problems created when patients arbitrarily lose their providers without adequate and proper notice. I live in a community of less than 500 people. The nearest pain management practice that uses oral medication is 45 miles away. The next one is two and a half hours away. Then there's University of Alabama Medical Center, which is six hours away. Right, I'll just pop into the pain center tomorrow. Like that's happening.

I have had it with all the buck passing by politicians, law enforcement agents, and the CDC making doctors too afraid to practice pain management correctly. Putting a sign in the lobby stating that under no circumstance does the practice treat pain is not correct medical intervention. In fact, since pain is a symptom of illness and that the body is imperiled, it is turning a blind eye to abandonment.

I am no longer going to be a good patient and not respect myself. I refuse to play the game anymore. Since I am dying, I am not going quietly into the night. I am going to advocate and do so loudly, visibly and boldly. I will advocate for patients one last time.

CindyLee Calaluca lives in Alabama. Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

After Brief Decline, ‘Exponential Trajectory’ of U.S. Overdose Crisis Resumes

By Pat Anson, PNN Editor

A brief decline in fatal overdoses in 2018 was just a blip in the trajectory of a 40-year pattern of rising drug deaths in the United States, according to a new study published in the journal Addiction.

Researchers at the University of Pittsburgh Graduate School of Public Health analyzed over a million overdose deaths in the U.S. between 1979 and 2019 – and developed a startling chart that shows an exponential curve in overdoses that continues to rise virtually unchecked. The number of deaths has doubled every 10.7 years.   

"The U.S. has not bent the curve on the drug overdose epidemic," said lead author Hawre Jalal, MD, an assistant professor of health policy and management at Pitt Public Health. "We are concerned that policymakers may have interpreted the one-year downturn in 2018 as evidence for an especially effective national response or the start of a long-term trend. Unfortunately, that isn't supported by the data."

PITT PUBLIC HEALTH

Overdose deaths fell about 4% in 2018, which public health officials attributed to a decline in deaths involving prescription opioids and heroin. However, overdoses began rising again in 2019 and preliminary data for 2020 suggests the upward trajectory has resumed.    

Jalal and co-author Donald Burke, MD, say the 2018 decline in overdoses was largely caused by a reduced supply of carfentanil, an illicit drug and potent analogue of fentanyl that is 10,000 times more powerful than morphine.

China added carfentanil to its list of controlled substances in 2017 and began shutting down illicit drug factories that produced it. The U.S. supply of carfentanil soon began to dry up and law enforcement seizures of the drug fell dramatically in five states -- Ohio, Florida, Pennsylvania, Kentucky and Michigan. It was the “sudden rise and then fall of carfentanil availability” that led to the drop in overdoses, researchers found.

"We all celebrated when the overdose death rate dropped, but it was premature," said Burke, former dean of Pitt Public Health and a professor in the Department of Epidemiology. "When policymakers believe a problem is solved, history has shown that funding is reprioritized to other efforts. The drug overdose epidemic is not solved. It continues to track along an ever-rising curve, with deaths doubling nearly every decade. We must address the root causes of this epidemic."

Jalal calls the U.S. overdose crisis an “entangled epidemic” that’s been fueled by multiple drugs, including prescription opioids, but is now largely caused by illicit fentanyl.

“There is a force that keeps overdose deaths on an exponential trajectory. This is in spite of policies that have been trying to bend the curve,” Jalal told PNN. “The main problem is that we don’t know why it keeps tracking an exponential trajectory. I think we should do everything we can to bend the curve, but the policies that we’ve used so far have been more targeted toward drugs that can be modified easily. We can target prescription opioids and we can increase the use of naloxone and methadone, but I think we also have to invest in understanding what’s driving people to use drugs. That’s a major problem that we still don’t have an answer for.”

Jalal says lack of economic opportunity and social isolation — so-called “deaths of despair” — may be partly responsible for the overdose crisis, but more research is needed into the underlying causes. As for possible solutions, he’s as stumped as anyone.

“I wish I knew. I truly wish,” Jalal said. “I think we have to pay attention to what’s driving this whole epidemic. Without understanding it, we are basically targeting our policies toward whatever we think might work or think we have control over. We’re not targeting why people use drugs or what’s causing people to die from drugs.”

A recent study by the CDC found that nearly 85% of overdose deaths in the first six months of 2019 involved illicit fentanyl, often taken in combination with other drugs. About 20% of overdoses were linked to prescription opioids.

The CDC study did not determine whether the opioid medication was obtained legally, or if it was diverted, stolen or bought on the street. Previous research in Massachusetts and British Columbia found that only about 2% of fatal overdoses involved a legitimate prescription for opioids.

Over 75% of MS Patients Face Financial Hardship

By Pat Anson, PNN Editor

Over 75% of American adults with multiple sclerosis face financial toxicity or hardship that has forced them to cut spending on food, clothing and housing. Many have gone into debt or filed for bankruptcy, and over a third have delayed or stopped filling prescriptions because they can’t afford them.

The findings come from a survey of 243 multiple sclerosis (MS) patients conducted by the Harvey L. Neiman Health Policy Institute. The study is the first of its kind to evaluate how financial hardship is forcing MS patients to forego treatment and make drastic changes in their lifestyles and spending.

In recent years, the cost of prescriptions for many disease-modifying MS drugs has nearly tripled to about $76,000 a year. While insurance pays for most of it, many patients are overwhelmed by deductibles and other out-of-pocket expenses. The lifetime cost of treating MS in the United States is estimated at over $4 million per patient.

“Over the last 20 years, higher out-of-pocket costs for advanced imaging tests and increased cost sharing have caused the financial burdens on MS patients to escalate. Among medically bankrupt families, MS is associated with the highest total out of-pocket expenditures exceeding those of cancer patients,” said lead author Gelareh Sadigh, MD, an assistant radiology professor at Emory University School of Medicine.

“Our study results demonstrate the high prevalence of financial toxicity for MS patients and the resulting decisions patients make that impact their health care and lifestyle.”

More Debt, Less Spending

The findings, published in the Multiple Sclerosis Journal, show that over half of MS patients (56%) reported decreases in their income due to disability, unemployment or retirement. To make ends meet, many cut spending on food and clothing (35%) and leisure activities (50%) or withdrew money from their savings (40%) and retirement accounts (15%). Others went into debt by borrowing money (19%) or charging their credit cards (30%).

Over a third of MS patients decided to forego some type of medical care or treatment, such as not filling a prescription (16%), skipping doses (13.5%) or stopped taking medication (13%).

“These data underscore the need for shared decision-making and an awareness of patient financial strain when planning treatment strategies,” said co-author and Neiman Institute researcher Richard Duszak, MD, a professor and vice chair for health policy at Emory University. “In addition to the impact on adherence, financial toxicity was associated with significantly lower physical health-related quality of life, demonstrating the broad consequences of treatment costs for many MS patients.”

MS is a chronic and progressive disease that attacks the body’s central nervous system, causing pain, numbness, difficulty walking, paralysis, loss of vision and fatigue. Disease modifying therapy (DMT) reduces the frequency and severity of MS flare-ups, but many patients can’t afford the drugs.

A 2019 survey by the National Multiple Sclerosis Society found that 40% of MS patients who take a DMT drug altered or stopped taking their medication due to the high cost. According to Healthcare Bluebook, a 30-day supply of a brand name DMT like Gilenya costs about $8,845, or over $106,000 a year.

Criticism of the high cost of MS drugs is growing. Last year when the FDA approved a new MS medication called Vumerity, drug maker Biogen set its wholesale price at $88,000 a year. That brought a rebuke from the National MS Society, which released a statement that accused Biogen of price gouging.

FDA Targets Online Pharmacies for Selling Opioids

By Pat Anson, PNN Editor

The Food and Drug Administration is once again playing whack-a-mole with illegal online pharmacies, warning 17 website operators to stop selling unapproved or misbranded opioid medications to U.S. consumers, including some drugs offered for sale without a prescription.

In recent years, the FDA has sent hundreds of warning letters to online pharmacies for illegally selling opioids and other controlled substances. Many of the websites are located overseas and outside U.S. jurisdiction or they shut down and soon reappear under new domain names.

According to the Alliance for Safe Online Pharmacies, there are over 30,000 online pharmacies operating worldwide, with 20 new illegal pharmacy websites being launched every day.

“Those who illegally sell opioids online put consumers at risk and undermine the significant strides we have made to combat the opioid crisis,” said Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We remain committed to using all available tools to stop the illegal sale of opioids online to help protect consumers from these potentially dangerous products.”

The 17 warning letters were issued late last month. Most of the online pharmacies appear to have been shut down or blocked, although some are still operating.

RxEasyMeds, for example, continues to sell an opioid medication called “Nalbin” that is “used to treat moderate to severe pain associated with acute and chronic medical disorders.”

Nalbin is produced by a drug company based in Islamabad, Pakistan called Global Pharmaceuticals.

The FDA warning letter to RxEasyMeds – which is located in China -- says Nalbin is not approved for sale in the U.S. and does not have an adequate warning label.  

“Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether,” the FDA letter warns. “Accordingly, FDA requests that you immediately cease offering violative drugs for sale to U.S. consumers.  This is critical to shielding the American public from harm.”

In addition to Nalbin, RxEasyMeds advertises codeine, morphine, tramadol, oxycodone and other controlled substances, which are all apparently available without a prescription.

In June, the FDA launched a pilot program to put more teeth into efforts to stop the illegal sale of opioids online. Under the program, the FDA will notify three internet registries when a warning letter is sent to an online pharmacy. The registries could then block or suspend the website domains, which would effectively take them offline.

Study Finds Acetaminophen Makes People More Likely to Take Risks

By Pat Anson, PNN Editor

We’ve learned some weird things about acetaminophen in recent years. The pain reliever not only helps treat headaches and fevers; it also appears to dull human emotions and have other psychological effects.

A new study at The Ohio State University suggests that acetaminophen could even make you more likely to go sky diving or bungee jumping off a tall bridge.

"Acetaminophen seems to make people feel less negative emotion when they consider risky activities - they just don't feel as scared," says co-author Baldwin Way, PhD, an associate professor of psychology at OSU.

Way and his colleagues enrolled 189 college students in the study, giving them either 1,000 mg of acetaminophen (the recommended dose for a headache) or a placebo that looked the same. Participants were then asked to rate on a scale of 1 to 7 how risky they thought various activities would be.

Students who took acetaminophen were more likely to rate bungee jumping, taking a skydiving class, and walking home late at night in an unsafe part of town as less risky than those who took the placebo. They were also less likely to view speaking up about an unpopular issue at work and playing in a high-stakes poker game as risky.

In short, the study found that acetaminophen makes people more likely to take risks, which is not inconsequential when you consider that about 50 million Americans take acetaminophen every week. The pain reliever is the active ingredient in Tylenol, Excedrin and hundreds of other pain medications, as well as cough, cold and flu remedies.

The OSU study, published in the journal Social Cognitive and Affective Neuroscience, was funded by a $500,000 grant from the National Science Foundation, a federal agency. It adds to a growing body of research that found acetaminophen and other over-the-counter pain relievers have psychological effects on humans.

“With nearly 25 percent of the population in the U.S. taking acetaminophen each week, reduced risk perceptions and increased risk-taking could have important effects on society,” said Way. "We really need more research on the effects of acetaminophen and other over-the-counter drugs on the choices and risks we take.”

Burst Balloons

To test their theory, OSU researchers conducted an experiment to see if volunteers would take more risks while inflating a virtual balloon on a computer screen. Participants clicked a button on a computer to inflate the balloon, earning virtual money as a reward each time they did.

"As you're pumping the balloon, it is getting bigger and bigger on your computer screen, and you're earning more money with each pump," Way explained. "But as it gets bigger you have this decision to make: Should I keep pumping and see if I can make more money, knowing that if it bursts, I lose the money I had made with that balloon?"

People who took acetaminophen were more likely to keep on pumping and had more burst balloons.

"If you're risk-averse, you may pump a few times and then decide to cash out because you don't want the balloon to burst and lose your money," said Way. "But for those who are on acetaminophen, as the balloon gets bigger, we believe they have less anxiety and less negative emotion about how big the balloon is getting and the possibility of it bursting."

Previous research at OSU found that acetaminophen seems to dampen human emotions. Student volunteers who took acetaminophen had fewer emotional highs and lows, and felt less empathy for the physical and emotional pain of others. Other studies have linked acetaminophen to hyperactivity and behavior problems in children.

It’s not just acetaminophen. A 2018 review of studies found that ibuprofen and other over-the-counter pain relievers can also dull your emotions and cognitive senses.

A recent study of calls to U.S. poison control centers found a significant increase in suicide calls involving acetaminophen, ibuprofen and other OTC analgesics.

Excessive use of acetaminophen -- also known as paracetamol – can lead to liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

DEA Proposes Cuts in Opioid Supply for Fifth Consecutive Year

By Pat Anson, PNN Editor

For the fifth year in a row, the U.S. Drug Enforcement Administration is proposing significant cuts in the supply of hydrocodone, oxycodone and several other opioid pain medications classified as Schedule II controlled substances.

The cuts are partly based on a prediction by the Food and Drug Administration that medical need for the drugs will decline by over a third in 2021.

In a notice published Tuesday in the Federal Register, the DEA proposes to reduce production quotas for hydrocodone by 9 percent and oxycodone by 13 percent in 2021. The supply of hydromorphone would be reduced by nearly 20% and fentanyl by 29% next year.  

The DEA first proposed cuts in the supply of opioids during the Obama administration and the trend has accelerated under President Trump. If approved, the 2021 production quotas would amount to a 53% reduction in the supply of both hydrocodone and oxycodone since 2017.

DEA consulted with the FDA, CDC and the Centers for Medicare & Medicaid Services (CMS) before making its recommendations. The key analysis came from the FDA, which provides DEA with annual estimates of medical usage for controlled substances like opioids.

“FDA's predicted levels of medical need for the United States was expected to decline on average 36.52 percent for calendar year 2021. These declines were expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, codeine, and morphine,” the DEA said.

The FDA’s analysis, however, came before COVID-19 infections became widespread in the United States. That led to an increase in demand for injectable opioids used to treat seriously ill coronavirus patients on ventilators.

Faced with growing shortages of those drugs, the DEA issued an emergency order in April raising production quotas for injectable pain medications. Many of those drugs, such as injectable fentanyl and hydromorphone, are still listed on an FDA database of drug shortages.     

DEA said its production quotas for 2021 reflect an “anticipated increase in demand for opioids used to treat patients with COVID-19.”

“Despite this public health emergency, DEA remains focused on the challenges presented by opioid addiction and its effect on the health and wellbeing of the millions of Americans and their families who have become dependent upon or addicted to them. The potential for addiction and misuse exists in every community and remains a pressing health issue with significant social and economic implications,” the agency said.

As PNN has reported, prescription opioids play only a small role in the U.S. opioid epidemic. A new CDC report estimates that nearly 85% of drug overdoses in the first six months of 2019 involved illicit fentanyl, heroin and other street drugs. Prescription opioids were linked to about 20% of overdoses.

In addition to reducing the supply of opioids, the DEA is proposing a significant cut in the production quota for marijuana, which is still classified as a Schedule I controlled substance. To accommodate increased demand for marijuana research, the DEA raised the 2020 quota for marijuana to 3,200 kilograms. Those gains would be reversed in 2021, with production quotas for marijuana and marijuana extracts being reduced to 1,700 kilograms.

Public comments will be accepted on the DEA’s proposed production quotas until October 1, 2020. Comments can be made by clicking here.

Nearly 85% of U.S. Overdose Deaths Linked to Street Drugs

By Pat Anson, PNN Editor

A new report by the Centers for Disease Control and Prevention shows that the vast majority of drug overdose deaths in the United States involve illicit fentanyl and other street drugs.  

The study, reported in the CDC’s Morbidity and Mortality Weekly Report, analyzed data from 24 states and the District of Columbia enrolled in the State Unintentional Drug Overdose Reporting System (SUDORS) from January to June, 2019. SUDORS captures detailed information from toxicology reports and death scene investigations, and is considered more reliable than overdose data gathered from death certificates.

Among the 16,236 overdose deaths reported by SUDOR during the study period, illicitly manufactured fentanyl (IMF), heroin, cocaine or methamphetamine were involved 83.8% of deaths, either alone or in combination with other drugs. Nearly half of those deaths involved two or more illicit drugs.

About one in five overdoses involved prescription opioids such as hydrocodone, oxycodone, morphine and buprenorphine. The study did not indicate whether the medication was obtained legally or if it was borrowed, stolen or purchased illicitly. What is clear, however, is that street drugs are the primary driver of the U.S. overdose crisis.

% RATE OF DRUGS INVOLVED IN FATAL OVERDOSES (JAN-JUNE, 2019)

SOURCE: CDC

“The finding of this report that nearly 85% of overdose deaths involved IMFs, heroin, cocaine, or methamphetamine reflects rapid and continuing increases in the supply of IMFs and methamphetamine, coupled with illicit co-use of opioids and stimulants,” researchers reported.

More than two thirds (68.5%) of overdose victims were male, and over half (53.3%) were 25 to 44 years of age; demographics that don’t fit the profile of most chronic pain patients, who are generally older and female.

NBER Report Blames Rx Opioids

The new CDC report is at odds with a working paper recently published by the National Bureau of Economic Research (NBER), a non-profit, private think tank. The NBER report largely blames prescription opioids for the U.S. overdose epidemic – not street drugs or so-called “deaths of despair” caused by rising social isolation and economic distress.  

“People have blamed all sorts of things, heroin from Mexico and fentanyl from China and economic decline and so on and so forth,” co-author Janet Currie, PhD, a professor of economics at Princeton University, told Yahoo Finance. “But really the issue is that a whole lot of people got addicted because they were prescribed pain medications which aren’t prescribed in the same way in other countries.”

Currie and co-author Hannes Schwandt, PhD, an economics professor at Northwestern University, say pharmaceutical companies aggressively marketed opioids at a time when doctors were being encouraged to treat pain as “the fifth vital sign.”

“We argue that the development and marketing of a new generation of prescription opioids sparked the epidemic and that provider behavior is still helping to drive it,” the NBER report states. “Prior to the marketing push, most doctors had believed that opioids were too addictive and dangerous for anyone except terminally ill patients. Aggressive marketing by pharmaceutical companies changed those perceptions: Sales of opioid pain killers quadrupled between 1999 and 2013, fueling the rise in overdose deaths.”

What Curry and Schwandt fail to mention is that opioid prescriptions have fallen by nearly 40% since 2013. And their report only briefly mentions the rising toll taken by illicit fentanyl and other street drugs.

Fatal drug overdoses fell in 2018, for the first time in nearly 30 years, but many signs indicate they are rising again and that the COVID-19 pandemic is making the crisis worse in the U.S. and Canada.   

Canada’s Chief Public Health Officer recently warned the pandemic is fueling another surge in drug deaths in Canada.

“Tragically, in many regions of the country, the COVID-19 pandemic is contributing to an increase in drug-related overdoses and deaths,” Dr. Theresa Tam said in a statement. “There are indications that the street drug supply is growing more unpredictable and toxic in some parts of the country, as previous supply chains have been disrupted by travel restrictions and border measures. Public health measures designed to reduce the impact of COVID-19 may increase isolation, stress and anxiety as well as put a strain on the supports for persons who use drugs.”

A Pained Life: Don’t Throw Out the Bathwater

By Carol Levy, PNN Columnist

In 1976, my trigeminal neuralgia started. In those days, the environment regarding chronic pain was very different. My doctor had only one agenda: He wanted to stop or reduce my constant debilitating and disabling pain.

He couldn’t cure me, so he ordered opioid pain medication. When one opioid didn’t work, he tried another; Darvon, Percocet, Percodan, Demerol. So many I can’t recall them all. When none helped, he prescribed an 8-ounce bottle of opium.

The first pharmacist who saw the opium prescription shook his head. “Sorry. We don't carry it,” he said. The next pharmacy did. “Have a seat. It'll just be a few minutes,” the pharmacist said.

I wasn't looked at askance. No questions were asked about my doctor or diagnosis. I wasn’t warned: “This is a very strong drug. You need to be careful. You could become addicted.”

They trusted that my doctor knew what he was doing. They trusted me to be a responsible patient. I doubt it ever entered the pharmacist’s mind that I might be a drug seeker or abuser.

Now the tables have totally turned. Many of us get questioned by pharmacists. And some of our doctors have stopped writing opioid prescriptions. They should be cautious, right? Because opioids are addictive, you can become dependent or have other bad side effects. And they can be used illegally.

The same is true for steroids. Yet there seem to be no politicians, physicians or groups with an agenda that are working to scare the public about steroids or trying to get doctors to stop “overprescribing” them.  

When steroids first came out there were many, many horror stories about them. The 1956 film Bigger Than Life was about a school teacher (James Mason) taking corticosteroids. They helped his pain from an autoimmune disorder, but he soon became hyper-manic and ultimately psychotic, even trying to murder his son.

His doctor reduced the dosage, but because steroids helped his pain, the teacher continued to take more than prescribed. He even goes to another town, impersonates a doctor, and writes a fake prescription to obtain more of the pills.

Sound familiar?

The movie was a caricature of the potential risks of steroids, which include dependency and addiction. Opioids have the same risks, but most patients with chronic pain take them responsibly, as most on steroids do, and they do not become addicted, try to obtain them fraudulently or go off the deep end.

There will always be bad actors who will be irresponsible, but users of any medication should not be demonized because of a few bad apples. Steroids are easily obtained and the patients who use them are not seen as potential felons. And why would they? For most patients, steroids can be very helpful.

Those who can still get opioids for their pain are often seen as potential miscreants. Yet studies also show that for most patients, opioids do help.

You don’t throw out the baby with the bathwater. You don’t create guidelines scaring doctors into not writing steroid prescriptions because a small percentage of people will misuse or abuse them.

The medical community and the government need to stop throwing out the bathwater. When they refuse to write prescriptions for opioids that have helped patients, the side effect — intentional or not — is to throw us away, too.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

Lawyers May Not Expand Lawsuits Against Pharmacy Chains

By Pat Anson, Editor, PNN Editor

Lawyers involved in class action lawsuits that allege pain patients were discriminated against by three major pharmacy chains are being tight-lipped about whether the lawsuits may be expanded to include additional plaintiffs and pharmacies.

The lawsuits were filed earlier this month in California and Rhode Island against CVS, Walgreens and Costco on behalf of two women who say the pharmacies refused to fill their prescriptions for opioid pain medication.

At least six different law firms around the country are handling the cases. They’ve set up a website called Seeking Justice for Pain Patients, which invites other patients to participate in the lawsuits by sharing their personal information and experiences at pharmacies. It’s not yet clear how the information will be used or if the cases will be expanded.

“Pain patients have been contacting us in response to the lawsuits. The overall response has been very positive and happy that some action is being taken,” Robert Redfearn, a Louisiana attorney, said in an email to PNN. “Though there are no plans to do so at this time, additional individual named plaintiffs could possibly be added, but if a national class is certified, it should not be necessary.” 

Other lawyers involved in the lawsuits did not respond to requests for comment.

Redfearn represents Susan Smith, a 43-year old mother from Castro Valley, California who lives with severe chronic migraines. The only medications that give her relief from head pain are opioids. Smith says pharmacists at Walgreens and Costco refused to fill her opioid prescriptions and publicly shamed her.

“After being harassed by pharmacists [and] pharmacy staff for a number of years — being laughed at, being called names in front of my child — I really couldn’t take it anymore,” Smith told the San Francisco Examiner. “It has been really stressful, demoralizing, not to mention discriminating. On top of that, they were making it really hard for me to live a pain-free life.”

‘Find a New Pharmacy’

“There has to be a change,” says Edith Fuog, a 48-year old Tampa, Florida mother who filed the lawsuit against CVS. Fuog has lived for many years with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions.

“People need to understand what is happening. Everybody in their life is going to be a pain patient at one point or another, whether it’s an accident, becoming elderly, a disease or cancer. If this is happening to people who have chronic pain, the people who are just coming in with acute pain are never going to be treated.”

Fuog told PNN she had no trouble getting her opioid prescriptions filled at a CVS pharmacy until the CDC’s controversial opioid prescribing guideline was released in 2016.

“As soon as those guidelines came out, my life changed. The manager pulled me aside and said, ‘Look, I’m not going to be able to fill these anymore. I suggest you find a new pharmacy.’” said Fuog, who then went to other CVS pharmacies in the Tampa area and was repeatedly turned down.

“They all said, ‘We’ll be happy to fill all your other meds, but we will not fill the opioids.’ And I said, ‘I take 13 other medications. Why would I come here then?’”

EDITH FUOG

Fuog eventually found a small neighborhood pharmacy that was willing to fill all of her prescriptions. She also found a lawyer to file the class action lawsuit against CVS. If her case is successful, Fuog anticipates making only a few thousand dollars in damages.

“It’s not like I’m going to make a bunch of money. The decision could come down for a hundred million dollars, but that’s for the class and the attorneys. I’ll get a ‘rep fee” being the class rep. That’s it. I don’t get anything for my damages or the stress I go through, and the fact I have severe anxiety because of this,” she said.

Fuog says she will only settle out-of-court if CVS adopts a written public policy that makes clear to its pharmacists that they should fill all legitimate prescriptions for opioids.

“My goal in this is to make change that affects the most amount of people with chronic pain. If I can get them a lot of money, I’m going to do it. Why wouldn’t I? To me, these companies deserve to pay all these people money for what they’ve been through,” she said.

Costco, CVS and Walgreens did not respond to requests for comment.  CVS, Walgreens and other large pharmacy chains have been named in lawsuits alleging they helped fuel the opioid epidemic by selling millions of pills in small communities. They’ve also been fined hundreds of millions of dollars for violating federal rules for dispensing controlled substances.

Most Americans Know Little About Opioid Medication

By Pat Anson, PNN Editor

Before the Covid-19 pandemic dominated the nation’s headlines, the opioid crisis was widely considered the most serious public health threat in the United States, with much of the news coverage and public attitudes focused on the role played by opioid pain medication.

A 2017 Pew Research survey found that 3 out of 4 Americans viewed prescription drug abuse as a serious public health problem. Another survey that year found that nearly half of Americans had a family member or close friend addicted to drugs.

It turns out most Americans know surprisingly little about opioid medication. A recent survey of over 1,000 U.S. adults by DrFirst, a healthcare technology company, found a significant lack of understanding about opioids.      

While more than three-quarters (76%) of respondents think they know whether or not they were prescribed an opioid, only 22% could correctly identify seven commonly prescribed opioid painkillers. The following medications were misidentified as not containing opioids:

• Tramadol (44%)

• Hydromorphone (32%)

• Morphine sulfate (27%)

• Methadone (27%)

• Hydrocodone (23%)

• Fentanyl (22%)

• Oxycodone (15%)

Many respondents also misidentified non-opioid medications. Nearly three quarters (73%) thought oxytocin was an opioid (apparently confusing it with oxycodone), even though it’s a hormone that helps women bond with their newborn babies.

Other medications that were often misidentified as opioids:    

• Oxymetolazine (56%)

• Trazodone (46%)

• Omeprazole (33%)

• Hydrocortisone (31%)

• Hyaluronic acid (23%)

“American consumers have some significant and dangerous misunderstandings about which medicines contain opioids,” said Colin Banas, MD, vice-president of clinical products for DrFirst. “This is concerning because patients need to know if they are prescribed an opioid so they can use and store it safely. It should be a wake-up call to physicians and pharmacists, who should not assume their patients know this information.”

One out of five survey respondents said they had been prescribed an opioid in the past year, but 21% of them said they didn’t get the prescription filled.

Over three-quarters of those who did get their prescriptions filled did not keep their opioids in a locked cabinet, as some safety experts recommend. Most kept the drugs within easy reach.

• In a locked cabinet (23%)

• On a nightstand table (14%)

• Kitchen table (13%)

• Bathroom cabinet (13%)

• Purse or backpack (10%)

• Bathroom counter (10%)

The DrFirst survey of 1,002 American adults was conducted online by Propeller Insights from June 16 to June 19, 2020.

Only 2% of British Columbia Overdoses Linked to Prescription Opioids

By Pat Anson, PNN Editor

A new analysis of fatal opioid overdoses in British Columbia found that only about 2% of the deaths were caused by prescription opioids alone. The other overdoses mainly involved illicit fentanyl and other street drugs or a combination of illicit drugs and other medications, which were often not prescribed.

“Our data show a high prevalence of nonprescribed fentanyl and stimulants, and a low prevalence of prescribed opioids detected on toxicology in people who died from illicit drug overdose. These results suggest that strategies to address the current overdose crisis in Canada must do much more than target deprescribing of opioids,” researchers reported in the Canadian Medical Association Journal (CMAJ).

Vancouver, British Columbia was the first major North American city to be hit by a wave of overdoses involving illicit fentanyl, a potent synthetic opioid. A public health emergency was declared in BC in 2016 and strict guidelines were released to limit opioid prescribing. Although prescriptions dropped dramatically, fatal overdoses in BC continued to rise.

Researchers looked at 1,789 fatal overdoses in BC from 2015 to 2017 for which toxicology reports were available and found that 85% of them involved an opioid. Of those, only 2.4% of the deaths were linked to opioid medication alone. Another 7.8% of cases involved a combination of prescribed or non-prescribed opioids.

The findings are similar to a 2019 study of opioid overdoses in Massachusetts, which found that only 1.3% of the people who died had an active prescription for opioid medication.   

“Pain patients and their medications have never been responsible for overdose deaths – not then or now. Will the anti-opiate zealots, with all their data-dredged studies be taken to task for all the unnecessary suffering, disability, and premature deaths they have contributed to within the Canadian pain population?” asked Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, a patient advocacy group.

“The ‘prohibition’ approach that has wrongly been applied for years that focused on reducing access to pharmaceutical products directly contributed to exposure to higher risk illicit substances, which put people at risk of overdose.”

Most Overdoses Linked to Illicit Fentanyl

Researchers say efforts to reduce opioid prescribing in Canada were “insufficient to address the current overdose crisis” because street drugs are involved in the vast majority of deaths. They also warned against the forced tapering of patients on opioid pain medication.

“The risk of harms from these medications must be balanced with the potential harms of nonconsensual discontinuation of opioids for long-term users, including increased pain, risk of suicide and risk of transition to the toxic illicit drug supply,” wrote lead author Alexis Crabtree, MD, resident physician in Public Health at the University of British Columbia.  

Crabtree and her colleagues found that most overdoses involved a street drug, with fentanyl or fentanyl analogues linked to nearly 8 out of 10 overdose deaths. Many of the deaths involved multiple substances, including medications such as stimulants, anti-depressants, benzodiazepines, antipsychotics and gabapentinoids, which were often not prescribed to the victim.   

Over 7% of the overdoses involved methadone or buprenorphine (Suboxone), opioids that are used to treat addiction. About a third of the people who died had a diagnosis of substance use disorder in the year before their overdose.

In a commentary also published in CMAJ, a leading public health expert said it was time to decriminalize drugs and offer a “safe supply” to illicit drug users.

“Unless there is a radical change in our approach to the epidemic, overdose deaths will continue unabated. It is time to scale up safe supply and decriminalize drug use.”

— Dr. Mark Tyndall

“Unless there is a radical change in our approach to the epidemic, overdose deaths will continue unabated. It is time to scale up safe supply and decriminalize drug use,” wrote Mark Tyndall, MD, Executive Director of BC Centre for Disease Control and a professor at the School of Population and Public Health, University of British Columbia.

Tyndall says blaming the opioid crisis on excess prescribing by doctors and the unethical marketing of opioids by pharmaceutical companies fails to address the reasons people abuse drugs in the first place.

“While having a cheap and ready supply of opioid drugs does allow for misuse and addiction, this narrative fails to acknowledge that drug use is largely demand-driven by people seeking to self-medicate to deal with trauma, physical pain, emotional pain, isolation, mental illness and a range of other personal challenges and these are the people overdosing,” Tyndall wrote.

(Update: Canada’s Chief Public Health Officer, Dr. Theresa Tam, issued a statement August 26 saying the COVID-19 pandemic is contributing to an increase in drug overdoses and deaths across Canada.

“There are indications that the street drug supply is growing more unpredictable and toxic in some parts of the country, as previous supply chains have been disrupted by travel restrictions and border measures. Public health measures designed to reduce the impact of COVID-19 may increase isolation, stress and anxiety as well as put a strain on the supports for persons who use drugs,” Tam said.

“For the third consecutive month this year, the number of drug overdose deaths recorded in British Columbia has exceeded 170. These deaths represent a 136% increase over the number of deaths recorded in July 2019. There are news reports of an increase in overdoses in other communities across the country.” )

New Hampshire Law Protects Patient Access to Rx Opioids

By Pat Anson PNN Editor

Patient advocates around the country are looking with keen interest at a new law in New Hampshire that stipulates chronic pain patients should have access to opioid medication if it improves their physical function and quality of life.

HB 1639 was signed into law by Gov. Chris Sununu late last month. It amends state law to add some key provisions that protect the rights of both pain patients and their doctors.

Under the law, physicians and pharmacists are required to consider the “individualized needs” of pain patients, treat them with dignity, and ensure that they are “not unduly denied the medications needed to treat their conditions."   

Since the CDC’s controversial opioid prescribing guideline was released in 2016, dozens of states have adopted laws and policies that restrict the prescribing of opioids to the CDC’s recommended daily limit of 90 MME (Morphine Milligram Equivalent). Doctors who exceed that dose often come under the scrutiny of law enforcement and some pharmacists have stopped filling their prescriptions. As a result, millions of patients have been tapered to lower doses or cut off from opioids altogether, causing withdrawal, poorly treated pain and increased disability.  

Under the New Hampshire law, “all decisions” regarding treatment are to be made by the treating practitioner, who is required to treat chronic pain “without fear of reprimand or discipline.” Doctors in the state are also allowed to exceed the MME limit, provided the dose is “the lowest amount necessary to control pain” and there are no signs of a patient abusing their opioid medication.

“Ordering, prescribing, dispensing, administering, or paying for controlled substances, including opioid analgesics, shall not in any way be pre-determined by specific Morphine Milligram Equivalent (MME) guidelines.

For those patients who experience chronic illness or injury and resulting chronic pain who are on a managed and monitored regimen of opioid analgesic treatment and have increased functionality and quality of life as a result of said treatment, treatment shall be continued if there remains no indication of misuse or diversion.”

Importantly, the new law broadly defines chronic pain to include any pain that is intractable, high impact, episodic or relapsing — meaning the pain doesn’t have to be continuous.

“This innovative new law is historic in that it states that controlled substances, including opioids, can't be pre-determined by specific morphine milligram equivalents,” says Dr. Forest Tennant, a retired pain management specialist in California. “The law specifically states that patients can't be unduly denied the medications needed to treat their conditions. This point can't be over-emphasized.”

Another provision of the law requires that a diagnosis of chronic pain made by a physician anywhere in the U.S. that is supported by written documentation should be considered adequate proof that a patient has chronic pain. That part of the law is intended to make it easier for out-of-state pain patients to get treatment in New Hampshire.      

The law is the result of two years of lobbying by a small group of patient advocates known as the New Hampshire Pain Collaborative, which worked closely with state Sens. John Reagan and Tom Sherman in drafting the legislation. Key provisions eventually became part of the healthcare omnibus bill that won bipartisan support in the New Hampshire Senate and House of Representatives, and was signed into law by Governor Sununu.

Bill Murphy, a member of the Pain Collaborative, made this video to help other patients and advocates create similar legislation in their states:

“I would like to say a big congrats to all who worked on that project! Isn't it amazing what you can accomplish when you all work together?” said Donna Corley, director of the Arachnoiditis Society for Awareness and Prevention (ASAP), a patient advocacy group.

“Many patients aren't aware of just how important this bill truly is. This should have been enacted and should be implemented in every state in the United States to help secure safe, and reliable pain care treatment for all patients who suffer chronic pain in the United States. To be able to have diagnoses from other states and it be accepted by your doctor is phenomenal as well.”

“All concerned parties need to salute and follow suit of the New Hampshire law,” Dr. Tennant said in an email to PNN. “The tragedy of the recent over-reach to control opioid abuse, diversion, and overdoses has caused immense suffering for legitimate, chronic pain patients, an epidemic of suicides among deprived pain patients, and the forced retirement of many worthy physicians (including yours truly). All this ugliness would have been prevented with the New Hampshire law.”

According to the CDC, New Hampshire physicians wrote 46.1 opioid prescriptions for every 100 persons in 2018. That’s well below that national average of 51.4 prescriptions. That same year, 412 people died of drug overdoses in New Hampshire, the vast majority of them involving synthetic opioids such as illicit fentanyl and other street drugs.  Only 43 of those 412 deaths involved a prescription opioid.