Study: Prescription Drug Databases Overestimate Opioid Misuse

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Are Most Retired NFL Players Really Addicts?

By Lynn Webster, MD, PNN Columnist

Many of us watched the Super Bowl on Sunday. It was a great defensive game, which means there was a lot of hard-hitting contact. Physical trauma can bring about long-term consequences and that is the subject of a recent New York Times column, "For NFL Retirees, Opioids Bring More Pain" by Ken Belson.

Belson suggests that many retired NFL players become addicted to opioid medication. I don’t know how many former players become addicted, but the summation of players he describes as addicted doesn’t quite add up.

The column cites a recent study published in the Clinical Journal of Sport Medicine that found about 26 percent of retired football players used opioid medication during the past 30 days. Belson suggests that percentage is excessive.

Of course, the players were not addicted just because they used an opioid. Moreover, 26 percent does not seem to be an unreasonable number, given that this is a population with a history of tremendous physical trauma. In fact, it seems like a surprisingly low number given that most former football players experienced enormous physical trauma for years.

Whatever the actual data may be, we can probably attribute the use or misuse of opioids to the fact that these retired players were trying to mitigate severe pain.  

What is Misuse?

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The accepted definition of opioid "misuse" is taking an opioid contrary to how it was prescribed, even if it is taken to treat pain. For example, let's say a person is told they can use one hydrocodone three times a day. If that person uses one pill six times a day so they can function (and not to get high), that is considered misusing. However, that is not a sign of addiction. It only reflects the person's desire to escape pain and the therapeutic inadequacy of the prescribed medication. 

Misuse of opioids in the general population is relatively rare, according to a large new study published in the journal Pharmacoepidemiology & Drug Safety. Over 31,000 adults were surveyed about their opioid use, and only 4.4% admitted taking a larger dose or a dose more frequently than prescribed.  

The figure below helps explain the relationships of misuse, abuse and addiction. Some retired football players may misuse their medication, but few will abuse them and even fewer will become addicted. All people with addiction abuse their medication. But people who misuse their medication may not be abusing or addicted to it.  

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In his column, Belson cites a 2011 survey by researchers at the Washington University School of Medicine that found over half of former NFL players used opioids during their playing careers and 71 percent misused them.

The same study found that many of these retired players who misused opioids were heavy drinkers. But in his column, Belson reported that "players who abused opioids” were likely to be heavy drinkers.  

Belson uses the words “misuse” and “abuse” interchangeably, as if they have the same meaning. They do not. If Belson means that retired players took opioids in excess of what their doctors prescribed due to uncontrolled pain, that would not be abuse. It would be misuse. If the players were using opioids to get high, that would be abuse. 

Belson mentions one retired player using the same amount of pain medicine as a stage 4 cancer patient and suggests that is an excessive amount. However, the player's need for that amount of opioids should not surprise us. Cancer pain is not more painful than non-cancer pain. People with painful diseases and physical injuries may have pain just as debilitating as a patient dying from cancer.

It is unfortunate, but not shocking, that a retired football player would have as much pain as someone dying of cancer. When someone who does not have cancer uses excessive medication to relieve pain, we are more likely to label that as "abuse." We show more compassion to patients with cancer pain than we do toward anyone else who requires treatment for chronic pain.  

Why We Need Clarity About Our Terms 

Belson writes, "Now, a growing number (of players) are saying the easy access to pills turned them into addicts." That is another statement that gravely concerns me. It is misleading and consistent with the common misunderstanding of what causes addiction or even what addiction is.  

Becoming dependent on opioids, becoming tolerant to opioids, requiring more opioids over time to achieve the same level of pain relief, and experiencing withdrawal if the opioids are suddenly stopped are not necessarily signs of addiction, any more than they would be if the same consequences resulted from taking a blood pressure medication or a sleep aid.  

People frequently write and talk about misuse, abuse and addiction, but many of them don't know what the terms mean.  This has troubling implications for the pain and addiction communities. Mislabeling and misdiagnosing people with addiction leads to harmful policies that adversely affect treatment. It even has legal implications that prevent people in pain or with addiction from accessing appropriate clinical care.  

Severe chronic pain and addiction can devastate lives. But we need to know the differences between misuse of, abuse of, and addiction to medications for the appropriate policies to be implemented. 

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Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

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.

Do Half of Americans Really ‘Misuse’ Drugs?

By Pat Anson, Editor

One of the nation’s largest drug testing companies has released a study claiming that over half of Americans who are prescribed medication show signs of drug misuse, including potentially dangerous drug combinations.

In 2016, Quest Diagnostics found that 52% of patient test results were “inconsistent” with their prescribed medications. That was an improvement over the rate found in 2011, when 63% of samples were inconsistent.

The Quest report, titled "Prescription Drug Misuse in America: Diagnostic Insights in the Growing Drug Epidemic," is based on an analysis of 3.4 million laboratory tests performed between 2011 and 2016.

Many of the specimen samples came from patients being treated in pain management and addiction treatment clinics, which are not representative of the population as a whole.

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Like previous studies of its kind, Quest broadly defines what constitutes drug “misuse” – a misleading term many people associate with abuse, addiction and diversion. Nearly a quarter of the patients (23%) with inconsistent results had no drugs detected in their system, which simply means they were not taking medications as directed.

The other 77% tested positive for illegal drugs or for a medication they were not prescribed.

"Over the past several years, federal and state government, clinician organizations, public health advocates and providers have all launched campaigns to educate the public about the perils of prescription drug misuse, which hypothetically should have yielded a significant rate of improvement. Yet our study shows that every other American tested for possible inappropriate use of opioids and other prescription drugs is potentially at risk," said F. Leland McClure, PhD, director of medical affairs at Quest Diagnostics.

"This finding is rather shocking, and speaks to the challenges of combating the nation's drug misuse epidemic."

Are the results really all that shocking? Or were they ginned up to hype the so-called epidemic? Consider some of the reasons a patient may not take a drug or have an inconsistent test result:

  • Patient didn't like side effects from a medication
  • Pain or other symptoms have subsided, so medication is not needed
  • Patient skipped a dose
  • Patient cannot afford a medication
  • Patient can’t find a pharmacy willing to fill their prescription
  • Patient may be a “rapid metabolizer” of a medication
  • Physician may not be aware another doctor prescribed a drug
  • Inaccurate drug test

The latter is a very real problem in the drug testing industry. As PNN has reported, “point-of-care” urine tests widely used by pain management and addiction treatment doctors to screen patients for illicit drug use are wrong about half the time, often giving false positive or false negative results for drugs like marijuana, oxycodone and methadone. 

The Quest study identified some disturbing and encouraging trends in drug use.

It wasn't opioids but benzodiazepines – a class of anti-anxiety medication that includes Xanax – that were most likely to be misused by adults over the age of 25.  Marijuana was most likely to be misused by people aged 18 to 24.   Opioids were second in both age groups.

Quest researchers found a striking decline in drug misuse among adolescents 10 to 17 years of age. The inconsistency rate for adolescents dropped from a whopping 70% in 2011 to 29% in 2016. Amphetamines and attention deficit disorder drugs were most likely to be abused by adolescents.

Among nearly 34,000 patient samples tested for opioids, alcohol and benzodiazepines, more than 20% were positive for opioids and benzodiazepines, 10% were positive for alcohol and opioids, and 3% were positive for all three.  Any combination of these drugs raises the risk of respiratory depression and overdose.

Misuse rates were higher for men and women of reproductive age (58%) than in the general study population (52%). The findings are significant because opioid and benzodiazepine use may decrease male fertility and, if taken during pregnancy, increase the risk of birth defects and other health concerns.

Quest is one of several drug testing laboratories that have been fined millions of dollars for paying kickbacks to physicians and patients for medically unnecessary tests.  Recent guidelines adopted by the American Society of Addiction Medicine warn doctors about ordering expensive drug tests that have led to “unethical and/or fraudulent activities.”

Poorly Treated Pain Main Reason for Opioid Misuse

By Pat Anson, Editor

Over a third of the U.S. adult population -- nearly 92 million Americans – used prescription opioids in 2015, according to a large new survey that found the primary reason people misuse opioid medication was to relieve pain.

The findings of the annual survey by the Substances Abuse and Mental Health Services Administration (SAMHSA), published in the Annals of Internal Medicine, seem likely to fuel another round of anti-opioid media coverage about the overdose crisis. 

The study estimated that 11.5 million Americans misused opioids in 2015, and nearly two million thought they were addicted and had an opioid use disorder. 

But a closer reading of the reasons behind the misuse indicates that pain is poorly treated by the healthcare system, especially for Americans who are economically disadvantaged or lack insurance.

“Misuse” in the survey was defined as using an opioid medication without a prescription, for reasons other than directed, or in greater amounts or more often than prescribed.

Asked what was the main reason behind their misuse, two-thirds (66%) of those who self-reported misuse said it was to relieve physical pain. Nearly 11 percent said it was to “get high or feel good” and less than one percent (0.6%) said they were “hooked” or addicted to opioids.

Our results are consistent with findings that pain is a poorly addressed clinical and public health problem in the United States and that it may be a key part of the pathway to misuse or addiction. Because pain is a symptom of many pathologic processes, better prevention and treatment of the underlying disorders are necessary to decrease pain and the morbidity and mortality associated with opioid misuse,” wrote lead author Beth Han, MD, PhD, a SAMHSA researcher.

“Simply restricting access to opioids without offering alternative pain treatments may have limited efficacy in reducing prescription opioid misuse and could lead people to seek prescription opioids outside the health system or to use nonprescription opioids, such as heroin or illicitly made fentanyl, which could increase health, misuse, and overdose risks.”

That appears to be what is happening. The CDC recently acknowledged that opioid prescribing has been in decline since 2010, yet opioid overdoses are soaring around the country, reaching 33,000 deaths in 2015, many of them caused by illicit opioids.  The DEA reported last week that over half the overdoses in Pennsylvania in 2016 were linked to illicit fentanyl. Prescription painkillers were involved in only about 25% of the overdoses, behind fentanyl, heroin, benzodiazepines (anti-anxiety medication), and cocaine.

In the SAMHSA survey, only a third of those who misused opioids said they obtained them legally from a doctor. The rest said they were obtained for free from a friend or relative, or were bought or stolen.

In addition to physical pain, the survey found that economic despair was a leading factor associated with opioid misuse. Uninsured, unemployed and low-income adults had a higher risk of opioid misuse and use disorder. People who were depressed, had suicidal thoughts, or were in poor health also were at higher risk.

“In more than 20 years practicing primary care in safety-net health settings, I have come to think of the patients at highest risk as my patients -- those with lower levels of education and income and higher rates of unemployment and uninsurance, our society's most vulnerable members,” wrote Karen Lasser, MD, Boston Medical Center and Boston University School of Medicine, in an editorial published in the Annals of Internal Medicine.

The fact that uninsured persons were twice as likely as those with insurance to report prescription opioid misuse and also had higher rates of use disorders augments the urgency of expanding insurance coverage. With insurance, persons suffering from pain could seek medical care rather than relying on opioids prescribed for others or purchased illegally.”

Over 72,000 American adults participated in the SAMHSA survey. Each interview lasted about an hour and participants received $30 in cash afterwards.

Do You Use Alcohol to Relieve Chronic Pain?

By Rochelle Odell, Columnist

I’m in a Complex Regional Pain Syndrome (CRPS/RSD) support group and one of our members recently asked if any members were turning to alcohol because their pain medication had been reduced or stopped.

It piqued my interest, so I began researching the topic. There aren’t many current studies or reports, but it’s a valid question since alcohol is much easier to obtain than pain medication.

Alcohol was among the earliest substances used to relieve physical pain and, of course, many people use it to cope with emotional pain.

According to the National Institute on Alcohol Abuse and Alcoholism, as many as 28% of people with chronic pain turn to alcohol to alleviate their suffering.

Another study from 2009 found that about 25% of patients self-medicated with alcohol for tooth pain, jaw pain or arthritis pain.

There is no documented increase in alcohol use by chronic pain patients at this time, although I would hope there are studies in process that further clarify the question and problems arising from it -- especially with opioid pain medication being reined in and so many patients left with nothing to relieve their pain.

There are many reasons why a person may self-medicate with alcohol.

“People have been using alcohol to help cope with chronic pain for many years. Many people also may use alcohol as a way to manage stress, and chronic pain often can be a significant stressor,” Jonas Bromberg, PsyD, wrote in PainAction.

“One theory about why alcohol may be used to manage chronic pain is because it affects the central nervous system in a way that may result in a mild amount of pain reduction. However, medical experts are quick to point out that alcohol has no direct pain-relieving value, even if the short-term affects provide some amount of temporary relief. In fact, using alcohol as a way to relieve pain can cause significant problems, especially in cases of excessive use, or when it is used with pain medication.”

Constant, unrelenting pain is definitely a stressor -- that's putting it mildly -- but I’ve never added alcohol to my pain medication regimen. I was always afraid of the possible deadly side effects, coupled with the fact my mother was an alcoholic who mixed her medication with it. That's a path I have chosen not to go down.

Bromberg also tells us that men may be more likely to use alcohol for pain relief than women, and people with higher income also tend to use alcohol more to treat their chronic pain.

Interestingly, the use of alcohol is usually not related to how intense a person’s pain is or how long they’ve had it. It was the regularity of pain symptoms – chronic pain -- that seemed most related to alcohol use, according to Bromberg.

Those who self-medicate with alcohol for physical or emotional pain often use it with a variety of substances, both legal and illegal.

Researchers at Boston University School of Medicine and Boston Medical Center reported last year in the Journal of General Internal Medicine that in a study of nearly 600 patients who screened positive for illicit drugs, nearly 90 percent had chronic pain. Over half of them used marijuana, cocaine or heroin, and about half reported heavy drinking.

“It was common for patients to attribute their substance use to treating symptoms of pain,” the researchers reported. “Among those with any recent heavy alcohol use, over one-third drank to treat their pain, compared to over three-quarters of those who met the criteria for current high-risk alcohol use.”

“Substance use” (not abuse) was defined as use of illegal drugs, misuse of prescription drugs, or high risk alcohol use. I had not heard of this term before, it’s usually called substance abuse.  Perhaps these researchers were onto something really important that needs further study, particularly with opioid medication under fire.

“While the association between chronic pain and drug addiction has been observed in prior studies, this study goes one step further to quantify how many of these patient are using these substances specifically to treat chronic pain," they added.

What this information shows is that if one is on pain medication, using alcohol or an illegal substance does not make one unique. It is certainly not safe, but it does occur. We are all struggling to find ways to cope with chronic pain, and if someone is denied one substance they are at high risk of turning to another.

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.