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.

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."

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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?

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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.

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.

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"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.”