Over three years ago… I posted this on my blog  Here comes Narxcare – to help manage your potential to abuse certain substances      Other things that I had read about NARXCARE when it was first released, I sensed at the time that NARXCARE was going to be nothing short of a high probability of being a NIGHTMARE for most pts taking controlled substances. According to this new article from Aug, 2021… it would appear that my first opinion(s) were probably pretty close to what now appears to be reality with NARXCARE

Now THREE YEARS LATER  here comes more of the FACTS

The Pain Was Unbearable. So Why Did Doctors Turn Her Away?

https://www.wired.com/story/opioid-drug-addiction-algorithm-chronic-pain/amp

A sweeping drug addiction risk algorithm has become central to how the US handles the opioid crisis. It may only be making the crisis worse.

One evening in July of 2020, a woman named Kathryn went to the hospital in excruciating pain.

A 32-year-old psychology grad student in Michigan, Kathryn lived with endometriosis, an agonizing condition that causes uterine-like cells to abnormally develop in the wrong places. Menstruation prompts these growths to shed—and, often, painfully cramp and scar, sometimes leading internal organs to adhere to one another—before the whole cycle starts again.

For years, Kathryn had been managing her condition in part by taking oral opioids like Percocet when she needed them for pain. But endometriosis is progressive: Having once been rushed into emergency surgery to remove a life-threatening growth on her ovary, Kathryn now feared something just as dangerous was happening, given how badly she hurt.

In the hospital, doctors performed an ultrasound to rule out some worst-case scenarios, then admitted Kathryn for observation to monitor whether her ovary was starting to develop another cyst. In the meantime, they said, they would provide her with intravenous opioid medication until the crisis passed.

On her fourth day in the hospital, however, something changed. A staffer brusquely informed Kathryn that she would no longer be receiving any kind of opioid. “I don’t think you are aware of how high some scores are in your chart,” the woman said. “Considering the prescriptions you’re on, it’s quite obvious that you need help that is not pain-related.”

Kathryn, who spoke to WIRED on condition that we use only her middle name to protect her privacy, was bewildered. What kind of help was the woman referring to? Which prescriptions, exactly? Before she could grasp what was happening, she was summarily discharged from the hospital, still very much in pain.

Back at home, about two weeks later, Kathryn received a letter from her gynecologist’s office stating that her doctor was “terminating” their relationship. Once again, she was mystified. But this message at least offered some explanation: It said she was being cut off because of “a report from the NarxCare database.”

Like most people, Kathryn had never heard of NarxCare, so she looked it up—and discovered a set of databases and algorithms that have come to play an increasingly central role in the United States’ response to its overdose crisis.

Over the past two decades, the US Department of Justice has poured hundreds of millions of dollars into developing and maintaining state-level prescription drug databases—electronic registries that track scripts for certain controlled substances in real time, giving authorities a set of eyes onto the pharmaceutical market. Every US state, save one, now has one of these prescription drug monitoring programs, or PDMPs. And the last holdout, Missouri, is just about to join the rest.

In the past few years, through a series of acquisitions and government contracts, a single company called Appriss has come to dominate the management of these state prescription databases. While the registries themselves are somewhat balkanized—each one governed by its own quirks, requirements, and parameters—Appriss has helped to make them interoperable, merging them into something like a seamless, national prescription drug registry. It has also gone well beyond merely collecting and retrieving records, developing machine-learning algorithms to generate “data insights” and indicating that it taps into huge reservoirs of data outside state drug registries to arrive at them.

NarxCare—the system that inspired Kathryn’s gynecologist to part ways with her—is Appriss’ flagship product for doctors, pharmacies, and hospitals: an “analytics tool and care management platform” that purports to instantly and automatically identify a patient’s risk of misusing opioids.

On the most basic level, when a doctor queries NarxCare about someone like Kathryn, the software mines state registries for red flags indicating that she has engaged in “drug shopping” behavior: It notes the number of pharmacies a patient has visited, the distances she’s traveled to receive health care, and the combinations of prescriptions she receives.

Beyond that, things get a little mysterious. NarxCare also offers states access to a complex machine-learning product that automatically assigns each patient a unique, comprehensive Overdose Risk Score. Only Appriss knows exactly how this score is derived, but according to the company’s promotional material, its predictive model not only draws from state drug registry data, but “may include medical claims data, electronic health records, EMS data, and criminal justice data.” At least eight states, including Texas, Florida, Ohio, and Michigan—where Kathryn lives—have signed up to incorporate this algorithm into their monitoring programs.

For all the seeming complexity of these inputs, what doctors see on their screen when they call up a patient’s NarxCare report is very simple: a bunch of data visualizations that describe the person’s prescription history, topped by a handful of three-digit scores that neatly purport to sum up the patient’s risk.

Appriss is adamant that a NarxCare score is not meant to supplant a doctor’s diagnosis. But physicians ignore these numbers at their peril. Nearly every state now uses Appriss software to manage its prescription drug monitoring programs, and most legally require physicians and pharmacists to consult them when prescribing controlled substances, on penalty of losing their license. In some states, police and federal law enforcement officers can also access this highly sensitive medical information—in many cases without a warrant—to prosecute both doctors and patients.

In essence, Kathryn found, nearly all Americans have the equivalent of a secret credit score that rates the risk of prescribing controlled substances to them. And doctors have authorities looking over their shoulders as they weigh their own responses to those scores.

Even after Kathryn had read up on NarxCare, however, she was still left with a basic question: Why had she been flagged with such a high score? She wasn’t “doctor shopping.” The only other physician she saw was her psychiatrist. She did have a prescription for a benzodiazepine to treat post-traumatic stress disorder, and combining such drugs with opioids is a known risk factor for overdose. But could that really have been enough to get her kicked out of a medical practice?

As Kathryn continued her research online, she found that there was a whole world of chronic pain patients on Twitter and other forums comparing notes on how they’d run afoul of NarxCare or other screening tools. And eventually she came upon an explanation that helped her understand what might have gone wrong: She had sick pets.

At the time of her hospitalization, Kathryn owned two flat-coated retrievers, Bear and Moose. Both were the kind of dog she preferred to adopt: older rescues with significant medical problems that other prospective owners might avoid. Moose had epilepsy and had required surgery on both his hind legs. He had also been abused as a puppy and had severe anxiety. Bear, too, suffered from anxiety.

The two canines had been prescribed opioids, benzodiazepines, and even barbiturates by their veterinarians. Prescriptions for animals are put under their owner’s name. So to NarxCare, it apparently looked like Kathryn was seeing many doctors for different drugs, some at extremely high dosages. (Dogs can require large amounts of benzodiazepines due to metabolic factors.) Appriss says that it is “very rare” for pets’ prescriptions to drive up a patient’s NarxCare scores.

As Kafkaesque as this problem might seem, critics say it’s hardly an isolated glitch. A growing number of researchers believe that NarxCare and other screening tools like it are profoundly flawed. According to one study, 20 percent of the patients who are most likely to be flagged as doctor-shoppers actually have cancer, which often requires seeing multiple specialists. And many of the official red flags that increase a person’s risk scores are simply attributes of the most vulnerable and medically complex patients, sometimes causing those groups to be denied opioid pain treatment. 

The AI that generates NarxCare’s Overdose Risk Score is, to many critics, even more unsettling. At a time of mounting concern over predictive algorithms, Appriss’ own descriptions of NarxCare—which boast of extremely wide-ranging access to sensitive patient data—have raised alarms among patient advocates and researchers. NarxCare’s home page, for instance, describes how its algorithm trawls patient medical records for diagnoses of depression and post-traumatic stress disorder, treating these as “variables that could impact risk assessment.” In turn, academics have published hundreds of pages about NarxCare, exploring how such use of diagnostic records could have a disparate impact on women (who are more likely to suffer trauma from abuse) and how its purported use of criminal justice data could skew against racial minorities (who are more likely to have been arrested).

But the most troubling thing, according to researchers, is simply how opaque and unaccountable these quasi-medical tools are. None of the algorithms that are widely used to guide physicians’ clinical decisions—including NarxCare—have been validated as safe and effective by peer-reviewed research. And because Appriss’ risk assessment algorithms are proprietary, there’s no way to look under the hood to inspect them for errors or biases.

Nor, for that matter, are there clear ways for a patient to seek redress. As soon as Kathryn realized what had happened, she started trying to clear her record. She’s still at it. In the meantime, when she visits a pharmacy or a doctor’s office, she says she can always tell when someone has seen her score. “Their whole demeanor has changed,” she says. “It reminds me of a suspect and a detective. It’s no longer a caring, empathetic, and compassionate relationship. It’s more of an inquisition.”

The United States’ relationship with opioid drugs has always been fraught. We either love them or we hate them. Historically, periods of widespread availability spur addictions, which lead to crackdowns, which lead to undertreatment of pain—and then another extreme swing of the pendulum, which never seems to settle at a happy medium.

The current anti-opioid climate has its roots in the overmarketing of Purdue Pharma’s OxyContin in the mid-1990s. Between 1999 and 2010, opioid prescribing in the US quadrupled—and overdose deaths rose in tandem. To many experts, this suggested an easy fix: If you decrease prescribing, then death rates will decline too.

But that didn’t happen. While the total amount of opioids prescribed fell by 60 percent between 2011 and 2020, the already record-level overdose death rate at least doubled during the same period. Simply cutting the medical supply didn’t help; instead, it fueled more dangerous drug use, driving many Americans to substances like illegally manufactured fentanyl.

The reason these cuts hadn’t worked, some experts believed, was that they had failed to target the patients at highest risk. Around 70 percent of adults have taken medical opioids—yet only 0.5 percent suffer from what is officially labeled “opioid use disorder,” more commonly called addiction. One study found that even within the age group at highest risk, teenagers and people in their early twenties, only one out of every 314 privately insured patients who had been prescribed opioids developed problems with them.

Researchers had known for years that some patients were at higher risk for addiction than others. Studies have shown, for instance, that the more adverse childhood experiences someone has had—like being abused or neglected or losing a parent—the greater their risk. Another big risk factor is mental illness, which affects at least 64 percent of all people with opioid use disorder. But while experts were aware of these hazards, they had no good way to quantify them.

That began to change as the opioid epidemic escalated and demand grew for a simple tool that could more accurately predict a patient’s risk. One of the first of these measures, the Opioid Risk Tool (ORT), was published in 2005 by Lynn Webster, a former president of the American Academy of Pain Medicine, who now works in the pharmaceutical industry. (Webster has also previously received speaking fees from opioid manufacturers.)

To build the ORT, Webster began by searching for studies that quantified specific risk factors. Along with the literature on adverse childhood experiences, Webster found studies linking risk to both personal and family history of addiction—not just to opioids but to other drugs, including alcohol. He also found data on elevated risk from particular psychiatric disorders, including obsessive-compulsive disorder, bipolar disorder, schizophrenia, and major depression.

Gathering all this research together, Webster designed a short patient questionnaire meant to suss out whether someone possessed any of the known risk factors for addiction. Then he came up with a way of summing and weighting the answers to generate an overall score.

The ORT, however, was sometimes sharply skewed and limited by its data sources. For instance, Webster found a study showing that a history of sexual abuse in girls tripled their risk of addiction, so he duly included a question asking whether patients had experienced sexual abuse and codified it as a risk factor—for females. Why only them? Because no analogous study had been done on boys. The gender bias that this introduced into the ORT was especially odd given that two-thirds of all addictions occur in men.

The ORT also didn’t take into account whether a patient had been prescribed opioids for long periods without becoming addicted.

Webster says he did not intend for his tool to be used to deny pain treatment—only to determine who should be watched more closely. As one of the first screeners available, however, it rapidly caught on with doctors and hospitals keen to stay on the right side of the opioid crisis. Today, it has been incorporated into multiple electronic health record systems, and it is often relied on by physicians anxious about overprescription. It’s “very, very broadly used in the US and five other countries,” Webster says.

In comparison to early opioid risk screeners like the ORT, NarxCare is more complex, more powerful, more rooted in law enforcement, and far less transparent.

Appriss started out in the 1990s making software that automatically notifies crime victims and other “concerned citizens” when a specific incarcerated person is about to be released. Later it moved into health care. After developing a series of databases for monitoring prescriptions, Appriss in 2014 acquired what was then the most commonly used algorithm for predicting who was most at risk for “misuse of controlled substances,” a program developed by the National Association of Boards of Pharmacy, and began to develop and expand it. Like many companies that supply software to track and predict opioid addiction, Appriss is largely funded, either directly or indirectly, by the Department of Justice.

NarxCare is one of many predictive algorithms that have proliferated across several domains of life in recent years. In medical settings, algorithms have been used to predict which patients are most likely to benefit from a particular treatment and to estimate the probability that a patient in the ICU will deteriorate or die if discharged.

In theory, creating such a tool to guide when and to whom opioids are prescribed could be helpful, possibly even to address medical inequities. Studies have shown, for instance, that Black patients are more likely to be denied medication for pain, and more likely to be perceived as drug-seeking. A more objective predictor could—again, in theory—help patients who are undermedicated get the treatment they need.

But in practice, algorithms that originate with law enforcement have displayed a track record of running in the opposite direction. In 2016, for example, ProPublica analyzed how COMPAS, an algorithm designed to help courts identify which defendants are most likely to commit future crimes, was far more prone to incorrectly flag Black defendants as likely recidivists. (The company that makes the algorithm disputed this analysis.) In the years since then, the problem of algorithmic unfairness—the tendency of AI to obscure and weaponize the biases of its underlying data—has become a increasingly towering concern among people who study the ethics of AI.

Over the past couple of years, Jennifer Oliva, director of the Center for Health and Pharmaceutical Law at Seton Hall University, has set out to examine NarxCare in light of these apprehensions. In a major recent paper called “Dosing Discrimination,” she argues that much of the data NarxCare claims to trace may simply recapitulate inequalities associated with race, class, and gender. Living in a rural area, for example, often requires traveling longer distances for treatment—but that doesn’t automatically signify doctor shopping. Similarly, while it’s a mystery exactly how NarxCare may incorporate criminal justice data into its algorithm, it’s clear that Black people are arrested far more often than whites. That doesn’t mean that prescribing to them is riskier, Oliva says—just that they get targeted more by biased systems. “All of that stuff just reinforces this historical discrimination,” Oliva says.

Appriss, for its part, says that within NarxCare’s algorithms, “there are no adjustments to the risk scoring to account for potential underlying biases” in its source data. 

Other communications from the company, however, indicate that NarxCare’s underlying source data may not be what it seems.

Early in the reporting of this piece, Appriss declined WIRED’s request for an interview. Later, in an emailed response to specific questions about its data sources, the company made a startling claim: In apparent contradiction to its own marketing material, Appriss said that NarxCare’s predictive risk algorithm makes no use of any data outside of state prescription drug registries. “The Overdose Risk Score was originally developed to allow for ingestion of additional data sources beyond the PDMP,” a spokesperson for the company said, “but no states have chosen to do so. All scores contained within NarxCare are based solely on data from the prescription drug monitoring program.”

Some states do incorporate certain criminal justice data—for instance, drug conviction records—into their prescription drug monitoring programs, so it’s conceivable that NarxCare’s machine-learning model does draw on those. But Appriss specifically distanced itself from other data sources claimed in its marketing material.

For instance, the company told WIRED that NarxCare and its scores “do not include any diagnosis information” from patient medical records. That would seem to suggest, contra the NarxCare homepage, that the algorithm in fact gives no consideration to people’s histories of depression and PTSD. The company also said that it does not take into account the distance that a patient travels to receive medical care—despite a chatty 2018 blog post, still up on the Appriss site, that includes this line in a description of NarxCare’s machine-learning model: “We might give it other types of data that involve distances between the doctor and the pharmacist and the patient’s home.”

These latest claims from Appriss only heighten Oliva’s concerns about the inscrutability of NarxCare. “As I have said many times in my own research, the most terrifying thing about Appriss’ risk-scoring platform is the fact that its algorithms are proprietary, and as a result, there is no way to externally validate them,” says Oliva. “We ought to at least be able to believe what Appriss says on its own website and in its public-facing documents.”

Moreover, experts say, even the most simple, transparent aspects of algorithms like NarxCare—the tallying of red flags meant to signify “doctor-shopping” behavior—are deeply problematic, in that they’re liable to target patients with complex conditions. “The more vulnerable a patient is, the more serious the patient’s illness, the more complex their history, the more likely they are to wind up having multiple doctors and multiple pharmacies,” notes Stefan Kertesz, a professor of medicine and public health at the University of Alabama at Birmingham. “The algorithm is set up to convince clinicians that care of anybody with more serious illness represents the greatest possible liability. And in that way, it incentivizes the abandonment of patients who have the most serious problems.”

To take some of the heat off of these complex patients, Appriss says that its algorithm “focuses on rapid changes” in drug use and deemphasizes people who have maintained multiple prescriptions at stable levels for a long time. But as ever, the company stresses that a NarxCare score is not meant to determine any patient’s course of treatment—that only a doctor can do that.

Doctors, however, are also judged by algorithms—and can be prosecuted if they write more prescriptions than their peers, or prescribe to patients deemed high risk. “I think prescribers have gotten really scared. They are very fearful of being called out,” says Sarah Wakeman, the medical director of the Substance Use Disorder Initiative at Massachusetts General Hospital, an assistant professor of medicine at Harvard, and a doctor who regularly uses NarxCare herself. Research has found that some 43 percent of US medical clinics now refuse to see new patients who require opioids.

Doctors are also, Wakeman says, “just not really sure what the right thing to do is.” A couple of academic surveys have found that physicians appreciate prescription drug registries, as they truly want to be able to identify patients who are misusing opioids. But doctors have also said that some registries can take too much time to access and digest. NarxCare is partly a solution to that problem—it speeds everything up. It distills.

The result of all that speed, and all that fear, says Kertesz, is that patients who have chronic pain but do not have addictions can end up cut off from medication that could help them. In extreme cases, that can even drive some chronic pain sufferers to turn to more dangerous illegal supplies, or to suicide. Among patients with long-term opioid prescriptions, research shows that stopping those prescriptions without providing effective alternative care is associated with nearly triple the risk of overdose death.

“The problem that really infuses the NarxCare discussion is that the environment in which it is being used has an intense element of law enforcement, fear, and distrust of patients,” Kertesz says. “It’s added to an environment where physicians are deeply fearful for their future ability to maintain a profession, where society has taken a particularly vindictive turn against both physicians and patients. And where the company that develops this interesting tool is able to force it onto the screens of nearly every doctor in America.”

As Kathryn became more steeped in online communities of chronic pain patients, one of the people she came into contact with was a 44-year-old woman named Beverly Schechtman, who had been galvanized by her own bad experience with opioid risk screening. In 2017, Schechtman was hospitalized for kidney stones, which can cause some of the worst pain known to humans. In her case, they were associated with Crohn’s disease, a chronic inflammatory disease of the bowel.

Because Crohn’s flare-ups by themselves can cause severe pain, Schechtman already had a prescription for oral opioids—but she went to the hospital that day in 2017 because she was so nauseated from the pain that she couldn’t keep them or anything else down. Like Kathryn, she also took benzodiazepines for an anxiety disorder.

That combination—which is both popular with drug users and considered a risk factor for overdose—made the hospitalist in charge of Schechtman’s care suspicious. Without even introducing himself, he demanded to know why she was on the medications. So she explained that she had PTSD, expecting that this disclosure would be sufficient. Nonetheless, he pressed her about the cause of the trauma, so she revealed that she’d been sexually abused as a child.

After that, Schechtman says, the doctor became even more abrupt. “Due to that I cannot give you any type of IV pain medication,” she recalls him saying. When she asked why, she says he claimed that both IV drug use and child sexual abuse change the brain. “‘You’ll thank me someday, because due to what you went through as a child, you have a much higher risk of becoming an addict, and I cannot participate in that,’” she says she was told.

Schechtman says she felt that the doctor was blaming her for being abused. She was also puzzled.

She had been taking opioids on and off for 20-odd years and had never become addicted. Wasn’t that relevant? And how could it be ethical to deny pain relief based on a theoretical risk linked to being abused? She wasn’t asking for drugs to take home; she just wanted to be treated in the hospital, as she had been previously, without issue.

As would later happen for Kathryn, the experience drove Schechtman onto the internet. “I just became obsessed with researching all of it,” Schechtman says. “I was asking people in these online groups, ‘Have any of you been denied opioids due to sexual abuse history?’ And women were coming forward.”

 Schechtman discovered that the question about sexual abuse history in the ORT unfairly targeted women, but not men. (An updated version of Webster’s tool now excludes the gender difference, but the older one seems to live on in some electronic medical record systems.)

She also found many pain patients who said they had problems with NarxCare. Bizarrely, even people who are receiving the gold standard treatment for addiction can be incorrectly flagged by NarxCare and then denied that very treatment by pharmacists.

Buprenorphine, best known under the brand name Suboxone, is one of just two drugs that are proven to cut the death rate from opioid use disorder by 50 percent or more, mainly by preventing overdose. But because it is an opioid itself, buprenorphine is among the substances that can elevate one’s NarxCare score—though typically it is listed in a separate section of a NarxCare report to indicate that the person is undergoing treatment. That separation, however, doesn’t necessarily prevent a pharmacist from looking at a patient’s high score and refusing to offer them prescriptions.

Ryan Ward, a Florida-based recovery advocate, has taken buprenorphine for nearly a decade. He also has a history of severe back pain and related surgeries. In 2018, when his pharmacy stopped carrying buprenorphine, he tried to fill his prescription at a Walmart and was turned away. Then he visited two CVS’s and three Walgreens, and was similarly stymied.

“I dress nicely. I look nice. And I would be friendly,” he says. “And as soon as they get my driver’s license, oh boy, they would change attitudes. I couldn’t figure out why.”

After panicking that he might plunge into withdrawal—and, ironically, be put at much higher risk of overdose—he changed tactics. He approached a pharmacist at a Publix, first showing her his LinkedIn page, which highlights his advocacy and employment. He described what had happened at the other drugstores.

When she checked the database, she immediately saw the problem: an overwhelmingly high Overdose Risk Score. Unlike her colleagues, however, she agreed to fill the prescription, realizing that it was nonsensical to deny a patient a medication that prevents overdose in the name of preventing overdose. Still, even three years later, if he tries another pharmacy he gets rejected.

Appriss stresses that its data is not supposed to be used in these ways. “Pharmacists and physicians use these scores as indicators or calls-to-action to further review details in the patient’s prescription history in conjunction with other relevant patient health information,” the company wrote in a statement. “The analysis and associated scores are not intended to work as sole determinants of a patient’s risk.” Appriss also says that prescriptions for buprenorphine have increased in areas of the country that use NarxCare.

But like the others, Ward has been unable to get his problem fixed. And since most states now require that physicians and pharmacists use these databases, millions are potentially affected. One survey of patients whose providers have checked these systems found that at least half reported being humiliated and 43 percent reported cuts in prescribing that increased pain and reduced quality of life.

Appriss says on its website that it’s up to each state to deal with patient complaints. Still, few know where to turn. “The states have made it very difficult,” says Oliva. Some don’t even allow for error correction. And when Ward tried contacting Appriss directly, he says, he was ignored.

In the early 2010s, Angela Kilby was seeking a topic for her PhD thesis in economics at MIT. When a member of her family, a doctor in the rural South, told her how tough it was to make decisions about prescribing opioids in a community devastated by overdoses, Kilby felt she had found her subject. She decided to study the doctor’s dilemma by examining how increased control over opioid prescribing actually affected patients. To track health outcomes, she used insurance claim data from 38 states that had implemented prescription monitoring databases at varying times between 2004 and 2014.

Going into her study, Kilby had been swayed by research and press reports—plentiful in an era of “pill mill” crackdowns and backlash against overprescribing—suggesting that opioids are not only addictive but also ineffective and even harmful for patients with chronic pain. She had predicted that reductions in prescribing would increase productivity and health. “I was expecting to see the opposite of what I saw,” she says.

In fact, her research showed that cutting back on medical opioid prescriptions led to increased medical spending, higher levels of pain in hospitalized patients, and more missed workdays. “These are people who are probably losing access to opioids, who are struggling more to return to work after injuries and struggling to get pain treatment,” she says.

Intrigued, she wanted to know more. So in the late 2010s, having become an assistant professor at Northeastern University, she decided to simulate the machine-learning model that generates NarxCare’s most algorithmically sophisticated measure, the Overdose Risk Score.

Although Appriss did not make public the factors that went into its algorithm, Kilby reverse engineered what she could. Lacking access to prescription drug registry data, Kilby decided to use de-identified health insurance claims data, a source that underlies all of the other published machine-learning algorithms that predict opioid risk. Using roughly the same method that Appriss lays out in accounts of its own machine-learning work, she trained her model by showing it cases of people who’d been diagnosed with opioid use disorder after receiving an opioid prescription. She sent it looking for resemblances and risk predictors in their files. Then she turned her model loose on a much larger sample, this time with those opioid-use-disorder diagnoses hidden from the algorithm, to see if it actually identified real cases.

What Kilby found was that while NarxCare’s model may trawl a different data set, it almost certainly shares an essential limitation with her algorithm. 

“The problem with all of these algorithms, including the one I developed,” Kilby says, “is precision.” Kilby’s complete data set included the files of roughly 7 million people who were insured by their employers between 2005 and 2012. But because opioid addiction is so rare in the general population, the training sample that the algorithm could use to make predictions was small: some 23,000 out of all those millions.

Further, 56 percent of that group had addictions before they received their first prescription, meaning that the medication could not have caused the problem—so they had to be excluded from the training sample. (This supports other data showing that most people with opioid addiction start with recreational, rather than medical, use.)

The result was that Kilby’s algorithm generated a large number of both false positive and false negative results, even when she set her parameters so strictly that someone had to score at or above the 99th percentile to be considered high risk. In that case, she found, only 11 percent of high scorers had actually been diagnosed with opioid use disorder—while 89 percent were incorrectly flagged.

Loosening her criteria didn’t improve matters. Using the 95th percentile as a cutoff identified more true positives, but also increased false ones: This time less than 5 percent of positives were true positives. (In its own literature, Appriss mentions these two cutoffs as being clinically useful.)

Kilby’s research also identified an even more fundamental problem. Algorithms like hers tend to flag people who’ve accumulated a long list of risk factors in the course of a lifetime—even if they’ve taken opioids for years with no reported problems. Conversely, if the algorithm has little data on someone, it’s likely to label them low risk. But that person may actually be at higher risk than the long-term chronic pain patients who now get dinged most often.

“There is just no correlation whatsoever between the likelihood of being said to be high risk by the algorithm and the reduction in the probability of developing opioid use disorder,” Kilby explains. In other words, the algorithm essentially cannot do what it claims to do, which is determine whether writing or denying someone’s next prescription will alter their trajectory in terms of addiction. And this flaw, she says, affects all of the algorithms now known to be in use.

In her paper “Dosing Discrimination,” about algorithms like NarxCare, Jennifer Oliva describes a number of cases similar to Kathryn’s and Schectman’s, in which people have been denied opioids due to sexual trauma histories and other potentially misleading factors. The paper culminates in an argument that FDA approval—which is currently not required for NarxCare—should be mandatory, especially given Appriss’ dominance of the market.

The larger question, of course, is whether algorithms should be used to determine addiction risk at all. When I spoke with Elaine Nsoesie, a data science faculty fellow at Boston University with a PhD in computational epidemiology, she argued that improving public health requires understanding the causes of a problem—not using proxy measures that may or may not be associated with risk.

“I would not be thinking about algorithms,” she says. “I would go out into the population to try to understand, why do we have these problems in the first place? Why do we have opioid overdose? Why do we have addictions? What are the factors that are contributing to these problems and how can we address them?”

In contrast, throughout the overdose crisis, policymakers have focused relentlessly on reducing medical opioid use. And by that metric, they’ve been overwhelmingly successful: Prescribing has been more than halved. And yet 2020 saw the largest number of US overdose deaths—93,000—on record, a stunning 29 percent increase from the year before.

Moreover, even among people with known addiction, there is little evidence that avoiding appropriate medical opioid use will, by itself, protect them. “I think undertreated pain in someone with a history of addiction is every bit, if not more, of a risk factor for relapse,” says Wakeman. She calls for better monitoring and support, not obligatory opioid denial.

Appriss has recognized the need to study NarxCare’s effects on the health and mortality of people flagged by the system—and not just whether it results in reduced prescribing. At a recent webinar, the company’s manager of data science, Kristine Whalen, highlighted new data showing that implementation of NarxCare sped up the decline in opioid prescribing in six states by about 10 percent, compared to reductions before it was used. When asked whether the company was also measuring NarxCare’s real-world effects on patients’ lives, Whalen said, “We’re actively looking for additional outcome data sets to be able to do what you are describing.”

For Kathryn, at least, NarxCare’s effect on her life and health has been pretty stark. Aside from her psychiatrist, she says, “I don’t have a doctor because of this NarxCare score.” She worries about what she’ll do the next time her endometriosis flares up or another emergency arises, and she still struggles to get medication to treat her pain.

And it’s not only Kathryn’s own pain prescriptions that require filling. Although her dog Moose died in late 2020, Bear continues to need his meds, and Kathryn has since gone on to adopt another medically demanding dog, Mouse. Some states have recognized the problem of misidentified veterinary prescriptions and require NarxCare to mark them with a paw print or animal icon on health providers’ screens. Apparently, though, those prescriptions can still influence the pet owner’s overall scores—and the next busy pharmacist who peers warily at a computer screen.

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Biden’s America: Supply Chain Breakdown Preventing Cancer Patients from Getting Life-Saving Drugs

https://www.westernjournal.com/bidens-america-supply-chain-breakdown-preventing-cancer-patients-getting-life-saving-drugs/

President Joe Biden’s inept leadership has spawned tragic tentacles as the supply chain shortages he inflamed threaten to kill cancer and COVID-19 patients who are unable to receive life-saving drugs.

The Food and Drug Administration currently lists 109 drugs in short supply nationally.

Three of the top five medications experiencing shortages are drugs used for chemotherapy, heart conditions and antibiotics, CBS News reported Thursday, citing the American Society of Health-System Pharmacists.

One of the scarce drugs is the anti-inflammatory tocilizumab, which is used by both cancer and COVID-19 patients. The scarcity has forced physicians to ration drugs, which means some patients are denied medication.

Dr. Patrick Jackson, an infectious-disease physician at the University of Virginia’s medical center, gives tocilizumab to chemotherapy patients while denying it to COVID patients because there simply isn’t enough to go around.

“It does mean that some patients are getting the drug that I would not ideally want to give them,” Jackson told CBS News.

Brian Spoehlhof, an assistant pharmacy manager at the medical center, said the hospital has no choice but to ration drugs because of the shortage.

“For a lot of patients, it will feel very unfair,” he said. “If I had a solution, we wouldn’t be in this situation.”

Spoehlhof said it’s impossible for him to restock the dwindling inventory because new supplies are not being delivered.

“By the time I come in, we have a new list of new medications that are short,” he told CBS News.

“What would happen if we run out of this, patients can’t get important chemotherapy — and without that chemotherapy they could die.”

The American Medical Association warned that the current drug shortage is an “urgent public health crisis” that “threatens patient care and safety,” CBS News reported.

Pharmacists across the country are also reporting shortages for popular drugs such as insulin, oxycodone and Adderall, which some people need to take every day.

Joyce McCroskey, a North Carolina mom, told WBTV-TV in Charlotte that her son had to wait four days for his anti-seizure medication because of the supply shortages.

The pandemic and resulting lockdowns have exacerbated a decade-long drug shortage that began in 2011 when Barack Obama was president.

However, the latest supply chain disruptions have been worsened by Biden’s policies, including an unreasonable vaccine mandate that has resulted in numerous workers quitting or being fired.

This workforce exodus because of the vaccine mandate comes on top of a labor shortage caused by overly generous government handouts during the pandemic.

In addition, numerous hospital workers have quit or were fired because of their opposition to vaccine mandates. This means that in addition to drug shortages, there’s also a frightening labor shortage in the health care sector — in the middle of a pandemic.

Thus, Biden’s vaccine mandate has further stymied a lagging economy and intensified a supply chain disruption that’s preventing cancer and COVID patients from getting the medication they need to survive.

Meanwhile, vaccine mandates are also escalating crime waves in Democrat-run cities as police officers quit or are fired en masse for opposing the forced injections.

But Biden apparently doesn’t mind more lawlessness across America, since he said last week that unvaccinated cops and other first responders should be fired.

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New Limitations on Chain Pharmacy Quotas in California

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Retail chain pharmacies should be aware of California’s recent passage of SB 362, signed into law by Governor Gavin Newson late last month, and the potential impact of the law on how chains evaluate their pharmacy staff and track individual productivity. At a high level, the law bars using “quota” metrics that track the number of times individual pharmacists and pharmacy technicians perform tasks or provide services while on duty. These quota systems have historically been used by various national retail pharmacy chains to track staff productivity and inform business operations. The bill cites various rationales for instituting quota prohibitions, including “overwhelming workloads” for pharmacists expected to meet certain fixed quotas and the associated negative impact on patient care. Of note, the bill noted that the Board of Pharmacy lacks the ability to determine whether to discipline non-compliant individual licensees or penalize pharmacies for created work environments that “leave little choice but noncompliance.”

The new law updates the California Business and Professions Code by adding two new Sections– 4113.7 and 4317. Section 4113.7 prohibits chain community pharmacies from establishing, utilizing, or communicating a quota. A “quota” is defined as a “fixed number or formula related to the duties for which a pharmacist or pharmacy technician license is required, against which the chain community pharmacy or its agent measures or evaluates the number of times either an individual pharmacist or pharmacy technician performs tasks or provides services while on duty related to any of the following:

• Prescriptions filled;
• Services rendered to patients;
• Programs offered to patients; and
• Revenue obtained.”

CA BUS & PROF § 4113.7(c)(1)(A-D).

Section 4317 grants the California Board of Pharmacy authority to take enforcement action against a violating pharmacy unless the pharmacy can show clear and convincing evidence that the quotas were used contrary to its policy.

Importantly, there are certain limiting factors to this quota prohibition. First, the restrictions only apply to “chain community pharmacies,” defined by California as “a chain of 75 or more stores in California under the same ownership.” CA BUS & PROF § 4001(c). Second, the following are not considered “quotas” and are therefore still permissible activities for applicable pharmacies:

• Revenue measurements for a particular pharmacy that are not calculated or measured by tasks performed/services provided by individual pharmacy staff;
• Evaluations of pharmacy staff competence, performance, or quality of care provided to patients so long as quotas are not used;
• Any performance metric required by state or federal regulators that does not use quotas; and
• Pharmacy policy and procedures that assist with assessing pharmacy staff competency and performance so long as quotas are not used.

CA BUS & PROF § 4113.7(c)(2)—(d).

In sum, large pharmacy chains may need to evaluate changes to their tracking and evaluation process for California-based pharmacy staff. However, it is important to note that SB 362 still gives California chain pharmacies room to evaluate employees and quantify productivity so long as the evaluation procedure falls in line with the delineated exceptions. Additionally, the law appears to only bar quotas used for individual pharmacy staff, meaning that pharmacy chains could arguably still use quota-type metrics to track performance on a pharmacy or entity level.

 

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Patients with opioid use disorder could see some of the biggest benefits of new CMS changes. The new rules would no longer require patients seeking opioid addiction treatment to appear on video. By allowing audio-only telehealth visits, patients would not feel the pressure to secure a space solely for telehealth services.

Part of assessing OUD patients is monitoring their appearance and mannerisms as a way to monitor medication adherence. Jittery patients can suggest withdrawal. With this promote individualized OUD treatment?

I made this post just yesterday 

QOL EQUITY: Homeostasis of the human body/biological systems

And the above statement showed up on a website – not CMS – and it would appear that there seems to be another divergent of the EQUITY between these two “disabled communities”.  Both of these communities rely on being prescribed CONTROLLED SUBSTANCES to help those in the community help manage their subjective diseases.

And then four days ago the DEA published this –

DEA looking for comments on their proposed opiate production quotas

Is it just me, or does it seem strange that CMS is making it EASIER for those in the substance abuse community to get appropriate treatment… including that there is no MME daily limits to the controlled substance that they can be provided…. while at the same time…  CMS & DEA is seeking ways & means to make appropriate therapy harder to get for those in the chronic pain community ?

This administration seem to promote EQUITY for every group… but… did CMS & DEA not get that memo ?

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When/if you download the 20 page proposed regulations… pay particular attention to PAGE 4 of that *.PDF… it explains the “statistical parameters” that the DEA used to come up with the “ESTIMATED DIVERSION ” of particular controlled substances.  First of all the database was on only 24% of the population – from only 17 different states PDMP databases and some “numeric numbers – like MME’s above a certain MME/day – would be a indication of diversion. Everyone – but the DEA – knows that those MME conversion programs are CRAP .. all one has to do is look at the footnotes on this MME conversion program https://globalrph.com/medcalcs/opioid-pain-management-converter-advanced/ The DEA should be ashamed to even state their “diversion numbers ” as estimates…. a more appropriate label would be “GUESSTIMATE ”  While our population typically grows abt 1% +/- in 2010 USA pop was 309 million and 2020 pop was 331 million.  Opiate Rxing peaked in 2011-2012… so while our population grew some 7%… the DEA has reduced opiate production quotas by some 50%.. New chronic pain pts are created every day from accidents to surgeries with BAD OUTCOMES.

Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2022

https://www.regulations.gov/document/DEA-2021-0014-0001

https://downloads.regulations.gov/DEA-2021-0014-0001/content.pdf

 

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Is the chronic pain community intentionally being left out of the current discussion on EQUITY ?  When each of us is born, NONE OF US ARE BIOLOGICALLY PERFECT. A lot of the practice of medicine focuses on using various therapies to help restore a person’s health/QOL that has deteriorated for numerous reasons.  Take places like St Jude    that focuses on curing childhood cancers and other serious – often fatal – childhood diseases.  Some of us are born with missing limbs and/or other major “defects” and places like Shriners deal with Physical therapy, Speech Therapy, Occupational therapy and orthotic/prosthetic to help kids to be able to function as normal as possible and optimize their QOL.

There is groups like Wounded Warriors    that provide all sorts of assistance to those who have come home after serving our country trying to deal with numerous physical and mental issues.

and  Tunnel to Towers       that provides a multitude of assistance for families of our first responders who have died in the line of duty, attempting to help to help the surviving family members to optimize their QOL as much as is possible.

Maybe it is time for the chronic pain community to ask our elected officials why the community is denied QOL EQUITY ? Congress has already passed at least two different law that has declared that discrimination of the disabled violates The Civil Rights Act and American with Disability Act is a civil rights violation.

Our healthcare system is so designed if one or more of a person’s biological processes goes outside of what is considered “normal” … there are therapies or medications that can hopefully restore the person’s biological function(s) to “normal” and restoring the person’s QOL.

Sometimes, the person will be required to take medications for a short period of time – like a antibiotic for a infection – or medication for – maybe – the rest of their life to restore blood pressure, blood sugar, high cholesterol etc…etc…  some times physical therapy is required and sometimes surgery is the only choice.

Here is a quote – that I like – from another Pharmacist….  who was  VP to President Johnson in the late 60’s. “The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey

This Administration is pushing EQUITY on just about anything and everywhere… why is that the chronic pain community does not deserve treatment to establish  QOL EQUITY for pts ?

Our federal bureaucracy and our healthcare system is breaking two laws on discriminating against disabled people – civil rights violations and now that the administration wants EQUITY for everyone … perhaps when pts talk to their members of Congress they should be asked to comment on why this is happening ?   Might also want to ask them why all sorts of money and resources are being thrown at those who are labeled as substance abusers/addicts… when many of those people really don’t wish to get sober.

Homeostasis

 https://courses.lumenlearning.com/nemcc-ap/chapter/1558/

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-688A]

Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2021

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

---

SUMMARY: The Drug Enforcement Administration proposes to adjust the 2021 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

DATES: Interested persons may file written comments on this notice in accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments must be submitted, and written comments must be postmarked, on or before October 4, 2021. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.

Based on comments received in response to this notice, the Administrator may hold a public hearing on one or more issues raised. In the event the Administrator decides in her sole discretion to hold such a hearing, the Administrator will publish a notice of any such hearing in the Federal Register. After consideration of any comments or objections, or after a hearing, if one is held, the Administrator will publish in the Federal Register a final order establishing the 2021 adjusted aggregate production quotas for schedule I and II controlled substances, and an adjusted assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

ADDRESSES: To ensure proper handling of comments, please reference “Docket No. DEA-688A” on all correspondence, including any attachments. DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission, you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments that duplicate electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (571) 776-2265.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also

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prominently identify confidential business information to be redacted within the comment.

Comments containing personal identifying information or confidential business information identified and located as directed above will generally be made available in redacted form. If a comment contains so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Legal Authority and Background

Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of DEA pursuant to 28 CFR 0.100.

DEA established the 2021 aggregate production quotas for substances in schedules I and II and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on November 30, 2020 (85 FR 76604). That order stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all aggregate production quotas and assessments of annual need are subject to adjustment.

Analysis for Proposed Adjusted 2021 Aggregate Production Quotas and Assessment of Annual Needs

DEA proposes to adjust the established 2021 aggregate production quotas to be manufactured in the United States in 2021 to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes. However, DEA’s analysis does not suggest the need for adjustment of the 2021 assessment of annual needs for the List I chemicals.

Factors for Determining the Proposed Adjustments

In determining the proposed adjustments, the Administrator has taken into account the criteria in accordance with 21 CFR 1303.13 (adjustment of aggregate production quotas for controlled substances) and 21 CFR 1315.13 (adjustment of the assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). The Administrator is authorized to increase or reduce the aggregate production quota at any time. 21 CFR 1303.13(a) and 1315.13(a). DEA regulations state that there are five factors that shall be considered in determining to adjust the aggregate production quota and the assessment of annual needs. 21 CFR 1303.13(b) and 1315.13(b).

DEA determined whether to propose an adjustment of the aggregate production quotas and assessment of annual needs for 2021 by considering the factors summarized below:

(1) Changes in the demand for that class or chemical, changes in the national rate of net disposal of the class or chemical, changes in the national rate of net disposal of the class or chemical by registrants holding individual manufacturing quotas for that class or chemical, and changes in the extent of any diversion in the class of controlled substance;

(2) whether any increased demand for that class or chemical, the national and/or individual rates of net disposal of that class or chemical are temporary, short term, or long term;

(3) whether any increased demand for that class or chemical can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota or assessment of annual needs, taking into account production delays and the probability that other individual manufacturing quotas may be suspended pursuant to Sec. 1303.24(b) and 1315.24(b);

(4) whether any decreased demand for that class or chemical will result in excessive inventory accumulation by all persons registered to handle that class or chemical (including manufacturers, distributors, practitioners, importers, and exporters), notwithstanding the possibility that individual manufacturing quotas may be suspended pursuant to Sec. 1303.24(b) and 1315.24(b) or abandoned pursuant to Sec. 1303.27 and 1315.27; and

(5) other factors affecting medical, scientific, research, and industrial needs in the United States, lawful export requirements, and other factors affecting importation needs of listed chemicals in the United States as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the class or the substances which are manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires. 21 CFR 1303.13(b) and 1315(b).

DEA considered the change in the extent of diversion of all controlled substances in proposing adjustments to the aggregate production quotas as required by 21 CFR 1303.13(b)(1). Pursuant to these factors, DEA has determined that any calculated changes from the previously determined initial calculations are slight and not statistically significant from the quantities originally calculated for the extent of diversion that were applied to the initial aggregate production quota valuations.

DEA also considered updated information obtained from 2020 year-end inventories, 2020 disposition data submitted by quota applicants, estimates of the medical needs of the United States, product development, and other information made available to DEA after the initial aggregate production quotas and assessment of annual needs had been established. Other factors the Administrator considered in calculating the aggregate production quotas, but not the assessment of annual needs, include product development requirements of both bulk and finished dosage form manufacturers, and other pertinent information.

In evaluating whether there is a need for adjustment of the 2021 assessment of annual needs for List I chemicals, DEA used the calculation methodology previously described in the 2010 and 2011 assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively). However, DEA’s analysis does not suggest the need for adjustment of the 2021 assessment of annual needs.

Considerations Based Upon the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act

Pursuant to 21 U.S.C. 826(a)(1), “production quotas shall be established in terms of quantities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance.” However, the Substance Use-Disorder Prevention that Promotes Opioid Recovery Treatment for Patients and Communities Act of 2018 (SUPPORT Act), (Pub. L. 115-271), provides an exception to that general rule by now giving DEA the authority to establish quotas in terms of pharmaceutical dosage forms if the

[[Page 49348]]

agency determines that doing so will assist in avoiding the overproduction, shortages, or diversion of a controlled substance.

DEA has stated before that while there is the authority to set aggregate production quotas in terms of pharmaceutical dosage form, DEA will not be using that authority at this time. Furthermore, when DEA does utilize the authority, it will be doing so at the individual dosage-form manufacturing level, as that is where it is most appropriate to do so. As such, there are no adjustments to set any controlled substances in terms of pharmaceutical dosage forms.

Under the SUPPORT Act, when setting the aggregate production quota, DEA must estimate the amount of diversion of any substance that is considered a “covered controlled substance,” as defined by the SUPPORT Act. 21 U.S.C. 826(i)(1)(A). The covered controlled substances are fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone. The SUPPORT Act also requires DEA to “make appropriate quota reductions, as determined by the [Administrator],\1\ from the quota the [Administrator] would have otherwise established had such diversion not been considered.” 21 U.S.C. 826(i)(1)(C). When estimating diversion, the “[Administrator]–(i) shall consider information the [Administrator], in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and (ii) may take into consideration whatever other sources of information the [Administrator] determines reliable.” 21 U.S.C. 826(i)(1)(B).

—————————————————————————

\1\ All functions vested in the Attorney General by the CSA have been delegated to the Administrator of DEA. 28 CFR 0.100(b).

—————————————————————————

In February 2021, DEA sent letters to the Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), and the states requesting overdose death and overprescribing data that could be considered for estimating diversion. DEA did not receive information from CMS. However, DEA did receive information from the CDC in June 2021 and has started to receive information from the states. DEA has begun to receive Prescription Drug Monitoring Program (PDMP) data from the states in a format that will allow the Agency to develop a more robust methodology to assist in the determination of the diversion estimate in the future. This information will be considered in determining the estimates of diversion for the five covered controlled substances in the Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2022.

To update the estimates of diversion, DEA used data from the Drug Theft and Loss Report, Statistical Management Analysis & Reporting Tools System (SMARTS), and System to Retrieve Information on Drug Evidence (STRIDE) databases to aggregate the active pharmaceutical ingredient (API) of each covered controlled substance by metric weight. From the databases, DEA gathered data involving employee theft, break-ins, armed robberies, and material lost in transit. DEA also used seizure data obtained from reports submitted by law enforcement agencies nationwide. This data was categorized by basic drug class and the amount of API in the dosage form was delineated with an appropriate metric for use in proposing the adjusted aggregate production quota values. Using the data, DEA calculated the estimates for the amount of diversion by multiplying the strength of the API listed for each finished dosage form by the total amount of units reported to estimate the metric weight in grams of the controlled substance being diverted. Below, DEA has updated the chart to include estimations of diversion for each of the covered controlled substances.

Diversion Estimates for 2020 (g)
Fentanyl	184
Hydrocodone	20,759
Hydromorphone	946
Oxycodone	47,316
Oxymorphone	534

DEA considered the change in the extent of diversion of all controlled substances in proposing adjustments to the aggregate production quotas as required by 21 CFR 1303.13(b)(1). Pursuant to these factors, DEA has determined that any calculated changes from the previously determined initial calculations are slight and not statistically significant from the quantities originally calculated for the extent of diversion that were applied to the initial aggregate production quota valuations.

Proposed Adjustments for the 2021 Aggregate Production Quotas and Assessment of Annual Needs

DEA is proposing significant increases to the APQs of the schedule I substances psilocybin, psilocin, marihuana, and marihuana extract, which are directly related to increased interest by DEA registrants in the use of hallucinogenic controlled substances for research and clinical trial purposes. DEA firmly believes in supporting regulated research of schedule I controlled substances. Therefore, the APQ increases reflect the need to fulfill research and development requirements in the production of new drug products, and the study of marijuana effects in particular, as necessary steps toward potential Food and Drug Administration (FDA) approval of new drug products.

The DEA established the 2021 aggregate production quotas for substances in schedules I and II on November 30, 2020 (85 FR 76604). Subsequent to that publication, DEA published in the Federal Register two final rules to permanently schedule 14 specific fentanyl-related substances under the CSA (86 FR 22113, April 27, 2021, and 86 FR 23602, May 4, 2021). The specific fentanyl-related substances are 2′-fluoro 2-fluorofentanyl, 4′-Methyl acetyl fentanyl, beta-Methyl fentanyl, beta-Phenyl fentanyl, Fentanyl carbamate, ortho-Fluoroacryl fentanyl, ortho-Fluorobutyryl fentanyl, ortho-Fluoroisobutyryl fentanyl, ortho-Methyl acetylfentanyl, ortho-Methyl methoxyacetyl fentanyl, para-Fluoro furanyl fentanyl, para-Methylfentanyl, Phenyl fentanyl, and Thiofuranyl fentanyl. As a result, these substances will continue to be subject to the CSA schedule I controls and are now being assigned individual aggregate production quotas.

On March 1, 2021, DEA published a temporary scheduling order placing Brorphine in schedule I of the CSA (86 FR 11862), making all regulatory controls pertaining to schedule I controlled substances applicable to the manufacture of these substances, including the requirement to establish an aggregate production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303. This notice proposes to establish an aggregate production quota for this substance.

On May 7, 2021, DEA published an interim final rule placing serdexmethylphenidate, a component in a combination drug product recently approved by FDA for the treatment of ADHD in patients six years of age and older, in schedule IV of the CSA (86 FR 24487). Serdexmethylphenidate is manufactured from methylphenidate, a schedule II controlled substance. In order to more accurately estimate and manage the quantity of methylphenidate necessary for direct formulation into schedule II drug products versus the

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quantity of methylphenidate necessary for the manufacturing of serdexmethylphenidate or other substances, DEA has delineated methylphenidate into methylphenidate (for sale) and methylphenidate (for conversion). This notice proposes to establish an aggregate production quota for methylphenidate (for conversion).

On June 20, 2021, DEA published the final rule to place oliceridine, a medication recently approved by FDA for medical use as an intravenous drug for the management of acute pain severe enough to require an intravenous opioid analgesic and for patients for whom alternative treatments are inadequate, in schedule II of the CSA effective July 12, 2021 (86 FR 30772). The placement of oliceridine in schedule II of the CSA, makes all regulatory controls pertaining to schedule II controlled substances applicable to the manufacture of this substance, including the requirement to establish an aggregate production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303.

The Administrator, therefore, proposes to adjust the 2021 aggregate production quotas for certain schedule I and II controlled substances. The Administrator does not propose an adjustment to the assessments of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The proposed adjusted APQs, as expressed in grams of anhydrous acid or base, are as follows:

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Now we have various state AG’s ( Attorneys) determining what medications licensed physicians can prescribe in treating COVID-19 infected people. Prescribing a FDA approved meds “off label” has been going on for as long as I can remember and I have been a licensed Pharmacists for 51 YEARS. And for all those years.. no one took issue with such prescribing.  But NOW… many attorneys have taken upon themselves to use their authority – or gave themselves authority – to “go after” prescribers that prescribe certain meds in treat pts dealing with COVID-19 …that those prescribers should have their medical license revoke, suspended or some other action by the state medical licensing board against prescribers.  It has been reported that President Biden  – who is an attorney – stated that he knew that the bureaucracy mandating people getting vaccinations was UNCONSTITUTIONAL….but… by the time that a legal challenge to that vaccination mandate made it thru out court system to be finally declared UNCONSTITUTIONAL…. millions of more people will would have “gotten the JAB”…   Isn’t it interesting that certain powerful bureaucrats can violate our constitution and/or our laws and do so without any fear of any consequences.

These groups – the American Medical Association, the American Pharmacists Association and the American Society of Health-System Pharmacists – have no legal authority and it would appear that they are active participants in the political theater surrounding the prescribing of the two meds in question off label.

Nebraska AG: Docs Can Prescribe Controversial COVID Drugs

https://www.medscape.com/viewarticle/961011

OMAHA, Neb. (AP) — Nebraska’s attorney general said Friday that he won’t seek disciplinary action against doctors who prescribe controversial, off-label drugs to treat and prevent coronavirus infections, as long as they get informed consent from patients and don’t engage in misconduct.

The office of Attorney General Doug Peterson released a legal opinion saying it didn’t see data to justify legal action against health care professionals who prescribe ivermectin, a decades-old parasite treatment, or hydroxychloroquine, a malaria drug that former President Donald Trump took to try to prevent a COVID-19 infection.

“Based on the evidence that currently exists, the mere fact of prescribing ivermectin or hydroxychloroquine for COVID-19 will not result in our office filing disciplinary actions,” the Republican attorney general said in the opinion.

Many health experts and leading medical groups have been trying to stop  the use of both drugs, arguing that they can cause harmful side effects and there’s little evidence that they help. It’s also unclear whether many doctors are actually prescribing them in Nebraska or elsewhere, although a few isolated cases have emerged nationally.

In a joint statement last month, the American Medical Association, the American Pharmacists Association and the American Society of Health-System Pharmacists said they strongly oppose the use of ivermectin as a COVID-19 drug outside of a clinical trial.

“We are alarmed by reports that outpatient prescribing for and dispensing of ivermectin have increased 24-fold since before the pandemic and increased exponentially over the past few months,” the groups said.

Ivermectin has been promoted by Republican lawmakers, conservative talk show hosts and some doctors, amplified via social media to millions of Americans who don’t want to get vaccinated. It has also been widely used in other countries, including India and Brazil.

Hydroxychloroquine has been boosted in a similar manner, despite American Medical Association warnings that the drug is an unproven and potentially dangerous treatment for the virus.

In Arkansas, a state medical board is investigating reports that a doctor prescribed ivermectin to county jail inmates, including several who said they didn’t know what they were being given.

Kansas U.S. Sen. Roger Marshall, a Republican and a doctor, has acknowledged that he took hydroxychloroquine throughout his 2020 campaign, along with his parents, siblings and wife, but he hasn’t said how they obtained their prescriptions.

In Nebraska, the attorney general’s office said it wasn’t recommending specific treatments for the virus and would still prosecute doctors who fail to get informed patient consent, prescribe excessively large doses or neglect to check what other drugs a patient is taking. The opinion only applies to doctors prescribing the drugs as a preventative measure and an early treatment for outpatients.

“Allowing physicians to consider these early treatments will free them to evaluate additional tools that could save lives, keep patients out of the hospital, and provide relief for our already strained health care system,” the opinion said.

The opinion came in response to a request from the Nebraska Department of Health and Human Services, which licenses and disciplines doctors. The attorney general’s office files complaints on the public’s behalf against health care providers who violate state regulations and put their patients at risk, and the department has the power to suspend or revoke their licenses or take other action.

Nebraska Department of Health and Human Services CEO Dannette Smith said in her request letter that consumers and doctors have been inundated with information about COVID-19 treatments, and “it may become difficult to discern the quality or validity of the information,” raising questions about what doctors can legally prescribe.

Peterson was first elected attorney general in 2014 and won re-election unopposed in 2018. He hasn’t said publicly whether he plans to run again next year.

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Walgreens says vaccine mix-ups are rare after Indiana family claims kids received COVID, not flu shots

https://www.foxbusiness.com/lifestyle/walgreens-vaccine-mixups-rare-covid-flu

Walgreens says vaccine mix-ups are rare after an Indiana family claimed that their children were given coronavirus shots rather than flu shots.

The family told WFIE in an exclusive interview that their two children, who are 4 and 5 years old, were mistakenly given full adult doses of the Pfizer vaccine rather than flu shots at a Walgreens in Evansville.

The mix-up allegedly occurred on Oct. 4.

Due to privacy laws, Walgreens told FOX Business that it isn’t allowed to comment on specific patient events but that patient safety is its “top priority” for the company and it takes such matters very seriously.

“Generally speaking, such instances are rare, and Walgreens takes these matters very seriously,” Walgreens said in a statement. “In the event of any error, our first concern is always our patients’ well-being.”

Walgreens says it has a multi-step vaccination procedure that “includes several safety checks to minimize the chance of human error.” The company also noted that it has reviewed the multi-step vaccination procedure with its pharmacy staff as a means to prevent these incidents from occurring.

The Price family didn’t find out about the mix-up until after a Walgreens employee called them admitting that they made a mistake, according to WFIE.

“Walgreens called me to say there was a mix-up, we did not receive the flu shot,” Alexandra Price said.After finding out that the kids were given a coronavirus shot instead, Price recalled thinking, “I was like, well what does this mean for my kids…?”The Price family’s attorney, David Tuley, told the outlet that the children were taken to the doctor and are showing signs of heart issues.GET FOX BUSINESS ON THE GO BY CLICKING HERE To date, Pfizer and BioNTech’s vaccine hasn’t been approved for children just yet. Earlier this month, however, the companies offered parents a sign of hope after asking the U.S. government to authorize its COVID-19 vaccine for youngsters ages 5 to 11.If regulators give the go-ahead, a reduced dose of the shot could be doled out within a matter of weeks. The companies said their research shows younger children should get one-third of the dose now given to everyone else.

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