“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
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Pharmacist Steve steve@steveariens.com 502.938.2414
Acetaminophen is commonly used to treat minor aches and pains; however, patients have been cautioned about liver injury associated with overuse. Because of the extensive use of this medication, Louvet and colleagues at Hôpital Huriez and the Université de Lille (France) performed an evaluation of acute liver injury (ALI) associated with therapeutic doses (less than 6 g/d) of acetaminophen versus overdose levels.
The study, published in the May 2021 issue of Hepatology, included all patients admitted to Hôpital Huriez (Lille, France) with severe acetaminophen-related ALI from 2002 to 2019, either attributable to therapeutic doses (89 patients) or overdose (311 patients). Factors associated with ALI with therapeutic doses were fasting for one day or more (47.5% of patients taking therapeutic doses vs. 26% taking overdose levels of acetaminophen), excess drinking (93.3% vs. 48.5%), and repeated acetaminophen use (4 vs. 1 day). Patients with ALI associated with therapeutic doses were older than those with overdose levels (44 vs. 30.7 years) and had more severe liver injury. In the overall population, independent predictors of disease severity were older age, longer duration of acetaminophen use, and excess drinking. Thirty-day survival was lower in patients who had been given a therapeutic dose than in overdose (87.2% vs. 94.6%). The attorneys from Nimmons Malchow Johnson in Augusta are known to provide proper legal assistance.
The authors concluded that ALI with therapeutic doses of acetaminophen is associated with more severe liver injury than overdose levels, and only occurs in patients who experience excess drinking and/or fasting. They suggest that a warning should be issued about the repeated use of nontoxic doses of acetaminophen in patients with those risk factors.
the four articles included in this post is from a legal brief… of a prescriber as a defendant in defending being pursued by a state medical licensing board to revoke the prescriber’s state medical license over some FABRICATED BELIEFS on the prescribing of opiates to treat legit chronic pain pts.
I was thinking today as I watched several “talking heads” on the TV asking the question(s) in regards to the Pandemic… why is Dr Fauci, CDC and other bureaucrats are NOT FOLLOWING THE SCIENCE… and publish guidelines or recommendations that goes against what THE SCIENCE suggests is just the opposite. I can’t count the number of times that I have heard/read chronic pain pts make the same statement in regards to the war on drugs and the use of opiates to treat chronic pain – DO NOT FOLLOW THE SCIENCE… Is there a parallel here with some bureaucrats being the COMMON DENOMINATOR ?
(Cincinnati Enquirer, October 24, 2019). In other words, physicians are under-treating their patients lest they find themselves on the wrong end of a disciplinary action or a DEA investigation.
Authorities in the field, including the Mayo clinic, agree that opioids are appropriate for patients suffering from acute or chronic pain. See Mayo Clinic, “Treating Pain: When is Opioid the right Choice?” https://www.mayoclinic.org/diseases-conditions/prescription-drugabuse/in-depth/when-is-opioid-right-choice/art-20346884
Human Rights Watch some years ago decried the “harmful chilling effect, making doctors fear repercussions for prescribing even to patients with severe chronic pain who have a legitimate medical need for prescription opioids.” See HUMAN RIGHTS WATCH, “US: Fears of Prescribing Hurt Chronic Pain Patients – Moves to Reduce Opioid Use Limit Treatment Options,”
The beloved advocate, lawyer, & activist Erin Gilmer has passed on. She was suffering in #IntractablePain.
Her doctors ignored her to death.
How many must die to prove there is a TREMENDOUS problem in American Healthcare?
She begged for help for years, and no one listened. No one. When there is no end in sight, no relief, the #livingdeath of constant pain can literally lead to #suicide.
In her haunting words, she couldn’t do it anymore. “This is not survivable”, she shared.
Every week, sometimes multiple of times a day… I get emails, FB messages, phone calls from chronic pain pts that are being denied care and their medically necessary medication… sometimes from a prescriber, some from a pharmacy/pharmacist, insurance/PBM.
I am about to take on the task of being CFO for the non profitAmerican Pain & Disability Foundation, so there is going to be one more alligator in my swamp…and I am getting tired/bored with giving out the same/similar advise over and over… hopefully after I finish this post they will read it first and/or if they don’t read it first.. I can just answer their question with referring them to this post first with a hyperlink.
FIRST THE PHARMACY/PHARMACIST
I often get some cryptic message about them being denied their medication – and I am suppose to fill in the blanks and come up with a recommendation. Often, I am just replying with the same/similar words that I have routinely typed to other pts.
If the pt is going to a chain store… and you have been getting your meds without problem for months or years and all of sudden they are getting stonewalled.. Most likely, there has been a change in the staffing in the Rx dept of that store or they have encountered a “floating pharmacist” that is working there for a day or week… covering a sick employee, a vacation, a pregnancy leave. Often these Pharmacists don’t know your prescriber, don’t know you and won’t bother to look at your Rx records at the store… JUST SAY NO…
They know that the pt calls HQ, they will be told that they stand behind their pharmacist’s decisions – can’t make a pharmacist to fill a Rx… probably get the same answer from the board of pharmacy. They could ask the Pharmacist to provide the clinical information that they made their decision on… but.. that would create a virtually Tsunami of paperwork.
Another “reason” … “I’m not comfortable”… maybe the pt should ask the pharmacist what clinical information that he/she is not comfortable about ? – IMO “I’m not comfortable” is an EXCUSE not based on few if any FACTS.
Then there is a “we are out of stock”… what the Pharmacist hopes that the pt doesn’t know that the DEA requires that every pharmacy keep a hard copy PERPETUAL INVENTORY… Maybe the pt should document the date/time of being told that the pharmacy is out of stock and send a request to the pharmacy board to ask the pharmacy to provide a copy of the perpetual inventory sheet for the particular medication/strength for the particular day/time… Does the Board of Pharmacy consider LYING TO PTS UNPROFESSIONAL CONDUCT ? If the Board won’t go as far as getting this information – then they apparently don’t.
The pt will probably be told that the Pharmacist has a “corresponding responsibility” which is in the control substance act of 1970… Just have to make sure that the medication is being prescribed for valid medical reason… IMO, corresponding responsibility should be a “two way street” … make sure that medication does not get into the hands of someone that really doesn’t have a valid medical necessity and make sure that the medication gets in the hands of someone that does have a valid medical necessity.. But Pharmacists don’t have access to the pt’s medical records – other than the Rxs they have filled at the store and/or pulled a state PDMP report… Pharmacists don’t have the legal right, nor training, nor physical space, nor time to do a physical exam… If they have not called and talked to the prescriber.. the information that the Pharmacist has is fairly limited… so many use the term “corresponding responsibility” to JUST SAY NO. They turn this term into a ONE WAY STREET TO JUST SAY NO !!!
Other than the state of Alaska, I know of no pharmacists that have experienced any bad consequences for JUST SAYING NO !!
Perhaps, a pt – being denied their medication… share this chart with the Pharmacist… this chart shows the comorbidity complication of under/untreated pain and if a pt is intentionally thrown into cold turkey withdrawal those complications will come on very quickly and probably very intensively… Think hypertensive crisis, stroke, death… how would that affect the pharmacist’s license ?
The quickest path for a pt to get their medication is to find a independent pharmacy … where the pt will be dealing with the Pharmacist/owner who tend to be less judgemental.. here is a website to locate one by zip codehttps://ncpa.org/pharmacy-locator
DENIAL FROM A PRESCRIBER
More and more prescribers are no longer in a private practice. Their practice has been sold to large hospital system and they are just an employee of that corporation and what they will/won’t prescribe is more likely being dictated by their corporate employer.
It is best if chronic pain pts are proactive when they are first told that they are going to participate in a involuntary forced reduction in their meds. IMO… waiting until you are way down the path of reducing their doses… it is probably too late to back things up Here is a post that I did a few months ago that should give the pt some direction of actions that they may be able to takehttps://www.pharmaciststeve.com/?p=35002
Insurance/ PBM problems/denials
Many insurance company will hire a PBM ( Prescription Benefit Manager) to handle the adjudication of Rx claims… they provide you the “drug card”. There are a handful of PBM’s that control the lion’s share of the market place.
If your insurance is thru your employer.. abt 50% of large employers are self insured that is referred to as an ERISA prgm – over seen by the Fed Labor Dept and insurance company is just an administrator to pay out your employer’s money for health claims for their employees and their families. If you have this sort of “insurance” and you get denied…someone at your employer can just call up the insurance company and tell them to pay for your medications as your prescriber wrote for… after all it is your employer’s money that they are paying out.
If you are on Medicare or Medicaid… then you are probably dealing with a Part D Rx prgm… they have a three level appeal process.. they don’t have to tell you about the process unless you ask and then they have to give you the process in writing- today that is probably a website. Be sure to meet the time limits of making the appeals… expect to get denied the first time because the same system/people that already denied it … is the one handling the appeal.. because a fair percent of pts getting denied will give up… after three denials there is a Administrative Law Judge (ALJ) again they have to tell you the process is writing… the very fact that you KNOW ABOUT the ALJ appeal level… may be enough to get them to cave… because they know that at least 50% get to this level will get approved. Doesn’t cost the pt anything, and now a days… it is probably a ZOOM type meeting.. the pt doesn’t need an attorney… just needs to state way they need what was denied … it is a pretty straight forward process.
It is also good if the pt calls 800-MEDICARE or www.cms.gov and file a complaint against any provider for denying you care.
Any other kind of health insurance… you just have to ask what their appeal process is and if they don’t offer… ask for the details in writing… the more times you appeal … the more likely the pt will get a YES/APPROVED.
Today, CMS released a Notice of Funding Opportunity (NOFO) to solicit applications for the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act post-planning period, demonstration project.
Open to only the 15 states receiving planning grants, this 36-month demonstration project seeks to increase the treatment capacity of providers, participating in the state’s Medicaid program, to provide substance use disorder treatment and recovery services.
Additionally, CMS released a technical supplement that provides detailed information regarding how the agency will implement the SUPPORT Act payment provision for the states that are selected for the demonstration.
The chronic pain community needs to make note of this … The PRIMARY CHARGE of the various State Boards of Pharmacy (BOP) is to protect the health/safety of the general public. Historically, when Pharmacists complain about working conditions .. the typical BOP’s response – if they bothered to responded at all – is that they don’t have the authority to interfere in how the owner of the pharmacy runs their business. It took HUNDREDS of complaints from Pharmacists to the MO BOP to get them to react and seemingly take action. Under the original Pharmacy practice acts, there was a Pharmacist that was designated “Pharmacist in Charge” (PIC) .. ” back in the day” the majority of community pharmacies were independently owned … so the Pharmacist/owner ended up being the “Pharmacist in Charge” and was legally responsible to the BOP for the legal operation of the pharmacy… Starting in the late 80’s the pharmacy chains started expanding dramatically… it was reported at their peak … one such national chain was opening a “brand new store” every 15 hrs – 7 days a week.
Now that the chain drug stores dominate the local community pharmacies … many BOP or state legislatures have changed the term PIC to Responsible Pharmacies… and in the case of the chain stores.. the former (PIC) is in CHARGE OF NOTHING and RESPONSIBLE FOR EVERYTHING THAT GOES WRONG.
Then this article appeared in 2008 Chains’ ties run deep on pharmacy boards So the majority of BOP’s were dominated by corporate Pharmacists… many no longer practicing… just executives of the pharmacy chains… and since the chains are the ones with the most lobbying money… either the BOP changed the designation of the PIC or the chains used their lobbying money to influence the state legislature to make the change.
Those in the community who believe that a few complaints to any state medical licensing board will gets some action, should pay attention that it took HUNDREDS OF PHARMACISTS to get – MAYBE – for the BOP to take some actions to help protect the health and safety of the general health – THEIR PRIMARY CHARGE ALL ALONG !
Missouri to probe pharmacists’ working conditions after hundreds of complaints
Missouri’s board of pharmacy is forming a task force to investigate working conditions at pharmacies across the state after hundreds of pharmacists have alleged they’ve been overworked, pressured to meet metrics and don’t have time to fill prescriptions safely, the St. Louis Post-Dispatch reported July 3.
Some pharmacists told the board they’re unable to take a break or go to the restroom during their shifts. Ron Fitzwater, CEO of the Missouri Pharmacy Association, told the Post-Dispatch: “I’ve heard pharmacists say that they don’t drink anything before they go on shift because they’re afraid they may not get a bathroom break. That’s not even healthy, much less a good business practice.”
The pharmacy board said it would appoint the task force this month, and that it will investigate pharmacists’ working conditions, including staffing, prescription volume and rest breaks.
“While the board recognizes business needs, patient safety should not be jeopardized for company profits,” the board stated in April.
Of 963 pharmacists surveyed in Missouri in 2019, 60% said they agreed: “I feel pressured or intimidated to meet standards or metrics that may interfere with safe patient care at my practice site,” the Post-Dispatch reported.
Fifty-two percent said they didn’t have adequate time to do their job safely and effectively. A 2019 study by the American Association of Colleges of Pharmacy found 71 percent of U.S. pharmacists rated their workload as “high” or “excessively high.”
Kimberly Grinston, executive director of the pharmacy board, told the Post-Dispatch that the COVID-19 pandemic has placed more demands on pharmacists, including administering COVID-19 vaccinations. There also have been more staff absences because of quarantine or illness, she said.
Some states have passed laws requiring breaks for pharmacists or mandating staffing ratios of pharmacists and pharmacy technicians, but Missouri doesn’t have any such laws, the Post-Dispatch reported.
Two of the nation’s largest retail pharmacy chains, CVS and Walgreens, both told the Post-Dispatch that they are committed to patient care.
CVS stated that it looks forward to “working cooperatively with the Board of Pharmacy in our common goal of providing safe and high-quality pharmacy services to Missouri patients.”
Walgreens said it is “committed to ensuring that the entire pharmacy team has the support and resources necessary to continue to provide the best care to our patients.”
HUNTINGTON — After resting its months-long case in which the city of Huntington and Cabell County accused drug distributors of helping to cause the opioid crisis in the area, the municipalities faced their biggest obstacle Thursday — satisfying an inquisitive judge.
The trial stemmed from the local governments’ accusations against AmerisourceBergen Corp., Cardinal Health and McKesson Co., who they accuse of fueling the opioid crisis by shipping 127.9 million dosage units of opioids to the community over eight years before a reduction of shipments made people with substance use disorder turn to illicit drugs.
The distribution companies argue the Drug Enforcement Administration, doctors’ prescribing habits and West Virginians’ history of poor health as the reasons behind the shipments.
After 32 days of testimony from witnesses, the plaintiffs rested their case Thursday, which was followed by a day of arguments from the defense, who seek to have the case tossed out.
A sharp statement by U.S. District Court Judge David A. Faber, the cases’ decider, set the tone at the beginning of Thursday’s arguments, begging the question if the public nuisance law was broad enough to address the plaintiffs’ cause of action, which seeks $2.54 billion to abate the opioid crisis over a 15-year period.
Faber, who is the ultimate decider in the bellwether bench trial, has been engaging with witnesses and attorneys since the trial began in early May, but his interest was heightened as he grilled plaintiff attorneys about the theory on which they built their case.
McKesson attorney Timothy Hester said the law did not cover the plaintiffs’ claims because they are attempting to disguise a damages case as an abatement one after having waived their claims for damages in exchange for a bench trial, he said.
“They are stuck in a box,” he said.
The abatement plan calls for prevention, treatment, recovery and the needs of special populations. The plan includes claims for future nuisance and treatment for future opioid use disorder (OUD) population, for which it would be improper for the judge to make them pay, Hester said.
The attorneys argued conduct must be proximate, not a remote cause of injury, for there to be guilt. They argued the proximate conduct was that of doctors over prescribing, illicit drug dealers and others. The plaintiffs lean solely on the high volume of pills being shipped to the county, the defense said, but the number of pills distributed matched the number of pills prescribed.
Hester said the plaintiffs bear a heavy burden of proving harm is reasonably certain in the future as a result of the defendants’ conduct. Hester said the plaintiffs did not prove during the trial future conduct by the defendants, and they don’t even know if the defendants would be shipping opioids to the county in the future.
The defendants have already highly reduced the number of pills shipped to the community, which remedies the future claims, he said.
Majestro said the defendants want to blame the people below and above them in the supply chain, but when it comes down to it, they were registrants with the DEA who had the same heightened responsibilities as others in the chain.
He pointed to a deposition the judge listened to in chambers in which someone testified the existence of an annual opioid quota set by the DEA did not negate the defendant’s duty to monitor and stop suspicious orders.
Hester said the court must avoid giving the two an “improper windfall.” He said it’s clear the community has a strong recovery community with the funds they have now.
The defendants did not say the plaintiffs did not prove their case; their argument is that their conduct was too remote for them to be held culpable, Majestro said.
Lane Heard, an attorney for Cardinal Health, said federal courts lack the power to grant relief not narrowly tailored to the wrongful conduct.
The defendants have continuously throughout the trial attempted to divide the opioid crisis into two — a prescription pill one and an illicit opioid drug one. The plaintiffs seek abatement for all opioid drug abuse and effects, but the defense argued it would be improper to blame the defendant’s for the illicit market. Several epidemiologists testified there is only one opioid crisis, which cannot be divided.
Heard said the plaintiffs want remedies for future addiction and the wrongs of others, remedies that are remote from Cardinal Health’s conduct and are instead related to the root causes of drug abuse.
Faber said the plaintiffs were seemingly casting a net too wide and called the gateway theory connecting heroin to prescription pills thin. Farrell said four out of five people who use heroin started opioid use with prescription pills.
He said what sets opioid use disorder aside from other harms, such as smoking, is that people with OUD are going into the community and creating community harms via crime, the spreading of disease and more.
Farrell asked the judge to imagine all people affected by the opioid use disorder placed in a pond polluted by multiple sources: community members, past and present prescription and illicit opioid users, governments, etc.
A company could be forced to clean the pond, but it would also screen out the pollutants dumped by others.
“It doesn’t negate the fact that a treatment facility is needed to begin with to treat this condition,” he said.
Neither the city nor the county run recovery programs or fund them fully, thus they cannot be awarded money to do so, and the plaintiffs did not evaluate the programs specifically to determine if they were enough, Hester said. Because of that, the plaintiffs did not give the judge enough guidance the court to know what type of relief would be proper, he said.
“There’s still an opioid epidemic in Cabell County, so whatever they are doing is not enough. (The current money) being spent is a drop in the bucket compared to what it’s going to take to eradicate the epidemic,” Majestro said.
Majestro said it’s not necessary for the plaintiffs to look at what the city and county are doing, because it is not enough. Most importantly, he said, what is happening now is not being done by the defendants, who caused it.
While the three defendants have reached several settlements with the DEA after alleged misconduct over the years, the defendants said those settlements did not prove guilt or wrongdoing by the companies.
The plaintiffs believe the evidence and testimony shows the trio had a systemic failure of their suspicious order monitoring programs; each defendant said they believe it proved the opposite.
AmerisourceBergen attorney Robert Nicholas said ABDC was sending shipment numbers to the DEA within two days, but the DEA witness said the amount of data was overwhelming and they didn’t know what to do with it.
The defendants said while the DEA took action against many of their various warehouses, none of them shipped pills to Cabell County.
“There’s no testimony the defendants’ policies were any different here than they were anywhere else,” Majestro said.
McKesson attorney Christian Pistilli said once you remove McKesson’s VA hospital shipments from the equation, it only accounts for less than 6% of the market share of opioids and much lower than the West Virginia average.
Faber took the defense’s motion under advisement and said he may rule on it later. The case will continue Friday, July 3, when the defense calls its first witness to the stand.
“The federal government’s current approach is a half-in, half-out regime that simultaneously tolerates and forbids local use of marijuana,” the conservative Supreme Court justice wrote.
Clarence Thomas, one of the Supreme Court‘s most conservative justices, said Monday that because of the hodgepodge of federal policies on marijuana, federal laws against its use or cultivation may no longer make sense.
“A prohibition on interstate use or cultivation of marijuana may no longer be necessary or proper to support the federal government’s piecemeal approach,” he wrote.
His views came as the court declined to hear the appeal of a Colorado medical marijuana dispensary that was denied federal tax breaks that other businesses are allowed.
Thomas said the Supreme Court’s ruling in 2005 upholding federal laws making marijuana possession illegal may now be out of date.
“Federal policies of the past 16 years have greatly undermined its reasoning,” he said. “The federal government’s current approach is a half-in, half-out regime that simultaneously tolerates and forbids local use of marijuana.”
Thirty-six states now allow medical marijuana, and 18 also allow recreational use. But federal tax law does not allow marijuana businesses to deduct their business expenses.
“Under this rule, a business that is still in the red after it pays its workers and keeps the lights on might nonetheless owe substantial federal income tax,” Thomas said.
The Department of Justice has instructed the nation’s federal prosecutors not to pursue cases against marijuana businesses that follow state law. And since 2015, Congress has prohibited the Justice Department from spending federal money to prevent states from carrying out their own laws.
But the IRS continues to enforce its own rules against growers and dealers.
The federal government’s “willingness to look the other way on marijuana is more episodic that coherent,” Thomas said.
It has often been reported that addicts that are being prescribed buprenorphine have often sold these meds on the street so that they can have money to buy illegal street opiates. It doesn’t seem to no strange coincidence that our Congress passed a law in 1999-2000 called the Decade of Pain Law and pain was quickly labeled as “the fifth vital sign” and the Join Commission who certifies hospitals to be able to bill Medicare & Medicaid and made it a MAJOR STANDARD to be met and failing to meet a major standard, which if broken could jeopardize the hospital’s certification. Doctors were encouraged to adequately manage a pt pain when in the hospital and of course.. those ideas of properly treating a pt’s pain became part of the doc’s treating pain when pts were in the doc’s office practice.
When the Decade of Pain law expired in 2009-2010… it was not renewed… The Joint Commission dropped the fifth vital sign as a major standard in their hospital certification process and opiate Rx prescribing peaked in 2011 -2012.
At the time, Florida seems to have a disproportionate rate of “pill mills” and in Jan ,2011 Rick Scott became governor and Pam Bondi because AG in Florida and they started a major crack down on those pill mills and President Obama & Joe Biden came to office in Jan 2009. Seemingly, those four people seems to trigger a “perfect storm of the war on drugs” In Bondi’s 2014 reelection campaign her videos claimed to have removed all the “pill mills/oxy docs” from the state https://youtu.be/jjlT8kgDQyo and after Rick Scott’s 8 yrs as FL governor… he was elected as FL’s new Junior Senator.
Many in the Federal and state governments started to “over utilizing” the Civil Asset Forfeiture Law… confiscating may be as much as tens of billions of dollars each year. Those confiscated assets these bureaucrats are able to put they in their budget coffers and those assets could be confiscated without any charges being filed nor convictions made. I was recently made aware of what appeared to be a new DEA agent in one of our southern states was harassing pharmacists that they were to limit all C-II Rxs to 90 DOSES… apparently she was so poorly trained that she was confused being the CDC dosing guidelines of 90 MME/day and 90 doses/month. I real good example that law enforcement has no business overseeing/interfering with medical care.
An undercover drug cop tried to shut down a doctor in Indiana. Soon, two patients were dead.
Ashley* lived with addiction and anxiety for years, but she was in recovery and making progress in 2017 after finding treatment at Jay Joshi’s clinic in northwestern Indiana. Joshi was known as a pioneer of telehealth visits for addiction patients that became widely used during the COVID pandemic, an expansion that lawmakers and the American Medical Association (AMA) are now pushing to make permanent. Joshi prescribed Ashley buprenorphine, a standard for treating opioid addiction and preventing overdose. Untreated mental health conditions can play a role in drug addiction that is often overlooked, so Joshi set Ashley up with a psychologist through a telehealth service. On November 21, 2017, Ashley was at Joshi’s office for a telehealth therapy appointment with her psychologist when Drug Enforcement Agency (DEA) agents arrived with a search warrant.
At the time, Joshi was unaware that an undercover DEA agent had posed as a patient at his office to build a drug trafficking case against him. Agents took Joshi to a local police station for hours of questioning, where Joshi surrendered his DEA registration that allowed him to prescribe controlled substances — including buprenorphine. When he returned from the police station, Joshi said Ashley was deeply traumatized. Ashley told Joshi that she protested the interruption of her therapy appointment, so a DEA agent pulled out a gun and ordered her onto the ground.
In grand jury testimony, former employees-turned-witnesses described the young primary care physician’s practice as sloppy and his patients as “addicts,” a deeply harmful and stigmatizing term for patients in recovery. Joshi was accused of operating a “pill mill” in the local media, a claim Joshi says was manufactured by the DEA. Ashley and other patients were blacklisted by other local doctors, and without a buprenorphine prescription, Ashley relapsed and suffered fatal overdose. Stephanie, another patient who had stabilized and quit using heroin under Joshi’s care, also lost her prescription to buprenorphine. She soon died of an overdose after returning to heroin.
“Any patient who was associated with me or had my DEA registration number on their prescription history, other physicians didn’t want to see them,” Joshi said.
Opioid Prescribing Plummets as Overdose Deaths Rise
Since the early 2000s, rising rates of fatal drug overdoses breathed new life into the failing war on drugs. As they have during drug scares of the past, the government and mainstream media declared an “epidemic” of opioid addiction, and the crackdown on painkiller prescribing that followed injected the DEA — the federal law enforcement agency charged with waging the drug war — deep into the medical system. Opioid painkiller prescribing dropped sharply as a result, but the number of overdose deaths continued to rise before skyrocketing during the COVID pandemic.
To understand the crackdown, Truthout obtained multiple DEA search warrants and court records detailing law enforcement efforts to shut down pharmacies and clinics, and interviewed chronic pain patients and their advocates, doctors, researchers, pharmacists and people recovering from opioid addiction across the United States. Their advocacy and research are poking big holes in longstanding media narratives linking painkiller overprescribing of the past to rising rates of fatal drug overdose today. A close look at the policing of opioids reveals a common theme of the war on drugs: Policymakers and drug police are harming the same people they claim to help. Like the drug war, the painful side effects of the opioid crackdown disproportionately fall on lower-income people and people of color, whether they use opioids for any reason or simply seek treatment for chronic pain. The prescribing crackdown appears to be exacerbating existing inequities in access to health care and addiction treatment, one reason why rates of fatal overdose are rising fastest in Black communities.
“I have seen how, in these public health crises, the people we sort of want to help become stigmatized and end up losing access to care,” said Kate Nicholson, a former civil rights attorney for people with disabilities and pain patients who founded the National Pain Advocacy Center, in an interview. “The way in which we wage the drug war disproportionately against communities of color means that they are likely to face much greater barriers to health care.”
Over the past decade, drug police began plundering data from private medical records services and statewide prescription monitoring databases to digitally surveil doctors, patients and millions of prescriptions. Often using federal prescribing guidelines that became a national controversyas a reference, drug cops with no formal medical training search for “red flags” in prescribing records, such as how far a patient travels to receive treatment or the total volume of controlled substances prescribed by a provider. The investigations have led to raids on hundreds of clinics and pharmacies across the country. In some cases, doctors and pharmacists strike plea deals for reduced sentences. In other cases, respected physicians, pharmacists and addiction specialists are caught in the dragnet and forced to fight the DEA in court.
Doctors and pharmacists became increasingly wary of prescribing and dispensing opioids or even agreeing to treat patients prescribed opioids for chronically painful conditions in the first place. Others had their registrations to prescribe controlled substances revoked by the DEA pending rulings by the agency’s own administrative courts, or they closed their practices in fear of being raided and charged with drug trafficking.
“I hear from people every day who have been forced off their meds and have lost their ability to work and function and are suicidal,” Nicholson said. “People are not just being force-tapered [off medication] … they can’t even get health care anymore, just because they need a prescribed opioid to treat pain.”
Both the legal and illicit markets for prescription painkillers shrank as a result of the crackdown and regulatory moves by the DEA. Illicit drugs such as heroin and counterfeit pills containing potent synthetic opioids replaced prescription painkillers in the illicit market. Opioid prescribing rateshave plummeted since 2012, but rates of fatal drug overdose increased for years before briefly leveling off in 2018 as policymakers worked to make treatment more accessible. Overdose deaths began rising again in 2019, and then the COVID pandemic hit, isolating patients and drug users from friends, family and health supports. From October 2019 to October 2020, the number of overdose deaths recorded by the CDC surpassed 92,000, the highest level in decades.
There are multiple factors and drugs besides opioids (methamphetamine, for example) behind the overdose epidemic. CDC overdose data is not always accurate, and overdose deaths often involve multiple drugs, including alcohol. Research shows that only a small percentage of overdose deaths are caused by prescription opioids alone. Illicit drugs containing fentanyl are driving the historic rates of death in part because, unlike prescription drugs, they can vary widely in potency, particularly when law enforcement disrupts the supply. A 2020 study found that 57 percent of 2,887 military veterans who died of overdose or suicide had a prescription to painkillers that was cut off by their doctors.
“I believe that a lot of the industrial binary focus on stopping opioid prescriptions reflects a belief that that will somehow stop overdoses from happening … that if we just stop these patients from receiving the pills they are on, they will be protected,” said Stefan Kertesz, a physician and professor of preventative medicine at the University of Alabama who is studying links between reductions in prescribing and suicides. “That presumption just has not held up, so far.”
At the same time, the government has been slow to lift barriers to the most effective medications for treating opioid addiction and preventing overdose, methadone and buprenorphine, which are heavily scrutinized by police and surveilled by the DEA because they are also prescription opioids.
Nationally, less than 6 percent of doctors are allowed to prescribe buprenorphine under a special federal waiver that medical experts and advocates say must be removed to save lives. The waiver takes a day or so to obtain, but advocates say many doctors don’t bother due to the stigma around treating people with opioid addiction. Like Joshi, numerous doctors who do prescribe buprenorphine have been targeted by the DEA. A study released in May by researchers in Oregon found that one in five pharmacies in counties with high rates of opioid overdose refuse to dispense buprenorphine. The problem is especially prevalent among independent pharmacies, which are often targetedover large companies by drug cops seeking out the latest “pill mill” to bust. Patients recovering from addiction say buprenorphine is often difficult to access even when it’s stocked by a local pharmacy due to stigma reinforced by fear of law enforcement.
A Safer Supply Is Criminalized
In the final days of the Trump administration, James Carroll, President Trump’s drug czar, boasted that the “prescription opioid epidemic is now over.” A major decrease in opioid prescribing and related overdoses, Carroll said, was one of the administration’s major achievements. Critics were irate. How could the Trump administration claim victory when overdose deaths were ballooning on their watch?
Six months earlier, the AMA warned the Trump administration that the overdose crisis had never just been about prescription opioids, and the nation is now facing an unprecedented “multi-factorial” crisis driven by drugs such as illicit fentanyl. The government could no longer view the crisis through a “prescription opioid-myopic lens.” Moreover, chronic pain patients are harmed by the crackdown and the CDC’s prescribing guidelines, which caused large numbers of patients to be forcibly tapered off their medication or cut off altogether, often against their will.
“There is no evidence that forced stoppage of the individual’s medications leads to a better outcome, none,” Kertesz said. “That’s crucial.”
Kertesz pointed to a new study showing that the net effects of policies that encourage doctors to lower the dose of opioids prescribed to patients are uncertain, but rapid discontinuation of opioid therapy is associated with increased risk of overdose and suicide. Abrupt stoppage of opioid therapy has become the “norm,” Kertesz said, and those who argue that policies aimed at decreasing opioid prescribing over the past decade simply represent more “judicious prescribing” practices are misleading the public.
“There are 8 to 10 million people on long-term opioids, and a meaningful number of those people actually need to be on them, so setting up a system that by design abandons 1 to 10 million patients is not a good thing, but we have set that up,” Kertesz said. “We have now set up incentives for doctors and pharmacists to avoid care for those people, many of whom have disabilities.”
In 2018, senior analysts at the CDC revealed that for years, the number of overdose deaths the agency attributed to prescription opioids was vastly inflated due to problems with data collection classification. For example, deaths caused by illicit fentanyl were blamed on the prescription form of fentanyl, which is often used in emergency rooms. Overdoses involving a combination of drugs were also misclassified. Last year, researchers concluded that, for over a decade, “millions of Americans” were “misled” by the CDC, politicians and the media to believe that the drug overdose crisis was driven by deaths caused by prescription opioids.
Patients prescribed opioids to treat long-term chronic pain are organizing across the country to overturn the CDC guidelines, and the debunking of CDC data and the AMA’s statement validated their cause. In interviews, multiple chronic pain patients said prescription opioids help them live more normal lives, but their lives became collateral damage of the war on opioid prescribing. Patients report that doctors refuse to treat them and pharmacies won’t fill their prescriptions, leaving them in disabling pain. Mothers are punished by hospitals after childbirth and even charged with crimes for continuing opioid therapy prescribed by a doctor during pregnancy.
“Opioids can be used safely during pregnancy, and we also know that when the response is immediately punitive or the application of the criminal legal system, there is actually far worse outcomes for babies and families, instead of being able to work that out with their doctor,” said Dana Sussman, deputy executive director of the National Advocates for Pregnant Women, in an interview.
Chronic pain patients and their advocates argue that the narrative linking opioid prescribing to the overdose epidemic is a “hoax,” and they are engaged in a pitched media battle with the “anti-opioid zealots” who pushed the CDC to discourage long-term opioid prescribing for anyone besides cancer patients and people dying in hospice. Advocates point to research showing that rates of fatal drug overdose correlate with economic decline in many communities and have been rising rapidly since the late 1970s, not the mid-1990s when painkiller prescribing became more liberal thanks to campaigns by drug companies that have garnered plenty of headlines. The prescribing debate is extremely emotional, with each side attacking the other over credentials and alleged ties to the pharmaceutical and biomedical industries. (Kertesz said he was attacked in the media by an “expert in the field” for simply announcing a study on deprescribing and suicides. “Attacking investigators in the absence of any knowledge of their work would not be customary behavior in any area of medicine,” he said in an email. “But in this topical area, it is.”)
“The way tapering is happening in the real world is just horrible, even for people who are using their medication appropriately,” Nicholson said.
As an addiction specialist working at an emergency room and poison control center in Ohio, Ryan Marino has plenty of experience on the front lines. The narrative that overprescribing is causing an overdose crisis is clearly overblown, Marino said, because reductions in prescribing has not brought down deaths. Marino says he often sees patients who were prescribed high doses of opioids for years until their medication was abruptly tapered or cut off after CDC prescribing “guidelines” became public policy and even law in some states.
“Those patients went through hell … naturally, some turned to street drugs because it is so miserable to have opioids cut off, whether you have addiction or not,” Marino told Truthout. “Seeing those patients has cast an additional shadow over this overdose epidemic that we are seeing, because the over-reactionary response is now creating additional harms.”
Marino said the manufacturing and dispensing of opioids can be a real money-maker in a for-profit health system, and overprescribing played a role early on in the crisis. At the same time, prescription drugs are much safer to use than illicit heroin and fentanyl. Marino said there are good arguments for access to a safe supply of opioids — including prescription heroin for people at high risk of overdose — because people using regulated opioids under medical supervision are far less likely to die.
“We need some sort of regulation [of prescribing], but the oversight the DEA provides seems more in line with reducing prescribing than ensuring that prescribing is appropriate and ensuring that people have access to prescriptions,” Marino said. “The reality is, most people who were using Oxycontin never wanted to switch to heroin, and people who were using heroin never wanted to switch to fentanyl.”
Kertesz, who has worked closely with low-income and houseless patients, also takes a nuanced view of prescribing. Like Marino, Kertesz said there were problems with overprescribing in the past, when medications were heaped upon patients instead of affording them more holistic care. However, abruptly cutting patients off from medicines they depend on can cause all sorts of problems, particularly for people who have trouble consistently accessing health care in the first place. Doctors must make prescribing decisions based on the particular needs of a patient, but the crackdown has siloed prescribing as either “appropriate” or potentially illegal.
“We have now set up an entire system to push a change to care that does not have evidence for being safe or effective for patients,” Kertesz said.
For example, law enforcement often sees a “red flag” when patients are prescribed high doses of opioids or combinations of controlled substances, even when the prescriber is simply continuing the patient on a long-term regimen. While scrutinized by drug police as a sign of criminal activity, Nicholson said some patients benefit from drug combinations under appropriate medical supervision. Kertesz said assuming something “criminal” is going on when patients are prescribed higher doses of opioids or more than one psychoactive drug at a time is “a big leap.” The same goes for other “red flags” drug police look for in statewide prescribing databases and records kept by pharmacies.
“A patient who has filled a script in two pharmacies, or a patient who has traveled a distance … anybody who has multiple complex needs is already suspect, anyone who is rural by definition is suspect,” Kertesz said. “Pharmacists are trying not to lose their jobs, so they transfer all this stigma and burden to patients.”
There is a difference between “drug dependence” and “drug addiction.” Addiction is characterized by impulsive drug use despite adverse consequences. Physiological drug dependence results from the continued use of many medications — not just opioids. Addiction is rare in patients prescribed opioids for pain, and while long-term use can create dependence, the benefits can also outweigh the harms. People living with opioid addiction may also be seeking relief from untreated pain, trauma or mental anguish. Either way, abruptly cutting people off from opioids is dangerous. That’s why methadone and buprenorphine are prescribed for opioid addiction and dependence. Both drugs stabilize patients and stave off painful withdrawal symptoms, which is crucial for preventing overdose.
Advocates say the nuance is lost on the DEA and other law enforcement agencies. Drug cops are laser-focused on opioid “diversion,” the idea prescription opioids are being sold and used outside of their intended purpose. Data on diversion varies by source; a 2017 federal survey found that less than 11 percent of people who misused prescription opioids bought them on the street or stole them from a pharmacy or medical facility. If the rest are “misusing” their own prescriptions or obtaining them from friends and family — an idea that often offends pain patients — then anti-diversion efforts are effectively targeting prescribers and patients themselves.
For years, the government and mainstream media claimed diversion was the source of the overdose crisis, even as the data began telling a much different story. There is plenty of anecdotal evidence, for example, that buprenorphine is usually diverted to people living with addiction. Vermont recently decriminalized possession of buprenorphine without a prescription for that reason. The crackdown on diversion created grey areas that turned doctors and pharmacists into suspected drug dealers and patients into suspected criminals. In an ironic way, it worked. Pills became harder to find on the street, but reducing the supply did nothing to treat chronic pain or addiction. Overdoses involving illicit opioids are surging, and a growing chorus of drug users and advocates declare that “every overdose is a policy failure.” The DEA did not respond to a list of questions by the time this article was published.
“They Look at Prescribing as a Crime”
Joshi ran a general medical practice in Indiana, and he prescribed opioids for chronic pain as well as addiction. The DEA claimed Joshi was writing more prescriptions for controlled substances than most doctors in Indiana; Joshi says he served a population with serious medical needs. It was the undercover DEA agent’s job to pose as a “drug seeking” patient and catch Joshi in the act of prescribing and secretly record it on video. Joshi says he tended to trust his patients, but trusting the undercover agent was his downfall. He also suspects a former employee wrote fraudulent prescriptions before becoming an informant for the DEA, although he has been unable to prove it.
“They are transplanting people in the health care field as a drug-dealing ring, so I am the captain drug dealer; you snitch on me and you go free,” Joshi said.
Terrified, Joshi accepted a plea deal after he was indicted on multiple drug charges. However, the DEA’s case against him shifted over time and relied on inconsistent witness testimony, leaving a federal judge frustrated when the time came for sentencing, according to a review of court documents. The DEA accused Joshi of recklessly prescribing controlled substances, but prosecutors were unable to produce evidence that his patients did not have legitimate medical needs for the drugs Joshi prescribed. Multiple patients testified that Joshi’s practice made serious improvements in their lives. A day before Joshi was indicted, his clinic was recognized by the National Committee for Quality Assurance for “patient-centered, coordinated care.”
“A lot of people have it a lot worse than I do; there really wasn’t any evidence in my case,” Joshi said. “They essentially made a bunch of false statements.… Just the act of prescribing, it was construed as a crime. They don’t look at the clinical decision-making behind a prescription, they look at prescribing as a crime.”
A young doctor with a new practice and a child on the way, Joshi admits that he made mistakes. After losing his registration to prescribe controlled substances, Joshi says he unknowingly broke state rules by hiring nurse practitioners to write prescriptions for his patients. He also wrote a handful of prescriptions under another doctor’s name. Joshi says he tried to find workarounds out of concern for his patients. He did not want their “continuum of care” to be interrupted, but the judge saw a violation of the law.
“I tried to do what was right for my patients, but that was a deviation against the regulatory policies,” Joshi said.
Joshi was sentenced to 15 months in prison for writing an unnecessary prescription to an undercover DEA agent. He got out a few months early on good behavior. By the time he was sentenced, many of his patients were receiving the same treatment they had received from Joshi from other doctors. Stephanie and Ashley were not so lucky. Both women overdosed and died after law enforcement suddenly interrupted their medical care and their safe supply of medication ran out.
*Ashley’s name has been changed to protected her identity.
Chargemaster prices for generic drugs in hospitals can be 6,000 percent higher than the price of the same drug in a pharmacy, according to an analysis by GoodRx, a pharmacy discount company.
GoodRx analyzed chargemaster prices for 12 common generic drugs at 16 geographically diverse hospitals across the U.S. and compared the prices to cash prices at pharmacies. The company said cash prices are readily available and provide a good benchmark for the “fair” price consumers should pay for a generic drug.
The researchers found that generic drugs may not be as affordable in an inpatient or emergency room setting as at a pharmacy, even if they’re the exact same medications, and that charges for routine generics vary greatly from hospital to hospital.
For example, Sunrise Hospital in Las Vegas charges $57 per 50 mg tablet of sertraline, the generic version of Zoloft, a popular antidepressant. Camden Clark Memorial Hospital in Parkersburg, W.V., charges three different prices for the pill, all around $0.50 per pill, a more than 115% difference in pricing compared to Sunrise Hospital.
Camden Clark Memorial Hospital and Albany Memorial Hospital in New York both charge about $0.40 per pill of lisinopril, which is used to treat high blood pressure and heart failure. But Greater El Monte Community Hospital in South El Monte, Calif., lists a price of $19 per pill, and Sunrise Hospital charges $43 per pill.
Aspirin, a widely used painkiller, has an average retail price of $0.15 in most U.S. pharmacies, according to GoodRx, making a monthly supply about $4.50. But in hospitals included in GoodRx’s analysis, the average price is about $6 per tablet, varying from as little as $0.17 to $19 per tablet, depending on the hospital.
The researchers noted that health insurance insulates many from paying the chargemaster prices at hospitals, but the prices still affect the uninsured, those with high deductibles and those treated in out-of-network hospitals.
