I have not had time to listen to this TWO HOUR webinar… just sharing it right now
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Medical Board of California Interested Parties Meeting Prescribing Guidelines November 15, 2022
Posted on November 17, 2022 by Pharmaciststeve
Oklahoma proposes landmark rule to keep mailed medications safe from extreme temperatures
Posted on November 17, 2022 by Pharmaciststeve
Most all medications have a temperature storage requirement – typically 59-86 F – and pharmas, wholesalers, pharmacies are required to keep medications within that range and if they are outside of that temp range > 24 hrs… the potency of the medications are generally considered “compromised”… BUT… when a mail order pharmacy hands off a package containing Rx meds to a delivery carrier ( USPS, Fedex, UPS) seldom is there any concern about the temp that the medications are exposed to and for how long. When specialty meds – that require being kept at refrigerator/frozen temps… the mail order pharmacies will typically take extra efforts to try to make sure that the meds are kept in the required temp range. Sometimes, the delivery carrier does not deliver the Rx meds in the expected time frame and they show up at the pt’s home… outside of the required storage temp and UNUSABLE. Many times, the med involved is a life critical matter and getting a replacement in a timely manner is not always possible.
Oklahoma proposes landmark rule to keep mailed medications safe from extreme temperatures
https://www.nbcnews.com/health/health-news/oklahoma-proposes-rule-keep-drugs-safe-hot-cold-rcna57492
There is little regulation of how pharmacies ship drugs to patients, though extremes of hot or cold can make medicine unsafe or ineffective.
Patients who get their prescription medications by mail in Oklahoma may soon have better protections for the safety of those drugs than any other state. On Wednesday, Oklahoma regulators proposed the nation’s first detailed rule to control temperatures during shipping, according to pharmacy experts.
“This is a huge step,” said Marty Hendrick, executive director of the Oklahoma State Board of Pharmacy, after the board voted to approve the rule Wednesday. “We’ve got a tremendous amount of prescriptions that get mailed to patients. … What we did today was make sure our patients in Oklahoma are receiving safe products.”
Exposure to extreme temperatures can degrade or weaken drugs, potentially changing their dosage or chemical makeup and rendering them ineffective or unsafe for patients. But while government oversight of how pharmacies store medications to keep them in defined safe temperature ranges is very detailed, an NBC News investigation in 2020 found oversight of shipping to patients — during which drugs might be exposed to heat waves and below-freezing temperatures — is largely a system of blind trust. Mail-order pharmacy is a booming business, with soaring profits for some of the nation’s largest companies last year and more than 26 million people receiving their medication by mail in 2017 — more than double the number two decades earlier, according to federal data.
NBC News found that most state pharmacy boards, the regulators responsible for pharmacy safety, did not have specific rules for how pharmacies should ship customers’ medication, few asked about this process in their inspections, and many said it was simply up to the pharmacy to ensure safe shipping.
Industry standards are clear that pharmacies should ship medications in their safe temperature range — set by the manufacturer after extensive testing under Food and Drug Administration guidelines — yet many patients have no way of knowing if the medications that arrive at their door have stayed within that range.
“So many insurance providers are really pushing patients to use mail order,” said Erin Fox, director of drug information at the University of Utah Health hospital system, who researches drug quality and shortages. “Unfortunately, many patients don’t have a choice in their insurance coverage to be able to use a local pharmacy, so having these protections is important.”
The proposed Oklahoma rule is the first of its kind to set clear guidelines on temperature safety during transit. It would require all pharmacies shipping or delivering medication to use packaging tested to ensure drugs do not go outside their safe temperature ranges, require them to be able to assess the safety of a medication if there are delays in delivery, and mandate that they give patients notification of shipping and delivery.
“Oklahoma is at the forefront in developing regulations on this topic,” said Desmond Hunt, the storage and distribution expert and senior principal scientist at United States Pharmacopeia, the nonprofit that sets the quality and safety standards for medications that are used by the FDA, manufacturers and pharmacy boards. “How this evolves within Oklahoma may be a blueprint or a template for other states.”
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a new “band-aid” for dealing with KNEE PAIN ?
Posted on November 17, 2022 by Pharmaciststeve
Want a Few Weeks of Knee Pain Relief? Try This
https://www.medpagetoday.com/meetingcoverage/acr/101699
Local nerve block proves mettle in randomized trial, though benefit didn’t last long
PHILADELPHIA — Blocking agents delivered to genicular nerves around the knee markedly reduced osteoarthritis patients’ perceptions of pain, far more than those receiving placebo injections, a randomized trial showed.
At week 4 following the injections, patients in the nerve block group reported mean reductions in pain scores of 3.0 points from baseline on a standard 10-point scale, compared with an average 0.2-point reduction among those assigned to placebo, reported Ernst Shanahan, BMBS, MPH, PhD, of Flinders Medical Centre in Adelaide, Australia, and colleagues.
But by week 8, the effect had clearly begun to fade, with average pain scores rising by 0.7 points from week 4 in the nerve block group. And at week 12, mean scores had increased another 0.7 points and no longer differed significantly from the placebo group.
The findings were published in Arthritis & Rheumatology and were also set to be presented Monday at the American College of Rheumatology annual meeting.
It’s the first demonstration in a randomized, placebo-controlled trial that local nerve block effectively relieves knee osteoarthritis pain.
Shanahan and colleagues conceived the trial to determine whether previous reports of success in individual cases were really credible. These were summarized in a recent review, which indicated that the approach improved function and reduced pain for up to 6 months. But these studies had no controls, a crucial limitation given that knee osteoarthritis pain is notoriously subject to the placebo effect.
For the randomized trial, Shanahan’s group enrolled 64 patients, assigned 1:1 to receive nerve blocks or placebo in a single session. Celestone chronodose and bupivacaine were the blocking agents used, injected adjacent to three nerves around the knee: the superolateral, superomedial, and inferomedial genicular nerves. These were located via ultrasound for precise placement. The placebo group received subcutaneous saline injections at the same sites on the skin surface but not penetrating to the nerves. Patients were allowed to continue taking their usual pain medications as needed.
Pain was assessed via visual analog scales. Overall osteoarthritis severity was evaluated with the Western Ontario-McMaster Universities Osteoarthritis Index (WOMAC) system, which measures pain, stiffness, and disability in separate domains and in a total score.
Mean patient age was about 70 in the nerve block group and 66 in the placebo group. Just over half of the former were women, while two-thirds were women in the placebo group. Baseline pain scores averaged 6.3 in the nerve block group and 5.5 in the placebo group.
All of the key outcome measures including WOMAC scores followed the same pattern: the nerve block group saw sharp improvements at their first post-injection evaluation, conducted at week 2, which was maintained through week 4. Scores on each then began returning to baseline levels. The placebo group, meanwhile, had little change in any measure during the study.
The latter may raise eyebrows among rheumatologists, given that placebo recipients in other intervention trials for osteoarthritis typically show major improvement, if temporary. Shanahan and colleagues offered an explanation in the journal report: “We speculate that the patients’ prior pain experiences, extending over years, the degree of severity of their structural changes (most were waiting for total knee arthroplasty), or the fact that the trial was a placebo-controlled study and not a comparator study may have diminished the placebo effect.”
Overall, though, the future looks bright for nerve block as an osteoarthritis palliative. “Many of the patients requested repeat [treatments] at the end of the study. Based on our findings, we believe it is reasonable to offer this intervention,” the researchers wrote.
The nerve blocks appeared safe as well as effective. Shanahan and colleagues said no complications were observed, either during procedures or at subsequent clinic visits.
Limitations included the small number of patients and the possibility that patients could tell which treatment they were getting (clinicians giving the injections obviously were not blinded). Also, the researchers noted that five patients were lost to follow-up, which “may have slightly affected the overall results of our study.”
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Could the way healthcare is provided be changing FOR THE BETTER ?
Posted on November 17, 2022 by Pharmaciststeve
Here’s what people were talking about at HLTH this year (it’s probably not what you think)
https://www.linkedin.com/pulse/heres-what-people-were-talking-hlth-year-its-probably-beth-kutscher/
I spent this past week at HLTH (https://www.hlth.com/), the healthcare innovation conference that brings together several thousand people from across healthcare’s different sectors: from hospitals to insurers to pharma to healthtech, and using healthcare is essential as well, and you can contact a health insurance agent near me to get the insurance.
The exhibit hall was filled with hopeful startups seeking interest and investment in a tough economic climate – while venture capitalists saw a buyer’s market as valuations soften, particularly for later-stage firms.
And yet if you want to know what was top-of-mind for the doctors and executives I interviewed, it was this: not technology, not innovation, but … value-based care. Not exactly what I was expecting.
Value-based care is the concept of paying healthcare providers for the outcomes they produce, rather than the number of services they perform. It’s about incentivizing them to keep people healthy, sharing in the savings when they do and taking on financial risk when they don’t.
It’s hardly a new concept – the Affordable Care Act accelerated the transition more than anything in recent years – but the COVID-19 pandemic seems to have created more momentum (or at least more acceptance) around the idea. Of course, with budgets being squeezed and providers feeling overwhelmed, perhaps it’s not that surprising that the biggest innovation they’re looking for is one that allows them to get back to basics.
Here are some of the ideas I heard in my conversations at HLTH:
Value-based payments could help with clinician burnout.
The old model of paying for care – or what’s known as fee-for-service – is often criticized for creating perverse incentives: the more billable services doctors provide, the more they get paid. But in specialties like family medicine and pediatrics, the most helpful interventions are often the least lucrative, like counseling patients on lifestyle changes. Doctors, then, are caught in the middle, unable to spend as much time with patients as they’d like while still making the numbers work.
Moreover, primary care providers often do the important work of keeping patients from needing higher-cost specialty care down the road – without seeing the financial benefit of doing so.
Would value-based care solve that problem? Toyin Ajayi, the co-founder and CEO of Cityblock Health, thinks it would, by allowing doctors to spend more time doing what they trained to do: helping people get better. And that could have the added benefit of keeping them in practice.
Cityblock, which operates in six states plus the District of Columbia, takes care of some of the most challenging patient populations, including Medicaid recipients. It focuses not only on providing medical care, but addressing social issues like transportation or housing. What it doesn’t focus on, though, is RVUs, a way of calculating physician reimbursement based on the number and type of services they provide.
“That has helped us a lot in recruiting people who really want to be here,” said Ajayi, a physician herself.
Value-based care will encourage team-based care.
Healthcare providers like Cityblock rely on integrated care teams that bring together clinical and non-clinical staff. And that’s a model that needs to be implemented more broadly, said Jay Bhatt, managing director at Deloitte.
As an internist, Bhatt could be scheduled to see as many as three-dozen patients each day – something that would be a recipe for burnout without other staff members to focus on patients’ non-medical needs. Hiring additional help also allows doctors to focus on doing the things where they can add the most value.
“Sometimes it feels easy to do it yourself but it actually takes more time,” Bhatt said, referring to the non-medical tasks that doctors do instead of delegating them. “We need to do something radical and different.”
Financial constraints will create pressure to hold down healthcare costs.
The macroeconomic climate is creating a “triple whammy” for health systems, said @Ralph de la Torre, chairman and CEO of Steward Health Care , which operates the country’s largest Medicare accountable care organization (an ACO is a type of value-based care model.)
Prices are increasing for healthcare equipment and supplies, while governments are trying to rein in spending by lowering reimbursement. Employers, meanwhile, also want to contain costs, which tends to mean moving more people onto high-deductible insurance plans – creating more challenges for healthcare providers when it comes time to collect payment.
“We haven’t had that in years and years and years,” de la Torre said.
He too predicted that the economic challenges will usher in more value-based contracts, and that hospitals will therefore need to run leaner operations to prepare for them. With the staffing crisis expected to continue, however, those savings won’t be through lower labor costs but efforts to change consumer behavior.
More specialties will warm to value-based care – even if they’ve been skeptical.
The psychiatry field has always been a bit wary of capitated payments; after all, mental health conditions can be notoriously hard to treat, with some disorders seeing high relapse rates. But with increasing research and attention on how someone’s environment impacts their mental wellbeing – whether that’s a history trauma, adverse childhood events or being in a tenuous living situation – figuring out how to compensate clinicians for addressing those issues is top of mind.
Juliana Ekong, who has spent most of her psychiatry career trying to help address those underlying stressors for patients, said she’s glad to see payment models moving in that direction. Ekong, who was previously at Cityblock, is now the CEO of Better Life Partners, which provides care to patients with substance abuse disorders, with engagement rates that are double what other providers see. Just over half of its payments come from capitated contracts.
“If I had the words [early in my career], what I wanted was someone who would pay me for outcomes,” she said. “I definitely don’t think you can do this work if you’re doing it as a point solution.”
Now tell me: What do you think of the transition to value-based payments? And if you were at HLTH, what do you think were some of the most interesting themes that emerged?
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Marijuana Smoking Increases Emphysema Risk, Study Suggests
Posted on November 15, 2022 by Pharmaciststeve
I am not opposed to the use of legal medical marijuana. I have always had a concern of the SMOKING of MJ and/or smoking anything for that matter. There are other ways to utilize medical MJ, eatables, compounded Troches that are put under the tongue and/or between the cheek & gum. There is also the potential use of a mini-nebulizer as long as the MJ is in a Sodium Chloride and not having some oily substance. All those people having serious lung damage and/or dying from vaping “boot-leg” vaping fluids that “they” used Vit E acetate as a thickening agent and Vit E is a fat soluble substance.
Marijuana Smoking Increases Emphysema Risk, Study Suggests
Airway inflammation also more common in marijuana smokers than tobacco-only smokers
https://www.medpagetoday.com/pulmonology/smoking/101765
Emphysema and airway inflammation were more common among marijuana smokers compared with tobacco-only smokers, according to a small retrospective case-control study.
In sex- and age-matched analyses, marijuana smokers — most of whom also smoked tobacco — had significantly higher rates of emphysema compared with tobacco-only smokers (93% vs 67%, P=0.009), and higher rates of paraseptal emphysema as well (57% vs 24%, respectively, P=0.09), reported Luke Murtha, MD, of the Ottawa Hospital in Ontario, Canada, and colleagues.
Overall, emphysema was slightly more common in marijuana smokers in the unmatched analysis as well (75% vs 67%), though the difference here was not significant, they noted in Radiology.
Marijuana smokers also had significantly higher rates of bronchial thickening (83% vs 42%, P<0.001), bronchiectasis (33% vs 6%, P=0.006), and mucoid impaction (67% vs 15%, P<0.001) in the matched (shown here) and unmatched analyses.
“It was surprising for us to find that more patients who smoked marijuana actually had emphysema than these heavy smokers … and more of them had airway inflammation than the cigarette smokers,” co-author Giselle Revah, MD, also of the Ottawa Hospital, told MedPage Today.
She noted that because the larger group of tobacco-only smokers were both older than the marijuana smokers and heavy smokers, it was presumed that they would have more exposure to smoke and therefore more serious adverse events.
“There’s this public perception that marijuana is safe, and a lot of people think that it’s safer than cigarettes,” Revah said. “And this study raises the concern that that may not be true.”
In an editorial accompanying the study, Jeffrey Galvin, MD, of the University of Maryland School of Medicine in Baltimore, and Teri Franks, MD, of the Joint Pathology Center in Silver Spring, Maryland, noted that “the presence of paraseptal emphysema, especially in young individuals, is a marker to the radiologist of increased strain in the lung and points to the potential use of marijuana or other inhaled drugs.”
Revah explained that she and her colleagues wanted to learn how to identify a marijuana smoker from a CT image in the way that is done for heavy cigarette smokers. “I was surprised at how little information there was,” she said. “And that’s probably because it [marijuana] was illegal in Canada, and it’s still illegal in many places in the United States, and no one could ethically study it.”
Having this information could make it easier to identify symptoms that come with marijuana use as opposed to tobacco-only use, she added. Only two previous studies had looked at a potential link between marijuana and emphysema via lung imaging, and couldn’t establish a strong association.
The current study also supported the known association between marijuana smoking and gynecomastia (an increase in breast tissue in males), which was seen in 38% of marijuana smokers compared with 11% of tobacco-only smokers (P=0.04), as well as 16% of nonsmoking controls (P=0.039).
There was no difference in coronary artery calcification between age-matched marijuana smokers (70%) and tobacco-only smokers (85%; P=0.16).
“The patients in our … group are very heavy smokers, so we’re not comparing marijuana [use] to light smoking, we’re comparing the group to heavy smokers,” Revah noted. “But the question is, is it the marijuana alone or the synergistic effect between the marijuana and tobacco?”
She added that many questions remain about the effects of marijuana smoking, and she’s currently working on a prospective study that fully separates marijuana-only users from tobacco-only users.
The authors hypothesized that higher rates of bronchial wall thickening and inflammation in marijuana users could be related to the use of filters on cigarettes. Longer inhalation times and keeping smoke in the mouth for longer could also be related to the higher rates of emphysema, but Revah emphasized that more research is needed.
This study included 56 marijuana smokers (mean age 49, 34 men), of whom 50 also smoked tobacco, and 33 tobacco-only smokers (mean age 60, 18 men) who were selected from a high-risk lung cancer screening program. The study also included 57 nonsmoking controls (mean age 49, 32 men).
Marijuana smokers who also smoked tobacco had an average smoking history of 25 pack-years, and the tobacco-only smokers had an average of 40 pack-years. The age- and sex-matched subgroups included 30 marijuana smokers, 33 tobacco-only smokers, and 23 controls.
Not surprisingly, higher rates of emphysema were seen among marijuana smokers compared with nonsmokers (75% vs 5%, P<0.001). Rates of bronchial thickening, bronchiectasis, and mucoid impaction were also significantly higher in the marijuana smokers versus nonsmokers.
Study limitations included the small sample sizes and the inability to quantify marijuana use — only 28 of 56 marijuana smokers specified the amount, and users often share joints, inhale in different ways, and use different strains of marijuana, Murtha and team noted. There were also differences in lifetime duration of smoking, since the tobacco-only cohort came from a lung cancer screening study where everyone was over 50.
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DEA Sets CDC Opioid Guidelines
Posted on November 15, 2022 by Pharmaciststeve
DEA Sets CDC Opioid Guidelines
https://www.daily-remedy.com/dea-sets-cdc-opioid-guidelines/
The CDC unveiled its latest opioid prescribing guidelines.
Let’s talk about the CDC and the DEA. Let’s talk about the newly minted 2022 CDC opioid prescribing guidelines and implementing those guidelines in the court of law.
Let’s start from the beginning. During the early 2010s, what most people characterize as the start of the opioid epidemic, we placed considerable emphasis on urine drug screens, and doses and quantities prescribed for opioids. In 2016, the CDC offered recommendations to help physicians navigate this increasingly complex, half-medical, half-legal world of opioids. They organized and codified newly minted guidelines through which providers were expected to manage patients. They standardized care, but shifted the provider’s perceptions away from direct communication, and toward the guidelines themselves.
As providers grew to rely on the guidelines to verify the need for opioids, they made decisions based on them.
If a urine drug screen came back positive for the prescribed opioids, then they would prescribe opioids. If negative, then they would abruptly stop. If a patient had a high dose of opioids, then they would be lowered to a recommended dose based on the guidelines. If the patient refused to lower her medications, then she would be dismissed by the provider.
Snap decisions based on the simplest interpretation of the guidelines limited all of patient care into an interpretation of the guidelines. But it was the safest decision for many providers, since it was the interpretation upheld in court. Sure, the CDC said back in 2016, and has continued to reiterate up to the present, including in the 2022 guidelines, that they are recommendations only – not hardened rules to adhere to. But the CDC isn’t implementing the guidelines in the court of law. That would be the DEA. And the rule of law has a funny way of setting the tone for the practice of clinical medicine.
George Washington said, “many ideas become false when taken to extremes”. The DEA’s simplistic interpretation of the CDC guidelines has led to an extreme approach to opioid prohibition. Countless physicians have faced criminal charges or DEA sanctions based on nothing more than an interpretation of a non-clinically trained DEA agent, who ascribes culpability by scrutinizing a provider’s clinical actions and decisions. Inevitably, this pits the provider against the CDC guidelines, with the DEA agent’s interpretation of the guideline holding the scales of moralized justice.
The opioid prescribing guidelines don’t address these differing perspectives. They won’t stop a drug-seeking addict from posing as a patient to secure prescription opioids, no matter how hard they try to scare providers. If the guidelines call for a restriction on the number of opioids prescribed, then an addict will simply visit the provider more often. If the guidelines call for urine drug screens, then an addict will find a way to pass the test. Restricting specific behavior in healthcare doesn’t stop the behavior, it simply makes that behavior harder to do – but it will get done, despite the increased risk.
We forget that. We think making something harder will stop it. It’s not true for other conditions like abortion or teen smoking, yet we doggedly insist on curtailing opioid prescribing through a maze of guidelines. Inevitably the guidelines fail in their intended purpose of reducing opioid abuse and overdose-related deaths. So we revise the guidelines. We add caveats. And then we revise them some more.
Instead of focusing on the guidelines, we should focus on the patient encounter. It’s where we find the perceptions that form between provider and patient. It’s in these critical moments that a patient with chronic pain receives a prescription for opioids.
It’s the heart of healthcare and is unlike any other setting found in society. Patients discuss the most vulnerable and intimate aspects of their lives, while providers analyze what they hear as they extract from their mental database of clinical knowledge. It’s a process that forms the patient narrative.
Though we never think of patient encounters as stories, our perceptions of healthcare are both conveyed and understood as narratives. This is what the guidelines miss. A single rule or a set of recommendations doesn’t capture the experience of implementing them in an encounter or having them implemented in your care. The real story of healthcare is the perceptions that form through that experience.
Marshall McLuhan’s famous quip, “the medium is the message”, conveys the notion that the context of a story – where and how it was said – is more important than the actual words spoken. Similarly, how the guidelines are implemented is far more important than the guidelines themselves, regardless of how many times we revise them.
This makes the DEA far more important than the CDC. The DEA is implementing the guidelines in the court of law, and their interpretation effectively defines the implementation of guidelines among providers and patients.
So when providers refer to the opioid guidelines when deciding whether to prescribe opioids, they aren’t parsing through the nuances underlying the context of the guidelines. They’re making the simplest, legally safest decision, using the guidelines merely to justify that course of action. This comes as the expense of good patient care. Look no further than the many chronic pain patients succumbing to suicide or suffering through intractable pain after their provider terminates their clinical relationship.
By reducing the complexity of medicine into simplified guidelines that serve as legal rubrics, the DEA has a framework to exact punitive measures against providers who veer away from their interpretations of what constitutes good care for chronic pain patients.
This is the elephant in the room, the thing that’s never mentioned when discussing the CDC guidelines. We applaud the revised guidelines for acknowledging uncertainty in patient care. We agree that individualized decisions must be made based on the unique needs of each patient.
That’s not the problem. The problem is that the DEA blatantly ignores this. That’s what’s missing in all the discussions about the revised guidelines.
It’s time we talk about it.
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I wonder how many members of Congress is aware of this – and have turned a blind eye and deft ear to how corrupt the DEA is ?
Posted on November 15, 2022 by Pharmaciststeve
UPDATE:
This is going to be on Jesse Watters show tonight (11/15/22) 7PM (EST) Fox Cable
A prescriber gets 20 yrs in prison for a FABRICATED charge of providing any controlled substances to someone that the DEA determines that is outside of “THEIR” idea of standard of care and best practices… “Drug mules”, caught with transporting tens of thousands of illegal fentanyl tabs – gets released within 24 hours because of NO CASH BAIL… and disappears. NO ONE IS ABOVE THE LAW… except MAYBE many who are in charge of enforcing the law.
‘The drug war is a game’: The most corrupt DEA agent in history claims he didn’t act alone during decade of debauchery
José Irizarry accepts that he’s known as the most corrupt agent in U.S. Drug Enforcement Administration history, admitting he “became another man” in conspiring with Colombian cartels to build a lavish lifestyle of expensive sportscars, Tiffany jewels and paramours around the world.
But as he used his final hours of freedom to tell his story to The Associated Press, Irizarry says he won’t go down for this alone, accusing some long-trusted DEA colleagues of joining him in skimming millions of dollars from drug money laundering stings to fund a decade’s worth of luxury overseas travel, fine dining, top seats at sporting events and frat house-style debauchery.
The way Irizarry tells it, dozens of other federal agents, prosecutors, informants and in some cases cartel smugglers themselves were all in on the three-continent joyride known as “Team America” that chose cities for money laundering pick-ups mostly for party purposes or to coincide with Real Madrid soccer or Rafael Nadal tennis matches. That included stops along the way in VIP rooms of Caribbean strip joints, Amsterdam’s red-light district and aboard a Colombian yacht that launched with plenty of booze and more than a dozen prostitutes.
“We had free access to do whatever we wanted,” the 48-year-old Irizarry told the AP in a series of interviews before beginning a 12-year federal prison sentence. “We would generate money pick-ups in places we wanted to go. And once we got there it was about drinking and girls.”
All this revelry was rooted, Irizarry said, in a crushing realization among DEA agents around the world that there’s nothing they can do to make a dent in the drug war anyway. Only nominal concern was given to actually building cases or stemming a record flow of illegal cocaine and opioids into the United States that has driven more than 100,000 drug overdose deaths a year.
“You can’t win an unwinnable war. DEA knows this and the agents know this,” Irizarry said. “There’s so much dope leaving Colombia. And there’s so much money. We know we’re not making a difference.”
“The drug war is a game. … It was a very fun game that we were playing.”
Irizarry’s story, which some former colleagues have attacked as a fictionalized attempt to reduce his sentence, came in days of contrite, bitter, sometimes tearful interviews with the AP in the historic quarter of his native San Juan. It was much the same account he gave the FBI in lengthy debriefings and sealed court papers obtained by the AP after he pleaded guilty in 2020 to 19 corruption counts, including money laundering and bank fraud.
But after years of portraying Irizarry as a rogue agent who acted alone, U.S. Justice Department investigators have in recent months begun closely following his confessional roadmap, questioning as many as two-dozen current and former DEA agents and prosecutors accused by Irizarry of turning a blind eye to his flagrant abuses and sometimes joining in.
With little fanfare, the inquiry has focused on a jet-setting former partner of Irizarry and several other trusted DEA colleagues assigned to international money laundering. And at least three current and former federal prosecutors have faced questioning about Irizarry’s raucous parties, including one still in a senior role in Miami, another who appeared on TV’s “The Bachelorette” and a former Ohio prosecutor who was confirmed to serve as the U.S. attorney in Cleveland this year before abruptly backing out for unspecified family reasons.
The expanding investigation comes as the nation’s premier narcotics law enforcement agency has been rattled by repeated misconduct scandals in its 4,600-agent ranks, from one who took bribes from traffickers to another accused of leaking confidential information to law enforcement targets. But by far the biggest black eye is Irizarry, whose wholesale betrayal of the badge is at the heart of an ongoing external review of the DEA’s sprawling foreign operations in 69 countries.
The once-standout agent has accused some former colleagues in the DEA’s Miami-based Group 4 of lining their pockets and falsifying records to replenish a slush fund used for foreign jaunts over the better part of a decade, until his resignation in 2018. He accused a U.S. Immigration and Customs Enforcement agent of accepting a $20,000 bribe. And recently, the FBI, Office of Inspector General and a federal prosecutor interviewed Irizarry in prison about other federal employees and allegations he raised about misconduct in maritime interdictions.
“It was too outlandish for them to believe this is actually happening,” Irizarry said of investigators. “The indictment paints a picture of me, the corrupt agent that did this entire scheme. But it doesn’t talk about the rest of DEA. I wasn’t the mastermind.”
The federal judge in Tampa who sentenced Irizarry last year seemed to agree, saying other agents corrupted by the “allure of easy money” need to be investigated. “This has to stop,” Judge Charlene Honeywell told prosecutors, adding Irizarry was “the one who got caught but it is apparent to this court that there are others.”
The Justice Department declined to comment. A DEA spokesperson said: “José Irizarry is a criminal who violated his oath as a federal law enforcement officer and violated the trust of the American people. Over the past 16 months, DEA has worked vigorously to further strengthen our discipline and hiring policies to ensure the integrity and effectiveness of our essential work.”
AP was able to corroborate some, but not all, of Irizarry’s accusations through thousands of confidential law enforcement records and dozens of interviews with those familiar with his claims and the ongoing investigation, including several who spoke on the condition of anonymity because they were not authorized to discuss them.
The probe is focused in part on George Zoumberos, one of Irizarry’s former partners who traveled overseas extensively for money laundering investigations. Irizarry told AP that Zoumberos enjoyed unfettered access to so-called commission funds and improperly tapped that money for personal purchases and unwarranted trips, using names of people that didn’t exist in DEA reports justifying the excesses.
Zoumberos remained a DEA agent even after he was arrested and briefly detained on allegations of sexual assault during a trip to Madrid in 2018. He resigned only after being stripped of his gun, badge and security clearance for invoking his Fifth Amendment rights to stay silent in late 2019, when the same prosecutor who charged Irizarry summoned him to testify before a federal grand jury in Tampa.
Authorities are so focused on Zoumberos that they also subpoenaed his brother, a Florida wedding photographer who traveled and partied around the world with DEA agents, and even granted him immunity to induce his cooperation. But Michael Zoumberos also refused to testify and has been jailed outside Tampa since March for “civil contempt” — an exceedingly rare pressure tactic that underscores the rising temperature of the investigation.
“I didn’t do anything wrong, but I’m not going to talk about my brother,” Michael Zoumberos told AP in a jailhouse interview. “I’m basically being held as a political prisoner of the FBI. They want to coerce me into cooperating.”
Some current and former DEA agents say Irizarry’s claims are overblown or flat-out fabrications. The former ICE agent scoffed at Irizarry’s accusation he took a $20,000 bribe, saying he raised early red flags about Irizarry. And the lawyer for the Zoumberos brothers says prosecutors are on a “fishing expedition” to bring more indictments because of the embarrassment of the Irizarry scandal.
“Everybody they connect to José is extraneous to his thefts,” said attorney Raymond Mansolillo. “They’re looking to find a crime to fit this case as opposed to a crime that actually took place. But no matter what happens they’re going to charge somebody with something because they don’t want to come out of all of this after five years and have only charged José.”
Making Irizarry’s allegations more egregious is that they came on the heels of a 2015 Inspector General’s report that slammed DEA agents for participating in “sex parties” with prostitutes hired by Colombian cartels. That prompted the suspension of several agents and the retirement of Michele Leonhart, the DEA’s administrator at the time.
Central to the Irizarry investigation are overly cozy relationships developed between agents and informants — strictly forbidden under federal guidelines — and loose controls on the DEA’s undercover drug money laundering operations that few Americans know exist.
Every year, the DEA launders tens of millions of dollars on behalf of the world’s most-violent drug cartels through shell companies, a tactic touted in long-running overseas investigations such as Operation White Wash that resulted in more than 100 arrests and the seizure of more than $100 million and a ton of cocaine.
But the DEA has also faced criticism for allowing huge amounts of money in the operations to go unseized, enabling cartels to continue plying their trade, and for failing to tightly monitor and track the stings, making it difficult to evaluate results.
A 2020 Justice Department Inspector General’s report faulted the DEA for failing since at least 2006 to file annual reports to Congress about these stings, known as Attorney General Exempted Operations. That rebuke, coupled with the embarrassment brought on by Irizarry’s confession, prompted DEA Administrator Anne Milgram to order an outside review of the agency’s foreign operations, which is ongoing.
“In the vast majority of these operations, nobody is watching,” said Bonnie Klapper, a former federal prosecutor in New York and outspoken critic of DEA money laundering. “In the Irizarry operation, nobody cared how much money they were laundering. Nobody cared that they weren’t making any cases. Nobody was minding the house. There were no controls.”
Rob Feitel, another former federal prosecutor, said the DEA’s lax oversight made it easy to divert funds for all kinds of unapproved purposes. And as long as money seizures kept driving stats higher — a low bar given abundant supply — few questions were asked.
“The other agents aren’t stupid. They knew there were no controls and a lot of them could have done what Irizarry did,” said Feitel, who represents a former DEA agent under scrutiny in the inquiry. “The line that separates Irizarry from the others is he did it with both hands and he did it over and over and over. He didn’t just test the waters, he took a full bath in it.”
Irizarry, who speaks in a smooth patter that seamlessly switches between English and Spanish, was a federal air marshal and Border Patrol agent before joining the DEA in 2009. He said he learned the tricks of the trade as a DEA rookie from veteran cops who came up in New York City in the 1990s when cocaine flooded American streets.
But another key part of his education came from Diego Marín, a longtime U.S. informant known to investigators as Colombia’s “Contraband King” for allegedly laundering dope money through imported appliances and other goods. Irizarry said Marín taught him better than any agent ever could the nuances of the black-market peso exchange used by narcotraffickers across the world.
Irizarry parlayed that knowledge into a life of luxury that prosecutors say was bankrolled by $9 million he and his Colombian co-conspirators diverted from money laundering investigations.
To further the scheme, Irizarry filed false reports and ordered DEA staff to wire money slated for undercover stings to international accounts he and associates controlled. Hardened informants who kept a hefty commission from every cash transfer sanctioned by the DEA also stepped in to fund some of the revelry in what amounted to illegal kickbacks.
Irizarry’s spending habits quickly began to mimic the ostentatious tastes of the narcos he was tasked with targeting, with spoils including a $30,000 Tiffany diamond ring for his wife, luxury sports cars and a $767,000 home in the Colombian resort city of Cartagena. He’d travel first class to Europe with Louis Vuitton luggage and wearing a gold Hublot watch.
“I was very good at what I did but I became somebody I wasn’t. … I became a different man,” Irizarry said. “I got caught up in the lifestyle. I got caught up with the informants and partying.”
Irizarry contends as many as 90% of his group’s work trips were “bogus,” dictated by partying and sporting events, not real work. And he says the U.S. government money that helped pay for it was justified in reports as “case-related — but that’s a very vague term.”
Case in point: an August 2014 trip to Madrid for the Spanish Supercup soccer finals that was charged as an expense to Operation White Wash.
But Irizarry told investigators there was little actual work to be done other than courtesy calls to a few friendly Spanish cops. Instead, he said, agents spent their time dining at pricey restaurants — racking up a 1,000-euro bill at one — and enjoying field-side seats for the championship match between Real and Atletico Madrid.
Joining the posse of agents at the game was Michael J. Garofola, a then-Miami federal prosecutor and erstwhile contestant on “The Bachelorette” who posted a thumbs-up photo on Instagram standing next to Irizarry and another agent — all clad in white Real Madrid jerseys.
“Soaking up the last bit of Spanish culture before saying adios,” he posted a few days later outside a pub.
Irizarry alleged that Garofola also joined agents, cartel informants and others in the Dominican capital of Santo Domingo in 2014 for a night at a strip club called Doll House. In a memo to the court seeking a reduction in his sentence, Irizarry recalled being in the VIP room with another agent and Garofola, racking up a $2,300 bill paid for by a violent emissary of Marín with a menacing nickname to match: Iguana.
Garofola said the trips included official business and he assumed everything was being paid for out of DEA funds.
“There were things about those trips that made me question why I was there,” Garofola told AP. “But Irizarry totally used me to ratify this behavior. I was brand new and green and eager to work money laundering cases. He used me just by my being there.”
When Irizarry was awarded with a transfer to Cartagena in 2015, the party followed. The agent’s rooftop pool, with sweeping ocean views, became an obligatory stop for visiting agents and prosecutors from the U.S.
One that Irizarry recalls seeing there was Marisa Darden, a prosecutor from Cleveland who he says traveled to Colombia in September 2017 and was at a gathering where he witnessed two DEA agents taking ecstasy. Irizarry says he didn’t see Darden taking drugs.
Federal authorities have taken a keen interest in that party, quizzing Irizarry about it as recently as this summer. At least one DEA agent who attended has been placed on administrative leave.
Darden went on to become a partner in a high-powered Cleveland law firm and last year was nominated by President Joe Biden to be the first Black woman U.S. attorney in northern Ohio. But soon after she was confirmed, Darden abruptly withdrew in May, citing only “the importance of prioritizing family.”
Darden refused to answer questions from AP but her attorney said in a statement that she “cooperated fully” with the federal investigation into “alleged illegal activity by federal agents,” an inquiry separate from the FBI background check she faced in the confirmation process.
“There is no evidence that she participated in any illegal activity,” Darden’s attorney, James Wooley, wrote in an email to AP.
A White House official said the allegations did not come up in the vetting process. And U.S. Sen. Sherrod Brown, an Ohio Democrat who put Darden’s name up for the post, was also unaware of the allegations in the nomination process, his office said, and had he known “would have withdrawn his support.”
Another federal prosecutor named by Irizarry and questioned by federal agents was Monique Botero, who was recently promoted to head the narcotics division at the U.S. attorney’s office in Miami. Irizarry told investigators and the AP that Botero joined a group of agents, informants, Colombian police and prostitutes for a party on a luxury yacht.
Botero’s lawyers acknowledge she was on the yacht in September 2015 for what she thought was a cruise organized by local police, but they say “categorically and unequivocally, Monique never saw or participated in anything illegal or unethical.”
“Irizarry has admitted that he lied to everyone around him for various nefarious reasons. These lies about Monique are part of a similar pattern,” said her attorney, Benjamin Greenberg. “It is appalling that Monique is being maligned and defamed by someone as disgraced as Irizarry.”
Irizarry’s downfall was as sudden as it was inevitable — the outgrowth of a lavish lifestyle that raised too many eyebrows, even among colleagues willing to bend the rules themselves. Eventually, he was betrayed by one of his closest confidants, a Venezuelan-American informant who confessed to diverting funds from the undercover stings.
“José’s problem is that he took things to the point of stupidity and trashed the party for everyone else,” said one defense attorney who traveled with Irizarry and other agents. “But there’s no doubt he didn’t act alone.”
Since his arrest, Irizarry has written a self-published book titled “Getting Back on Track,” part of his attempt to own up to his mistakes and pursue a simpler path after bringing so much shame upon himself and his family.
Recently, his Colombian-born wife — who was spared jail time on a money laundering charge in exchange for Irizarry’s confession — told him she was seeking a divorce.
Adding to Irizarry’s despair is that he is still the only one to pay such a heavy price for a pattern of misconduct that he says the DEA allowed to fester. To date, prosecutors have yet to charge any other agents, and several former colleagues have quietly retired rather than endure the disgrace of possibly being fired.
“I’ve told them everything I know,” Irizarry said. “All they have to do is dig.”
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PBM industry: your appropriate healthcare and well being – may not be their number one goal
Posted on November 15, 2022 by Pharmaciststeve
Mail order pharmacies pic.twitter.com/yJDZYqMYzp
— Dr. Glaucomflecken (@DGlaucomflecken) November 12, 2022
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Substance-use struggles are a daily occurrence for the 1 in 10 Americans battling addiction
Posted on November 14, 2022 by Pharmaciststeve
For >100 yrs, our country, we have had between 1%-2% of our population being serious addicts to opiate and similar substances. Currently it is being reported that some 70K-75K /yr die from a OD/poisoning of illegal Fentanyl. Now it is stated that abt 9% of our population are seriously addicted to the abuse of the drug ALCOHOL and that drug is involved with abt 100,000/yr deaths.
Congress created both the DEA and the ATF in 1973. Does anyone find it strange that Congress assigned two dangerous & potentially addicting drugs (Alcohol & Nicotine) to one new federal agency and created a second federal agency (DEA) to handle what ended up being “controlled substances”. At the same time these two different new federal agencies took totally different approaches to deal with the manufacturing, wholesaler and retail distribution system under their control. Of course, the two potentially addicting drugs under the ATF generates a very substantial tax revenue for various bureaucracies.
Here’s How Managers Can Make the Office Holiday Party Recovery-Friendly
https://www.pharmaciststeve.com/dea-proposed-cut-in-pharmas-opiate-production-quotas/
For many companies, this December will be the first time since 2019 that employees can come together for an in-person holiday party. However, mental health experts warn that more employees may be dealing with alcohol addiction than in years past, and managers should be mindful of employees who are in recovery or trying to cut back on their alcohol consumption.
“Substance-use struggles are a daily occurrence for the 1 in 10 Americans battling addiction, and it only got worse with the pandemic,” said Marc Turner, interim president and CEO of Gateway Foundation, which manages 16 drug and alcohol treatment centers in Illinois.
Since 2019, more people have had to face the reality that they have an alcohol use disorder and need to navigate the world differently while others are trying to cut back on their alcohol dependence, Turner said.
In the early days of the COVID-19 pandemic, an increasing number of people turned to alcohol to cope. According to the Centers for Disease Control and Prevention, as of June 2020, 13 percent of Americans reported starting or increasing substance use as a way of coping with stress related to the pandemic.
This increase in alcohol consumption was sustained through at least November 2020, according to a study by RTI International, a nonprofit research institute in Research Triangle Park, N.C. The study found that, compared with February 2020, alcohol consumption in November 2020 was 39 percent higher, in terms of drinks per month.
Meanwhile, about 22.3 million Americans—more than 9 percent of adults—live in recovery after some form of substance-use disorder, according to a peer-reviewed study published in October by the Recovery Research Institute at Massachusetts General Hospital.
“While many have long awaited the opportunity to gather in person with co-workers to celebrate the holidays once again, it’s important for those who are planning holiday celebrations to be aware of the significant increases in those reporting substance abuse issues since the pandemic, and to create an event everyone can enjoy and where everyone feels safe,” said Barbie Winterbottom, CEO of the Business of HR, a consulting firm based in Tampa, Florida. “Creating an event that is psychologically safe and inclusive is critically important for all employees to feel a sense of belonging.”
Here are four ways to make the office holiday party more inviting to employees who are in recovery or trying to cut back on their alcohol consumption.
Make the event about more than just drinking.
Create an event that employees can enjoy even if they’re not drinking, said Ashley Loeb Blassingame, co-founder and chief people officer of Lionrock Recovery, an online substance abuse counseling service based in Petaluma, Calif.
“Make sure the whole premise of the party isn’t based on consumption of alcohol,” she said. Find an activity that gets everyone engaged and talking. Possible ideas include cookie decorating, games and contests, or attending a concert or sporting event.
An officewide gift exchange is a fun activity that involves everyone, but be sure to set ground rules ahead of time by letting people know that no alcohol or substance-related gifts are allowed, said Lisa Blanchard, chief clinical officer at Spectrum Health Systems in Worcester, Mass.
Put mocktails on the menu.
The event invitation should clearly state that alcoholic and nonalcoholic beverages will be available, so employees know they will have options, Winterbottom said.
Rather than having only soda and juice available as alternatives to alcoholic drinks, be more creative and offer nonalcoholic beer and mocktails. “Present the nonalcoholic option as equal,” said Casey Davidson, a Seattle-based life and sobriety coach and owner of Hello Someday Coaching.
For instance, place the nonalcoholic options on the bar along with wine, beer and other alcoholic drinks being served. If waiters are passing around trays of drinks, make sure there are nonalcoholic options on that tray, she said. If there’s a seated dinner, avoid having wine glasses on the table waiting to be filled by waiters, because to say no, an employee would have to put a hand over the glass and ask the waiter not to fill it.
“The sober curious movement is growing, and lots of people are struggling with their alcohol consumption, so it’s important to normalize not drinking,” Davidson said.
Consider having a daytime event.
Many holiday parties tend to be after work or on the weekends, and that timing is often associated with drinking. “Consider a brunch or lunch party where it wouldn’t be appropriate for drinking, as the staff will need to get back to work after,” said Nicole Lacherza-Drew, Psy.D., owner of Vici Psychological Care, LLC, in Denville, N.J.
Keep the celebration optional.
Some employees may not want to celebrate the holidays at all, so be sure to keep holiday celebrations optional. “Remind employees that it is their choice whether or not to participate, and company leadership should make it clear that attendance is optional,” said Star Carter, co-founder, chief operating officer and general counsel at Kanarys Inc., a Dallas-based software firm that focuses on diversity, equity and inclusion data.
Also, make it easy for employees to leave the party when they’re ready. For instance, don’t require employees to stay until after the CEO makes a toast, Turner said. “Allow employees to make an individual choice in how they will navigate the holiday party.”
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DEA: when their own statistics do not support their actions – they DO IT ANYWAY !
Posted on November 14, 2022 by Pharmaciststeve
The primary function of bureaucrats is to perpetuate and grow the bureaucracy. How are they to meet those goals without being able to create additional crisis that takes more people and larger budget.
Here is a recent article DEA PROPOSED cut in pharmas’ opiate production quotas about the DEA cutting opiate production quota, when their statistics shows – within statistical margin of error – they were as close as possible to the pharmas having adequate production to “MAYBE” have sufficient quantities to meet the legit medical needs of pts in our society. I have been an observer of our various bureaucrats and you can put money on… that when they propose something… and have a public comment period … they are most likely going to implement whatever they propose… without the first word in the proposal being changed. Here is a quote from a pharmacist that held the second highest office in the USA
“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
Op-Ed: Don’t let Adderall scarcity trigger a repeat of the opioid epidemic
U.S. pharmacies are critically low on Adderall and its generic equivalents, leaving more than 26 million patients scrambling and competing for the pills since late summer. The scarcity is going to last for many more months because of supply chain problems as well as federal restrictions on manufacturers and imports.
If we don’t act fast, this shortage could trigger two major public health crises.
Many people who have been taking this amphetamine-based stimulant – whether prescribed for attention deficit or narcolepsy or used illicitly as a performance or party drug – will lose access. This carries serious physical and mental health risks.
Amphetamine withdrawal symptoms, including depression, are not easily addressed with other kinds of drugs. So as countless individuals are confronting having to rapidly taper or stop, we’re facing a real possibility of a public health disaster on a scale not seen since the prescription opioid crisis that began a decade ago.
Instead of enduring withdrawal, other individuals cut off from Adderall are likely to turn to alternative stimulants like crystal meth, fueling a much broader crisis.
The early 2010s taught us that dependence and addiction don’t simply disappear when the pills do. At that time, catastrophic regulation failures contributed to widespread opioid dependence and addiction. The government response to the prescription opioid crisis focused on rapidly reducing supply: crackdowns on pill mills, tightened restrictions on prescribing and reformulation of products to make them harder to snort and inject. This approach backfired, pushing many users onto the illicit market.
As a chemical analog of prescription opioids, heroin was widely available and far cheaper than its pharmaceutical cousins. But its unpredictable quality and link with injection drug use made heroin a much more dangerous alternative; the recent rise in fentanyl contamination has further fueled the crisis. Overdose rates have continued to soar, spiking from 16,000 during the height of the prescription opioid crisis to more than 100,000 annually. The number of cases of blood-borne infections like HIV and hepatitis has spiked in tandem.
Today’s Adderall shortage is setting up a similar crisis. For those losing adequate access to prescription amphetamine, illicit alternatives – especially methamphetamine – are readily available. Just as with heroin, years of increasingly punitive policies, aggressive law enforcement, government fear-mongering and growing public panic failed to address the “meth problem.”
If anything, interventions like the Combat Methamphetamine Epidemic Act of 2005 disrupted meth production by a domestic cottage industry, cementing its reorganization as an international, industrial-level cartel operation – dramatized in the narrative arc of “Breaking Bad.” This made meth more ubiquitous, more potent and cheaper than ever.
Crisis events and cardiac arrests involving stimulants are already at an all-time high. Methamphetamine injection is helping to drive infectious disease cases. And there are also concerns about street stimulants, including counterfeit pills, being contaminated with fentanyl, creating the risk of opioid overdose.
Enter the Adderall shortage.
A massive influx of people forced to switch from a pharmaceutical amphetamine to street methamphetamine would be nothing short of a nightmare. But there is still time to prevent a stimulant remake of the tragic scenario we have seen play out with opioids.
The F.D.A. has powerful tools at its disposal to ease the Adderall shortage. This includes attracting and fast-tracking approval for international manufacturers and helping rapidly develop domestic production.
Maintaining a reliable, safe supply of amphetamine medications is crucial to avoid a major public health crisis. Bigger thinking is also vital to prevent other similar crises from occurring in the future.
The current Adderall shortage is a symptom of deep structural dysfunction in our institutions, policies and systems responsible for drugs. As with opioids, stewardship of prescription stimulants in American healthcare is poor, often vacillating between excess and deficit. We need far more nuanced, patient-centered approaches to medication access that are not bogged down in drug panics and concerns about law enforcement.
Meanwhile, our streets are flooded with illicitly manufactured alternatives of unpredictable content and dosage, despite cavalier investments in criminal justice efforts to stem their supply. Instead, cost-effective lasting solutions like housing, social services, and wrap-around supports are necessary to make our society healthier and safer.
Bold actions are urgently needed to prevent history from repeating itself.
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