Laws Based on Rapid Drug Tests Are Unscientific and Unfair

Posted on September 22, 2023 by Pharmaciststeve

https://www.acsh.org/news/2023/09/15/laws-based-rapid-drug-tests-are-unscientific-and-unfair-17337

Are impending drug DUI laws scientifically justified, accurate, or fair? If you’re pulled over for a traffic violation in certain locations and asked to take a roadside saliva test, you may learn they’re anything but. Drs. Josh Bloom and Henry Miller discuss this in an opinion piece published in the law journal Law360.

Photo credit: Picryl

Laws based on roadside saliva tests for drug-impaired driving, especially for marijuana, are quietly being implemented in state legislatures across the country. Alabama, Michigan, and Kansas already have programs in place, and Minnesota is about to join the fray. While this may seem to be an admirable effort, it is a classic example of what happens when law enforcement and science clash.

Currently, roadside drug DUI laws are not simply lagging behind the science, they actively contradict it. It is fairly straightforward to determine whether a driver is impaired by drinking. A roadside Breathalyzer test measures the concentration of alcohol in a driver’s breath, and the magnitude of the readout is proportional to the level in the blood, a known measure of the degree of impairment.

But the same cannot be said for drugs, either prescription or recreational. Of particular importance is THC, the primary psychoactive drug in cannabis. For this drug, which is second only to alcohol in terms of impaired driving, blood concentrations do not correlate well with driving performance.

If field sobriety tests are being used as a measure of impairment from drugs, it is fair to ask how good they are. By any measure, it is safe to say that these tests fail miserably.

In a recently published article in JAMA Psychiatry, researchers at the University of California, San Diego, performed a double-blind, placebo-controlled randomized clinical trial to evaluate how accurate field sobriety tests are in identifying drivers under the influence of THC.

It showed that tests administered by law enforcement officers could differentiate between individuals who had consumed THC versus those who had not at certain time points, but, as the study’s lead author noted in a press release,

“[f]ield sobriety tests are useful additions to overall evaluations of drivers but are not accurate enough on their own to determine THC impairment.” New effective measures for identifying cannabis impairment are needed to ensure the safety of all drivers on the road.

And, as the authors wrote, “One court concluded that ‘there is as yet no scientific agreement on whether, and, if so, to what extent, these types of tests are indicative of marijuana intoxication.'”

As states attempt to crack down on drivers who are impaired by drugs — reflected in the growing patchwork of differing state laws — multiple technologies have been developed to rapidly determine the presence of drugs, both legal and otherwise. But roadside tests provide only a yes-no answer — whether the drug can be detected within the limit of the instrument. Presence is not indicative of impairment.

The fundamental problem with these state efforts is that we have neither the technology to measure drug levels, especially with a rapid test, nor laws or guidelines to properly interpret measurements of these levels, even if this information were available.

But government officials often think it is better to do something, valid or not, than be accused of negligence. Therefore, largely meaningless tests are increasingly being developed and used in an attempt to detect impaired drivers, just as they have been used against workers in a variety of occupations. People can lose their jobs based on yes-no tests that cannot determine individuals’ ability to either work or drive.

The increased use of spurious drug testing has been propelled by the decriminalization of marijuana. According to the Centers for Disease Control and Prevention, that change in the law presents an enormous challenge to public safety because of driving impaired by cannabis use.

The agency reports that in 2018, “approximately 12 million (4.7%) U.S. residents aged [16 years or older] reported driving under the influence of marijuana, and 2.3 million (0.9%) reported driving under the influence of illicit drugs other than marijuana” during the previous 12 months.

Thus, there are large and growing numbers of potentially drug-impaired drivers on the road, but no scientifically valid method to determine their level of impairment.

A yes-no test may be punitive, and it does not meaningfully reflect impairment for most drugs, which is especially true for cannabis. First, unlike alcohol, Delta-9 THC — the primary psychoactive chemical in cannabis — is metabolized, and thus cleared, very slowly from the body; it is stored in fat tissues where it can persist for days or even weeks.

It is problematic that a yes-no test cannot distinguish between a driver who is impaired from recently smoking several cannabis cigarettes, and another who took a couple of puffs a week earlier and is not impaired at all.

Although a concentration of five nanograms per milliliter of Delta-9 THC in the blood is often considered the threshold for impairment, a 2022 article in the journal Nature concluded that “single measurements of [Delta-9 THC] in blood, and now in exhaled breath, do not correlate with impairment following inhalation.”

In Kansas, they’ve purportedly solved this conundrum by simply ignoring it. In an attempt to address drivers’ impairment, state troopers now use a rapid, roadside instrument called SoToxa, which can detect THC as well as five other classes of drugs. But this ostensible solution may be worse than the problem.

SoToxa, like previously developed tests, determines only whether or not the drug is present in saliva at the level of detection of the instrument: an essentially useless bit of information. Why? Because pharmacology does not work that way.

Just like “the dose makes the poison” — an adage first coined by Paracelsus, the father of modern pharmacology, in the 16th century — the dose also determines the degree of impairment.

Although courts are not allowing SoToxa results to be cited as evidence at this time, it is likely that positive tests will eventually show up as black marks on some drivers’ records, especially since the tests also detect commonly used, legal prescription drugs for conditions like attention-deficit/hyperactivity disorder and anxiety.

Four other states are in various stages of implementing these tests, so we shouldn’t be surprised to see these faulty tests spreading throughout the country.

The repercussions of faulty drug tests may be worse when it comes to employment. There are a number of industries, including transportation, health care and construction, that require drug testing, and workers who fail a yes-no test for common recreational drugs, as well as certain prescription drugs, can lose their jobs.

A truck driver who tests positive for THC can be terminated, even though the test may detect a pharmacologically insignificant level of the drug. Worst of all, this can occur even if the driver hasn’t actually used cannabis. Hemp-based CBD oil, which is now legal and commonly used in the U.S., can contain up to 0.3% of THC. This alone can cause a positive test.

The disconnect between legality and illegality is perhaps most obvious here. How can an unimpaired person who used a perfectly legal product be prosecuted or lose their job?

We’re not advocating a transportation system full of drug-addled truck drivers or train operators, but given the wholesale decriminalization of marijuana by many states, our archaic standards must be updated if they are going to be useful and fair.

Unfortunately, this is easier said than done. Even Stop Drugged Driving, an organization that is especially concerned with driving under the influence of drugs, calls impairment thresholds “a fool’s errand” because there is no correlation between THC levels and the degree of impairment.

Similarly, a 2016 technical report issued by the AAA Foundation for Traffic Safety concluded, “[b]ased on [its] analysis, a quantitative threshold for per se laws for THC following cannabis use cannot be scientifically supported.” Although many countries, especially in Europe, use a zero tolerance policy, where the presence of a drug is considered evidence of impairment, we cannot recommend this approach. It is both scientifically inaccurate and unfair to determine guilt or innocence based on advancements in analytical chemistry instruments, which can now detect chemicals at concentrations millions of times lower than what was possible in the 1960s.

Ultimately, it would be an easy fix to adopt a zero tolerance policy, or to codify an arbitrary drug concentration that has little or nothing to do with actual impairment, but these laws are both punitive and contrary to scientific principles, and there is no question that unimpaired people would be caught in the net.

It is unfortunate that reliable standards have not been established to save lives, but this does not warrant the use of deeply flawed testing policies as window dressing. As in medicine, it is better to do no harm.

Josh Bloom is the director of chemical and pharmaceutical science at the American Council on Science and Health. Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. He previously served as the founding director of the U.S. Food and Drug Administration’s Office of Biotechnology.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of their employer, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal

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Is the result of the Crackdown on ‘Fentanyl Chemicals’ Deadlier Nitazenes?

Posted on September 22, 2023 by Pharmaciststeve

https://www.acsh.org/news/2023/09/21/result-crackdown-fentanyl-chemicals-deadlier-nitazenes-17347\

As if fentanyl isn’t bad enough, a series of opioid receptor agonists called nitazines is making its way into the street drug supply. But is this because the chemicals used to make fentanyl are now more difficult to obtain? It’s certainly possible, if not likely. Organic chemists are nothing if not versatile.

Image: Wikimedia Commons

Oxycodone, heroin, fentanyl, xylazine. And now we have nitazines, for example, isotonitazine, which is about ten times more potent than fentanyl and increasingly showing up in street drugs.

The order in which I placed these drugs is not accidental; they are progressively more deadly. It’s an example of the “iron law of prohibition,” which Cato Institute’s Dr. Jeffrey Singer, also an ACSH Scientific Advisory board member, has been writing about for some time. In particular, Dr. Singer authored a piece titled “Nitazene Overdose Deaths on the Rise—The Iron Law of Prohibition Cannot Be Repealed” – the harder the enforcement, the harder the drug.

As a chemist, I was intrigued by a paragraph in a recent JAMA Network Open article:

The exact motivation to produce nitazenes and brorphine (1) are unclear. The increased regulation of fentanyl and fentanyl analogues throughout the last decade may have led to a change in the chemical precursors required for clandestine laboratory production that were not yet regulated. This change in chemical precursors may have led to these newer and more potent opioids. [emphasis mine]

Source: JAMA Network Open

Is it possible that strict regulation of the chemicals used to make illicit fentanyl and its analogs encouraged the production of other illegal drugs, such as isotonitazene or clonitazene – members of the benzimidazole class of opioids? Since nitazines bear no chemical resemblance to either morphine or fentanyl, it is a given that they are prepared from a different set of chemicals (Figure 1).

Figure 1. Although fentanyl, isotonitazine, and morphine are all opioid receptor agonists, they have nothing in common chemically, so they must, by definition, be synthesized from completely different chemical building blocks (starting materials and intermediates).

DEA is behind the curve

Is it possible that making fentanyl precursors harder to get was in any way responsible for the uptick in nitazine overdose deaths? A look at the DEA List 1 restricted chemicals (2) suggests this is possible.

Of the 39 List 1 chemicals (3), five chemical reagents or intermediates are used to synthesize fentanyl (Figure 2). The colors of the fragments of fentanyl correspond to those same fragments in the chemicals used to make the drug. Although there are multiple ways to synthesize fentanyl, there can be little doubt that if the chemicals in Figure 2 are difficult to get, fentanyl production will suffer.

Top: The chemical structure of fentanyl. Bottom: Five chemicals defined by the DEA as List 1 fentanyl precursors.

What about etonitazene chemicals?

The chemical structure of etonitazene bears no resemblance to any fentanyl analog.

Even a brief look at the chemical literature (not to mention the chemical structure) makes it clear how different the structure and synthesis of fentanyl and nitazenes, e.g., etonitazene are. There are multiple syntheses in the literature for the preparation of etonitazene, a drug first made in the 1950s. From two of these synthetic routes, I picked out 10 chemicals that have been used to prepare the drug:

o-phenylenediamine
4-nitro-o-phenylenediamine
p-ethoxybenzyl cyanide
2,4-dinitrochlorobenzene
2,4-dinitroaniline
1-chloro-2-dialkylaminoethane
1-amino-2-diethylaminoethane
2-(β-dialkylaminoalkylamine)-5-nitroaniline
phenylacetonitrile (4)

How many of them are on the DEA List 1? Zero.

This means that any of the chemicals required to make etonitazene – only one of a series of highly potent nitazene analogs – can be ordered from chemical supply companies without regulation.

Only time will tell whether nitazene opioids will replace illicit fentanyl as the primary killer, much like heroin replaced prescription opioids and fentanyl replaced fentanyl. But it makes sense. Drugs like etonitazene are extremely potent (less is needed) and very easy to synthesize. Chemists who may switch to a deadlier drug will find all the supplies they need to do so.

Is this an atypical example of the “iron law” in action? It’s certainly possible. Both precedent and the power of organic chemistry make it reasonable, if not inevitable.

NOTES:

(1) Brorphine is another opioid agonist, but it does not belong to any of the opioid classes I have discussed.

(2) According to the DEA: “These chemicals are designated as those that are used in the manufacture of the controlled substances and are important to the manufacture of the substances.”

(3) The number 39 is not strictly correct. For example, piperidine, one of the List 1 chemicals, can be purchased as the free base (amine) or any of several salts, e.g., hydrochloride, hydrobromide, sulfate…

(4) It is nothing short of astounding that phenylacetonitrile, aka benzyl cyanide, is not on the DEA List 1, since it can easily be converted to phenyl-2-propanone (P2P) – one of the chemicals now used to make methamphetamine.

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DEA ENFORCEMENT: THE RISE OF AMERICAN FASCISM, PERSECUTION AND CRIMINALIZATION OF YOUR DOCTOR AND MEDICAL HEALTHCARE TREATMENT: HOW DID WE GET HERE!!!

Posted on September 22, 2023 by Norman Clement

FORMER US AG JEFFEREY BOLEGARD SESSION
“…these things which have been hidden from you shall be brought to the light…”

HFPP ALERT: “BROKEN ARROW,” THE RISE OF AMERICAN FASCISM, PERSECUTION AND CRIMINALIZATION OF YOUR DOCTOR AND MEDICAL HEALTHCARE: HOW DID WE GET HERE!!!

Filed under: General Problems | 4 Comments »

Ivermectin Suit Revived; Curbing Fentanyl Deaths in Kids; Medicare Spending Plateau

Posted on September 21, 2023 by Pharmaciststeve

Do any of you remember during the early Covid-19 pandemic? Some docs were claiming that ivermectin and hydroxychloroquine worked against Covid-19. some/many of these docs were chastised by some medial licensing boards and some lost their job or hospital privilege. Because those two meds were not approved for treating the COVID-19 virus,and being prescribed “off label” . Of course, the Covid-19 virus was a NEW VIRUS and there was some who suggested that the Covid-19 virus was “man-made” using gain of function methodology. Then again, some 30%-50% of ALL PRESCRIPTIONS are prescribed OFF LABEL – EVERY DAY, but no one seems to care about all those Rxs, out of some 4 billion Rxs that are filled every year “off label”?

Ivermectin Suit Revived; Curbing Fentanyl Deaths in Kids; Medicare Spending Plateau

https://www.medpagetoday.com/special-reports/features/106202

Doctors’ Ivermectin Lawsuit Revived

Last week, the 5th U.S. Circuit Court of Appeal in New Orleans revived a lawsuit brought by three doctors alleging that the FDA overstepped in its public statements about ivermectin as a COVID-19 treatment, the Associated Pressopens in a new tab or window reported.

The lawsuit argues FDA messaging such as, “I’m not a horse!” interfered with their practice, and in “most of that messaging,” left out the human version of ivermectin that the plaintiffs were prescribing.

The lawsuit was originally brought by otolaryngologist Mary Talley Bowden, MD, and critical care doctor Paul E. Marik, MD — both of whom have faced professional repercussions after touting the anti-parasitic, among other controversies — and emergency medicine doctor Robert L. Apter, MD.

A district court judge had dismissed the lawsuit in December, but the New Orleans appellate court argued that the FDA exceeded its authority under federal law, though normally government entities have more protections from civil lawsuits because of what’s known as “sovereign immunity.”

“FDA is not a physician. It has authority to inform, announce, and apprise — but not to endorse, denounce, or advise,” Judge Don Willett, MA, JD, a Trump appointee, wrote for the panel, according to the AP. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.

State Laws Attempt to Curb Fentanyl Deaths in Kids

The synthetic opioid fentanyl claimed the lives of 1,800 teenagers between July 2019 and December 2021 in the U.S. — and a number of states are passing legislation geared toward preventing these deaths, according to Politicoopens in a new tab or window.

In California, a bill named for a 15-year-old who died in a Hollywood high school would require schools to include responses to overdoses into their safety plans. In Texas, middle and high schoolers learn about the dangers of fentanyl in a new education campaign. Mississippi created a media campaign.

But families of youths that have died from overdoses want more to be done. They cite pandemic-era lockdowns and social media as drivers of declining mental health and easy access to drugs available for purchase. Surprisingly few treatment options are available for adolescents struggling with substance abuse, and naloxone (Narcan) isn’t readily available in many overdose situations, according to Politico.

On the national level, members of Congress have introduced a bill that would fund education on fentanyl for children, and provide school employees with naloxone and training for its use. Likewise, Surgeon General Vivek Murthy, MD, MBA, has said he supports age limits for social media use.

Medicare Spending Plateau

Medicare spending per beneficiary has ceased its dramatic trend upward, baffling experts who projected a continued steady climb would strain the federal budget and lead to increasingly difficult spending choices. Spending would have been $3.9 trillion higher since 2011 had it not been for the change, the New York Timesopens in a new tab or window reported.

Possible reasons for the relative plateauing at $12,459 per beneficiary per year include the Affordable Care Act, which cut Medicare payments to hospitals and Medicare Advantage insurers. Older Americans are also having fewer heart attacks and strokes because of effective drugs for cholesterol and blood pressure. Some parts of healthcare have become more efficient, with some care shifting out of hospitals into cheaper settings, for example.

However, the shift may also reflect slowing life expectancy for seniors because of a lack of major medical breakthroughs in recent years, the death of many older Americans from COVID-19, and seniors being denied the care of their choice as hospitals contain costs.

Trump tax cuts, a deficit reduction deal, and the recent Medicare drug negotiation policy wouldn’t have come close to this magnitude of government savings, according to the New York Times, although Medicare spending is still likely to increase in the coming years. An aging population, and a new development like an Alzheimer’s drug or the burden of long COVID, for example, could push spending up again.

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Recent DC trip update PLUS What’s Next for Pain Patients in Federal Legislation

Posted on September 21, 2023 by Pharmaciststeve

I will be live on Twitter Spaces and YouTube discussing the events leading up to and during my recent trip to Washington DC. I am hoping to also stream on FaceBook simultaneously while being open to live questions on any/all platforms. It may or may not work, but I am hoping to update everyone once and answer any questions at once. I will also discuss my next DC trip, which will be in about 10 days because we FINALLY have great news to share about progress at the federal level

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THE WRONGFUL DECEPTIVE CONVICTION OF DR. TERENCE SASAKI, MD

Posted on September 19, 2023 by Norman Clement

Terence Sasaki, M.D., is a Neurologist who received his Medical degree from the University of Hawaii and did his residency at New York University (NYU). Supposedly confessing to a 2005 crime in a 2007 interrogation the DEA claimed was unrecorded, Dr. Sasaki was indicted (2010) and then convicted (2012) of conspiracy to distribute controlled substances and launder money.

INNOCENT CONVICTS ORGANIZATION DEMANDS THE OVERTURNING OF DR. TERENCE SASAKI’S CONVICTION: SEEKING JUSTICE AND EXONERATION

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Marie-Antoinette, the queen of France said let them eat cake: today docs say, just push thru the pain

Posted on September 18, 2023 by Pharmaciststeve

Well here we go again Vanderbilt loves to buy all the struggling hospitals and has new innovated ways to torture kids! 72 hour Tylenol IVs and lessons on how to cure pain that would kill a small animal with mind control therapy! So of course my email is blowing up with desperate parents wanting help ASAP so their children don’t feel like committing suicide and parents don’t loose their job because some clueless doctor has a plan that doesn’t involve the life saving opioid medication to be used as intended! Just what I needed at this point in life with my own medical shit going on! 5 steps forward 20 steps back! I’m trying to prioritize who will be out first and who can take tapers vs smaller doses and split them into groups! This is frigging ridiculous and torture on these kids! From Henderson KY to Paducah and from Clarksville to Nashville, Louisville to Chattanooga! I’ll need local advocates to help me again please and this will bankrupt us without help to get these people to these kids. Donate at Www.4apdf.org... We stopped them before but this reload of idiotic ideology my be the grave stone for some of these sick kids.. Some I’ve helped before and brand new kids who are brand new to the suffer train! Yall get me whatever you can and I’ll do my best! Stage 4 of eliminating pain patients has promptly taken effect! KY and TN you should be ashamed of yourselves for this one! I don’t know how to take so many kids on right now but as always will figure it out! What a shame! Lower doses on end of life and chronic pain kids who are already suffering! SMH is an understatement! A trip to Washington DC is needed badly! Share this and help all you can so I don’t have to sell everything I have again please! Looks like a long full time job is headed my way again!

There was no sound evidence of Acetaminophen’s ability to treat most all painful condition

Perhaps most telling is a 2021 review that included 36 systematic studies of 44 painful conditions. It concluded that acetaminophen provided modest pain relief for one of them, osteoarthritis of the hip and knee. There was no sound evidence of the drug’s ability to treat any other painful condition.

Do any of you remember during the start of the COVID-19 pandemic, how many practitioners were prescribing certain medications to treat pts with COVID-19 …but.. some of the healthcare system they worked for revoked their privileges at their hospital, and some state medical boards sanctioned prescribers for prescribing medications that had been clinical studies on to treat COVID-19… otherwise known as “off label”. Yet some 30%-50% of all prescriptions are prescribed & filled “off label” EVERY DAY…

The first paragraph is a description what Vanderbilt Hospital system is doing in treating end of life pediatric cancer pts’ PAIN. That a 2021 review of 36 systematic studies of 44 painful conditions. Does not provide any pain management for cancer pain.

Here is a article from 18 months ago that https://news.vumc.org/2021/12/07/vanderbilt-university-hospital-named-a-top-teaching-hospital-nationally-by-the-leapfrog-group/

Does this mean that Vanderbilt university is graduating medical students that are being taught to prescribe therapies for which their is little/no evidence that – Acetaminophen/Tylenol – is ineffective is nearly all painful conditions.

What would happen to parents if they inflicted as much pain on their children as these healthcare professionals are causing these end of life pediatric pts to live/exist in? Does anyone think that Child Protective Services would be knocking on their door? Taking their kids away and put into foster care and the parents put in JAIL?

A number of years ago, our SCOTUS ruled that the 18th amendment – you know the one about prohibiting cruel & unusual punishment – only applied to prisoners.

Forget the “DO NO HARM”, it is really not stated in the original Hippocrates oath, nor any revisions. some believe that it is IMPLIED https://doctors.practo.com/the-hippocratic-oath-the-original-and-revised-version/

So it would appear that physicians – depending on their own personal morals and ethics – can leave pts to suffer in pain

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Has these law firms drawn a target on the backs of chronic pain pts?

Posted on September 16, 2023 by Pharmaciststeve

Amazing that what appears to be the lead law firm in suing the 3 largest drug wholesalers and 3 major chain pharmacies (CVS, Walmart, Walgreen) is claiming that they WON THE WAR ON DRUGS – apparently by causing untold number of chronic pain pts are going to be indiscriminately denied their medically necessary pain medication for their chronic health issues.

I think that it is interesting that the law firm admits that they are using all the media’s routine talking about OD’s involving “fentanyl”, with seldom mentioning that the opioid that people are dying from is an ILLEGAL ANALOG being provided by China & the Mexican cartels, while at the same time the media shows a graphic of the FDA approved Fentanyl and seldom/never do they mentioned that it is actually a POISONING.

Attorney Mike Moore seems to state that these large corporations won’t go bankrupt, but what happens if these major wholesalers and/or major chain pharmacies decide to stop inventorying controlled meds and/or wholesalers only sell control meds to hospitals and nursing home pharmacies. Are these law firms indemnified for any of the consequences to chronic pain pts for not being able to get their medically necessary controlled medications?

We have all seen/read about pts who were cut off from their medications because the DEA raided a practitioner’s office. Some committed suicide, some have died from cold turkey withdrawal. Some will end up using/abusing NSAID’s, alcohol, Acetaminophen trying to reduce their torturous intensity of pain. Many will end up with liver, kidney damage, heart attack, stroke and eye damage.

The three major drug wholesalers that settled, controls about 80%-85% of all Rx meds to pharmacies. The typical community pharmacy may have up to 30 days of inventory on hand. So if a wholesaler notifies a pharmacies they will no longer be getting controlled meds from their wholesaler. Within 60 days, most of the pharmacy’s chronic pain pts will be in cold turkey withdrawal.

One can only guess how rapidly the average life expectancy of all these chronic pain pts will decline?

Winning the War on Opioids: A Behind the Scenes Look at The Largest and Most Complex Deal In The History of Jurisprudence

“Winning the War on Opioids: A Behind the Scenes Look at The Largest and Most Complex Deal In The History of Jurisprudence”
-or
“How US DOJ & Trial Lawyers circumvented public consent to create a work-around ban on rx opioids thru mass tort litigation.”

“A nationwide solution. If you impose serious restrictions in one community, but not the next, offenders simply move their operations. By getting all states & all communities on board, it created a truly nationwide solution to a public health crisis.”

-mass rx restrictions 🤔

“This reform package includes the creation of a groundbreaking clearinghouse through which the Big Three will be required to account not only for their own shipments, but also the shipments of the other distributors, in order to detect, stop, and report suspicious orders.”

“Trial lawyers, processing & organizing almost a billion lines of data tracking every pill from the manufacturer, to the distributor, to the pharmacy. This created the roadmap for the clearinghouse & gave it to every federal, state & local law enforcement officer in the country.”

“a mix of collaboration with highly competent specialists, old-fashioned detective work, big data analysis, and a very innovative legal strategy will help deliver the largest financial proposed settlements in tort history”.
-slow clap, everybody-
specialists like Andrew Kolodny?

“A unique collaboration of law firms led by Florida’s Levin Papantonio Rafferty was at the forefront of the litigation with its large base of city and government clients”

*Papantonio regularly invites govt officials to go sailing on his FL yacht. You know, to talk business.*

“We have always recognized at our firm that walking into massive fights like this is risky and expensive, but we’ve also always recognized that part of our jobs as consumer lawyers is to put it all on the line for American consumers and that’s exactly what we did”.-Papantonio

“And it was all spiraling out of control until this group of private attorneys put the opioid crisis on the front page by filing hundreds of lawsuits against the distributors beginning in early 2017, while the majority of the other lawsuits focused purely on the manufacturers.”

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Fine tuning Pharmaceutical Warehouse Monitoring for Optimal Ambient Conditions

Posted on September 15, 2023 by Pharmaciststeve

Fine tuning Pharmaceutical Warehouse Monitoring for Optimal Ambient Conditions

https://drugstorenews.com/finetuning-pharmaceutical-warehouse-monitoring-optimal-ambient-conditions

With specialty medications now accounting for over half of all drug spending in the U.S., wholesalers and retailers need to ensure the safe and effective delivery of critical, hard-to-get medications to patients who rely on safe, efficient supply chains for their health and well-being.

Drug Distributor Accreditation, previously known as Verified-Accredited Wholesale Distributors Program (VAWD), from the National Association of Boards of Pharmacy (NABP) is a crucial certification program that ensures pharmaceutical wholesalers and national retailers are following best practices for warehouse holding conditions, protocols for excursions, and corrective action paths. Legacy tools that rely on outdated data loggers, delayed visibility, and spotty Wi-Fi connectivity may help warehousing operations technically meet minimum compliance requirements. However, real-time visibility into different areas of a warehouse’s ambient condition and corresponding alerting is attainable with technology available on the market today that helps operators exceed regulatory compliance requirements and ensure patient safety, inventory freshness, and proactive actions.

With specialty medications now accounting for over half of all drug spending in the U.S., it is especially important for wholesalers and retailers to ensure the safe and effective delivery of critical, hard-to-get medications to patients who rely on safe, efficient supply chains for their health and wellbeing.

Recent Developments with OTC Regulation

Distribution centers that store and transport Over-the-Counter Medicines (OTCs) have always been FDA regulated at some level. However, lately, regulatory bodies have been paying much more attention to OTCs and biosimilars than ever before. State Boards of Pharmacy have significantly increased their vigilance in inspections over the past 2 years because of recent uncoverings that have surfaced from taking a deeper dive into storage conditions. Because OTCs are not refrigerated, their governance has been considered less important compared to refrigerated drugs. Monitoring temperature and humidity of storage conditions has always been a CDC suggestion, but not firmly regulated or enforced.

Family Dollar’s recent Advil recall is an illustration of the need for real-time intelligence into the state of pharmaceutical inventories. OTCs becoming too cold or too hot can cause the drugs to become unstable and even degrade, posing a risk of negative side effects and decreasing their effectiveness.

Warehouse Heatmapping

Warehouses feature shelving and cages that can be segmented into different “zones” within the footprint of the building. Ambient temperature varies between the zones of a warehouse, especially large warehouses that operate with a spoke–hub distribution paradigm. Similar to refrigeration assets, these zones have a certain temperature profile that can be optimized for inventory safety and product quality.

Conducting a thermal heat mapping study is a critical step in ensuring that a pharmaceutical warehouse meets FDA and NABP regulatory requirements. The study involves placement of numerous temporary sensors throughout the warehouse zones to gather temperature and humidity data that reveals the coldest and warmest areas of the warehouse. The data is analyzed, and a report is produced revealing the Mean Kinetic Temperature (MKT) for each zone, informing the placement of permanent sensing capabilities throughout the facility. Studies must be completed in both summer and winter of the same calendar year to account for differences in temperature throughout seasons. Regulations require these studies to be done once every three years for accreditation to remain current.

Mean Kinetic Temperature

MKT measures temperatures fluctuations in a way that provides a more useful picture of asset conditions over time. MKT smoothes out the outlier extremes and provides a sophisticated average that gives operators a clearer idea of product safety during storage. Let’s say the temperature threshold is 77 degrees Fahrenheit, and the product temperature rises to 82 degrees Fahrenheit for five minutes but then comes back down to the acceptable range. The product doesn’t necessarily need to be disposed of or destroyed because operators who have access to the MKT have the context of the products’ stability and the effects of any degradation during excursion are factored in. Use of MKT is critical for monitoring ambient temperature and relative humidity.

The contextual nature of MKT helps operators optimize their warehouse with insights and actions concerning where to store different types of inventories. Based on zone behavior, dry foods, medications, vaccines, and other pharmaceuticals should be placed in different shelving units or cages throughout the warehouse to ensure maximum product quality and safety. Adjustments to the HVAC system and energy consumption can be informed with intelligence gathered from the sensing capabilities, optimizing storage and creating ease and confidence for operators and facilities management. The MKT process also accurately generates an output of the locations to place NIST compliance sensors to check the extreme temperatures in the warehouse and preserve quality and compliance.

Cross Docking

In a cross-docking operation, products are transferred directly from incoming shipping vehicles to outbound vehicles with minimal storage time during transfer. Certain facilities or warehouses are designed specifically for the practice of cross docking. As a logistics strategy, the intent of cross docking is to speed up delivery times while minimizing warehousing and handling costs. Goods arriving at a cross-dock have a pre-assigned destination and are un-packaged then re-packaged with blister cards – Andex, and organized accordingly allowing seamless movement through the supply chain. Successful cross-dock operations build efficiency and cost-savings into the delivery process.

For cross-docking applications, storage conditions are not the main concern since storage is not the intended activity. However, heat mapping and MKT tracking are still essential functions to optimize the path of products in transit. Especially warm or cold areas of a cross-docking facility need to be accounted for to avoid the damage of crucial inventory, especially in the case of pharmaceutical transfer when specialty medications and critical vaccines are involved.

Internet of Things (IoT) Opportunities

When maintaining the quality of inventory is critically important, the data that operators use to base their decisions and adjustments upon must be accurate. Traditional sensing capabilities used in pharmaceutical warehouses typically have a manual component to their data transfer process, causing delays in visibility into conditions that may be actively changing. The sensing capabilities of modern IoT infrastructure alleviates the issues associated with conventional processes, providing real-time visibility into ambient conditions, increased accuracy and reliability in data collection, and even prescriptive insights that highlight opportunities for warehousing optimization. For pharmaceutical manufacturers, logistics providers, and retailers alike the opportunities to mitigate unnecessary risk and reduce product loss with modern sensing capabilities are extensive and cost-effective, all while easing the compliance process and building increased patient safety measures into operations.

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Reducing opioid use one ambulance ride at a time

Posted on September 15, 2023 by Pharmaciststeve

Reducing opioid use one ambulance ride at a time

https://oilcity.news/community/health/2023/09/13/reducing-opioid-use-one-ambulance-ride-at-a-time/

Data show a 28% drop in opioid administrations following an alternative pain treatment training for Laramie County first responders.

In what is possibly a first-of-its-kind approach in the country, Laramie County emergency medical services have undertaken training to reduce the administration of opioids — and the results are encouraging.

“We just analyzed our one year data for that, and we actually had a 28% decrease in opioid administration without any change in patient satisfaction or patient pain control,” said Angela Vaughn, a community health project director through Cheyenne Regional Medical Center.

The reduction in opioid prescriptions is important because experts have identified overprescriptions as one of the key drivers of opioid addiction in the U.S.

In the years leading up to the training, an average of 32% Cheyenne Fire and Rescue patients received non-opioid pain treatments, according to Vaughn. After specialty training and a one year trial period that ended in June, that grew to about 60%.

“This is the first [project] of its kind that we know of where we have completely redone all of the pain protocols, switched up all of the medications and done these really heavy workshops with [over 100 members of] our EMS,” she said.

More data are expected to come from the ambulance service AMR, she said.

Opioids in an emergency

This latest push for opioid alternatives started in the emergency room.

Following similar efforts in Colorado, Cheyenne Regional Medical Center’s ER started to follow an Alternative to Opioid — or ALTO — program, but Vaughn said the initial results weren’t as significant as she hoped.

That could be in part because the effort started during the height of the COVID-19 pandemic — a tumultuous time to introduce new protocols — but also because EMS had yet to be trained on opioid alternatives.

“We still saw a 10% decrease in opioid administration within the first six months,” when just ER staff were trained, Vaughn said. “But then when we queried our providers afterwards, their main barrier was that the patients were coming to them with opioids already on board.”

That is, EMS had already administered opioids to some patients before they got to the hospital.

What makes Laramie County’s program unique is that it goes beyond the ER to train EMS providers.

As the data now show, that novel idea has had significant effects.

Firefighting pain

Patients were already becoming wary of opioids a few years ago, said Lt. Brice Jacobson, the EMS coordinator for Cheyenne Fire Rescue.

“They’re so afraid that if they get that first dose, they’re now going to be addicted,” he said.

Being able to offer alternatives to opioids for those who didn’t want those drugs to begin with, “we actually get them excited. Those patients are pretty happy with that,” Jacobson said.

Opioid alternatives have historically been fairly limited in the prehospital setting, he said, especially when compared to emergency rooms that can stock more medications. At the same time, he added, they can’t just ignore people’s pain.

“Pain does have a negative effect on the body, especially with healing,” he said.

Now, armed with new research and training through ALTO programs, Jacobson said paramedics in his crew have new protocols for using alternatives to opioids, like intravenous Tylenol and Motrin. While there had been concerns about side effects of alternatives like Ketorolac before, new research has found the risks are lower than anticipated with small doses, he said.

“We just analyzed our one year data for that, and we actually had a 28% decrease in opioid administration without any change in patient satisfaction or patient pain control.”

ANGELA VAUGHN, CHEYENNE REGIONAL MEDICAL CENTER

While there was some provider pushback to the new way of doing things, Jacobson said, EMS members are also better trained at talking to patients and assessing how manageable their pain is without opioid intervention.

“I’m also asking … how much pain can you tolerate?” he said. “ And what we find even with that change, a lot of people are like, ‘it’s tolerable. I don’t need this [pain medication].’”

While opioid administrations went down, satisfaction levels have remained largely unchanged, and even improved for some patients, Jacobson found.

He cautions that opioids, including fentanyl, are still the best way to relieve pain in certain instances, like in a major car crash.

“If someone’s in a car accident, they’re in so much pain and they’re having so many injuries, that it’s just not going to be easy to manage with our non-opioid alternatives,” he said. “So our fentanyl, morphine, those kinds of things might be a little bit better for them. But even then, in those scenarios, we’re still using things more specific like ketamine, and then we’re supplementing … with opiates.”

This isn’t the first time firefighters have been on the cutting edge of fighting the opioid crisis around Laramie County, Jacobson said. While high doses of ketamine have been under scrutiny since Elija McClain’s death, Jacobson said, his department has been using small doses to replace opioids since 2017.

“What the data and research have found before we even went this route [with the ALTO project] was we can still use things like ketamine at a lower dose to manage pain,” he said. “And we’d seen a huge reduction in opiates, just on that alone.”

For Jacobson, trying to combat the opioid crisis is also about making sure people understand how prevalent and dangerous it is. The stigma around it makes it harder to know how many neighbors or friends either have or are in recovery from an opioid use disorder, he said.

“[An opioid use disorder] affects everyone equally,” he said. “There’s no prejudice, it doesn’t care who you are. It affects everyone.”