I made this blog post a couple of days ago and today got around to watching the video that I shared in the blog post. The 10 minute video is made by a non-profit that seems opposed to these guidelines.

UPDATED:Proposed tapering guideline by American Society of Addiction Medicine

some well-thought-out suggestions in commenting, like references supporting your position.

My first thought was..I’m going to waste all my time digging up references to what I consider common sense. Then again, I looked at who was involved with creating these proposed guidelines – a whole lot of academia types… who are focused on ADDICTION and they live and die on footnotes, citations, and references.

My whole life has been driven by the motto “work smarter not harder…”  I was tired and decided to take a nap, I turned on Pandora on my iPhone to listen to “My 60s Music Station”. My mind decided that “job one” was to find a shortcut to get answers and references!

I have been playing around with a couple of AI Chats for a few weeks. Asking them questions and what they come back with – normally within SECONDS – has often been IMPRESSIVE!

I put on my Pharmacist and my chronic pain advocate hats and started thinking about how chronic pain and anxiety intersect and how forced tapers and increased anxiety interact.

https://openai.com/chatgpt/

https://www.perplexity.ai/

So I asked the latter chat above: studies of chronic pain patients being forced tapered and anxiety levels increase and this is what I got back, including citations – SON OF A BITCH!

Based on the search results, there is evidence that tapering opioid medications in chronic pain patients can lead to increased anxiety levels and other negative outcomes:

1. Suggesting an opioid taper can trigger extreme anxiety in patients. Physicians are advised to acknowledge this anxiety, normalize it, and express empathy when broaching the subject of tapering[2].

2. A large study found that opioid dose tapering was significantly associated with increased risk of mental health crisis. Specifically, tapering was associated with an adjusted incidence rate of 7.4 mental health crisis events per 100 person-years compared to 4.3 events in non-tapered periods[3].

3. The risk of mental health crisis was even higher for patients tapering from higher baseline opioid doses. The study suggests that “especially careful mental health monitoring may be warranted for patients tapering from higher opioid doses”[3].

4. Standard opioid tapers tend to be associated with increased patient anxiety and higher pain ratings[4].

5. Anxiety and fear-based beliefs and behaviors have been strongly implicated in negative outcomes for chronic pain patients. Studies have shown that fear of movement and reinjury is a better predictor of self-reported disability than biomedical findings or pain intensity levels[1].

6. The fear of pain can create a self-perpetuating dynamic where patients avoid physical activity, leading to deconditioning and further disability. This same dynamic may apply to opioid use, as patients associate taking opioids with avoiding pain[1].

While these studies don’t specifically focus on “forced” tapering, they do highlight the significant anxiety and mental health risks associated with opioid tapering in chronic pain patients. The research suggests that tapering should be done carefully, with close monitoring of patients’ mental health, especially for those on higher doses. Physicians are advised to approach the topic sensitively and provide support throughout the tapering process to help manage patients’ anxiety and other potential negative outcomes.

Citations:
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8427345/
[2] https://www.aafp.org/pubs/afp/issues/2020/0101/p49.html
[3] https://jamanetwork.com/journals/jama/fullarticle/2782643
[4] https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.820357/full
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7754260/

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https://downloads.asam.org/sitefinity-production-blobs/docs/default-source/guidelines/bzd-cpg-narrative-draft-for-public-comment.pdf?sfvrsn=6d96408_1

Above is the link that shows in the graphic – may have to click on the graphic a couple of times to get it to resize properly

Link to make comment

https://bit.ly/BZDCPG

I went back and did a few word searches.  I really didn’t feel like reading 146 pages.

The words I searched for – but did not find:

LME ( lorazepam milligram equivalent ) but there is an app for that https://globalrph.com/medcalcs/benzodiazepine-converter-dosage-conversions/

Pharmacogenomics

I am concerned that some well-intentioned bureaucrats will take these guidelines, and go down a similar path that was done with the 2016 CDC guidelines, and take these guidelines and codify them in many different ways.

I am also concerned that these guidelines seem to follow the Beers Criteria https://my.clevelandclinic.org/health/articles/24946-beers-criteria with the exception that they lowered the age to 60 y/o.

I did find this interesting on page 20:

Considerations for Tapering BZD5

The recommendations in this CPG should be interpreted in the context of shared decision-1
making with patients. In other words, when a recommendation says, “Clinicians should 2
consider”, it should be understood to include “in partnership with the patient”
In 2020, the FDA updated the required Boxed Warning for BZD medications to describe the 6
risks of physical dependence, withdrawal, and SUD.33 The associated Drug Safety7
Communication encouraged prescribers to carefully weigh the risks and benefits of BZD8
medications, limit the dose and duration to what is needed to achieve the clinical goal, and 9
monitor patients for BZD misuse and use disorder. When prescribing BZDs, it is important for10
prescribers to have a thoughtful strategy for medication management that regularly reassesses the11
risks and benefits of continued prescribing, as well as a patient-centered plan for tapering the12
medication when the benefits no longer outweigh the risks.13
The risks of BZD use continue while a patient continues to take the medication. In addition, the14
risk for physical dependence and BZD use disorder, particularly in patients who use alcohol or15
other drugs, increases with time.34 As such, long-term BZD use is frequently associated with16
more risks than benefits. Significant risks include oversedation, cognitive impairment, falls,17
motor vehicle crashes, and nonfatal and fatal overdose. 9 Despite this, clinicians often encounter18
patients who have been taking prescribed BZD for months or years.19
While short-term BZD use is associated with decreased anxiety and insomnia, it is commonly20
recommended that use not exceed 4 weeks, because at that point clinical benefits often decrease21
while risks increase.28,35 Meta-analyses of patients taking BZD for insomnia demonstrated minor22
improvements in sleep onset, increased duration, and decreased nighttime awakenings.36,37
23
However, therapeutic effects diminish in days or weeks due to changes in BZD receptor density24
and/or affinity resulting from chronic use, while risks continue. A meta-analysis of RCTs25
comparing BZD to placebo for insomnia in adults over age 60 showed 3.8 -fold increase in26
daytime sedation, and 4.8-fold increase in cognitive impairment and increased incidence of27
psychomotor effects (e.g., falls, motor vehicle accidents). 36 Another meta-analysis showed28
increased risk for fractures associated with current and recent BZD use in older adults.

https://youtu.be/nDZggME3uUo?si=SJASo-arlnn_ZL2b

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Popular weight loss and diabetes drugs linked to increased risk of rare form of blindness

https://www.cnn.com/2024/07/03/health/ozempic-wegovy-blindness-rare-risk/index.html

People who take Ozempic or Wegovy may have a higher risk of developing a rare form of blindness, a new study suggests. Still, doctors say it shouldn’t deter patients from using the medicines to treat diabetes or obesity.

Last summer, doctors at Mass Eye and Ear noticed an unusually high number of patients with non-arteritic anterior ischemic optic neuropathy, or NAION, a type of eye stroke that causes sudden, painless vision loss in one eye.

The condition is relatively rare — up to 10 out of 100,000 people in the general population may experience it — but the doctors noted three cases in one week, and each of those patients was taking semaglutide medications.

A look back at six years of medical records showed that people with diabetes were more than four times more likely to be diagnosed NAION if they were taking a prescription semaglutide, and those who were overweight or obese were more than seven times more likely to experience the condition if they were taking the medication. The risk was found to be greatest within the first year of receiving a prescription for semaglutide.

The study, published Wednesday in the medical journal JAMA Ophthalmology, cannot prove that semaglutide medications cause NAION. And the small number of patients — an average of about 100 cases were identified each year — from one specialized medical center may not apply to a broader population.

Novo Nordisk, the manufacturer of the only semaglutide medications in the US, emphasized that the data in the new study is not sufficient to establish a causal association between the use of semaglutide medications and NAION.

“Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from the use of our medicines very seriously,” a company spokesperson wrote in an email to CNN.

Semaglutide prescriptions have soared in the US, which could raise the number of people at risk for a potential side effect. And NAION is the second-leading cause of optic nerve blindness after glaucoma.

But even with an increased risk, the condition remains relatively uncommon.

“The use of these drugs has exploded throughout industrialized countries and they have provided very significant benefits in many ways, but future discussions between a patient and their physician should include NAION as a potential risk,” lead researcher Dr. Joseph Rizzo, director of the neuro-ophthalmology at Mass Eye and Ear and a professor at Harvard Medical School, said in a news release. “Our findings should be viewed as being significant but tentative, as future studies are needed to examine these questions in a much larger and more diverse population.”

Experts agree that the potential risk of NAION should not deter the use of semaglutide medications to treat diabetes or obesity.

“In the ever-changing landscape of systemic therapies, being vigilant for potential new disease associations is a duty we all share on behalf of patients,” Susan Mollan, an ophthalmologist with the University Hospitals Birmingham in the UK wrote in a related commentary. But the large number of people who are taking semaglutide should raise confidence that the absolute risk of developing NAION as a result is rare.

The ways that semaglutides interact with the eyes are not entirely understood. And the exact cause of NAION is not known either. The condition causes damage to the optic nerve, but there is often no warning before vision loss.

Changes in blood sugar levels can affect the shape of an eye’s lens and may affect vision, said Dr. Disha Narang, an endocrinologist and director of obesity medicine at Endeavor Health in Chicago. She was not involved in the new study.

And the use of semaglutides, which prompt the body to create more insulin to reduce blood sugar, has been previously linked to temporary vision changes — new or worsening cases of diabetic retinopathy, or damage to blood vessels at the back of the eye — likely related to the rapid improvement of blood sugars.

The US Food and Drug Administration-approved labels for both Ozempic and Wegovy include vision changes among potential side effects, and Novo Nordisk is exploring the link between semaglutide use and diabetic retinopathy in a trial which they expect to complete 2027.

“Patient safety is paramount at the FDA and we continuously review available sources of data and new information on potential risks of drugs, including GLP-1 receptor agonists, and update labeling as needed to communicate new information on potential risks to healthcare providers and to patients as soon as possible,” Chanapa Tantibanchachai, a press officer with the FDA, told CNN over email.

While there is a “biologically plausible mechanism” for a potential interaction, “‘association is not causation’ and diabetes mellitus is a known risk factor for NAION,” Dr. Andrew Lee, clinical spokesperson for the American Academy of Ophthalmology and neuro-ophthalmologist at Houston Methodist Hospital, told CNN in an email. He was not involved in the new study.

For now, patients who are taking semaglutide or considering treatment should discuss the risks and benefits with their doctors, especially those who have other known optic nerve problems such as glaucoma or preexisting visual loss, experts say

“It is important to consult with ophthalmology if patients experience visual changes,” Narang said. “It is important to make sure patients are consulting with physicians who are also comfortable prescribing semaglutide and talking through what may be clinically relevant versus irrelevant, and discussing benefits versus risks of long-term therapy.”

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Pain Doesn’t Belong on a Scale of Zero to 10

https://www.medpagetoday.com/opinion/second-opinions/110926

The real answer is long, complicated, and not measurable in this one-dimensional way

Over the past 2 years, a simple but baffling request has preceded most of my encounters with medical professionals: “Rate your pain on a scale of zero to 10.”

I trained as a physician and have asked patients the very same question thousands of times, so I think hard about how to quantify the sum of the sore hips, the prickly thighs, and the numbing, itchy pain near my left shoulder blade. I pause and then, mostly arbitrarily, choose a number. “Three or four?” I venture, knowing the real answer is long, complicated, and not measurable in this one-dimensional way.

Pain is a squirrely thing. It’s sometimes burning, sometimes drilling, sometimes a deep-in-the-muscles clenching ache. Mine can depend on my mood or how much attention I afford it and can recede nearly entirely if I’m engrossed in a film or a task. Pain can also be disabling enough to cancel vacations, or so overwhelming that it leads people to opioid addiction. Even 10+ pain can be bearable when it’s endured for good reason, like giving birth to a child. But what’s the purpose of the pains I have now, the lingering effects of a head injury?

The concept of reducing these shades of pain to a single number dates to the 1970s. But the zero-to-10 scale is ubiquitous today because of what was called a “pain revolution” in the ’90s, when intense new attention to addressing pain — primarily with opioids — was framed as progress. Doctors today have a fuller understanding of treating pain, as well as the terrible consequences of prescribing opioids so readily. What they are learning only now is how to better measure pain and treat its many forms.

About 30 years ago, physicians who championed the use of opioids gave robust new life to what had been a niche specialty: pain management. They started pushing the idea that pain should be measured at every appointment as a “fifth vital sign.” The American Pain Society went as far as copyrighting the phrase. But unlike the other vital signs — blood pressure, temperature, heart rate, and breathing rate — pain had no objective scale. How to measure the unmeasurable? The society encouraged doctors and nurses to use the zero-to-10 rating system. Around that time, the FDA approved oxycodone hydrochloride (OxyContin), a slow-release opioid painkiller made by Purdue Pharma. The drugmaker itself encouraged doctors to routinely record and treat pain, and aggressively marketed opioids as an obvious solution.

To be fair, in an era when pain was too often ignored or undertreated, the zero-to-10 rating system could be regarded as an advance. Morphine pumps were not available for those cancer patients I saw in the ’80s, even those in agonizing pain from cancer in their bones; doctors regarded pain as an inevitable part of disease. In the emergency room where I practiced in the early ’90s, prescribing even a few opioid pills was a hassle: It required asking the head nurse to unlock a special prescription pad and making a copy for the state agency that tracked prescribing patterns. Regulators (rightly) worried that handing out narcotics would lead to addiction. As a result, some patients in need of relief likely went without.

After pain doctors and opioid manufacturers campaigned for broader use of opioids — claiming that newer forms were not addictive, or much less so than previous incarnations — prescribing the drugs became far easier and were promoted for all kinds of pain, whether from knee arthritis or back problems. As a young doctor joining the “pain revolution,” I probably asked patients thousands of times to rate their pain on a scale of zero to 10 and wrote many scripts each week for pain medication, as monitoring “the fifth vital sign” quickly became routine in the medical system. In time, a zero-to-10 pain measurement became a necessary box to fill in electronic medical records. The Joint Commission on the Accreditation of Healthcare Organizations made regularly assessing pain a prerequisite for medical centers receiving federal healthcare dollars. Medical groups added treatment of pain  to their list of patient rights, and satisfaction with pain treatment became a component of post-visit patient surveys. (A poor showing could mean lower reimbursement from some insurers.)

But this approach to pain management had clear drawbacks. Studies accumulated showing that measuring patients’ pain didn’t result in better pain control. Doctors showed little interest in or didn’t know how to respond to the recorded answer. And patients’ satisfaction with their doctors’ discussion of pain didn’t necessarily mean they got adequate treatment. At the same time, the drugs were fueling the growing opioid epidemic. Research showed that an estimated 3% to 19% of people who received a prescription for pain medication from a doctor developed an addiction.

Doctors who wanted to treat pain had few other options, though. “We had a good sense that these drugs weren’t the only way to manage pain,” Linda Porter, PhD, director of the National Institutes of Health’s Office of Pain Policy and Planning, told me. “But we didn’t have a good understanding of the complexity or alternatives.” The enthusiasm for narcotics left many varietals of pain underexplored and undertreated for years. Only in 2018, a year when nearly 50,000 Americans died of an overdose, did Congress start funding a program — the Early Phase Pain Investigation Clinical Network, or EPPIC-Net — designed to explore types of pain and find better solutions. The network connects specialists at 12 academic specialized clinical centers and is meant to jump-start new research in the field and find bespoke solutions for different kinds of pain.

A zero-to-10 scale may make sense in certain situations, such as when a nurse uses it to adjust a medication dose for a patient hospitalized after surgery or an accident. And researchers and pain specialists have tried to create better rating tools — dozens, in fact, none of which was adequate to capture pain’s complexity, a European panel of experts concluded. The Veterans Health Administration, for instance, created one that had supplemental questions and visual prompts: A rating of 5 correlated with a frown and a pain level that “interrupts some activities.” The survey took much longer to administer and produced results that were no better than the zero-to-10 system. By the 2010s, many medical organizations, including the American Medical Association and the American Academy of Family Physicians, were rejecting not just the zero-to-10 scale but the entire notion that pain could be meaningfully self-reported numerically by a patient.

In the years that opioids had dominated pain remedies, a few drugs — such as gabapentin and pregabalin for neuropathy, and lidocaine patches and creams for musculoskeletal aches — had become available. “There was a growing awareness of the incredible complexity of pain — that you would have to find the right drugs for the right patients,” Rebecca Hommer, MD, EPPIC-Net’s interim director, told me. Researchers are now looking for biomarkers associated with different kinds of pain so that drug studies can use more objective measures to assess the medications’ effect. A better understanding of the neural pathways and neurotransmitters that create different types of pain could also help researchers design drugs to interrupt and tame them.

Any treatments that come out of this research are unlikely to be blockbusters like opioids; by design, they will be useful to fewer people. That also makes them less appealing prospects to drug companies. So EPPIC-Net is helping small drug companies, academics, and even individual doctors design and conduct early-stage trials to test the safety and efficacy of promising pain-taming molecules. That information will be handed over to drug manufacturers for late-stage trials, all with the aim of getting new drugs approved by the FDA more quickly.

The first EPPIC-Net trials are just getting underway. Finding better treatments will be no easy task, because the nervous system is a largely unexplored universe of molecules, cells, and electronic connections that interact in countless ways. The 2021 Nobel Prize in Physiology or Medicine went to scientists who discovered the mechanisms that allow us to feel the most basic sensations: cold and hot. In comparison, pain is a hydra. A simple number might feel definitive. But it’s not helping anyone make the pain go away.

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Optum to pay $20M to settle improper prescription allegations

https://www.beckershospitalreview.com/legal-regulatory-issues/optum-to-pay-20m-to-settle-improper-prescription-allegations.html

OptumRx will pay $20 million to settle allegations it improperly dispensed some opioid medications, the Justice Department said June 27. 

The settlement resolves an investigation into if OptumRx improperly filled certain opioid prescriptions between 2013 and 2015. The Justice Department alleged the pharmaceutical benefit manager improperly dispensed opioids in combination with other drugs, including benzodiazepines and muscle relaxants, from its mail-order pharmacy operations in Carlsbad, Calif. 

Opioids prescribed alongside benzodiazepines and muscle relaxants are commonly referred to as “trinity” prescriptions. These prescriptions raise red flags that the drugs may not be for legitimate medical use, and could lead to the diversion of controlled substances, the Justice Department said. In its investigation, the department alleged OptumRx dispensed trinity prescriptions without resolving red flags. 

OptumRx does not admit liability as part of the settlement. The company has instituted policies to reduce the number, dose and duration of opioids distributed, according to the Justice Department, and instituted more robust procedures to identify prescriptions for dangerous combinations of drugs or doses. Optum closed its Carlsbad mail-order operations during the course of the investigation, according to the Justice Department. 

OptumRx is a pharmaceutical benefit manager owned by UnitedHealth Group. 

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It is easy to see from this graphic why independent pharmacies are going out of business and why the insurance/pbm industry wants to get all pts to move their Rxs over to their mail-order pharmacy.

According to the graphic the mail-order pharmacy got paid as much as $4,000+ more than the community pharmacy got paid to fill the same Rx.

On every Rx, the mail-order pharmacy got paid SUBSTANTIALLY more than the community pharmacy was paid.

One particular Rx the community pharmacy was paid abt $2,000 LESS THAN THE COST OF THE MEDICATION FROM THE DRUG WHOLESALER. It does not take an MBA or a PhD in business management to figure out that selling products for substantially less than it costs to buy the product from a wholesaler, is not a good business plan to help ensure the business has a profitable/sustainable future.

YOU WILL HAVE TO CLICK ON THE GRAPHIC TWICE TO GET IT TO BE MORE READABLE

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I have been waiting for this to happen! This is the last part of various entities that have “touched” opioids in some manner that have not been sued for “contributing” to our fabricated opioid crisis.

By suing Express Scripts, they are indirectly suing Cigna – the insurance company that owns Express Scripts. In suing Optum, they are indirectly United Healthcare because Optum is part of that huge healthcare organization.

Are they not suing Caremark this time, because CVS Health owns that PBM, and they have already sued/fined CVS Health for billions?

Could all this activity going after any entity that is involved with the manufacturing, prescribing, dispensing, wholesaling, and paying for opioids? Because the 1999 Tobacco Settlement Agreement annual payments to states will start to be reduced in 2025 and years going forward. It has been claimed that abt 3% of all the billions paid out to the states since 1999 has been used for the stated purpose of the agreement. The vast majority of the dollars paid out have been put in the state’s coffers to be used as the state’s bureaucrats wished.

Arkansas is suing pharmacy benefit managers Express Scripts and Optum, accusing them of fueling the state’s opioid crisis

https://fortune.com/2024/06/25/arkansas-suing-pharmacy-benefit-managers-express-scripts-optum-opioid-crisis/

Arkansas on Monday sued two pharmacy benefit managers that oversee coverage for insurers, employers and other large clients, accusing them of fueling the opioid crisis in the state.

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Top Law Firms in US Opioid Lawsuits to Get Hundreds of Millions in Fees

https://www.usnews.com/news/top-news/articles/2024-06-07/top-law-firms-in-us-opioid-lawsuits-to-get-hundreds-of-millions-in-fees

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WHO and Eli Lilly caution patients against falling for fake versions of popular weight-loss drugs

https://apnews.com/article/wegovy-zepbound-ozempic-mounjaro-counterfeit-8302657de25a0c9c343abe20802d35a7

The World Health Organization and drugmaker Eli Lilly and Co. are warning people to be wary of fake versions of popular weight-loss and diabetes medicines.

WHO said Thursday that it has fielded several reports of fake semaglutide — the active ingredient in Novo Nordisk’s Wegovy and Ozempic — in all geographic regions of the world since 2022.

Lilly said in an open letter that it was “deeply concerned” about growing online sales and social media posts involving phony or compounded versions of tirzepatide, the active ingredient behind its drugs Mounjaro and Zepbound.

The Indianapolis-based company said it was the only lawful supplier of those drugs, and it does not provide tirzepatide to compounding pharmacies, wellness centers or online retailers.

Lilly said fake versions of its drugs frequently advertised or sold online are never safe to use.

Novo Nordisk has issued similar warnings in the past about its medications.

WHO said patients can protect themselves by using prescriptions from licensed physicians to buy the medications. The agency said patients also should avoid buying the drugs from unfamiliar sources.

Lilly said any products marketed as tirzepatide and not Mounjaro or Zepbound were not made by the drugmaker and are not approved by the U.S. Food and Drug Administration.

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US Drug Shortage Reaches a Decade High: US Pharmacopeia Reports

There were 125 drug shortages by the end of 2023

https://www.theepochtimes.com/health/us-drug-shortage-reaches-a-decade-high-us-pharmacopeia-reports-5665830

Drug shortages are the highest in a decade, with 2023 topping the charts, according to United States Pharmacopeia’s first annual Drug Shortage Report (USP).

“The number of drug shortages has increased over a decade, with 125 active drug shortages monitored by FDA at the end of 2023. … This high number of shortages is a direct result of persistent market vulnerabilities,” the report authors wrote. “According to our analysis, over a quarter of drugs in shortage were new drug shortages (34 products) in 2023.”

USP is a nonprofit organization that sets quality standards for medication, dietary supplements, and food ingredients worldwide.

These drug shortages indicate vulnerability in the market and affect patient care.

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