Clampdown on opioids is hurting pain patients

https://starledger-nj.newsmemory.com/?publink=09353ea64

In the summer of 1994, I was working at my desk at the Department of Justice when my back started to burn. Moments later, my body seized up and I fell to the floor. Suddenly, at the age of 30, I was no longer able to sit or stand. I could barely walk short distances. These limitations, related to a surgical mishap, would continue for almost 20 years.

After dozens of failed treatments, I reluctantly tried prescription opioids. The pain medication enabled me to work despite my condition. I argued cases in federal court from a foldable reclining chair, negotiated settlements by video teleconference and, working remotely, managed litigation in U.S. attorney’s offices across the country.

When medical advancements led to an improvement of my health, I went off opioids without incident.

I was, as it turns out, incredibly lucky. A report released last month by Human Rights Watch paints a cautionary and at times harrowing picture of what pain patients are experiencing today.

Because of well-intended efforts to address the overdose crisis, many doctors are severely limiting opioid prescriptions. Patients who rely on opioid analgesics are being forcibly weaned off the medication or seeing their prescriptions significantly reduced. Other patients are unable to find doctors willing to treat them at all.

One such patient, Maria Higginbotham, has had more than a dozen surgeries to correct the collapse of her spine. She suffers from a painful condition in which the spinal cord fuses with adjacent membranes. Last year, her physician cut her pain medication by 75 percent, explaining that the reduction was to comply with federal guidelines.

In the past, Higginbotham could function. Now she needs assistance just to get out of bed and go to the bathroom.

The federal guidelines Higginbotham’s doctor cited were issued in 2016 by the U.S. Centers for Disease Control and Prevention. They were intended as nonmandatory recommendations for primary care physicians.

Increasingly, the guidelines are treated not as recommendations but as one-size-fits-all mandates. They are being misapplied by physicians, state legislatures, insurers and Medicaid programs.

Some physicians told Human Rights Watch researchers that they had taken patients off opioids, or reduced patients’ prescriptions, against their better clinical judgment.

“You set yourself up for a liability, even when you know they’re not addicted and they’re benefiting from opioids,” one physician said.

Other doctors said they had stopped treating pain patients altogether — even patients who don’t use prescription opioids.

It’s true that opioids were prescribed liberally in recent decades. Doctors began doing this in the 1990s. There were some bad actors, such as “pill mills” and wayward pharmacies. Opioid medication too often fell into the wrong hands.

Moreover, opioids are not the magic bullet we once believed them to be. The evidence about their efficacy across a broad population is limited. Even when their use is appropriate, opioids carry risks, and the risks increase at higher doses. The CDC was right to encourage judicious, responsible prescribing. But chronic pain is a large umbrella category, encompassing a wide range of injuries and diseases, some of which are incurable. A one-size-fits-all approach to treatment does not work.

The recent clampdown has had harmful consequences. Some patients told researchers that they were forced to quit working or go on disability when their medication was denied. Others are now homebound. Many mentioned the possibility of suicide.

Patients also said that they were turning to alcohol or illegal substances to treat their pain.

What began as an effort to protect patients may be morphing into one that is harming them. The CDC’s National Center for Health Statistics estimates that 50 million Americans have pain every day and nearly 20 million have pain that limits major life activities. If the experiences that patients described to Human Rights Watch are common, the harm to patients could be widespread.

The CDC’s own data show that fatal overdoses are driven largely by illegally produced fentanyl, its analogs and heroin, not by medically prescribed opioids.

For all these reasons, the CDC should address the misapplication of its guidelines, as the American Medical Association recently did. The agency needs to revise its guidelines to recommend that physicians not abandon pain patients or engage in “forced tapering.”

The CDC should also study and address any unintended consequences of its 2016 guidelines, as it promised to do.

Tackling the overdose crisis is a vital public policy goal. But chronic pain patients should not become casualties in that fight. Kate M. Nicholson is a civil rights and health policy attorney. She served for 20 years in the Justice Department’s civil rights division, where she drafted current regulations under the Americans with Disabilities Act. She gave a TEDx talk about chronic pain, “What We Lose When We Undertreat Pain.”

What began as an effort to protect patients may be morphing into one that is harming them.

Filed under: General Problems | 6 Comments »

www.kevinmd.com/blog/2019/01/the-conflict-between-pharmacists-and-their-corporate-superiors.html

Pharmacists play an essential role in today’s ever-expanding health care system today. They check for drug interactions, watch for signs of opioid overprescribing and try to determine whether a drug for one condition prescribed by one doctor will negatively impact the patient because of another diagnosis the patient has. In hospital units, their roles have become yet more complex — often serving on various quality committees, managing daily dosages of medications like warfarin and vancomycin — and more. I rely upon them in the hospital daily to catch mistakes and advise on drug dosages and choices. Many in the community give flu vaccinations. Some are even trying to gain ”provider” status under Medicare, allowing them bill directly for treating patients. This has been accompanied by a drastic change in the preparation of the average pharmacist. Where once it was a five-year bachelor’s degree, now it is a graduate degree — a change recent enough that as of 2014, over 60 percent of pharmacists practicing had trained under the old system.

Some of these changes are controversial — a recent article put out by the Texas Medical Association details how some pharmacists inappropriately deny pain medication to cancer patients because of concerns over the opiate crisis, though CDC guidelines explicitly exempt such patients from the guidelines. The American Medical Association has come out as well, noting the story of a patient who attempted to commit suicide due to bone pain from metastatic prostate cancer after his perfectly appropriate opiate prescription was denied by a pharmacist.

But these stories of prescriptions denied and conflicts miss a more fundamental issue. As pharmacists’ roles have changed, their professional norms, practices, and regulations have not kept up to date. This means that corporate policies may have inappropriate influence over their decisions and provide an unbalanced incentive towards one action.

Let me give an analogy. Suppose a homeless patient with no money or insurance is assaulted or hit by a car. They are taken to the nearest ED and wind up in that hospital’s ICU with a brain injury. No one is paying for that patient’s care. And the hospital is losing millions every week for what promises to be an extended stay. Can the hospital CEO march down and order the doctors to make the patient DNR/DNI and turn off the ventilator — or be fired? No. In California, this is explicitly prohibited by law as a “corporate bar” on the practice of medicine. But in every state, the prevailing norms of medical practice means that an attempt to do this would be met by howls of outrage by doctors who would recognize this as a grievous breach of medical ethics, which obligate us to treat all patients equally and never withdraw life-sustaining treatment on cost grounds alone. Few, if any, doctors or nurses would comply, and threats of reporting the case to the local district attorney for murder charges would promptly start flying.

But if you read the articles from the Texas Medical Association and the American Medical Association, it is clear that corporate policies are significantly affecting how pharmacists practice at a time when their role has significantly changed. Once, pharmacists were primarily concerned with one thing: the safe production and dispensation of medications. Their calls to doctors once consisted of, “Did you really mean to write for 50 mg Tramadol for this patient?” If the answer was yes, they dispensed the medication. Now, as their training and role have changed, their calls are, “Are you sure 30 pills of 50 mg Tramadol is the correct choice for this patient?” And if the doctor can’t explain convincingly enough, they may well deny the prescription. And I don’t believe there is necessarily anything wrong with that. Pharmacists have a right to refuse to dispense medication and a duty to use their medical knowledge to help their patients. Like nurses, there are actions they may disagree with and vocalize their disagreement but carry them out anyway. And there are actions which they feel are so wrong that they refuse to dispense a medication.

But the fact is: Unlike doctors, pharmacists do not have a professional culture or legal protections that fights strongly against interference from their corporate superiors. Corporations almost overwhelmingly employ them. And under threat of losing their jobs, they are forced to bend to the orders of their corporate superiors to dispense thousands of opiate prescriptions without question thanks to the massive profits involved. And now after lawsuits against those same companies over those practices to deny opiates under blanket policies without consideration to individual patient characteristics. When a patient walks in with severe pain for any reason and needs opiate pain medication — whether for cancer, severe trauma, or another cause that requires them, rare as they may be — the pharmacist has every incentive to deny that script, and no repercussions if they say no. Contrast that to the physician, who is obligated and held liable in a balanced way for both acting and failing to act. Of course, a common response is that a patient can always go to another pharmacy. But this justification becomes increasingly thin as patients are directed to order from certain pharmacies by their insurance companies or else face sky-high copays (not that they may not face sky-high copays anyway).

When they decide to push back on, approve or deny medications based on medical merit, pharmacists are effectively practicing medicine. I don’t even believe this is necessarily a bad thing, provided the training is appropriate and roles delineated. But as pharmacists’ abilities to deny and change medications on both cost and medical grounds expands, it is time to expand the profession’s protections against corporate interests, and provide for a balanced oversight that appropriately recognizes both a duty to stop dangerous prescriptions and to allow through legitimate ones.

Vamsi Aribindi is a surgery resident who blogs at the Medical Intellectual.

This article does a very good job of explaining why the average pts dealing with subjective diseases that requires the pt takes one or more controlled substances is probably better served by patronizing a independent pharmacy.  Where the pt is typically dealing with the Pharmacist/owner and what is absent is the “corporate overlord” that the chain pharmacist employee has to deal with and most likely has to fear for his job for trying to do what their education/experience and common sense tells them what to do that is in the best interest of the pt.

We have a serious and growing Pharmacist SURPLUS… it is claimed that we are graduating 15,000 new Pharmacists each year but there is only a job opening for 10,000 of them.  So we have 5,000 new pharmacist with many having > $100,000 student loans that they have to start making payments on in 6-9 months after graduating.  Salaries are falling to levels that have not been seen since about the turn of the century.

The typical independent will provide much more prompt and timely service in getting prescription(s) filled for several reasons. Without all that corporate overhead cost and the stock holders and stock market to “make happy” they can afford to have more staff on hand.  Most independents offer home delivery service and can put a priority on “walk in “prescriptions because the deliveries are typically bunched into few/several larger runs during the day, so putting some walk in prescriptions to the head of the line… doesn’t cause any home delivery to be delayed and gets the walk in prescription finished and the pt promptly on their way.

How to find a local independent pharmacy/Pharmacist

---

Filed under: General Problems | Leave a Comment »

https://www.ktuu.com/content/news/Board-reprimands-pharmacists-over-refusals-to-fill-opioid-prescriptions-504881401.html

Filed under: General Problems | 2 Comments »

Filed under: General Problems | 3 Comments »

Dan Laird👨‍⚕️🇺🇸🏴󠁧󠁢󠁳󠁣󠁴󠁿🏥🏛‏ @DanLairdMD

Toradol (Ketorolac) is a very potent NSAID… so potent that there is a FDA BLACK BOX restrictions that it should not be given for more than 5 days in a row.  Mainly because it can easily cause gastric bleeding.  I have not seen much information on details behind this trial, but Sickle Cell disease can have some very painful flairs and Nevada has been one of the states whose bureaucrats took some fairly draconian actions last year to address the fabricated opiate crisis with limits on how much, when, where and by whom may prescribe opiates for pain.

What institution or prescriber who tried to avoid using a controlled substance/opiate to treat this young Mother’s Sickle Cell induced pain… apparently the pt’s health took a serious and FATAL turn because of whatever policies or edicts that was being followed.

This is just the FIRST of these types of lawsuits that I think that we will start seeing.  We have seen where large healthcare corporation have/are seeing them implementing policies/procedures/edits for their employees in how they are going to treat – or not treat – a pt’s pain and/or other subjective diseases with controlled meds.

These large healthcare corporations are large hospital complexes, PBM (Prescription Benefit Managers), Insurance companies and pharmacy chains and they all have “VERY DEEP POCKETS” and that is what plaintiff attorneys go after when people have been harmed.

Filed under: General Problems | 19 Comments »

This is a interesting exchange in the confirmation between a Senator from Utah and the nominee for Attorney General. Most everyone is familiar with the Civil Asset Forfeiture Act and their discussion as to how many – including a Supreme Court Justice considers the act UNCONSTITUTIONAL and how some states have made the seizing of assets under this act – prohibited in their state – and the state law enforcement pulls in federal law enforcement in some actions so that the feds can seize the assets and then “share” the proceeds with those in the particular states where it is illegal. 

Likewise, even though this act is considered UNCONSTITUTIONAL … the two attorneys seem to agree that this law is a “useful tool” for law enforcement. You can see here to get a lawyer.

Makes one wonder just how many laws are on the books that many believe are UNCONSTITUTIONAL, but law enforcement continue to use them because they consider them to be “useful”.  One also has to wonder what all is encompassed under the definition of “useful” ? Ask an expert from Austin personal injury attorneys more about the same.

At the Federal level, it is claimed that typically 40% of Congress is attorneys and so how many bills that are passed by Congress that are known or should have been known to be UNCONSTITUTIONAL when they are voted on.. and apparently our bureaucratic system has no checks/balances to help assure that all bills sent to the President to be signed into law are in fact constitutional ?

Filed under: General Problems | 4 Comments »

An Opioid Study So Bad That It Disproves Itself?

https://www.acsh.org/news/2019/01/23/opioid-study-so-bad-it-disproves-itself-13753

Here’s a first. A study that might actually disprove itself. I’ve never seen anything like it.

A paper in JAMA Open Network tries to hop on the anti-opioid bandwagon but fails so badly that I had to stare at the screen in disbelief for a while. Did I really just see this? Does it mean what I think it does? Did the authors fail to realize what their own data say?

Here’s the title:

The intent of the study is obvious – to let us know that more pharmaceutical money leads to more opioid prescriptions being written, which results in more OD deaths. While this may be “intuitively obvious,” this does not make it correct. Here’s why.

The authors, mainly from Boston Medical Center, gathered prescription data from 67,507 US physicians in 2,208 counties between August 1, 2013, and December 31, 2015. They used these data to assert (Cue to “Same Old Song,” Four Tops, 1966) that the more that drug companies push opioid pills to doctors the more people died over a 2+ year period. But they may have given us cause to reach an entirely different conclusion.

Let’s start with their Table 2, which examines the association between pharma money and OD death using three different models, each of them representing a different way of measuring “money.” 

Table 2 (partial): Source: JAMA Network

There are three ways that the scientists used to measure pharma money: marketing dollars (A), the number of physician payments (B), and the number of physicians who received payments (C). In each model, there is an associated relative risk (RR) of increased deaths in those counties ranging from 1.09-1.18, which means a 9-18% increase.

ACSH advisor and expert biostatistician Dr. Stan Young is uncharacteristically understated: 

“An odds ratio, OR, of 1.000 is even odds, no effect. If an OR is close to 1.000, then any small bias could have produced the effect. An OR of 1.1 is not impressive.”

Dr. Stan Young, private communication, 1/23/19

In other words, when the increased relative risk is so low the presence of any kind of bias, for example, age, race, socioeconomic status, or the presence of other drugs, could turn the very low observed increase could turn into a zero increase. Even if we assume a perfect selection process, we are looking at an increase in deaths of about 15% at best. In other words, not much.

Now let’s look at Table 3, which shows that more pharma money results in doctors writing more prescriptions – something that can’t be a huge surprise. 

Table 3 (partial): Source: JAMA Network

But now we see that pharma money results in a large increase in the number of prescriptions written by doctors. With a higher relative risk (1.8-13.6-fold, 80-1260 % increase) the chance of bias affecting the results is quite low. 

So, let’s put these two conclusions together:

A. More pharma money leads to a very small (perhaps, zero) increase in overdose deaths.

B. More pharma money leads to a significant increase in written prescriptions.

So, it is reasonable to conclude that:

C. Despite a whole lot more written prescriptions, the rise in OD deaths is minimal, if any.

So, it’s also reasonable to conclude that:

D. Prescribed opioids aren’t causing many (or any) deaths, something that patient advocates have been screaming forever.

There are other limitations of the study that are disclosed in the paper as required. It would be rather easy to debunk the study based on these alone. But let’s not. Instead, let’s ask a question: Did the authors start out trying make a point only to end up making the opposite point instead? If so, do they realize this? Or are they just hoping that we don’t?

I have no idea. Perhaps someone can explain? Crazy.

Filed under: General Problems | 2 Comments »

The DEA Thinks You Have “No Constitutionally Protected Privacy Interest” in Your Confidential Prescription Records

https://www.aclu.org/blog/national-security/privacy-and-surveillance/dea-thinks-you-have-no-constitutionally-protected

Filed under: General Problems | 7 Comments »

Filed under: General Problems | Leave a Comment »

Filed under: General Problems | Leave a Comment »