Many employees that work for large companies may or may not be aware that their health insurance is provided by their employer on a self-insured basis, this is referred to as a ERISA prgm. It is claimed that about 50% of large employers are self-insured.  The employee is presented with a “health insurance card” and or a “Prescription drug card”  What the employee may or may not understand is that the well recognized name on their health insurance card is NOT AN INSURANCE but acting as an administrator for the employee to pay the medical expenses that is incurred by the employees and their families.  The “insurance company” has no real financial liability… they could be working on an administrative fee of so many $$$/employee/family and/or some percent of what is paid out as a administrative fee.

The insurance company will generally win the business from the employer with some “dog and pony show” … promising to help the employer lower overall health expenditures for the company. What the employer may not realize that saving money will mean coercing employees to use their mail order pharmacy, step therapy where the pt has to fail on the least costly med before they can “try” the next high cost med and sometimes any improvement is where the next step in the therapy is allowed to be tried… any improvement in QOL … is sufficient.

Also,what many employees don’t understand that there is someone within the company that has the authority to call the insurance/PBM company and tell them to pay for any med or procedure, because it is the employer’s money that is being spent.

Hypothetical,  an employee’s spouse is a chronic pain pt.  The insurance/PBM approached the employer to implement a opiate dosage reduction program… help prevent addiction among employees and/or family members.  So the insurance/PBM implements the CDC opiate dosing guidelines and puts a max MME/day at 90 MME’s. One or more of the employees or their spouses are fast/ultra fast metabolizers and dealing with CRPS… meaning that they are going to need high single doses and very frequent dosing per 24 hrs to help maintain their QOL.  These pts have been stable on very high doses for several years or a couple of decades… and their dose is slowly – or very quickly – reduced  and the pt starts becoming chair/bed/house confined..

Using the chart belong the employee goes to the person that oversees ERISA program.  Need to point out to this insurance/pbm point person… the number of very possible compromising the existing comorbidity issues and/or creates new comorbidity issues… One example is that under/untreated pain… will cause the pt’s system to keep pumping out adrenaline … which will mean that the pt’s adrenal glands will eventually fail and the pt will end up with Addison’s disease.

Here is a post on how liver damage can be for a pt who is taking Tylenol/Acetaminophen  https://www.pharmaciststeve.com/liver-injury-from-acetaminophen-at-low-doses-linked-to-fasting-heavy-drinking/   I can hear the first comment … my spouse doesn’t drink… great… but what happens when the pt goes into a flair and ends up in bed or on the living room couch for a few days..  DOESN’T EAT MUCH – like FASTING ?… they continue to take their Tylenol/Acetaminophen and ends up with liver damage.

Point out to the insurance/pbm contact person… things like their spouse could end up hypertension, resulting in eye and/or kidney damage. Could suffer a hypertensive crisis and end up with a paralyzing stroke and/or death…

The pt being forced to take NSAID and/or Tylenol/Acetaminophen… 15,000 people die every year from gastro bleeds from use/abuse of NSAID

The pt could end up with increased anxiety and/or depression

All of these issues – except death – is going to cost the employer money… paying for increase medical/hospital expenses because the insurance/PBM got the employer to let them introduce a opiate reduction program to help to keep employees and their family members from becoming addicted to opiates.

The number of possible complicated health issues for the chronic pain pt that has their opiate therapy reduced/eliminated.

Give the insurance/pbm contact person this chart and let them assign a $$$ figure to each of the possible health complications for their spouse and/or how many other spouses of employees could be impact in a equal or similar manner…  I suspect that the potential costs to the employer is MUCH … MUCH greater that the cost of paying for rehab for anyone who might become addicted and seeks treatment.

There is very seldom a situation when a MIDDLEMAN comes into a process that can cut overall costs of a program. Middlemen have a cost overhead and a desire to show a profit. It is more likely that middlemen will increase overall costs of a process.

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https://www.drugs.com/interactions-check.php?drug_list=2758-0,531-0

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Per the Civil rights law, racism is a civil rights violation… as is discrimination under the Americans with Disability Act. It becomes more and more obvious that the FEDS/DOJ are the driving force behind discrimination – or even favoritism – of certain segments of the populations.  Right now Gov Abbott has stated that he is going to arrest/jail illegal aliens coming into Texas – for trespassing on private property of numerous family farms that are on the Texas/Mexican border.

It has been reported that some 10%-20% of these illegal aliens test COVID-19 positive and abt 30% refuse a COVID-19 vaccination when offered. The Federal DOJ Attorney General Garland it has been reported that he is going to sue Gov Abbott if he starts arresting/jailing illegal aliens.

Reportedly, abt ONE MILLION + illegal aliens have been allowed into our country in the last SIX MONTHS.  While legal citizen have been encouraged to get COVID-19 vaccination and seemingly many businesses, academia and federal employees are in the process being mandated to get vaccination … if they wish to keep their job. Discrimination/Racism now seems to be a TWO WAY STREET.  What happened to all the EQUITY that has been a major battle cry since the beginning of the year?

Racism as a Chronic Disease: We Are All Affected

https://www.clinicaladvisor.com/home/the-waiting-room/racism-chronic-disease-we-are-all-affected/

Recent literature has increased the focus on health disparities related to racism, not race, as a major cause of illness.

Since the inception of Western medicine, however, there has been an effort to identify genes specific to certain races that would explain why minority populations, including Black, Indigenous, and people of color (BIPOC), have a higher disease burden than White populations.

I attended PA school from 1998 to 2000, and even then our lectures frequently discussed how certain populations are more likely to have certain diseases, including heart disease, diabetes, and hypertension. We know that it is true, but we also know that race is a non-scientific construct, widely based on racist beliefs. I recall a Black classmate who would mumble to those of us around him during lectures, “oh great, here’s something else that is wrong with me.” His comments were certainly reflective of the false and unscientific beliefs that race is a cause of illness.

The issue of how to view the impact of institutional and individual racism on the health of BIPOC has gained increased attention, including exploring new and novel ways to think about racism and health. A Baylor College of Medicine blog post from 2020 illustrates some new and creative thinking on this topic. Blogger Haley Jackson Manley, research assistant in the Center for Medical Ethics and Health Policy at Baylor College of Medicine, shared her insightful take in that post:

“It’s more than just semantics that irks me when people talk about racism as a pandemic. A pandemic implies an outbreak. A disease that is fleeting and may be new or has seasons, such as the flu. Racism is not that. Racism is not new. It’s unceasing with no treatment or vaccine in sight. A more appropriate diagnosis would be racism as a chronic disease, like cancer or diabetes. But this particular chronic disease does not destruct the body of the individual who is infected. Instead, in America, its effects are felt throughout the entire African American community and are not only physical but also emotional and social.”

This really got me thinking about the concept of racism as a chronic disease that affects the physical and mental health of BIPOC. But it also posed questions about how to view this perspective. For example, if we accept that racism is a chronic illness, it leads me to wonder who then has the illness. We know that BIPOC are most affected by racism. But are such populations the ones with the disease or is it those who have racially biased beliefs and actions?

Just because BIPOC bear the brunt of demonstrated negative health impacts from racism, does that really equal having the illness? For example, if an authoritarian parent berates and abuses their child, and causes the child harm, who has the disease in that case? It hardly seems reasonable to describe the harmed child as the diseased party. Instead, it’s the parent with the illness.

But racism can be more subtle. Certainly, explicit racist behavior would lead us to conclude that the source of the behavior is the root cause of the illness. But what about when implicit and unconscious bias and racism is the root of the problem? Research repeatedly demonstrates that implicit and unconscious biases are pervasive among all humans. It also tells us that it predictably affects the health of minority populations. So, does that mean that all humans who hold implicit biases should be viewed as having a disease? Or is implicit bias itself a disease?

I’m inclined to think that it is, depending on how we define disease. Part of being a human being is dealing with our own inevitable disease states, ranging from rhinitis to cancer, from COVID-19 to depression. A reasonable assertion would be that our implicit and explicit biases may need to be viewed as a disease state because of the known negative health impacts they have on others. 

Finally, what about society itself? Can a society with various cultures have a disease? It makes sense to me that societies can indeed be ill, with the illness caused by collective biases, hatred, ignorance, and racism. In the end, we know that the primary sufferers of racism are BIPOC. But asserting that they are the ones with the disease feels like a blaming-the-victim exercise, something that medicine knows much about. What really matters, however, is the chronic occurrence of ignorance, hatred, explicit and implicit bias, and historic prejudice within the medical community that dates back to its origins. This has resulted in premature death and unequal burden of illness and misery on BIPOC. Our job as PAs, nurse practitioners, and other health care providers is to understand how racism impacts us and our patients and establish ways to mitigate this impact. The job of medicine is to address how explicit, or even implicit biases, have made those of us with racial biases sick as well.

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https://youtu.be/pj1IpD7_aT8?t=586

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Congresswoman Kat Cammack website

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I just got a text from Paula and Joe suddenly passed away last night… Those Pharmacist that know Joe will remember him for “taking on” CVS Health over ADA, EEOC and Whistle blower lawsuit… and walked away a WINNER, that was abt 5 yrs ago.

I think that Joe was 69 y/o and regardless of him dealing with MS… was able to work as a Pharmacist for some 40 yrs.

Joe was one of those “good old time Pharmacists” that always tried to meet the pt’s needs.

RIP Gravestone

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Pfizer Vaccine Protection Wanes After 6 Months

https://www.medscape.com/viewarticle/955601

Pfizer’s COVID-19 vaccine continues to show strong protection against serious illness and hospitalization after 6 months, but overall protection against the virus appears to wane after a half a year, according to a new study.

The July 28 preprint report of the study, which has not been peer reviewed, suggests a gradual “declining trend in vaccine efficacy” over 6 months after a two-dose regimen of the Pfizer vaccine. The study included more than 45,000 people worldwide.

The study found that overall effectiveness fell from 96% to 84%.

A third booster dose of the Pfizer vaccine increases neutralizing antibody levels against the Delta variant by more than five times compared to levels after a second dose in people aged 18 to 55 years, new data from Pfizer show.

The immune response to the third dose appears even more robust ― more than 11 times higher than the response to second shot ― among people aged 65 to 85 years.

The company noted this could mean an estimated 100-fold increase in Delta variant protection after a third dose. These new findings are outlined in a Pfizer second quarter 2021 earnings report, which notes that the data are submitted for publication in a medical journal.

The data come from a relatively small number of people studied. There were 11 individuals in the 18- to 55-year-old group and 12 people in the 65- to 85-year-old cohort.

“These preliminary data are very encouraging as Delta continues to spread,” Mikael Dolsten, MD, chief scientific officer and president of the worldwide research, development and medical organization at Pfizer, said during prepared remarks on a company earnings call today, CNN reported.

Availability of a third dose of any of the current COVID-19 vaccines would require either amending the US Food and Drug Administration (FDA) emergency use authorization or granting full FDA approval status to the vaccine.

The possibility of a third-dose authorization or approval has not been without controversy. When Pfizer announced intentions to file for FDA authorization of a booster dose on July 8, the Centers for Disease Control and Prevention, the FDA, and the National Institutes of Health were quick to issue a joint statement saying that they would decide when the timing is right for Americans to have a third immunization. The agencies stated, in part, “We are prepared for booster doses if and when the science demonstrates that they are needed.”

In addition, the World Health Organization said at a media briefing on July 12 that rich countries should prioritize the sharing of COVID-19 vaccine supplies to other countries in need worldwide before allocating doses for a booster shot of its own residents.

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More Medical Device Deaths Than We Previously Thought?

https://www.medpagetoday.com/publichealthpolicy/fdageneral/93768

A significant number of medical device adverse events that resulted in patient deaths were miscategorized in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, according to an analysis using a natural language processing algorithm.

Flagging terms commonly associated with death, the algorithm identified 290,141 reports in which a serious injury or death was reported; 52.1% of these events were reported as deaths, and 47.9% were classified as either malfunction, injury, or missing (the report was not put in any category), reported Christina Lalani, MD, of the University of California San Francisco, and colleagues.

From their overall sample, they found that 23% of reports with a death were not placed in the death category, amounting to roughly 31,552 reports filed from Dec. 31, 1991, to April 30, 2020, they noted in JAMA Internal Medicine.

The physicians and manufacturers who report adverse events with medical devices must choose whether to classify the event as a malfunction, injury, death, or “other.” Per FDA instructions, the reporter is required to categorize an adverse event as an official death if the cause of death is unknown, or if the device “may have caused or contributed to a death.”

In the current analysis, about 56% of reports involving patient deaths were for class III devices — the highest-risk medical devices — and 40.1% were for class II devices, Lalani and team wrote.

The three most common product codes among the adverse event reports were for ventricular assist bypass devices (38,708 reports), dialysate concentrate for hemodialysis (25,261 reports), and transcervical contraceptive tubal occlusion devices (14,387 reports).

The natural language processing algorithm used in this study was implemented to scan through reports and identify terms such as “patient died,” “patient expired,” “could not be resuscitated,” and “time of death.” Of the 70 natural language processing terms in total that were associated with a death, 62 (88.6%) were found among miscategorized adverse event reports involving a patient death. And, of all 62, there were 17 terms that had an estimated percentage of 100%, meaning that “every time that term was used, the patient had died, even though the reporter had not classified the report as death,” the team wrote.

Only 18 terms had sample sizes large enough for researchers to calculate confidence intervals; among them, the words “death” or “deaths” were linked to 12% of adverse event reports in which a patient died, but were classified as malfunction, other, or missing — the highest rate of all the analyzed terms.

Lalani and colleagues acknowledged that one of their study’s major limitations was that they only included reports that contained at least one term associated with death, as opposed to all the reports from the MAUDE database. This, they noted, will likely lead to the underestimation of the actual number of deaths that were improperly categorized.

“The classification chosen by the reporter is vital, as the FDA must review all adverse events reported as deaths, which is not the case for other reporting categories,” the authors wrote. Improving the accuracy of these reports is crucial, since the frequency of patient deaths is what can prompt the FDA to pursue investigations into the device’s safety, they added.

Notably, almost all of the reports analyzed in this study — 95.9% — were submitted by manufacturers, pointing to an inherent conflict of interest, the authors pointed out.

“It may not be in their interest to facilitate identification of serious problems with their own devices in a timely manner,” they wrote. “There have been multiple instances of delays by manufacturers in reporting serious malfunctions and deaths that were associated with medical devices, as well as complete failures to report.”

Therefore, it’s likely that a significant number of patients have been unknowingly treated with devices that were later revealed to be dangerous, Lalani and colleagues noted. For example, they referenced the reporting failures that occurred from 2002 to 2013, when 32,000 women reported adverse events associated with the permanent birth control device Essure; the FDA, however, only received 1,023 adverse event reports from the manufacturer during that 11-year period.

“For these reasons, physicians, hospitals, and patients should submit reports directly to the FDA instead of or in addition to reporting through the manufacturer,” they concluded.

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