Study finds many reports of patient deaths that were not classified as a death in FDA database

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.

 

Facts vs assertions

I often see letters that pts post on the web that they have received from various insurance/PBM companies.

ASSERTION: Opiates are ADDICTING                           

FACT: when prescribed to chronic pain pt, there is a POTENTIAL of addition but depending on what studies you read, various percentages are claimed but generally most will be < 2%

ASSERTION:  OTC meds (NASIDS, Aspirin (ASA, Tylenol (Acetaminophen (APAP)) are as effective as opiates

FACT:   everything is DOSE DEPENDENT… a high dose of NASIDS/ASA/APAP vs a low dose of opiates – in some incidents may be true

ASSERTION: OTC MEDS are SAFE

                                                              FACT: all meds are potentially dangerous, ASA/NASID can cause kidney damage and intestinal bleeds (est 15,000/yr die from bleed outs). APAP can cause liver damage Liver injury from acetaminophen at low doses linked to fasting, heavy drinking

Under/Untreated pain can have its serious health consequences to pts – see chart below –  things like high blood pressure/hypertensive crisis… which can cause stroke, kidney/eye damage, death for starters.  It can cause increased anxiety, depression, suicidal idealization and even suicide itself.

The pt might want to respond to such letters with asking the insurance company if they understand and are prepared to incur the cost of treating all the comorbidity issues that could be worsened or other health issues that the pt might develop because of their under/untreated pain.

The pt might also want to state that he/she is sharing their letter and this letter with my family … in case the pt dies prematurely from the actions of the insurer/PBM. So that they will have documentation to consult legal counsel for any rights that the pt had under various disability laws and what options they have to seek restitution.

 

 

 

Land of the free , home of the brave – or at least it use to be

It would appear that according to this video poster,  during a pandemic/emergency situation… the Secretary of Health and Human Service pretty much is granted dictatorial powers and all those  other Federal/State laws are suspended during the emergency period.  Any adverse consequences to any person being affected by the mandates of HHS… the person has no legal recourse and all those entities involved in following HHS mandates are indemnified from any liability and/or defending any lawsuits. So it would appear that the FEDS can mandate that EVERYONE gets a COVID-19 vaccination and neither the individual nor any state could put any exemptions in place.

 

 

The Final Solution – to end their pain – is a Major Component of the Opioid Crisis that Must Be Addressed

It is claimed that of all the opiate OD’s,  a low percentage of people  OD by using their own Rx meds… our system declares their deaths Opiate related death, but in reality it is most likely a SUICIDE.  The chart below, explains the issues that a chronic pain pts has to deal with when their chronic pain is under/untreated. The pt may end up with a heart attack, stroke, death or even suicide… all a directly related to a pt having their meds involuntarily reduced/eliminated … but no one within the medical system is charged with any responsibility for the death.  If a person OD’s with any opiate/street drug that was at one time a pt of a prescriber…  the prescriber may be brought up on charges for that death.   Maybe surviving family of the pt who takes the final solution to end their torturous level of pain legally goes after the prescriber for assisting suicide, involuntary manslaughter or whatever charge can be filed against the prescriber and/or if the prescriber is an employee of a large healthcare corporation… and the prescriber is just following a corporate policy/edict. Could the surviving family go to the local prosecutor/district attorney to file charges against those entities.   The surviving family would not have hire any attorney, just let the judicial system take care of death/suicide.

The Final Solution – to end their pan – is a Major Component of the Opioid Crisis that Must Be Addressed

https://www.drugabuse.gov/about-nida/noras-blog/2019/09/final-solution-deaths-are-major-component-opioid-crisis-must-be-addressed

September is National Suicide Prevention Awareness Month. In observance, our two institutes, the National Institute on Drug Abuse (NIDA) and National Institute of Mental Health (NIMH), are taking this opportunity to highlight a dimension of the opioid crisis that receives too little attention—the links between opioid use, opioid use disorder (OUD), and suicide.

We’ve heard a lot about the opioid epidemic, and the rising toll it is taking on our communities. In 2017, 47,600 people died from overdoses involving prescription or illicit opioids. But the opioid overdose epidemic is not limited to people with opioid addiction who accidentally take too much of a pain reliever or unknowingly inject a tainted heroin product. Concealed in the alarming number of overdose deaths is a significant number of people who have decided to take their own life.

It can be challenging to discover the true relationship between suicide and drug use. In the absence of a suicide note, it is difficult to assess the intentions of an individual who has died of an overdose, other than circumstantially. Also, the intentions of someone with OUD who overdoses may not always be clear-cut. In a study last year of current and past overdose experiences among patients seeking treatment in a Flint, Michigan emergency department

(link is external), 39% of those whose worst overdose had involved an opioid or sedative reported wanting to die or not caring about the risks; another 15% reported they were unsure of their intentions.

While we don’t know exactly how many opioid overdoses deaths are actually suicides, some experts estimate that up to 30% of opioid overdoses may fit this description. The connection between opioid overdose and suicide has appeared to increase over time, with one 2017 analysis of National Vital Statistics data showing significant increases in suicides involving opioids among all age groups except teens and young adults between 1999 and 2014; in those aged 55-64, the rate quadrupled.

Research seeking to understand the link between suicide and opioid use suggests the two may be entangled in multiple ways and for many reasons. A 2017 study using national survey data showed that people who misused prescription opioids were 40-60% more likely to have thoughts of suicide, even after controlling for other health and psychiatric conditions. People with a prescription opioid use disorder were also twice as likely to attempt suicide as individuals who did not misuse prescription opioids.  

People with substance use disorders also frequently have other psychiatric disorders—for example, they are twice as likely to have mood and anxiety disorders, which are independently associated with increased suicide risk. The reverse is also true. Half of all individuals with a mental illness will—at some point in their life—have a substance use disorder. Moreover, mental illnesses are also associated with accidental overdoses of medications and illicit drugs.

Pain is another important factor when considering the complex relationships between opioids, overdose (both suicidal and accidental), and mental illnesses. Individuals suffering from chronic pain conditions—the primary reason people are prescribed opioids—may also have comorbid depression or other mental illnesses, and they may be at increased risk of suicide simply because of their pain. Individuals who take higher quantities of prescribed opioids for pain are also at an increased risk of accidental overdose death. With current initiatives to reduce opioid prescribing, many pain patients find themselves either unable to get treatment they need or stigmatized as “addicts” by the healthcare system, compounding their difficulties.

Our Institutes are engaged in research initiatives that address the suicide component of the opioid crisis. NIDA funds research aimed at understanding the complexities of addiction, including co-occurring mental health problems and shared environmental and genetic risk factors for addiction and mental illness. NIMH funds research aimed at understanding the causes of suicide and suicidal ideation and seeks to develop new prevention and treatment interventions specifically targeting suicide.

The opioid crisis and the deaths of despair associated with it demand addressing the larger mental health context of opioid use and misuse. We must fully utilize the effective OUD medications at our disposal in addition to addressing the many risk factors for suicide, particularly co-occurring mental illness and pain, in those who use opioids. This is why the NIH HEAL (Helping to End Addiction Long-termSM) Initiative is so important. The initiative builds upon well-established NIH research to improve prevention and treatment for opioid misuse and addiction. It also aims to enhance pain management by developing effective but safer substitutes for opioids.

As part of this initiative, participating NIH institutes will be funding clinical trials of collaborative care models to treat people with opioid use disorder and co-occurring mental disorders. Collaborative care models, which involve mental health professionals, care managers, and primary care physicians all working together, are already recommended for depression and post-traumatic stress disorder. Recent evidence suggests they could be effective for substance use disorders and for reducing suicide risk. These new grants aim to demonstrate this efficacy definitively and to show how collaborative care can be implemented in community health centers in the areas hardest hit by the twin epidemics of opioid overdose and suicide deaths.

 

CDC Calls for Masks in Schools, Hard-Hit Areas, Even if Vaccinated

It would seem like ONCE AGAIN the CDC comes out with a RECOMMENDATION and it quickly becomes a MANDATE, and according to this article those who have been vaccinated have a RARE chances of catching COVID-19 -Delta from others. Personally, I am not going to wear a mask and any business that mandates that a mask be worn… I will shop somewhere else. Right now, all the “talking heads” state that we are not going back to LAST YEAR … closing down businesses, schools…  but as the “SCIENCE” seems to change from  day to day…  With 67% of our population >12 y/o has had at least one shot… we are on the precipice of the percent vaccination that they said we would have “heard immunity” and was at once time was considered would be a “win” over the virus.

CDC Calls for Masks in Schools, Hard-Hit Areas, Even if Vaccinated

https://www.medscape.com/viewarticle/955488

The Centers for Disease Control and Prevention (CDC) once again is recommending that some Americans wear masks indoors. The agency called today for masks in K-12 school settings and in areas of the United States experiencing high or substantial SARS-CoV-2 transmission, even for the fully vaccinated against COVID-19.

The move reverses a controversial announcement the agency made in May 2021 that fully vaccinated Americans could skip wearing a mask in most settings.

Unlike the increasing vaccination rates and decreasing case numbers reported in May, however, some regions of the United States are now reporting large jumps in COVID-19 case numbers. And the Delta variant as well as new evidence of transmission from breakthrough cases are largely driving these changes.

“Today we have new science related to the [D]elta variant that requires us to update the guidance on what you can do when you are fully vaccinated,” CDC Director Rochelle Walensky, MD, MPH, said during a media briefing today.

New evidence has emerged on breakthrough-case transmission risk, for example. “Information on the [D]elta variant from several states and other countries

indicates that in rare cases, some people infected with the [D]elta variant after vaccination may be contagious and spread virus to others,

” Walensky said, adding that the viral loads appear to be about the same in vaccinated and unvaccinated individuals.

“This new science is worrisome,” she said.

Even though unvaccinated people represent the vast majority of cases of transmission, Walensky said, “we thought it was important for [vaccinated] people to understand they have the potential to transmit the virus to others.”

As a result, in addition to continuing to strongly encourage everyone to get vaccinated, the CDC recommends that fully vaccinated people wear masks in public indoor settings to help prevent spread of the Delta variant in areas with substantial or high transmission, Walensky said. “This includes schools.”

Masks in Schools

The CDC is now recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Their goal is to optimize safety and allow children to return to full-time in-person learning in the fall.

The CDC tracks substantial and high-transmission rates through the agency’s COVID Data Tracker site. High transmission means between 50 and 100 cases per 100,000 people reported over 7 days and substantial means more than 100 cases per 100,000 people.

The B.1.617.2, or Delta, variant is believed to be responsible for COVID-19 cases increasing more than 300% nationally from June 19 to July 23, 2021.

“The highest spread of cases and [most] severe outcomes are happening in places with low vaccination rates and among unvaccinated people,” Walensky said. “With the [D]elta variant, vaccinating more Americans now is more urgent than ever.”

“This moment, and the associated suffering, illness and death, could have been avoided with higher vaccination coverage in this country,” she said.

Based on a July 27, 2021, news briefings from the CDC.

Modeling Patient Irrationality

Modeling Patient Irrationality

https://daily-remedy.com/modeling-patient-irrationality/

In chess, there is an infinite number of movements and combinations, but only one optimal sequence. Likewise, for any decision, there is an infinite number of pathways, but only one optimal sequence.

So from a probability standpoint, it is more likely that a sub-optimal decision will be made instead of an optimal decision.

This may explain why irrational behavior is so commonly seen – it is just more likely.

But for most healthcare insurances, and the actuaries who work for these companies modeling the financial remuneration for clinical services, the models assume patients behavior rationally – that patients consistently make optimal decisions regarding their health.

Clearly there is a conceptual disconnect – beginning with the very concept of optimal itself.

What is optimal to a patient who would rather binge eat at night rather than cope with her stress, willing to suffer obesity in the process?

What is optimal to a rural family that distrusts their local healthcare system and refuses the COVID-19 vaccine in the midst of a pandemic outbreak?

Patient decision-making is guided by intuition; there is no absolute right or wrong for all patients. Rather there are relative benefits and costs, as most medical decisions are an opportunity cost.

A hyper-vigilant patient with hypertension is willing to take the necessary time to organize the medications, taking them daily, and to make the necessary behavioral changes in order to avoid a hypertensive spike.

Many of us are not willing to do so – and knowingly accept the risks of hypertension.

What then is optimal?

It is a relative decision each of us make, daily, weighing the decision in the moment with the short term and long term implications of our health – often with little to no foresight taken.

Behavioral economics have studied this phenomenon, calling it K-level thinking, in reference to the number of conceptual iterations taken before making a decision. Most people are either a K-level zero or one, meaning we either make decisions without thinking or with little thought ahead of time. Few possess higher K-level thinking, which means few fully think through their decisions when making them.

So what is optimal in a world of healthcare where patients make impromptu decisions as opportunity costs – balancing a relative benefit against a relative cost?

It is definitively not rational, like most insurance models would define rational.

It is intuitive, a relative decision, specific to the context in which a patient makes a decision, with little foresight.

Fortunately we have models that approximate this form of thinking.

These models are more complex than the models healthcare insurance companies currently use and integrate probability and spontaneity into the decision-making.

Unfortunately, most insurance companies fail to incorporate these realistic tendencies into the models.

Instead, insurance companies doggedly adhere to antiquated models and antiquated beliefs of patient behavior – living in an era when homo economicus was the model for economic thought.

We now live in a post-rational era, in which the study of irrationality has supplanted the study of a rational economic model.

But insurance companies refuse to accept this new reality, preferring to impose prior authorizations and variable deduction rates against insurers instead of a more realistic model of patient behavior – willing to impose the headache they cause patients.

But it does not have to be this way. Prior authorizations and variable deduction rates are glorified error mechanisms for models that poorly approximate how patients think, decide, and behave overall.

Mechanisms we could eliminate if the models better predicted patient behavior, with greater accuracy – more realistically.

But that would require insurance companies to think rationally about patient behavior – to acknowledge the irrational.

Perhaps that is itself, irrational.

Figures never lie and liars always figure

Look at the statements in this slide 

FLORIDA – 95% hospitalized, not vaccinated – what time frame… no numbers gives for hospitalizations and no number of deaths EVEN MENTIONED

Ohio – 99% of hospitalizations & Deaths in 2021, were unvaccinated ..  The first of the vaccines were readily available first of Jan and a pt had to have two shots 3 or4 weeks apart and was not considered fully vaccinated for another 3-4 weeks..  So one would expect that the vast majority of the COVID-19 infections would be UNVACCINATED in the first half of 2021  No mention of hospitalization or death numbers. 99% of TEN is still TEN

North Carolina – Once again 99% number used for MAY… and what percent of the population had been fully vaccinated ? No hospitalization or death numbers

Colorado – Same/similar quote as that of Ohio…   more NUMERICAL BS !!

White House press secretary Jen Psaki speaks during the daily briefing at the White House in Washington, Tuesday, July 27, 2021. (AP Photo/Susan Walsh)

https://www.foxnews.com/politics/white-house-masks-extra-protection-for-vaccinated-vaccines-work

“What the American people should feel confident in is that we are going to continue to be guided by science, look at public health data in order to provide new guidance if it’s needed to save lives, protect the American people,” Psaki said. 

“When [the president] made those comments back in May, we were dealing with a very different strain of the virus than we are today,” Psaki continued. “And delta is more transmissible. It is spreading much more quickly.” 

Psaki said that at the time of the CDC’s May guidance, and the president’s remarks, the delta variant was “nearly nonexistent in the United States.” 

Despite the evolving guidance from the CDC, Psaki said that the president is “satisfied with the fact that they are continuing to look at public health data and provide public health guidance to the American public about how they can protect their lives and the lives of loved ones around them.” 

As for vaccines, Psaki said getting vaccinated “can save your life.” 

“I think the clear data shows that this pandemic is killing, it is hospitalizing, and it is making people very sick who are not vaccinated,” she said. “That still continues to be the case regardless of what the mask guidance is.”

She added: “The vaccines work.” 

The delta variant has ripped through the unvaccinated population in America, with CDC Director Dr. Rochelle Walensky saying the variant is “spreading with incredible efficiency and now represents more than 83% of the virus circulating the United States.” 

According to the CDC, more than 163 million Americans have been fully vaccinated, while more than 188 million Americans have received at least one dose of a COVID vaccine. 

AMA, ANA, 54 Other Associations Call for Industry wide Vax Mandate


Today Barb had an appointment with our optometrist for an eye exam… and on the front door there was a sign “MASK MANDATORY “.. We have been going to this profession for some 40+ yrs and I asked his receptionists “what is with the mask mandate ?”… and her answer was that “we don’t want anyone to feel uncomfortable”… They only mandating wearing a mask in the reception/waiting area..  I got up and went out to the car to wait for Barb to get finished. Anyone who has chosen to not get vaccinated and chosen not to wear a mask… It is not my fault if they catch COVID-19.  We are vaccinated  !! I am UNCOMFORTABLE wearing a mask … for no reason.

AMA, ANA, 54 Other Associations Call for Industry wide Vax Mandate

https://www.medscape.com/viewarticle/955436

As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association (ANA), and 54 other medical and allied healthcare associations released a joint statement today calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

This injunction covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania and the organizer of the joint statement, told Medscape Medical News.

That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilling nursing facilities, pharmacies, laboratories, and imaging centers, he said.

The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system, TriCare and the Department of Veterans Affairs, which today instituted a mandate.

Last week, the American Hospital Association (AHA) and other hospital groups said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.

A substantial fraction of US healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.

More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare and Medicaid Services (CMS) data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention (CDC).

The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.

Ethical Commitment

The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”

In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.

The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.

Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.

While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”

There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the US Food and Drug Administration (FDA) has not yet fully authorized any of the COVID-19 vaccines.

But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.

“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.

“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.

FACE BOOK… banned this post… because it was against their community standards.

 Apparently FB’s community standards are getting more and more strange… The only think that they have found an objection to is that the WORD SUICIDE appeared in the text… Of course, they would be taking the word out of context. Apparently their AI program is like a DI (DUMB INTELLIGENCE)

 

Pts/prescribers need to start doing CYP-450 and PGx testing.. that will demonstrate – via DNA testing – how fast a opiate metabolizer the pt is and what opiates is the best for the pt – these DNA testing. Use the attached chart – effects on pts’ comorbidity issues by under/untreated pain. APPEAL…APPEAL… APPEAL denials… show the insurance company where under treating pain is going to cost them more money treating pts comorbidity issue as they worsen. Use this process https://www.pharmaciststeve.com/?p=35002 warn the insurance/PBM, prescriber if under/untreated pain cause harm to the pt – per the chart… then those entity may have some financial liabilities… pt dies from stroke or commits suicide… they have been warned and once warned and they don’t change their denials… they have been warned about their direct/informed contribution to the bad pt outcomes

The ONLY Thing that CVS Management Fears – Strong and Sustained Negative Publicity!

The ONLY Thing that CVS Management Fears – Strong and Sustained Negative Publicity!

https://pharmacistactivist.com/2021/July_2021.shtml

The CVS Underground

CVS has enough wealth that it can buy almost any company it wants (e.g., Caremark, Omnicare, Aetna), settle every lawsuit arising from medication errors out of court, terminate many pharmacists and other employees by alleging they violated a policy, and require its pharmacists and other employees to function in understaffed, stressful, and error-prone workplace conditions.

CVS can usually prevent widespread awareness of harmful and sometimes fatal medication errors, as well as unjustified/retaliatory terminations of employees who voice concerns, by offering confidential settlement agreements to the victims of errors and management failures. It does this to avoid negative publicity that would likely be occurring every day because it would result in a loss of customers/revenue and a loss in its stock values.

I will quickly acknowledge that my strong and repeated criticisms of CVS have had absolutely no influence on the decisions and actions of CVS management. Even Ellen Gabler’s three excellent investigative reports in The New York Times (NYT; Jan. 31, 2020, Feb. 21, 2020, July 16, 2020) that exposed the errors and horrible working conditions at CVS and certain other chain stores had limited influence, notwithstanding a readership of many millions.. However, the NYT coverage did elicit a response from the highest level of CVS denying certain concerns and reiterating its big lie that the safety of its customers is its highest priority. But even though the situations described in the NYT reports were shocking, the attention of the public and regulators rapidly diminished in the face of the avalanche of media coverage of the presidential elections and the COVID-19 pandemic. What CVS management fears most is strong and sustained negative publicity, and the recognition of this is increasing the size and activity of the CVS Underground of current and recent CVS employees. Almost all of these individuals must remain anonymous because of the likelihood of retaliation/termination. However, they can provide information to members of the media and individuals such as myself who can disseminate the horror stories and protect the identity of our sources.

Many have experienced or are otherwise aware of CVS errors or its harassment of its pharmacists and other employees. These should be documented and provided to a newspaper or television news reporter. Although members of the media must be able to communicate with and confirm the credibility of the individual who is the source of information, most will protect the confidentiality of their sources. If there is concern that CVS management could identify a current employee as the source of the information and retaliate, the specific incident could be described in a general manner that would protect the identity of the individual involved. Patient safety and employee well-being are in jeopardy, and the following are continuing examples that have been provided to me by current and former CVS employees.

From the CVS underground

    1. “I will remember the day forever. It was in March 2020. Store management and support staff marched to the edge of the pharmacy and started taping off for social distancing. Sheets were handed to the pharmacy staff with orders to wipe down the counters and credit card touch pads. We were instructed to do this hourly and sign the sheet when this hourly task was completed. This program lasted for maybe a day at my store. Later masks were handed out and we were told to wear them until further notice. Employee temperature checks were also ordered for the beginning of shifts. I had my temperature taken only once since March 2020. It gets worse. A more aggressive phone call program started. We began to make calls on prescriptions that had refills left and needed to be filled. We also started offering free delivery through the USPS. Actually they were mailed and not hand delivered as the CVS television ads showed. I have become aware of prescriptions left in customers’ mailboxes when the temperature was about 100°. CVS also wants us to mail out some prescriptions for which a copay is not needed. Some of these prescriptions had been in the waiting bin for days, and patients did not respond to our phone messages. As a pharmacist, I know that prescriptions for certain medications were not or no longer needed if they were not picked up in a timely fashion. However, CVS mailed them and got paid for them.When COVID vaccinations became available CVS appeared to be prepared with plenty of pharmacists and support staff to direct traffic in stores. This went great. We even had extra people in the pharmacy to help us with the normal workflow. During this period we were instructed to promote our other immunizations like tetanus, shingles, pneumonia. Quotas were then established for each store. More pressure for all of us. Confusion resulted as patients asked, ‘why more vaccinations? We are only here for COVID shots.’

      The demand for shots has diminished and so has the staffing for the COVID clinics in the stores. Pressure has increased for pharmacists to step up and give the shots as part of the workflow of filling prescriptions. We do not have the personnel to watch the patient for the 15 minutes after the shot. Once again, CVS fails to provide services that the U.S. is paying us to do. This is dangerous. CVS is placing its customers at risk but I need my job and there are no other positions for pharmacists in my area.”

 

    1. “I worked at Omnicare. The job was terrible, management was terrible, but my hours were regular and it paid the bills. A lot of us had complaints but we had no idea what was about to come our way.Omnicare started laying off thousands of employees across the nation. They laid off people who had been loyal employees for the company for over 20 years. Rumors began to circulate that they were preparing to sell the company. In a short time, it was announced that Omnicare had been acquired by CVS Health. From there, things only went further downhill. Management was given a ‘scheduling tool’ that changed the schedules and shift times for everyone. Everyone was required to be available 24 hours a day and no one was guaranteed a regular schedule of any kind. These and other changes they were making were of the highest level of idiocy.CVS continued to change policies and made several more rounds of layoffs. Work conditions and relations with management got so bad that a lot of people left. Departments in this large-scale pharmacy had been decimated. Meanwhile, management had taken on new contracts with nursing homes and increased the workload by at least 50%. This only worsened the situation.

      Techs began to speak up about it. They felt they could trust me to back them up and, on at least 3 occasions, I was asked to be a witness to the official complaint to management. I am not one to sit back and watch bullying happen, and that is exactly what management was doing. I went with the technicians to their meetings with management and every time I was sent out of the room by management, and someone else (usually FROM management) was brought in to be the official ‘witness.’ So basically, complaints about a bully management team were being met with more bullying. I made no secret of my dislike for the new changes and the ways the techs were being treated, and the news made its way to the bullies in the offices.

      I was eventually terminated for a technician failing to deliver an intravenous medication to a facility. This happened after my shift had ended, and I was not in the building. Still, I had been the last pharmacist to work on the IV order, and management held me responsible and deemed it ‘extreme negligence.’ It was clearly retaliation, but because I was so fed up with the company, I just left. I have many other horrible stories about that place. There was another incident that happened to me which I could have sued over, but I didn’t because I wanted to give management the benefit of the doubt. Never again!

      I stay in touch with a friend who is part of the management team. It has lost almost 70% of its business and had to cut hours and staff back even further. All because CVS would not hire enough staff to cover the workload. Our ‘profession’ is doomed if it isn’t reclaimed by the pharmacists themselves, but it’s not looking good.”

 

    1. A long-term CVS pharmacist was terminated after she voiced concerns that there was not compliance with DEA regulations, as well as concerns about other situations and policies. Following her termination she sued CVS alleging retaliation and other issues. She was offered a settlement but declined it, and the litigation continues. CVS must have great concerns regarding this situation as it already has used two law firms and multiple attorneys.

 

  1. “My long-term CVS employment was terminated shortly after I turned 60. The only other pharmacist who was ‘laid off’ was about the same age. I had to fight for several months to get my stock purchase money.”

Share your concerns with your local media and beyond. The Pharmacist Activist is only published once a month, but readers who are current or former employees of CVS can add their concerns in the media every day.

More potent than ipecac

As I was concluding this editorial I was made aware of a message, “CVS introduces new purpose statement.” The new statement is:
“Bringing our heart to every moment of your health”

I had an instant recall of a popular song that most readers are too young to have heard. It was a hit song from the 1950s by the Fontane sisters titled, “Hearts of Stone” that featured the line, “Hearts of stone will cause you pain.”

I went on the CVS website to learn more and found a longer statement that included “Our purpose,” “Our strategy,” “Our values,” and “The heart of health.” I urge you to read it but observe the following: WARNING: May cause violent emesis. Take the maximum dose of ondansetron before reading!

When I recovered, I thought of a possible “silver lining” that has inspired the first CONTEST in the history of The Pharmacist Activist. Current employees of CVS are eligible and should submit proposed revisions of the “Our purpose” and “Our values” sections of the CVS statement based on your experience and opinions regarding the realities of your CVS employment and CVS management. The prize is publication (anonymously) in a future issue, with the possibility of a second contest to put it to music as a theme song for the CVS Underground. Entries that include profanity, vulgarity, or blatant slander will not be considered. Submit your entry via email to danandsue3@verizon.net.

Daniel A. Hussar
danandsue3@verizon.net