THE FUTURE OF PHARMACY: THE SUICIDE OF OUR ONCE-NOBLE PROFESSION – UNLESS THERE IS A REVOLUTION!

Independence Day and Independents Day
THE FUTURE OF PHARMACY:
THE SUICIDE OF OUR ONCE-NOBLE PROFESSION – UNLESS THERE IS A REVOLUTION!

http://pharmacistactivist.com/2022/July_2022.shtml

I had initially intended to include three briefer editorial commentaries in this July issue on the topics of the importance of independent pharmacies, more errors and terrible working conditions in chain pharmacies, and the continuation of the COVID-19 challenge and chaos. However, I did not sleep well last night. Although sleep prevailed, there were extended periods in which I laid awake thinking about the future of the profession of pharmacy. Was I dreaming? No! I had sufficient clarity of thought that I considered getting up and writing down the ideas that occurred to me lest I not remember them when I awakened this morning. But I did not get up and record them because the thoughts were so strong and clear that I knew I would not forget them. The result is that this commentary will focus on the essential role of independent pharmacists/pharmacies, the failure of most of the rest of our profession to recognize their importance, and the likely consequences absent a commitment and effort to take urgent actions – a REVOLUTION!

I have been greatly blessed by my studies and practice in the profession of pharmacy. Words can’t capture the joy I continue to derive from my friendships with so many dedicated pharmacists, the accomplishments of my former students who are now my friends and colleagues, recognizing the value of the medications, advice, and services provided by pharmacists for the benefit of their patients and society, and the excitement of knowing that there is still unlimited potential and value in expanding the role of pharmacists.

Victor Rossi taught the pharmacology courses that I took as an undergraduate pharmacy student; I consider him to be the “master teacher” whose combination of expertise, eloquence, and wit are unsurpassed in my more than 60 years of experience. We were faculty colleagues for many years and we stay in touch in our “retirements.” His skills have not diminished and, at his present age of 93, he is persistent in urging me to write an editorial about the future of pharmacy. I have declined to do that because of my lack of clarity and confidence in my ability to make such predictions. However, I have now overcome that reticence and Victor and my wife Suzanne are the only individuals whom I will ask to critique and suggest revisions in this commentary before I publish it.

Some of my comments in this editorial, although well-intended, are provocative and critical. They are made in the context of my recognition that I, personally, have not done enough to address the challenges described and to give back to our profession that has provided such a fulfilling experience and career for me and a comfortable lifestyle for our family. I need to do more!

Community pharmacy – Then

A pharmacy education and a license to practice provide an excellent foundation to assume a wide range of employment responsibilities within, concurrently with, or beyond the profession of pharmacy. Historically and today the number of pharmacists practicing in the community setting far exceeds the combined total of pharmacists employed in all other opportunities and settings.

Over a period of more than 150 years, the large majority of pharmacists developed their enthusiasm for and made their decisions to study pharmacy as a result of the positive influence of parents or a family friend who owned a community pharmacy and/or the employment experience as a high-school student in a community pharmacy. The latter situation was my personal experience. The commitment of the pharmacist owner and the other full-time and part-time pharmacists to know and serve their customers (prior to the time when we considered them our patients) and communities were impressive. Customers greatly appreciated and valued these positive relationships with the pharmacists and respectfully addressed them as “Doc” or greeted them by name. These personal qualities and services of pharmacists, combined with the “mysteries” of drug therapy for a high-school student who had not yet taken a chemistry course, as well as the willingness of the pharmacists to explain things to me, have motivated me and so many others to study pharmacy.

Community pharmacists have been the face and identity of the profession of pharmacy for the vast majority of the public, our legislators, and others. This is the reality, and does not diminish the importance of the roles of those pharmacists with employment responsibilities that are invisible or less visible to the public. Aside from my family, circle of friends, students, and pharmacists, few would know that I am a pharmacist, and the same is true for most other pharmacists who are not in community practice.

During this period of time there were no corporately-owned chain pharmacies and the “chain” pharmacies that did exist (e.g., Walgreens) were started and managed by pharmacists who were committed to the profession of pharmacy and serving their customers and communities.

Community pharmacy – Now

Over the past 50 years there have been dramatic changes in the profession of pharmacy and community pharmacy. Examples of progressive changes include customers becoming “patients” for whom pharmacists can provide information, counseling, advice, and monitoring of the use of increasingly complex medications, maintain patient profiles, perform drug utilization reviews, and provide immunizations.

Unfortunately, there have also been changes that have had a destructive impact on patient care and our profession. Examples include the establishment and growth of mail-order pharmacies, online pharmacies, and specialty pharmacies owned by corporations that provide medications from invisible pharmacists with whom either phone or other communications are rare occurrences. Health insurance companies and pharmacy benefit managers (PBMs) have seized the dominant roles in drug therapy decisions and compensation for the provision of medications to patients. The growth and number of corporately-owned chain pharmacies has been exponential as exemplified by CVS and Walgreens each owning approximately 10,000 pharmacies. Very few, if any, of the executives and other high-level decision-makers of these corporations are pharmacists and they often have no or limited experience in health care.

There are tens of thousands of excellent chain pharmacists. However, the egregious, understaffed, error-prone, metrics-dominated, and stressful working conditions that are determined by non-pharmacist executives prevent the availability of time for pharmacists to communicate with and advise customers. As a consequence, although some customers are observant and sympathetic to the pharmacist’s dilemmas (“you need more help”), many are angry, impatient and file complaints following long waits for prescriptions, appeals to purchase CarePass or participate in other company promotions, nuisance calls from the stores to obtain refills, immunizations, and other services they have not requested, etc. The frustration and anger of customers are often directed at the pharmacist and also include criticism of the high cost of drugs and increases in co-pays over which pharmacists have no control. Chain executives further exacerbate existing minimally-tolerable working conditions by reducing hours of pharmacist and technician staffing.

The strongest critics of chain pharmacies are their own pharmacists and other employees. Thousands vent their anger, burnout, mental health issues, and worse on social media. Chain pharmacists who are in a position to do so quit their jobs and sometimes leave our profession entirely. The turnover of pharmacy technicians is even higher, many of whom take positions at fast-food businesses with better pay and less stress.

Independent pharmacists
Independent pharmacies have been decimated by factors such as the non-negotiable policies/terms and abysmal compensation mandated by the largest PBMs, direct and indirect remuneration fees (DIRs) that are often based on generic drug utilization rates for which pharmacists have no knowledge or control, and the predatory tactics of large chain stores that steal patients and purchase independent and smaller local/regional chain pharmacies, sometimes under the threat of establishing their own pharmacies in the communities and forcing the already established pharmacies out of business.

Many independent pharmacists have sold their pharmacies to a large chain, often for an amount that is far less than their previous financial value. Others experiencing the challenge of financial survival have not been able to identify a purchaser and have had to close their pharmacies, possibly receiving pennies on the dollar for their inventories. For many, the higher previous value of their pharmacy was anticipated to be the equivalent of a pension that would be an important component of support following their retirement.

One consequence of these coinciding pressures has been a substantial reduction in the number of independent community pharmacies. Some of the independent pharmacist owners who continue have been able to combine imagination, creativity, and opportunity in their practices and services that have enabled them to not only survive but thrive under the present challenges. However, some others have succumbed to the “tyranny of the urgent” – and the perceived need to dispense more prescriptions faster and more efficiently. But this response is usually at the expense of the time and service these pharmacists can devote to providing personal attention and advice for individual patients. This is the single most valuable service that distinguishes the independent pharmacist from other stores and sources of medications, but some fail to recognize its importance with the result that it declines or disappears.

Customers using a busy, understaffed chain pharmacy usually have communication only with a technician, clerk, or cashier, but they may catch a glimpse of a pharmacist multi-tasking several counters behind the prescription counter where they are waiting. For this and other reasons previously identified, it is the independent community pharmacists who are the face and identity of pharmacy for the public. In addition, they represent the heart and soul of our profession. As my students and readers of The Pharmacist Activist are aware, I have been a strong advocate for independent pharmacy and have often voiced my belief that the ability of the entire profession of pharmacy to survive and thrive is inextricably linked to the ability of independent pharmacies to survive and thrive. I have been remiss in not recognizing at a much earlier time but independent pharmacists have also been the most influential and effective motivators and recruiters of young people to study pharmacy and enter our profession.

The profession’s “response”

The profession of pharmacy should feel greatly indebted to independent community pharmacists for the consistently excellent results for pharmacists in polls of the public regarding those in whom they place great trust for their integrity and ethical standards. HOWEVER, the profession of pharmacy has essentially ABANDONED independent community pharmacists.

Professional associations
With the noteworthy exceptions of organizations such as the National Community Pharmacists Association, American College of Apothecaries, Alliance for Pharmacy Compounding, many state/local pharmacy organizations, and wholesalers and buying groups of independent pharmacists, most national pharmacist membership organizations focus exclusively on the “specialty” practices and sites of their members while seldom, if ever, acknowledging the value of the profession, education, license, and the community pharmacists who provided the foundation that has enabled the development of newer and specialized roles and opportunities. The American Pharmacists Association (APhA) and other smaller organizations that purport to represent all pharmacists in the profession have provided some services that are of value for community pharmacists. However, they have FAILED in addressing the issues and individuals which are the most threatening for community pharmacists. These and other pharmacy organizations have developed some important initiatives to assist pharmacists in addressing well-being, burnout, resiliency, and mental health issues. At the same time they recognize the intolerable, error-prone working conditions many chain pharmacists experience, they REFUSE to challenge either privately or publically the executives of the large chains (e.g., CVS, Walgreens, Walmart, Rite Aid) who are most responsible for these working conditions.

To the contrary, these organizations show no hesitancy to accept revenue from these companies for meeting exhibits, unrestricted educational grants, and other programs. On some occasions they have even given awards to these same companies which are destroying the profession of pharmacy. Are there conflicts of interest? Are they afraid of losing members who work for these companies? It is significant that investigational journalist Ellen Gabler of the New York Times in several thoroughly-researched articles has been more effective than our pharmacy organizations in exposing medication/dispensing errors and the working conditions in chain pharmacies.

Our professional organizations act more often as competitors than colleagues in areas such as recruitment of members, development of continuing education programs and publications, and what some describe as the “sale” of credentials and accreditations. Some suggest that they are more committed to self-preservation and programmatic and membership growth than they are to addressing the issues of greatest importance to their members and being advocates for the entire profession of pharmacy that has enabled the opportunities they enjoy and from which they derive their livelihood. They fail to pursue the opportunity for greater strength and synergy if they were to function in a unified organizational structure, notwithstanding the myriad (and variable depending on the issue) “coalitions” of dozens of pharmacy organizations with an alphabet soup of acronyms that are more confusing than helpful for legislators and others to whom the requests and position statements are sent.

Colleges of pharmacy
Colleges of pharmacy and their faculties, as well as the American Association of Colleges of Pharmacy (whose preference is to be viewed as The Academy) also have done little or nothing to address the working conditions in chain pharmacies or to be advocates for and protect the financial survival of independent pharmacies. Many pharmacy students and some pharmacy faculty have never been inside an independent pharmacy or even know a pharmacist who works in one other than current or former students whom they might know. Some pharmacy faculty actively discourage or even belittle excellent students who wish to go into community practice, and suggest they would be wasting their expertise and potential if they do not participate in a residency or fellowship program or go into a graduate program. Some faculty have predicted the complete disappearance of independent pharmacies, and show no concern in doing so.

Many colleges of pharmacy do, however, solicit scholarships from the large chain pharmacies, as well as grants and gifts as large as amounts that would provide “naming rights” for a classroom, laboratory, building, or even the entire college of pharmacy. Are there conflicts of interest? The American Association of Colleges of Pharmacy is meeting later this month in Dallas. Following the meeting, I urge you to check its website and review the actions taken by the House of Delegates and identify the resolutions you consider most important for the profession and your responsibilities.

Pharmaceutical companies
Some of the largest pharmaceutical companies were founded by pharmacists, and achieved their early success that positioned them for subsequent dramatic growth and revenues because community pharmacists and hospitals purchased their products. Today, these same companies reject and ignore independent community pharmacists who, because they are the only participants in the prescription drug distribution system who are visible and accessible to patients, are the recipients of angry comments about the unconscionably high prices of trade name pharmaceuticals. After establishing the list price for these drugs the companies negotiate secret and unethical rebate deals with PBMs which they then blame for the high cost of the drugs.

Professional organizations of pharmacists, colleges of pharmacy, and pharmaceutical companies usually provide health benefits coverage for their employees that includes a prescription drug plan that is most often administered by CVS Caremark, Express Scripts, or Optum. These PBMs have engaged in fraud and deception and have had the most destructive impact of all on the profession of pharmacy that has forced many independent pharmacies to close, resulting in pharmacy “deserts” because the regions have an insufficient population base to attract a chain pharmacy with high profit expectations. Colleges of pharmacy then have the nerve to ask the same alumni who are victimized by the PBMs the colleges patronize to give generously to support their alma mater.

Selected relevant issues

In the late 1900s and early 2000s the available positions for pharmacists significantly exceeded the supply of pharmacists to the point that large chain pharmacies were offering signing bonuses to recruit pharmacists. Existing colleges of pharmacy increased their enrollments, even during the time of the transition to Doctor of Pharmacy programs that extended the duration of a pharmacy education from three professional years to four professional years plus at least two years of pre-professional studies. During this same period of time new colleges of pharmacy were established in numbers that bring the total to more than 140, approximately twice as many as the 72 that had remained constant for several previous decades. The larger number of colleges of pharmacy recruited many more student pharmacists and the number of pharmacy graduates markedly increased in a corresponding manner. This has resulted in a situation in which there are more pharmacists than there are positions in many parts of the country. Chain pharmacy executives seized this opportunity to cut the hours of pharmacists and technicians, reduce salaries for pharmacists, and terminate or otherwise force older and experienced higher-salaried pharmacists out of their positions to replace them at lower salaries with new graduates who were desperate for employment to start repaying college debts.

During the last several years there have been limited geographical areas in which there are shortages of pharmacists to the point that large chains have again provided signing bonuses (for a 2-year employment commitment) in certain regions, at the same time there is a surplus of pharmacists in most parts of the country. However, the reasons for these spot shortages differ from those of previous experiences. Some have resulted from the temporary greater demand for pharmacists to provide more immunization and other services necessitated by the COVID-19 pandemic, and include situations in which certain chains have closed earlier or for several hours on weekdays and entire days of a weekend. These usually unannounced temporary closings infuriate customers who arrive during “usual hours” for medications needed on a timely basis only to find the store closed and no guidance as to when they will be able to obtain their prescriptions. However, the more important and continuing reason for pharmacist shortages in some areas is the large number of pharmacists leaving their employment in chain pharmacies because of the working conditions, burnout, and stress that jeopardize their mental health.

Concurrent with these changes has been a decline in the number of high school graduates and a substantial reduction in the number of applications to study pharmacy and enrollments in colleges of pharmacy. To achieve even reduced enrollments, some colleges of pharmacy have reduced admissions standards and discontinued requirements for applicants to take the Pharmacy College Admission Test or the SAT or ACT. Enrollments and tuition revenues of some colleges of pharmacy have declined to the extent that faculty positions are being cut. At least one college of pharmacy has been “sold” to a larger university that wants to expand its programs in health care, several colleges that had accepted students and opened have closed, and several universities that intended to establish pharmacy programs have canceled those plans.

Some colleges of pharmacy that have taken pride in being collegial and not competitive in recruiting students are now intensely competing and actively promoting statistics that support their promotional efforts such as high employment placement rates following graduation and highly successful first-time NAPLEX pass rates. Other colleges dodge questions about NAPLEX pass rates and try to avoid disclosing them. These pass rates are publicly available but many applicants and their families are not aware of that. More colleges of pharmacy will close!

We have considered the marked decline in the number of independent community pharmacies and their positions for pharmacists. Few anticipated, however, that some large chain pharmacies would suspend their plans for geographical and numerical growth, and actually start closing their unprofitable pharmacies (e.g., CVS has announced plans to close 900 pharmacies over a period of 3 years and Rite Aid is closing a number of its pharmacies). As a consequence of mergers, acquisitions, and cost-reducing strategies by pharmaceutical companies, the number of positions for pharmacists in these organizations has also declined.

Who will study pharmacy?

The number of high-school students who are making college and career decisions is declining. Most colleges of pharmacy are experiencing reduced enrollments, resulting in increased competition in recruiting the best-qualified applicants. The typically higher tuitions of private colleges/universities add to their challenge in recruiting students.

Although the demographics and costs of a pharmacy education are important, there are other factors that influence decisions to study pharmacy that are even more important. Young people can not be expected to be aware of the multitude of opportunities one can pursue with an education in pharmacy. Therefore, their perspectives and opinions about a career in pharmacy are usually based on what they hear, observe, and learn about pharmacy and, in many cases, personally experience by working in a community pharmacy. Traditionally, community pharmacists have been the most influential and effective motivators and recruiters of young people to study pharmacy. But this is no longer the case!

The marked decline in the number of independent community pharmacists has resulted in the scarce availability of part-time positions for young people in these pharmacies. Even daughters and sons of parents who own independent pharmacies, who “grew up” working in the family’s pharmacy, may be sufficiently discouraged by what they experience and observe to be the influence on their parents and family relationships of long hours and the stress, problems, and challenges associated with the ownership and survival of an independent pharmacy. Indeed, many of these parents actively discourage their children from studying pharmacy and following in their footsteps.

There continue to be thousands of high-school and college-age young people who are employed in chain pharmacies. But what are they hearing, observing, and learning from these experiences? They observe first-hand the stressful and frantic working conditions and burnout, as well as the rapid turnover of technicians. They hear pharmacists say that they hate their district leader, employer, and sometimes even angry customers, and that they would never permit one of their own children to study pharmacy. They read the postings of these pharmacists on social media. They observe pharmacists resigning as soon as they can identify a better opportunity, or just quit to protect their mental health even before they can find another position. These experiences are strong disincentives to study pharmacy and they don’t. So who will study pharmacy?

The precipice of pharmacy’s suicide

There is a long list of external organizations, individuals, and factors that can be faulted as contributing to the desperate situation and challenges that the profession of pharmacy now faces. This is an exercise in futility. We must self-assess the actions, and lack of action, of the profession of pharmacy and acknowledge our own failures and that the arrival of the profession on the precipice of suicide is primarily self-inflicted rather than caused by external factors.

Many pharmacists will quickly exempt themselves from any responsibility or even any interest in the challenges identified. They typically are employed in innovative and progressive opportunities that are vastly different, and assumed to be unaffected by the problems of the “commoner” pharmacists whom they do not think have the vision, expertise, or motivation to aspire to the elite positions they hold. This is foolish and naïve reasoning, Very few outside of their families and colleagues know what they do, or even that they are pharmacists and their careers were launched with an education in pharmacy. When the foundation of pharmacy (i.e., community pharmacy) crumbles, the rest of the profession will soon follow. There is no immunity!

Health-system pharmacy is a distant second to community pharmacy with respect to the number of pharmacists employed. Some health-system pharmacists take great pride in distinguishing their professional roles and responsibilities from those of community pharmacists. There are some health-system administrators who have the vision to substantially expand the professional roles and numbers of positions for pharmacists. They are to be commended but these situations are the exception. In many health systems the pharmacists have traditional and routine responsibilities in providing medications for patients. Health-system pharmacy is at risk of becoming the next chain pharmacy. Some will be shocked at and quickly reject that thought. However, there are important similarities in the two settings in that the pharmacist Director of a health-system pharmacy does not have final decision-making and budgetary authority. It is the non-pharmacist CEO/Director of the health-care system that does in a manner analogous to the authority of the non-pharmacist CEO/Director of a chain pharmacy.

There is also no consolation in the recognition that other health professions including medicine are facing some of the same challenges as pharmacy. Many physicians experience the same intrusions in their practice roles and authority that pharmacists do, including those imposed by health insurance companies, PBMs (e.g., prior authorizations), and CEOs of health systems that own many physician practices. There is, however, an important distinction in that physicians are considered essential participants as “captains” of health care teams. Pharmacists may also consider ourselves to be essential participants but the reality is that some others do not concur. In the opinion of some, certain of the traditional responsibilities of pharmacists can be performed by technicians and robots. Consider also the rapid emergence of the roles of physician assistants and advanced-care nurse practitioners. Some states have provided the authority for nurse practitioners to have their own practices that are independent of a working relationship with a physician. Some physicians and medical associations are threatened by this possibility and strongly oppose it, as they have in opposing expansion of the roles of pharmacists in providing immunizations for children and in having prescribing authority for Paxlovid.

Our profession of pharmacy is on suicide watch! That will be our destiny UNLESS we start a REVOLUTION! I have not given up and am determined to be part of that revolution! My editorial in the August issue will include strategies and recommendations.

If I am asked…

If my grandchildren or other young people request my opinion as to whether they should study pharmacy, my response would be an emphatic YES, but with certain conditions. I would want to personally advise them on a continuing basis regarding specific opportunities for pharmacists that would enable them to obtain their full personal and professional potential and, if I am no longer available to provide that advice, I would choose someone to continue that guidance. And nothing would please me more than having the REVOLUTION once again provide opportunities for owning an independent community pharmacy if that would fulfill their professional, entrepreneurial, and financial aspirations.

Daniel A. Hussar
July 4, 2022
DanH@pharmacistactivist.com

Would You Like Shots With That? Potential Netflix Documentary on Under staffing in Retail Pharmacy

Would You Like Shots With That? Potential Netflix Documentary on Under staffing in Retail Pharmacy

Opioids In Good Faith: Dr. Jay Joshi Weighs In On The Supreme Court Decision On Opioid Prescribing

Opioids In Good Faith: Dr. Jay Joshi Weighs In On The Supreme Court Decision On Opioid Prescribing

https://youarewithinthenorms.com/2022/07/18/opioids-in-good-faith-dr-jay-joshi-weighs-in-on-the-supreme-court-decision-on-opioid-prescribing/

REPUBLISHED AND REPORTED BY (COPY PASTE)

NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

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JUST AS THE VIDEO WAS RECORDED BY THE CELL PHONE CAMERA OF YOUNG DARNELLA FRAZIER, BORE WITNESS TO THE MURDER OF GEORGE FLOYD THE BLOG youarewithinthenorms.com BARES WITNESS AND BOTH ALLOWS THE SYSTEM TO BE HELD ACCOUNTABLE”

“WE ARE HEALTHCARE PROVIDERS, PHYSICIANS, DENTISTS, PHARMACISTS, NOT STREET DRUG DEALERS “

By ACSH Staff — July 18, 2022

Dr. Jay K Joshi is the editor-in-chief of Daily Remedy, a blog created in 2020 as a “trusted source of editorialized healthcare content for both patients and healthcare policy experts.” Here is his take on the Supreme Court’s recent decision on the controversial Ruan vs. the United States case

Dr. Jay Joshi

In a time when few can agree on anything, the Supreme Court unanimously agreed to vacate the conviction of two physicians who were convicted of prescribing opioids to their patients in the course of legitimate practice.

When they were indicted and subsequently went to trial, they were not afforded the right to defend themselves, as the right to a good faith defense was not permitted by the courts. In layman’s terms, the two accused physicians could not defend their actions, despite being in the service of patient care. Instead, their actions were interpreted by non-clinically trained law enforcement officers to be criminal.

Which begs the question: Why is the opinion of law enforcement even considered legitimate when evaluating the clinical decisions of a physician? To which the Supreme Court answered resoundingly: It is not legitimate.

“We could not disagree more”, wrote Justice Alito, when reiterating the court’s opinion that the federal government’s interpretation of the Controlled Substance Act as it applies to physicians is plain wrong.

It was a stark rebuke of a legal approach to criminalizing patient care that hearkens back to the early days of the Trump administration when the aggressive prosecution of physicians was viewed as the solution to the rising opioid overdoses. Flash forward half a decade, and the clinical data is undeniable – Trump’s policies were an unmitigated disaster. They cost the lives of hundreds of thousands of Americans and forced many physicians to turn away from their oaths to serve patients out of fear of facing the ire of the law.

This makes the Supreme Court’s ruling a welcomed return toward sound health policy, which is especially remarkable for a court so heavily influenced by Trump era policies that run contrary to established clinical norms. It reflects the egregious harms of that era, and the effects those policies had on everyday Americans with chronic pain and substance use dependencies.

But now that we have addressed the issue of good faith, at least in terms of court rhetoric, the remaining unknown is how the ruling will affect healthcare. Some speculate little to no difference while others laud a new era of physician autonomy.

The truth is likely somewhere in between, with the court ruling having some, albeit limited, positive effect on patients. Which may seem like an odd thing to say: How can a ruling that affects physicians help patients?

Well, to answer that question, we must understand the nature of fear, particularly as it manifests in the medical setting. Fear affects the implicit cognition that determines the subconscious drivers of clinical decisions.

When a doctor prescribes a medication, the implicit fears drive the decision, and only afterward does the doctor justify the decision with data or clinical guidelines. In this vein, the concept of evidence-based medicine is not a guide for making clinical decisions but a means to justify preconceived decisions made through more subtle, abstract reasoning.

To describe modern medicine in such a way would appear heretical, particularly to those in the ivory towers of academic medicine. But it remains true, nevertheless. No matter how advanced or technologically sophisticated medicine becomes, clinical decisions will forever remain in the realm of human decision-making, rife with bias, subjectivity, and irrationality. Nowhere is this more manifest than in how law enforcement regulates opioid prescriptions.

Opioids have been unfairly maligned of late, even obtaining the ignominious moniker: drugs of abuse. But opioids have been around for centuries, and they have significant value for patients with chronic pain. But for law enforcement agents and their accompanying policymakers, opioids are deemed equivalent to illicit drugs, like any substance of abuse.

And in conflating prescription medications with illicit substances, the federal government has ushered in an era of Medical McCarthyism. One in which the mere accusation of prescribing abuse merits criminal liability for anyone involved, physician and patient alike.

It is not surprising that in such an environment, extremism took over. And that such extremism would affect the quality of care. When a physician decides whether to prescribe opioids, he or she chooses between legal liability and clinical care. When fear enters this decision-making equation, physicians usually choose to protect their legal liability and sacrifice clinical care. As a consequence, patients suffer.

In this light, it is pleasantly surprising to see the Supreme Court step in to rectify such a pervasive harm in such a rapid manner. We should heed this lesson closely, as the issue of good faith affects patients and physicians every day across all healthcare settings.

#Reprinted with permission. Dr. Joshi’s original blog post can be read here

Dr. Jay K Joshi is a physician entrepreneur who writes about all things healthcare through his blog, Daily Remedy (www.daily-remedy.com). He currently practices primary care in Northwest Indiana. He completed his medical school and internship training at the University of Illinois Medical Center and his masters in business administration at the University of Chicago Booth School of Business. His book, Burden of Pain, which details his journey through the opioid epidemic and insights gleaned, will be available in early 2023.

Greg’s Solo E-bike Tour Across America: Research for Peripheral Neuropathy fund raiser

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Find & compare nursing homes, hospitals & other providers near you

Find & compare nursing homes, hospitals & other providers near you.

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Fauci Makes Surprising Concession Regarding COVID-19 Vaccines

Fauci Makes Surprising Concession Regarding COVID-19 Vaccines

https://www.theepochtimes.com/fauci-makes-surprising-concession-regarding-covid-19-vaccines_4595318.html

White House COVID-19 adviser Anthony Fauci conceded Wednesday morning that COVID-19 vaccines don’t protect “overly well” against the virus.

Speaking during a Fox News interview, Fauci told host Neil Cavuto that “one of the things that’s clear from the data [is] that … vaccines—because of the high degree of transmissibility of this virus—don’t protect overly well, as it were, against infection.”

But Fauci said later that the vaccines “protect quite well against severe disease leading to hospitalization and death” before he made note of his recent COVID-19 diagnosis.

“At my age, being vaccinated and boosted, even though it didn’t protect me against infection, I feel confident that it made a major role in protecting me from progressing to severe disease,” said Fauci, who is 81 and has worked in various capacities in the federal government since the late 1960s. He’s also headed the National Institute of Allergy and Infectious Diseases since the Reagan administration.

Fauci then said it’s because of the vaccination that it is “very likely why I had a relatively mild course.”

Natural Immunity

The official’s comments come just days after a bombshell study revealed that natural immunity, or the immunity conferred via a previous COVID-19 infection, provides superior protection against the virus when compared with vaccines.

Researchers in Qatar said that individuals who survived a COVID-19 infection and weren’t vaccinated had very high protection against severe or fatal disease.

“Effectiveness of primary infection against severe, critical, or fatal COVID-19 reinfection was 97.3 percent … irrespective of the variant of primary infection or reinfection, and with no evidence for waning. Similar results were found in sub-group analyses for those ≥50 years of age,” Dr. Laith Abu-Raddad of Weill Cornell Medicine–Qatar wrote.

But the researchers noted that both natural and artificial immunity conferred via vaccines waned over time. People who were previously infected with COVID-19 and were not vaccinated had half the risks of reinfection as compared to those that were vaccinated with two doses but not infected.

During an interview with the Washington Post this week, Fauci suggested that Americans aged 5 to 50 should be allowed to get a second booster shot.

The federal government, he argued, “need[s] to allow people who are under 50 to get their second booster shot, since it may have been months since many of them got their first booster.”

“If I got my third shot [in 2021], it is very likely the immunity is waning,” Fauci proclaimed.

Medicare Advantage Tied to Less Use of Pricey Diabetes Drugs

Medicare Advantage Tied to Less Use of Pricey Diabetes Drugs

https://www.medscape.com/viewarticle/977181

US Medicare beneficiaries with type 2 diabetes who had health coverage through a Medicare Advantage (MA) plan received treatment with an SGLT2 inhibitor or GLP-1 receptor agonist significantly less often than patients with traditional fee-for-service (FFS) Medicare coverage in 2014-2019, according to a study of more than 411,000 patients.

“MA beneficiaries had modestly but significantly poorer intermediate health outcomes and were less likely to be treated with newer evidence-based antihyperglycemic therapies compared with Medicare FFS beneficiaries,” conclude Utibe R. Essien, MD, and coauthors in a study published July 6 in Diabetes Care.

The report comes as the US Congress is looking closely at the MA program and evidence that insurance companies that provide these policies sometimes impose inappropriate barriers on enrolled beneficiaries by denying or limiting access to treatments and interventions in ways that run counter to Medicare’s coverage policies.

According to Representative Diana DeGette (D-CO), who chaired a hearing on MA plans on June 28 by the House of Representatives’ Energy and Commerce Subcommittee on Oversight and Investigations, beneficiaries who are covered through an MA plan “do not always get the care that they are entitled to.”

The study by Essien and colleagues also documents some positives of care delivered through MA plans for patients with type 2 diabetes compared with what FFS Medicare beneficiaries generally receive, such as significantly higher rates of screening for nephropathy and ophthalmologic disorders, and foot examinations.

But the apparently dampened use of sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists among MA beneficiaries stand out as notable shortcomings, Essien maintained.

Cost Containment May Limit Use

“The differences in health outcomes and in treatments in MA plans are important to highlight,” Essien said in an interview. “We worry that the cost-containment challenges [associated with MA plans] may be limiting use of these newer treatments.”

The study was based on 2014-2019 data from the Diabetes Collaborative Registry, which collects information from more than 5000 US clinicians whose practices include patients with diabetes, as well as claims data recorded by the Centers for Medicare and Medicaid Services during 2014-2017.

The main analysis focused on 345,911 Medicare beneficiaries ≤ 75 years old with diabetes, which included 34% with MA coverage and 66% with FFS coverage. The two subgroups had similar ages, about 75 years old, and roughly half were women in both subgroups. The rate at which both subgroups received statin treatment was nearly the same: 72% for those with MA coverage and 71% for those with FFS Medicare.

But MA beneficiaries differed from those with FFS coverage in several other ways. MA beneficiaries had a higher prevalence of Medicaid eligibility than the FFS group (20% vs 12%) and lower rates of consultations with cardiologists (41% vs 45%) or endocrinologists (7% vs 10%).

Some of the positive differences in the care received by MA beneficiaries compared with FFS beneficiaries, after adjustment for potential clinical and sociodemographic confounders, included:

  • Screening for nephropathy, at a significant 14% higher relative rate.
  • Screening for ophthalmologic disorders, at a significant 8% higher relative rate.
  • Undergoing a diabetic foot examination, at a significant 13% higher relative rate.
  • Receiving smoking-cessation counseling, at a significant 5% higher relative rate.
  • Receiving treatment with an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker (87% vs 81%).
  • More consistently receiving treatment with metformin, with rates of 72% versus 69% in 2017.

However, these positive differences were accompanied by these relative shortcomings for those with MA compared with FFS coverage:

  • Lower rates of treatment with an SGLT2 inhibitor (5.4% vs 6.7%), a significant 9% relative difference after adjustment.
  • Lower rates of treatment with a GLP-1 agonist (6.9% vs 9.0%), a significant 20% relative difference after adjustment.
  • Higher average levels of low-density lipoprotein cholesterol (81.5 vs 78.9 mg/dL), a significantly higher average A1c level (7.1% vs 7.0%), and a trend toward a lower prevalence of blood pressure control (70.3% vs 71.5%).

Researchers also highlight that the lower rate at which people with MA coverage received SGLT2 inhibitors or GLP-1 agonists was consistent in patients with established cardiovascular or kidney disease, for whom these agents are particularly recommended.

In addition, a secondary analysis of data for another 65,000 Medicare beneficiaries in 2018 and 2019 showed the disparity in use of agents from these two drug classes continued.

Low Systemic Use of SGLT2 Inhibitors, GLP-1 Agonists

Essien acknowledged that, even in people with FFS Medicare coverage, use of SGLT2 inhibitors and GLP-1 agonists was low, but the difference between those with MA coverage is “important,” he stressed.

Researchers offered four factors that might drive reduced prescribing of agents from these two classes for patients with type 2 diabetes with MA coverage: cost-containment strategies put in place by MA plans; the lower rate of consultations with specialists (cardiologists and endocrinologists); possible exclusion of clinicians from MA provider networks who tend to prescribe these higher-price agents; and lower household incomes of people with MA plans, which may lead to cost-related nonadherence.

Most SGLT2 inhibitors have an average retail cost of about $6,000/year, and some GLP-1 agonists cost more than $10,000/year.

In general, MA coverage includes more oversight of care and its cost than occurs with FFS coverage, noted Essien, an internal medicine physician at the University of Pittsburgh and a researcher at the Center for Health Equity Research and Promotion of the VA Pittsburgh Healthcare System, Pennsylvania.

“Incentives for using these more expensive treatments may not be there in MA plans,” he explained. Overcoming cost-related barriers is a challenge that will require “bold policy changes,” as well as better education of clinicians so they make correct treatment decisions, and of patients to resolve possible concerns about treatment safety.

Representative DeGette hinted during her remarks at the June hearing that policy changes may be coming from Congress.

“Our seniors and their doctors should not be required to jump through numerous hoops to get coverage for straightforward and medically necessary procedures,” she said.

U.S. Public Health Agencies Aren’t ‘Following the Science,’ Officials Say: ‘People are getting bad advice and we can’t say anything.’

U.S. Public Health Agencies Aren’t ‘Following the Science,’ Officials Say

‘People are getting bad advice and we can’t say anything.’

https://www.commonsense.news/p/us-public-health-agencies-arent-following

The calls and text messages are relentless. On the other end are doctors and scientists at the top levels of the NIH, FDA and CDC. They are variously frustrated, exasperated and alarmed about the direction of the agencies to which they have devoted their careers.

“It’s like a horror movie I’m being forced to watch and I can’t close my eyes,” one senior FDA official lamented. “People are getting bad advice and we can’t say anything.”

That particular FDA doctor was referring to two recent developments inside the agency. First, how, with no solid clinical data, the agency authorized Covid vaccines for infants and toddlers, including those who already had Covid. And second, the fact that just months before, the FDA bypassed their external experts to authorize booster shots for young children.

That doctor is hardly alone.

At the NIH, doctors and scientists complain to us about low morale and lower staffing: The NIH’s Vaccine Research Center has had many of its senior scientists leave over the last year, including the director, deputy director and chief medical officer. “They have no leadership right now. Suddenly there’s an enormous number of jobs opening up at the highest level positions,” one NIH scientist told us. (The people who spoke to us would only agree to be quoted anonymously, citing fear of professional repercussions.) 

The CDC has experienced a similar exodus. “There’s been a large amount of turnover. Morale is low,” one high level official at the CDC told us. “Things have become so political, so what are we there for?” Another CDC scientist told us: “I used to be proud to tell people I work at the CDC. Now I’m embarrassed.”

Why are they embarrassed? In short, bad science. 

The longer answer: that the heads of their agencies are using weak or flawed data to make critically important public health decisions. That such decisions are being driven by what’s politically palatable to people in Washington or to the Biden administration. And that they have a myopic focus on one virus instead of overall health.

Nowhere has this problem been clearer—or the stakes higher—than on official public health policy regarding children and Covid. 

First, they demanded that young children be masked in schools. On this score, the agencies were wrong. Compelling studies later found schools that masked children had no different rates of transmission. And for social and linguistic development, children need to see the faces of others. 

Next came school closures. The agencies were wrong—and catastrophically so. Poor and minority children suffered learning loss with an 11-point drop in math scores alone and a 20% drop in math pass rates. There are dozens of statistics of this kind.

Then they ignored natural immunity. Wrong again. The vast majority of children have already had Covid, but this has made no difference in the blanket mandates for childhood vaccines. And now, by mandating vaccines and boosters for young healthy people, with no strong supporting data, these agencies are only further eroding public trust.

One CDC scientist told us about her shame and frustration about what happened to American children during the pandemic: “CDC failed to balance the risks of Covid with other risks that come from closing schools,” she said. “Learning loss, mental health exacerbations were obvious early on and those worsened as the guidance insisted on keeping schools virtual. CDC guidance worsened racial equity for generations to come. It failed this generation of children.”

An official at the FDA put it this way: “I can’t tell you how many people at the FDA have told me, ‘I don’t like any of this, but I just need to make it to my retirement.’”

Supreme Court Tells Cops To Stop Playing Doctor – BUT – will they listen – or – back to business as usual ?

Supreme Court Tells Cops To Stop Playing Doctor

https://www.acsh.org/news/2022/07/15/supreme-court-tells-cops-stop-playing-doctor-16434

A unanimous Supreme Court decision is a good first step for getting law enforcement out of prescription decisions. Drs. Jeffrey Singer and Josh Bloom in Reason Magazine.

No one witnessing a burglary in progress would call 911 and ask for a doctor. Likewise, it makes no sense for a doctor to consult a cop about prescribing medications. Yet in the past decade, law enforcement, driven by the Drug Enforcement Administration (DEA), has taken a large and inappropriate role in monitoring and dictating the amount and kind of pain medications doctors may prescribe. Once this threshold is crossed, doctors are subjected to tactics that would horrify anyone with even a passing knowledge of the Constitution. Fortunately, the U.S. Supreme Court unanimously decided such tactics are unacceptable.

The Supreme Court reined in overzealous prosecutors who arrested doctors for treating their patients as individuals rather than conforming to law enforcement’s accepted standards. In Ruan v. United States, the Court overturned a decision that would have sent board-certified pain management specialist Xiulu Ruan to prison for 21 years for not conforming to law enforcement’s arbitrary and misguided standards. Ruan was not allowed to introduce expert testimony to argue that his pain management decisions were reasonable and based upon clinical experience as well as his patients’ individual needs—a so-called good faith defense.

When the public hears opioids, most reflexively think of prescription pain pills. But the term opioids actually refers to a broad category of drugs, including illicit “street” fentanyl, now widely known as the most dangerous of them all. The Centers for Disease Control and Prevention (CDC) reported that 77,000 of the 105,000 drug overdose deaths in 2021 are opioid-related, 90 percent of which are due to illicit fentanyl. The rest are mostly due to heroin, cocaine, and methamphetamine.

Although fentanyl alone can easily be lethal, the overwhelming majority of overdose deaths are “polysubstance” deaths: opioids mixed with stimulants, sedatives, and alcohol. To wit, nearly 70 percent of the fentanyl deaths also involved mixtures of cocaine, methamphetamine, and heroin, while the number involving prescription pills was only 16 percent. In 2020, CDC data showed that a mere 7 percent of fatal overdoses involved prescription opioids alone.

Apparently, the Department of Justice didn’t get the memo. On June 29, just two days after the Supreme Court’s Ruan ruling, the DOJ announced the formation of the New England Prescription Opioid Strike Force, targeting doctors who law officers decide are “overprescribing” opioid pain medications.

There is a term for this: Cops practicing medicine.

The timing of this strike force is curious because the opioid prescribing rate has dropped precipitously—60 percent since its peak in 2011. Furthermore, in 2019, one of us co-authored a paper in the Journal of Pain Research which demonstrated that between 2002 and 2014, per-capita pain reliever prescriptions doubled while nonmedical use of and addiction to prescription pain relievers remained unchanged. The paper’s inescapable conclusion was that there is no correlation between the number of pain pill prescriptions and either nonmedical use of or addiction to these pills.

While in the past nonmedical drug users may have preferred “diverted” black market prescription pain pills (they’re safer than unknown street drugs peddled by dealers), by 2018, according to a DEA report, the supply of diverted prescription opioids amounted to “less than one percent of the total quantity of pills distributed to retail purchasers.” There is another term for this: Chasing the wrong suspect.

The country is not awash in pain pills—quite the opposite. 

It is now evident that cops practicing medicine has been disastrous, both for doctors terrified that a strike force might burst into their clinics, and longtime pain patients who have had their medications forcibly tapered or discontinued altogether. Millions of these patients have become “pain refugees.” Some, lacking other options, are forced to the street where the “medicine” they purchase is often counterfeit lookalike prescription pain pills laced with fentanyl. Worse still, suicide is becoming an increasingly common option.

Clinicians regularly debate the proper treatment of various conditions, whether hypertension, diabetes, or pain. Patients and clinical contexts vary; there is no one right way to treat any single medical condition. Lacking any medical background, the DEA and other law enforcement agents fail to appreciate this.

Fortunately, all nine Supreme Court justices did. The majority opinion stated, “the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.” The newly formed New England Prescription Opioid Strike Force should heed the Court’s instructions.

The Supreme Court’s decision is a good start. Lawmakers can build on it by requiring a warrant from the courts before police or the DEA go snooping through drug prescribing databases. Nineteen states already require this. If police officers find no evidence of a crime yet believe a practitioner’s prescribing patterns fall outside the norm, they should only be allowed to report it to a state licensing board for investigation and possible discipline.

Until federal and state lawmakers stop cops from overseeing the practice of medicine, doctors will fear treating pain, and millions will suffer needlessly.

JEFFREY A. SINGER practices general surgery in Phoenix, Arizona, and is a senior fellow at the Cato Institute. (Singer is also an ACSH advisor)

JOSH BLOOM is the director of chemical and pharmaceutical science at the American Council on Science and Health.

Express Scripts Sued by AIDS Healthcare Foundation (AHF) Over ‘Claw Backs’

Express Scripts Sued by AIDS Healthcare Foundation (AHF) Over ‘Claw Backs’

https://www.aidshealth.org/2022/07/express-scripts-sued-by-ahf-over-claw-backs/

Sweeping federal lawsuit, asserting 14 claims of violations of law in nine U.S. states where AHF operates pharmacies, was filed in federal court in St. Louis, MO

 AHF asserts Express Scripts, a huge pharmacy benefits manager, manipulates loophole in Medicare “Star Ratings” system as purported justification for “clawing back” millions of dollars of Medicare benefits from AHF pharmacies, creating higher profits for Express Scripts at the expense of patients

LOS ANGELES (July 13, 2022) AIDS Healthcare Foundation (AHF), the largest global AIDS organization, which cares for over 100,000 individuals living with HIV or AIDS in the United States, filed a lawsuit in the U.S. District Court for the Eastern District of Missouri, Eastern Division, against Express Scripts, one of the three dominant U.S. pharmacy benefits managers (PBMs), and a subsidiary of Cigna, the $47-billion global health-insurance behemoth. The case, AIDS Healthcare Foundation v. Express Scripts, Inc. (Case No. 4:22-cv-00743), was filed yesterday.

AHF is the owner of the “AHF Pharmacy” chain of pharmacies, serving primarily people of limited economic means living with HIV/AIDS. Because Express Scripts manages pharmacy benefits for – and effectively controls access to – tens of millions of people with health insurance in the United States, Express Scripts has much greater bargaining power than much smaller community and specialty pharmacies like AHF’s (even in small chains).  Express Scripts offers AHF and other pharmacies essentially “take-it-or-leave-it” contracts with terms and conditions excessively favorable to Express Scripts and deleterious to AHF.  Pharmacies like AHF must accept these contracts or lose access to countless patients.

Specifically, AHF asserts that Express Scripts manipulates the Medicare “Star Ratings” system – which are used to score insurance plans – to give unfairly low “performance” scores to participating pharmacies, and that, as a result of these arbitrary low scores, the PBM then ‘claws back’ Medicare benefits from pharmacies—often months and years after the fact—actions that result in higher profits for Express Scripts at the expense of HIV/AIDS and other patients served by AHF and other independent and mom-and-pop pharmacies.

“AHF brought this civil action to recover many millions of dollars taken by Express Scripts, purportedly pursuant to unconscionable contracts with AHF yet in violation of those very contracts and the covenant of good faith and fair dealing implied in those contracts, among other violations of AHF’s rights,” said Andrew F. Kim, AHF’s lead counsel on the matter.

AHF asserts 14 counts of Express Scripts law violations in nine U.S. states where AHF operates pharmacies. Among the counts are “unfair” or “deceptive” trade or business practices in California, Florida, Louisiana, New York, and Washington state.  Five other counts assert violations of “any willing provider” laws in Georgia, Illinois, Louisiana, Mississippi, and South Carolina.

AHF is demanding a jury trial in the case, which was filed by AHF in-house counsel and Kim Riley Law.