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"And we rejoice in the hope of the glory of God. Not only so, but we also rejoice in our sufferings, because we know that suffering produces perseverance, perseverance, character, and character, hope." Romans 5: 2b-4
Each issue will include an editorial on a topic that is important for the profession of pharmacy, as well as a review of a new drug that includes a comparison of the new drug with previously marketed drugs that are most similar in activity, and a New Drug Comparison Rating (NDCR) for the new drug. Read on for this month's issue.

February 2021 Issue [Download PDF format]
In this issue:
Chain Pharmacy Greed is Damaging the COVID-19 Immunization Program, And Increasing Prescription Errors!
Calamities Eclipsing COVID
New Drug Review
EDITORIAL:

Chain Pharmacy Greed is Damaging the COVID-19 Immunization Program, And Increasing Prescription Errors!

The efforts to develop, distribute, and administer COVID-19 vaccines are a race against time in reducing the number of deaths and other consequences. Problems have and will continue to occur, but some are preventable. The federal government awarded huge contracts to CVS and Walgreens to immunize residents of nursing homes and assisted-living facilities in deals that are potentially so lucrative that one financial analyst estimated that CVS could make $1billion in gross profits over the next year. Although CVS and Walgreens moved very quickly to obtain the federal contracts, they have not given the same priority to distributing and administering the vaccines on a timely basis. Their greed and management failures have resulted in chaos in their programs and substantial delays in providing life-protecting immunizations for the most vulnerable patients in nursing homes. Their ineptitude in providing adequate staffing and resources, and adequate workplace protections for their pharmacists and other front-line employees must not be tolerated.

News releases from CVS and Walgreens have stated that they are hiring tens of thousands of new employees (pharmacists, technicians, etc), the vast majority of whom are technicians. The lack of commitment and respect of CVS for its pharmacists is evident in its advertisement: "Staff Pharmacist Floater Part-time Temporary Seasonal Jobs Hiring." To be completely clear, this commentary is NOT a criticism of the front-line pharmacists and other employees at CVS and Walgreens. Rather it is directed at management that is responsible for the understaffed, stressful workplace environment that often does not provide sufficient protections for its employees, and increases the risk of vaccine and medication errors.

There has been an avalanche of social media posts and news stories that are highly critical of CVS and Walgreens. Examples include the following:

"Pharmacists work in fear of making mistakes, retaliation, and accusations of not following policy."

"Leaked emails reveal CVS district leader instructed pharmacy staff not to tell patients their medications were filled by someone who tested positive for COVID-19." (Irene Jiang; Business Insider).

"Leave it to corporate to expect us to scramble to fix their ineptitude."

"Thousands of vulnerable people in those states' (NJ, PA) highest priority group – people who live in nursing homes and assisted living facilities – are still waiting for shots. They are part of a federal program that gave pharmacy giants CVS and Walgreens the responsibility of going from facility to facility to give shots. So far, that program, which began vaccinating nursing home residents and staff on Dec. 28, has used only about 16% of allocated doses in Philadelphia and 14.5% in New Jersey, according to health department data." (Stacy Burling; The Philadelphia Inquirer, Jan. 25, 2021).

A great program in W. Virginia

"W. Virginia a vaccine success story," is the title of a recent news story (Cuneyt Dil; Associated Press/The Philadelphia Inquirer, Jan. 18, 2021). It provides an inspiring account of the excellent leadership and immunization services of the independent pharmacists in West Virginia Excerpts are provided below:

"Griffith & Feil Drug has been in business since 1892, a family-owned, small-town pharmacy. This isn't their first pandemic. (Pharmacist Ric Griffith is the owner who is featured in the story).

More than a century after helping West Virginians confront the Spanish flu in 1918, the drugstore in Kenova, a community of about 3,000 people, is helping the state lead the nation in COVID-19 distribution.

West Virginia has emerged as an unlikely success in the nation's otherwise chaotic vaccine rollout, largely because of the state's decision to reject a federal partnership with CVS and Walgreens and instead enlist mom-and-pop pharmacies to vaccinate residents against the virus.

More shots have gone into people's arms per capita across West Virginia than in any other state, with at least 7.5% of the population receiving the first of two shots, according to federal data.

West Virginia was the first in the nation to finish offering first doses to all long-term care centers before the end of December, and the state expects to give second doses at those facilities by the end of January."

Congratulations and thank you to the pharmacists, government officials, and residents of West Virginia! This is a wonderful example for those of us living in the other 49 states to emulate!

Daniel A. Hussar
danandsue3@verizon.net


Addendum

I wrote this editorial on Tuesday, February 2. Soon after I completed it, I looked at today's issue of the Wall Street Journal and the story, "Retailers To Take Key Role in Vaccine," (Sharon Terlep and Jaewon Kang; pB1). It includes the following comments:

"Some of America's biggest retailers are preparing to take a central role in administering COVID-19 shots, hoping to avoid logjams and other complications that have slowed the vaccine rollout's early days."

"The federal Centers for Disease Control and Prevention aims to make them available in local pharmacies beginning next month."

"The job of vaccinating swaths of the population will fall largely on retail pharmacies, with companies such as CVS Health Corp.,Walgreens-Boots Alliance Inc., Walmart Inc. and Kroger Co, saying they are prepared to give tens of millions shots a month."

CVS and Walgreens were entrusted with this responsibility already and they failed. They can't be trusted to do it right this time and they should not be permitted to participate. Our national pharmacy associations must send a strong message to the CDC promoting the West Virginia experience in using independent pharmacies. Pharmacists should do the same with their legislators and state health departments. Like West Virginia, other states should reject the federal partnership with chain pharmacies and work with their independent pharmacists who know so many of the residents of their communities.

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Calamities Eclipsing COVID

The number of deaths in the United States that have been reported to be caused by COVID-19 now exceeds 400,000. However, even this staggering statistic does not capture the many destructive consequences in addition to the deaths. Unless there is greater collaboration, as well as the development and implementation of effective strategies and plans, the consequences will worsen.

We often hear comments that the COVID-19 pandemic is the worst experience in our lifetimes and that we must take actions to prevent such tragedies from ever occurring again. These are valid observations with respect to the experiences of many individuals, but I would suggest that there are situations and consequences that are even worse than COVID-19, although some are intertwined with the pandemic.

Politicization

In addition to policies and strategies regarding COVID-19, the consideration of almost every other important issue is highly politicized. If this is the situation that characterizes the "leadership" of our country, we can't expect the behavior of the citizenry to be any different. Both President Trump and President Biden reversed executive orders of their predecessors, resulting in major disruptions among those directly affected by these decisions. Is this the situation we should now have to expect with every newly elected President? Political differences are to be expected, but when anger, alienation, and gridlock result, progress in dealing with COVID-19 and other important issues will be delayed or prevented.

Censorship

Censorship and selective manipulation (commission and omission) of news and views by many in the press and social media are an assault on the freedom of speech, and destructive to increased learning. I learn from multiple perspectives and opinions that differ from my own. When news and opinions are recognized as not being objective and complete, distrust in the media grows with the result that there is greater use and reliance on other sources of information that may also be inaccurate or biased. The COVID-19 pandemic is replete with mysteries that require objective and comprehensive investigation (e.g., the origin of the virus), but many in the press have abandoned investigation and journalism. However, censorship is the worst offense.

Hatred and intolerance

Much of the antagonistic rhetoric that has become so pervasive is rooted in hatred that many don't even attempt to disguise. Some not only contend that opinions that differ from their own must be rejected, but also that those who voice them should be silenced. Some who are the strongest advocates for tolerance are the least tolerant of those whose views differ from their own. Hatred, racism, and intolerance are wrong and must be rejected. However, false accusations of others as racists, misogynists, homophobic, supremacists, and/or conspiracy theorists must also be rejected or the valid identification of these unacceptable attitudes and behaviors will diminish. Many accusers have become misologists.

Poverty

Poverty is an extremely important factor in many societal problems and must be effectively addressed. The answer is not robbing or taxing the rich to give to the poor. However, those with wealth have a greater responsibility to help those who are less fortunate and who have had less opportunity, and many have been very generous. A Proverb says "He who gives to the poor will lack nothing, but he who closes his eyes to them receives many curses."

Violence

Rioting, arson, theft, and injuring or killing others are unequivocally wrong, and perpetrators must be identified and prosecuted, whether the offenses occur in the Capitol building or city streets. In Philadelphia (the city of brotherly love) last year there were 499 murders, one short of the all-time record.

Smoking, opioid overdoses, alcoholism

It has been approximately one year since the first COVID-19 infection was identified in the U.S. but during this same period of time there have been more deaths from smoking-related complications (approximately 480,000) than deaths attributable to COVID-19. Opioid overdosages and alcoholism and its consequences are epidemics. Where is our outrage, or even concern?

The many problems and challenges facing our society are so destructive that we must not let anger, bitterness, and excessive partisan politics divide us. We can't change the things that have been done or said in the past, but we can learn from them in a manner that will assure a better future. We can, and must, rise above our current failures!

Daniel A. Hussar
danandsue3@verizon.net

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NEW DRUG REVIEW:

Hypercholesterolemia

Bempedoic acid
(Nexletol – Esperion)

Description:
An adenosine triphosphate-citrate lyase (ACL) inhibitor.

Indication:
Administered orally as an adjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C.

New Drug Comparison Rating (NDCR) = 4
in a scale of 1 to 5, with 5 being the highest rating

Comparable drugs:
Statins (atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin); atorvastatin is the statin used for the comparisons below:

Advantages:
  • Has a unique mechanism of action (ACL inhibitor);
  • Extends the low-density lipoprotein cholesterol (LDL-C)-lowering effect of the statins;
  • Is not likely to cause skeletal muscle adverse events (e.g., myopathy);
  • Is less likely to interact with other drugs.
Disadvantages:
  • Is not a first-line treatment for lowering LDL-C;
  • Effect on cardiovascular morbidity and mortality is not yet known;
  • May cause hyperuricemia and gout, and tendon rupture;
  • Has not been evaluated in pediatric patients (whereas atorvastatin is indicated for use in patients 10 years of age and older);
  • Labeled indications are more limited (whereas atorvastatin reduces other blood lipids [e.g., triglycerides], is indicated for a number of types of dyslipidemias, and has been demonstrated to reduce the risk of myocardial infarction, stroke, and other cardiovascular events).
Recommended dosage:
180 mg once a day with or without food.

Products:
Tablets – 180 mg; combination tablets (Nexlizet) – 180 mg and 10 mg ezetimibe.

Contraindications/most important risks:
  • Hyperuricemia and gout: uric acid concentration should be monitored periodically;
  • Tendon rupture: use should be avoided in patients with a history of tendon disorders or tendon rupture; risk is increased in patients over 60, and in patients treated with a fluoroquinolone or corticosteroid;
  • Pregnancy: risk of harm based on animal studies and mechanism of action in reducing cholesterol synthesis;
  • Lactation: breastfeeding is not recommended;
  • Hepatic impairment: has not been studied in patients with severe hepatic impairment;
  • Interactions: increases concentrations of pravastatin and simvastatin and may increase risk of myopathy; dosage of pravastatin should not exceed 40 mg daily, and dosage of simvastatin should not exceed 20 mg daily;
Most common adverse events:
Upper respiratory tract infection (5%), muscle spasms (4%), hyperuricemia (4%), back pain (3%), abdominal pain/discomfort (3%), bronchitis (3%), pain in extremity (3%), anemia (3%).

Comments:
Bempedoic acid inhibits ACL, an enzyme upstream of HMG-CoA reductase in the cholesterol biosynthesis pathway. Its effectiveness was evaluated in two placebo-controlled trials as add-on to a maximally tolerated dose of a statin alone or in combination with other lipid-lowering therapies. The primary efficacy outcome measure was the change from baseline to week 12 in LDL-C, and the difference between the drug and placebo in mean percent change was -18% and -17% in the two trials. There were also reductions of at least 10% in total cholesterol, non-HDL cholesterol, and apolipoprotein B. In a study of patients already being treated with a statin, the addition of both bempedoic acid and ezetimibe in the combination formulation provided a 36% reduction in LDL-C, which was significantly greater than that with either of these agents alone.

Daniel A. Hussar
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