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"Blessed is the nation whose God is the Lord." Psalm 33:12a
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.

November 2020 Issue [Download PDF format]
In this issue:
Editorial - THANK YOU! To the Front-line Heroes
Editorial - The Great American Smokeout
New Drug Review
EDITORIAL:

THANK YOU!

To the Front-line Heroes

The election is over, but division and anger persist. The deadly challenge of COVID-19 continues with no end in sight. Other societal problems remain unresolved, and some have resulted in rioting and looting. While these issues continue to require urgent attention, we must not permit problems and resultant negativity to obscure the many things for which we can be appreciative and thankful. Thanksgiving Day is November 26, but I suggest that we set some time aside every day to thoughtfully reflect on the family members and others to whom we are grateful, and for the events through which we have been blessed.

Even though the elections process has been very contentious, we must value our citizenship in a country that provides the right and freedom to vote. It hasn't always been that way, and individuals in some other countries continue to fight for this right to elect their leaders, a privilege we often take for granted.

Military personnel

I have not served in the military but have so much appreciation and admiration for those who have, as well as their families. They serve all of us and we and our country have been blessed through their service. Each time I read a story or see a movie about war-time experiences, I marvel at the courage and bravery of those who have served, many of whom were killed or seriously injured. The last line of our national anthem, "Land of the free and home of the brave," has been paraphrased to, "Land of the free because of the brave," and both of these statements have great significance.

My thinking of those in the military is infrequent and sporadic, and is usually prompted by news reports of individuals in the service returning home to their families and communities, observations of Veterans Day (November 11), and televised messages requesting financial support for those who have experienced serious injuries in service to our country. The questions that go through my mind each time I see one of these messages is, "How can our society and government not already be doing everything possible to not only meet the needs, but also to reward the individuals and their families who have served and put their lives on the line for the benefit and safety of all of us? Can there be any greater purpose for the taxes we pay?" Clearly, I and we are not doing enough, but my concern is interrupted/forgotten as I view the next message on the TV screen.

Of particular concern are the news stories about deficiencies in the scope and quality of health care for our veterans at certain VA hospitals and other facilities, and the long delays that many veterans have experienced in receiving needed services. Our veterans have earned and deserve the best possible health care and, if anything, the hospitals and other facilities that serve the veterans should be models of excellence. Elected officials, health professionals, and society should establish this as a high priority.

Police and firefighters

In our communities, no one is at greater risk of harm or death than our police and firefighters. They are our front line of defense and response to local emergencies such as fires, violence, and other potentially life-threatening events. They must respond to the worst imaginable situations in our communities and we do not often act to recognize and celebrate their service, heroism, and maintenance of law, order, and safety. I recently attended a "Back the Blue" rally in our community and was very impressed by the number of participants and the mutual respect, appreciation, and camaraderie among members of the community and our local police and firefighters. I encourage you to consider organizing or participating in such events in your communities.

Pharmacists, other health professionals, and first responders

The COVID-19 pandemic arrived with little warning and, even now, there are more unanswered questions about the disease than what we know with some certainty. One thing that was clear from the beginning was that the virus could be deadly for many. However, pharmacists, other health professionals, and first responders acted without hesitation in not only fulfilling their usual responsibilities, but in also expanding their services to meet COVID-related needs and precautions as they became known. They placed the interests of their patients and communities above their personal interests, and often had to do so without adequate protective equipment and other safeguards against transmission of the virus. Some have been victims of the disease because of their commitment to serve others. Some independent pharmacies and small group practices of physicians have been forced to close or are at peril of doing so because of the financial impact of the COVID restrictions.

In addition to the COVID challenges, many pharmacies in Philadelphia and some other cities have been vandalized and looted. The October 30 edition of The Philadelphia Inquirer carries the story, "Pharmacy owners left shaken," (Aubrey Williams, Sam Wood, and Katie Park; p. A8). Excerpts from the story are provided below:

"Just as Tuesday turned into Wednesday, Rich Ost got a call from the alarm company he uses to secure his pharmacy on Lehigh Avenue in Kensington. Someone was breaking in. From his home, Ost checked the video feed at the store, which he's run for the last 37 years. About 10 people had broken through the security gates and entered through the front door."

"Ost and his wife stayed up all night, watching people come in and out of his pharmacy on the video feed. By morning about 80% of his inventory was gone. Ost's Philadelphia Pharmacy was one of more than 80 that were looted into Wednesday morning amid unrest scattered across the city."

"For small independent pharmacies like Ost's, the thefts were another blow in an already difficult year. The coronavirus pandemic has increased the demand for medicine, but low reimbursements for these drugs mean Ost and others are operating on razor-thin margins."

"Ost and other pharmacy owners scrambled to open after break-ins and directed customers to other pharmacies where they could get their prescriptions filled. He had been encouraged by customers who called his store this week, offering support. "We got calls yesterday from so many people who heard about what happened, customers telling us, ‘Please don't give up on our neighborhood,' he said. They were more concerned for the pharmacy and employees' welfare than their own need to get their prescriptions filled, said Angela Ocasio, who has worked at the pharmacy for five years."

"Despite the pharmacy's loss of a quarter million dollars and a store in shambles, orders were steadily filled Thursday, Ost said."

Rich Ost and other pharmacists who have endured similar experiences are HEROES on the front lines. For some it was the second time within a 6-month period that their pharmacies had been vandalized and looted. Some of these pharmacies have closed and will not reopen. The determination and resilience that Rich Ost and other pharmacists have demonstrated in continuing their services to their patients and communities is inspiring! The concern and support for their pharmacies that has been voiced by members of their communities are also very encouraging. However, a very important question continues: "To what extent does our profession of pharmacy value and support the independent pharmacists who provide care and services for patients and communities that have the greatest needs?"

THANK YOU to Rich Ost and the other pharmacist HEROES on the front lines for your commitment to serve your communities! You also bring great credit to our profession of Pharmacy!

Daniel A. Hussar
danandsue3@verizon.net

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The Great American Smokeout

Initiated by pharmacist Fred Mayer more than 50 years ago, the Great American Smokeout is observed on the third Thursday in November (November 19 this year). Fred passed away last November at the age of 87, only several weeks after he actively participated in the annual meeting of the American Public Health Association (APHA) and received the Lifetime Achievement Award from pharmacist Nancy Lewis of the Pharmacy Section of APHA. Fred was a passionate and tireless advocate for addressing many public health issues, and for encouraging pharmacists to be more actively involved with these initiatives as a natural extension of their care and services to their patients and communities. Those of us who are the beneficiaries of Fred's friendship and leadership, are motivated by his example to honor and maintain his legacy.

Smoking cessation programs and discontinuation of the sale of tobacco products in pharmacies were among Fred's "signature" issues. My last editorial on this topic was published last November ("Cigarettes and Vaping Products – Much Smoke and Rhetoric, But No Action"). The COVID-19 pandemic and the elections have so dominated the attention of the public and the media during the past year that it is tempting to conclude that this has been another year with "no action" regarding tobacco products. However, that would be a disservice to pharmacists such as Robin Corelli and Karen Hudmon, organizations such as Truth Initiative, and others whose leadership and advocacy in this area are as strong as ever. Far too many others, however, continue to ignore the fact that smoking and its complications are factors in the deaths of approximately 480,000 Americans each year. Prominent among those who ignore this reality are Rite Aid, Walgreens, and Walmart. They attempt to convince the public they care about their health because they have pharmacies, but then betray their customers and the profession of pharmacy by continuing to sell cigarettes that are destructive to health.

Last month, Rite Aid introduced its "store of the future" in two of its stores. Among the features in this "Rx Revolution" corporate strategy are a new logo, remodeling, better lighting and visual features, supplements, snacks and beauty supplies made with natural ingredients, pet supplies, and more approachable pharmacists. It is my understanding that these two Rite Aid stores do not sell tobacco products and I was initially surprised that this was not among the features emphasized. However, I quickly realized that doing so would expose Rite Aid's hypocrisy in continuing to sell tobacco products in its approximately 23,998 other stores.

In 2014 CVS stopped selling cigarettes and other tobacco products, declaring that the decision "…is the right thing for us to do…" This was an excellent decision for which I commended CVS ("Commendation for CVS!" in the February 2014 issue of The Pharmacist Activist). However, I deplore the self-serving promotion and what I consider to be bogus claims of leadership CVS has made during the last several years for a decision it could have and should have made decades earlier.

It is ironic that on the date (November 6) that I am writing this commentary, CVS has announced that its CEO is retiring in spring 2021. Among the comments of the Chair of the Board of CVS Health is the following: "No discussion of Larry's tenure would be complete without recognizing his leadership of the company's bold decision to eliminate the sale of tobacco products from all CVS Pharmacy stores, which was widely credited with being a catalyst for the reduction in smoking levels in the U.S."

It is an important decision that Rite Aid, Walgreens, Walmart and many other facilities with pharmacies still refuse to make. However, the risks of smoking were known long before 2014 and neither the current CEO of CVS nor his predecessors have shown any remorse or even acknowledgement that many CVS customers have died as a result of complications from smoking cigarettes they purchased at CVS stores while executives knew of the risks and consequences.

Daniel A. Hussar
danandsue3@verizon.net

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NEW DRUG REVIEW:

Brolucizumab-dbll
(Beovu – Novartis)
Agent for Macular Degeneration

New Drug Comparison Rating (NDCR) = 4
(significant advantages)

in a scale of 1 to 5, with 5 being the highest rating

Indication:
Administered by ophthalmic intravitreal injection for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Comparable drugs:
Aflibercept (Eyelea), ranibizumab (Lucentis).

Advantages:
  • Maintenance doses may be administered less frequently in some patients (every 12 weeks, whereas aflibercept is usually administered every 8 weeks and ranibizumab is usually administered every 4 weeks).
Disadvantages:
  • Labeled indications are more limited (comparable drugs are also indicated for the treatment of diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion, and ranibizumab is also indicated for the treatment of myopic choroidal neovascularization);
  • Is not available in prefilled syringes (whereas comparable drugs are supplied in single-dose vials and prefilled syringes).
Most important risks/adverse events:
Contraindicated in patients with ocular or periocular infection, or active intraocular inflammation; endophthalmitis; retinal detachment; increased intraocular pressure; arterial thromboembolic events (e.g., nonfatal stroke).

Most common adverse events:
Blurred vision (10%), cataract (7%), conjunctival hemorrhage (6%), eye pain (6%), vitreous floaters (5%.

Usual dosage:
Administered by intravitreal injection; 6 mg (0.05 mL) monthly (approximately every 25-31 days) for the first 3 doses, followed by 6 mg every 8 or 12 weeks.

Products:
Single-use vials – 6 mg (should be stored in a refrigerator); adequate anesthesia and a topical broad-spectrum microbicide are administered prior to injection.

Comments:
In neovascular (wet) age-related macular degeneration (AMD), abnormal blood vessels form underneath the macula and leak blood and fluid into the retina, resulting in disruption of the normal retinal structure and subsequent damage to the macula and impairment of central vision. The growth of abnormal blood vessels is thought to primarily result from the overexpression of vascular endothelial growth factor (VEGF). VEGF-A has three major isoforms that interact with receptors VEGFR-1 and VEGFR-2 that are present on the surface of endothelial cells.

Brolucizumab is a humanized monoclonal single-chain antibody fragment that binds with the three major isoforms of VEGF-A and suppresses neovascularization and vascular permeability. It is the fourth VEGF inhibitor to be approved for the treatment of wet AMD, joining pegaptanib (Macugen), ranibizumab, and aflibercept. Ranibizumab is a small antibody fragment that is derived from the same antibody as the antineoplastic drug bevacizumab (Avastin). Sterile, diluted solutions of bevacizumab have been used off-label as a less expensive alternative to ranibizumab with similar benefits.

The effectiveness of brolucizumab was demonstrated in two active-controlled studies in which it was compared with aflibercept. Both agents were administered monthly for the first 3 doses, following which brolucizumab was administered every 8 or 12 weeks and aflibercept was administered every 8 weeks. Following one year of treatment, the vision benefits (reduced vision loss and improved vision) with brolucizumab were noninferior to those with aflibercept, and slightly more than one-half of patients remained on brolucizumab administered every 12 weeks without a reduction in effectiveness. Although the dosage recommendations do not provide specific guidance with respect to decisions whether to administer maintenance doses every 8 weeks or every 12 weeks, the experience in the clinical studies of maintaining clinical benefits with administration every 12 weeks in some patients provides an advantage of brolucizumab over aflibercept.

Daniel A. Hussar
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