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"The Lord is my strength and my shield; my heart trusts in him, and I am helped." Psalm 28:7a
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.

October 15, 2020 Issue [Download PDF format]
In this issue:
Editorial - The Presidential Debate Debacle! Can we Proceed with Respect and Civility?
Editorial - BUY LOCAL FROM SMALL BUSINESSES!
New Drug Review
EDITORIAL:

The Presidential Debate Debacle!

Can we Proceed with Respect and Civility?

I had made my decision for whom to vote for President prior to the first debate. However, watching the first debate was an alarming and disturbing experience. Nothing or very little was learned or clarified regarding the important and urgent issues our country faces. Rather the debate was dominated by the lack of respect and courtesy of the candidates for each other. If this situation characterizes the candidates for what many view as the most important office in the world, can it be expected that the rest of society will treat each other any differently? At the conclusion of the debacle, my question became, "Can I vote for either candidate?" given my concern for their lack of civility. Some would choose to discuss which candidate was most responsible for the failure of the debate, but I view that as an unproductive exercise that could further exacerbate the polarization. Both candidates were at fault!

I have a civic and moral responsibility to vote, and to not do so is unacceptable. A friend made a very helpful observation. He shared my concerns about the personal conduct of both candidates but noted that he was viewing his vote as support for the issues/policies that he considers most important rather than support for an individual. We both recognize that it is impossible to separate the authority and influence of the individual serving as President from the consideration and outcome regarding the issues we feel are most important, but his comment was of value in confirming the importance of voting.

Issues

In my editorial, "Coronavirus Conundrum: Part 3," in the September 15 issue, I had noted that my wife and I had hosted a "greet and meet" reception at our home in support of Dasha Pruett, a candidate for Congress in our district. I appreciate that some readers were interested enough in that observation that they went online to learn more about her (even though one friend who did so is supporting her opponent). We first became interested in Dasha Pruett when we saw the theme of her campaign on a lawn sign. The theme is "God, Family, Country, Jobs, and Security." This theme strongly resonated with us and we went online to learn more about her and her positions that include her pro-life beliefs. We then attended an event at which we spoke with her and were very impressed with her positions, personal qualities, and experiences (that include coming to this country from Russia at the age of 10 because of her family's concerns about socialism). These are the basic reasons for which we are enthusiastically supporting her candidacy and hosted the reception for her and have her lawn sign in our yard. Dasha Pruett is the Republican candidate for Congress. However, we would support her if she was the Democratic candidate. We are also very pleased that she is conducting a positive campaign that emphasizes her positions on issues, rather than criticizing and attacking her opponent and her positions.

In addition to the issues embraced in Dasha Pruett's campaign theme and pro-life position, there are numerous issues that require urgent attention including poverty, racism, violence, education, Supreme Court appointments, health care, and many others. My personal responsibilities to which I devote a large amount of time center around pharmacy issues and my advocacy for the professional role and services of pharmacists, and optimal drug therapy and health care for patients. However, as important as these issues continue to be for me, I must acknowledge that other issues such as those mentioned above are of greater importance for society in general and our country. It is very unlikely that the issues and positions that I, you, or other individuals consider most important will perfectly align with those of any candidate for elected office. Therefore, the challenge becomes prioritizing and balancing the importance of multiple issues in making decisions for whom we should vote.

Priorities

I am an evangelical Christian and I consider my faith in God to be the most important source of guidance and influence in my decisions and actions, although I often fall short in doing this. Several days ago, a friend forwarded to me the statement of the Pro-life evangelicals for Biden. The statement includes the following positions:

"As pro-life evangelicals, we disagree with Vice President Biden and the Democratic platform on the issue of abortion, but we believe a biblically shaped commitment to the sanctity of human life compels us to a consistent ethic of life that affirms the sanctity of human life from beginning to end."

"Poverty, lack of accessible health care services, smoking, racism, and climate change are all pro-life issues."

"We oppose 'one issue' (editor's note: the issue of abortion) political thinking because it lacks biblical balance."

"We believe that, on balance, Joe Biden's policies are more consistent with the biblically shaped ethic of life than those of Donald Trump."

Also of interest to me was that one of the authors of the document is a friend of mine. My response to the individual who sent the information to me includes these comments:

"I respect the perspectives that are shared and their willingness to communicate their opinions, as well as the opportunity I have to learn from their observations and opinions."

"I fully concur that poverty, lack of accessible health care services, smoking, and racism are pro-life issues. I would also identify additional issues as pro-life such as immigration policies, Supreme Court appointments…All of these matters should receive high priority, bipartisan, and respectful attention and action."

"Unlike the issues above, abortion is a specific, intentional decision of a woman (often encouraged by others such as a boy friend or husband) to terminate the life of an unborn child with no voice. For these reasons, I believe there are very important differences between the action of abortion and the other issues identified as pro-life." "I agree that we have a responsibility to consider and prioritize many issues when we make a decision for whom to vote."

I then shared my comments with my friend who is one of the authors of the Pro-life evangelicals for Biden statement. He responded promptly and voiced appreciation for my perspectives. We have engaged in a thoughtful, cordial, and respectful discussion from which my understanding of the range and specifics of pertinent opinions has been increased. I anticipate that we will vote for different candidates, but we are still friends.

Respect and civility

The politically-charged atmosphere that we experience is often characterized by distrust, harsh rhetoric, anger, and even hate. Polarization, extremism, and even violence have reached a level that results in many being intimidated to the point of silence in voicing their personal opinions related to political, religious, and other sensitive issues. We are on a downward spiral that is destructive. Why should so many, including myself, be reluctant to share my opinions regarding political candidates, religious beliefs, and other issues, or even place a lawn sign for a political candidate in my yard? We have the right to form our personal opinions and speak in support of them. At the same time I admire those who thoughtfully voice such opinions, even when they differ from my own, why have I been timid in voicing my political opinions when I like to think I have been bold in communicating my views on pharmacy and healthcare issues?

I need to be bolder in sharing my political views and my reasoning that supports them. However, such communication will not be productive, and may be counterproductive, if it does not occur in a courteous and civil manner that demonstrates respect for others and a willingness to listen to and learn from differing views. We must work toward achieving greater respect and civility in our society, and greater boldness in addressing important issues.

I identified earlier many of the issues that I consider important in deciding for whom to vote. I have continued to learn from other viewpoints, as well as discussions and events of the last several weeks. I have prioritized the issues I consider most important and balanced them with the platforms of the Democratic and Republican parties. I have concluded that President Trump has demonstrated a much stronger commitment than former Vice President Biden to the issues and values I consider most important, and I plan to vote for President Trump.

An important contributing factor to my conclusion is that, whether you like or dislike President Trump and his policies/opinions, most would agree that we know what they are. I don't have the same understanding and confidence of knowing what candidate Biden's positions are, and the extent to which they may be influenced or changed by those working with him.

Daniel A. Hussar
danandsue3@verizon.net

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BUY LOCAL FROM SMALL BUSINESSES!

Even before the COVID-19 pandemic, many small businesses including independent pharmacies had closed, not only in small towns in which the population was declining, but also in local communities within larger cities and suburbs. "Closed" signs in windows and boarded-up storefronts are increasingly common. Although some of these closures may have resulted from the retirement of the owner of a viable business who was not successful in selling it to someone else, most of the closures follow desperate efforts to remain viable in the face of escalating financial pressures. The restrictions of the COVID-19 pandemic have accelerated the closure of small businesses and have devastated many small communities. At the same time, some large businesses (e.g., Walmart, CVS, Amazon) are thriving and hiring thousands of new employees.

The number of independent pharmacies has been declining for years. Many of the closures have resulted from the destructive impact of unfair compensation and policies of the PBMs and health insurance companies, as well as the predatory practices of the large chain corporations. Hardly a week goes by without an announcement that CVS, Walgreens, or Rite Aid has bought out an independent pharmacy or a regional group of pharmacies. Although many of these communities will have a chain pharmacy available, the term "pharmacy desert" is appearing more frequently. This term is applied to the small communities that have been served by a single independent pharmacy that is now closed, and the population and resources of the community are insufficient to meet the profit projections that would prompt a chain store to open a pharmacy in the community. The closure of the independent pharmacy not only has a negative impact on employment, business, and vitality of the community, but the people in the community who have used the pharmacy in obtaining medications and health care services often do not have convenient access to medications and services in large geographical areas (the "deserts"). Some residents of these communities are able to cope well with these circumstances, but many others can not. For some, the only option is to obtain prescription medications via mail, but the personalized service, advice, and friendship of the local pharmacist are lost.

This situation is of concern not only for pharmacies and for rural geographical areas, but also for small businesses in general, and local communities in cities and suburbs in which large retail corporations are becoming increasingly dominant. Small business owners must meet with local civic leaders in developing and publicizing strategies that would encourage residents of a community to purchase products and services from local businesses and local residents who have franchises from larger corporations. Such purchases are of benefit not only for the business owners and franchise holders, but also for the community in which the funds from profits and taxes are being retained. This is in contrast to purchases from Walmart at which revenues/profits go to headquarters in Arkansas or CVS at which revenues/profits go to headquarters in Rhode Island.

Howard, South Dakota

Several years ago I read the book, Switch: How to Change Things When Change is Hard, by Chip Heath and Dan Heath that was published in 2010 by Broadway Books. Among the many informative experiences the authors describe (pages 67-72) is one which was started in 1995 in Howard, South Dakota. The following situation is described:

"Howard and surrounding Miner County had been shrinking for decades. Farm and industrial jobs had slowly dried up, and nothing replaced them….The population was about 3,000 and shrinking. The county had the highest elderly population per capita in South Dakota, and it also had the highest rate of youth out-migration in South Dakota, meaning that when young people got old enough, they left and didn't return."

"At Howard High School, the students had just finished reading a book about the death of rural communities in Iowa. The students said, 'That's us, it's just seventy years from now.'"

With the support of Randy Parry, a local resident who taught a business class at the high school, the students embarked on an ambitious project. They designed a survey that was sent to members of the community. One of the survey findings was that half the survey respondents were shopping outside the county, driving an hour to shop in larger stores. The students organized a campaign to spend money locally with the theme, "Let's keep Miner dollars in Miner County."

With extensive effort on the part of the students, their teacher, and residents, the project was successful and inspirational. I hope that Howard, SD has been able to maintain and build further on the success of this project. I believe that the motivation, strategy, and hard work in this experience would be of value in many communities today.

Daniel A. Hussar

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NEW DRUG REVIEW:

Trifarotene
(Aklief – Galderma)
Agent for Acne

New Drug Comparison Rating (NDCR) = 2
(significant disadvantages)

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

Indications:
Topical treatment of acne vulgaris in patients 9 years of age and older.

Comparable drugs:
Other topical retinoids: Tretinoin (e.g., Retin-A), tazarotene (e.g., Tazorac), adapalene (e.g., Differin).

Advantages:
  • Exhibits greater selectivity at gamma subtype of retinoic acid receptors (although a clinical benefit of this selectivity has not been demonstrated);
  • May be safer when used during pregnancy (compared with tazarotene that is contraindicated during pregnancy).
Disadvantages:
  • Has not been directly compared with other topical retinoids in clinical studies;
  • Requires a prescription (whereas adapalene 0.1% gel is available without a prescription);
  • Labeled indications are more limited (compared with tazarotene that is also indicated for the topical treatment of plaque psoriasis);
  • Formulations are more limited (comparable drugs are available in both cream and gel formulations);
  • Combination formulations are not available (whereas topical adapalene/benzoyl peroxide [Epiduo] and tretinoin/clindamycin [e.g., Veltin] combination formulations are available).
Most important risks/adverse events:
Skin irritation (e.g., erythema, stinging/burning; moisturizer should be used); sunburn (unprotected exposure to ultraviolet rays [sunlight, sunlamps, tanning beds] should be avoided; if high levels of sun exposure cannot be avoided, the use of a sunscreen [SPF of 15 or more] and protective clothing over treated areas is recommended); risk of use during pregnancy is not known.

Most common adverse events:
Application site irritation (8%), sunburn (3%), application site pruritus (2%).

Usual dosage:
A thin layer of cream should be applied to the affected areas that are clean and dry once daily in the evening; one pump actuation should provide enough cream to cover the face and two actuations enough to cover the upper trunk (i.e., reachable back, shoulders, and chest); an additional pump actuation may be used for the middle and lower back if acne is present in those areas; use of a moisturizer is recommended and, in the clinical studies, was applied at an interval of approximately 1 hour before or after application with the medication; contact of the cream with the eyes, lips, paranasal creases, and mucous membranes should be avoided.

Products:
Cream – 0.005% in a pump container.

Comments:
Trifarotene is the fourth topical retinoid to be approved for the treatment of acne, joining tretinoin, tazarotene, and adapalene. The retinoids act as agonists at retinoic acid receptors (RAR), and the stimulation of these receptors is associated with cell differentiation and mediation of inflammation. Trifarotene exhibits selective activity at the gamma subtype of RAR, but it is not known whether this greater selectivity is of clinical importance.

Trifarotene cream was evaluated in two vehicle-controlled studies in patients with moderate facial and truncal acne, with moderate acne defined as a score of 3 on a 5-point assessment scale. Success of treatment was defined as a score of 0 (clear) or 1 (almost clear) and at least a 2-point improvement from baseline. The co-primary endpoints (evaluated on the face) were the percentage of the subjects achieving success on the Investigator's Global Assessment (IGA) scale, the mean absolute change in facial inflammatory lesion count from baseline, and the mean absolute change in facial non-inflammatory lesion count from baseline, all evaluated at Week 12. In the two studies, 29% and 43% of the patients treated with trifarotene experienced IGA success, compared with 20% and 26%, respectively, in those treated with the vehicle cream. The new agent was also more effective in reducing the number of facial inflammatory and non-inflammatory lesions, as well as providing greater effectiveness in the improvement of truncal lesions.

Daniel A. Hussar
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