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"Let us not become weary in doing good, for at the proper time we will reap a harvest if we do not give up." Galations 6:9
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.

July 1, 2020 Issue [Download PDF format]
In this issue:
EditorialNew Drug Review
EDITORIAL:

INDEPENDENCE DAY
For Independent and Chain Pharmacists From the Evil and Tyranny of Chain Executives, PBMs, and Health Insurance Companies!

CVS is Destroying the Profession of Pharmacy: Part 5!

I wanted to focus this issue of The Pharmacist Activist on the positive events and experiences that we have cause to appreciate and honor during the celebration of our country's Independence Day on July 4. However, parades and fireworks for July 4 have been canceled, as are my initial plans for this issue. COVID-19, riots, and destruction of statues dominate the national news, and much of the attention of Pharmacists is focused on the continued evil and tyranny of chain pharmacy executives, PBMs, and health insurance companies. I do not have any influence over COVID-19, riots, and destruction of statues, but some respect my concerns and ideas about Pharmacy, and this is where I will direct my attention.

I had planned to "pause" my series of commentaries about CVS with Part 4 that was published in the June 15 issue. However, the continuing evil and fraud of CVS makes this an inopportune time to stop this series. In addition, the triple threat of CVS as a drugstore, PBM, and health insurance company (not even including Omnicare) is unique and amplifies its evil and tyranny. Thus, Part 5! I wish to assure the Pharmacists at Walgreens, Walmart, Rite Aid, as well as the besieged Pharmacists at other chains, that I am not ignoring them because they are also victims of their employers and others. Future issues of The Pharmacist Activist will address matters such as Walgreens' termination of Pharmacist Maurice Shaw because he did comedy shows (not in the store), the scandal of Walmart management's preventing its Pharmacists from intervening in situations that resulted in opioid overdoses and deaths, and Rite Aid's continued stonewalling with respect to important healthcare issues.

The media

As much as I wish we could get more media coverage of the exceptional services and counseling many Pharmacists provide for patients, and also more recognition for the dangerous error and abuse-preventing interventions and heroic participation of Pharmacists in COVID-19 experiences, these types of public recognition are only rarely provided. There is, however, much greater media attention being given to closures of independent pharmacies, dangerous, deplorable working conditions and fraud in chain pharmacies, and errors and potency/quality-jeopardizing shipping conditions for medications by mail-order pharmacies. Even though many of these experiences reflect negatively on our profession of Pharmacy and some pharmacists who are part of the problem instead of part of the solution, this media attention must be continued and extended.

There are an increasing number of heroes in the media who have provided excellent and continuing coverage of the above concerns. Most prominent in this recent media coverage are Marty Schladen and his colleagues at the Columbus Dispatch (Ohio) and Ellen Gabler of the New York Times (NYT). Ms. Gabler's two front-page stories in the NYT several months ago regarding CVS and other chain pharmacies have "gone global." I am probably unaware of important coverage provided by some others in the media and I would request readers to provide pertinent information to me at the email address below.

A primary reason for my focusing this editorial on CVS is the article that was published on June 26 in The Philadelphia Inquirer (Stacey Burling; page A4) titled, "Pennsylvania to pay CVS to test care homes." The article begins with the following statements:

"The Pennsylvania Department of Health announced this week that it will pay CVS Health up to $9.5 million to test 50,000 residents and staff members of the state's 693 nursing homes for the coronavirus. That's about a quarter of the 80,000 residents and 115,000 staff the state says are in nursing homes."

At a later point in the article it is noted:

"The new testing program will be undertaken by Omnicare, a CVS company, which will administer the tests. The state expects a turnaround time of 72 hours, Wardle (the Department of Health spokesman) said,"

I find it remarkable that CVS, the company that can't provide sanitary and safe conditions for immunizations in many of its own stores, can find a way to conduct 50,000 tests in 72 hours. It is amazing what $9.5 million can buy, but I don't expect the test results to be accurate/reliable, and we can only hope that the tests being used are not the same ones that have been discovered to give many false-positive results. If the Pennsylvania Department of Health is going to pay millions to CVS/Omnicare to test these individuals, it should work with and pay independent pharmacists to provide the influenza immunizations, and COVID vaccine when it is developed and becomes available, to individuals in the care homes.

In response to this article, I sent an email message to Ms. Burling (the reporter), and sent copies to some Pennsylvania health officials and pharmacy leaders. I was pleased that Ms. Burling responded very quickly and we had a productive series of messages in which she raised several excellent questions to which I was also able to respond. I highly commend her for her willingness to engage in communication and to explore these issues further.

Communication with Ms. Burling (June 26, 2020)

Dear Ms. Burling:

The very superficial reporting in your story is extremely disappointing ("Pennsylvania to pay CVS to test nursing home residents and staff for coronavirus"). The following questions should be asked:
  1. Were independent community pharmacists in the communities in which the nursing homes are located offered the opportunity to do this testing? If not, why not?
  2. Did the Department of Health request bids for this agreement worth up to $9.5 million that has been awarded to CVS Health?
  3. Are you and the Department of Health aware that Omnicare and CVS Health "are defendants in a federal lawsuit alleging that hundreds of thousands of drugs were improperly dispensed to senior housing residents over a period of years?" Why are companies that are being sued by the Federal government awarded contracts in Pennsylvania?
  4. Are you and the Department of Health aware of the information that investigations in Ohio, West Virginia, and Pennsylvania (see Auditor General Eugene DePasquale's report) have revealed about the secretive, highly suspicious (I would say fraudulent) government (i.e, taxpayer)-funded prescription benefit programs that pharmacy benefit managers (PBMs) such as CVS Caremark are administering?
  5. Are you and the Department of Health aware that the monopolistic, anticompetitive, and alleged fraudulent practices of CVS/Caremark/Aetna/Omnicare/etc. are crushing independent pharmacies to the point that many have been forced to close, resulting in pharmacy deserts in many areas of the state in which it is not sufficiently profitable for CVS to have a pharmacy?
  6. Why is the Department of Health awarding a contract to a Rhode Island-based company rather than to independent pharmacists who live in their communities and are committed to serve the residents in their communities?
  7. If you, like myself, are a resident of Pennsylvania, why are taxes we pay being sent to out-of-state companies rather than to support local pharmacies that are being forced out of business by companies like CVS?
  8. You report that the Department of Health "will pay CVS Health up to $9.5 million to test 50,000 residents and staff members of the state's 693 nursing homes for the coronavirus," and that, "That's about a quarter of the 80,000 residents and 115,000 staff the state says are in nursing homes." Independent pharmacists should be provided the opportunity to conduct the tests for the remaining patients, and compensated accordingly. Will that be done?
Response of Ms.Burling:

Some of these are good questions. Mine to you is this: Do independent pharmacies have the capacity to quickly send their staff into nursing homes and test residents and staff throughout the state?

My response:

Thank you for your fast response. You also have a good question. Although I am not in the best position to respond for the independent pharmacists, they are located throughout the state (to a much greater degree than Omnicare) and I would like to think they could provide such testing on a timely basis. Dr Levine's (the Secretary of Health) order was issued on June 9 and the target date for completion is July 24. That should provide adequate time for independent pharmacists to participate.

I am interested in learning which of my questions you consider to be the "good" ones and whether you will try to obtain answers. Thank you.

Response of Ms. Burling:

There was considerable repetition in your questions. I thought the first two were especially important. The others are more philosophical. Should the state have a preference for local, independent companies even if they cost more? (Obviously, I don't know they'd cost more, but I think they easily could because CVS can get economies of scale and they can't.) I don't know whether PA typically looks for companies without the kind of legal record you mention.

The problem I see with trying to give work like this to multiple, local entities is that it requires multiple contracts and a different kind of vetting. I'm not saying that's not doable, but I can imagine that it could work against efficiency. Also, to my knowledge, going into other facilities to do testing is not something that local, independent pharmacies normally do so they wouldn't necessarily have the infrastructure to do it.

I did send your questions to the spokesman for the health department. He hasn't responded yet.

My response:

Thanks for identifying the repetition in my questions and which ones are more philosophical. As a writer and editor myself (www.pharmacistactivist.com), I always appreciate learning from the writing and editing skills of others.

Although you anticipate that local, independent companies might cost more, I appreciate your recognizing you don't know that even though CVS might have economies of scale. I do not know the comparative data either, but I fully expect that it would be less expensive for the Department of Health and the citizens of Pennsylvania to use local independent pharmacists for these services. I feel very confident in this expectation because I am aware, without the benefit of specific data, of how CVS builds huge profits for itself into secretive agreements that are not available for public review. This is a primary part of the reason for which Omnicare and CVS Health are defendants in a federal lawsuit. I would suggest that is a story in which the Inquirer should also be interested rather than it being viewed as a philosophical question.

Although you identify multiple reasons for excluding independent pharmacists from being engaged in this service for the Commonwealth, I am able to identify a larger number of better reasons for using independent pharmacists, starting with the fact that numerous independent pharmacists already have working relationships with many nursing homes in the provision of medications and consultant services for their residents. I believe that you have received the comments from Pat Epple, the CEO of the Pennsylvania Pharmacists Association, that independent pharmacists "have also asserted that while in discussing the testing issue, Omnicare tried to 'steal' the rest of their business, as several facilities have reported." When those allegations are confirmed, CVS and Omnicare should be disqualified from participating in this program and prosecuted.

Comments from CVS pharmacists (continued)

The messages and experiences I receive from CVS pharmacists are too numerous to publish most of them but selected examples follow:

"A pharmacist was supposed to dispense a prescription for liquid propranolol for a 3-year old girl. The mom who is a family friend called me hysterical because the medication looked different. I told her to promptly return to CVS and demand to see the stock bottle and the color of its contents. It turns out it was the wrong medication – she does not know the name of the medication that was given in error for her daughter, but she was angry and frightened and burst into tears after realizing how serious a situation this was. She asked me what people do if they don't know a pharmacist personally to ask these questions. She is supposed to get a call from the district manager. I told her to emphasize that CVS needs to increase staffing levels pronto! I also told her to go public with this but she is afraid to do so as she is a business owner in town."

"A few years ago we were required to view the hard copy of each order we verify. This includes the original fill and all the refills on the prescription. I have personally caught mistakes on the 6th or 7th refill meaning that the patient had received the wrong drug or dose for 6 months. A couple of years ago the system stopped prompting us to review the original hard copy after the first refill. We are now told by management that we should view the original only if we had reason to believe there was a patient safety issue. We are now being monitored on every scan or step when filling orders. We are being counseled or written up for underperformance if they catch us going back to view the hard copy when not prompted."

"It is making me and other pharmacists very angry when we have to stay and finish other tasks after our shift has ended. There is no end in sight as to how many extra hours they want us to stay and catch up with duties besides filling prescriptions. Most pharmacists do not get a 40-hour week. When we have our salary cut in mid-year and we are asked to stay and work extra and not get paid, it is too much to handle."

"CVS has done much to destroy what pharmacists were trained to do. You teach students and provide them with so much knowledge. Then CVS takes us and tries to brainwash us."

"Phone calls have become a nuisance or harassing situation for many customers. We have become one of the worst telemarketers. Wells Fargo got into a lot of trouble years ago for opening accounts and selling goods that their customers did not need."

"When we request additional staffing we are told we are experienced pharmacists and need to work smart. We are also told that he (district leader) has dozens of applications from pharmacists waiting to take our job."

"I have been encouraged to keep an ear out for 'struggling independents' during COVID-19 who may 'benefit from a buyout.' That broke my heart and angered me deeply."

"I recently had a call from a deaf patient and through the audio service she used, she begged us to please stop calling and filling prescriptions she did not need. I also have family and friends contact me and ask, "what can I do to stop CVS from filling these prescriptions I do not need?'"

"A neighbor told me that his doctor told him he kept getting faxes for 90-day refills that he did not request. The doctor informed him that this is taking away time that he should be spending with his other patients."

In addition to local and national media, I am also hearing from attorneys. CVS has enough ill-gained wealth to pay any amount to confidentially settle lawsuits regarding deaths and other consequences resulting from errors, but it is concerned about negative publicity and tries to suppress it, as has occurred with respect to a recent suicide in a CVS store. There will be a Part 6 in this series.

Daniel A. Hussar
danandsue3@verizon.net


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NEW DRUG REVIEW:

Pitolisant hydrochloride
(Wakix – Harmony)
Agent for Excessive Daytime Sleepiness

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

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

Indication:
Treatment of excessive daytime sleepiness in adult patients with narcolepsy.

Comparable drugs:
Modafanil (e.g., Provigil), armodafanil (e.g., Nuvigil).

Advantages:
  • Has a unique mechanism of action (histamine-3 [H3] receptor antagonist/inverse agonist);
  • Is not a controlled substance (whereas modafanil and armodafanil are in Schedule IV);
  • Is less likely to increase blood pressure and heart rate;
  • Is less likely to cause hypersensitivity and dermatologic adverse events.
Disadvantages:
  • May be less effective (was not demonstrated to be noninferior to modafanil);
  • Prolongs the QT interval and increases the risk of cardiac arrhythmias;
  • Labeled indications are more limited (modafanil and armodafanil are also indicated for the treatment of excessive sleepiness associated with obstructive sleep apnea and shift work disorder);
  • Interacts with more medications;
  • Contraindicated in patients with severe hepatic impairment;
  • Dosage titration/adjustment is more complex;
  • Dosage adjustment is necessary in patients with moderate or severe renal impairment.
Most important risks/adverse events:
Prolongation of QT interval (use should be avoided in patients with a history of cardiac arrhythmias, or who have risk factors for arrhythmias including congenital prolongation of the QT interval, symptomatic bradycardia, hypokalemia, or hypomagnesemia; use should be avoided in patients taking other medications known to prolong the QT interval such as Class 1 antiarrhythmic agents [quinidine, procainamide, disopyramide], class 3 antiarrhythmic agents [amiodarone, sotalol], antipsychotic agents [ziprasidone, chlorpromazine, thioridazine], and antibacterial agents [moxifloxacin]; risk is increased in patients with hepatic or renal impairment); contraindicated in patients with severe hepatic impairment; dosage should be reduced in patients with moderate hepatic impairment or with moderate or severe renal impairment; is a substrate of the CYP2D6 pathway and dosage should be reduced in patients known to be poor CYP2D6 metabolizers or patients taking a strong CYP2D6 inhibitor (e.g., fluoxetine, paroxetine) concurrently; concurrent use of H1 receptor antagonists that cross the blood-brain barrier (e.g., diphenhydramine, chlorpheniramine) should be avoided; strong CYP3A4 inducers (e.g., carbamazepine, rifampin) may reduce activity and an increase in dosage may be necessary; may induce the CYP3A4 pathway and reduce the activity of sensitive CYP3A4 substrates (hormonal contraceptives, midazolam, cyclosporine); women using hormonal contraception (e.g., ethinyl estradiol) should be advised to use an alternative nonhormonal contraceptive method during treatment with pitolisant and for at least 21 days following the discontinuation of treatment.

Most common adverse events:
Headache (18%), nausea (6%), upper respiratory tract infection (5%), musculoskeletal pain (5%), anxiety (5%), increased heart rate (3%).

Usual dosage:
Administered once a day in the morning upon awakening; 8.9 mg (two 4.45 mg tablets) daily during Week 1, 17.8 mg daily in Week 2, and may be increased in Week 3 and thereafter to 35.6 mg (two 17.8 mg tablets); product labeling should be consulted for recommendations for patients needing dosage adjustments.

Products:
Film-coated tablets – 4.45 mg, 17.8 mg pitolisant base.

Comments:
The effectiveness of pitolisant is thought to be mediated through its activity as an antagonist/inverse agonist at histamine-3 (H3) receptors. Unlike the comparable drugs, it is not a controlled substance. When compared with placebo, it provided statistically significant reduction/improvement in Epworth Sleepiness Scale scores. However, it was not determined to be noninferior to modafanil.

Daniel A. Hussar
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