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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 2014 Issue [Download PDF format]
In this issue:
EditorialNew Drug Review
EDITORIAL:

Health, Wellness, and Cigarettes

Although Rite Aid, Walgreens, and Walmart try to convince the public that they are committed to health and wellness programs and services, their messages are contradicted by their blatant hypocrisy in continuing to sell cigarettes. Early this year, CVS made the decision to discontinue the sale of tobacco products and these products are no longer available in CVS stores (please see my editorials, "Commendation for CVS!" and "Commendation for the Pharmacies that Never Sold or have Discontinued the Sale of Tobacco Products!" [February 2014 issue] of The Pharmacist Activist). The CVS decision motivated me to contact the CEOs of Rite Aid, Walgreens, and Walmart to urge them to make a similar decision. On February 24, 2014, I sent letters that included the message and request noted below to Mr. John Standley, the CEO of Rite Aid, and Mr. Greg Wasson, the President and CEO of Walgreens. A similar letter was sent to Mr. Bill Simon, the President and CEO of Walmart U.S.

"I urge you to become a leader among chain pharmacies and discontinue the sale of tobacco products in your pharmacies. It is my understanding that (name of chain organization) has considered this matter on previous occasions but declined to take this action. However, recent events make this an opportune time to take this step.

I wish to request the opportunity to meet with you to discuss what I am confident will be the positive outcomes of an action by (name of chain organization) to discontinue the sale of tobacco products in your pharmacies. I will contact your office soon for the purpose of requesting a meeting with you.

Thank you for your consideration of this matter."

Rite Aid

On March 5, I tried to call Mr. Standley at Rite Aid. The automated phone system provided an option for a directory of names of employees and their phone extensions. However, an extension number was not available for Mr. Standley. After listening to additional "prompts," I reached an operator and asked to be transferred to Mr. Standley's office. I was greeted by a voicemail message from an individual whom I assume was Mr. Standley's executive assistant. I left a message explaining the purpose of my call and requesting a meeting with Mr. Standley. On March 10, I called again and left the same voicemail message and, when I had not received any response by March 19, I called again and left my third voicemail message. Approximately a week later I received a letter from Pharmacist Daniel Miller, the Senior Vice President of Pharmacy Operations at Rite Aid with the following message:

"Thank you for your recent letter and outreach to our Rite Aid Corporation Chairman and CEO John Standley asking for a meeting to discuss the sale of tobacco products in our stores. He is not available to meet with you: however, he asked that I follow up with you regarding this matter.

We do appreciate that you have taken the time to express your viewpoint and will take it under consideration. We are always evaluating options and programs for our stores and our customers. Rite Aid also offers a wide variety of smoking cessation products and provides additional resources, including our pharmacists, who are available to counsel people trying to stop smoking."

Rite Aid's slogan is "With us, it's personal." However, after my letter and three phone calls, I am no closer to having a personal discussion with the only individual in the company with the authority to make the decision to discontinue the sale of tobacco products.

Walgreens

On March 10, I tried to call Mr. Wasson at Walgreens. In response to a prompt, I requested to be transferred to his office. The individual who answered the phone had not seen my letter but said that she would locate it. She requested my contact information and asked for some times that were best for me to meet. I provided her with some dates and she said I would receive a response. I was encouraged but my encouragement was short-lived. Several days later I received a letter dated March 11 from Wendy B, a Consumer Relations Specialist who apparently prefers to be anonymous by not providing her last name. Her message is provided, in part, below:

"Thank you for writing us about your concern over the sale of tobacco at our stores.

We have been evaluating this product category for some time to balance the choices our customers expect from us, with their ongoing health needs. We will continue to evaluate the choice of products our customers want, while also helping to educate them and providing smoking cessation products and alternatives that help to reduce the demand for tobacco products.

Over the past year, Walgreens has partnered to conduct broad-based, in-store smoking cessation campaigns to provide consumers with educational health support. . . . These campaigns demonstrate the value and benefits of smoking cessation by providing consumers incentives to start a smoking cessation program and also support caregivers. With this approach we are able to address the root cause and offer customers solutions to help change behavior.

Thank you for contacting us and sharing your concerns. We value your business and look forward to serving you again."

I could not let Wendy B's letter go unanswered and the following is part of my response:

"I am both surprised and disappointed by your letter of March 11 in response to my letter to Mr. Greg Wasson. I am surprised because, based on a telephone conversation on March 10 with an individual in the Walgreens Corporate Offices, I was optimistic that I would be able to arrange a meeting with Mr. Wasson as I had requested.

I am disappointed that your letter does not respond to my request to meet with Mr. Wasson. Should I interpret your silence with respect to this request to mean that Mr. Wasson refuses to meet with me or that you have made this decision on his behalf?

You comment on smoking cessation programs in which Walgreens is involved and note that 'With this approach we are able to address the root cause. . . ' We all know what the 'root cause' is, and it is right there for sale in Walgreens stores.

As you are aware, CVS has announced its decision to discontinue the sale of tobacco products. That action sends a strong message that there is recognition of the health risks and deaths that result from the use of tobacco products. I would expect that Walgreens would not want even a perception to exist that you have less concern for the health of your customers than CVS has for its customers.

I repeat my request to schedule a meeting with Mr. Wasson."

I have received no response.

Walgreens has had a motto, "The Pharmacy America Trusts." More recently its location has been identified as at "The Corner of Happy and Healthy." Yet another slogan appears at the top of the letter I received from Wendy B. that reads: "Walgreens There's a way" Frankly, I am baffled by what message that statement is intended to convey. However, I will think positively and suggest: "There's a way in which Walgreens can better protect the health of it customers - by discontinuing the sale of tobacco products."

Walmart

On March 10, I tried to call Mr. Simon at Walmart. I responded to a prompt designated for the corporate home office. The individual who answered asked me if Mr. Simon was expecting my call. When I responded that he wasn't, my call was transferred to a priority assistance line. An individual answered and then placed my call on hold. I suspect that my letter was located while I was on hold, and another individual got on the line and informed me that Mr. Simon was in a meeting and that my call was being transferred to customer relations. The individual in customer relations indicated that I should receive a response within 30 days from the date my letter was written. However, they must have been eager to move on to their next concern/complaint because later that day I received an email message from Emily Schmid in Walmart Executive Communications that included, in part, the following message:

"Thank you for writing to Bill Simon regarding the sale of tobacco products. Mr. Simon is unable to schedule a meeting, so I wanted to follow up with you on his behalf. We take our responsibilities as a retailer seriously, and we appreciate your input on this matter.

With more than 140 million people shopping our stores each week, we serve a diverse customer base with a variety of wants and needs. Our merchandising decisions are based on our customers' preferences, and we strive to offer a broad assortment to meet a range of demands. While we understand the sensitivity surrounding tobacco products, our role is to provide our customers with access to the choices they are looking for - and also to ensure that we are doing so safely, legally, and responsibly.

It is important to note that our commitment to offering choices includes stocking a number of over-the-counter smoking cessation products, such as nicotine patches, gum and lozenges, as well as nicotine inhalers and nasal sprays by prescription.

At Walmart, we are always evaluating our product assortment. Listening makes us a better company, and we thank you again for sharing your views and allowing us the opportunity to engage in this conversation. We will continue to be purposeful about serving our customers and associates and operating as a responsible retailer."

Money and excuses

The CEOs of Rite Aid, Walgreens, and Walmart know that smoking cigarettes is responsible for more preventable deaths than any other cause. However, their decisions appear to be driven only by money and they reject the recommendations of others to discontinue the sale of tobacco products - a decision that their own consciences should also be demanding. Not only do they refuse to consider this decision, but they also reject the requests of those who request a meeting to discuss it. I recognize the value of the time of CEOs and that they have no obligation to meet with me. I have also heard all of the explanations and excuses that continue to be provided to justify the continued sale of tobacco products. However, if Rite Aid, Walgreens, and Walmart want to have any credibility as organizations that claim to promote health and wellness, they must discontinue the sale of tobacco products.

Negative publicity for CVS

The extensive favorable publicity that CVS received following its decision to discontinue the sale of tobacco products was unprecedented for a pharmacy organization. However, CVS appears determined to forfeit much of the good will and favorable publicity it has received by engaging in activities that are questionable, inappropriate, or illegal. It has proposed a prescription benefit program that would charge patients up to $15 more for medications that are obtained from pharmacies that sell tobacco products. At first glance such a plan would appear to provide a positive incentive for more pharmacies to discontinue the sale of tobacco products. However, such a plan would have the potential to be a self-serving initiative that would promote the use of CVS's own pharmacies. Although companies such as CVS and Target would be prominently identified as qualifying pharmacies, a list of qualifying pharmacies must also include the independent pharmacies that do not sell tobacco products.

Numerous other allegations have been made against CVS and/or Caremark. In a period of just a little more than a week, three situations (and perhaps more that I am not aware of) resulted in negative publicity. Caremark agreed to pay $6 million to settle federal false claims allegations that it knowingly failed to reimburse Medicaid for prescription drug costs paid on behalf of patients who were also covered by private health plans it administered. CVS will provide refunds to approximately 11,000 women who were charged co-payments for generic prescription birth control products, a violation of the federal health law. CVS has also agreed to pay a $225,000 penalty in California for mislabeling store-brand beauty products. And criticisms from independent pharmacists and other chain organizations regarding Caremark prescription benefit programs continue to increase.

A special anniversary for Rite Aid

It was 10 years ago that Rite Aid stopped selling CANDY cigarettes. But even this decision was not entirely voluntary. It was part of an agreement to settle investigations of tobacco sales to minors, in which Rite Aid also paid the amount of $250,000.

The Great American Smokeout

Started by California pharmacist Fred Mayer more than 40 years ago, the Great American Smokeout will be observed on Thursday, November 20, 2014 and deserves our support.

Daniel A. Hussar
NEW DRUG REVIEW:

Apremilast
(Otezla - Celgene)
Anti-inflammatory Agent

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


Indication:
Treatment of adult patients with active psoriatic arthritis (has been subsequently approved for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate).

Comparable drugs:
Tumor necrosis factor (TNF) blockers (adalimumab [Humira], certolizumab [Cimzia], etanercept [Enbrel], golimumab [Simponi], infliximab [Remicade]), and the interleukin-12 and -23 inhibitor ustekinumab (Stelara).

Advantages:
  • Has a unique mechanism of action (is a phosphodiesterase-4 [PDE4] inhibitor);
  • May be effective in some patients who have not experienced an adequate response or satisfactorily tolerated other treatments;
  • Is administered orally (whereas comparable drugs are administered subcutaneously or intravenously);
  • Less risk of infection.
Disadvantages:
  • Has not been directly compared with other medications in clinical studies;
  • Appears to be less effective based on data from noncomparative studies;
  • Labeled indications are more limited (e.g., labeled indications for adalimumab also include rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis);
  • May cause the emergence or worsening of depression;
  • Dosage titration is complex.
Most important risks/adverse events:
Depression and suicide ideation/behavior (caution should be observed in deciding whether the drug should be used in patients with a history of these experiences; patients and caregivers should be alert for the emergence or worsening of these responses); weight loss (if excessive weight loss occurs, discontinuation of treatment should be considered); is a substrate for the CYP3A4 metabolic pathway and effectiveness may be reduced by the concurrent use of a strong cytochrome P450 enzyme inducer (e.g., rifampin, carbamazepine; concurrent use is not recommended); dosage should be reduced in patients with severe renal impairment.

Most common adverse events:
Upper respiratory tract infection (14%), diarrhea (13%), nausea (11%), injection-site reaction (11%).

Usual dosage:
Dosage is titrated over the first 5 days of treatment to reduce gastrointestinal symptoms; on Day 1, a dose of 10 mg is administered in the morning, on Day 2, 10 mg is administered in both the morning and evening, on Day 3, 10 mg is administered in the morning and 20 mg in the evening, on Day 4, 20 mg is administered in both the morning and evening, on Day 5, 20 mg is administered in the morning and 30 mg in the evening, and on Day 6 and thereafter, the recommended maintenance dosage of 30 mg in both the morning and evening is administered; in patients with severe renal impairment, the morning doses should be administered, but not the evening doses, with a recommended maintenance dosage of 30 mg once a day.

Products:
Film-coated tablets – 10 mg, 20 mg, 30 mg.

Comments:
Phosphodiesterase-4 (PDE4) mediates the conversion of cyclic adenosine monophosphate (cAMP) to AMP that can contribute to the occurrence of inflammation. By inhibiting PDE4, apremilast increases intracellular cAMP concentrations resulting in a reduced inflammatory response. The effectiveness of apremilast was evaluated in three placebo-controlled studies in patients with active psoriatic arthritis despite prior or current therapy with a disease-modifying antirheumatic drug (DMARD). Some patients had been previously treated with a biologic, including a TNF blocker. The percentages of patients treated with apremilast who achieved an American College of Rheumatology (ACR) 20 response (representing at least a 20% improvement from baseline in most measures of disease activity) at Week 16 were 38%, 32%, and 41%, compared with 19%, 19%, and 18%, respectively, in patients receiving placebo. The patients treated with apremilast experienced improvement in each of the seven components of the ACR evaluation (e.g., number of tender joints, number of swollen joints, patient's assessment of pain).

Daniel A. Hussar