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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.
November 2012 Issue
New Drug Review
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Pharmacy-Assisted Suicide - at CVS, Rite Aid, Walgreens, Walmart, etc.
Suicide by smoking cigarettes! "Warning: Smoking Can Kill You," is the title of an editorial in The New York Times (August 27, 2012). It is a slower death than what we usually associate with the word "suicide." But premature death is the consequence for many smokers. More than 400,000 Americans die each year as a result of disease and complications from smoking. Smoking cuts lives short an average of 13 years. Suicide is intentional, not accidental. As one smoker has noted, "I never smoked a cigarette by accident."
Physician-assisted suicide prompts emotional debate, and even outrage. Pharmacy-assisted suicide - selling cigarettes - is ignored by most and is an outrage to only a few. The use of the word "Pharmacy" rather than "Pharmacist" is intentional. The vast majority of cigarettes sold in pharmacies or retailers that include pharmacies are sold in chain pharmacies, grocery stores, and retailers like Walmart. It is not the pharmacists who work in these locations who personally sell cigarettes or who have the authority for the decision to sell them. Indeed, it is my opinion that an overwhelming majority of the pharmacists employed in these stores would not permit the sale of these products if they were able to take that action without fear of retaliation from management. Rather, it is corporate management, most of whom are not pharmacists, and specifically the CEOs, who are responsible for the decision to sell cigarettes (please see my editorial, "Merchants of Death - Chain Pharmacy CEOs Must Stop the Sale of Cigarettes!" in the November 2011 issue of The Pharmacist Activist).
Some chain updates
Various recent events and situations call further attention to the hypocrisy of the largest chain pharmacies that try to create an image of being interested in the health of their customers while continuing to sell the product that is the most preventable cause of death.
CVS - Dr. Terence Gerace is the National Coordinator of the CVS Sells Poison Project. The "Poison" is cigarettes. He has conducted 122 peaceful protests outside of CVS pharmacies in the Washington, D.C. area to publicize the harm that is caused by their sale of cigarettes (www.Toxic-TobaccoLaw.org/13news.shtml#CVS). Protests 121 and 122 were held outside of the Four Seasons Hotel because the CEO of CVS was to participate in The Wall Street Journal's annual meeting of the CEO Council. Information regarding the discussions that occurred at this forum is included in the November 19 issue of The Wall Street Journal. The CVS CEO is identified as a co-chair of the group addressing the topic, "Remaking Health Care." The summary of the discussion of this topic refers to ideas such as "...looking at the agricultural subsidies that might contribute to bad habits like smoking..." However, there is no reason to think that anyone mentioned or dared question the CVS CEO about the role of his company in the distribution of the product that causes more harm and death than any other product. Dr. Gerace is to be commended for his commitment to increase public awareness of this hypocrisy. CVS ignores him but hundreds of passersby applaud his concern.
Rite-Aid - Earlier this fall it was announced that Rite Aid was unveiling the next generation of wellness store. A ribbon-cutting ceremony that included company and community officials was conducted at the grand re-opening of the store located near Rite Aid headquarters in Pennsylvania. Among the areas featured are an expanded men's grooming area, a nail bar, a hair care aisle, and a grab and go cooler ("for quick pick up of milk, eggs, and other convenience items"). Identified at the end of the announcement are "expanded clinical pharmacy services with pharmacists specially trained in diabetes care, immunizations and medication therapy management," [editor's note: assuming the pharmacists have the time available after dispensing the number of prescriptions management expects before more personnel are provided.] Reference is also made to the newly designed smoking cessation department (it is an exaggeration to call this display a "department"), but it is much smaller and less prominent than the area where cigarettes (featuring Marlboro) are sold at the check-out at the front of the store. The Rite Aid chief operating officer is quoted as saying, "We know our customers' health and wellness needs are always changing." That is fine but there is one health fact that doesn't and won't change - Smoking kills! However, Rite Aid ignores its role in encouraging smoking and continues its charade of pretending to be interested in the wellness of its customers.
Rite Aid management gives every appearance of taking positions based exclusively on the financial implications for the company. In a recent situation, Rite Aid took a position that essentially denied that pharmacists are health care providers. Fortunately, a Superior Court judge, based on her determination that pharmacists are health care providers, ruled in favor of the plaintiff and against Rite Aid (Landay v. Rite Aid). I have tried to meet with Rite Aid executives to discuss this situation, as well as its sale of tobacco products. They do not respond, which is perhaps an understandable strategy if there is not a valid response.
Walgreens - In addition to conducting protests outside of CVS stores, Dr. Terence Gerace has communicated his concerns to Walgreens regarding the sale of cigarettes in its pharmacies. He received a response from a customer relations specialist identified as Wendy B. Apparently the level of guilt associated with efforts to defend their management's decision to sell cigarettes has resulted in the respondents not wishing to identify their last name. Aside from not disclosing her last name, Wendy B. is candid. She notes that "Many of us at Walgreens have personally lost good friends to smoking and cancer." She further notes, "While we've made a business decision (but not a personal one) to continue selling cigarettes, it's a decision we constantly review." Her letter continues: "If Walgreens stopped selling tobacco products, we'd lose sales from the other convenience items that smokers normally would purchase while at our stores. That's not good for our employees, our shareholders or the convenience of the more than 20 percent of Americans who still smoke." With a response like this, I can better understand why Wendy B. does not identify her last name. Walgreens' concern for the convenience of its customers who wish to buy cigarettes can't justify its lack of concern for their health.
My first communication with the CEOs of CVS, Rite Aid, Walgreens, and Walmart encouraged them to be a leader among chain pharmacies in discontinuing the sale of tobacco products, and also requested the opportunity to meet with them. None of those individuals, or their successors in the position of CEO, has been willing to meet with me, although I was able to speak with an executive (without decision-making authority) at three of these organizations (Walmart being the exception). In these discussions I encouraged the consideration of strategies through which the loss of revenue resulting from the discontinuation of cigarette sales would be replaced or exceeded by the sale of products or services that have health benefits. I encouraged them to involve their pharmacists in submitting recommendations and provide a bonus for the best ideas. I observed that a decision by the first, and probably the second, of these companies to discontinue the sale of cigarettes would result in more positive national publicity than even their large company could afford to buy. These efforts have failed but the experience has made me all the more determined.
It is noteworthy that, during this same period of time, a very important pharmacy initiative - immunization - has been implemented that has been not only of great value in protecting public health but also has been a source of substantial revenue for pharmacies. Some chain pharmacies have viewed the provision of immunizations at any time a customer requests one to be so important that they have required every one of their pharmacists to become certified to provide immunizations. The revenue to be generated from immunizations must be substantial because some chains have fired pharmacists who do not obtain this certification.
I have learned that there is only one thing that gets the attention of the CEOs of these chain pharmacies - MONEY! And when professional initiatives like immunization generate revenue, the obsession becomes MORE MONEY, rather than a willingness to discontinue the sale of the product that causes addiction, disease, and death. I do not like calling these individuals merchants of death or referring to their decisions as pharmacy-assisted suicide. I would be very pleased to applaud and congratulate them if they stopped the sale of cigarettes. However, I consider the current situation to be a huge contradiction and embarrassment for the profession in which I am proud to be a member. I have become convinced that nothing short of the strongest of terms and outrage from the profession of pharmacy and the public has any chance of convincing the CEOs of these chains to stop selling cigarettes.
New strategies are needed
Bolder and widely-publicized strategies are needed to get cigarettes out of pharmacies.
The following ideas come to mind:
A public opinion survey with the question - Which of the following retailers sells the most cigarettes in the United States (and, therefore, is responsible for the most smoking-related deaths)?
- Rite Aid
Highway billboards identifying the estimated number of smoking-related deaths in 2011 in a particular state based on the number of cartons of cigarettes sold by a particular chain pharmacy in that state during that year.
I have additional ideas but have run out of space in this issue. I know that readers will also have strategies to suggest.
Daniel A. Hussar
New Drug Review
(Xeljanz - Pfizer)
New Drug Comparison Rating (NDCR) = 4
in a scale of 1 to 5, with 5 being the highest rating
For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate; may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
Adalimumab (Humira), as well as other tumor necrosis factor (TNF) inhibitors.
- Is administered orally (whereas adalimumab is administered subcutaneously);
- Is effective in some patients who have had an inadequate response to adalimumab and other biologic DMARDs;
- May be less likely to cause serious allergic reactions, neurologic reactions, and heart failure.
Most important risks/adverse events:
- Is not indicated for first-line use;
- Labeled indication for rheumatoid arthritis is more limited (indication for adalimumab includes inhibition of progression of structural damage and improving physical function);
- Labeled indications are more limited (whereas adalimumab also has labeled indications for juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn's disease, and ulcerative colitis);
- Has a greater risk of gastrointestinal perforation;
- Monitoring of liver function tests, blood lipids, and other laboratory parameters is recommended;
- Interacts with more medications;
- Has not been evaluated in pediatric patients;
- Use is not recommended in patients with severe hepatic impairment.
Serious infections (boxed warning; e.g., tuberculosis [TB], invasive fungal infections, other opportunistic infections [patients should be tested for latent TB infection]; treatment should not be initiated in patients with an active infection, including a localized infection; treatment should be interrupted if a serious infection develops; should not be used concurrently with a biologic DMARD or with a potent immunosuppressant [e.g., cyclosporine]; live vaccines should not be used concurrently); risk of lymphoma and other malignancies (boxed warning; risk vs. benefit must be evaluated in patients with a known malignancy other than a successfully treated non-melanoma skin cancer; Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has occurred at an increased rate in patients who were recipients of renal transplants and received tofacitinib and concurrent immunosuppressive medications); gastrointestinal perforation (caution must be exercised in patients with a history of diverticulitis and certain other GI conditions); may reduce lymphocyte and neutrophil counts and hemoglobin concentrations, and increase blood lipid concentrations and liver enzymes (appropriate laboratory parameters should be periodically monitored); is extensively metabolized via the CYP3A4 pathway and to a lesser extent via the CYP2C19 pathway (action may be increased by the concurrent use of inhibitors of these pathways [e.g., ketoconazole, fluconazole], and reduced by inducers of these pathways [e.g., rifampin]; use is not recommended in patients with severe hepatic impairment.
Most common adverse events:
Upper respiratory tract infection (5%), nasopharyngitis (4%), headache (4%), diarrhea (4%).
5 mg twice a day; dosage should be reduced to 5 mg once a day in patients with moderate or severe renal impairment or moderate hepatic impairment, receiving a potent CYP3A4 inhibitor, or receiving one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19; interruption of treatment based on the guidelines included in the product labeling is recommended for the management of lymphopenia, neutropenia, and anemia.
Tablets - 5 mg (provided by 8 mg of tofacitinib citrate).
Biologic agents have been highly effective in the treatment of rheumatoid arthritis and other diseases and include the TNF inhibitors etanercept (Enbrel), infliximab (Remicade), adalimumab (Humira), certolizumab (Cimzia), and golimumab (Simponi), the selective costimulation modulator abatacept (Orencia), and the interleukin-6 antagonist tocilizumab (Actemra). However, a disadvantage of each of these agents is that they must be administered by injection. Janus kinases (JAK) are intracellular enzymes that mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Tofacitinib is the second Janus kinase inhibitor to be marketed, joining ruxolitinib (Jakafi) that was marketed in 2011 for the treatment of myelofibrosis. Both agents are effective following oral administration.
Tofacitinib was evaluated in seven clinical trials in patients with moderately to severely active rheumatoid arthritis who had an inadequate response to methotrexate and/or another DMARD. Two of the studies included patients who had experienced an inadequate response to a biologic DMARD (e.g., adalimumab). In all seven of the studies, patients treated with tofacitinib experienced improvement in clinical response and physical functioning compared with patients receiving placebo. Its effectiveness following oral use in patients whose response with other treatments has been inadequate represents important progress in expanding the therapeutic options for the treatment of patients with rheumatoid arthritis.
Daniel A. Hussar