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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.

April 2014 Issue [Download PDF format]
In this issue:
• Editorial • New Drug Review

EDITOR'S NOTE:
This is the 100th issue of The Pharmacist Activist. Thank you for reading the information and commentary I have provided. I value and have learned from the opinions and ideas you have shared in response.
EDITORIAL:

Pharmacy's National Treasure –
COMMUNITY PHARMACISTS!
But They are Threatened!

The extent to which members of the public are aware of and understand the responsibilities of pharmacists is almost always based on their interaction with community pharmacists. This is due, in part, to the fact that more pharmacists practice in the community setting than in any other area of pharmacy. However, more importantly, for the vast majority of individuals, the communication with their community pharmacist has been a very positive professional experience. These are the experiences they think of as they rate pharmacists so positively in opinion polls year after year for qualities such as integrity and ethics.

There are many dedicated and highly professional pharmacists in every area of pharmacy. However, very few people outside of my family and circle of friends know about my responsibilities as a pharmacist in a college of pharmacy. And the same is true for pharmacists in other areas of the profession such as hospital practice, long-term care practice, and pharmaceutical companies. We also value and benefit from the high ratings that pharmacists receive in opinion polls, but to what extent do we acknowledge and support the community pharmacists who have earned this positive reputation for all of us in pharmacy? WE DON'T!

Community pharmacy is the foundation of our profession. No other area of pharmacy would have started and grown were it not for this foundation (I will spare you the early history of pharmacy in the US when a group of community pharmacists convened to form the Philadelphia College of Pharmacy in 1821). Over the years additional practice settings and responsibilities have been developed within pharmacy, and many of these have had a more comprehensive, specialized, and/or professional emphasis and required additional training. However, even the combined influence and number of pharmacists participating in these areas do not come close to the number of community pharmacists and the scope/influence of this area of our profession.

Independent pharmacists

Pharmacist owners of independent pharmacies established the foundation for our profession, and have been the pillars (no pun intended) of this foundation during both good and challenging times. However, independent pharmacists are threatened and some have even predicted that they will disappear. I refuse to accept that prediction for many reasons. However, one of the most important reasons is that independent pharmacy may be the only area of the profession in which pharmacists still have some control over their responsibilities and professional destiny, as limited as that control may often seem.

The greatest threat to community pharmacy is the pharmacy benefit managers (PBMs) and the mail-order pharmacies they own. The PBMs steal patients from community pharmacies that patients have used for years (unless the PBMs also own the community pharmacies as CVS Caremark does). The following letter from CVS Caremark to a long-term patient of an independent pharmacy is an example of what is done:

Action Needed. Please Call Immediately To Ensure Your Refill Is Covered!


Dear xxxxxx xxxxxx:

We'd like you to know about an important part of your prescription plan: In order to save both you and your plan money, your plan design requires that you receive long-term medications in a quantity between 84 and 100 days at either a CVS/pharmacy retail store or through CVS Caremark Mail Service. It's important to call us toll-free at (xxx) xxx-xxxx as soon as possible to ensure that we are able to process your prescription without disruption. Our Customer Care team can then take care of obtaining your new long-term prescription(s) from your doctor and arrange for your next fill to be ready.

You will be able to choose one of these options:
  • Pick up at your local CVS/pharmacy
  • Use CVS Caremark Mail Service to have it delivered to the address of your choice in confidential, tamper-resistant and (when necessary) temperature controlled packaging. Standard shipping is available at no additional cost.
Our records show that your long-term prescription(s) for: (The name of the medication, prescription number, and date when dispensed are provided here.)

was filled at: (The name and address of the current pharmacy are provided here.)

Please keep in mind that if you continue to utilize the pharmacy identified above no additional fills of your prescription(s) will be covered. However, when you call the phone number listed above we can help you save money and get your prescription(s) without disruption through CVS/pharmacy or CVS Caremark Mail Service Pharmacy.

CVS Caremark is pleased to manage your prescription benefit plan. Learn about your prescription benefit and more by visiting xxx.xxxxxxxx.xxx. We are ready to help you save money and get your medications easily.

Sincerely,
CVS Caremark

Prescription "benefit" plans like this are a disservice to patients (or "customers" to use the terminology of the letter). It is also noteworthy that there is no mention in the letter of communication with a pharmacist or the services that pharmacists could provide. In my opinion, programs like this significantly compromise the pharmaceutical services and health care for patients and, therefore, increase risk. However, the profession of pharmacy has not been effective in preventing these programs that undermine the goals for which we strive.

Chain pharmacists

There are many very capable and highly professional pharmacists working in chain pharmacies, and some enjoy their responsibilities. However, many others do not. Their greatest threat comes from the executives and other decision-makers in the companies in which they are employed. The concerns I hear most often from chain pharmacists pertain to the stressful workplace environment, inadequate staffing (both pharmacists and technicians), very low salaries for technicians, the metrics and the clock (e.g., quotas for the number of prescriptions and immunizations; the number of minutes in which a prescription is expected to be dispensed; the number of rings within a phone call must be answered), no or limited time to speak with patients, the lack of professional fulfillment, and the intimidation of higher managers and a fear of retaliation. These concerns are even greater now than they were just several years ago because of the tightening of the employment market for pharmacists. Chain pharmacists who have concerns or even constructive suggestions are more reluctant to communicate them to their manager and above for fear they might be putting their job at risk at a time when employment elsewhere may not be available.

Many organizations and individuals within the profession are giving the highest priority to attaining "provider status" for pharmacists. It is anticipated that attaining this status will result in the provision by pharmacists of more comprehensive services for patients and the opportunity to be paid for these services. The Patient Access to Pharmacists' Care Coalition (PAPCC), comprised of 22 organizations, has been formed and I support its mission to develop federal policy that would enable patient access to Medicare Part B services and payment for pharmacists that provide them. The Coalition includes most (but not all, and that is another story) of the national organizations that we would expect to be supportive of this initiative (e.g., APhA, ASHP, NCPA, AACP, ASCP). The Coalition also includes chain pharmacies such as CVS Caremark, Rite Aid, and Walgreens, and this is where I have great concern. I do not believe that their concept of "Pharmacists' Care" comes anywhere close to what I and most of the national organizations of pharmacists advocate. The following situation is an example that underlies my concern.

There is litigation in Pennsylvania (Landay v. Rite Aid) that revolves around the question of whether individuals who obtain prescriptions at Rite Aid are considered "customers" or "patients." Shockingly, because it can charge more to provide copies of prescription records if individuals are classified as customers rather than patients, Rite Aid is insisting that those whom it serves should be considered customers and is appealing the decision of a judge who recognizes the broader responsibilities of pharmacists. (I encourage you to read David Stanley's column on page 17 of the April issue of Drug Topics). Rite Aid's obsession with charging more for prescription records undermines the professional standing of its pharmacists, and contradicts its company's message that it is interested in the health of its customers.

The Coalition mentioned above includes the word "Patient" in its title. Rite Aid should either withdraw its appeal of the judge's decision in Landay v. Rite Aid, or it should withdraw from the Coalition. It must not be permitted to continue its blatant hypocrisy. If it takes neither of these actions, the other members of the Coalition should expel Rite Aid.

The rest of us

Every pharmacist has a responsibility to give something back to the profession, and I would extend this further to indicate that every pharmacist has a responsibility to support community pharmacists in their battles against injustices and disservices that compromise the scope and quality of pharmacists'services. However, many of us even work at professional organizations, hospitals, colleges of pharmacy, and pharmaceutical companies that use the egregious prescription plans identified earlier, and most of us do not voice any concern about them.

For much of our history, independent pharmacists have had the primary responsibility of advancing and protecting the profession of pharmacy. However, they are now severely threatened by PBMs, mail-order pharmacies, and even the executives of chain pharmacies who should be allies in efforts to further strengthen community pharmacy.

In my opinion, the future success of the entire profession of pharmacy is inextricably entwined with the extent to which independent pharmacists can not only survive, but thrive. We all have a responsibility to support them!

Daniel A. Hussar
 NEW DRUG REVIEW:

Dapagliflozin propanediol
(Farxiga - Bristol-Myers Squibb; AstraZeneca)
Antidiabetic Agent

New Drug Comparison Rating (NDCR) = 3
(no or minor advantages/disadvantages)
in a scale of 1 to 5, with 5 being the highest rating

Indication:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus..

Comparable drug:
Canagliflozin (Invokana).

Advantages:
  • May be less likely to cause hypersensitivity reactions and hyperkalemia;
  • May be less likely to interact with other medications;
  • May be used in patients with severe hepatic impairment, whereas canagliflozin has not been studied in patients with severe hepatic impairment and use is not recommended.
Disadvantages:
  • Bladder cancer has been infrequently reported in clinical studies and should not be used in patients with active bladder cancer;
  • Recommendations for use in patients with impaired renal function are more restrictive (e.g., treatment should not be initiated in patients with an estimated glomerular filtration rate [eGFR] less than 60 mL/min/1.73 m², whereas treatment with canagliflozin should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m²).
Most important risks/adverse events:
InRenal function impairment (contraindicated in patients with severe renal impairment; renal function should be monitored during therapy); hypersensitivity reactions (contraindicated in patients with a history of a serious hypersensitivity reaction); hypotension (risk is increased in patients with impaired renal function or low systolic blood pressure, the elderly, and in patients treated with a diuretic); hypoglycemia (when used concomitantly with insulin or an insulin secretagogue [e.g., a sulfonylurea]); bladder cancer (reported infrequently in clinical studies but at a higher rate that in patients treated with comparator antidiabetic agents or placebo; should not be used in patients with active bladder cancer).

Most common adverse events (and the incidence in patients treated with a dosage of 10 mg daily):
Female genital mycotic infections (7%; e.g., vulvovaginal candidiasis), nasopharyngitis (6%), urinary tract infections (4%), increased urination (4%), back pain (4%), male genital mycotic infections (3%; e.g., balanitis), nausea (3%), dyslipidemia (3%; e.g., increased LDL-C).

Usual dosage:
Initially, 5 mg once a day in the morning; in patients who tolerate treatment and require additional glycemic control, dosage may be increased to 10 mg once a day in the morning; treatment should not be initiated in patients with an eGFR less than 60 mL/min/1.73 m², and treatment should be discontinued if the eGFR is persistently below this value.

Product:
Film-coated tablets - 5 mg, 10 mg.

Comments:
Sodium-glucose cotransporter 2 (SGLT2) is expressed in the proximal renal tubules and is responsible for the reabsorption of the majority of glucose filtered by the kidney, Dapagliflozin is the second SGLT2 inhibitor, joining canagliflozin, and these agents reduce the reabsorption of filtered glucose, thereby increasing urinary glucose secretion and lowering blood glucose and glycosylated hemoglobin (hemoglobin A1c [HbA1c]) concentrations. Its effectiveness has been demonstrated in studies in which it has been used as monotherapy, or in combination regimens with metformin, glipizide, glimepiride, pioglitazone, sitagliptin (Januvia), or insulin. The use of dapagliflozin resulted in reductions in HbA1c and fasting plasma glucose (FPG) concentrations and, in many patients, weight reduction. In a placebo-controlled study, the percentage of patients achieving a HbA1c of less than 7% was 44% and 51% in patients receiving daily doses of 5 mg and 10 mg of dapagliflozin, respectively, compared with 32% of those receiving placebo. The use of dapagliflozin in combination with other antidiabetic agents resulted in greater reductions in HbA1c and FPG concentrations. Patients treated with regimens that included dapagliflozin typically lost an average of 1 to 3 kg of body weight over a 24-week period, whereas those who were treated with other antidiabetic agents usually either lost less weight or experienced weight gain.

Daniel A. Hussar