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 2011 Issue
New Drug Review
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The Large Chains are making a Mockery of our Profession–
and our Profession is a Co-conspirator through our Silence!
LOOK! OVER ON THE CORNER! It's a fast-food drive-through! It's a photo center! It's a tobacco shop! It's a supermarket! IT'S SUPERMEGACHAINPHARMACY! (with apologies to Superman).
It used to be that the large chain pharmacies like CVS Caremark, Walgreens, and Rite Aid would be satisfied to expand their lines of retail merchandise while permitting the Pharmacy department to function in as professional a manner as possible in an environment that increasingly resembles a convenience store or mini-mall. However, in recent years, they have commercialized, discounted, and demeaned the importance and risks of prescription medications, as well as the value of the professional role and services of their own pharmacists. Many of these actions insult and make a mockery of the profession of pharmacy – the very profession that has made possible what they might count as their success.
Rite Aid coupons
The chains have used various strategies to increase the speed of dispensing prescriptions as one measure of evaluating their pharmacists. However, Rite Aid has added an additional incentive for speed by promoting to consumers that, if their prescription is not ready within 15 minutes, they will receive a $5 coupon for store merchandise. How can this promotion not place added pressure and stress on the already-busy pharmacist whose performance might be evaluated negatively by management if too many $5 coupons have to be given to customers on her/his shift?
Many Rite Aid employees have concerns about and even ridicule this promotion, but their management does not listen to them. Some customers play games with the promotion and "hide out" in a corner of the store or step outside until the 15 minutes elapse to increase their likelihood of obtaining the $5 coupon. The employees in the front end of the store chide those in the Pharmacy department that there is not a similar $5 coupon incentive to help customers speed their way through the lines at the front of the store.
As people learn of this promotion, the instant recall for many is the Domino Pizza promotion to deliver pizzas within 30 minutes, one of the consequences of which was an increased number of accidents of Dominos' delivery vehicles. I would contend that the Rite Aid promotion has serious negative implications with respect to patient safety. I have written the following letter to the Pennsylvania State Board of Pharmacy and encourage pharmacists in all states in which Rite Aid uses this promotion to send a similar letter to their Boards of Pharmacy.
I am writing to voice my concern about a promotion that Rite Aid is using in its pharmacies. Rite Aid promotes that, if a prescription is not prepared within 15 minutes, the customer will be provided a $5 coupon. This emphasis on speed in completing a prescription places more pressure and stress on the pharmacists who are expected to meet this goal. In my opinion, this promotion increases the risk of dispensing errors and compromises safeguards for the safety of patients.
CVS Caremark steals patients
I urge the Board of Pharmacy to take action to require Rite Aid to discontinue this program. It is noteworthy that the New York Board of Pharmacy has done this. If the Board does not feel that existing laws and regulations give it the authority to do this, it should pursue the establishment of such authority. I further recommend that the Board require Rite Aid to submit information regarding all dispensing errors in its Pennsylvania pharmacies during the period of time in which this or similar promotions are being offered.
Caremark is one of the largest administrators of prescription benefit programs. It establishes the criteria and policies of these programs that local pharmacies can accept or reject, but not negotiate or collaborate. Many of these programs require participating patients to obtain their medications for chronic conditions from a Caremark mail-order pharmacy or a local CVS pharmacy. Unless a patient is willing to incur financial penalties for not abiding by the conditions of the prescription program, they are forced to obtain these medications from a pharmacy other than the one that they might have been using for decades and in which they have a long-standing and trusted relationship with the pharmacist. CVS Caremark is stealing these patients from their local pharmacies and, by fragmenting their care by having them use additional pharmacies, is placing them at greater risk of drug interactions and other drug-related problems. Legislative initiatives that would prevent these practices are being pursued in many states and at the national level and require extensive support from the profession.
The most recent public embarrassment for CVS and our profession is the announcement that CVS will pay $17.5 million to the federal government and 10 state governments to settle allegations that it overcharged Medicaid programs. A CVS pharmacist was a whistleblower in this case and must have provided compelling evidence, even though CVS provided its standard response when they settle allegations for millions of dollars-acknowledging no wrongdoing but agreeing to settle to avoid additional expense and uncertainty. In my opinion, the federal and state governments should not settle cases such as this, but rather should continue to investigate and prosecute these situations so that innocence or guilt can be clearly determined. If there is guilt, the participation of the guilty party/company in the government prescription program should be terminated.
It was only in October that CVS agreed to pay $75 million in civil penalties following its admission that it unlawfully sold pseudoephedrine to criminals who made methamphetamine (please see the editorial in the November, 2010 issue of The Pharmacist Activist). It is bad enough that CVS is engaged in such activities. Unfortunately, our entire profession is the victim of the negative publicity that results.
I am sometimes contacted by attorneys who ask me to consider serving as a consultant or expert witness in potential or current litigation involving a drug-related problem. In many situations, my conclusion is that the drug-related problem could not have been anticipated or avoided, and that there is no basis for a lawsuit, and I decline to be involved any further. Situations become more complex when the problem/harm/death appears to have occurred as a consequence of an error or negligence. My personal philosophy is that I will not participate as an expert witness in a lawsuit unless I am absolutely convinced that the position I am supporting is the valid one that will withstand any challenge. I have been able to assist some pharmacists/pharmacies in their successful defense against lawsuits in which I was convinced they were not at fault. Ordinarily I do not participate in support of a plaintiff who is suing a pharmacist/pharmacy. However, there have been certain situations in which I have agreed to do this-situations in which I have considered the defense for the pharmacist/pharmacy to be outrageous in denying that pharmacists/pharmacies have any responsibility with respect to the safety of patients in using medications. If a judge and/or jury would agree with a defense that a pharmacist has no responsibility other than doing exactly what a prescriber requests, the conclusion would be that pharmacists have no independent responsibility or role with respect to the appropriateness and safety of drug therapy.
It has been my observation that when an error or negligence involves a chain pharmacy, the attorney for the plaintiff identifies the pharmacy as the defendant (i.e., the pharmacy has "deeper pockets" than individual pharmacists). However, in two recent cases, both the pharmacy and pharmacist were identified as defendants. When I asked why the pharmacist was being included as a defendant, the attorney responded that his recent experience has been that, when the pharmacy is the only defendant, the pharmacy has attempted to do everything possible to absolve the pharmacy of responsibility by placing the blame on its own pharmacist who was not named as a defendant. This "strategy" was evident in the press coverage of the recent dispensing error in Colorado in which a patient was given a prescription for methotrexate that was intended for another patient. The woman who took the methotrexate in error is pregnant and there is concern about the possibility of harm to her baby. The statement from the grocery store pharmacy in which the error was made is that it has policies that should have prevented this error but that one of its employees did not comply with the policy.
One message for pharmacists is that they must have insurance coverage for themselves as individuals.
The continued sale of cigarettes by the large chain pharmacies is a blatant contradiction to the health care role of its pharmacists and the chains' deceptive messages suggesting an interest in the health of their customers that they voice out of the other side of their mouths. The hypocrisy of this situation is escalated even further by something I recently learned. At least some of the large chains have tobacco-free programs that are promoted to their employees with an incentive of lower rates for their share of the health benefit plan. It can be expected that the chain pharmacy that encourages this program also benefits financially. However, these same chains have such disregard for the health of their customers that they will continue to sell them as many cartons of cigarettes as they want to buy.
Tightening job market for pharmacists
It was only several years ago that there was a significant shortage of pharmacists in many parts of the country, and the large chain pharmacies had difficulty hiring as many pharmacists as they needed. A very different situation exists now and some chains have responded by finding reasons to terminate pharmacists they do not wish to retain (e.g., some older pharmacists with higher salaries) and being less willing to tolerate concerns voiced by their pharmacists (e.g., inadequate staffing). With increasing frequency, new graduates are being offered "full-time" positions with a commitment of at least 32 hours per week plus benefits. This offer is usually accompanied by the observation that, although the commitment is for at least 32 hours per week, pharmacists are likely to work 40 hours a week or more. However, some pharmacists who have developed their personal budget with the expectation of a salary for at least 40 hours a week are experiencing shortfalls in hours and income. Newly-hired pharmacists should be alert that an agreement for at least 32 hours a week may very well involve no more than 32 hours.
Situations such as the above through which large chain pharmacies make a mockery of the profession of pharmacy are not only of concern to those in our profession, but are also increasingly evident to patients and others outside the profession. The May 2011 issue of Consumer Reports includes an article, "Best Drugstores," in which more than 43,000 readers rate pharmacies on factors such as accuracy, knowledge, helpfulness, and personal service. Thirty-three pharmacy chains and other entities were evaluated and the five receiving the lowest ratings are the following:
29-31 - tie between CVS, Giant Eagle, and Walgreens
32 - Rite Aid
33 - Walmart
The five receiving the highest ratings are the following:
1 - Independent drugstores
2-3 - tie between Health Mart and The Medicine Shoppe
4-5 - tie between Bi-Mart and Publix
The silence of our profession
Many of the situations described above might be expected to generate outrage from within our profession. Are these the ways in which we want our profession to be known to the public? Are these the types of practice situations in which we want pharmacists and student pharmacists to be employed? Are patients not being placed at excessive risk of drug-related problems? Are these not situations that severely compromise the attainment of the vision for the profession that we rally around?
What are our national and state pharmacy associations, our state boards of pharmacy, and our colleges of pharmacy saying about these situations? With few exceptions, SILENCE has been their response. To give credit where credit is due, the National Community Pharmacists Association has been highly active in addressing the concerns associated with CVS Caremark operations, Mike Cohen and the Institute for Safe Medication Practices have been exceptional in addressing patient safety issues including the Rite Aid coupons, and the New York Board of Pharmacy has been bold in prohibiting the Rite Aid coupon program.
Where are all the other boards, colleges, and pharmacy associations? Our profession has become a co-conspirator through our silence!
Daniel A. Hussar
New Drug Review
(Edarbi - Takeda)
New Drug Comparison Rating (NDCR) = 3
(no or minor advantages/disadvantages)
in a scale of 1 to 5, with 5 being the highest rating
Treatment of hypertension, either alone or in combination with other antihypertensive agents.
Other angiotensin II receptor blockers: Candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (e.g., Cozaar), olmesartan (Benicar), telmisartan (Micardis), valsartan (Diovan).
- More effective in lowering 24-hour blood pressure (compared with olmesartan and valsartan).
Most important risks/adverse events:
- Fewer labeled indications (compared with candesartan, irbesartan, losartan, valsartan, and telmisartan);
- Is not available in a combination formulation with another antihypertensive agent (e.g., hydrochlorothiazide).
May cause harm to the fetus if administered during the second or third trimester of pregnancy (boxed warning; Pregnancy Category D [second and third trimesters] and Category C [first trimester]); hypotension in volume-depleted or salt-depleted patients; renal function should be monitored in patients with renal impairment.
Most common adverse events:
80 mg once a day; an initial dosage of 40 mg once a day should be considered in patients being treated with high doses of diuretics.
Tablets - 40 mg, 80 mg; should be dispensed and stored in the original container to protect from light and moisture.
The potassium salt of azilsartan medoxomil (also known as azilsartan kamedoxomil) is included in the tablet formulations. Azilsartan medoxomil is a prodrug that is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. It is the eighth angiotensin II receptor blocker (ARB) to be marketed in the United States and its properties are generally similar to those of the other ARBs. In studies in which it was compared with olmesartan and valsartan, azilsartan was more effective in lowering 24-hour blood pressure. The reduction in the 24-hour mean systolic blood pressure was 14.3 mm Hg with azilsartan (80 mg once a day), compared with reductions of 11.7 mm Hg and 10 mm Hg with olmesartan (40 mg/day) and valsartan (320 mg/day), respectively. As with the other ARBs, the blood pressure lowering effect was lower in black patients.
The treatment of hypertension is the only labeled indication for azilsartan, whereas certain other ARBs have additional indications (e.g., losartan for diabetic nephropathy in patients with type 2 diabetes and hypertension; valsartan for patients with heart failure).
Daniel A. Hussar