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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.
March 2009 Issue
New Drug Review
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Coupons, $4 generics, and Free Generic Antibiotics - Disservices to Patients and
Insults to Pharmacists
In my opinion, the cost of many medications is too high and I strongly support appropriate initiatives that will make them more affordable for patients. Many patients, for cost considerations, reduce dosages to enable their prescriptions to last longer or do not obtain their prescriptions at all. This situation not only results in inadequate therapy but also results in bad economics as inadequate drug therapy leads to more serious health problems that require even more costly interventions (e.g., additional physician visits, hospitalizations).
Many pharmacies, primarily chain pharmacies, grocery store pharmacies, and "big-box" pharmacies, have undertaken some aggressive programs to promote themselves and selected prescription medications. Some of these programs are disguised as compassionate initiatives developed for the purpose of saving patients money during challenging economic times. Please spare us the charade! These programs are, in fact, marketing efforts designed for just one purpose — to bring more people into these stores with the expectation that they will not only dispense more prescriptions but also increase the sales of other merchandise.
Coupons represent a long-standing tactic that has been employed by pharmaceutical companies and some pharmacies. Pharmaceutical companies have provided coupons or other promotions in newspapers, magazines, and physicians' offices to offer a free or reduced cost first prescription or initial supply of selected trade-name medications that are not available generically. This strategy is used for medications for maintenance conditions with the expectation that the medication will be taken for many months and years. Using a free initial supply of medication as an inducement for patients to ask their physicians to prescribe it will result in numerous refills and repeat prescriptions for a medication that may be far more costly than other satisfactory alternatives. However, for the companies, the small expense they assume for the initial prescription is far more than offset by the revenue from refills and subsequent prescriptions.
Some pharmacies have used coupons in a different way. One large chain pharmacy has recently promoted coupons for $25 of merchandise for each prescription that is transferred from another pharmacy, up to a limit of four prescriptions/coupons. Not to be outdone, other chains have developed similar promotions. The result is chaos in which the services to and care of patients is fragmented, and patients are using more than one pharmacy and sometimes forgetting which prescription is at which pharmacy. A pharmacist at one of these chains recently shared the following experience with me — a patient requested an authorized refill for a medication but was informed that this prescription was no longer active at this pharmacy. The "history" of this prescription was that it was initially dispensed at one chain pharmacy, was transferred to another chain pharmacy in response to a $25 coupon offer, and was later transferred to yet another chain pharmacy that apparently provided an even better coupon offer. I do not fault patients for trying to obtain prescription medications at lower prices. However, I feel that the "games" these pharmacies are playing with the quality of care for their customers are deplorable.
$4 generic prescriptions
When the $4 generic prescription promotions (for a 30-day supply) started in 2006 I wrote an editorial (October, 2006; www.pharmacistactivist.com) with the opinion that such programs are scams that ignore the professional role of pharmacists. Three years and many variations of these programs later, I hold the same opinion. Many patients do not know whether their medication is available generically and may assume that it is by the promotions suggesting that hundreds of products are available for the $4 cost.
However, the number of different drugs is much smaller than the hundreds of products to which reference is made because multiple potencies and formulations of the same drugs are included in the count. In addition, generic drugs for which the cost is higher than most are not usually included in the program.
Free generic antibiotics
Some grocery store pharmacies have recently been promoting free generic antibiotic prescriptions, with the offers typically continuing until the end of March. One company's press release announces that free prescriptions for oral antibiotics will be available "during cough-and-cold season." As we know, colds are almost always caused by viruses that are not susceptible to any antibiotic or any other antimicrobial agents. However, the promotion misleads consumers into expecting that an antibiotic might be prescribed for their cold. While pharmacists, physicians, and other health care professionals are trying to address concerns about the overuse/misuse of antibiotics and the resultant faster emergence of resistance, these promotions increase the expectation that antibiotics should be prescribed when the symptoms experienced are often associated with infection. The public perception is "if the antibiotic is free, why not use one?"
The public does realize though that medications cost something and that when they are dispensed free of charge, this cost must be subsidized with funds from somewhere else. The promotions invite the question as to whether prices for other medications have been increased to subsidize free antibiotics. Although the companies with these antibiotic promotions insist that this is not the case, they are not humanitarian organizations. If we accept their explanation, that essentially reveals the promotion as a marketing strategy designed to bring more people into their stores.
Disservice to Patients
Although reducing the cost of medications is a desirable goal, the promotions described above are misleading and are a disservice to patients and the public. They create confusion and often fragment the provision of medications and pharmacist services to patients (i.e., from multiple pharmacies) in a manner that will increase the risk of drug-related problems.
Insulting to Pharmacists
The promotion of free prescriptions for antibiotics and cheap prescriptions for generics are demeaning and insulting to the professional role of pharmacists. If the knowledge, skills, and services of pharmacists have value, how can prescriptions be dispensed free of charge? What message does this provide to patients about the expertise and role of pharmacists? And if patients do not think about the expertise and role of pharmacists, we have an even larger challenge to address.
I wrote to one of the companies that is promoting free antibiotics to voice several concerns, including my opinion that this is insulting to the professional role of their pharmacists. I received a response that the program was discussed extensively with their pharmacists and none of them expressed the concern that I did. There could be several explanations for this but to discuss them would go beyond the scope of this commentary.
I have heard some pharmacists say that they would not work for an organization that conducts marketing programs that devalue the expertise and role of the pharmacist. The pharmacists who do work for these companies should insist that their expertise and services must not be used as "loss-leaders" in marketing programs. There are other ways in which medications can be provided to patients less expensively and also promote the value of the roles and services of pharmacists rather than demean them.
Daniel A. Hussar
New Drug Review
(Rapaflo - Watson)
Agent for Benign Prostatic Hyperplasia
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 the signs and symptoms of benign prostatic hyperplasia.
Tamsulosin (Flomax), alfuzosin (Uroxatral), doxazosin (e.g., Cardura XL), terazosin (e.g., Hytrin).
- Convenient dosage regimen that does not require dosage titration (compared with tamsulosin, doxazosin, and terazosin);
- Less likely to cause a reduction in blood pressure (compared with doxazosin and terazosin);
- Has not been associated with prolongation of the QT interval of the electrocardiogram (compared with alfuzosin);
- May be used in patients with moderate hepatic impairment (compared with alfuzosin that is contraindicated in patients with moderate or severe hepatic impairment);
- Has not been associated with reactions in patients who are allergic to sulfonamides (compared with tamsulosin with which there have been rare reports of such reactions);
- Has not been associated with interactions with cimetidine (compared with tamsulosin).
Most important risks/adverse events:
- Studies that directly compare silodosin with similar agents are limited;
- Labeled indication is more limited (compared with tamsulosin that has also been approved for concurrent use with dutasteride [Avodart]);
- Is contraindicated in patients with severe renal impairment;
- Is contraindicated in patients who are also being treated with a strong CYP3A4 inhibitor (compared with tamsulosin, doxazosin, and terazosin);
- Concurrent use with strong P-glycoprotein inhibitors (e.g., cyclosporine [e.g., Neoral]) is not recommended;
- More likely to cause retrograde/abnormal ejaculation (compared with alfuzosin, doxazosin, and terazosin).
Contraindicated in patients with severe renal impairment, severe hepatic impairment, and in patients being treated with a strong CYP3A4 inhibitor (e.g., clarithromycin [e.g., Biaxin]); postural hypotension; intraoperative floppy iris syndrome (caution must be observed during cataract surgery); should not be used concurrently with other alpha-adrenergic blocking agents.
Most common adverse events:
Retrograde/abnormal ejaculation (28%); orthostatic hypotension (3%), dizziness (3%), diarrhea (3%).
8 mg once a day with a meal; in patients with moderate renal impairment, 4 mg once a day with a meal.
Capsules - 4 mg, 8 mg.
Silodosin is the fifth alpha-1-adrenergic receptor antagonist (alpha-blockers) to be approved for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Its properties and actions are most similar to those of tamsulosin. The effectiveness of silodosin was demonstrated in two placebo-controlled studies which evaluated irritative (e.g., frequency, urgency) and obstructive (e.g., hesitancy) symptoms. The results of one study in Japan reported that silodosin was more effective than placebo and not inferior to tamsulosin, although the latter agent was used in a lower dosage (0.2 mg once a day) than is generally used in the United States (0.4 mg once a day). The alpha-blockers often are used concurrently with finasteride (Proscar) or dutasteride (Avodart) to reduce the symptoms of BPH via two mechanisms of action. In 2008, the FDA approved the use of tamsulosin and dutasteride in combination; however, studies of the use of silodosin with finasteride or dutasteride have not been conducted.
Daniel A. Hussar