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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.
February 2011 Issue
New Drug Review
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Priorities for our Profession
Choosing the topic for this month's issue of The Pharmacist Activist was more of a challenge than usual. Not because there are not enough important issues to address, but rather because there are so many. Indeed, pharmacy faces so many challenges that identifying the degree of priority with which they should be addressed is an important decision in and of itself. Therefore, the purpose of this editorial is to identify the issues that, in my opinion, require our profession's highest priority attention.
Daniel A. Hussar
- Commitment, passion, and activism
Many pharmacists are apathetic or even negative about pharmacy and their individual responsibilities, and it is no consolation that this situation exists in every profession and area of employment. Tens of thousands of pharmacists are not members of even one professional association. Some would contend that the wide availability of employment opportunities (at least until recently) and high salaries have contributed to the apathy and complacency that is so widespread. Pharmacy has provided a good livelihood for the vast majority of pharmacists and every pharmacist should recognize a responsibility to give something back to our profession. This should be motivated by our enthusiasm for and pride in our profession, and demonstrated through a commitment to and passion for what we represent and can do individually and collectively for our patients and profession. We need thousands more activists within pharmacy. The colleges of pharmacy have an extremely important responsibility in encouraging these attitudes, qualities, and involvement among student pharmacists that will be continued through their professional careers. Our professional organizations must be more innovative and effective in increasing membership and active participation in professional initiatives.
- More effective professional organizations
Our profession needs an organizational structure at the national, state/regional, and local levels that will serve and advance the interests of pharmacy in a more effective manner than is being accomplished through our current system (please see the editorial in the January 2011 issue [www.pharmacistactivist.com] for possible national organizational structure options). Leaders of the national pharmacy organizations should meet to actively consider these options in the context of what is best for the profession, and not just what is best for individual organizations. Many state/regional pharmacy organizations are struggling financially and have limited effectiveness. In my opinion, the profession is best served by having one organization of pharmacists in each state, and the leaders of the multiple pharmacy organizations within a state should be encouraged to develop and approve such a structure.
- Independent pharmacies must thrive
Notwithstanding the importance of the roles and accomplishments of pharmacists in all areas of professional responsibility, it is the independent pharmacists who are the "face" of our profession with the public and who have the most prominent identity that is responsible for the reputation for trust and integrity that our profession enjoys. It is also the independent pharmacists who are the most likely to have the personal interaction with the largest number of patients who receive the medications and services around which the expanding roles of pharmacists are based. As the number of chain/corporate and mail-order pharmacies has increased in recent years and the number of independent pharmacies has declined, some have predicted the disappearance of independent pharmacies. However, we must not let that happen! A number of years ago I voiced the opinion that the future roles and success of the profession of pharmacy are inextricably linked to the extent that independent pharmacists can be successful in their professional responsibilities. My conviction regarding the validity and importance of this opinion is even stronger today. Our entire profession must be strongly supportive of efforts that will enable independent pharmacies to not only survive, but thrive.
- Tightening of the job market
The economic challenges of the last several years coupled with the large increase in the numbers of colleges of pharmacy and pharmacy graduates have resulted in a significant tightening of the employment opportunities for pharmacists and student pharmacists. This situation has many extremely important implications that are as positive as a much larger number of opportunities in which the abilities and skills of pharmacists can be utilized in providing optimal drug therapy for many more patients, and as negative as widespread pharmacist unemployment. We must not be content to sit back and watch how this situation evolves. Our profession must be actively engaged in developing plans and strategies that will result in the assimilation of a much larger number of pharmacists in the provision of more comprehensive services of documented value to an increasingly elderly patient population with greater needs for optimal drug therapy. The alternative would be the worst possible contradiction - a country with millions of people who have a great need for the expertise possessed by pharmacists who can not provide it because of the failure of a healthcare system that does not recognize and pay for that expertise.
- "Walking the talk"
As much as many of us extol the expertise of pharmacists and the value of our advice and services, optimal services are not the norm and, indeed, for many, are not evident at all. We must provide to a much greater extent what we claim as the value of our role and responsibilities. We must do much better in providing even the most basic information and services, and develop programs that will provide pharmacists with the information and confidence necessary to extend their services. As a profession we have the potential to assume "ownership" of important challenges such as the prevention of medication/dispensing errors and increasing patient compliance with the instructions for using medications. If pharmacists do not respond to these opportunities that can be viewed as such a natural part of our domain of responsibilities, it will only be a matter of time before other health professionals will.
- Prescription benefit programs
The inequitable compensation and conditions of most prescription benefit programs are continuing important concerns for pharmacists. Pharmacists must document the value of their services and the cost of dispensing a prescription so that they are well positioned to demonstrate inequities in programs in which they are asked to participate. Pharmacists should not reduce the scope and quality of their services to try to adjust for the inadequacies of the program but rather should decline to participate in programs in which the compensation or other conditions are not equitable. Notwithstanding the need to avoid specifics of compensation issues because of antitrust implications, the profession should develop a model prescription benefit program that would effectively address the drug therapy needs of patients, and encourage and recognize the value of the information and services provided by pharmacists.
- Legislative influence
Pharmacists and our professional associations must have much more extensive and effective communication with our legislators. The geographical distribution of pharmacists provides an excellent opportunity for legislative influence. However, we are not even close to reaching our potential in this regard. In addition to having pharmacy's interests and services considered in new and revised national health insurance legislation (e.g., Obamacare), other issues require the attention of the profession. Examples include legislative changes that would permit pharmacists and our organizations to collectively negotiate for equitable compensation for the services we provide, and changes that would prevent mandated participation of patients in mail-order pharmacy programs.
- Taking a stand
The profession of pharmacy, primarily through its professional organizations, must demonstrate the courage to address situations that place patients at risk and/or are potentially damaging to the profession, even if they may be controversial or sensitive. For example, excessively busy and stressful working conditions that increase the risk of dispensing errors must not be tolerated. Employers who persist with policies that place patient safety in jeopardy must be challenged. Likewise, prescription benefit programs that require or provide financial incentives for patients to obtain medications from a mail-order pharmacy and decrease personal communication between patients and pharmacists must be challenged. The continuing establishment of new colleges of pharmacy in the face of a saturated marketplace for pharmacists is another situation that must be questioned.
- Developing leaders
The urgent attention that is needed to address the numerous current issues can easily obscure the importance of developing the future leaders for the profession. The identification and development of new leaders is a critical component of plans to position pharmacy for success in the future.
- Expanded and new opportunities
At the same time that current challenges demand priority attention, there must be a vision for expanding some existing opportunities and developing new ones. The manner in which some pharmacists have developed practices that focus on compounding prescriptions to meet individualized needs of patients is one such example. Other examples include expanded roles in medication therapy management (MTM) programs, immunization programs, the self-care of patients with nonprescription products, the provision of durable medical equipment products and services, and the provision of specialty pharmaceuticals.
New Drug Review
(Krystexxa - Savient)
Agent for Gout
New Drug Comparison Rating (NDCR) = 4
in a scale of 1 to 5, with 5 being the highest rating
Administered intravenously for the treatment of chronic gout in adult patients refractory to conventional therapy; is not recommended for the treatment of asymptomatic hyperuricemia.
Allopurinol (e.g., Zyloprim), febuxostat (Uloric).
- Is effective in some patients with chronic gout that is refractory to conventional therapy;
- Has a unique mechanism of action (reduces serum uric acid concentration by catalyzing the oxidation of uric acid);
- Less likely to interact with other medications.
Most important risks/adverse events:
- Must be administered intravenously;
- Risk of anaphylaxis and infusion reactions;
- May cause exacerbation of congestive heart failure;
- Formation of antibodies may reduce effectiveness.
Contraindicated in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency (risk of hemolysis and methemoglobinemia); anaphylaxis (generally manifests within two hours of an infusion; should be administered in a healthcare setting by providers who are prepared to manage anaphylaxis; patients should receive premedication with an antihistamine and corticosteroid, and be closely monitored for an appropriate period of time following administration); infusion reactions; gout flares (prophylaxis with a nonsteroidal anti-inflammatory drug or colchicine is recommended for at least the first six months of treatment); exacerbation of congestive heart failure.
Most common adverse events:
Gout flare (77%; incidence similar to placebo), infusion reaction (26%), nausea (12%), contusion/ecchymosis (11%), nasopharyngitis (7%), chest pain (6%), anaphylaxis (5%), vomiting (5%).
8 mg every two weeks administered by intravenous infusion over no less than 120 minutes via gravity feed, syringe-type pump, or infusion pump (must not be administered as an intravenous push or bolus); patients should be premedicated with an antihistamine and corticosteroid; continued observation of patients for at least one hour following completion of the infusion should be considered; serum uric acid concentrations should be monitored prior to infusions (discontinuation of treatment should be considered if concentrations rise to above 6 mg/dL, particularly when two consecutive concentrations above 6 mg/dL are observed).
Single-use vials - 8 mg/mL (should be stored in a refrigerator); 1 mL is withdrawn from the vial and injected into a bag of 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection.
Pegloticase is a uric acid specific enzyme that is a PEGylated product. It consists of recombinant urate oxidase (uricase) that is covalently conjugated to monomethoxypoly(ethylene glycol). It catalyzes the oxidation of uric acid to allantoin, thereby lowering serum uric acid. Its effectiveness was demonstrated in two placebo-controlled studies of six months duration in patients with a baseline serum uric acid of at least 8 mg/dL, at least three gout flares in the previous 18 months or at least 1 gout tophus or gouty arthritis, and had a contraindication to allopurinol or failure to normalize uric acid with at least three months of allopurinol treatment at the maximum dosage. The primary endpoint was attainment of plasma uric acid less than 6 mg/dL for at least 80% of the time during Month three and Month six. This endpoint was attained in 47% and 38% of the patients in the two studies, compared with 0% of the patients receiving placebo.
Daniel A. Hussar