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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.
May 2012 Issue
New Drug Review
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The "Tyranny of the Urgent" Must Not Compromise our Commitment to our Priorities!
Many of the topics that I address in editorials in The Pharmacist Activist involve issues that I consider to be deserving of high-priority attention from our profession. The editorial in the February 2011 issue is titled, "Priorities for our Profession," and identifies ten suggested priorities. Some of these priorities have been considered in expanded discussions in subsequent editorials. Although priorities lack the authority of "commandments," there is good reason to think that nothing is more important for the profession of pharmacy than the priorities we establish and work to attain. However, there is seemingly no end to the challenges, some of which are important and urgent, that distract us and interrupt our efforts to establish our priorities and to implement strategies and action plans to make our vision and ambitions a reality. We must do more than periodically revisit, review, and revise our priorities. Their importance demands a continuing commitment and action. But we seem to never have enough time or resolve to make that commitment.
In Charles Hummel's essay, "Tyranny of the Urgent," he observes, "The issue is not so much a shortage of time as a problem of priorities." Certain of the challenges that require our urgent attention can also be identified as priorities for our profession. However, some other seemingly urgent matters do not rise to a level of importance that we should permit them to interrupt and compromise our commitment to actively address our priorities.
What are the highest priorities for our profession? Opinions differ but, perhaps, not to the extent we might initially assume. In this editorial I have identified the priorities that I consider to be the most important for our profession. They are all important but I have ranked them in what I consider to be their relative importance, with the first being the most important.
1. Commitment, passion, and activism of individual pharmacists
Many pharmacists are apathetic or even negative about their individual responsibilities/employment and the profession. Tens of thousands of pharmacists are not members of even one professional association. Every pharmacist should accept a responsibility to give something back to our profession from which the vast majority of us have derived a good livelihood. Ideally, giving back should be motivated by our enthusiasm for and pride in our profession. However, apathy toward or criticism of the profession is not a valid excuse for failing to contribute to efforts to make our profession better.
The success of the profession in addressing its priorities can only result from its strength, made possible by the collective commitment and activism of its members as individuals.
I have a responsibility! You have a responsibility!
2. Effective organizational structure
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. Most, if not all, of our pharmacy organizations give primary or exclusive attention to self-preservation and growth of its own membership, programs, and finances. As important as these things are, not enough attention is being given to identifying and taking action on the issues that are of the greatest importance for the profession.
3. Vision for 2015
In late 2004 the Joint Commission of Pharmacy Practitioners (JCPP), comprised of the leaders of the national pharmacy organizations, developed the following vision statement that was endorsed the following year by all of the major pharmacy practitioner organizations:
"Pharmacists will be the health care professionals responsible for providing patient care that ensures optimal medication therapy outcomes."
This vision statement is followed by a discussion titled, "Pharmacy Practice in 2015," that embraces the patient-centered role of the pharmacist, and pharmacists doing in practice what we have long been saying we are capable of doing (i.e., "walking the talk").
The development of this vision statement is a bold initiative from which patients and the profession of pharmacy can greatly benefit, and which demonstrates a positive outcome when our national professional organizations work with each other.
We can identify numerous patient-centered practice accomplishments of individual pharmacists and individual associations. However, these accomplishments are for the most part isolated and few in number compared with the potential that exists. Although the year 2015 is a goal and not a rigid deadline, it is appropriate to assess what progress has been made.
At a recent meeting of approximately 30 pharmacists, most of whom were recent graduates, I asked how many could state in general terms, "Pharmacy's vision for 2015." No one raised her/his hand. I do not fault these pharmacists for not being familiar with the vision. Rather, it is our professional organizations and colleges of pharmacy that are not communicating it adequately, or at all.
If the vision for 2015 is as important as many of us think it is, the organizations and colleges must be held accountable in communicating it and assuming much greater responsibility in its implementation.
Pharmacy's vision for 2015 is followed by a discussion that addresses "The Foundations of Pharmacy Practice," "How Pharmacists Will Practice," and "How Pharmacy Practice will Benefit Society." However, there is little evidence that the organizations that developed the vision have communicated or worked together to develop strategies or action plans that will enable/facilitate their members and networks of pharmacists in implementing the vision.
There is a saying that those who fail to plan, plan to fail. The vision for 2015 is so bold and so different from what the public, other health professionals, and legislators are accustomed to receiving (or not receiving) in the way of pharmacists' services and counseling today, that strategies and comprehensive plans must be developed. One of the important topics to be addressed in the planning process is the establishment of financial models that will provide appropriate support for pharmacists who provide the services that are consistent with the vision of 2015.
5. Communication and collaboration with other
Just as it is very important that there be more effective communication and collaboration within the profession of pharmacy, it is also essential that this occur between pharmacists and their professional organizations with their counterparts in the other health professions with which we work most closely. Although some might anticipate contentiousness and "turf battles," I am of the belief that the challenges of improving the health care of patients and avoiding drug- and other health-care related problems can be best met by closer working relationships between the health professionals involved in patient care. As an important step in this direction, pharmacists should be certain that they are communicating effectively with other pharmacists involved in the care of patients (e.g., when being admitted to or discharged from the hospital).
Self-assessment - what grades have we earned?
It is appropriate that we assess our progress as individual pharmacists and as professional organizations in addressing these priorities. Please use the traditional academic grading system of A, B, C, D, and F in responding to the following questions.
What grades do you give yourself as an individual pharmacist with respect to priorities 1, 3, and 5 (as applicable)?
What grades do you give the national professional organization with which you are most closely associated with respect to priorities 1, 2, 3, 4, and 5?
I have limited this discussion to the consideration of 5 priorities. There are dozens of other issues that are of importance to individual pharmacists and the profession of pharmacy. Paramount among these are prescription benefit programs and their inequities for pharmacists and disservices to patients, and I have discussed these in detail in previous editorials, and will continue to do so. I recognize that if pharmacists are not compensated equitably, they will not be available to provide the scope and quality of professional services for which I am an advocate and that are the centerpiece of the vision for 2015. This is why I identify the establishment of financial models as an essential component of the plans to be developed for the implementation of the vision for 2015.
Sometimes, however, we allow the most current problem, injustice, or outrage (i.e., the urgent matters) to dominate our attention and actions to the extent that we do not give enough attention to the priorities for the profession that, in the larger picture, are of even greater importance with respect to the quality of care we provide for patients and for the advancement of our profession. If we can be highly successful in addressing these five priorities, I am confident that many of the other issues will also be resolved concurrently. The "tyranny of the urgent" must not be permitted to compromise our commitment to these priorities!
Daniel A. Hussar
New Drug Review
(Picato - LEO)
Agent for Actinic Keratosis
New Drug Comparison Rating (NDCR) = 4
in a scale of 1 to 5, with 5 being the highest rating
For the topical treatment of actinic keratosis.
Fluorouracil (topically applied; e.g., Carac).
- Much shorter duration of treatment (2-3 days, compared with weeks [e.g., 4 weeks] of treatment with fluorouracil);
- Less risk during pregnancy (Pregnancy Category C, compared with Category X for fluorouracil).
Most important risks/adverse events:
- Labeled indications are more limited (fluorouracil is also indicated for topical treatment of superficial basal cell carcinoma).
Eye disorders (e.g., severe eye pain, eyelid edema) may occur after exposure (patients should avoid transfer of the drug to the periocular area during and after application, and should wash hands well following application; if accidental exposure of the eyes occurs, area should be flushed with water and medical care should be obtained); severe skin reactions in the treated area (product should not be applied until the skin is healed from previous drug or surgical treatment).
Most common adverse events (with the incidence in patients with actinic keratoses of the face and scalp):
Erythema (94%), flaking/scaling (85%), crusting (80%), swelling (79%), vesiculation/pustulation (56%), erosion/ulceration (32%).
Actinic keratosis on the face and scalp - 0.015% gel applied to the affected area once a day for 3 consecutive days: actinic keratosis on the trunk and extremities - 0.05% gel applied to the affected area once a day for 2 consecutive days; following application, the gel should be allowed to dry for 15 minutes; patients should avoid washing and touching the treated area for a period of 6 hours after application; following this time, patients may wash the area with a mild soap.
Gel - 0.015%, 0.05% in unit-dose tubes (should be stored in a refrigerator).
Actinic keratosis is a dry, scaly skin lesion that forms following cumulative exposure to ultraviolet light, such as sunlight. Often called sun spots and/or age spots, they are the most common precancerous condition and have the potential to progress to squamous cell carcinoma, the second most common type of skin cancer. The treatment of actinic keratoses has included cryosurgery, photodynamic therapy, and the topical application of medications such as fluorouracil, imiquimod (e.g., Aldara), and diclofenac (e.g., Solaraze). However, treatment with these agents must be continued for weeks to months.
Ingenol mebutate is the active component in the sap of a plant that has been used topically as a remedy for various skin lesions. It is an inducer of cell death although the specific mechanism by which it exhibits this action is not fully understood. The effectiveness of ingenol mebutate in the topical treatment of actinic keratoses was demonstrated in vehicle-controlled studies. In the studies of patients with lesions on the face and scalp, 60-68% of those treated with ingenol mebutate experienced a 75% or greater reduction in existing lesions, compared with 7-8% of those treated with the gel vehicle. Of those treated with the new drug, 37-47% experienced complete clearance of the lesions. In the studies of patients with actinic keratoses on the trunk and extremities, 44-55% of those treated with ingenol mebutate experienced a 75% or greater reduction in lesions, compared with 7% of those treated with the gel vehicle. Twenty-eight to 42% of the patients experienced complete clearance of the lesions.
Almost all patients experience dermatologic adverse events. Other agents such as fluorouracil that are used topically for the treatment of actinic keratoses are also often associated with dermatologic effects. The much shorter treatment regimen for ingenol mebutate provides greater convenience of administration and patients are more likely to be compliant in completing the 2- or 3-day course of treatment.
Daniel A. Hussar