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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.

January 2016 Issue [Download PDF format]
In this issue:
EditorialNew Drug Review
EDITORIAL:

A New Year – An Old Theme

Pharmacy Must Have a More Effective Organizational Structure!
The United Pharmacists of America

For many years—no, it is now decades—I have been an advocate for a more effective organizational structure for the profession of pharmacy (please see my editorial with a similar title in the January 2011 issue of The Pharmacist Activist and my editorial, "The APhA and ASHP should Merge" [January 2013 issue]). Although my recommendations have been ignored by those who are in positions to provide leadership in this direction, I would contend that the need for a more effective organizational structure has become even greater and more urgent. The need for action must receive a higher priority.

I wish to be clear regarding what this editorial is NOT. It is NOT a criticism of specific organizations or the individuals who serve as the employed, elected, and/or volunteer leaders of these organizations. Indeed, we are indebted to these individuals for the expertise, leadership, service, and time they have committed on behalf of our profession and that have resulted in important accomplishments. However, in my opinion, the challenges, problems, and threats facing our profession are occurring with greater strength and at a faster pace that exceeds our efforts to effectively respond and successfully develop additional opportunities. At the same time, many local associations of pharmacists are no longer active and many state pharmacy associations are weak, primarily as a consequence of low membership and inadequate resources.

Many of the national pharmacy associations can claim to be strong and effective, but even some of these associations have faced challenges in recent years to an extent that reductions in staff have been necessary. As an association faces such challenges, there is a natural tendency to give priority to efforts that will strengthen its own membership, resources, and services, and perhaps even include attention to a strategy for survival. These situations increase the likelihood that the associations will be competing with each other for pharmacist members and with respect to the programs and services they provide (e.g., educational programs and publications, legislative activities). Instead of working with each other in the interest of advancing the entire profession, priority may be given to activities that will protect and promote the interests of an individual association, with the risk of competition and fragmentation of effort within the profession rather than unification that could be in the best interest of the entire profession.

"Pharmacy's Vision for 2015" provides an example of what can be accomplished when the national pharmacy associations work together, and what can happen when they are not working closely together or not participating in an organizational structure that would require a continued and shared commitment to fulfill the vision (please see my editorial in the March 2015 issue of The Pharmacist Activist). In 2004 officers of 15 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 addresses "The Foundations of Pharmacy Practice," "How Pharmacists Will Practice," and "How Pharmacy Practice Will Benefit Society." This vision statement and the supporting discussion are both bold and progressive, and have the potential to be of great value for patients, society, and the profession of pharmacy. It was also very encouraging that 15 national pharmacy organizations collaborated and agreed to the vision statement.

The year 2015 has come and gone. Has Pharmacy's vision for 2015 become a reality? The answer is "No." Although there have been some noteworthy accomplishments of individual pharmacists and the national associations during the last 10 years, we are not even close to attaining our vision of ensuring optimal medication therapy outcomes for patients.

What happened? The great importance and anticipated benefit of convening 15 national pharmacy organizations in 2004 and having them agree on the vision statement can't be overstated. However, in the years that followed, the individual associations gave priority to their own agendas and did not communicate and work with each other to an extent that would result in the vision for 2015 being fulfilled. The failure or lengthy delay in attaining this vision has very important implications for the profession of pharmacy, and I am not optimistic that the existing, fragmented organizational structure will be effective in accomplishing in a widespread and effective manner what needs to be done for the benefit of patients and the profession of pharmacy. We need to take action to develop a single, unified, and strong organizational structure for pharmacy! A preliminary proposal for consideration follows:

The United Pharmacists of America (UPA)

The United Pharmacists of America (UPA) is suggested as the preliminary name for the new organizational structure. The organization would include academies and other groups based on professional responsibilities and other interests. Officers would be elected by the entire membership, and additional members of a Board of Directors would be elected to represent the academies and other member groups. A House of Delegates with appropriate representation of the entire membership would be the policy-making body for the organization. Academies and other membership groups would include, but not be limited to, the following areas of practice and interest:

Academies
(based on primary position and/or type of practice)

  • Community pharmacists (chain)
  • Community pharmacists (independent)
  • Compounding pharmacists
  • Faculty pharmacists
  • Health-system pharmacists
  • Information/communications pharmacists
  • Long-term care pharmacists
  • Mail-order pharmacists
  • Managed care pharmacists
  • Military pharmacists
  • Pharmaceutical scientists
  • Pharmacist attorneys
  • Public Health Service pharmacists
  • Residents and Fellows
  • Specialty pharmacy
  • State/regional association pharmacist executives
  • Student pharmacists

Academies with specialty recognition

  • Ambulatory care pharmacists
  • Critical care pharmacists
  • Nuclear pharmacists
  • Nutrition support pharmacists
  • Oncology pharmacists
  • Pediatric pharmacists
  • Pharmacotherapy
  • Psychiatric pharmacists

State associations

Cultural and/or ethnic groups

  • African-American pharmacists
  • Chinese-American pharmacists
  • Indian-American pharmacists

Fraternal and honorary groups

  • Kappa Epsilon
  • Kappa Psi
  • Lambda Kappa Sigma
  • Phi Delta Chi
  • Phi Lambda Sigma
  • Rho Chi
  • Rho Pi Phi

Religious groups

  • Catholic pharmacists
  • Christian pharmacists
  • Jewish pharmacists
  • Muslim pharmacists
Although this list of suggested academies and other groups is long, there are probably some that have inadvertently not been included. I welcome the identification of additional areas of practice and interest with which pharmacists are involved. A pharmacist's primary membership in the new organization (UPA) would be in the academy based on her/his position and type of practice. Secondary memberships could be held in an academy with specialty recognition and other groups based on her/his interests.

The House of Delegates of UPA would be the policy-making body of the organization and the Officers/Board of Directors would be the governing body. Certain academies would have a large enough membership and scope of interests to have multiple divisions (e.g., special interest groups) and a structure that would facilitate the development of positions on selected issues. It is likely that certain existing national associations with a particular type of practice responsibilities could become the corresponding academy in UPA. For example, the National Community Pharmacists Association could be the academy for independent community pharmacists, the American Society of Consultant Pharmacists could be the academy for long-term care pharmacists, and the American Society of Health-System Pharmacists could be the academy for health-system pharmacists.

Many pharmacists are very frustrated that our profession and organizations have not been more effective in addressing serious challenges that exist, and that we have not made more progress in obtaining recognition of the value of the services pharmacists can provide and compensation for these services. I anticipate that many pharmacists who are currently members of our national pharmacy associations would be very enthusiastic about the concept of a new organizational structure that would offer the potential of a single, unified, and strong organization representing our profession. Many of the tens of thousands of pharmacists who are not members of any national pharmacy organization now would also be enthusiastic about this potential and would join this initiative.

I also anticipate that most of the current national organizations will not be interested in considering a new organizational structure for the profession because of a fear of reduced authority, autonomy, and strength for their organizations and the area of practice they represent. However, individually and collectively, our national associations have not been effective enough in protecting and advancing our profession. It is the profession of pharmacy that provides the foundation from which focused and specialty areas of practice can develop and thrive. However, if the foundation is weakened, it is only a matter of time until the activities that depend on the foundation are also weakened. Therefore, all pharmacists and pharmacy associations must recognize a responsibility to increase the strength and effectiveness of our entire profession. The organizational status quo is no longer acceptable.

The Joint Commission of Pharmacy Practitioners (JCPP) provides the forum in which leaders of the national pharmacy organizations convene to discuss pertinent issues. It was under the auspices of the JCPP that leaders convened in 2004 and developed "Pharmacy's Vision for 2015." I urge the JCPP to give high priority to considering the development of a new organizational structure for the profession. We must make the laudable vision a reality!

Daniel A. Hussar

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NEW DRUG REVIEW:

Secukinumab
(Cosentyx – Novartis)
Agent for Psoriasis

New Drug Comparison Rating (NDCR) = 4
(significant advantages)

in a scale of 1 to 5, with 5 being the highest rating

Indications:
Administered subcutaneously for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy; (has been subsequently approved for the treatment of patients with psoriatic arthritis or ankylosing spondylitis).

Comparable drugs:
Ustekinumab (Stelara), etanercept (Enbrel).

Advantages:
  • Is more effective (based on limited comparative studies);
  • Has a unique mechanism of action (is an interleukin-17A antagonist);
  • Is administered less frequently (compared with etanercept that is administered once a week for maintenance treatment).
Disadvantages:
  • Two injections are needed for administration of the usual 300 mg dose;
  • Is administered more frequently (compared with ustekinumab that is administered every 12 weeks for maintenance treatment);
  • Labeled indications are more limited (compared with ustekinumab that is also indicated for the treatment of patients with psoriatic arthritis, and etanercept that is also indicated for the treatment of patients with psoriatic arthritis, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and ankylosing spondylitis).
Most important risks/adverse events:
Risk of infection (if a serious infection develops during treatment the drug should be discontinued until the infection resolves; in patients with a chronic infection or history of a recurrent infection, use of secukinumab should be carefully evaluated); exacerbation of tuberculosis (patients should be evaluated for tuberculosis infection prior to initiating treatment); exacerbation of active Crohn's disease; hypersensitivity reactions (prefilled syringes and the removable cap of the pen device contain natural rubber latex that may cause a reaction in latex-sensitive individuals); live vaccines should not be administered during treatment; non-live vaccinations administered during treatment may not elicit an immune response sufficient to prevent disease.

Most common adverse events:
Nasopharyngitis (11%), diarrhea (4%), upper respiratory tract infection (3%).

Usual dosage:
Administered subcutaneously – 300 mg at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks; each 300 mg dose is given as two subcutaneous injections of 150 mg.

Products:
Single-use prefilled syringes and single-use Sensoready pen – 150 mg/mL; single-use vial – 150 mg as a lyophilized powder requiring reconstitution (should be prepared and reconstituted by a healthcare provider; product labeling should be consulted for specific recommendations); products should be stored in a refrigerator.

Comments:
Interleukin-17A (IL-17A) is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. It is present in elevated concentrations in psoriatic plaques. Secukinumab is a human monoclonal antibody that selectively binds to IL-17A and inhibits its interaction with IL-17 receptors, thereby inhibiting the release of proinflammatory cytokines and chemokines. Its effectiveness was demonstrated in four placebo-controlled trials that included more than 2,400 participants. The primary endpoints were a reduction in the Psoriasis Area and Severity Index (PASI) score of at least 75% (PASI 75) from baseline to week 12 and treatment success (clear or almost clear) on the Investigator's Global Assessment after 12 weeks of treatment. In the four studies, between 75% and 87% of patients treated with 300 mg doses of secukinumab attained a PASI 75, compared with 3% or fewer of the patients who received placebo. In one study, some patients were treated with etanercept, and a significantly larger number of patients treated with secukinumab attained the endpoints. In a preliminary study, secukinumab has also been reported to be more effective than ustekinumab.

Daniel A. Hussar
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