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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.
September 2008 Issue
APhA's Executive Search
New Drug Review
Click Here to download PDF format
North Dakota has it
Challenges to its Pharmacy Ownership Law must be Rejected!
North Dakota has a law regarding the ownership of pharmacies that is unique among all the states. Many within our profession are not even aware of it. This law requires that the majority ownership of pharmacies must be held by licensed pharmacists. The question that almost immediately follows this observation is, "What about chain pharmacies?" The answer is that publicly-held chain pharmacies may legally operate in North Dakota but there must be a contractual arrangement through which pharmacists must have majority ownership of the pharmacy department within the store.
In my opinion, the extent to which corporations own pharmacies at the present time is the most important reason for which pharmacy has lost control of its destiny. These corporations are typically managed by executives, most or all of whom are not pharmacists and who are beholden to their boards and stockholders. Although some chain pharmacies have developed programs that expand the professional role of pharmacists for the benefit of patients and the community, these initiatives are often limited in scope and duration rather than representing an ongoing chain-wide commitment. My sense is that such commitments are not likely to be made by these corporations unless they anticipate that it will be financially beneficial. We all know how difficult it is to attain equitable compensation for the dispensing of prescriptions. Being compensated fairly for the provision of additional professional services represents such a formidable challenge that most chains and some pharmacist owners do not pursue offering additional services from which their patients will benefit. However, for a pharmacist owner, there is often more of a professional incentive to be a leader in the community, not only in the provision of pharmacy services, but also as an active participant in business and civic activities from which the entire community and state benefit.
There have been previous challenges to North Dakota's pharmacy ownership law, and there are challenges now from organizations such as Wal-Mart and Walgreens. However, North Dakota's law serves its citizens well, and the legislators and governor must reject the challenge to the current ownership law! In addition to the reasons identified above, permitting these corporations to fully own the pharmacies in their stores would result in more revenues leaving the state to their corporate headquarters elsewhere. There are also questions regarding the commitment of some of these large retail organizations to the provision of the scope and quality of pharmacy/health care services that should be expected. In a Boston Globe editorial (September 7, 2008), the CEO of Walgreens is quoted as having told analysts in May that - "One thing I'd like to make clear is we are definitely not becoming a healthcare company... If you're going to go into a store, and you're going to see various accessories - it could be toys, it could be candy, cosmetics..." Not only is this executive not promoting a healthcare identity for Walgreens, but his comments send a message that he wants to avoid such an identity. This corporate philosophy/attitude is not needed in the ownership and operation of North Dakota pharmacies.
One of the arguments put forth by those challenging the North Dakota law is that the other states permit them to own pharmacies and that North Dakota should have laws like those in these other states. My response is - The other states should have laws like those in North Dakota.
Daniel A. Hussar
APhA's Executive Search
John Gans has announced his plan to retire in 2009 from his position as Executive Vice President of the American Pharmacists Association (APhA). The search process that will lead to the appointment of the individual to succeed him in this position is well underway. The candidates being considered for the position have not been identified. I am not involved in the search process but I have found myself thinking about the following personal qualities, credentials, and experiences that I feel should be given the highest priority as candidates are being considered for this very important position.
INTEGRITY - The successful candidate must have demonstrated a strong commitment to professional and personal integrity. There are numerous examples of fraud and other major problems experienced by a corporation or other organization that have resulted from a lack of integrity on the part of the chief executive. If there is reason to doubt one's truthfulness with respect to one activity or responsibility, there will also be questions as to whether integrity will be demonstrated in their other responsibilities.
COURAGE - Although the APhA House of Delegates establishes policy and the Board of Trustees also has important responsibilities, the chief executive will face situations in which difficult decisions will need to be made. The courage to make the best, rather than an expedient, decision is essential.
PASSION FOR THE PROFESSION - An early decision was made by the APhA Board that the executive vice president must be a pharmacist. The successful candidate should demonstrate a passion for the profession in a manner that is encouraging and motivating for members and colleagues, as well as pharmacists who are not yet members of APhA.
RESPECT - The successful candidate should demonstrate respect toward others and be receptive to considering the observations and recommendations of others. He/she should have earned the respect of colleagues and others with whom there has been interaction in professional and personal capacities.
LEADERSHIP - In addition to having the needed administrative/management abilities, the individual should demonstrate leadership qualities.
The demonstration of the qualities identified above will position the individual well to be successful in fulfilling the responsibilities of the chief executive. Several of these responsibilities are particularly important:
There are other qualities and abilities that are also important but the ones identified above should provide a strong start in identifying the best candidate. I wish the search committee and the APhA Board of Trustees success in reaching this decision that will have such an important influence on the future of APhA and the profession of pharmacy.
- The individual must demonstrate excellent communication skills.
- The individual must demonstrate a commitment to advance and expand the role of pharmacists in the provision of medications and monitoring their use in a manner that will optimize effectiveness and increase safety.
- The individual must demonstrate a commitment to emphasize the value of the counseling and services provided by pharmacists to patients, and the importance of these services being personalized and provided in face-to-face discussions between pharmacists and patients.
Daniel A. Hussar
New Drug Review
(Kuvan - BioMarin)
Agent for Phenylketonuria
New Drug Comparison Rating (NDCR) = 5
in a scale of 1 to 5, with 5 being the highest rating
To reduce blood phenylalanine concentrations in patients with hyperphenylalaninemia due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria; used in conjunction with a phenylalanine-restricted diet.
- First drug to be approved for the reduction of phenylalanine concentrations for patients with phenylketonuria.
Most important risks/adverse events:
- Only available through a restricted distribution program.
Blood phenylalanine concentrations should be monitored during treatment; women who are treated with the drug during pregnancy are encouraged to enroll in a patient registry; should be used with caution in patients who are also being treated with drugs that inhibit folate metabolism (e.g., methotrexate), drugs that affect nitric oxide-mediated vasorelaxation (e.g., PDE-5 inhibitors [sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra)]), and levodopa.
Most common adverse events:
Headache (15%), upper respiratory tract infection (12%), rhinorrhea (11%), pharyngolaryngeal pain (10%), diarrhea (8%), vomiting (8%), cough (7%).
10 mg/kg/day administered once a day; should be administered with food to increase absorption; dosage may be adjusted within the range of 5 to 20 mg/kg/day based on the response to therapy (i.e., blood phenylalanine concentrations).
Tablets - 100 mg; tablets should be dissolved in 120-240 mL of water or apple juice and administered within 15 minutes.
Phenylketonuria (PKU) is an inherited disorder in which the activity of the enzyme phenylalanine hydroxylase (PAH) is deficient. PAH helps break down phenylalanine in the body and, when there is a deficiency of this enzyme, the increase in blood concentrations of phenylalanine results in an increased risk of neurologic and other problems. Tetrahydrobiopterin (BH4) is a cofactor for PAH, without which PAH does not function properly. Sapropterin is a synthetic form of BH4 that can activate residual PAH and decrease phenylalanine concentrations in some patients. Not all patients with PKU will respond to sapropterin and, in clinical trials, 20% to 56% of patients responded to treatment (BH4-responsive PKU). It is not possible to predict which patients will respond to sapropterin and the only way to know if a patient will respond is to initiate treatment with the medication and monitor blood phenylalanine concentrations. Patients who are treated with sapropterin must still be managed with a low-phenylalanine diet, and should have regular monitoring of blood phenylalanine concentrations.
Daniel A. Hussar