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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 2014 Issue [Download PDF format]
In this issue:
New Drug Review
We Will Try Resolutions Again but Pharmacy May Need a Revolution!
For many individuals and organizations, the arrival of a new year is the time to determine resolutions to be accomplished. Although I have not designated them specifically as "resolutions," some of my editorials in The Pharmacist Activist have addressed what I consider to be the priorities for our profession of pharmacy (please see "The 'Tyranny of the Urgent' Must Not Compromise our Commitment to our Priorities," [May 2012 issue] and "Priorities for our Profession" [February 2011 issue] of The Pharmacist Activist).
Most of the priorities/resolutions I have identified in earlier editorials have been recognized as challenges for decades and could be recited on an annual basis. As I again read the two editorials mentioned above, my assessment is that there has been very little progress made in addressing important issues. I accept my share of the responsibility for this limited progressI need to do more!
I recognize that pharmacists and the leaders of our profession do not have any obligation to read or agree with anything I write or recommend. And often they don't. There can very well be concerns and priorities that are more important than the ones that I identify, and/or I may not be clear enough, persuasive enough, or bold enough in communicating my recommendations. However, I continue to contend that there are challenges that pharmacy must effectively and urgently address. This time I will call them "Resolutions" and many of my comments that follow will be very familiar. I have limited this commentary to five areas. There are many more that are also deserving of our attention. They are provided for the purpose of generating discussion, action, and better ideas and recommendations.
Resolutions for pharmacy
The list goes on but these five resolutions will suffice for now. Not only are they important but there is an urgent need to be effective in addressing them. Changes in health care are occurring at an unprecedented pace. If we are not successful in responding to these challenges soon, a revolution in our profession will be needed!
- Individual pharmacists must demonstrate more commitment, passion, and activism on behalf of our profession. It starts with me/us! What have we done as individuals to advance our profession and to address the problems that exist? If we have done nothing, we forfeit our right to complain about or criticize what others are doing or not doing. We must start by being members and, optimally, active participants in our professional associations. In my opinion, every pharmacist and pharmacy student should be a member of the American Pharmacists Association, the one national pharmacy organization that is positioned to represent the entire profession. We also have a responsibility to be members of the state and local associations of pharmacists that represent the entire profession. In addition, there are many other associations with focused/specialized programs and services in which membership and participation will be of great value for pharmacists with specific practice interests and responsibilities.
I strongly encourage not only involvement but activism of pharmacists as individuals in programs and initiatives that will promote and advance our profession. However, as active as we may be as individuals, our sphere of influence is limited, and the resources and strength of associations with a large membership is essential.
- Our national pharmacy associations must be more effective and more accountable. Our profession needs an organizational structure that will serve and advance the interests of pharmacy in a much more effective manner than is being accomplished through our current system. Our national associations give primary or exclusive attention to self-preservation and growth of their individual 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 as a whole. Indeed, it often appears as if the national associations are competing with each other more than they are collaborating with each other.
Our national associations and our leaders need to be more accountable by responding to concerns experienced by tens of thousands of practicing pharmacists such as understaffed and stressful workplace environments that increase the risk of errors and harm to patients. Issues such as the abuse and overdose deaths from prescription products containing hydrocodone or oxycodone cry out for leadership and initiatives that will greatly reduce these tragedies. But how does pharmacy respond? With conflicting opinions from the national organizations as to whether hydrocodone combination products should be transferred from Schedule III to Schedule II. Our profession and the public deserve better!
The importance of building the strength and effectiveness of pharmacy at the national level can't be overstated, as this will also be essential for success with respect to the following resolutions.
- The Vision for 2015 must be implemented. In late 2004 the Joint Commission of Pharmacy Practitioners (JCPP), comprised of the leaders of the national pharmacy associations, developed the following vision statement that was endorsed by all of the major national 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. This is a bold initiative from which patients and the profession of pharmacy can greatly benefit, and which demonstrates a positive outcome when our national associations work with each other.
The year 2015 is a goal and not a rigid deadline. However, we are only one year away from 2015, and it is appropriate to assess what progress has been made over the last 10 years. There are 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 what needs to be done to implement the vision. What happened to the progressive vision for which there was such agreement in 2004? It would appear that the national associations that developed the vision statement did not continue to collaborate, but went their separate ways. They should be accountable in explaining why there has not been substantive progress in working together and attaining this vision. Instead, the priority of the JCPP appears to be to revise the vision statement. The new statement is reported to be:
"Patients achieve optimal health and medication outcomes with pharmacists as essential and accountable providers within patient-centered,
team-based health care."
Will JCPP be accountable to pharmacists in describing its lack of involvement/progress in attaining the vision for 2015? Will the national associations be as accountable with respect to their responsibility in attaining the revised vision as they are in expecting their members to be accountable in providing the health care described?
- The profession of pharmacy must establish a model prescription benefits and services program. The vast majority of prescription benefit programs administered by pharmacy benefit managers, insurance companies, and government agencies are seriously flawed. They fall far short in using the knowledge and skills of pharmacists and in assuring optimal effectiveness and safety of drug therapy for patients. Numerous efforts to improve these programs have failed, and many programs are getting worse. We can't depend on others to design a program that will assure the quality of medications and the services of pharmacists that will also be cost-effective. We must do it ourselves!
Many of our national pharmacy associations do not presently provide a prescription benefit program for their own employees that includes the services and other quality measures that they expect their pharmacist members to provide to patients. This situation should be given immediate attention. The national associations should work together to identify the resources and expertise needed to establish a model prescription benefit program and network of participating pharmacists in the Washington, D. C. area. This program would first be made available to employees of the national pharmacy associations. As soon as possible, it should be made available to legislators and government officials and their staffs. There would be a considerable cost to establish such a program but I can't think of a more important investment for our national associations. I have full confidence that the quality and value of such a program would be quickly recognized and publicized to the extent that others would also adopt it.
- The profession of pharmacy must do much more to provide fulfilling employment opportunities. Several factors (e.g., national economic challenges, many new colleges of pharmacy) have converged to create a situation in which many pharmacists are having difficulty in obtaining employment. Colleges of pharmacy and the pharmacy associations must do much more to assist pharmacists in obtaining positions. Some contend that when the Vision for 2015 is implemented there will be a shortage of pharmacists. However, that is not the reality now and will not be soon. But it does provide all the more reason to move as quickly as possible to implement the Vision.
Additional strategies must be developed to assist pharmacists and students who will be graduating soon to have fulfilling employment responsibilities. For example, two independent pharmacies might each fund one-half of a full-time position. Also important is the recognition that some employers of pharmacists will reduce the staffing of pharmacies with the expectation that pharmacists will not leave because employment may not be available elsewhere. It is very difficult for employee pharmacists to challenge management regarding understaffing or a stressful workplace environment because they might be placing their job at risk. The pharmacy associations and colleges of pharmacy have a responsibility to do more to assist pharmacists in obtaining employment in which they can provide the expertise and services that patients need.
Daniel A. Hussar
NEW DRUG REVIEW:
New Drug Comparison Rating (NDCR) = 3
(Brintellix - Lundbeck; Takeda)
(no or minor advantages/disadvantages)
in a scale of 1 to 5, with 5 being the highest rating
Treatment of major depressive disorder.
Other serotonin reuptake inhibitors (e.g., selective serotonin reuptake inhibitors [SSRIs]; escitalopram [e.g., Lexapro] is the specific agent to which comparisons are made).
- In addition to inhibiting serotonin reuptake, has a unique combination of actions on multiple serotonin receptor types;
- May be more effective in some patients (however, the contribution of its additional actions on serotonin receptors has not been established and the clinical relevance is not known);
- May be less likely to cause sexual dysfunction.
Most important risks/adverse events:
- Has not been directly compared with other antidepressants in clinical studies;
- Labeled indications are more limited (escitalopram is also indicated for the treatment of generalized anxiety disorder, and fluoxetine, paroxetine, and sertraline have multiple additional labeled indications);
- Has not been evaluated in patients less than 18 years of age (whereas escitalopram is indicated in the treatment of depression in adolescent patients aged 12-17 years);
- Interacts with CYP2D6 inhibitors (e.g., quinidine) and CYP inducers (e.g., carbamazepine);
- Dosage titration is needed.
Risk of suicidal thinking and behavior in children, adolescents, and young adults to 24 years (boxed warning); concurrent use with a monoamine oxidase inhibitor (MAOI; e.g., tranylcypromine, linezolid [Zyvox], intravenous methylene blue) is contraindicated (an MAOI for the treatment of a psychiatric disorder should not be initiated within 21 days after stopping treatment with vortioxetine); serotonin syndrome (risk is increased by the use of other agents having serotonergic activity (e.g., SSRIs and certain other antidepressants, triptans, tramadol, tryptophan, St. John's wort); activation of mania/hypomania; hyponatremia; abnormal bleeding (risk is increased in patients being treated with an anticoagulant, aspirin, or an NSAID); may cause CNS effects and patients should not engage in potentially hazardous activities until they have observed how the medication affects them; action may be increased by the concurrent use of a strong CYP2D6 inhibitor (e.g., bupropion, quinidine) and decreased by a strong CYP inducer (e.g., carbamazepine, rifampin).
Most common adverse events
(and incidence reported with a dosage of 20 mg once a day):
Nausea (32%), dizziness (9%), vomiting (6%), constipation (6%).
Recommended starting dosage - 10 mg once a day; should be subsequently increased to 20 mg once a day as tolerated; in patients known to be CYP2D6 poor metabolizers, the maximum recommended dosage is 10 mg once a day; dosage should be reduced by one-half in patients treated with a strong CYP2D6 inhibitor; discontinuation of treatment with dosages of 15 mg or 20 mg a day should involve an initial reduction of dosage to 10 mg once a day for one week.
Tablets - 5 mg, 10 mg, 15 mg, 20 mg.
The primary mechanism of vortioxetine is inhibition of serotonin (5-HT) reuptake. In addition, it acts as an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors, and an antagonist at 5-HT3, 5-HT1D, and 5-HT7 receptors. It is the only antidepressant with this combination of actions at serotonin receptors, but the contribution of any of these additional actions to the antidepressant effect has not been established. Its effectiveness has been demonstrated in 6 placebo-controlled, short-term studies, one of which was conducted in elderly patients. In addition, it was evaluated in a long-term study in which its use resulted in a longer time to recurrence of depressive episodes, compared to placebo.
Daniel A. Hussar