Core Entrustable Professional Activities in Clinical Pharmacology for Entering Residency: Value of Interprofessional Health-Care Teams in Medication Prescribing and Medication Error Prevention.

In recent years, health care has been increasingly delivered by interprofessional teams in the inpatient, outpatient, and transition-of-care arenas. For many reasons, effective communication between patient-centered care teams and patients is critically important in order to optimize care, ensure patient safety, and prevent medical and medication misadventures. In rapid-paced, high-stress medical environments, it is especially important to carefully evaluate the causes of all misadventures in a manner that avoids assigning blame and identifies the root causes and, through team activity, leads to development of remedies that reduce the likelihood of future misadventures. Using a series of illustrative cases, this paper seeks to bring attention to these issues and provide insights regarding some tools developed to assist in improving patient safety and effective team communication.

ACCP Clinical Pharmacist Competencies.

The purpose of the American College of Clinical Pharmacy (ACCP) is to advance human health by extending the frontiers of clinical pharmacy. Consistent with this mission and its core values, ACCP is committed to ensuring that clinical pharmacists possess the knowledge, skills, attitudes, and behaviors necessary to deliver comprehensive medication management (CMM) in team-based, direct patient care environments. These components form the basis for the core competencies of a clinical pharmacist and reflect the competencies of other direct patient care providers. This paper is an update to a previous ACCP document and includes the expectation that clinical pharmacists be competent in six essential domains: direct patient care, pharmacotherapy knowledge, systems-based care and population health, communication, professionalism, and continuing professional development. Although these domains align with the competencies of physician providers, they are specifically designed to better reflect the clinical pharmacy expertise required to provide CMM in patient-centered, team-based settings. Clinical pharmacists must be prepared to complete the education and training needed to achieve these competencies and must commit to ongoing efforts to maintain competence through ongoing professional development. Collaboration among stakeholders will be needed to ensure that these competencies guide clinical pharmacists' professional development and evaluation by educational institutions, postgraduate training programs, professional societies, and employers.

Hormone-Related Migraine Headaches and Mood Disorders: Treatment with Estrogen Stabilization.

Because estrogens and the trigeminal system are inherently linked, prescribers who are treating a woman with a hormonally related mood disorder and migraine headaches should consider hormonal options to optimize the patient's treatment. This article discusses the interrelationships of estrogen, serotonin, and the trigeminal system as they relate to menstrual migraine occurrence and hormone-related mood symptoms. In addition, clinical examples are provided to facilitate the prescribers treating women during reproductive transitions in which declining estrogens are related to their suffering.

The association between comorbid anxiety disorders and the risk of stroke among patients with diabetes: An 11-year population-based retrospective cohort study.

BACKGROUND: Diabetes and anxiety disorders are independent risk factors for stroke. However, it remains unclear whether the risk of stroke is higher among diabetic patients with comorbid anxiety than without comorbid anxiety. Therefore, the purpose of this study was to investigate the association between comorbid anxiety and the risk of stroke among patients with diabetes. METHODS: This is a retrospective cohort study. We used the National Health Insurance Research Database in Taiwan to identify a diabetes cohort with a new diagnosis of an anxiety disorder but without a history of stroke. The enrollment period was 2001-2006 with up to 11 years of follow-up data. Comorbid anxiety was defined by both a clinical diagnosis of the DSM-IV (ICD-9-CM) and prescriptions for anxiolytic medications. Propensity score matching was performed to balance the selected confounders between the anxiety-exposed group and anxiety non-exposed group. Cox-propositional hazard regression models were used to evaluate the association between comorbid anxiety and the risk of stroke. RESULTS: Among patients with diabetes (N=40,846), an estimated 5.8% (N=2374) of patients had comorbid anxiety disorders. Diabetic patients with comorbid anxiety were significantly associated with a higher risk of stroke compared to patients without comorbid anxiety (hazard ratio: 1.33, 95% confidence interval: 1.02-1.72). LIMITATIONS: The severity of anxiety or diabetes could not be measured from the claims data. Residual confounding may still exist. CONCLUSION: A significantly elevated risk of stroke was observed in association with comorbid anxiety among patients with diabetes. Psychiatrists should consider routine screening for anxiety disorders to prevent a stroke event among patients with diabetes.

Selegiline transdermal system: use pattern and adherence in patients with major depressive disorder.

OBJECTIVE: To discern the pattern of use of selegiline transdermal system as well as the level of adherence relative to other pharmacotherapies for treatment of major depressive disorder. METHOD: Deidentified patient-level data (2010-2011; N = 2,985) were abstracted from US longitudinal archives (Medicaid, Medicare, managed care) in this retrospective exploratory claims-based analysis. Major depressive disorder was defined as ICD-9-CM codes 292.2, 296.3, 300.4, or 311. Antidepressant treatment failure was defined as receipt of < 90 days of initial antidepressant. RESULTS: Most patients received selegiline transdermal system as a second or third treatment option following treatment failure, and only 71 patients received it as first-line therapy. Patients were more likely to receive selegiline transdermal system for 60, 90, or 180 days compared to other therapies irrespective of treatment failure (P < .05). Among patients who did not fail treatment in the first 90 days, selegiline transdermal system was associated with a greater probability of receipt compared to selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors at 120 days (odds ratio [OR] = 1.21; 95% CI, 1.14-1.47) and 180 days (OR = 1.09; 95% CI, 1.01-1.28). CONCLUSION: Although limited by the small sample size of patients receiving selegiline transdermal system versus other pharmacotherapies, the results suggest that after antidepressant treatment failure, earlier use of selegiline transdermal system may be warranted.

MAOIs: issues in treatment adherence and rates of treatment failure.

Treatment guidelines recommend initiating newer antidepressants as first-line therapy for patients with depression, but response and remission rates remain low and multiple treatment trials are often needed. Adherence to medication affects response and remission rates, and nonadherence is common among patients with depression. While MAOIs have proven efficacy for depression, particularly for patients with treatment-resistant or atypical depression, this class of drugs is underprescribed due, in part, to concerns over dietary and drug restrictions that are required to avoid potential serious side effects. However, a newer MAOI formulation has an improved safety and tolerability profile and avoids or lessens the need for dietary restrictions, giving clinicians another option for treating patients who may be nonadherent or nonresponsive to their current antidepressant.

Issues in adherence to treatment with monoamine oxidase inhibitors and the rate of treatment failure.

In 2000, the economic burden of depression in the United States was estimated to be $83.1 billion. Although many effective treatments are available and treatment rates have increased, response and remission rates for patients with depression remain low and multiple treatment trials are often required. Whether patients are adherent to their medication affects response and remission rates, and nonadherence is common among patients with depression. Increasing adherence improves treatment outcomes and lowers treatment costs. Interventions that increase adherence include educational, behavioral, affective, and provider-targeted strategies; transdermal delivery of drugs also may increase adherence by simplifying the patient's medication regimen. While monoamine oxidase inhibitors (MAOIs) have proven efficacy for depression, particularly for patients with treatment-resistant or atypical depression, they are underprescribed due, in part, to concerns over dietary and drug restrictions that are required to avoid potential serious side effects. However, newer MAOI formulations, including a transdermal delivery system, have improved safety and tolerability profiles and avoid or lessen the need for dietary restrictions, giving clinicians another option for treating patients who may be nonadherent or nonresponsive to their current antidepressant.

Coverage of atypical antipsychotics among medicare drug plans in the state of washington: changes between 2007 and 2008.

OBJECTIVE: To examine changes in the cost and coverage of atypical antipsychotics among Medicare prescription drug plans and Medicare advantage plans in the state of Washington. METHOD: Coverage and cost data were obtained in February 2007 and 2008 from the Medicare Prescription Drug Plan Finder, an online database administered by the Centers for Medicare and Medicaid Services. Premiums, deductibles, out-of-pocket costs, and coverage limits were compared for prescription drug plans (PDPs) and for Medicare advantage plans (MAPs). RESULTS: The number of PDPs in the state of Washington fell slightly from 57 in 2007 to 53 in 2008, while the number of MAPs rose from 43 in 2007 to 52 in 2008. In 2008, the mean monthly drug premium increased by 15% among PDPs and by 20% among MAPs. Mean copayments for the majority of atypical antipsychotics increased from 2007 to 2008. More plans added quantity limits for atypical antipsychotics, but use of other pharmacy management tools varied by type of plan and antipsychotic. CONCLUSIONS: PDP and MAP participants in the state of Washington paid more for atypical antipsychotics in 2008 than they did in 2007. Affordability of atypical antipsychotics continues to be a concern, particularly for beneficiaries who are not eligible for Medicaid or the low-income subsidy.

The association between class of antipsychotic and rates of hospitalization: results of a retrospective analysis of data from the 2005 Medicare current beneficiary survey.

BACKGROUND: When second-generation antipsychotics (SGAs), also called atypical antipsychotics, were introduced in the 1990s, early research suggested that these drugs offered better tolerability and adherence than first-generation antipsychotics (FGAs), or typical antipsychotics. This presumably would reduce the need for hospital services. However, health research to test this hypothesis has focused mostly on psychiatric readmissions. OBJECTIVE: The objective of this study was to compare rates of all-cause hospitalization among patients receiving different classes of antipsychotics (SGAs, FGAs, both, or neither) in a large, all-ages sample of both institutionalized and noninstitutionalized Medicare beneficiaries. METHODS: We examined the 2005 Medicare Current Beneficiary Survey Cost and Use file for 11,236 survey participants. Antipsychotic utilization was characterized in terms of class: FGA (ie, chlorpromazine, fluphenazine, haloperidol, loxapine, perphenazine, thiothixene, thioridazine, or trifluoperazine) or SGA (ie, aripiprazole, clozapine, olanzapine, quetiapine, risperidone, or ziprasidone). Hospitalization was defined in terms of whether a Medicare beneficiary was admitted to the hospital for any reason in 2005, and was measured in terms of the number of hospital visits. In our final model, we included the following confounding variables: disability status (> or =1 limitation in activities of daily living), Rosow-Breslau impairment score (difficulty with walking, stooping, crouching, kneeling, or doing heavy housework), cognitive impairment (diagnosis of Alzheimer's disease or memory loss that interfered with daily activity), and health behavior variables (body mass index and smoking status). RESULTS: A total of 3.5% of Medicare beneficiaries (1.3 million) filled > or =1 prescription for an antipsychotic medication in 2005. Controlling for demographic, socioeconomic, health, and disability variables, SGA-only users were more than twice as likely (odds ratio [OR] = 2.2 [95% CI, 1.7-2.9]) and combination users were more than 6 times as likely (OR = 6.3 [95% CI, 2.4-16.2]) as nonusers to be hospitalized. The odds of FGA users being hospitalized were not significantly different from nonusers (OR = 1.4 [95% CI, 0.7-2.8]). CONCLUSIONS: This analysis yielded provocative, but by no means conclusive, evidence that SGAs as a class are not necessarily superior to FGAs in mitigating patient's use of hospital services under real-world conditions. Systematic analysis of this relationship with a large, multiple-year sample of Medicare beneficiaries is warranted.

Coverage of atypical antipsychotics among medicare drug plans in the state of washington for fiscal year 2007.

OBJECTIVE: To examine drug coverage and patient costs for 6 atypical antipsychotics (olanzapine, quetiapine, ziprasidone, aripiprazole, clozapine, and risperidone) in Medicare Part D formularies using health plan data from the state of Washington. METHOD: Fiscal year 2007 coverage and cost-sharing characteristics for 57 prescription drug plans (PDPs) and 43 Medicare advantage prescription drug plans (MAPDs) were collected from the Centers for Medicare and Medicaid Services. Plans were compared in terms of formulary restrictions, out-of-pocket costs, and premium charges. Medicare released plan information for fiscal year 2007 in October 2006. Data were collected for this study in February 2007. RESULTS: Almost all plans covered the 6 atypical antipsychotics. The PDPs were more likely to restrict coverage than the MAPDs. Prior authorization requirements were enforced in 5% to 21% of plans, depending on plan type and medication. Monthly drug plan premiums were higher for PDPs than MAPDs, but the MAPDs had concurrent monthly health premiums. About 80% of MAPDs and 60% of PDPs also had no annual deductible for medications. The patient out-of-pocket cost for atypical antipsychotics varied depending on the stage of coverage-median monthly drug costs ranged from $5 to $50 during the initial period, but if costs exceeded the annual cap, patients were responsible for the full cost of the drug, which ranged from $292 to $665. Patients with low incomes and those who exceeded the annual spending limit ($3850 in fiscal year 2007) had a median monthly cost of $17 to $33. CONCLUSION: There is considerable variation across health plans in terms of patients' out-of-pocket drug costs. Given the significant needs and vulnerabilities of Medicare beneficiaries with mental illness, changes for atypical antipsychotic coverage should be monitored carefully, and the complexity of Medicare drug plans should be minimized.

Estimating the potential savings with vagus nerve stimulation for treatment-resistant depression: a payer perspective.

OBJECTIVE: To provide a formula estimating potential reductions in healthcare utilization costs with adjunctive vagus nerve stimulation (VNS Therapy) in treatment-resistant depression (TRD). METHODS: This payer-perspective formula incorporates costs of treatment as usual for TRD patients from a published analysis of the MarketScan private payer claims database and the 2004 Medicare 5% standard analytic file. Estimated remission and response rates are from the published VNS pilot and pivotal studies. Costs were converted to 2008 US dollars per the US Bureau of Labor Statistics medical care costs, consumer price index. Device and implantation costs were calculated at $28,336. RESULTS: From the MarketScan and pooled outcomes data (VNS pilot and pivotal studies), potential per patient savings (hospitalization directly and indirectly related to depression) was $2974 at 5 years of device life, $23,539 at 8 years (moderate cost reduction scenario); $12,914 at 5 years, $40,935 at 8 years (optimistic scenario). Corresponding break-even device life was 4.57 and 3.62 years, respectively. From the Medicare file and pooled outcomes, potential per patient savings (inpatient and outpatient directly and indirectly related to depression) was $8358 at 5 years of device life, $32,385 at 8 years (moderate scenario); $19,837 at 5 years, $52,473 at 8 years (optimistic scenario). Corresponding break-even device life was 3.96 and 3.18 years, respectively. CONCLUSIONS: The formula allows an evaluation of expected reductions in healthcare costs as a function of input cost variables, efficacy rates, and benefit scenarios. Cited costs differ relative to care settings, diagnostic principles, and procedural volume. This formula can help assess moderate-to-longer-term economic benefits of VNS for a particular institution. Results suggested that potential reductions in healthcare costs with VNS for TRD may be substantial. Break-even device life for the scenarios presented ranges between 2.3 and 5.7 years.

A managed care perspective of individualized care.

OBJECTIVE: To examine the concept of individualized care for people with major depressive disorder, understand the drugs currently available, and review the implications of switching drug therapy solely for cost reasons. SUMMARY: The use of antidepressant drugs and their associated costs has been the subject of many pharmacoeconomic analyses. Each particular type of analysis has strengths and weaknesses, and their value can only be determined by stakeholders, all of whom have different perspectives. The development of new and better drugs to treat depression has had a significant impact on the nation.s rate of suicide. For managed care pharmacists, cost is often a concern, especially for patients who are treatment refractory. Studies have demonstrated that attempts to reduce prescription drug use in mental health settings increase other costs in a magnitude of $17 spent for every $1 saved. Adequate treatment, careful cross-tapering, and cultural concerns are addressed. CONCLUSION: Pharmacists who practice in managed care must be cognizant of the implications of inadequate treatment of depression, the potential morbidity and mortality that may result from switching antidepressants based on cost alone, and the most appropriate ways to switch from one drug to another.