Integrating real-world skills and diabetes lifestyle coach training into a revised health promotion and communications course.

BACKGROUND AND PURPOSE: Effective communication skills are essential for all pharmacists, regardless of practice setting. An implicit need in pharmacy education is to emphasize direct application of these skills to future healthcare practice prior to experiential rotations. The aim of this article is to describe how we revised a required first professional year (P1) doctor of pharmacy course to achieve two main goals: 1) improve the course relevance by connecting content to real-world skills; and 2) qualify all pharmacy students at our institution as certified National Diabetes Prevention Program (DPP) lifestyle coaches upon course completion. EDUCATIONAL ACTIVITY AND SETTING: Lifestyle coach training approved by the Centers for Disease Control and Prevention (CDC) was integrated into a P1 communications course consisting of 14 modules that include: review of diabetes pathophysiology, group facilitation skills, social determinants of health, food tracking, action planning, participant retention and program administration. This content serves as a direct application of pre-existing course objectives related to knowledge (evidence-based theory) and skills (technical and counseling) required for effective communication with patients, families, and health professionals. FINDINGS: Between 2019 and 2022, the redesigned course was offered to 373 P1 students. Course evaluations during this time were consistently positive. The average evaluation score since DPP activities were integrated into the course was 3.41 (on a 4-point scale). Based upon course evaluations, students appreciated three main benefits of incorporating lifestyle coach certification into the pharmacy curriculum: 1) a certified skill that can differentiate them in the job market; 2) practice of skills on real patients under faculty supervision in the community setting; 3) early exposure to pharmacy patient care topics, thus contributing to professional identity. SUMMARY: Integration of lifestyle coach training into an existing core P1 pharmacy course increased application and assessment of communications skills and allowed wider availability of trained coaches to deliver DPP in the community.

Longitudinal medication adherence group-based trajectories of aging adults in the US: A retrospective analysis using monthly proportion of days covered calculations.

BACKGROUND: It is thought that half of the patients with chronic conditions are not adherent to their medications, which contributes to significant health and economic burden. Many studies estimate medication non-adherence by implementing a threshold of ≥80% of Proportion of Days Covered (PDC), categorizing patients as either adherent or non-adherent. Healthcare quality metrics pertaining to medication use are based on this dichotomous approach of medication adherence, including the Medicare Part D Star Ratings. Among others, the Medicare Part D Star Ratings rewards part D plan sponsors with quality bonus payments based on this dichotomous categorization of beneficiaries' medication adherence. OBJECTIVES: Describe the longitudinal adherence trajectories of adults ≥65 years of age covered by Medicare for 3 classes of drugs in the Part D Star Ratings: diabetes medications, statins, and select antihypertensives. METHODS: This study used Medicare healthcare administrative claims data linked to participants from the Health Retirement Study between 2008 and 2016. Group-based trajectory models (GBTM) elicited the number and shape of adherence trajectories from a sample of N = 11,068 participants for the three pharmacotherapeutic classes considered in this study. Medication adherence was estimated using monthly PDC. RESULTS: GBTM were estimated for the sample population taking antihypertensives (n = 7,272), statins (n = 8,221), and diabetes medications (n = 3,214). The hypertension model found three trajectories: high to very high adherence (47.55%), slow decline (32.99%), and rapid decline (19.47%) trajectories. The statins model found 5 trajectories: high to very high adherence (35.49%), slow decline (17.12%), low then increasing adherence (23.58%), moderate decline (12.62%), and rapid decline (11.20%). The diabetes medications model displayed 6 trajectories: high to very high adherence (24.15%), slow decline (16.84%), high then increasing adherence (25.56%), low then increasing (13.58%), moderate decline (10.60%), and rapid decline (9.27%). CONCLUSIONS: This study showed the fluid nature of long-term medication adherence to the medications considered in the Medicare Part D Star Ratings and how it varies by pharmacotherapeutic class. These challenge previous assumptions about which patients were considered adherent to chronic medications. Policy and methodological implications about medication adherence are discussed.

Cost-Effectiveness of Pharmacist Prescribing for Managing Hypertension in the United States.

Importance: Pharmacist-led interventions can significantly improve blood pressure (BP) control. The long-term cost-effectiveness of pharmacist-prescribing interventions implemented on a large scale in the US remains unclear. Objective: To estimate the cost-effectiveness of implementing a pharmacist-prescribing intervention to improve BP control in the US. Design, Setting, and Participants: This economic evaluation included a 5-state Markov model based on the pharmacist-prescribing intervention used in The Alberta Clinical Trial in Optimizing Hypertension (or RxACTION) (2009 to 2013). In the trial, control group patients received an active intervention, including a BP wallet card, education, and usual care. Data were analyzed from January to June 2023. Main Outcomes and Measures: Cardiovascular (CV) events, end-stage kidney disease events, life years, quality-adjusted life years (QALYs), lifetime costs, and lifetime incremental cost-effectiveness ratio (ICER). CV risk was calculated using Framingham risk equations. Costs were based on the reimbursement rate for level 1 encounters, medication costs from published literature, and event costs from national surveys and pricing data sets. Quality of life was determined using a published catalog of EQ-5D utility values. One-way sensitivity analyses were used to assess alternative reimbursement values, a reduced time horizon of 5 years, alternative assumptions for BP reduction, and the assumption of no benefit to the intervention after 10 years. The model was expanded to the US population to estimate population-level cost and health impacts. Results: Assumed demographics were mean (SD) age, 64 (12.5) years, 121 (49%) male, and a mean (SD) baseline BP of 150/84 (13.9/11.5) mm Hg. Over a 30-year time horizon, the pharmacist-prescribing intervention yielded 2100 fewer cases of CV disease and 8 fewer cases of kidney disease per 10 000 patients. The intervention was also associated with 0.34 (2.5th-97.5th percentiles, 0.23-0.45) additional life years and 0.62 (2.5th-97.5th percentiles, 0.53-0.73) additional QALYs. The cost savings were $10 162 (2.5th-97.5th percentiles, $6636-$13 581) per person due to fewer CV events with the pharmacist-prescribing intervention, even after the cost of the visits and medication adjustments. The intervention continued to produce benefits in more conservative analyses despite increased costs as the ICER ranged from $2093 to $24 076. At the population level, a 50% intervention uptake was associated with a $1.137 trillion in cost savings and would save an estimated 30.2 million life years over 30 years. Conclusion and Relevance: These findings suggest that a pharmacist-prescribing intervention to improve BP control may provide high economic value. The necessary tools and resources are readily available to implement pharmacist-prescribing interventions across the US; however, reimbursement limitations remain a barrier.

Assessment and management of statin-associated muscle symptoms (SAMS): A clinical perspective from the National Lipid Association.

Statin-associated muscle symptoms (SAMS) are the most common form of statin intolerance and are associated with increased risk of cardiovascular events that manifest from statin underutilization and discontinuation. The reported frequencies of SAMS are divergent in the literature. The writing group estimates the prevalence of SAMS, namely all muscle symptoms temporally related to statin use but without regard to causality, to be about 10% (range 5% to 25%), and the prevalence of pharmacological SAMS, specifically muscle symptoms resulting from pharmacological properties of the statin, to be about 1-2% (range 0.5% to 4%). In clinical practice, SAMS are likely to result from a combination of pharmacological and nonpharmacological effects, however this does not make the symptoms any less clinically relevant. Regardless of the etiology, SAMS need to be addressed in accordance with patients' preferences and experiences. This clinical perspective reviews the epidemiology and underlying pathophysiology of SAMS, and the cardiovascular consequences resulting from statin discontinuation. We present patient-centered clinical and communication strategies to mitigate SAMS and improve medication adherence and outcomes among statin users. Treatment strategies include 1) optimizing lifestyle interventions, 2) modulating risk factors that may contribute to muscle symptoms, 3) optimizing statin tolerability by dose reduction, decreased dosing frequency, or use of an alternate statin with more favorable pharmacokinetic properties, and 4) use of non-statins, emphasizing those with evidence for atherosclerotic risk reduction, either in combination with or in place of statin therapy depending on the patient's circumstances. The focus of this clinical perspective is sustainable lipoprotein goal achievement, which is important for cardiovascular risk reduction.

The impact of PCSK9 modulation on cardiovascular outcomes: recent advances and the managed care implications.

Cardiovascular disease (CVD) remains the leading cause of death globally. Hypercholesterolemia is a major modifiable risk factor for developing atherosclerotic CVD (ASCVD). Although statins are the foundational evidence-based treatment option, significant gaps in care exist as approximately 5% to 30% of patients do not tolerate statin therapy. Ezetimibe provides additional, but modest, reductions in low-density lipoprotein cholesterol (LDL-C) and ASCVD risk. The PCSK9 enzyme has emerged as a viable therapeutic target, resulting in the approval of 2 monoclonal antibodies, alirocumab and evolocumab, and a small interfering RNA molecule, inclisiran, that reduce LDL-C levels by approximately 60% and 50%, respectively. Alirocumab and evolocumab were approved in 2015 and have been shown to reduce ASCVD risk in secondary prevention patients; however, the cost of therapy has been a barrier to uptake despite significant price reductions. Inclisiran is unique in that it requires administration by a healthcare professional, thus creating challenges and unknowns when it comes to implementing this drug in clinical practice. Managed care professionals have considerable experience with developing approaches to providing access to novel injectable lipid-lowering therapies, such as alirocumab and evolocumab, and with the approval of inclisiran, they now have an expanding list of such therapies to incorporate into their care plans.

The cost-effectiveness of pharmacist-physician collaborative care models vs usual care on time in target systolic blood pressure range in patients with hypertension: a payer perspective.

BACKGROUND: Hypertension is highly prevalent in the United States, affecting nearly half of all adults (43%). Studies have shown that pharmacist-physician collaborative care models (PPCCMs) for hypertension management significantly improve blood pressure (BP) control rates and provide consistent control of BP. Time in target range (TTR) for systolic BP is a novel measure of BP control consistency that is independently associated with decreased cardiovascular risk. There is no evidence that observed improvement in TTR for systolic BP with a PPCCM is cost-effective. OBJECTIVE: To compare the cost-effectiveness of a PPCCM with usual care for the management of hypertension from the payer perspective. METHODS: We used a decision analytic model with a 3-year time horizon based on published literature and publicly available data. The population consisted of adult patients who had a previous diagnosis of high BP (defined as office-based BP ≥ 140/90 mmHg) or were receiving antihypertensive medications. Effectiveness data were drawn from 2 published studies evaluating the effect of PPCCMs (vs usual care) on TTR for systolic BP and the impact of TTR for systolic BP on 4 cardiovascular outcomes (nonfatal myocardial infarction [MI], stroke, heart failure [HF], and cardiovascular disease [CVD] death). The model incorporated direct medical costs, including both programmatic costs (ie, direct costs for provider time) and downstream health care utilization associated with acute cardiovascular events. One-way sensitivity and threshold analyses examined model robustness. RESULTS: In base-case analyses, PPCCM hypertension management was associated with lower downstream medical expenditures (difference: -$162.86) and lower total program costs (difference: -$108.00) when compared with usual care. PPCCM was associated with lower downstream medical expenditures across all parameter ranges tested in the deterministic sensitivity analysis. For every 10,000 hypertension patients managed with PPCCM vs usual care over a 3-year time horizon, approximately 27 CVD deaths, 29 strokes, 21 nonfatal MIs, and 12 incident HF diagnoses are expected to be averted. CONCLUSIONS: This is the first study to evaluate the cost-effectiveness of PPCCM compared to usual care on TTR for systolic BP in adults with hypertension. PPCCM was less costly to administer and resulted in downstream health care savings and fewer acute cardiovascular events relative to usual care. Although further research is needed to evaluate the long-term costs and outcomes of PPCCM, payer coverage of PPCCM services may prevent future health care costs and improve patient cardiovascular outcomes. DISCLOSURES: No funding was received for the completion of this research. The authors have nothing to disclose. Study results were presented as an abstract at the AMCP 2021 Virtual, April 12-16, 2021.

Medicare reimbursement policy for ambulatory blood pressure monitoring: A qualitative analysis of public comments to the Centers for Medicare and Medicaid Services.

Ambulatory blood pressure monitoring (ABPM) is considered the best means of diagnosing hypertension. However, it is rarely used and is reimbursed only under narrow conditions. We sought to gain insight into the perceived value of ABPM among stakeholders who responded to the Centers for Medicare and Medicaid Services' (CMS) request for comments to inform the first revision of ABPM reimbursement policy in over 15 years. We found that most comments were classifiable in two main themes, current coverage and future coverage. Individuals and institutions representing multiple disciplines and specialties were highly supportive of expanding the current CMS coverage of ABPM, including for a wide range of clinical indications and populations. It is clear from the comments reviewed that there is wide support for expanding CMS coverage for ABPM. Broad support for a change in ABPM reimbursement policy may lead to changes in the way this technology is used in the United States.

Enhancing the value of PCSK9 monoclonal antibodies by identifying patients most likely to benefit. A consensus statement from the National Lipid Association.

Acquisition costs and cost-effectiveness have limited access and recommendations to use proprotein convertase subtilisin/kexin type 9 (PCSK9)-inhibiting monoclonal antibodies (mAbs). Recently, prices were reduced by 60% for alirocumab and evolocumab. This statement systematically reviewed subgroup analyses from statin and PCSK9 mAb trials to identify higher risk groups for which PCSK9 mAbs at the new price could be considered a reasonable (

Pharmacist-physician collaborative care model and time to goal blood pressure in the uninsured population.

Pharmacist-physician collaborative practice models (PPCPMs) improve blood pressure (BP) control, but their effect on time to goal BP is unknown. This retrospective cohort study evaluated the impact of a PPCPM on time to goal BP compared with usual care using data from existing medical records in uninsured patients with hypertension. The primary outcome was time from the initial visit to the first follow-up visit with a BP <140/90 mm Hg. The study included 377 patients (259 = PPCPM; 118 = usual care). Median time to BP goal was 36 days vs 259 days in the PPCPM and usual care cohorts, respectively (P < .001). At 12 months, BP control was 81% and 44% in the PPCPM and usual care cohorts, respectively (P < .001) and therapeutic inertia was lower in the PPCPM cohort (27.6%) compared with usual care (43.7%) (P < .0001). Collaborative models involving pharmacists should be considered to improve BP control in high-risk populations.

The CardioMetabolic Health Alliance: Working Toward a New Care Model for the Metabolic Syndrome.

The Cardiometabolic Think Tank was convened on June 20, 2014, in Washington, DC, as a "call to action" activity focused on defining new patient care models and approaches to address contemporary issues of cardiometabolic risk and disease. Individual experts representing >20 professional organizations participated in this roundtable discussion. The Think Tank consensus was that the metabolic syndrome (MetS) is a complex pathophysiological state comprised of a cluster of clinically measured and typically unmeasured risk factors, is progressive in its course, and is associated with serious and extensive comorbidity, but tends to be clinically under-recognized. The ideal patient care model for MetS must accurately identify those at risk before MetS develops and must recognize subtypes and stages of MetS to more effectively direct prevention and therapies. This new MetS care model introduces both affirmed and emerging concepts that will require consensus development, validation, and optimization in the future.

Collaborative drug therapy management and comprehensive medication management-2015.

The American College of Clinical Pharmacy (ACCP) previously published position statements on collaborative drug therapy management (CDTM) in 1997 and 2003. Since 2003, significant federal and state legislation addressing CDTM has evolved and expanded throughout the United States. CDTM is well suited to facilitate the delivery of comprehensive medication management (CMM) by clinical pharmacists. CMM, defined by ACCP as a core component of the standards of practice for clinical pharmacists, is designed to optimize medication-related outcomes in collaborative practice environments. New models of care delivery emphasize patient-centered, team-based care and increasingly link payment to the achievement of positive economic, clinical, and humanistic outcomes. Hence clinical pharmacists practicing under CDTM agreements or through other privileging processes are well positioned to provide CMM. The economic value of clinical pharmacists in team-based settings is well documented. However, patient access to CMM remains limited due to lack of payer recognition of the value of clinical pharmacists in collaborative care settings and current health care payment policy. Therefore, the clinical pharmacy discipline must continue to establish and expand its use of CDTM agreements and other collaborative privileging mechanisms to provide CMM. Continued growth in the provision of CMM by appropriately qualified clinical pharmacists in collaborative practice settings will enhance recognition of their positive impact on medication-related outcomes.

Lomitapide and mipomersen: novel lipid-lowering agents for the management of familial hypercholesterolemia.

BACKGROUND: Familial hypercholesterolemia (FH) is an autosomal dominant disorder caused primarily by mutations in the low-density lipoprotein receptor gene. Familial hypercholesterolemia is characterized by exceedingly high levels of low-density lipoprotein cholesterol (LDL-C) and subsequent premature coronary heart disease. Homozygous FH (HoFH) is less prevalent, but more severe, than heterozygous FH. Current treatment options include dietary therapy, lipid-lowering agents (eg, statins), and/or LDL-C apheresis. PURPOSE: Despite the available treatment options, patients with FH rarely attain treatment goals. This review will focus on 2 novel agents, lomitapide and mipomersen, with recently approved US Food and Drug Administration (FDA) labeling for use in patients with HoFH. CONCLUSIONS: Lomitapide and mipomersen are 2 agents with novel mechanisms of action and the ability to significantly lower LDL-C, apolipoprotein B, and non-high-density lipoprotein cholesterol levels. A black box warning exists for lomitapide and mipomersen regarding the risk for transaminase elevations and hepatic steatosis. Furthermore, these agents are currently restricted for use only in patients with HoFH and have been required by the FDA to participate in a Risk Evaluation and Mitigation Strategy. CLINICAL IMPLICATIONS: These new agents offer additional treatment options for clinicians managing patients with HoFH, but it remains uncertain whether lomitapide and mipomersen will gain FDA approval for use in patients with heterozygous FH or in the general population. Cost and concern for the risk for hepatotoxicity will remain limiting factors to these agents being more widely used.