Aprocitentan (a Dual Endothelin-Receptor Antagonist) for Treatment-Resistant Hypertension.

ABSTRACT: Treatment-resistant hypertension (TRH) is associated with increased cardiovascular risks and progression of chronic kidney disease. The pathophysiology of TRH is multifactorial, including overactivity of the renin-angiotensin-aldosterone system and sympathetic nervous system, endothelial dysfunction, and volume overload. Endothelin-1 is a vasoconstrictive peptide that causes neurohormonal and sympathetic activation, increased aldosterone synthesis and secretion, endothelial dysfunction, vascular hypertrophy and remodeling, and fibrosis. Endothelin-1 acts through 2 receptors, ETA and ETB. Activation of ETA receptors in vascular smooth muscle cells results in vasoconstriction, whereas ETB receptor activation results in vasoconstriction in the vascular smooth muscle cells and vasodilation through nitric oxide release in endothelial cells. Aprocitentan is novel, oral, dual endothelin-receptor antagonist that has demonstrated a more favorable tolerability and safety profile in early clinical trials compared with other endothelin-receptor antagonists studied. Phase 2 trial data support a significant reduction in blood pressure compared to placebo and similar blood pressure reduction compared to a moderately dosed angiotensin-converting enzyme inhibitor in patients with essential hypertension. An ongoing phase 3 randomized clinical trial is evaluating aprocitentan's efficacy and safety in patients with TRH receiving multiple antihypertensives. Additional research is needed to determine aprocitentan's role in therapy, but this agent may be a suitable treatment option for TRH.

Impact of SGLT2 inhibitors on cardiovascular outcomes in patients with heart failure with reduced ejection fraction.

Heart failure (HF) impacts more than 6 million Americans with an annual mortality rate approaching 22%. Along with optimizing guideline-directed management and therapy (GDMT), the development of treatment options to improve mortality and morbidity in patients with HF with reduced ejection fraction (HFrEF) is paramount. Cardiovascular outcome trials in patients with type 2 diabetes have shown that sodium-glucose cotransporter-2 (SGLT2) inhibitors improve both cardiovascular (CV) and renal outcomes and have consistently reduced hospitalizations for HF in patients with and without a previous history of HF. A precise mechanism by which SGLT2 inhibitors provide benefits for patients with HFrEF has not been identified, and it is probable that multiple pathways may best explain the outcomes seen in recent clinical trials. The mounting evidence that SGLT2 inhibitors reduce HF-related hospitalizations in patients with type 2 diabetes led to the publication of two pivotal trials, the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) trial and the Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure (EMPEROR-Reduced) trial. Data from these publications demonstrate significant benefit of dapagliflozin and empagliflozin on a variety of CV and HF quality of life end points in patients with HFrEF independent of the presence of type 2 diabetes. Now, widespread application of the clinical findings from the DAPA-HF and EMPEROR-Reduced trials must follow with SGLT2 inhibitors incorporated into GDMT for HFrEF regardless of the presence or absence of diabetes. In this review, we examine key literature surrounding the CV outcome data for SGLT2 inhibitors with a specific focus on patients with HFrEF.

Development of self-directed activities and a validated exam for primary care advanced pharmacy practice experiences.

INTRODUCTION: The impact of required self-directed activities (SDAs) measured by written exam on advanced pharmacy practice experiences (APPEs) has not been reported. The primary objective of this study was to determine the validity and reliability of a pre/post exam to measure knowledge when SDAs are incorporated into primary care APPEs. Secondary objectives included assessment of pre/post exam scores and students' perceptions of their learning through SDAs. METHODS: Two faculty implemented required SDAs and a pre/post-exam in their APPEs. Face and content validity were assessed using expert consensus. A retrospective exam of student performance from May 2016 to April 2018 was performed (n = 42). Additional APPE assessment scores were also collected to determine correlations and establish criterion validity. Students who completed the APPE during May 2016 to February 2017 (n = 17) were invited to complete an anonymous, 15-item cross-sectional survey to assess student perceptions of the activities. Differences in self-rated knowledge before and after the rotation were assessed. RESULTS: Pre-exam and post-exam scores positively correlated with journal club and the APPE grading rubric and final scores. Overall, interrater reliability was excellent. Significant improvement was seen between pre-/post exam scores with a mean (SD) change of 21.5% (9.4%). Thirteen (77%) students completed the anonymous survey and rated their perceived knowledge significantly higher after completing the SDAs. CONCLUSIONS: The pre/post exam was valid, reliable, and positively correlated with other graded assignments. Significant improvements in exam scores and survey results support SDAs as an effective teaching method on primary care APPEs.

The Role of Pharmacists in Addressing Vaccine Hesitancy and the Measles Outbreak.

Vaccine hesitancy has been identified as a top threat to global health by the World Health Organization. The current measles outbreak in the United States places even greater emphasis on the relevance of this topic. Vaccination is one of the most cost-effective methods to avoid preventable disease and associated complications. Safety concerns and lack of education commonly contribute to vaccination refusals. By providing patients evidence-based facts and education, pharmacists have the opportunity to address common misconceptions influencing the antivaccination movement and prevent future outbreaks of vaccine-preventable diseases.

Assessing student confidence in interprofessional communication during primary care advanced pharmacy practice experiences (APPEs).

BACKGROUND AND PURPOSE: Students must have experience communicating and interacting with healthcare professionals throughout pharmacy school curricula to effectively develop interprofessional communication abilities and confidence. This study's purpose was to assess student confidence in interprofessional communication utilizing a rubric and checklist inspired by the situation-background-assessment-recommendation (SBAR) technique throughout five-week primary care advanced pharmacy practice experiences (APPEs). EDUCATIONAL ACTIVITY AND SETTING: A six-item rubric was created for student self-evaluation of interprofessional communication throughout their APPE. Students completed the rubric twice to evaluate change in confidence. Additionally, a pre-post rotation survey was developed to assess students' comfort level rounding with healthcare professionals and interacting/intervening with other healthcare professionals to address a medication-related problem. A paired t-test was used to evaluate changes in perceived student confidence in rubric self-evaluations and pre- and post-APPE surveys. FINDINGS: From May 2017 to April 2019, 93 students completed primary care APPEs with faculty authors, and 181 encounters were self-evaluated using the rubric. Forty-eight students completed all rubric sections twice; their mean self-evaluation score increased significantly from 15.25/18 to 17.10/18 (P < .001). Self-evaluation scores increased significantly on all rubric sections (P < .05) except professional language (P = .133). Student comfort level rounding with healthcare professionals and interacting/intervening with healthcare professionals to address a medication-related problem increased significantly (P < .001). SUMMARY: Interprofessional communication practice, preceptor observations and feedback, and utilization of an interprofessional SBAR-inspired communication rubric contributed to improved student confidence in making patient care recommendations to physicians.

Ambulatory care preceptors' perceptions on SOAP note writing in advanced pharmacy practice experiences (APPEs).

INTRODUCTION: Descriptions of SOAP note requirements and assessment methods used during advanced pharmacy practice experiences (APPEs) are limited in the literature. This study aimed to gather information from preceptors regarding SOAP note writing and assessment methods utilized during ambulatory care APPEs. METHODS: A survey was developed and distributed to ambulatory care preceptors with data collected via Qualtrics and analyzed using descriptive statistics, Fisher's exact test to assess the significance for associations between dependent and independent variables, and the Gamma test to assess dependent variables in grading habits and feedback types. RESULTS: The survey response rate was 62% with 75% of preceptors having students write SOAP notes during APPEs. A majority of preceptors (84%) do not formally grade SOAP notes with full-time faculty being more likely to grade and provide written feedback. Half of the preceptors perceived students as either prepared or very prepared to write SOAP notes but the majority felt that students struggle with the assessment portion of the note. There were significant differences between schools in the percentage of preceptors that formally grade SOAP notes, ranging from 2 to 45%. CONCLUSIONS: Preceptors' perception of student preparedness to write SOAP notes on ambulatory APPEs was similar, despite assessment methods varying widely.

Development and Validation of a Rubric to Evaluate Diabetes SOAP Note Writing in APPE.

Objective. To develop and establish validity for a grading rubric to evaluate diabetes subjective, objective, assessment, plan (SOAP) note writing on primary care (PC) advanced pharmacy practice experiences (APPEs), and to assess reliability and student perceptions of the rubric. Methods. Ten PC APPE faculty members collaborated to develop a rubric to provide formative and summative feedback on three written SOAP notes per APPE student over a 10-month period. Correlation analyses were conducted between rubric scores and three criterion variables to assess criterion-related validity: APPE grades, Pharmaceutical Care Ability Profile Scores, and Global Impression Scores. Inter-rater and intra-rater reliability testing were completed using Cohen's kappa and Intraclass Correlation Coefficients (ICC). Student perceptions were assessed through an anonymous student survey. Results. Fifty-one students and 167 SOAP notes were evaluated using the final rubric. The mean score significantly increased from the first to second SOAP note and from the first to third SOAP note. Statistically significant positive correlations were found between final rubric scores and criterion variables. The ICC for inter-rater reliability was fair (.59) for final rubric scores and excellent for intra-rater reliability (.98 to1.00). Students responded that the rubric improved their ability (84.9%) and confidence (92.4%) to write SOAP notes. Conclusion. The rubric may be used to make valid decisions about students' SOAP note writing ability and may increase their confidence in this area. The use of the rubric allows for greater reliability among multiple graders, supporting grading consistency.

Innovative utilization of pharmacist-led board review in a family medicine residency curriculum.

BACKGROUND AND PURPOSE: The Society of Teachers of Family Medicine Group on Pharmacotherapy recommends a formal curriculum during family medicine residency training and describes benefits of utilizing pharmacists. Limited literature exists on how programs have incorporated questions from family medicine board preparation sources into pharmacotherapy academic education. The primary objective was to assess the impact on family medicine residents' perceived knowledge after incorporation of board review items into pharmacotherapy sessions. EDUCATIONAL ACTIVITY AND SETTING: Pharmacists affiliated with the University of Alabama Family Medicine Residency program incorporated questions from board preparation sources into monthly interactive pharmacotherapy sessions as part of a didactic curriculum between 2014 and 2016. An anonymous survey was administered for two consecutive years in 2015 and 2016 to assess residents' perceptions of the sessions and utilization of board-type questions as an active learning component. The change in residents' perception of knowledge was quantitatively analyzed and written comments were evaluated for recurring themes. FINDINGS: The cumulative survey response was 78% (68/87). Over 80% of residents reported that pharmacotherapy sessions and the use of board-type questions was quite or very helpful. The percent of residents that rated their knowledge as good or excellent significantly increased after every session compared to baseline. Residents noted the sessions' information, applicability, interactive nature, and relevance as strengths. SUMMARY: Incorporation of board preparation questions into interactive pharmacotherapy sessions was well received and improved residents' perception of pharmacotherapy knowledge. Utilizing this model in a formal pharmacotherapy curriculum taught by pharmacists is beneficial for family medicine resident learners.

Is an SGLT2 inhibitor right for your patient with type 2 diabetes?

Metformin isn't quite doing the job or is contraindicated? Here's a look at the patients who may benefit from these agents and the monitoring required.

Critical appraisal of paroxetine for the treatment of vasomotor symptoms.

BACKGROUND: Vasomotor symptoms (VMS), characterized by hot flashes and night sweats, are the most commonly reported symptoms associated with estrogen deficiency during menopause and occur in up to 70% of women. The goal of treatment is to reduce the frequency and severity of symptoms. Although hormone therapy (HT) is generally recommended as first-line treatment, it is not appropriate for all patients. Antidepressants, specifically selective serotonin reuptake inhibitors, have been evaluated and utilized internationally for alternative treatment for VMS. In 2013, paroxetine mesylate (Brisdelle(®)) received a US Food and Drug Administration-labeled indication for moderate-to-severe hot flashes, making it the first nonhormonal treatment for VMS associated with menopause. The objective of this review is to critically evaluate available clinical data regarding the efficacy and safety of paroxetine for the treatment of VMS in menopausal women. METHODS: MEDLINE, PubMed, and Google Scholar were searched using the keywords paroxetine, vasomotor symptoms, hot flashes, and menopause. Searches were limited to humans, English language, and clinical trial design with a primary outcome of hot flash/vasomotor changes. RESULTS: Paroxetine (hydrochloride and mesylate) has been associated with a 33%-67% reduction in hot flash frequency with 6-12 weeks of treatment compared to 13.7%-37.8% reductions with placebo in patients both with and without a history of breast cancer. It was also associated with significant reductions in hot flash severity. Benefits of treatment persisted through 24 weeks in the study of the longest duration. Most adverse effects reported were of mild-to-moderate severity, with improved tolerability associated with lower doses (7.5-12.5 mg/day). CONCLUSION: Paroxetine is a safe and effective therapy for the treatment of VMS during menopause. Paroxetine (7.5-12.5 mg/day) should be considered a first-line therapy option for VMS in patients when HT is either inappropriate or intolerable.

Evaluation of a Pharmacist-Specific Intervention on 30-Day Readmission Rates for High-Risk Patients with Pneumonia.

BACKGROUND: Pharmacist interventions have been shown to have an impact on reducing readmission rates, however further research is necessary to target resources to high-risk populations and determine the most effective bundle of interventions. OBJECTIVE: To evaluate the effect of a pharmacist-bundled intervention on 30-day readmission rates for high-risk patients with pneumonia. METHODS: A pilot study with a historical control conducted at a community, teaching-affiliated medical center. Up to 65 selected subjects were included if they had pneumonia and any of the following high-risk criteria: admission within 6 months, at least 5 scheduled home medications, chronic obstructive pulmonary disease (COPD), or heart failure. A retrospective chart review was conducted to compile the historical control group that received usual care between June and November 2013. Patients admitted from December 2013 through March 2014 were reviewed to receive a bundled intervention. The primary outcome was 30-day readmission rates. Risk factors and reasons for readmission, pharmacist clinical interventions, and the time interval between discharge and readmission were also evaluated. RESULTS: A trend toward a reduced 30-day readmission rate was observed in the intervention group (n = 43) compared to those who received usual care (n = 65) (27.9% vs 40.0%; relative risk [RR], 0.6977; 95% CI, 0.3965-1.2278; P = .2119). The most commonly identified high-risk inclusion criteria were having at least 5 scheduled home medications and COPD. The time interval between discharge and readmission did not considerably differ between groups (10.8 vs 10.6 days). CONCLUSIONS: The pharmacist-bundled intervention was associated with a reduced 30-day readmission rate for high-risk patients with pneumonia.