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BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors are effective for glycemic control and have demonstrated cardiorenal benefits. The U.S. Food and Drug Administration (FDA) released a boxed warning in 2018 regarding the potential development of Fournier's gangrene (FG) with the use of SGLT2 inhibitors. FG is a serious perineal infection with a mortality rate of up to 88% in some cases. OBJECTIVES: To report spontaneous post-marketing cases from the FDA Adverse Event Reporting System (FAERS) database and case reports from the literature of FG associated with the use of SGLT2 inhibitors and to determine whether correlations exist with specific agents. METHODS: A search of the FAERS database was conducted to identify reported cases of FG associated with the use of any FDA-approved SGLT2 inhibitor between 1 March 2013 and 30 June 2020. Additionally, a literature search was conducted of PubMed, Embase, and the Cochrane library using PRISMA guidelines to identify case reports of FG with the use of SGLT2 inhibitors up to 9 October 2020. RESULTS: A total of 491 cases from the FAERS database were included for review. Descriptive analysis depicted more cases in the empagliflozin, canagliflozin, and dapagliflozin groups than in the ertugliflozin group. Nine case reports were included from the literature review; four attributed to dapagliflozin, three to empagliflozin, and two to canagliflozin. The median ages from cases reported in the FAERS database and from the literature review were 54 and 52 years, respectively. In both datasets, males had a higher incidence of FG than females. Additional data reported include clinical outcomes and concomitant antihyperglycemic medications. CONCLUSION: Consistent findings are noted in this systematic review and warrant further investigation to elucidate the association between SGLT2 inhibitor use and the development of FG. These results may drive enhanced prescribing patterns to consider patient-specific risk factors and timely monitoring, especially as more indications are approved related to these medications' cardiorenal protective properties.
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Objective: This study aims to review the pharmacology, efficacy, and safety of the soluble guanylate cyclase stimulator, vericiguat, in patients with symptomatic congestive heart failure with ejection fraction less than 45% for the reduction of cardiovascular deaths. Also, to evaluate heart failure-related hospitalization in patients following a hospital discharge secondary to heart failure or those that require outpatient intravenous diuretics. Data source: MEDLINE/Pubmed and National Institutes of Health Clinical Trial Registry were searched between January 1989 to February 2021 using the following terms: vericiguat, soluble guanylate cyclase stimulator, heart failure, (was also known as) BAY 1021189. Study Selection and Data Extraction: The following study designs were included in the analysis: phase I, II, and III clinical trials; systematic reviews; and meta-analyses. Articles were included if they were published in English and evaluated vericiguat pharmacology, pharmacokinetics, efficacy, and safety. Data Synthesis: The Food and Drug Administration approved vericiguat for the reduction of cardiovascular death and hospitalization after having a related hospitalization or the need for outpatient intravenous diuretics, in those with symptomatic chronic heart failure and ejection fraction less than 45%. In the VICTORIA trial, vericiguat demonstrated a 10% reduction in risk of death from cardiovascular causes or first hospitalization for heart failure compared with placebo. Vericiguat was well tolerated overall with hypotension, syncope, and anemia noted as the most common side effects, similar to the other agent in its class. Conclusion: Vericiguat may be appropriate as add-on therapy for patients already on guideline-directed medical therapy with recent decompensated HFrEF to reduce hospitalization.
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Insuficiência Cardíaca , Humanos , Insuficiência Cardíaca/tratamento farmacológico , Guanilil Ciclase Solúvel/uso terapêutico , Resultado do Tratamento , Volume Sistólico , Hospitalização , Diuréticos/uso terapêuticoRESUMO
BACKGROUND AND PURPOSE: Pharmacy capstone exams are an example of an assessment strategy to evaluate student competency and practice-readiness. Capstone exam processes have been discussed in the literature; however, description of format, evolution of the process, and implementation in the year prior to rotations is lacking. This manuscript discusses the development, implementation, and utilization of a third professional year pharmacy capstone exam to assess advanced pharmacy practice experience (APPE) readiness. EDUCATIONAL ACTIVITY AND SETTING: A pharmacy year three (PY3) capstone exam was initially developed prior to enrollment of the inaugural graduating class. Since the first iteration, utility has remained the same, but the overall development and implementation process has evolved due to changes in programmatic and student learning outcomes, curricular mapping, student and faculty feedback, and practice expectations. FINDINGS: The entities responsible for exam implementation perceive faculty and students have a positive perception of the exam evolution and improvements implemented. Specifically, feedback from students and faculty mentioned clear expectations, comfort with the new capstone exam process, and an appreciation for the focus on interrater reliability. As assessment is an iterative process, quality improvement strategies continue to be implemented to address feedback regarding the PY3 capstone exam. SUMMARY: Purposeful utilization of capstone exams in the third year is one method to assess APPE readiness. Sharing one college's experience with the evolution of such an exam, quality improvement methods, and experience in implementing reliability and validity measures may provide a model for institutions to implement similar assessment methods efficiently.
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Educação em Farmácia , Estudantes de Farmácia , Humanos , Educação em Farmácia/métodos , Currículo , Reprodutibilidade dos Testes , Avaliação Educacional/métodosRESUMO
Objective. To assess third-year pharmacy students' knowledge and application of renal pharmacotherapy using a renal replacement therapy (RRT) simulation. Methods. A simulation was developed that involved three stations related to RRT: peritoneal dialysis, continuous renal replacement therapy (CRRT), and hemodialysis. Stations involved demonstration of each modality, literature searches for drug information questions related to renal dosing with written recommendations, and utilization of an electronic medical record (EMR) to develop a verbal Situation, Background, Assessment, Recommendation (SBAR) for a patient with chronic kidney disease (CKD). Pre- and post-simulation assessments regarding therapeutic knowledge of RRT was used. Results. All 174 students completed the pre- and post-simulation assessments over the course of two years. Student performance indicated significant improvement in overall knowledge based on the assessments with significant overall differences in questions relating to indications for RRT, type of RRT indicated for hemodynamic instability, and agents used to maintain circuit patency. Overall inter-class differences were also identified at baseline and specifically for the questions regarding indications for RRT and agents used to maintain circuit patency. Both classes showed significant improvement in overall knowledge based on the post-simulation assessments. Debrief sessions and course evaluations indicated student satisfaction with the simulation experience. Students reported that the experience met the simulation objectives. Conclusion. Participation in an RRT simulation allowed pharmacy students to apply knowledge and skills learned didactically related to renal pharmacotherapy.
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Educação em Farmácia/métodos , Terapia de Substituição Renal/tendências , Treinamento por Simulação/métodos , Competência Clínica , Terapia de Substituição Renal Contínua , Avaliação Educacional , Humanos , Diálise Peritoneal , Diálise Renal , Estudantes de FarmáciaRESUMO
INTRODUCTION: Regardless of the practice setting, pharmacists' roles often expand beyond patient-centered services and into health-related educational roles for patients, healthcare providers, and student pharmacists. Teaching roles of a clinical pharmacist can include providing invited presentations (such as continuing education lectures), teaching colleagues about new clinical initiatives, precepting students during advanced pharmacy practice experiences (APPEs) and introductory pharmacy practice experiences (IPPEs), and precepting residents on rotations. This program was designed to evaluate the effect of a university-affiliated pharmacy teaching certificate program on participant knowledge and perceived confidence in specific areas of academic pharmacy and preceptor development. METHODS: A 10-month program consisting of four live modules with associated continuing education (CE) credit was offered to pharmacy residents and practicing pharmacists in the surrounding area. The program format utilized didactic and active learning strategies with "at home" assignments to reinforce material presented. Content knowledge was measured with written summative assessments provided at the start and end of each module. Perceived confidence was assessed through online surveys provided at the start and end of the program. All results were evaluated using paired t-tests. RESULTS: Data were obtained from 14 participants in the first cohort and 18 participants in the second cohort. For each of the four modules, there was a significant difference in pre- and post-knowledge assessments. Confidence data was also significantly increased regarding topics in each module. CONCLUSION: Knowledge assessments and perception surveys suggest that this university-affiliated teaching certificate program improved both knowledge and perceived confidence for program participants.
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Certificação/estatística & dados numéricos , Educação em Farmácia/métodos , Farmacêuticos/psicologia , Certificação/tendências , Estudos de Coortes , Educação em Farmácia/tendências , Educação Continuada em Farmácia/métodos , Educação de Pós-Graduação em Farmácia/métodos , Feminino , Humanos , Conhecimento , Masculino , Assistência Centrada no Paciente , Percepção/fisiologia , Farmácias/estatística & dados numéricos , Farmacêuticos/estatística & dados numéricos , Preceptoria/métodos , Inquéritos e Questionários , EnsinoRESUMO
Background: Pharmacy students often find the pathophysiology and treatment of comorbid heart conditions challenging to understand. The objective of this study is to evaluate the impact of a cardiac catheterisation lab simulation on pharmacy students' knowledge related to cardiology and critical care pharmacotherapy. Methods: Third-year pharmacy students at the University of South Florida completed a high-fidelity cardiac catheterisation simulation. Specific aspects within the activity involved review of clinical parameters and images during catheterisation, identification of access points for catheter insertion, review of the types of stents available and associated pharmacotherapeutic considerations, and discussion of protective measures to prevent radiation exposure. Students completed knowledge-based presimulation and postsimulation assessments regarding these aspects of cardiac catheterisation. Results: All students (n=111, 100%) completed the presimulation and postsimulation assessments. There was an increase in knowledge after the simulation, which was statistically significant in five out of nine questions, P<0.001. Based on course evaluations, students believed this activity enhanced their learning and ability to apply the material due to the close alignment and timing with their acute coronary syndrome lectures and the critical care module in the Pharmacotherapeutics course. Conclusions: Participation in the simulation improved students' knowledge related to cardiology pharmacotherapy and associated acute procedures.
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BACKGROUND AND PURPOSE: The purpose of this study was to evaluate students' knowledge and perceptions of the clinical application of pharmacogenetics through a simulation activity and to assess communication of pharmacogenetic-guided treatment recommendations utilizing standardized patients. EDUCATIONAL ACTIVITY AND SETTING: Third-year students in the four-year doctor of pharmacy (PharmD) program at University of South Florida College of Pharmacy completed a pharmacogenetics simulation involving a patient case review, interpretation of pharmacogenetic test results, completion of a situation, background, assessment, recommendation (SBAR) note with drug therapy recommendations, and patient counseling. Voluntary assessments were completed before and after the simulation, which included demographics, knowledge, and perceptions of students' ability to interpret and communicate pharmacogenetic results. FINDINGS: Response rates for the pre- and post-simulation assessments were 109 (98%) and 104 (94%), respectively. Correct responses in application-type questions improved after the simulation (74%) compared to before the simulation (44%, p < 0.01). Responses to perception questions shifted towards "strongly agree" or "agree" after the simulation (p < 0.01). DISCUSSION AND SUMMARY: The simulation gave students an opportunity to apply pharmacogenetics knowledge and allowed them to gain an appreciation of pharmacists' roles within the pharmacogenetics field.
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Competência Clínica/normas , Percepção , Farmacogenética/educação , Estudantes de Farmácia/psicologia , Currículo , Educação em Farmácia/métodos , Educação em Farmácia/normas , Avaliação Educacional/métodos , Florida , HumanosRESUMO
Objective. To evaluate the impact of a comprehensive oncology simulation on pharmacy students' knowledge and perceptions related to oncology pharmacy practice. Methods. Third-year pharmacy students at the University of South Florida completed an ovarian cancer case-based simulation. Stations involved patient-specific order set completion, counseling, order verification, and aseptic technique. Pre- and post-simulation assessments regarding therapeutic knowledge and aseptic technique as well as perceptions of pharmacists' roles in oncology practice were evaluated. Results. All students (n=109, 100%) completed the pre- and post-simulation assessments. There was an increase in knowledge after the simulation, which was statistically significant in three of the six questions. Furthermore, students' perceptions regarding pharmacist roles and self-confidence in ability to prepare patient-specific regimens increased on a 5-point Likert scale from 3.8 and 3.2 to 4.5 and 4.2 on the post-assessment, respectively. Conclusion. Participation in the simulation improved students' oncology-related knowledge and perceived understanding of the roles of oncology pharmacists.
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Educação em Farmácia/métodos , Assistência Farmacêutica/organização & administração , Farmacêuticos/organização & administração , Estudantes de Farmácia , Competência Clínica , Currículo , Avaliação Educacional , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Neoplasias Ovarianas/terapia , Papel Profissional , AutoimagemRESUMO
OBJECTIVES: To integrate fourth-year student pharmacists on advanced pharmacy practice experience (APPE) rotations within several different ambulatory clinics to perform medication reconciliations and enhance interdisciplinary practice. METHODS: The study design was a descriptive, prospective multisite study among a variety of ambulatory care outpatient clinics. Student pharmacists were partnered with physicians to conduct medication reconciliations during clinic visits for 4 hours per week, with data collection from January 2016 to September 2016. This program originated from physician requests for additional pharmacy involvement and led to the development of a successful implementation strategy to involve student pharmacists in the medication reconciliation process. RESULTS: Student pharmacists identified 537 medication discrepancies among 491 patients, including commission of medications (36%), documentation of previously omitted medications (27%), and incomplete patient allergy information (11%). Students spent an average of 10 minutes on each encounter. CONCLUSION: Documentation from this innovative program suggests improvement in medication reconciliation and enhanced patient care with limited time required of student pharmacists. A similar program could be developed and utilized at other clinical sites.
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Centros Médicos Acadêmicos/métodos , Assistência Ambulatorial/métodos , Reconciliação de Medicamentos/métodos , Avaliação de Programas e Projetos de Saúde/métodos , Estudantes de Farmácia , Centros Médicos Acadêmicos/tendências , Assistência Ambulatorial/tendências , Humanos , Reconciliação de Medicamentos/tendências , Avaliação de Programas e Projetos de Saúde/tendências , Estudos ProspectivosRESUMO
BACKGROUND AND PURPOSE: To evaluate the impact of a pharmacist-focused transitions of care (TOC) simulation on students' perceptions and knowledge of pharmacist roles in the healthcare continuum. Educational Activity and Setting: Two simulations, highlighting pharmacist roles in various practice settings, were conducted within the Pharmaceutical Skills courses in the third-year doctor of pharmacy curriculum. Patient cases were built utilizing electronic medical records (EMR). Students' knowledge was assessed before and after the simulations regarding pharmacist involvement in medication reconciliation, reduction in patient readmissions, reduction of inappropriate medication use, roles and communication on an interprofessional team, and involvement with health information technology (HIT) during care transitions. FINDINGS: Fifty-one third-year pharmacy students were anonymously evaluated prior to and following the simulation to assess changes in knowledge and perceptions during the fall semester. Thirty-two (62.7%) students completed the pre-simulation and 21 (41.2%) students completed the post-simulation assessments, respectively. In the spring semester, 40 (80%) students completed the pre-simulation and 23 (46%) students finished the post-simulation assessments. Students predominately had community pharmacy work experience (n=28, 55%). Overall, students enjoyed the variety of pharmacist-led encounters throughout the simulation and assessments demonstrated an increase in knowledge after the simulations. SUMMARY: TOC simulations enhance students' understanding of the significant impact that pharmacists have in ensuring continuity of care as members of an interdisciplinary team.
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Avaliação Educacional/métodos , Papel Profissional , Estudantes de Farmácia , Adulto , Currículo/tendências , Educação em Farmácia/métodos , Feminino , Humanos , Masculino , Reconciliação de Medicamentos , Farmacêuticos , Treinamento por Simulação/métodosRESUMO
The objectives of this workshop were to characterise the use of mobile health (mHealth) devices among second year pharmacy students, discover perception of their potential use in practice and obtain workshop feedback. The workshop consisted of two sessions. The first session introduced the concept of mHealth and allowed for hands-on experience with wireless mHealth devices such as blood pressure cuffs, scales and smart body analysers, personal health devices and glucometers. The second session consisted of a facilitated discussion and lecture that addressed these concepts. Students completed a preworkshop and postworkshop survey. 106 students completed the preworkshop survey and 96 students completed the postworkshop survey. 22% of the class owned an mHealth device and a majority of students reported increased knowledge of mobile health devices due to this simulation. The workshop was successful in introducing mHealth technology. The change in students' perception that such devices could be useful in practice or easily incorporated could be due to technical difficulties and cost of the devices.