Implementation of standard setting for high-stakes objective structured clinical examinations.

BACKGROUND AND PURPOSE: To describe one institution's approach to transformation of high-stakes objective structure clinical examinations (OSCEs) from norm-referenced to criterion-referenced standards setting and to evaluate the impact of these changes on OSCE performance and pass rates. EDUCATIONAL ACTIVITY AND SETTING: The OSCE writing team at the college selected a modified Angoff method appropriate for high-stakes assessments to replace the two standard deviation method previously used. Each member of the OSCE writing team independently reviewed the analytical checklist and calculated a passing score for active stations on OSCEs. Then the group met to determine a final pass score for each station. The team also determined critical cut points for each station, when indicated. After administration of the OSCEs, scores, pass rates, and need for remediation were compared to the previous norm-referenced method. Descriptive statistics were used to summarize the data. FINDINGS: OSCE scores remained relatively unchanged when switched to a criterion-referenced method, but the number of remediators increased up to 2.6 fold. In the first year, the average score increased from 86.8% to 91.7% while the remediation rate increased from 2.8% to 7.4%. In the third year, the average increased from 90.9% to 92% while the remediation rate increased from 6% to 15.6%. Likewise, the fourth-year average increased from 84.9% to 87.5% while the remediation rate increased from 4.4% to 9%. SUMMARY: Transition to a modified Angoff method did not impact average OSCE score but did increase the number of remediations.

Vonoprazan: A New Potassium-Competitive Acid Blocker.

Objective: To review the safety, efficacy, and tolerability of vonoprazan for the treatment of Helicobacter pylori infection in adults. Data Sources: A literature search was performed through PubMed using the following key terms: vonoprazan, Voquezna, TAK-438, potassium-competitive acid blocker, H pylori, and gastrointestinal. Study Selection and Data Extraction: Selected articles included those which described clinical studies of the pharmacology, pharmacokinetics, efficacy, safety, or tolerability of vonoprazan. Data Synthesis: Vonoprazan works by competing with potassium on the proton pump to inhibit gastric acid secretion. Phase 3 clinical trials have shown that vonoprazan is noninferior to proton pump inhibitors (PPIs) as a component of H pylori eradication regimens. Vonoprazan has also shown promise in duodenal ulcer-healing rates and in reducing symptoms of heartburn. Common adverse effects associated with vonoprazan include nasopharyngitis, diarrhea, constipation, flatulence, dyspepsia, headache, and abdominal pain. Conclusion: Clinical practice guidelines recommend PPIs as the antisecretory agent of choice in H pylori eradication regimens with histamine-2 receptor antagonists (H2RAs) as potential alternatives. However, the use of either class of medications may be limited by adverse effects, drug interactions, and tolerability. Potassium-competitive acid blockers (P-CABs), like vonoprazan, may be safe and effective alternative antisecretory agents for H pylori eradication regimens, as well as other gastrointestinal disorders.

Curricular changes in times of crisis: Lessons learned.

BACKGROUND AND PURPOSE: During the early months of the COVID-19 pandemic, experiential education became challenging as sites began to cancel scheduled rotations, and the University of Florida College of Pharmacy had to cancel the first advanced pharmacy practice experience (APPE) block. This was allowable given the excess number of experiential hours built into the curriculum. EDUCATIONAL ACTIVITY AND SETTING: To meet total program credit hour requirements, a six-credit virtual course was created to mimic an experiential rotation. This course was designed to bridge didactic learning with experiential learning. The course included presentation of patient cases, topic discussions, pharmaceutical calculations, self-care cases, disease state management cases, and career development. FINDINGS: Students provided feedback via a survey containing 23 Likert type questions and four open-ended questions. Most students agreed or strongly agreed that participation in self-care scenarios, small group discussions (calculations and topic discussion), and disease state management cases (preceptor dialogue and verbal defense activities) were valuable learning experiences. The verbal defense portion of the disease management case and the self-care scenarios were the most highly rated learning activities. Peer review activities in the career development assignments were seen as the least beneficial component of the course. SUMMARY: This course allowed students an opportunity to further prepare for APPEs in a unique learning environment. The college was able to identify students requiring additional support during APPEs and provide earlier intervention. Additionally, data supported exploring incorporation of new learning activities into the current curriculum.

Romosozumab: A Novel Agent in the Treatment for Postmenopausal Osteoporosis.

Objective: To review the safety and efficacy of romosozumab (Evenity) in the treatment of osteoporosis in women. Data Sources: An English-language search of PubMed and Medline (1966 to August 2020) was conducted using the keywords romosozumab, sclerostin inhibitor, AMG785, and osteoporosis. Manufacturer prescribing information, abstracts, fda.gov, and ClinicalTrials.gov data were incorporated for additional materials. In addition, a review of bibliographies of retrieved articles was performed to identify additional references. Study Selection/Data Extraction: Articles selected included those that described clinical studies of pharmacokinetics, efficacy, or safety of romosozumab. Data Synthesis: Romosozumab is a human monoclonal antibody that inhibits the action of sclerostin and is the first agent in its class to reach Phase III trials. Significant increases in bone mineral density and decreases in vertebral and hip fractures are demonstrated in Phase III trials. Favorable results led to its marketing approval in several countries. Major adverse cardiac events were observed in one clinical trial. Other adverse effects include arthralgia, headache, and injection site reactions. Place in Therapy: Romosozumab is the first agent to inhibit bone resorption and stimulate bone formation. Romosozumab should be reserved for postmenopausal women at highest risk for fracture and should be followed by an anti-resportive agent to maintain or further increase bone mineral density. This injectable agent should not be considered for women with a history of or at high risk of cardiovascular disease.

Diabetes: Type 1 Diabetes.

Type 1 diabetes is defined as a state of hyperglycemia due to insulin deficiency caused by autoimmune pancreatic beta-cell destruction. The risk among individuals in the general population has been estimated at 0.5%. A family history of diabetes and a personal history of conditions associated with type 1 diabetes (ie, autoimmune diseases) increase the risk. Currently, the American Diabetes Association (ADA) recommends screening asymptomatic patients for type 1 diabetes autoimmune markers in the context of clinical research trials. All patients with diabetes should be referred to a diabetes self-management education program and for medical nutrition therapy. Medical nutrition therapy has been shown to lower the A1c by up to 1.9% in patients with type 1 diabetes. The mainstay of management is a regimen of multiple daily injections of insulin or continuous subcutaneous insulin delivered via an insulin pump. For most patients, a regimen consisting of 50% of the total daily dose prescribed as basal insulin and 50% prescribed as bolus insulin is used. Currently, pramlintide is the only Food Drug Administration (FDA)-approved adjunct to insulin therapy for patients with type 1 diabetes. Patients with type 1 diabetes should be screened regularly for hypertension and other associated conditions and complications.

Diabetes: Pharmacotherapy for Type 2 Diabetes.

For most patients with type 2 diabetes, the American Diabetes Association (ADA) recommends an A1c goal of less than 7%. However, this goal may be adjusted depending on certain patient factors. Metformin should be used as a first-line treatment in all patients with type 2 diabetes unless contraindicated. Add-on treatment with a sodium-dependent glucose cotransporter 2 inhibitor or glucagon-like peptide 1 receptor agonist should be considered in patients who have or are at high risk of cardiovascular disease and in patients with kidney disease. Insulins, sulfonylureas, thiazolidinediones, and dipeptidyl-peptidase 4 inhibitors also have roles in management. With use of drugs with varied mechanisms of action, the various pathophysiologic mechanisms responsible for progression of type 2 diabetes can be managed. Microvascular and macrovascular complications of diabetes contribute to significant morbidity and mortality, so evaluation for and management of hypertension, hyperlipidemia, and other associated conditions also are essential.

Opicapone (Ongentys): A New COMT Inhibitor for the Treatment of Parkinson's Disease.

OBJECTIVE: To describe the safety and efficacy of opicapone, a newly Food and Drug Administration-approved catechol-O-methyltransferase (COMT) inhibitor, as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing off episodes. DATA SOURCES: A literature search through PubMed and International Pharmaceutical Abstracts (January 2000 to October 2020) was conducted using the following search terms: Ongentys, opicapone, COMT inhibitor, Parkinson's disease, and Parkinson's. STUDY SELECTION AND DATA EXTRACTION: Articles selected included those describing preclinical and clinical studies examining the pharmacokinetics, efficacy, and/or safety of opicapone. DATA SYNTHESIS: In preclinical trials, opicapone demonstrated marked S-COMT inhibition, despite its short half-life, while maintaining an acceptable safety and efficacy profile. Results from phase 3 clinical trials further supported the safety and efficacy of opicapone as an adjunct to levodopa. In addition, opicapone, at a dose of 50 mg once daily, was shown to be superior to placebo and noninferior to entacapone in reducing time spent in the off state. Adverse effects commonly reported with opicapone include dyskinesias, constipation, hypotension/syncope, increased blood creatine kinase, and decreased weight. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Additional medications, such as COMT inhibitors, become necessary adjunctive treatments as the disease progresses. Compared to other COMT inhibitors currently on the US market, opicapone offers the advantage of once-daily dosing. CONCLUSION: Opicapone is a safe and effective COMT inhibitor shown to reduce off episodes in patients with PD.

Ambulatory care elective: Introduction to core practice concepts.

BACKGROUND AND PURPOSE: Introduction to various pharmacy practice environments is effectively accomplished through concentrated elective courses. The ambulatory care elective utilized innovative active learning strategies to enhance chronic disease management, foster empathy, and introduce strategic planning in an ambulatory care center. EDUCATIONAL ACTIVITY AND SETTING: A new two-credit hour ambulatory elective course was offered to third-year pharmacy students in a four-year doctor of pharmacy program. This 30-hour, 2-week long course, ran simultaneously between three campuses, and included six modules. The course employed lectures, active learning activities, shadowing, role playing, and a simulation. FINDINGS: Course evaluations and student reflections indicate high satisfaction with the course and reveal value in the simulation. SUMMARY: Active learning sessions in this third-year pharmacy elective allowed application of lecture materials to explore the focused practice of ambulatory care. Discussion topics were varied, allowing students to gauge the breadth of opportunities offered in ambulatory pharmacy, while also appreciating the scope of skills required for successful and sustainable practice. Students valued the chronic disease state simulation, which provided a unique approach to foster personal attributes.

The Role of Glucagon-like Peptide-1 Receptor Agonists in the Treatment of Type 2 Diabetes.

The role of GLP-1 agonists in the treatment of type 2 diabetes have been shown to be viable options for add-on therapy in diabetic patients, as well as potential monotherapy options. With six available GLP-1 agents, and new combination products in the pipeline, they are a promising drug class for type 2 diabetic patients, especially due to their extended dosing interval and potential weight loss benefits.

Sitagliptin/Metformin (janumet) as combination therapy in the treatment of type-2 diabetes mellitus.

Used together, sitagliptin (Januvia) and metformin (Glucophage) help to improve glycemic levels in diabetic patients, suggesting a synergy between the agents. However, the cost of sitagliptin and the need for more data may restrict its use. More studies are needed to assess the effects of long-term sitagliptin and to determine its role in combination therapy.

Otelixizumab: a novel agent for the prevention of type 1 diabetes mellitus.

INTRODUCTION: Type 1 diabetes mellitus is a chronic, progressive autoimmune disorder linked to numerous genetic and environmental factors. Insulin is the only treatment and preventative strategies do not currently exist. An obvious need exists to develop a safe regimen that suppresses the progression of the disease. AREAS COVERED: A MEDLINE search (1966-June 2011) was conducted for English-language articles using the terms 'otelixizumab', 'anti-CD3 antibody' and 'prevention of type 1 diabetes mellitus'. Relevant literature on otelixizumab, an anti-CD3 monoclonal antibody, currently in Phase III clinical trials for prevention of T1DM is discussed. EXPERT OPINION: Studies suggest that a monoclonal antibody directed against CD3 mitigates the deterioration in insulin production and decreases the rise in insulin requirement in recent onset T1DM for up to five years. The benefit was most pronounced in younger patients and in those with higher initial ß-cell function. Adverse effects were significant but transient. Otelixizumab shows great promise but leaves room for improvement. Results of ongoing trials will help define its role in the prevention of T1DM.

Redesign of a pediatric pharmacotherapy elective course to accommodate budget reductions.

OBJECTIVE: To redesign a pediatric elective pharmacotherapy course and determine whether the redesign resulted in changes in outcome measures. DESIGN: Active learning activities were moved to an online format. Prerecorded lectures continued to be used. Peer evaluation was incorporated to give the students more feedback on their performance. ASSESSMENT; Presentation grades, average examination grades, course grades, and evaluation scores from each student who completed University course evaluations were documented for students during the 2 semesters before and the 2 semesters after the course redesign. Although for undetermined reasons a drop in examination grades occurred after the course redesign, no significant differences in presentation grades, final grades, or course evaluation grades occurred. CONCLUSIONS: A strategic course redesign successfully reduced the costs and faculty time required to offer an elective course viewed as essential to the curriculum, allowing the course to be continued in the face of state budget cuts.

Albiglutide: a new GLP-1 analog for the treatment of type 2 diabetes.

IMPORTANCE OF THE FIELD: Despite the wide array of treatments available, a significant number of patients with type 2 diabetes continue to remain uncontrolled. The discovery of the incretin hormones and their role in glucose homeostasis has brought about a new class of medications called the glucagon-like peptide-1 (GLP-1) analogs. This new class of medications provides the benefits of weight loss as well as a lack of hypoglycemia. However, the currently available agents require once or twice daily injections. AREAS COVERED IN THIS REVIEW: Relevant literature will be discussed on albiglutide, a new GLP-1 analog in Phase III clinical trials. Several clinical trials examining the use of albiglutide as combination therapy are currently ongoing. WHAT THE READER WILL GAIN: To date, results of clinical trials suggest that albiglutide may provide a more attractive dosing profile compared with the currently available GLP-1 analogs. TAKE HOME MESSAGE: The results of ongoing trials will help define the role of albiglutide in treating patients with type 2 diabetes.

Sitagliptin as combination therapy in the treatment of type 2 diabetes mellitus.

The American Diabetes Association and The European Association for the Study of Diabetes recommend metformin as the initial agent of choice in the treatment of type 2 diabetes mellitus. Unfortunately, most patients require multiple medications to obtain glycemic control. One of the newest additions to the antidiabetic armamentarium is the class of drugs known as dipeptidyl-peptidase IV (DPP-IV) inhibitors. This novel approach focuses on harnessing the beneficial effects of GLP-1, an incretin hormone released from the gut postprandially. The first DPP-IV inhibitor approved in the United States was sitagliptin. It has been studied in both monotherapy and combination therapy. Combination studies with metformin realize a hemoglobin A1c reduction of 0.65%-1.1%. The combination of the two has a modest positive effect on body weight with the convenience of an oral route of administration. It has also been shown to be highly tolerable, efficacious and with little risk of hypoglycemia. This review will focus on combination therapy with sitagliptin with emphasis on combination with metformin.

Angiotensin II vaccine: a novel approach in the treatment of hypertension.

BACKGROUND: Hypertension affects approximately 65 million Americans, resulting in 30 million office visits per year. Only about one third of patients have blood pressure below goal. Poor adherence to drug therapy is an important contributor to this statistic. An active immunization, which would induce antibodies against angiotensin, could simplify and improve treatment. An ideal regimen would be a few subcutaneous injections per year, which in turn could vastly improve adherence and subsequent outcomes. OBJECTIVE: To discuss Cyt006-AngAb, a novel vaccine targeting angiotensin II, which is chemically linked to recombinant virus-like particles. Emphasis is placed on current progress of this vaccine's clinical trials. METHODS: Relevant literature is discussed. CONCLUSION: Although advances in hypertension vaccines have faced challenges, the angiotensin II vaccine may provide a promising approach in the control of hypertension.

Sitagliptin: a dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes.

OBJECTIVE: To review the pharmacology, pharmacokinetics, safety, and efficacy of sitagliptin, a dipeptidyl peptidase IV (DPP-IV) inhibitor in the management of type 2 diabetes mellitus. DATA SOURCES: A MEDLINE search (1966-February 2006) was conducted for English-language articles using the terms dipeptidyl peptidase IV inhibitor, incretin, MK-0431, and sitagliptin. Abstracts from the American Diabetes Association annual meetings in 2004 and 2005 were included as sources of data. STUDY SELECTION AND DATA EXTRACTION: Articles pertaining to the pharmacology of sitagliptin, its pharmacokinetics, safety and efficacy were reviewed. DATA SYNTHESIS: Sitagliptin is a potent, competitive, reversible inhibitor of the DPP-IV enzyme. It is eliminated renally, with a terminal half-life of 11.8-14.4 hours. In Phase II clinical trials, sitagliptin was found to be superior to placebo for the treatment of type 2 diabetes mellitus. Results of a small trial comparing sitagliptin with glipizide indicate that both treatments are comparable. The efficacy of sitagliptin has also been demonstrated when used as adjunctive therapy with metformin. Few adverse effects have been reported. Weight gain and hypoglycemia have not been seen with sitagliptin therapy. CONCLUSIONS: Based on its unique mechanism of action, sitagliptin will provide practitioners with an additional tool in the treatment of diabetes. Review of the literature to date implies sitagliptin may be effective as monotherapy in type 2 diabetes. In addition, existing evidence supports the use of sitagliptin as adjunct therapy to sulfonylureas and metformin. Another advantage of sitagliptin use is that it appears to be free from the adverse effects of weight gain and hypoglycemia that are associated with currently available treatments.