Review of Best Practices for Diversity, Equity, and Inclusion Committees Within Colleges of Pharmacy.

Objective. To provide a review of best practices for diversity, equity, and inclusion (DEI) committees at United States colleges of pharmacy.Findings. In colleges of pharmacy, DEI committees can play a crucial role in promoting a culture change to ensure pharmacy graduates are equipped to provide equitable and representative care for the patients they serve. There is limited literature available on DEI committee composition, roles, and responsibilities, and their place within a college of pharmacy's organizational structure. A commitment to DEI should be part of the college's strategic plan and embedded and supported at all levels of the college and university to ensure success of DEI-related strategic initiatives. For a DEI committee to be effective, its composition should be intentional to include change agents, campus leaders, and members who are passionate and knowledgeable to execute the DEI goals. For sustainable change, involvement of the entire learning community and an organizational culture change is also important. Thus, DEI committees need to establish active bidirectional collaborations and communication with all key committees, offices, community leaders, and alumni to implement diversity goals.Summary. The DEI committee's established place in the organizational structure of the college is essential to ensure fair and appropriate representation of the community it serves. A clearly defined DEI committee with committee composition, roles, responsibilities, and its association with all constituents of the college and community can help achieve its intended strategic goals.

Journal club exams: A unique approach in an evidence-based health care course for student pharmacists.

PURPOSE: The purpose of this article is to reflect on the use of journal club exams in an evidence-based health care course for student pharmacists. DESCRIPTION: Three journal club exams were developed and administered: one on a randomized controlled trial, one on an observational study, and one on a meta-analysis. Prior to each exam, students were given about one week to evaluate a study on their own and in collaboration with their peers. The exam consisted of 25 multiple-choice questions that were specific to the study. Students completed the exam on an individual basis, while referring to an unmarked copy of the study. After each exam, a journal club presentation on the study was given by the instructor. ANALYSIS/INTERPRETATION: An analysis of the experience provided valuable insights. Journal club exams seemed to promote students' thorough reading of studies, extensive discussion of studies with peers, and active engagement during journal club presentations. However, the exams created some concerns for students and required a high workload for the instructor. CONCLUSIONS: Journal club exams may be a useful tool to teach evaluation of primary literature in an evidence-based health care course for student pharmacists. IMPLICATIONS: Faculty who are interested in this unique approach should carefully consider the advantages and disadvantages that were described in this reflection.

Amisulpride: A New Drug for Management of Postoperative Nausea and Vomiting.

OBJECTIVE: To review the pharmacology, efficacy, and safety of amisulpride and determine its role in the management of postoperative nausea and vomiting (PONV). DATA SOURCES: A PubMed search (1946 to November 2020) using the terms amisulpride and APD421 was conducted. STUDY SELECTION AND DATA EXTRACTION: Relevant reports on intravenous amisulpride were included. DATA SYNTHESIS: Six clinical trials were evaluated. In 4 trials on the prevention of PONV, a greater percentage of patients who received amisulpride 5 mg compared with placebo experienced a complete response (44%-60% vs 31%-33%, respectively, when used as monotherapy; 58% vs 47%, respectively, when used in combination with another antiemetic). In 2 trials on the treatment of PONV, a significantly greater percentage of patients who received amisulpride 10 mg compared with placebo experienced a complete response (31.4% vs 21.5%, respectively, in patients who had not received prophylaxis; 41.7% vs 28.5%, respectively, in patients who had received prophylaxis). Adverse effects included infusion site pain, chills, hypokalemia, procedural hypotension, and abdominal distension. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Amisulpride is effective for the management of PONV and may be less likely to cause QT prolongation and extrapyramidal symptoms than other dopamine antagonists. Additional information is needed on its use for chemotherapy-induced nausea and vomiting and in children. CONCLUSIONS: Amisulpride is an important new option for the multimodal management of PONV in adults, and it may be the preferred dopamine antagonist because of the more favorable safety profile that results from its unique pharmacological properties.

Lifitegrast: a novel drug for patients with dry eye disease.

The objective of this article is to review the pharmacology, efficacy, and safety of lifitegrast and determine its role relative to other agents in the management of dry eye disease. A PubMed search (1946 to December 2018) using the terms lifitegrast and SAR 1118 was conducted to identify relevant articles. In vitro or in vivo evaluations of lifitegrast published in the English language were eligible for inclusion. Phase II and III trials were selected for review of efficacy and safety. Four randomized controlled trials evaluated the efficacy and safety of lifitegrast 0.5% ophthalmic solution for 12 weeks, and 1 additional trial assessed safety for 1 year. In a majority of the trials, lifitegrast caused statistically significant improvements in inferior corneal fluorescein staining scores and eye dryness scores. The most common adverse effects were eye irritation, dysgeusia, and reduced visual acuity, and most were mild to moderate in severity. Lifitegrast has a novel mechanism of action and is safe and effective for the treatment of dry eye disease. At this time, lifitegrast may be considered as an option for patients who have an inadequate response to artificial tears.

Fecal microbiota transplantation for recurrent Clostridioides difficile infection.

PURPOSE: Randomized controlled trials investigating the efficacy and safety of fecal microbiota transplantation (FMT) for recurrent Clostridioides difficile infection (CDI) are reviewed, and practical issues for pharmacists to consider are discussed. SUMMARY: Eight randomized controlled trials evaluating the use of FMT for recurrent CDI were analyzed. The trials varied in the type of sample (fresh, frozen, lyophilized), route of administration (nasogastric tube, colonoscopy, enema, oral), and comparator agent (different type of FMT, vancomycin). Efficacy rates ranged from 43.8% to 96.2% with FMT, and safety data were relatively similar. With these favorable data, pharmacists are likely to be involved at multiple steps in the delivery of FMT to patients with recurrent CDI, including the procurement, documentation, and administration of various products and patient education. CONCLUSION: FMT is an option for recurrent CDI that is supported by findings of randomized controlled trials, although a preferred method for the delivery remains to be defined. Pharmacists can play an important role in the successful management of patients with recurrent CDI who may benefit from FMT.

Lesinurad: A Novel Agent for Management of Chronic Gout.

OBJECTIVE: To review the pharmacology, efficacy, and safety of lesinurad and determine its role relative to other agents in the management of chronic gout. DATA SOURCES: A PubMed search (1946 to February 2018) using the terms lesinurad and RDEA594 was conducted to identify relevant articles. STUDY SELECTION AND DATA EXTRACTION: In vitro or in vivo evaluations of lesinurad published in the English language were eligible for inclusion. Phase II and III trials were selected for review of efficacy and safety. DATA SYNTHESIS: Five clinical trials were evaluated. In 4 trials in which lesinurad was used in combination with a xanthine oxidase inhibitor (XOI), a greater percentage of patients receiving lesinurad 200 mg (54.0%-63.0%) compared with placebo (23.3%-46.8%) achieved a serum uric acid (sUA) level of <6 mg/dL at 1 to 6 months. In one trial involving lesinurad used as monotherapy, a sUA level of <6 mg/dL was achieved by a significantly greater percentage of patients receiving lesinurad 400 mg (29.9%) compared with placebo (1.9%) at 6 months. When used as combination therapy, the drug had an acceptable safety profile, with upper-respiratory-tract infection, nasopharyngitis, and hypertension occurring most commonly and transient renal-related events detected less frequently. CONCLUSIONS: Lesinurad has a novel mechanism of action and is safe and effective for the treatment of chronic gout. At this time, lesinurad may be considered as an add-on therapy for patients who have an inadequate response to maximum tolerated doses of a XOI.

Apremilast: A Novel Drug for Treatment of Psoriasis and Psoriatic Arthritis.

OBJECTIVE: To review the pharmacology, efficacy, and safety of apremilast and determine its role relative to other agents in the treatment of psoriasis and psoriatic arthritis. DATA SOURCES: A PubMed search (1946 to December 2015) using the terms apremilast and CC-10004 was conducted to identify relevant articles. STUDY SELECTION AND DATA EXTRACTION: In vitro or in vivo evaluations of apremilast published in the English language were eligible for inclusion. Controlled clinical trials that involved psoriasis or psoriatic arthritis were selected for review. DATA SYNTHESIS: Four trials were identified on the treatment of psoriasis. In those that involved doses of 30 mg twice daily, a significantly greater percentage of patients receiving apremilast (28.8% to 40.9%) compared with placebo (5.3% to 5.8%) achieved at least 75% improvement from baseline in Psoriasis Area and Severity Index score at 16 weeks. Two trials were identified on the treatment of psoriatic arthritis. In the one that involved a dose of 30 mg twice daily, a significantly greater percentage of patients receiving apremilast (38.1%) compared with placebo (19.0%) achieved the American College of Rheumatology criteria for 20% improvement at 16 weeks. In all trials, the drug had an acceptable safety profile, with the most common adverse effects of diarrhea, nausea, and headache. CONCLUSIONS: Apremilast has a novel mechanism of action and is safe and effective for the management of psoriasis and psoriatic arthritis. At this time, apremilast should be reserved for patients unable to take disease-modifying antirheumatic drugs.

Principles in the Evaluation of Systematic Reviews.

Literature reviews summarize information from individual studies and are an important tool in the practice of evidence-based medicine. Various types of reviews, including narrative and systematic reviews, may be found within the biomedical literature. Systematic reviews are the strongest type and are often rated as the highest level of evidence. Thus it is important that clinicians understand how to evaluate them critically. This article is intended to enhance clinicians' understanding of the unique methods commonly used in systematic reviews by using the reporting standards to formulate evaluation principles. Explanations of the statistical tests and types of biases that are frequently encountered in systematic reviews are discussed. Lastly, an evaluation of a meta-analysis using these principles is provided.

Safety of varenicline in patients with cardiovascular disease.

Smoking cessation lowers the risk of death substantially in patients with cardiovascular disease. Although varenicline is an effective medication for smoking cessation, its safety in this population has been questioned and evaluated in several studies. In 2 randomized controlled trials of patients with cardiovascular disease, the rates of serious cardiovascular events were up to 2% higher in patients receiving varenicline than placebo, though the differences were not statistically significant. In the first meta-analysis of mostly trials involving patients with a history of cardiovascular disease, varenicline was found to significantly increase the risk of cardiovascular events by 72%; however, a second meta-analysis did not find a significant increased risk. In an observational study, varenicline was not associated with an increased risk of events when compared to bupropion in a subgroup analysis of patients with a history of cardiovascular disease. Because the evidence on the safety of varenicline in this population is limited and conflicting, additional data are needed to formulate stronger conclusions. In the meantime, health care professionals should consider individual smoking patterns, concomitant medical conditions, and cost when recommending smoking cessation pharmacotherapy for patients with cardiovascular disease.

An evaluation of the use of oral bisphosphonates and risk of esophageal cancer.

OBJECTIVE: To evaluate the use of oral bisphosphonates and risk of esophageal cancer. DATA SOURCES: MEDLINE (1948-October 2011) was searched using the terms esophageal cancer, esophageal carcinoma, bisphosphonate, bisphosphonates, etidronate, pamidronate, alendronate, tiludronate, risedronate, zoledronic acid, and ibandronate. Citations from relevant publications were reviewed for additional information. STUDY SELECTION AND DATA EXTRACTION: A comprehensive review of the available literature was performed. DATA SYNTHESIS: Two summaries of case reports and 3 observational studies were retrieved and reviewed. Oral bisphosphonates can cause esophageal irritation; therefore, it is biologically plausible that they may increase the risk of esophageal cancer. Although many cases were reported, causality was difficult to determine due to their weak methodology, and subsequent evaluations from national registers did not support an increased risk. Of the 3 observational studies (1 in patients with Barrett's esophagus and 2 using the same patient database), only 1 found an increased risk with use of daily or weekly regimens, and significant limitations were noted in each. CONCLUSIONS: Evidence on the use of bisphosphonates and risk of esophageal cancer is weak and conflicting. Additional studies are needed to further evaluate this issue and formulate stronger conclusions. In the meantime, health care professionals should ensure that patients take oral bisphosphonates properly to minimize esophageal irritation, are prescribed regimens that minimize exposure if adherence is difficult, and are evaluated for discontinuation of the drugs if appropriate. For patients at increased risk of esophageal cancer for other health reasons, nonoral bisphosphonates may be considered.

Cranberry and warfarin interaction: a case report and review of the literature.

This case reports on a patient whose International Normalized Ratio (INR) increased after ingestion of cranberry sauce while stabilized on warfarin. It is followed by a review of the published literature on the potential interaction between the two.An 85-year-old woman on chronic warfarin therapy for atrial fibrillation experienced INR elevations of two- to three-fold after two separate ingestions of cranberry sauce. In each case, her INR values decreased after withholding three to four doses and resuming a similar maintenance dose of warfarin. Although the majority of the pharmacokinetic and pharmacodynamic studies did not find a significant interaction between cranberry and warfarin, several case reports indicate that cranberry products may increase INR values in patients on warfarin. Practitioners should consider cranberry usage as a potential contributor in the evaluation of supratherapeutic INR values in patients on warfarin.

Elevated international normalized ratio associated with use of dronedarone and warfarin.

OBJECTIVE: To describe a case of elevated international normalized ratio (INR) after addition of dronedarone to warfarin therapy. CASE SUMMARY: A 72-year-old white female with a history of tinnitus, gastroesophageal reflux disease, and permanent pacemaker implantation was taking warfarin (target INR 2-3) and sotalol for chronic atrial fibrillation; atorvastatin for hyperlipidemia; and risedronate for osteopenia. Her warfarin therapy had been managed by a nurse-run anticoagulation clinic for several years. During the prior year, her INR had been stable with a weekly dose of warfarin 25 mg. After persistent episodes of atrial fibrillation, the antiarrhythmic agent was changed from sotalol to dronedarone 400 mg twice daily. Approximately 10 days after starting dronedarone, the INR was 4.8; she stated that there was no bleeding. The warfarin dose was decreased to 20 mg/wk, and the INR remained stable with that dosage for the next 11 months. DISCUSSION: Postmarketing surveillance has revealed cases of increased INR values with or without bleeding in patients taking warfarin who were started on dronedarone. In this case, the Horn Drug Interaction Probability Scale suggested a probable causality for an interaction between dronedarone and warfarin. Based on current knowledge, this interaction may involve an indirect gastrointestinal mechanism and/or a direct pharmacokinetic mechanism. CONCLUSIONS: Clinicians should monitor patients who are taking warfarin and dronedarone for INR changes and bleeding episodes about 1 week after initiation of dronedarone. If a significant interaction is noted, the warfarin dosage should be decreased and the patient should be monitored within 2 weeks to assess the need for further adjustments.

Prasugrel: a novel antiplatelet agent.

PURPOSE: The pharmacology, pharmacokinetics, safety, and adverse effects of prasugrel, a novel antiplatelet agent, are described. SUMMARY: Prasugrel is a third-generation thienopyridine. Like clopidogrel, prasugrel is a prodrug requiring hepatic metabolism to its active form to bind irreversibly to the P2Y(12) adenosine diphosphate receptor and inhibits platelet aggregation for the life of the platelet. Prasugrel's pharmacokinetic profile has not been clearly defined. Several preclinical and early-phase clinical trials of prasugrel have been completed. Five trials have assessed the platelet aggregation of prasugrel alone or compared with placebo or clopidogrel. Certain populations with acute coronary syndrome (ACS) may be at higher risk for major bleeding episodes leading to fatal events when using prasugrel with other antithrombotic agents and antiplatelet agents. Information on drug or food interactions with prasugrel is limited. Since prasugrel is still under investigation, an official recommended dosage regimen has yet to be determined. Clinical trials are still being conducted to determine prasugrel's exact place in therapy. In early trials, prasugrel has demonstrated a faster onset of action, higher rate of platelet inhibition, and lower rate of response variability compared with clopidogrel. CONCLUSION: Prasugrel has demonstrated a greater platelet inhibition and a decreased incidence of ischemic events compared with clopidogrel, but with an increased incidence of bleeding events. Future studies with prasugrel should determine its optimal dosage regimen to minimize bleeding risks and evaluate its outcomes in ACS and safety profile in special patient populations.