Role of a Pharmacist in Postdischarge Care for Patients With Kidney Disease: A Scoping Review.

OBJECTIVE: The objective was to explore and describe the role of pharmacists in providing postdischarge care to patients with kidney disease. DATA SOURCES: PubMed, Embase (Elsevier), CINAHL (Ebscohost), Web of Science Core Collection, and Scopus were searched on January 30, 2023. Publication date limits were not included. Search terms were identified based on 3 concepts: kidney disease, pharmacy services, and patient discharge. Experimental, quasi-experimental, observational, and qualitative studies, or study protocols, describing the pharmacist's role in providing postdischarge care for patients with kidney disease, excluding kidney transplant recipients, were eligible. STUDY SELECTION AND DATA EXTRACTION: Six unique interventions were described in 10 studies meeting inclusion criteria. DATA SYNTHESIS: Four interventions targeted patients with acute kidney injury (AKI) during hospitalization and 2 evaluated patients with pre-existing chronic kidney disease. Pharmacists were a multidisciplinary care team (MDCT) member in 5 interventions and were the sole provider in 1. Roles commonly identified include medication review, medication reconciliation, medication action plan formation, kidney function assessment, drug dose adjustments, and disease education. Some studies showed improvements in diagnostic coding, laboratory monitoring, medication therapy problem (MTP) resolution, and patient education; prevention of hospital readmission was inconsistent. Limitations include lack of standardized reporting of kidney disease, transitions of care processes, and differences in outcomes evaluated. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: This review identifies potential roles of a pharmacist as part of a postdischarge MDCT for patients with varying degrees of kidney disease. CONCLUSIONS: The pharmacist's role in providing postdischarge care to patients with kidney disease is inconsistent. Multidisciplinary care teams including a pharmacist provided consistent identification and resolution of MTPs, improved patient education, and increased self-awareness of diagnosis.

The impact of tirzepatide and glucagon-like peptide 1 receptor agonists on oral hormonal contraception.

BACKGROUND: Tirzepatide is a dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) whose mechanism of action leads to a greater effect of gastric emptying (GE) than typical GLP-1 RAs. After the first dose of tirzepatide, GE is most substantially delayed. The drug then undergoes tachyphylaxis after subsequent doses. Although data on GLP1-RAs have historically demonstrated a lack of impact on bioavailability of oral hormonal contraceptives, manufacturer recommendations for tirzepatide indicate an interaction exists. OBJECTIVES: The objectives of this literature review were to review trial data on differences in the impact of tirzepatide and GLP-1 RAs on oral hormonal contraceptives and provide an analysis of safety data between oral contraceptives and incretin agents. METHODS: PubMed and Google Scholar were searched using the generic name for the GLP-1/GIP agent, the generic names for GLP-1 RAs and hormonal contraceptives, followed by the generic names plus the interacting medication. A total of 6 clinical trials were selected for inclusion in the literature review. RESULTS: Of the 6 articles included in the review, one investigated the use of tirzepatide and showed a statistically significant reduction in area under the plasma drug concentration-time curve, maximum concentration, and time to maximum plasma concentration when tirzepatide was concomitantly administered with an oral hormonal contraceptive. The remaining 5 studies involving GLP-1 RAs did not show a statistically or clinically significant difference of impact of the agents on oral hormonal contraceptives. CONCLUSION: It could be suggested that tirzepatide had a greater impact on absorption of oral hormonal contraceptives than other GLP-1 RAs. The rapid dose escalation and greater delay on GE enhanced the impact on oral medications such as contraceptives. This differed from other GLP-1 RAs and creates a unique need for enhanced provider and patient education regarding the management of this interaction and future studies to evaluate this interaction further.

Impact of a pharmacist-driven COPD clinic on outcomes related to COPD in a federally qualified health center.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) affects many patients across the United States. Morbidity related to COPD can lead to increased financial strain to health care system. The United States is also shifting toward value-based payments, which rely on satisfying quality measures. Pharmacists are equipped with knowledge in adjusting medications based on symptom burden and guideline recommendations in COPD and are equipped with the proper knowledge to address quality measures. OBJECTIVE: This project aimed to determine the impact of a clinical pharmacy service centered around inhaler education and optimization on COPD morbidity and Uniform Data System (UDS) quality measure satisfaction in a federally qualified health center. METHODS: This quality improvement project consisted of patient referrals by and reports from a population health software for the pharmacy service from November 2022 to March 2023. The outcomes in this study included symptom change measured by follow-up modified Medical Research Council (mMRC) Dyspnea Scale in addition to changes in compliance with UDS quality measures. At follow-up, patients were administered another mMRC to evaluate treatment effect and determine quality measure satisfaction. RESULTS: Thirteen patient visits were conducted. Most patients were female (84.6%) with an exacerbation in the previous year (46.1%). All patients received an adjustment in their pharmacotherapy along with inhaler education. The average baseline mMRC score decreased from 2.1 to 0.6, indicating a decrease in overall COPD symptoms. Five quality measures of 13 were satisfied during the follow-up period. CONCLUSION: The COPD clinical pharmacy service led to an increase in guideline-driven pharmacotherapy regimens for patients with COPD while having an overall decrease in morbidity. Quality measures were also addressed and satisfied after the appointment. Continuation of this quality improvement service will ensure proper assessment of COPD along with addressing UDS quality measures.

Strategies for overcoming therapeutic inertia in type 2 diabetes: A systematic review and meta-analysis.

AIMS: To systematically investigate the effect of interventions to overcome therapeutic inertia on glycaemic control in individuals with type 2 diabetes. MATERIALS AND METHODS: We electronically searched for randomized controlled trials or quasi-experimental studies published between January 1, 2004 and December 31, 2019 evaluating the effect of interventions on glycated haemoglobin (HbA1c) control. Characteristics of included studies and HbA1c difference between intervention and control arms (main outcome) were extracted. Interventions were grouped as: care management and patient education; nurse or certified diabetes educator (CDE); pharmacist; or physician-based. RESULTS: Thirty-six studies including 22 243 individuals were combined in nonlinear random-effects meta-regressions; the median (range) duration of intervention was 1 year (0.9 to 36 months). Compared to the control arm, HbA1c reduction ranged from: -17.7 mmol/mol (-1.62%) to -4.4 mmol/mol (-0.40%) for nurse- or CDE-based interventions; -13.1 mmol/mol (-1.20%) to 3.3 mmol/mol (0.30%) for care management and patient education interventions; -9.8 mmol/mol (-0.90%) to -6.6 mmol/mol (-0.60%) for pharmacist-based interventions; and -4.4 mmol/mol (-0.40%) to 2.8 mmol/mol (0.26%) for physician-based interventions. Across the included studies, a reduction in HbA1c was observed only during the first year (6 months: -4.2 mmol/mol, 95% confidence interval [CI] -6.2, -2.2 [-0.38%, 95% CI -0.56, -0.20]; 1 year: -1.6 mmol/mol, 95% CI -3.3, 0.1 [-0.15%, 95% CI -0.30, 0.01]) and in individuals with preintervention HbA1c >75 mmol/mol (9%). CONCLUSIONS: The most effective approaches to mitigating therapeutic inertia and improving HbA1c were those that empower nonphysician providers such as pharmacists, nurses and diabetes educators to initiate and intensify treatment independently, supported by appropriate guidelines.

Frontline perspective on credentialing and privileging of ambulatory care pharmacists.

OBJECTIVES: To present the current state of, and frontline advice on, the implementation of successful credentialing and privileging processes for practicing pharmacists in the United States. METHODS: The American Society of Health-System Pharmacists (ASHP) Section Advisory Group on Compensation and Practice Sustainability surveyed ambulatory care pharmacists via ASHP Connect about the status, structure and oversight of their ambulatory care clinical practice sites with credentialed and privileged (C&P) pharmacists. KEY FINDINGS: Over 80% of survey respondents identified themselves as a C&P pharmacist, and over 90% indicated it is 'Important' or 'Very Important' for pharmacists to be C&P. Qualitative survey responses indicated the most important considerations for establishing or expanding a credentialing and privileging process for ambulatory care pharmacists were 'don't re-create the wheel', 'establish a physician champion and/or obtain leadership buy-in', 'be persistent and patient', 'develop a guidance document' and 'work within existing processes'. CONCLUSIONS: Starting a credentialing and privileging process is critical in preparation for, or response to, provider status recognition of pharmacists in the United States. When used with existing guidance documents on credentialing and privileging, 'front line' advice from practicing pharmacists can help promote expanded roles for pharmacists within healthcare systems.

Use of cannabidiol in anxiety and anxiety-related disorders.

OBJECTIVE: Cannabidiol (CBD) has a proposed novel role in the management of anxiety owing to its actions on the endocannabinoid system. The purpose of this systematic review was to evaluate the current evidence on the safety and efficacy of CBD in anxiety and anxiety-related disorders. DATA SOURCES: A literature search was conducted on PubMed, Google Scholar, and International Pharmaceutical Abstracts from database inception through June 2019. A bibliographic search of relevant articles was also conducted. STUDY SELECTION: Articles published from case reports, case series, or randomized controlled trials on human subjects were included in the review if they examined the safety and efficacy of CBD therapy in anxiety and anxiety-related disorders. DATA EXTRACTION: Two reviewers independently extracted the following data from the articles: year of publication; study design; patient characteristics (sex; type of anxiety disorder; use of concomitant anxiolytic therapy); dosing strategy and route of CBD administration; and safety and efficacy outcomes. RESULTS: Eight articles were included in the review: 6 small, randomized controlled trials; 1 case series; and 1 case report. These studies examined the role of CBD in the anxiety response of healthy volunteers; in generalized anxiety disorder; in social anxiety disorder; and in the anxiety component of posttraumatic stress syndrome. No articles that evaluated CBD in panic disorder, specific phobia, separation anxiety, and obsessive-compulsive disorder were identified. In the studies, CBD was administered orally as a capsule or as a sublingual spray and as either monotherapy or adjunctive therapy. Doses varied widely, with studies employing fixed CBD doses ranging from 6 mg to 400 mg per dose. Various anxiety assessment scales were used in the studies to assess efficacy, with CBD demonstrating improved clinical outcomes among the instruments. In general, CBD was well-tolerated and associated with minimal adverse effects, with the most commonly noted adverse effects being fatigue and sedation. CONCLUSION: CBD has a promising role as alternative therapy in the management of anxiety disorders. However, more studies with standardized approaches to dosing and clinical outcome measurements are needed to determine the appropriate dosing strategy for CBD and its place in therapy.

Students' Perceptions on a Business Plan Assignment for an Ambulatory Care Pharmacy Elective.

Objective. To evaluate a business-centered assignment implemented in a pharmacy elective course at two different institutions and analyze student perceptions of the delivery platforms used and the value and utility of the assignment. Methods. The ambulatory care electives at Butler University and Samford University introduce students to the expanding role of the ambulatory care pharmacist, emphasizing business plan development for new ambulatory care pharmacy services. As part of the elective, students are asked to work in groups to complete a business plan for a new ambulatory care service of their choosing. A survey was conducted to assess student perceptions on the assignment. Results. Of the 58 students who completed the business plan assignment, 49 completed the survey and were included in the data analysis. Overall, 100% of Samford students and 97% of Butler students either strongly agreed or agreed that the business plan was an innovative assignment unlike others completed in the curriculum. Samford students strongly agreed (100%) that if asked by a future employer to develop a new pharmacy service, concepts learned from this assignment would be useful, compared to 59% of Butler students who felt this way. While both the web and written delivery platforms had identical learning outcomes, the written business plan was the approach that the majority of students were more comfortable using. Conclusion. The business plan assignment was used as a method to familiarize students with the process of developing new ambulatory care pharmacy services. Based on survey results, the students perceived this to be an innovative assignment that allowed them to feel confident in developing and communicating ambulatory care business plans. As the practice of ambulatory care pharmacy expands, assignments such as this can be included in the pharmacy curriculum to meet the need for teaching effective business strategies to future pharmacists.

Efficacy of Bifidobacterium Species in Prevention of Necrotizing Enterocolitis in Very-Low Birth Weight Infants. A Systematic Review.

Necrotizing enterocolitis (NEC) is one of the most common and serious gastrointestinal diseases in preterm infants. The aim of this systematic review examines the effects of probiotics on preventing NEC in very-low birth weight (VLBW) infants with a focus on the Bifidobacterium species and its strains. A systematic review of randomized trials and retrospective studies analyzing the use of probiotics to prevent NEC in VLBW infants was conducted using PubMed, Cochrane Central Registry of Controlled Trials, and Google Scholar (1996-2016). Trials reporting NEC involving preterm infants who were given Bifidobacterium alone in the first month of life were included in the systematic review. Nine studies were suitable for inclusion. Nine studies involving VLBW infants were analyzed for strain specific effects of Bifidobacterium for the prevention of NEC ≥ Stage II. B breve showed some benefit in infants < 34 weeks GA with relative risk (RR) of 0.43 (95% confidence interval [CI]: 0.21-0.87) p = 0.019, but not in neonates < 28 weeks. B lactis greatly reduced the incidence of NEC with a RR 0.11 (95% CI: 0.03-0.47), p = < 0.001. B bifidum was not widely studied but resulted in no cases of NEC. Bifidobacterium proved to be statistically significant in reducing the incidence of NEC in preterm infants.

Extended-Duration Use of Direct Oral Anticoagulants to Prevent VTE in Acutely III Medical Patients.

OBJECTIVE: To evaluate current clinical evidence for the use of direct oral anticoagulants (DOACs) for extended-duration thromboprophylaxis in the acutely ill medical population for venous thromboembolism (VTE) and bleeding events.
DATA SOURCES: Were obtained through a MEDLINE/PubMed search for clinical trials conducted from March 2008 to 2018 using relevant key words. Limitations of English and human subjects were applied to search results.
STUDY SELECTION AND DATA EXTRACTION: Forty-one articles were identified, and abstracts reviewed by the authors for inclusion of the study population (acutely ill medical patients) and VTE outcomes. Clinical studies evaluating the use of DOACs for extended duration of VTE prevention in acutely ill medical patients were included in the review, resulting in three clinical trials and two subgroup analyses. The participants enrolled had an overall mean age of 71.4 years.
DATA SYNTHESIS: The DOAC trials collectively demonstrated a positive outcome in composite endpoints of VTE prevention with extended-duration thromboprophylaxis in acutely ill medical patients compared with enoxaparin. As for safety, rivaroxaban and apixaban trials reported more major bleeding events compared with enoxaparin. The betrixaban trial demonstrated no difference in bleeding compared with enoxaparin.
CONCLUSION: DOACs reduced the number of VTE events in acutely ill medical patients on extended-duration thromboprophylaxis, but with an overall increased bleeding risk. An individualized patient approach based on risk factors should be utilized for treatment with extended-duration DOAC in the older adult population with recent hospitalization.

Opioid Prescribing Habits in a Family Medicine Residency Program for the Management of Non-Cancer Pain.

OBJECTIVES: 1. List components of the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain, 2. Describe the prescribing habits of medical residents and attending physicians within a family medicine residency program, 3. Discuss the direction of future research. METHODS: A report was generated for all patients with opioids listed as a medication at Christ Health Center family medicine clinic from July 2016 to June 2017. A total of 153 patients were identified with prescriptions written for chronic non-cancer pain indications. Clinical management via a retrospective chart review was completed utilizing a standardized data collection form centered around four of twelve recommendations within the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain: (1) Avoid concurrent opioid and benzodiazepine prescribing; (2) evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy; (3) perform urine drug testing before starting opioids and consider at least annually; and (4) offer/prescribe medication for opioid use disorder for all patients taking chronic opioids. RESULTS: A total of 153 prescriptions were written for chronic indications. The most common indications were chronic back pain (32.0%), unspecified chronic pain (31.4%), and osteoarthritis (9.8%). Average duration of therapy was 26.6 months. Forty-two (27.5%) patients were concurrently receiving benzodiazepine therapy. Eighteen (11.8%) patients performed a drug test before or during therapy. Twenty-two (14.4%) patients had documented discussion with their prescriber evaluating the benefits and harms of their opioid regimens. No patients were prescribed medication for opioid overdose. CONCLUSION: Prescribing habits did not align with the four-guideline recommendations evaluated. The need for provider-focused education on current pain management practice guidelines was identified.

Clinical potential of canagliflozin in cardiovascular risk reduction in patients with type 2 diabetes.

Cardiovascular disease is the leading cause of morbidity and mortality among patients with diabetes mellitus, as well as the leading diabetes-associated health care cost. The prevalence and associated impact of cardiovascular disease among those with diabetes engenders the need to identify cardiovascular effects of antihyperglycemic agents. This review seeks to evaluate the impact of canagliflozin, a SGLT2 inhibitor, on cardiovascular risk factors and outcomes. The 14 published trials to-date exploring various cardiovascular risk factors and outcomes among patients receiving canagliflozin were identified and included within the review. Overall these studies demonstrate that among patients with type 2 diabetes mellitus, canagliflozin results in decreased systolic and diastolic blood pressure, lower body weight, and also exhibits renoprotective effects. These findings were similar when canagliflozin was compared to placebo or other antihyperglycemic agents and explored among subsets such as those with chronic kidney disease. In addition, findings from the three trials exploring cardiovascular outcomes of canagliflozin included reduction in cardiovascular mortality and lower incidence of heart failure-associated hospitalizations. Results from studies including other SGLT2 inhibitors suggest that cardiovascular benefits are likely a class-effect found among current SGLT2 inhibitors. Continued research specific to canagliflozin is needed to clarify risks of adverse effects and determine optimal dosing requirements for canagliflozin in regard to cardiovascular risk reduction.

Betrixaban (Bevyxxa): A Direct-Acting Oral Anticoagulant Factor Xa Inhibitor.

Betrixaban (Bevyxxa): a direct-acting oral anti-coagulant factor Xa inhibitor.

The use of direct oral anticoagulants in inherited thrombophilia.

To review the use of the direct oral anticoagulant (DOAC) agents in inherited thrombophilia based on the literature. MEDLINE, International Pharmaceutical Abstracts, and Google Scholar searches (1970-May 2016) were conducted for case reports, case series, retrospective cohorts, or clinical trials using the key words: protein C deficiency, protein S deficiency, antithrombin deficiency, activated protein C resistance, Factor V Leiden, hypercoagulable, NOACs, dabigatran, apixaban, rivaroxaban, betrixaban, edoxaban, Xa inhibitor, direct thrombin inhibitor. Results were limited to English-only articles. Clinical studies evaluating the use of DOACs for hypercoagulable states related to inherited thrombophilia were selected and evaluated. Thrombophilia, a predisposition to thrombosis, manifests predominantly as venous thromboembolism. Causes of inherited thrombophilia include antithrombin deficiency, deficiencies of proteins C and S, and Factor V Leiden mutation. Many patients with thrombophilia receive anticoagulant therapy for primary or secondary prevention of VTE, historically either warfarin or a heparin product. DOAC's have been considered as potential alternatives to traditional agents based on their pharmacologic activity. Case reports and a post-hoc analysis of a clinical trial have indicated positive results in patients with inherited thrombophilia and VTE. Positive results have been reported for the use of DOACs in inherited thrombophilia. Further robust studies are needed for definitive decision making by clinicians.

Clinical Management of ADHD in a Family Medicine Residency Program: Comparison with AAP Guidelines.

OBJECTIVES: Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder. Research has shown that even with the growing incidence of children diagnosed as having ADHD, physicians may find providing optimal care to these patients challenging. Our objective was to contrast existing clinical management of ADHD in a family medicine setting with published American Academy of Pediatrics guidelines and review the literature pertinent to differences. METHODS: A report was generated for all visits with "ADHD" or "ADD" (attention-deficit disorder) as a current or past medical problem that had been addressed at the family medicine clinic from July 2012 to June 2014. A total of 60 pediatric patients were identified. A retrospective chart review of clinical practice and management patterns for these patients was completed using a standardized data collection form based on the 2011 ADHD treatment guidelines set by the American Academy of Pediatrics. RESULTS: Fifty-seven (95%) patients had documentation of at least one core symptom of ADHD, and 27 (45%) patients had documentation of these symptoms in more than one setting (clinic/school/home). Only 30 (50%) patients were assessed at the initial ADHD visit for coexisting conditions. Coexisting conditions were found to be present in 20 (33.3%) patients. Of these 20 patients, coexisting conditions were not addressed during the visit in 12 (60%) patients before drug therapy for ADHD was initially prescribed. Behavioral therapy was initiated as first-line monotherapy in one of the nine preschool-age patients (4-5 years old). Fifty-two (86.7%) patients received a preferred initial medication as identified by guidelines, and 41 (78.8%) of those patients received an appropriate initial dose. Fifty-one (85%) patients were assessed for improvement of symptoms, and 39 (65%) were assessed for adverse events. Of 62 documented medication adjustments, 54 (87.1%) adjustments coincided with current practice guidelines. Sixteen (26.7%) patients were referred to mental health specialists. CONCLUSIONS: This retrospective review identified areas of strength and weakness for attending physicians and medical residents in the diagnosis, evaluation, and treatment of children with ADHD. A significant need was identified for more physician-focused education on the evaluation of coexisting conditions and long-term management associated with ADHD therapy. Further training in the initiation of behavioral therapy as a first-line treatment above drug therapy and proper medication selection in children aged 4 to 5 years also are recommended.

Novel oral anticoagulants for heparin-induced thrombocytopenia.

To review the use of the novel oral anticoagulant (NOAC) agents for the treatment of heparin-induced thrombocytopenia (HIT) from relevant clinical trial data. A MEDLINE, International Pharmaceutical Abstracts, ClinicalTrials.gov, and Google-Scholar searches (1966-March 2016) were conducted using the keywords: thrombocytopenia, NOACs, dabigatran, apixaban, rivaroxaban, edoxaban, Xa inhibitor, direct thrombin inhibitor. Articles evaluating the new oral anticoagulants for thrombocytopenia published in English and using human subjects were selected. Eight clinical trials were identified. References cited in identified articles were used for additional citations. Approximately 12 million hospitalized patients each year are exposed to heparin for thromboprophylaxis. HIT, an immune-mediated, prothrombotic adverse reaction is a potential complication of heparin therapy. As a result, heparin products must be immediately withdrawn and replaced by alternative anticoagulants to compensate for the thrombotic risk associated with HIT. Limitations exist with the only currently FDA approved heparin alternative, argatroban. NOACs have been considered as potential alternatives to traditional agents based on their pharmacologic activity. Case reports have indicated positive results in patients, with clinical outcomes and tolerability supporting the use of the NOACs as alternative agents in the treatment of HIT. Positive results have been reported for the use of NOACs in the treatment of HIT. Further robust studies are needed for definitive decision making by clinicians.

Near-miss transcription errors: a comparison of reporting rates between a novel error-reporting mechanism and a current formal reporting system.

PURPOSE: The medication use process comprises several steps. In institutions without full implementation of computerized prescriber order entry (CPOE), transcription is a critical step in this process. As focus is increasingly placed on identifying near-miss errors, this study aimed to compare near-miss transcription error (NMTE) reporting rates between an institution's formal reporting system and an NMTE reporting mechanism. METHODS: Two NMTE reporting mechanisms were assessed for 3 months. These mechanisms included the institution's formal error-reporting system and a specific transcription error queue within the institution's order imaging software. Date, patient-care unit, and type of transcription error were recorded for each order image in the transcription error queue and for each transcription error reported formally. Following data collection, reporting rates for both systems were compared. RESULTS: Data collection spanned 92 days and an estimated 460,000 medication orders. In total, 1,563 NMTEs were reported using the transcription error queue and 12 errors were reported via the formal reporting mechanism. Of the 1,563 errors identified via the transcription error queue, 325 (20.79%) were of an unknown type. Reporting rates (with unknown errors removed) were 0.27% and 0.0026% for the novel system and formal reporting system, respectively (P < .001). CONCLUSION: Significantly more NMTEs were reported utilizing the novel system compared with the formal reporting system.

A review of the efficacy and safety of canagliflozin in elderly patients with type 2 diabetes.

OBJECTIVE: To review the efficacy and safety of canagliflozin (CAN) in elderly patients with type 2 diabetes mellitus (T2DM). DATA SOURCES: Studies were identified using PubMed, International Pharmaceutical Abstracts, MEDLINE, Academic Search Premier, SCOPUS, and Google Scholar from 2011 to August 2013. The following key words were reviewed: canagliflozin, canagliflozin elderly, canagliflozin geriatrics, dapagliflozin, sodium glucose cotransporter 2 (SGLT2) inhibitors, and SGLT2 receptor inhibitors. DATA EXTRACTION: Articles evaluating CAN for diabetes that were published in English and used human subjects were selected. Fifteen clinical trials were identified and evaluated. STUDY SELECTION: Of 15 identified articles, 2 articles, 2 published posters, and unpublished information from the manufacturer were chosen based on the mean age of the study subjects. DATA SYNTHESIS: Evidence that elderly patients with T2DM have less A1C reduction with CAN is presented; the benefit on A1C is significant. Systolic blood pressure (SBP) and body weight reduction in the elderly were consistent with younger patients. Adverse effects such as increased urinary frequency, genital mycotic infections, and urinary tract infections may discourage the use of CAN in the elderly patient. CONCLUSION: Treatment with CAN improves A1C levels, reduces SBP and body weight, and is overall well tolerated in older subjects with T2DM. Risks and benefits of treatment with CAN should be assessed in geriatric patients on a case-by-case basis. Safety in elderly patients was consistent with that of other phase 3 trials in the general population. Additional longterm cardiovascular studies are needed.

Aclidinium bromide for the treatment of chronic obstructive pulmonary disease.

PURPOSE: The safety and efficacy of the second U.S.-approved long-acting inhaled anticholinergic for controlling bronchospasm in patients with chronic obstructive pulmonary disease (COPD) are reviewed. SUMMARY: Aclidinium bromide (Tudorza, Forest Pharmaceuticals) is indicated for long-term maintenance therapy for COPD-associated bronchospasm. It is marketed as a 60-dose metered-dose inhaler to be used twice daily. In Phase II and III clinical trials involving a total of more than 3000 patients, daily use of aclidinium bromide was found to significantly improve selected key indicators of lung function (trough values for forced expiratory volume at one second [FEV1] and other FEV1 outcome measures) compared with placebo use. Other benefits of aclidinium bromide therapy, including a significant reduction in nighttime COPD symptoms, were demonstrated for up to one year. However, aclidinium bromide has not been consistently demonstrated to be more effective than the other currently available long-acting inhaled anticholinergic, tiotropium bromide. Furthermore, the clinical trials indicated no significant difference between aclidinium bromide and tiotropium bromide with regard to rates of systemic adverse effects. For some patients, aclidinium bromide may offer advantages over tiotropium bromide (e.g., a faster time to peak FEV1, lower cost of therapy). CONCLUSION: Aclidinium bromide is an inhaled anticholinergic that improves lung function measures in patients with COPD. The most common adverse effects during clinical trials of the drug were headache, nasopharyngitis, and cough, none of which occurred at significantly higher rates than were seen with placebo use.

A small group assignment gives students a novel opportunity to demonstrate current clinical controversies in a self-care course.

OBJECTIVE: To design and implement a small-group assignment on current event, nonprescription drug therapy questions in a self-care course, and to evaluate student performance in predefined areas. DESIGN: Students self-identified a current clinical question in nonprescription therapy, searched primary literature, and presented their findings to peers in class. ASSESSMENT: Students were evaluated using a grading rubric on communication skills, ability to retrieve and analyze biomedical literature, and ability to formulate and defend an evidence-based recommendation. Overall, students performed well in all competencies, with grades ranging from 84% to 100% (median=92%). Faculty members completing a postassignment survey gave positive feedback regarding the educational value of the assignment and the ease of use of the designed rubric. CONCLUSION: A course assignment that involved peer-to-peer presentations and dealt exclusively with applicable, relevant, clinical questions regarding nonprescription drug therapy gave students a novel opportunity to practice drug information skills.

Dolutegravir: An Integrase Strand Transfer Inhibitor for the Treatment of Human Immunodeficiency Virus 1 in Adults.

Objective: To review the efficacy, safety, pharmacokinetics, pharmacodynamics, administration, drug interactions, and cost of dolutegravir (Tivicay), a third in class integrase strand transfer inhibitor (INSTI), for the treatment of human immunodeficiency virus (HIV-1) in adults. Data Sources: MEDLINE, International Pharmaceutical Abstracts, ClinicalTrials.gov, and Google Scholar searches (January 2000 to May 2014) were conducted for articles published in English and limited to human subjects, using the key words antiretroviral drugs, HIV integrase strand transfer inhibitors, dolutegravir, DTG, and S/GSK1349572. Study Selection and Data Extraction: Following MEDLINE, International Pharmaceutical Abstracts, ClinicalTrials.gov, and Google Scholar searches, 6 clinical trials were identified and included in this review. Phase III/IV studies evaluating the safety and efficacy of dolutegravir in humans were selected and evaluated. Data Synthesis: In treatment naïve and experienced patients dolutegravir was noninferior to raltegravir at suppressing viral load when added to background therapy. Abacavir/lamivudine/dolutegravir was noninferior to efavirenz/emtricitabine/tenofovir disoproxil fumarate and darunavir/ritonavir plus background therapy at suppressing viral load. In patients with multiple-class antiretroviral resistance at baseline, dolutegravir decreased HIV RNA by 1.4 log10 copies/mL at day 8, 63% of patients had achieved virologic suppression at week 8, and retained potency in treatment-experienced INSTI-resistant patients up to week 48 or 96 of follow-up. Conclusion: Dolutegravir is a safe, effective, and well-tolerated treatment option for adults with HIV-1, even in the setting of resistance to other antiretrovirals.