Assessing Confidence and Competence of Student Pharmacists in a Virtual Medication Adherence Training Program.

OBJECTIVE: To assess the impact of a virtual medication adherence training (VMAT) program on students' perceived confidence and perceived competency in delivering medication adherence services via telehealth. METHODS: This pilot pre-/post-observational study consisted of 2 subsequent sections: (1) 4 asynchronous self-study modules via Canvas (Instructure, Inc.) learning management system, and (2) 2 live application-based sessions involving virtual and telephonic standardized patients. A pre-/post-survey was given to first-, second-, and third-year Doctor of Pharmacy students to assess perceived confidence and perceived competence. Participants completed a 5-question multiple-choice quiz before and after each module to assess knowledge. RESULTS: Students' overall perceived confidence and perceived competency significantly increased upon completing VMAT. Knowledge in each module assessment also significantly improved. During the assessment of performance throughout the live sessions, most participants lost points when resolving issues within the interaction, addressing the need for patient follow-up, and assessing patient knowledge of medication adherence. CONCLUSION: This novel VMAT suggests that this or similar programs would be beneficial to improve pharmacy students' perceived confidence, perceived competence, and knowledge in delivering virtual medication adherence services in the telehealth setting. The incorporation of such training within the didactic curriculum of doctoral pharmacy programs should be considered to improve patient care skills for future medication experts.

Barriers and Best Practices on the Management of Opioid Use Disorder.

Opioids refer to chemicals that agonize opioid receptors in the body resulting in analgesia and sometimes, euphoria. Opiates include morphine and codeine; semi-synthetic opioids include heroin, hydrocodone, oxycodone, and buprenorphine; and fully synthetic opioids include tramadol, fentanyl and methadone. In 2021, an estimated 5.6 million individuals met criteria for opioid use disorder. This article provides an overview of the pharmacology of heroin and non-prescription fentanyl (NPF) and its synthetic analogues, and summarizes the literature related to the management of opioid use disorder, overdose, and withdrawal. This is followed by a description of barriers to treatment and best practices for management with a discussion on recent updates and their potential impact on this patient population. This is followed by a description of barriers to treatment and best practices for management with a discussion on recent updates and their potential impact on this patient population.

Identification of Inappropriate Antibiotic Orders During Implementation of a Multidisciplinary Antimicrobial Stewardship Program Within the Primary Care Setting.

OBJECTIVE: The aim of the study was to describe implementation of an outpatient antibiotic stewardship program at primary care practices in South Florida and the proportion of appropriate and inappropriate orders and reasons for inappropriateness during the intervention. METHODS: An antibiotic stewardship committee at a large hospital system implemented aspects of The Core Elements of Outpatient Antibiotic Stewardship at outpatient facilities in 2018. Interventions included an education/awareness campaign directed at prescribers (audit and feedback, routine education at prescribers' meetings, availability of updated guidelines in a shared drive and antibiogram via intranet) and patients (posters, tear-off sheets on symptom relief for viral illness). Orders were evaluated using clinical documentation, current antibiogram, and Infectious Diseases Society of America guidelines. An appropriate order was defined as a correct antibiotic and dose/frequency and duration of therapy. An inappropriate antibiotic order was defined as not meeting 1 or more of the abovementioned conditions. Descriptive statistics assessed the data. RESULTS: In this retrospective review of 2934 oral antibiotic orders from January 1 to December 31, 2018, 2565 (87.4%) were necessary while 369 (12.6%) were unnecessary. Of 2565 necessary orders, 1448 (56.5%) were appropriate while 1117 (43.5%) were inappropriate. Of 1117 inappropriate orders, 24.9% had all 3 conditions; 41.5% of inappropriate orders were solely due to wrong duration of therapy. CONCLUSIONS: Although our institution demonstrated commitment to optimizing antibiotic prescribing by providing resources to clinicians and patients about evidence-based antibiotic prescribing, inappropriate antibiotic prescribing was persistent. The interventions used must continue to evolve and include point-of-care access to guidelines and clinical decision support tools.

Impact of pharmacy-supported interventions on proportion of patients receiving non-indicated acid suppressive therapy upon discharge: A systematic review and meta-analysis.

OBJECTIVE: Conduct a systematic review and meta-analysis to estimate the impact of pharmacy-supported interventions on the proportion of patients discharged from the hospital on inappropriate acid suppressive therapy (AST). METHODS: To identify studies, the following databases were systematically searched on October 14th, 2018 and repeated on September 12th, 2019: Ovid MEDLINE(R) and In-Process & Other Non-Indexed Citations and Daily, Embase.com, CINAHL, Web of Science, Cochrane CENTRAL (EBSCO), and ClinicalTrials.gov. Eligible studies consisted of adults, intervention and historical/usual care groups, description of active pharmacy-supported intervention, and proportion of patients discharged on inappropriate AST. Qualitative assessments and quantitative analyses were performed. Modified funnel plot analysis assessed heterogeneity. Preferred reporting items of systematic reviews and meta-analyses (PRISMA) methodology was used to evaluate studies in this review. RESULTS: Seventeen publications resulting in 16 studies were included in the review. Using random effects model, meta-analysis showed a significant reduction in the odds of being discharged on inappropriate AST from the hospital in the pharmacist-supported intervention arm versus comparator (Odds Ratio 0.33 [95%CI 0.20 to 0.53]), with significant heterogeneity (I2 = 86%). Eleven studies favored pharmacy-supported interventions, four were inconclusive and one favored usual care. Using modified funnel plot analysis, our final evaluation was distilled to 11 studies and revealed a similar outcome (OR 0.36 [95%CI 0.27 to 0.48]), but with less heterogeneity (I2 = 36%). CONCLUSION: This systematic review and meta-analysis showed that pharmacy-supported interventions were associated with a significantly reduced probability of patients discharged on inappropriate AST. However, heterogeneity was high and may affect interpretation of results. Using funnel plot optimization method, three positive and two negative studies were objectively removed from analyses, resulting in a similar effect size, but with less heterogeneity. To improve study quality, future researchers should consider utilizing a pre-post, multi-arm, prospective design with sampling randomization, training of data extractors (preferably two extractors), re-evaluating a small dataset to check for agreement and providing a comprehensive methodology in subsequent publications.

Efficacy and Usability of Intranasal Glucagon for the Management of Hypoglycemia in Patients With Diabetes: A Systematic Review.

PURPOSE: Hypoglycemia is a common and sometimes life-threatening adverse event associated with insulin, sulfonylurea, and meglitinide therapies. In patients who are disoriented or unconscious, treatment with injectable glucagon is recommended, along with a call for emergency medical assistance. However, limitations of this formulation include difficulty with reconstitution and an unwillingness to administer an injection. In July 2019, intranasal glucagon was approved for use in the acute treatment of severe hypoglycemia in patients ≥4 years of age with diabetes. The purpose of this systematic review was to describe the efficacy, usability, and tolerability of intranasal glucagon 3 mg in patients with diabetes. METHODS: To identify studies, the following databases were systematically searched: Ovid MEDLINE, Embase, CINAHL, Web of Science Core Collection, Cochrane CENTRAL (EBSCO), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform, from inception to March 3, 2020. Comparative studies included patients with diabetes and an active comparator. Usability studies enrolled participants who used a device for glucagon administration. FINDINGS: Ten studies met the inclusion criteria. In 5 comparative studies in insulin-induced hypoglycemia (intranasal vs injectable glucagon), the criteria for successful treatment varied. In 3 studies, it was defined as an increase in blood glucose of ≥70 mg/dL (3.9 mmol/L) or an increase of ≥20 mg/dL (1.1 mmol/L) within 30 min of glucagon administration. In 1 study, the criteria were stricter, with success defined as an increase in blood glucose of ≥27 mg/dL (≥1.5 mmol/L) within 15 min. In the pediatrics study, success was defined as an increase in blood glucose of ≥25 mg/dL (1.4 mmol/L) within 20 min. In 2 studies of intranasal glucagon monotherapy in clinical practice, the primary end point was the percentage of patients who awakened or returned to normal status within 30 min of intranasal glucagon administration. In these 7 studies, almost all of the participants met the criteria for success as defined in their respective studies. The mean time to treatment success was between 10 and 20 min with intranasal and injectable glucagon. Nausea and vomiting were common adverse events with both formulations; watery eyes and runny nose occurred more frequently with intranasal glucagon. In 3 simulation studies, caregivers and noncaregivers administered intranasal glucagon within 1 min versus 1.3-5 min with IM glucagon. IMPLICATIONS: In patients who are disoriented or unconscious, treatment with injectable or ready-to-use intranasal glucagon increases blood glucose within 15-30 min. Intranasal glucagon was preferred by most caregivers and noncaregivers due to its ease of use. Additional studies of intranasal glucagon in younger patients (1-<3 years of age), pregnant women, and in comparison with SC glucagon are needed to further clarify bioavailability, efficacy, and tolerability.

Allocation of faculty and curricular time to the teaching of transitions of care concepts by colleges of pharmacy.

INTRODUCTION: To determine the allocation of faculty and curricular time to the teaching of transitions of care (ToC) concepts by colleges of pharmacy (COPs) to equip students with the necessary skills for the provision of these services. METHODS: A novel 15-question anonymous electronic survey was sent to 136 pharmacy practice chairpersons. RESULTS: Response rate was 26.5% (n = 36). Of these, 47% employed ToC faculty while 44% are not actively recruiting for that position in the foreseeable future. Median total curriculum hours dedicated to teaching ToC was four (interquartile range two to 10 hours). Medication reconciliation skills were taught didactically and via interactive lab sessions by 53% of respondents. Only 11% offered an interdisciplinary ToC program. A significant association between not having ToC faculty and lack of implementation of ToC concepts within a pharmacy curriculum (p = 0.02, Fisher's Exact) and practice site (p = 0.045, Pearson's) was observed. Barriers to adopting ToC within the curriculum (e.g., uncertainty of placement within curriculum, resistance by faculty and administrators) and at a practice site (e.g., inadequate infrastructure to accommodate ToC delivery, ToC faculty unavailability and resistance by other health care providers) were reported. DISCUSSION AND CONCLUSIONS: This study demonstrated that COPs devote curricular time to ToC activities and involve dedicated faculty in the provision of these services. Several barriers to employing ToC faculty and planning additional time in the curriculum for teaching these skills were identified. Future research should determine the best methods for training students to ensure competence in performing ToC tasks.

Oral anticoagulation therapy upon discharge in hospitalized patients with nonvalvular atrial fibrillation: a retrospective cohort study.

OBJECTIVES: Availability of direct oral anticoagulants and CHA2DS2VASc/HAS-BLED scoring tools underscore the importance of appropriate and safe use of oral anticoagulation therapy (OACT). The purpose of this study was to evaluate stroke prevention pharmacotherapy in adult patients with nonvalvular atrial fibrillation (NVAF) discharged from a large, community-based hospital. METHODS: A retrospective cohort study was conducted using a de-identified data collection sheet for data extraction (demographics, admitting diagnosis, OACT prior to admission and at discharge, concomitant medications that could increase bleed risk and/or acid-suppressive therapies). CHA2DS2VASc and HAS-BLED scores were calculated. Descriptive statistics were generated to describe all parameters. Frequency counts and percentages summarized categorical variables while mean ± standard deviation were determined for continuous variables. RESULTS: Data from 180 patients were evaluated and of these 177 (98.3%) received OACT regardless of stroke risk upon discharge, as determined by CHA2DS2VASc scoring tool. The mean CHA2DS2VASc and HAS-BLED scores were 3.61 ± 1.7 and 2.13 ± 1.26, respectively. At discharge, eight patients at low-stroke risk received OACT for unclear reasons, one intermediate-stroke risk patient received aspirin only, and two patients at high-stroke risk did not receive OACT due to concerns about bleeds. In 66 patients at high-bleed risk, only half received concomitant acid-suppressive therapy. CONCLUSIONS: Decision to add OACT is often guideline-driven, however, individualized circumstances in which clinicians and patients find themselves are also important considerations. Determination of ischemic stroke risk should be performed with CHA2DS2VASc scoring tool to exclude patients who may not benefit from OACT. HAS-BLED scoring tool should be used to identify any modifiable bleeding risk factors present with subsequent initiation of management strategies. Availability of complete medical histories and meticulous documentation are necessary for multiple clinicians to continuously determine optimal pharmacotherapy during follow-up visits.

Patient perspectives on peripheral neuropathic pain experience within the community.

Purpose of this cross-sectional study was to explore the relationship between neuropathic physical complaints (NPC) and quality-of-life (QoL) in community-dwelling patients with diabetes in Broward County, Florida. Adult patients were invited to complete a 10-minute paper questionnaire at a community hospital between October 2014-April 2016. Analysis of data from 124 participants (60 with distal symmetric polyneuropathy (DSPN) diagnosis versus 64 without DSPN diagnosis) with NPC, showed those with DSPN had a longer duration of diabetes, suffered a higher number of NPC, and had a lower QoL (all p≤0.001) with more impediments to performing daily activities. While differences in pain severity and QoL were present in patients with DSPN versus those without DSPN diagnosis, NPC were still reported by those without DSPN diagnosis. Healthcare providers are encouraged to identify possible NPC during earlier stages of glycemic dysregulation and address foot care issues promptly to mitigate the disease's effect on QoL.

An updated systematic review and meta-analysis on the efficacy and tolerability of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes with moderate to severe chronic kidney disease.

OBJECTIVE: This updated meta-analysis determines the effect of dipeptidyl peptidase-4 inhibitors on glycemic and tolerability outcomes in patients with type 2 diabetes mellitus and chronic kidney disease with glomerular filtration rate of ⩽60 mL/min or on dialysis. METHODS: In all, 14 citations were identified from multiple databases. Qualitative assessments and quantitative analyses were performed. RESULTS: There were 2261 participants, 49-79 years of age, 49% men and 44% Caucasians. In seven placebo-comparator studies, reduction in hemoglobin A1c at weeks 12-24 was 0.55% (95% confidence interval: -0.68 to -0.43), P < 0.00001). In three sulfonylurea-comparator studies, dipeptidyl peptidase-4 inhibitors did not significantly reduce hemoglobin A1c at weeks 52-54 (-0.15% (95% confidence interval: -0.32 to 0.02)). In one sitagliptin versus albiglutide study, albiglutide significantly reduced hemoglobin A1c in patients with moderate renal impairment (-0.51%). A similar reduction in hemoglobin A1c was seen with sitagliptin versus vildagliptin (-0.56% vs -0.54%). Compared with placebo or sulfonylurea, dipeptidyl peptidase-4 inhibitors did not significantly reduce hemoglobin A1c after 12 and 54 weeks in patients on dialysis. Hypoglycemia was reported by ~30% of patients in both dipeptidyl peptidase-4 inhibitors and placebo groups over 24-52 weeks. While hypoglycemia was more common with a sulfonylurea at 52-54 weeks (risk ratio: 0.46 (95% confidence interval: 0.18 to 1.18)), there was significant heterogeneity (I (2) = 87%). Limitations included high drop-out rate from most studies and small number of active-comparator studies. CONCLUSIONS: Dipeptidyl peptidase-4 inhibitors in patients with chronic kidney disease caused a modest reduction in hemoglobin A1c versus placebo, but not when compared with sulfonylureas or albiglutide, or when used in patients on dialysis. Additional active-comparator studies are needed to further elucidate the role of dipeptidyl peptidase-4 inhibitors in patients with chronic kidney disease stages 3-5 or on dialysis.

Potential for dipeptidyl peptidase-4 inhibitor and sodium glucose cotransporter 2 inhibitor single-pill combinations.

With prolonged duration of Type 2 diabetes mellitus, most patients need a combination of antihyperglycemic drugs to reach their target HbA1c. Evidence shows that single-pill combinations (SPCs) may increase patient satisfaction, adherence, and reduce overall health-care costs. Several SPCs containing metformin and another oral antidiabetic drug (OAD) are available on the market. Although well established in clinical practice, long-term durability and tolerability of traditional OADs can be inadequate. Dipeptidyl peptidase (DPP)-4 inhibitors and sodium glucose cotransporter (SGLT) 2 inhibitors are two newer classes of OADs that are efficacious and are less likely to induce adverse effects such as gastrointestinal reactions, hypoglycemia and weight gain when compared with metformin, sulfonylureas, and thiazolidinediones. This article describes current efficacy and safety data of DPP-4/SGLT2 inhibitor combination therapy. Pharmacokinetics, mechanism-of-action based rationale for the combination and timing of the addition of a SPC to the treatment regimen are discussed.

Social media use and educational preferences among first-year pharmacy students.

BACKGROUND: Social media may offer a means to engage students, facilitate collaborative learning, and tailor educational delivery for diverse learning styles. PURPOSE: The purpose of this study is to characterize social media awareness among pharmacy students and determine perceptions toward integrating these tools in education. METHODS: A 23-item survey was administered to 1st-year students at a multicampus college of pharmacy. RESULTS: Students (95% response rate; N = 196) most commonly used wikis (97%), social networking (91%), and videosharing (84%). Tools reported as never used or unknown included social bookmarking (89%), collaborative writing (84%), and RSS readers (73%). Respondents indicated that educational integration of social media would impact their ability to learn in a positive/very positive manner (75%) and make them feel connected/very connected (68%). CONCLUSIONS: Selectively targeting social media for educational integration and instructing pharmacy students how to employ a subset of these tools may be useful in engaging them and encouraging lifelong learning.

Improvement in surrogate endpoints by a multidisciplinary team in a mobile clinic serving a low-income, immigrant minority population in South Florida.

To determine effect on surrogate endpoints for cardiovascular disease (CVD), we performed a retrospective chart review of 114 patients seen by a multidisciplinary team that provided primary care services in a mobile clinic over 12 months. Eligible patients had outcomes available for at least six months. Mixed effect modeling examined variation in surrogate markers for CVD: blood pressure (BP), heart rate, and body mass index. Repeated measures ANOVA compared lipids, hemoglobin A1c, and medication use from baseline and throughout study. Most patients were female (75%), Haitian (76%), and low-income ($747/month) with average age 63 years. Common diagnoses were hypertension (82%) and hyperlipidemia (63%). Significant reduction in systolic BP, total- and LDL-cholesterol, and hemoglobin A1c were found (p<.05). Use of ACE-inhibitors, beta-blockers, diuretics, aspirin, metformin, and statins increased significantly (p<.05). Mobile clinic with a multidisciplinary team improved surrogate endpoints over 12 months in underserved, low-income, mostly foreign-born, Haitian population in U.S.

Concurrent use of an audience response system at a multi-campus college of pharmacy.

OBJECTIVE: To assess the impact of an audience response system (ARS) on student engagement at a multi-campus college of pharmacy. METHODS: An online questionnaire was designed and administered to measure the impact of an ARS on student engagement, distance education, projected use, and satisfaction among pharmacy students for a course delivered across 3 sites via synchronous video transmission. RESULTS: Students reported that use of the ARS made it easier to participate (85.3%) and helped them to focus (75.7%) in classes when the lecturer was physically at a different site. They also valued that the ARS allowed them to respond anonymously (93.2%). A minority of students indicated that use of the ARS was distracting (11.8%). CONCLUSIONS: Implementation of an ARS was associated with positive student perceptions of engagement and may improve feelings of connectedness among students at schools with multiple sites. Use of ARSs could also represent a cognitive intercession strategy to help reduce communication apprehension.

A review of exenatide as adjunctive therapy in patients with type 2 diabetes.

BACKGROUND: Incretin glucagon-like peptide-1 (GLP-1) is a hormone released from cells in the gastrointestinal tract (GI), leading to glucose-dependent insulin release from the pancreas. It also suppresses postprandial hyperglycemia, glucagon secretion and slows gastric emptying. Exenatide (EXE), a functional analog of human GLP-1, was approved by the US FDA in April 2005. OBJECTIVE: This article reviews current primary literature on the clinical efficacy and safety of EXE in the treatment of type 2 diabetes mellitus (DM) and describes the pharmacokinetics, pharmacodynamics, dosing and administration of EXE. METHODS: English-language articles were identified through a search of MEDLINE (1966 to March 2009), International Pharmaceutical Abstracts (1970 to present), and Cochrane Database of Systemic Reviews (1995 to March 2009). Search terms included EXE, diabetes mellitus, postprandial hyperglycemia, gastric emptying, glucagon, pharmacokinetics and pharmacodynamics. Articles were selected for review if their designs were randomized, blinded and of controlled design that focused on clinical outcomes of patients with type 2 DM. RESULTS: EXE is administered subcutaneously in the thigh, abdomen or upper arm within the 60-minute period before the morning and evening meals. Its C(max) is reached within 2.1 hours, and its T(1/2) in 2.4 hours. EXE's metabolism is primarily through the kidneys. For the patients who received EXE 10 microg SC BID in three, 30-week, placebo-controlled studies with background sulfonylureas (SUs), metformin (MET), or SU + MET, there were significant reductions in HbA(1c) (0.77 to 0.86%), fasting plasma glucose (0.6 mmol/L) and body weight (1.6 to 2.8 kg) (P < or = 0.05 vs PCB) that were sustained in patients who completed two open-label phase trials with an additional 52 weeks of therapy. The use of thiazolidinediones was associated with a slight advantage over EXE in improving HbA(1c) along with increased weight gain; those who received EXE lost weight, but experienced more GI adverse effects. Patients who received EXE lost significant body weight while patients who received insulin gained weight. Patients receiving insulin had lower fasting, prelunch and predinner glucose excursions while patients in the EXE groups had lower postprandial glucose levels. Nausea was most frequently (>20%) reported in patients receiving the highest dose of EXE (10 microg SC BID vs 5 microg SC BID). CONCLUSIONS: EXE at the dose of 10 microg SC BID has been proven to decrease HbA(lc) by 1.3% +/- 0.1% and decrease body weight by up to 5.3 +/- 0.8 kg at week 82. Nausea was the most frequently reported adverse event (>20%) especially in patients being treated with EXE 10 microg SC BID. EXE can be safely added to MET therapy, SU therapy or MET + SU combination to effectively target glycemic goals in patients with type 2 DM. Long-term, head-to-head studies assessing the effect of the EXE +/- oral agents/insulins in patients with HbA(lc) > or = 10% are still needed to fully clarify the role of EXE in poorly controlled patients with type 2 DM.

Levocetirizine for the treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children.

BACKGROUND: Levocetirizine (LCZ) is a second-generation antihistamine that was approved in January 2008 for the relief of symptoms of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), and chronic idiopathic urticaria (CIU) in adults and children aged > or = 6 years. OBJECTIVES: This article reviews the available literature on the pharmacokinetics and pharmacodynamics, clinical efficacy and tolerability, and effect on quality of life (QoL) of LCZ. METHODS: A search of the English-language literature was performed using the following databases: MEDLINE (1966-February 2009), International Pharmaceutical Abstracts (19 70-February 2009), Database of Abstracts of Reviews of Effectiveness, Cochrane Database of Systematic Reviews, EMBASE Drugs & Pharmacology (1991-February 2009), Blackwell Synergy, CINAHL Plus with Full Text, EBSCOhost, ScienceDirect, and Wiley Interscience. The search terms were levocetirizine, allergic rhinitis, chronic idiopathic urticaria, antihistamine, pharmacokinetics, quality of life, drug interactions, case reports, and cost. Publications describing studies of > or = 2 weeks' duration that concerned the efficacy, tolerability, pharmacoeconomics, and/or QoL effects of LCZ were included in the review. RESULTS: In 4 studies in adult patients with moderate to severe PAR, LCZ 5 mg/d was associated with significant improvements in symptom scores for sneezing, rhinorrhea, and ocular/nasal pruritus at 4 to 6 weeks compared with placebo (P < or = 0.05). In 3 studies, nasal congestion scores were significantly improved within 4 to 6 weeks compared with placebo (P < 0.001). LCZ 5 mg/d was associated with improvements compared with placebo in scores for the ability to do housework, complete work activities, and engage in outdoor activities at 6 months (P < or = 0.011). In a 6-week study in children with moderate to severe SAR, LCZ 5 mg/d was associated with significant improvements compared with placebo in sneezing, rhin-orrhea, and itchy nose (P < 0.004); significant improvements in symptoms from baseline were also seen in a 4-week study in adults with SAR (P < 0.001). One study in patients with SAR reported no significant difference between LCZ and fluticasone compared with fluticasone monotherapy in terms of improvement in QoL, nasal airflow obstruction, sneezing, or pruritus. In a 6-week study in patients with moderate to severe CIU, LCZ 5 mg/d was significantly more effective than placebo in reducing overall CIU symptoms (P < 0.05). In two 4-week studies, one comparing LCZ 5 mg/d with placebo and the other comparing it with desloratadine (DSL), LCZ was significantly more effective than either comparator in terms of improvement in scores for pruritus severity (P < or = 0.001 vs placebo; P < 0.004 vs DSL) and duration (P < or = 0.001 vs placebo; P = 0.009 vs DSL). LCZ was significantly more effective than placebo (but not DSL) in reducing the number and size of wheals (both, P = 0.001). In a 12-week, open-label, crossover study, patients reported significantly longer symptom relief with cetirizine than LCZ (P < 0.005). The most commonly reported adverse events in two 6-month studies in adults with PAR treated with LCZ 5 mg/d included headache (23.8%), pharyngitis (19.4%), influenza (14.6%), fatigue (8.3%), and somnolence (8.3%). There is serious concern about the possibility of febrile seizures in infants treated with LCZ. Three pharmacoeconomic studies of LCZ 5 mg/d were identified, one comparing it with placebo in patients with PAR, one comparing it with placebo in patients with CIU, and another comparing it with second-generation antihistamines and montelukast in patients with PAR. Because of design limitations and differences in comparators in these studies, it was not possible to determine the cost-effectiveness of LCZ in the treatment of PAR or CIU. CONCLUSIONS: In the studies reviewed, LCZ 5 mg/d was effective in reducing symptoms of PAR, SAR, and CIU and improving QoL, with an acceptable tolerabili-ty profile. There is a need for studies of longer durations, head-to-head comparisons against other anti-histamines, drug-interaction studies, safety studies in infants, and cost-effectiveness analyses.

A review of the efficacy of smoking-cessation pharmacotherapies in nonwhite populations.

BACKGROUND: Cigarette smoking continues to be the leading cause of preventable morbidity and mortality in the United States. Research suggests that behavioral support strategies and pharmacotherapy can improve abstinence rates. However, both approaches, especially pharmacotherapy, have been understudied in nonwhite US populations. OBJECTIVE: The aim of this review was to evaluate the efficacy of smoking-cessation pharmacotherapy in nonwhite US populations. METHODS: Using search terms smoking cessation, nicotine replacement therapy, bupropion SR, varenicline, minority, ethnicity, African American, black, Hispanic, American Indian, and Alaska Native, a literature search was conducted to identify English-language studies that evaluated the use of smoking-cessation pharmacotherapies in nonwhite patients in MEDLINE (1966\2-December 2007), International Pharmaceutical Abstracts (1980\2-January 2008), Database of Abstracts of Reviews of Effectiveness (1990\2-December 2007), and EMBASE Drugs & Pharmacology (1991\2-third quarter 2007). RESULTS: Nine studies were identified and assessed. Six studies looked at smoking-cessation pharmacotherapy in black smokers, 1 in Hispanic smokers, 1 in Native American smokers, and 1 in white and nonwhite smokers. In black smokers (N = 410; mean cigarettes per day [cpd], 20.4) who received the nicotine patch versus placebo, the 30-day self-reported abstinence rates were 21.5% versus 13.7% (P = 0.03) at 10 weeks and 17.1% versus 11.7% (P = NS) at 6 months. In black smokers (N = 600; mean [SD] cpd, 16.1 [7.5]) who received sustained-release (SR) bupropion 150 mg BID versus placebo for 7 weeks, the 7-day biochemically verified abstinence rates at weeks 6 and 26 were 36.0% versus 19.0% (Delta, 17%; 95% CI, 9.7\2-24.4; P < 0.001) and 21.0% versus 13.7% (Delta, 7.3%; 95% CI, 1.0\2-13.7; P = 0.02). Predictors of smoking cessation included use of bupropion SR (abstinence rate, 41.5% vs 21.1%; P<0.001); smoking nonmentholated cigarettes (abstinence rate, 28.3% in mentholated smokers [n = 417] vs 41.5% in nonmentholated smokers [n = 118]; P = 0.006); not smoking within 30 minutes of awakening (abstinence rate, 26.4% [n = 420] in those who did vs 48.7% [n = 115] in those who did not; P < 0.001); and lower baseline salivary cotinine levels (256.8 [137.0] ng/mL in those who became abstinent vs 305.6 [143.4] ng/mL in those who remained smokers; P < 0.001). In black light (or=7 consecutive days (odds ratio, 0.20; 95% CI, 0.05-0.77; P = 0.02). CONCLUSIONS: Data from the studies in this review support the use of smoking-cessation pharmacotherapy (nicotine patch and bupropion SR) in nonwhite patients. Black patients, who smoked within 30 minutes of awakening, smoked mentholated cigarettes, and had high salivary cotinine levels may have difficulty quitting regardless of the number of cigarettes smoked per day; therefore, determining the type of cigarettes smoked (mentholated vs nonmentholated) and salivary cotinine levels may be helpful in assessing the severity of smoking addiction and guide pharmacotherapy (eg, starting at higher doses of nicotine-replacement therapy in a light smoker). Other than smoking-cessation behavioral studies, there is a lack of congruent smoking-cessation pharmacotherapy studies in American Indian/Alaska Native, Hispanic, and other ethnic populations.

Effect of faculty-mediated interventions on pharmacy students' pursuit of postgraduate training.

PURPOSE: The influence of faculty-mediated interventions on the pursuit of postgraduate training (PGT) by pharmacy students was studied. METHODS: Three weeks before graduation, members of the class of 2005 (control group) at a Florida pharmacy school completed a questionnaire assessing their understanding of PGT opportunities. Members of the class of 2006 (intervention group) were exposed to faculty-mediated interventions during their final academic year of pharmacy school. The interventions consisted of informational pamphlets, a PGT booth during the school's career day, and PGT-related dinner programs. These students were surveyed before and after the interventions. RESULTS: Seventy-three percent (120/165) of control-group students and 63% (132/211) of intervention-group students completed the survey. Of the control students, 14% (15/108) reported plans to enter PGT after graduation. Sixteen percent (21/132) of intervention-group students reported such plans; the difference was not significant. All faculty-mediated interventions were reported to be helpful to students in making their postgraduation plans. Analysis of the combined groups suggested that students' interaction with faculty and residents during advance practice experiences positively affected pursuit of PGT. CONCLUSION: Students who received faculty- mediated interventions designed to inform them about PGT were not significantly more likely to pursue such training than students who did not receive the interventions. However, students reported the information to be helpful.

Pramlintide acetate injection for the treatment of type 1 and type 2 diabetes mellitus.

BACKGROUND: Amylin is a hormone cosecreted with insulin by the beta cells of the pancreas. It suppresses postprandial glucagon secretion and slows gastric emptying. Pramlintide acetate is an amylin analogue that was approved by the US Food and Drug Administration in March 2005. OBJECTIVE: This article reviews the current primary literature on the clinical efficacy and tolerability of pramlintide injection in the treatment of type 1 and type 2 diabetes mellitus (DM). Among other topics covered are the pharmacokinetics, pharmacodynamics, and dosing and administration of pramlintide. METHODS: Pertinent English-language articles were identified through a search of MEDLINE (1966-January 2007), International Pharmaceutical Abstracts (1970-present), Database of Abstracts of Reviews of Effectiveness (1995-January 2007), Cochrane Database of Systematic Reviews (1995-January 2007), and EMBASE Drugs & Pharmacology (1991-1st quarter 2007). The search terms included pramlintide, amylin, gastric emptying, pharmacokinetic, pharmacoeconomic, postprandial hyperglycemia, and glucagon. Articles were selected for review if they described studies having a randomized, double-blind, controlled design and included glycosylated hemoglobin (HbA(1c)) as an end point. RESULTS: Pramlintide is administered subcutaneously in the abdominal area or thigh immediately before each main meal to achieve maximal reductions in post-prandial glucose excursions. Its C(max) is reached within 20 minutes, and its t(1/2) is 48 minutes. Metabolism is primarily via the kidneys. Pramlintide therapy was associated with inhibition of postprandial glucagon secretion in 24 patients with type 2 DM; prolonged gastric emptying in 11 patients with type 1 DM; a 23% reduction in total energy intake in 11 patients with type 2 DM; and a reduction in markers of oxidative stress in 18 patients with type 1 DM (all, P <- 0.05 vs placebo). In two 52-week studies in patients with type 1 DM, the groups that received pramlintide 30 to 60 microg QID (n = 243), 60 microg TID (n = 164), and 60 microg QID (n = 161) had respective 0.39%, 0.29%, and 0.34% reductions in HbA(1c) and 0.5-, 0.3-, and 0.6-kg reductions in body weight, respectively (all, P < 0.05 vs placebo). In two 52-week studies in patients with type 2 DM, the groups that received pramlintide 120 microg BID (n = 166) and 150 microg TID (n = 144) had respective 0.62% and 0.6% reductions in HbA(1c) and 1.4- and 1.3-kg reductions in body weight (all, P < 0.05 vs placebo). Hypoglycemia, nausea, vomiting, and anorexia were the most frequently reported (>/=10% occurrence) adverse events in patients receiving pramlintide compared with placebo. These events were mild to moderate and occurred more frequently during the first month of therapy. CONCLUSIONS: Pramlintide therapy was associated with reductions in HbA(1c) and body weight in four 52-week studies in patients with type 1 DM and type 2 DM. Hypoglycemia, nausea, vomiting, and anorexia were the most frequently occurring adverse events, particularly during the first month of therapy. Pramlintide was associated with reductions in measures of oxidative stress, but studies are needed to evaluate the effects of this agent on DM-related complications.

Solifenacin succinate for the treatment of symptoms of overactive bladder.

BACKGROUND: Overactivity of the bladder detrusor muscle can result in urinary urgency, frequency, and incontinence. Antimuscarinic agents are the treatment of choice, as they reduce the contractility of this muscle. Solifenacin succinate (SOL) is a competitive muscarinic-receptor antagonist approved by the US Food and Drug Administration in late 2004 for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. OBJECTIVE: This article reviews the current primary literature concerning the pharmacokinetics, efficacy, and tolerability of SOL in the treatment of OAB. METHODS: Pertinent English-language articles were identified through a search of MEDLINE (1966-week 4, 2006), EMBASE (1991-first quarter of 2006), Current Contents/Clinical Medicine (week 10, 2005-week 9, 2006), the Cochrane Database of Systematic Reviews, MICROMEDEX Healthcare Series, and International Pharmaceutical Abstracts (1970-present). The search terms were overactive bladder, urinary incontinence, solifenacin, YM905, pharmacokinetics, and cost. RESULTS: SOL is highly lipophilic (50:1 octanol:water distribution at pH 7.0), completely orally bioavailable, and 98% protein bound. It is metabolized by the cytochrome P450 3A isozyme, and approximately 50% of a dose is eliminated renally as parent compound, with 1 active and 3 inactive metabolites. In two 12-week Phase III studies, patients receiving SOL 5 or 10 mg had significant reductions compared with placebo in the numbers of voids (P < or = 0.01), incontinence episodes (P < or = 0.05), and urgency episodes (P < or = 0.01) per 24 hours; the volume voided per micturition was significantly increased (P < or = 0.01). In a study that compared SOL 5 and 10 mg with tolterodine extended release 4 mg, both agents were associated with significant reductions in the number of voids per 24 hours (-2.45 and -2.24 episodes, respectively; P = 0.004 for noninferiority). In a study of pooled data from two 12-week studies, patients who received SOL 5 or 10 mg reported significant improvements in a number of quality-of-life domains (P < or = 0.05). In a pooled analysis of 4 studies, the most common adverse effects (occurring in > or =3% of any group) in patients receiving SOL 5 mg (n = 266) and 10 mg (n = 612) were dry mouth (10.9% and 27.1%, respectively), constipation (5.3% and 12.9%), and blurred vision (4.5% and 4.7%). CONCLUSIONS: In the studies reviewed, SOL was effective in the treatment of OAB with urge incontinence. Adverse effects included dry mouth, constipation, and blurred vision. Further studies are needed to determine the efficacy and tolerability of SOL in patients with hepatic or renal impairment.