Assessment of a Mindfulness Meditation Elective in an Accelerated Doctor of Pharmacy Program.

Objective. The objective of this study was to determine the effect of a live 14-week mindfulness elective course on the well-being of Doctor of Pharmacy (PharmD) students in an accelerated program.Methods. Pharmacy students enrolled in a mindfulness elective participated in weekly class sessions that included an eight-week mindfulness program geared toward emerging adults. Eight weekly reflections were assigned to students and evaluated using the Text iQ text-analysis tool in Qualtrics. Investigators analyzed the sentiment scores assigned by Text iQ to detect differences in the tone of student reflections over time.Results. Twenty-four students were enrolled in this elective, and 22 students submitted complete reflections for evaluation. Mean sentiment scores and the percentage of responses in sentiment score categories (very positive and positive, mixed and neutral, very negative and negative) for these reflections showed significant differences between weeks.Conclusion. The tone of student reflections was more positive after the students learned and incorporated mindfulness practice into their accelerated PharmD curriculum.

Exploring the effects of a smartphone-based meditation app on stress, mindfulness, well-being, and resilience in pharmacy students.

PURPOSE: The purpose of this study was to investigate the effects of the smartphone-based meditation app Ten Percent Happier on stress, mindfulness, well-being, and resilience in pharmacy students. METHODS: Pharmacy students in a professional year of study were recruited to participate. Students were instructed to meditate using the Ten Percent Happier app for at least 5 days a week for 4 weeks. Students could use the app at their discretion for weeks 5 to 12. Baseline, week 4, and week 12 responses were collected from the following instruments: the Perceived Stress Scale, the Five-Facet Mindfulness Questionnaire-15, the Flourishing Scale, and the Brief Resilience Scale. RESULTS: Eighty-nine pharmacy students volunteered for the study. Sixty (67%) enrolled by completing the baseline survey. Of these, 28 (47%) completed the week 4 survey and 22 (37%) completed the week 12 survey. Participants experienced a reduction in perceived stress (P = 0.0005) and increases in resilience (P < 0.0001) and well-being (P = 0.0006). Increases in mindfulness were seen in 4 of the 5 subscales of the Five-Facet Mindfulness Questionnaire-15 (P ≤ 0.05). These benefits were noted at week 4 and maintained at week 12. CONCLUSION: Pharmacy students who practiced mindful meditation through the Ten Percent Happier app for an average of 5 days a week for 4 weeks experienced reduced stress and improved mindfulness, well-being, and resilience. Benefits experienced during the intervention were maintained at the 8-week follow-up, despite app usage decreasing to an average of 4 days a week.

Role of Immune Checkpoint Inhibitors in Small Cell Lung Cancer.

BACKGROUND: Small cell lung cancer (SCLC) accounts for approximately 13% of all lung cancer diagnoses each year. SCLC is characterized by a rapid doubling time, early metastatic spread, and an unfavorable prognosis overall. AREAS OF UNCERTAINTY: Most patients with SCLC will respond to initial treatment; however, the majority will experience a disease recurrence and response to second-line therapies is poor. Immune checkpoint inhibitors may be an option given the success in other diseases. DATA SOURCES: A literature search was conducted using Medline (1946-July week 1, 2017) and Embase (1996-2017 week 28) with the search terms small cell lung cancer combined with nivolumab or ipilimumab or pembrolizumab or atezolizumab or tremelimumab or durvalumab. Five clinical trials, including extended follow-up for 2, that evaluated immune checkpoint inhibitors in limited stage or extensive stage SCLC were included. RESULTS: In 2 phase 2 trials, ipilimumab was added to upfront chemotherapy. In both trials, an improvement in progression-free survival was seen. Toxicity, when combined with a platinum and etoposide, was significant. In a confirmatory phase 3 trial, ipilimumab did not prolong overall survival when added to first-line chemotherapy. Overall, response rates were similar between the placebo and ipilimumab groups. A phase 1/2 trial evaluated nivolumab alone or in combination with ipilimumab in recurrent SCLC. Results revealed that nivolumab monotherapy and the combination of nivolumab and ipilimumab were relatively safe and had antitumor activity. Pembrolizumab has been evaluated in a multicohort, phase 1b trial. Preliminary data showed a durable response in the second-line setting. CONCLUSION: Given the lack of overall survival data and significant toxicity associated with the combination of ipilimumab with first-line chemotherapy, this treatment is not a reasonable option at this time. Nivolumab alone or in combination with ipilimumab is a valid option for recurrent SCLC.

Vancomycin Dosing in Obese Patients: Special Considerations and Novel Dosing Strategies.

OBJECTIVE: To review the literature regarding vancomycin pharmacokinetics in obese patients and strategies used to improve dosing in this population. DATA SOURCES: PubMed, EMBASE (1974 to November 2017), and Google Scholar searches were conducted using the search terms vancomycin, obese, obesity, pharmacokinetics, strategy, and dosing. Additional articles were selected from reference lists of selected studies. STUDY SELECTION AND DATA EXTRACTION: Included articles were those published in English with a primary focus on vancomycin pharmacokinetic parameters in obese patients and practical vancomycin dosing strategies, clinical experiences, or challenges of dosing vancomycin in this population. DATA SYNTHESIS: Volume of distribution and clearance are the pharmacokinetic parameters that most often affect vancomycin dosing in obese patients; both are increased in this population. Challenges with dosing in obese patients include inconsistent and inadequate dosing, observations that the obese population may not be homogeneous, and reports of an increased likelihood of supratherapeutic trough concentrations. Investigators have revised and developed dosing and monitoring protocols to address these challenges. These approaches improved target trough attainment to varying degrees. CONCLUSIONS: Some of the vancomycin dosing approaches provided promising results in obese patients, but there were notable differences in methods used to develop these approaches, and sample sizes were small. Although some approaches can be considered for validation in individual institutions, further research is warranted. This may include validating approaches in larger populations with narrower obesity severity ranges, investigating target attainment in indication-specific target ranges, and evaluating the impact of different dosing weights and methods of creatinine clearance calculation.

New and Emerging Antibiotics for Complicated Intra-Abdominal Infections.

The purpose of this review is to evaluate the efficacy and safety of ceftazidime/avibactam and ceftolozane/tazobactam in patients with complicated intra-abdominal infections (cIAI), and review eravacycline and other agents in the pipeline for management of cIAI. The increasing incidence of multidrug resistant strains of bacteria has led to the need for additional antibiotics with activity against these organisms. There are 2 newly approved antibiotics, ceftazidime/avibactam and ceftolazane/tazobactam for treatment of cIAI. Both agents have been shown to exert activity against resistant bacteria, including extended-spectrum beta-lactamase-producing organisms. Several other antibiotics are currently under investigation for this indication. Included in the pipeline of agents is a new tetracycline, an aminoglycoside, 2 new fluroquinolones, and 2 new beta-lactamase inhibitor combinations with carbapenems. Although the mechanisms for these new agents are not novel, promising data have shown their ability to overcome class resistance. The passing of the Generating Antibiotic Incentives Now Act has led to an increasing number of fast tracked antibiotic approvals. In addition to recent approval of ceftazidime/avibactam and ceftolazane/tazobactam, several other emerging antibiotics are under investigation which will aid in the management of resistant cIAI.

Oritavancin: A Novel Lipoglycopeptide.

OBJECTIVE: To review the pharmacology, pharmacokinetics, drug interactions, microbiologic profile, dosage and administration, safety, clinical efficacy, and potential place in therapy for the new lipoglycopetide, oritavancin. DATA SOURCES: MEDLINE and PubMed searches of available literature in English were conducted for oritavancin. Principal supplementary sources include the Food and Drug Administration (FDA) package insert, and FDA/European Medicines Agency guidances on acute bacterial skin and skin structure infections (ABSSSI). STUDY SELECTION AND DATA EXTRACTION: Information from all stages of clinical development was evaluated to provide an overview of oritavancin, from in vitro susceptibility, to early human studies, to the latter stages of clinical trials. DATA SYNTHESIS: Oritavancin is a lipoglycopeptide antibiotic that has a mechanism of action and broad-spectrum gram-positive coverage similar to other glycopeptides. Compared with other glycopeptides, oritavancin minimum inhibitory concentrations tend to be lower. Oritavancin also has coverage against glycopeptide-resistant gram-positive organisms. Oritavancin does not require dose adjustment for mild-to-moderate hepatic or renal impairment, and its prolonged half-life of 245 hours allows for a one-time administration in the treatment of ABSSSI. In phase 2 and 3 clinical trials, oritavancin was shown to be well-tolerated in addition to being noninferior to vancomycin for the treatment of ABSSSI. The most common side effects experienced were gastrointestinal in nature. CONCLUSIONS: Oritavancin was approved by FDA for the treatment of ABSSSI in August 2014 and is marketed under the trade name Orbactiv. Its reduced dosing and monitoring requirements and efficacy against resistant gram-positive pathogens provide a unique profile that distinguishes it from current options in the treatment of ABSSSI.

Ceritinib: a new tyrosine kinase inhibitor for non-small-cell lung cancer.

OBJECTIVE: To review ceritinib for the treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC). DATA SOURCES: Literature searches were conducted in PubMed, EMBASE (1974 to July week 5, 2014), and Google Scholar using the terms ceritinib, LDK378, and non-small-cell lung cancer. STUDY SELECTION AND DATA EXTRACTION: One phase 1 trial and 2 abstracts were identified. DATA SYNTHESIS: Ceritinib is approved for the treatment of ALK-positive metastatic NSCLC in patients who are intolerant to or have progressed despite therapy with crizotinib. In the phase 1 clinical trial, the maximum tolerated dose was determined to be 750 mg once daily. The overall response rate (ORR) was 58% (95% CI = 48-67) in patients who received ≥400 mg daily (n = 114). In this group, the ORR was 56% (95% CI = 41-67) and 62% (95% CI = 44-78) among crizotinib-exposed and -naïve patients, respectively. The ORR was 59% (95% CI = 47-70) in patients who received 750 mg daily (n = 78). The ORR was 56% (95% CI = 41-70) in crizotinib-treated patients and 64% (95% CI = 44-81) in crizotinib-naïve patients, respectively, in this subset. The median duration of response was 8.2 months. Median progression-free survival was 7.0 months. The most common adverse reactions included diarrhea, nausea, vomiting, abdominal pain, anorexia, constipation, fatigue, and elevated transaminases. CONCLUSIONS: Ceritinib has activity in crizotinib-resistant and crizotinib-naïve patients and appears to be a viable alternative for ALK-positive NSCLC. Long-term data are needed to further define the role of ceritinib in the treatment of NSCLC.

Daptomycin use in pediatric patients.

PURPOSE: Currently available evidence on the use of daptomycin in pediatric patients is reviewed and evaluated. SUMMARY: Although guidelines on the treatment of methicillin-resistant Staphylococcus aureus infections recommend daptomycin for use in pediatric patients, that recommendation is primarily based on expert opinion. A literature search for articles on pediatric daptomycin use identified three pharmacokinetic studies, three case reports, and one retrospective review. The limited body of published evidence indicates that pediatric patients may require higher daptomycin doses than adult patients in order to attain therapeutic serum concentrations. Pharmacokinetic studies in pediatric patients demonstrated faster daptomycin clearance (CL) and a decreased area under the concentration-time curve (AUC) relative to values reported in adults. Daptomycin appears to have a shorter half-life in patients 2-6 years of age relative to those 12-17 years of age. A retrospective review of 16 cases in which pediatric patients were treated with daptomycin for invasive gram-positive infections indicated positive outcomes after the addition of daptomycin to standard therapy. Overall, daptomycin appears to be well tolerated in pediatric patients. CONCLUSION: Due to the limited nature of the available literature, use of daptomycin in pediatric patients should be limited to situations in which other options are not viable due to toxicity, local susceptibility patterns, or likely treatment failure. As a result of faster drug CL and lower AUC values, higher doses may be necessary in pediatric patients to achieve serum concentrations similar to those seen with adult dosing.

Dosing of enoxaparin for venous thromboembolism prophylaxis in obese patients.

OBJECTIVE: To evaluate the appropriate dosing of enoxaparin as a venous thromboembolism (VTE) prophylaxis in hospitalized obese patients. DATA SOURCES: Literature articles were accessed through MEDLINE (1946 to August week 1, 2013) and EMBASE (1980 to 2013 week 33) searches using the terms enoxaparin, obesity, and thromboprophylaxis. STUDY SELECTION AND DATA EXTRACTION: All articles that involved human subjects and were published in the English language, evaluating the appropriate dose of enoxaparin for VTE prophylaxis in hospitalized, obese patients were included. DATA SYNTHESIS: Appropriate enoxaparin dosing for thromboprophylaxis in adult patients is 40 mg subcutaneously daily or 30 mg subcutaneously twice daily. Although obesity is considered one of the risk factors for thromboembolism, morbidly obese patients were excluded from most clinical trials; therefore, the appropriate enoxaparin preventive dose is not clear in this population. In recent years, the appropriate dose of enoxaparin for VTE prophylaxis in obese patients has been evaluated in 3 clinical studies. All studies enrolled patients with various risk factors for thromboembolism and evaluated different enoxaparin dosing regimens. End point analyses were all based on anti-Xa levels. CONCLUSIONS: Due to a lack of well-designed prospective, randomized control studies, varying doses of enoxaparin are used for VTE prophylaxis in hospitalized, obese patients. All doses studied were monitored using anti-Xa levels. Patient follow-up was of short duration in all studies and did not show long-term effectiveness of enoxaparin. Prospective, randomized controlled studies are warranted to show efficacy and safety of one dosage regimen over another.

Practical considerations for optimal transdermal drug delivery.

PURPOSE: The properties of various transdermal drug delivery system (TDDS) products are reviewed, with safety recommendations and guidance on addressing questions frequently posed by patients and caregivers. SUMMARY: Drug delivery via a TDDS can offer many advantages over other methods of administration, but those benefits can be compromised by improper use or alteration of medication patches or a lack of awareness of the properties of different patch types (reservoir, matrix, drug-in-adhesive). To assess current TDDS technologies and recommended practices for safe and effective use of medication patches, a literature search for articles on commonly used TDDS products available in the United States was conducted; supplemental information was obtained from package inserts and through direct communication with manufacturers. In addition to recommendations on the site and duration of TDDS application and proper patch disposal, clinicians must consider (1) potential problems with cutting patches as a method of dosage adjustment, (2) safety concerns related to the electric conductivity of metal-containing patches, (3) appropriate strategies for managing patch adhesion failures, and (4) the advisability of writing on patches for medication safety or compliance reasons. Clinicians should also be prepared to counsel patients about TDDS-specific recommendations on the avoidance of sunlight and other external heat sources during the use of a medication patch. CONCLUSION: Practical considerations related to transdermal drug delivery include the appropriateness of cutting patches, the implications of their containing metallic components, and whether they may be covered with tape or written on. Manufacturers of patches provide some useful information on these topics.

Proton Pump Inhibitor use in Hospitalized Patients: Is Overutilization Becoming a Problem?

Proton pump inhibitors (PPIs) are among the most common classes of medications prescribed. Though they were previously thought of as safe, recent literature has shown risks associated with their use including increased risk for Clostridium difficile infection, pneumonia, and fractures. Due to these risks, it is important to determine if PPIs are being used appropriately. This review evaluates seven studies in hospitalized patients. Additionally, this review evaluates literature pertaining to recently discovered adverse reactions; all studies found PPIs are being overutilized. Findings highlight the importance of evaluating appropriate therapy with these agents and recommending discontinuation if a proper indication does not exist.

Single-agent, broad-spectrum fluoroquinolones for the outpatient treatment of low-risk febrile neutropenia.

OBJECTIVE: To evaluate the use of oral, single-agent, broad-spectrum fluoroquinolones in the treatment of low-risk febrile neutropenia (FN). DATA SOURCES: MEDLINE via Ovid (1948 to May, week 3, 2011) and EMBASE (1980 to 2011, week 21) were searched using the terms febrile neutropenia, fluoroquinolone, quinolone derivative, levofloxacin, moxifloxacin, and neoplasm. References of selected articles, review articles, and treatment guidelines were reviewed. STUDY SELECTION AND DATA EXTRACTION: Trials evaluating the efficacy of oral, single-agent, broad-spectrum fluoroquinolones in the treatment of chemotherapy-induced FN were included if the majority of patients in the study had low-risk FN. Trials involving pediatric patients, non-Food and Drug Administration-approved fluoroquinolones, or monotherapy with ciprofloxacin or ofloxacin were excluded. Data extracted included study design, patient demographics, antiinfective regimens, and treatment outcomes. DATA SYNTHESIS: Four clinical trials were included. One trial compared levofloxacin with piperacillin/tazobactam with a success rate (afebrile at 72 hours) of 76.5% in the levofloxacin group compared with 88.3% in the piperacillin/tazobactam group. This trial was not limited to low-risk patients. The remaining 3 trials investigated moxifloxacin monotherapy in low-risk patients. Two of these were noncontrolled trials with success rates (afebrile at 5 days) of 91% and 95%. The final trial randomized patients to moxifloxacin or ceftriaxone and had success rates (hospital discharge at 48 hours) of 79.2% and 73.9%, respectively. In all 4 trials, treatment of FN with levofloxacin or moxifloxacin was deemed to be safe and effective. Although all studies had positive results, they were limited by small sample sizes and the absence of universal use of control comparisons. CONCLUSIONS: Use of oral, single-agent, broad-spectrum fluoroquinolones for outpatient treatment of FN in low-risk patients has shown promising results. At this time, this type of therapy should be limited to low-risk patients. Future clinical trials should include larger sample sizes and a comparison with existing first-line oral therapy-oral ciprofloxacin plus amoxicillin/clavulanate.

Effects of an interdisciplinary volunteer experience on students' knowledge of and attitudes toward the health care team.

PURPOSE: To assess the effect of an interdisciplinary, volunteer clinical experience completed by physician assistant (PA), pharmacy, and nursing students and whether the experience will change students' knowledge of, or attitudes toward, a team approach to health care. METHODS: Surveys were conducted before and after the project using a 5-point Likert scale that measured the impact of the project on a nonrandom sample of PA, pharmacy, and nursing students who completed a minimum of four hours of service at Head Start preschool sites in southern New Hampshire. Students were recruited through email announcements and a lunchtime information session describing the program. Presurveys were completed using Blackboard before the student's scheduled participation day. Postsurveys were completed onsite at the end of the volunteer time. Surveys were blinded using a number and letter code. Students' knowledge (survey questions 1-4) and attitudes (survey questions 5-7) toward the health care team were evaluated in several areas including the importance of working in a team, knowledge level of other team members, awareness of community agencies as part of the team, and the importance of communication within the health care team. Paired t-tests were used to determine whether significant changes occurred in attitudes or knowledge as a result of the interdisciplinary volunteer experience. Approval of the study protocol was granted by the college's institutional review board. RESULTS: Statistically significant increases were noted in awareness of community resources, understanding of the strengths and skills of other members of the health care team, and experiences in working with other disciplines. Student attitudes toward a team approach to health care did not significantly change as a result of this experience. CONCLUSION: Enabling students to interact with other disciplines and to provide care to patients significantly increased students' awareness of community resources as well as their understanding of the strengths and skills of other members of the health care team. Students also gained experience working in a health care team. This demonstrates that a volunteer experience involving interdisciplinary collaboration can be used to enhance students' knowledge of the health care team.