Outpatient Administration of Paclitaxel

Paclitaxel (Taxol®, Bristol-Meyers Squibb), anti neoplastic agent made from the bark of the Pacific yew tree, is undoubtedly one of the most exciting agents to be evaluated over the past decade. Paclitaxel has demonstrated significant promise against ovarian and metastatic breast cancer, and appears to be the most effective single agent to date for non-small-cell lung cancer in trials conducted by Eastern Cooperative Oncology Group (ECOG)

Drug-Drug Interactions in Subjects Enrolled in SWOG Trials of Oral Chemotherapy

Background Patients with cancer are at increased risk of drug-drug interactions (DDI), which can increase treatment toxicity or decrease efficacy. It is especially important to thoroughly screen DDI in oncology clinical trial subjects to ensure trial subject safety and data accuracy. This study determined the prevalence of potential DDI involving oral anti-cancer trial agents in subjects enrolled in two SWOG clinical trials. Methods Completed SWOG clinical trials of commercially available agents with possible DDI that had complete concomitant medication information available at enrollment were included. Screening for DDI was conducted through three methods: protocol-guided screening, Lexicomp® screening, and pharmacist determination of clinical relevance. Descriptive statistics were calculated. Results SWOG trials S0711 (dasatinib, n = 83) and S0528 (everolimus/lapatinib, n = 84) were included. Subjects received an average of 6.6 medications (standard deviation = 4.9, range 0–29) at enrollment. Based on the clinical trial protocols, at enrollment 18.6% (31/167) of subjects had a DDI and 12.0% (20/167) had a DDI that violated a protocol exclusion criterion. According to Lexicomp®, 28.7% of subjects (48/167) had a DDI classified as moderate or worse, whereas pharmacist review indicated that 7.2% of subjects (12/167) had a clinically relevant interaction. The majority of clinically relevant DDI identified were due to the coadministration of acid suppression therapies with dasatinib (83.3%, 10/12). Conclusions The high DDI prevalence in subjects enrolled on SWOG clinical trials, including a high prevalence that violate trial exclusion criteria, support the need for improved processes for DDI screening to ensure trial subject safety and trial data accuracy

\u3cem\u3eIn Vitro\u3c/em\u3e and \u3cem\u3eEx-Vivo\u3c/em\u3e Evaluation of Topical Formulations Designed to Minimize Transdermal Absorption of Vitamin K1

Topical application of Vitamin K1 has been demonstrated to effectively treat papulopustular skin rash, a serious and frequently encountered side effect of Epidermal Growth Factor Inhibitors (EGFRIs). Systemic absorption of vitamin K1 from skin and the resultant consequence of antagonizing EGFRIs anticancer effects jeopardizes the clinical acceptability of this rather effective treatment. The purpose of the present study was to rationally formulate and evaluate the release rate and transdermal absorption of a wide range of Vitamin K1 dermal preparations with a variety of physiochemical properties. A library of 33 formulations with were compounded and tested for Vitamin K1 permeation using hydrophobic membranes and porcine skin mounted in a Fran diffusion cells. Our results demonstrate the lowest diffusion for water-in-oil emulsions, which also demonstrated a negligible transdermal absorption. The statistical analysis showed a significant correlation between in vitro and ex vivo results. While viscosity did not have a significant impact on the diffusion or absorption of vitamin K1, an increase in the lipid content was correlated with an increase in transmembrane diffusion (not with transdermal absorption). Overall, formulation design significantly impacts the release rate and transdermal absorption of vitamin K1, and confirms the possibility of minimal systemic distribution of this vitamin for this specific purpose

Improvement Initiative to Develop and Implement a Tool for Detecting Drug-Drug Interactions During Oncology Clinical Trial Enrollment Eligibility Screening

Objectives Screening subjects for drug-drug interactions (DDIs) before enrollment in oncology clinical trials is integral to ensuring safety, but standard procedures or tools are not readily available to screen DDI in this setting. Our objectives were to develop a DDI screening tool for use during oncology clinical trial enrollment and to test usability in single-center and multicenter pilot studies. Methods A multistage approach was used for this quality improvement intervention. Semistructured interviews with individuals responsible for DDI screening were conducted to develop a prototype tool. The tool was used for screening DDI in subjects enrolling in National Clinical Trials Network trials of commercially available agents during a single-center 3-month pilot. Improvements were made, and a 3-month multicenter pilot was conducted at volunteer SWOG Cancer Research Network sites. Participants were surveyed to determine tool usability and efficiency. Results A tool was developed from semistructured interviews. A critical feature was reporting which medications had specific pharmacokinetic and pharmacodynamic characteristics including transporter and cytochrome P450 substrates, inhibitors, or inducers and QT prolongation. In the 12-site study, average (SD) DDI screening time for each patient decreased by 15.7 (10.2) minutes (range, 3–35 minutes; P \u3c 0.001). Users reported the tool highly usable, with \u3e90% agreeing with all positive usability characterizations and disagreeing with all negative complexity characterizations. Conclusions A DDI screening tool for oncology clinical trial enrollment was created and its usability confirmed. Further testing with more diverse investigator sites and study drugs during eligibility screening is warranted to improve safety and data accuracy within clinical trials

Gaps in Patient Education on Safe Handling and Disposal of Oral Chemotherapy Drugs: A Pilot Prospective Cohort Survey Study

Background Oral anticancer chemotherapy (OC) has been misperceived as being safer than intravenous chemotherapy, leading to its increased risk of improper handling and disposal. This survey study assessed the knowledge, practices and attitudes of pharmacists and patients regarding OC handling and disposal, gaps in knowledge and barriers to patient education. Methods Surveys were developed based on literature review and pilot study validation results. Patients completed a 33-item paper or electronic survey whereas pharmacists completed a 38-item electronic survey. Descriptive statistics and Fisher’s exact test computed using the R Project were used for analyses. Results Pharmacist group (16/25, 62.5%) and patient group (14/29, 48.3%) believed that the oral route is safer than IV. Average overall correct response rates for pharmacist and patient groups were 78.3% and 61.9%, respectively. Significant gaps in knowledge between groups were observed in three sections (p \u3c 0.05). Common barriers to providing patient education were insufficient training (70.8%) and insufficient time (50%). Conclusion Pharmacist and patient knowledge, awareness and practices of OC safe handling and disposal are suboptimal. Areas of knowledge gaps and barriers to patient education were identified. Enhanced supports are needed to empower pharmacists to assume an active role in patient education on safe handling and disposal of OC

Challenges to Implementation of the Co-Curriculum in Accredited Pharmacy Programs

Objective. To determine areas of concern, and challenges to implementing and assessing the co-curriculum in accredited Doctor of Pharmacy programs, along with how confident programs are in their ability to meet the co-curriculum requirement as mandated by the Accreditation Council for Pharmacy Education (ACPE). Methods. A survey was administered to all ACPE-accredited pharmacy programs to collect information regarding areas of concern, challenges, and confidence in their ability to meet the co-curriculum requirement. The frequency of responses to items are presented along with comparisons based on characteristics, including institution type, cohort size, most recent ACPE accreditation review, and supporting offices. Results. The most common concerns centered on the documentation and assessment process. The most commonly reported challenges were lack of enthusiasm or buy-in from faculty, staff, and students; lack of a clear definition of co-curriculum; and faculty time and insufficient staff. Overall, programs had a high level of confidence in their ability to meet the requirements for co-curriculum. The only differences found were related to supporting offices and cohort size. Conclusion. The results suggest that having supporting offices may reduce the co-curriculum burden. Similarly, student cohort size may have an impact on the challenges for some programs, particularly those with moderate-sized cohorts reporting challenges related to faculty and staff. Further research is needed to determine how programs address these critical issues, and to explore whether programs report differently on these areas after completing an accreditation review. The study results may be useful to members of the Academy when evaluating co-curriculum

Co-Curriculum Implementation and Assessment in Accredited Doctor of Pharmacy Programs

Objective. To determine how accredited Doctor of Pharmacy programs implement and evaluate the co-curriculum requirement as mandated by the Accreditation Council for Pharmacy Education (ACPE). Methods. A survey was administered to all ACPE-accredited pharmacy programs to collect information regarding how co-curriculum models were being implemented, including types of activities, structure, learning outcomes, oversight, and assessment. The frequency of responses to items were presented to describe the general features of co-curriculum models. Results. The types of co-curricular activities reported by programs were generally consistent, with the majority of programs categorizing these activities and allowing students to choose which they would engage in. Most respondents reported that the program mapped co-curricular activities to learning outcomes, primarily ACPE Standards 1-4. The structural oversight of the co-curriculum typically included a co-curriculum committee, subcommittee, or task force, and supporting offices. The most common offices/departments involved in the co-curriculum were assessment, student affairs/services, experiential education, and academic/curricular affairs. The most common assessments were reflections, self-assessment surveys, and checklists. Conclusion. In most programs, implementation of the co-curriculum was a joint effort among various individuals, committees, and offices. Given the developing nature of programs, descriptive studies should be repeated to identify how programs develop and enhance co-curriculum models. The study results may be useful to members of the Academy when evaluating the current state of co-curriculum implementation and potential areas for program development

Co-Curriculum Implementation and Assessment in Accredited Doctor of Pharmacy Programs

Objective. To determine how accredited Doctor of Pharmacy programs implement and evaluate the co-curriculum requirement as mandated by the Accreditation Council for Pharmacy Education (ACPE). Methods. A survey was administered to all ACPE-accredited pharmacy programs to collect information regarding how co-curriculum models were being implemented, including types of activities, structure, learning outcomes, oversight, and assessment. The frequency of responses to items were presented to describe the general features of co-curriculum models. Results. The types of co-curricular activities reported by programs were generally consistent, with the majority of programs categorizing these activities and allowing students to choose which they would engage in. Most respondents reported that the program mapped co-curricular activities to learning outcomes, primarily ACPE Standards 1-4. The structural oversight of the co-curriculum typically included a co-curriculum committee, subcommittee, or task force, and supporting offices. The most common offices/departments involved in the co-curriculum were assessment, student affairs/services, experiential education, and academic/curricular affairs. The most common assessments were reflections, self-assessment surveys, and checklists. Conclusion. In most programs, implementation of the co-curriculum was a joint effort among various individuals, committees, and offices. Given the developing nature of programs, descriptive studies should be repeated to identify how programs develop and enhance co-curriculum models. The study results may be useful to members of the Academy when evaluating the current state of co-curriculum implementation and potential areas for program development

A Prospective Study to Validate the Functional Assessment of Cancer Therapy (FACT) for Epidermal Growth Factor Receptor Inhibitor (EGFRI)-induced Dermatologic Toxicities FACT-EGFRI 18 Questionnaire: SWOG S1013

Background Papulopustular rash is a common class effect of epidermal growth factor receptor inhibitors (EGFRI) that can affect patients’ health-related quality of life and cause disruptions to treatment. SWOG S1013 (NCT01416688) is a multi-center study designed to validate the Functional Assessment of Cancer Therapy EGFRI 18 (FACT-EGFRI 18) using 7-items from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 to assess EGFRI-induced skin-related toxicities and their impact on functional status. Methods Patients with a diagnosis of colorectal or lung cancer to receive EGFRI therapies for at least 6 weeks were enrolled. Patient self-assessments using the FACT-EGFRI 18 were completed prior to undergoing CTCAE assessment by trained clinicians at baseline, weekly × 6, and then monthly × 3. The psychometric properties of the FACT-EGFRI 14 (skin toxicity items only) and 18 (plus 2 nail and 2 hair items) were established based on criterion validity, known groups validity, internal consistency reliability, and responsiveness to change. Results Of the 146 registered patients, 124 were evaluable. High Cronbach’s alpha (\u3e 0.70) for both FACT-EGFRI 14 and FACT-EGFRI 18 scores across assessment times were observed. Although agreement (i.e. criterion validity) between individual and summary scales of the FACT-EGFRI 18 for assessing skin toxicity was good, agreement with the clinician-reported CTCAE was only fair. The minimal important difference was determined to be 3 points. The results also demonstrated responsiveness to symptom change. Discussion Based on the results of this multi-center validation study, the FACT-EGFRI 18 patient-reported outcome instrument provided data from the patient’s perspective yielding unique information as well as complementing clinician-rated CTCAE grades, especially for the symptoms of pain, pruritus, and paronychia. Conclusions Good to excellent psychometric properties for the FACT-EGFRI 18 were demonstrated, supporting further use of this patient-reported outcomes measure. Additional validation with a more diverse group of patients should be conducted

Towards a global partnership model in interprofessional education for cross-sector problem-solving

Objectives A partnership model in interprofessional education (IPE) is important in promoting a sense of global citizenship while preparing students for cross-sector problem-solving. However, the literature remains scant in providing useful guidance for the development of an IPE programme co-implemented by external partners. In this pioneering study, we describe the processes of forging global partnerships in co-implementing IPE and evaluate the programme in light of the preliminary data available. Methods This study is generally quantitative. We collected data from a total of 747 health and social care students from four higher education institutions. We utilized a descriptive narrative format and a quantitative design to present our experiences of running IPE with external partners and performed independent t-tests and analysis of variance to examine pretest and posttest mean differences in students’ data. Results We identified factors in establishing a cross-institutional IPE programme. These factors include complementarity of expertise, mutual benefits, internet connectivity, interactivity of design, and time difference. We found significant pretest–posttest differences in students’ readiness for interprofessional learning (teamwork and collaboration, positive professional identity, roles, and responsibilities). We also found a significant decrease in students’ social interaction anxiety after the IPE simulation. Conclusions The narrative of our experiences described in this manuscript could be considered by higher education institutions seeking to forge meaningful external partnerships in their effort to establish interprofessional global health education