Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act.

INTRODUCTION: Recent research has raised questions about potential unintended consequences of the Inflation Reduction Act's Drug Price Negotiation Program (DPNP), suggesting that the timelines introduced by the law may reduce manufacturer incentives to invest in post-approval research towards additional indications. Given the role of multiple indications in expanding treatment options in patients with cancer, IRA-related changes to development incentives are especially relevant in oncology. This study aimed to describe heterogeneous drug-level trajectories and timelines of subsequent indications in a cohort of recently approved, multi-indication oncology drugs, including overall, across subgroups of drugs characterized by the timing and pace of additional indications, and by drug type (i.e., small molecule vs. biologic). METHODS: This cross-sectional study evaluated oncology drugs first approved by the FDA from 2008 to 2018 and later approved for one or more additional indications. Numbers, types, and approval timelines of subsequent indications were recorded at the drug level, with drugs grouped by quartile based on the pacing of post-approval development (i.e., "rapid pace" to "measured pace"). RESULTS: Multi-indication oncology drugs (N = 56/86, 65.1%) had one or more subsequent indication approved in a new: cancer type (60.7%), line of treatment (50.0%), combination (41.1%), mutation (32.1%), or stage (28.6%). The median time between FDA approvals for indications increased from 0.6 years (IQR: 0.48, 0.74) in the "rapid pace" group to 1.6 years (IQR: 1.32, 1.66), 2.4 years (IQR: 2.29, 2.61), and 4.9 years (IQR: 3.43, 6.23) in the "moderate," "measured-moderate," and "measured" pace groups, respectively. Drugs in the "rapid pace" group often received their first subsequent indication approval within 9 months of initial approval (median: 0.7 years; IQR: 0.54, 1.59), whereas the "measured pace" group took a median of 5.7 years (IQR: 3.43, 6.98). Across all multi-indication drugs, the median time to the most recent approval for a subsequent indication was 5.5 years (IQR: 3.18, 7.95). One quarter (25%) of drugs were approved for their most recent subsequent indication after the time at which they would be DPNP-eligible. CONCLUSION: Approval histories of new oncology drugs demonstrate the role of post-approval indications in expanding treatment options towards new cancer types, stages, lines, combinations, and mutations. Heterogeneous clinical development pathways provide insights into potential unintended consequences of IRA-related changes surrounding post-approval research and development.

Pain, Substance Use Disorders, Mental Health, and Buprenorphine Treatment among Patients With and Without HIV.

Treatment of opioid use disorder (OUD) with buprenorphine improves outcomes and mortality among people with HIV (PWH). However, engagement is low and is influenced by comorbidities. We examined the impact of patterns of co-occurring pain, substance use disorders (SUDs), and mental health diagnoses on buprenorphine initiation and retention in PWH. The Veterans Aging Cohort Study contained 7,875 patients (2,702 PWH and 5,173 without HIV) with new OUD clinical encounters (2008-2017). Buprenorphine initiation and retention were derived from prescription data. We identified patterns of co-occurring diagnoses (via ICD codes) and assessed the effects of class membership on both outcomes using latent class analysis and regression analyses. The mean age of patients was 55, 98% were male, 58% Black, 8% Hispanic, and only 8% initiated buprenorphine within 12 months of OUD diagnosis. Four classes of co-occurring diagnoses were identified: "Few Co-occurring Diagnoses" (42.3%); "Multiple Pain Conditions" (21.3%); "Pain + SUD" (18.4%) and "Pain + SUD + Mental Health" (18.0%). Patients in the "Pain + SUD" class and "Pain + SUD + Mental Health" class were significantly less likely to initiate buprenorphine and had 59% and 45% lower odds, respectively, of initiating buprenorphine compared with patients in the "Few Co-occurring Diagnoses" class; this effect did not vary by HIV status. Buprenorphine retention was not significantly associated with HIV status or class membership. However, Black Veterans were less likely to initiate or be retained in buprenorphine treatment. Higher comorbidity burden was negatively associated with buprenorphine initiation but not with retention. More research is warranted to determine other factors that may influence treatment retention.

Medicare Part D Coverage of Drugs Selected for the Drug Price Negotiation Program.

This cross-sectional study describes and historically benchmarks Medicare Part D coverage in 2019 and 2023 for the first 10 drugs selected for negotiation.

Longitudinal medication adherence group-based trajectories of aging adults in the US: A retrospective analysis using monthly proportion of days covered calculations.

BACKGROUND: It is thought that half of the patients with chronic conditions are not adherent to their medications, which contributes to significant health and economic burden. Many studies estimate medication non-adherence by implementing a threshold of ≥80% of Proportion of Days Covered (PDC), categorizing patients as either adherent or non-adherent. Healthcare quality metrics pertaining to medication use are based on this dichotomous approach of medication adherence, including the Medicare Part D Star Ratings. Among others, the Medicare Part D Star Ratings rewards part D plan sponsors with quality bonus payments based on this dichotomous categorization of beneficiaries' medication adherence. OBJECTIVES: Describe the longitudinal adherence trajectories of adults ≥65 years of age covered by Medicare for 3 classes of drugs in the Part D Star Ratings: diabetes medications, statins, and select antihypertensives. METHODS: This study used Medicare healthcare administrative claims data linked to participants from the Health Retirement Study between 2008 and 2016. Group-based trajectory models (GBTM) elicited the number and shape of adherence trajectories from a sample of N = 11,068 participants for the three pharmacotherapeutic classes considered in this study. Medication adherence was estimated using monthly PDC. RESULTS: GBTM were estimated for the sample population taking antihypertensives (n = 7,272), statins (n = 8,221), and diabetes medications (n = 3,214). The hypertension model found three trajectories: high to very high adherence (47.55%), slow decline (32.99%), and rapid decline (19.47%) trajectories. The statins model found 5 trajectories: high to very high adherence (35.49%), slow decline (17.12%), low then increasing adherence (23.58%), moderate decline (12.62%), and rapid decline (11.20%). The diabetes medications model displayed 6 trajectories: high to very high adherence (24.15%), slow decline (16.84%), high then increasing adherence (25.56%), low then increasing (13.58%), moderate decline (10.60%), and rapid decline (9.27%). CONCLUSIONS: This study showed the fluid nature of long-term medication adherence to the medications considered in the Medicare Part D Star Ratings and how it varies by pharmacotherapeutic class. These challenge previous assumptions about which patients were considered adherent to chronic medications. Policy and methodological implications about medication adherence are discussed.

Cost minimization analysis of short-duration antiviral prophylaxis for hepatitis C positive donor kidney transplants.

BACKGROUND: Trials describing 4-12 week courses of direct-acting antiviral drugs (DAAs) to treat hepatitis C virus (HCV) transmission from infected donors to uninfected kidney transplant recipients (D+/R-transplants), may be limited in application by costs and delayed access to expensive DAAs. A short prophylactic strategy may be safer and cost-effective. Here, we report a cost minimization analysis using the health system perspective to determine the least expensive DAA regimen, using available published strategies. OBJECTIVES: To conduct cost-minimization analyses (CMAs) from the health system perspective of four DAA regimens to prevent and/or treat HCV transmission from D+/R-kidney transplants. METHODS: CMAs comparing 4 strategies: 1) 7-day prophylaxis with generic sofosbuvir/velpatasvir (SOF/VEL), with 12-week branded glecaprevir/pibrentasvir (G/P) for those with transmission; 2) 8-day branded G/P prophylaxis, with 12-week branded SOF/VEL/voxilaprevir for those with transmission; 3) 4-week perioperative generic SOF/VEL prophylaxis, with 12-week branded G/P for those with transmission; and 4) 8-week branded G/P "transmit-and-treat." We included data from published literature to estimate the probability of viral transmission in patients who received DAA prophylaxis, and assumed a 100% transmission rate for those who received the "transmit-and-treat" approach. RESULTS: In base-case analyses, strategies 1 (expected cost [EC]: $2326) and 2 (expected cost: $2646) were less expensive than strategies 3 (EC: $4859) and 4 (EC: $18,525). Threshold analyses for 7-day SOF/VEL versus 8-day G/P suggested that there were reasonable input levels at which the 8-day strategy may be least costly. The threshold values for the SOF/VEL prophylaxis strategies (7-day vs. 4- week) indicated that the 4-week strategy is unlikely to be less costly under any reasonable value of the input variables. CONCLUSIONS: Short duration DAA prophylaxis using 7 days of SOF/VEL or 8 days of G/P has the potential to yield significant cost savings for D+/R- kidney transplants.

Evaluation of Commercially Available Infant-feeding Mobile Applications Using App Quality Evaluation Tool.

OBJECTIVE: Assess the quality of free, commercially available infant-feeding mobile applications (apps) and their appropriateness for audiences with low income and of racial and ethnic diversity using the App Quality Evaluation tool. METHODS: Researchers selected apps using an iterative process (n = 6). Health professionals (n = 10) who work with mothers with infants and low income who completed the App Quality Evaluation tool for each app, consisting of 7 domains of app quality. Average domain scores were calculated for each app (> 8 indicates high quality). RESULTS: Evaluators highly rated app function and purpose for WebMD Baby (8.0 ± 1.8 and 8.2 ± 0.9, respectively) and Baby Center (8.0 ± 2.1 and 8.0 ± 2.6, respectively). For other apps, no domains were highly rated. No apps were rated highly for appropriateness (range 5.7-7.7) nor provided high-quality infant-feeding information for mothers with low income. Few apps were rated highly appropriate for mothers who are Black or Hispanic. CONCLUSIONS AND IMPLICATIONS: Commercially available infant-feeding apps are of limited quality, indicating the need to develop high-quality apps for audiences with low income and Black and Hispanic identities.

Retention of students' knowledge of immunizations following a one-day or a five-week course.

INTRODUCTION: The American Pharmacists Association (APhA) Pharmacy-Based Immunization Delivery Certificate Program is commonly used by schools of pharmacy to train student pharmacists in immunizations. This study compared student pharmacists' knowledge retention of immunization content when the live seminar of the APhA Program was delivered as a one-day co-curricular activity or as a five-week required course. The impact of immunization experience on students' knowledge retention was a secondary objective. METHODS: A 45-question knowledge assessment about immunizations was administered to second and third-year student pharmacists eight months after completing either a five-week course (second-year students) or a one-day seminar (third-year students). Students were also asked about their experience providing patient education, screening, and administering immunizations. RESULTS: Knowledge assessment scores declined by an average of 26.3% from the initial to the eight-month assessment, and declines were similar for second and third-year students. However, students who reported immunizing over 50 patients had significantly higher knowledge retention than those who reported never immunizing. CONCLUSIONS: A live immunization training given over one day or five weeks did not impact the retention of immunization knowledge eight months later. However, students who immunized >50 patients had greater knowledge retention. These findings indicate the importance of including the application of immunization knowledge in pharmacy curricula to enhance long-term knowledge retention.

Patterns of school and college of pharmacy engagement in addressing the opioid crisis.

INTRODUCTION: The American Association of Colleges of Pharmacy (AACP) has emphasized the need to prepare pharmacy students for practicing amidst the opioid crisis. This research aimed to identify patterns and predictors of pharmacy program participation in skills-based education, research, and service activities designed to address this crisis. METHODS: Opioid-related activities were identified from the AACP opioid-related activities database and classified by two independent reviewers. The final activities included: (1) direct participation in drug disposal and/or naloxone outreach, (2) opioid-focused research, and (3) skills-based training in the doctor of pharmacy curriculum. Latent class analysis was used to identify classes of program involvement in these activities. Differences in class membership based on program and geographic characteristics were examined using multivariable logistic regression. RESULTS: Of the 106 schools included, a minority reported opioid-focused research (38.7%), drug disposal or naloxone outreach (30.2%), or hands-on learning (22.6%). A "highly engaged" class (34.9%) and a "limited engagement" class (65.1%) were identified. "Highly engaged" programs were more likely to report opioid-related research (65.9% vs. 24.6%, P < .001), drug disposal or naloxone outreach events (86.5% vs. 0%, P < .001), and skills-based education (40.5% vs. 13%, P = .001) than "limited engagement" programs. No school or geographic factors were significantly associated with class membership. CONCLUSIONS: Nearly two-thirds of schools and colleges of pharmacy reported limited involvement in skills-based education, research, and outreach efforts. Future research should explore other predictors of school-level opioid-related activities, including faculty expertise and institutional priorities.

Predictors of job satisfaction among pharmacists: A regional workforce survey.

Background: Job satisfaction affects organizational outcomes including performance and retention. The pharmacy job satisfaction literature points to several predictors of job satisfaction, but educational debt and various work settings have not been previously examined. Objectives: To identify predictors of Virginia pharmacists' job satisfaction. Methods: This cross-sectional study used data from the 2018 Virginia Pharmacist Workforce Survey. Of 15,424 registered pharmacists, 13,962 (90.5%) completed the survey. Pharmacists who reported being employed and working in Virginia in the previous year (2017) were included in the analysis (n = 6042). Data were summarized using descriptive statistics. Multiple logistic regression identified predictors of job satisfaction. Results: Respondents were primarily female (66.3%), Pharm.D. degree holders (65.5%), with a 14.8-year average work experience. Most pharmacists (86%) reported being very/somewhat satisfied with their job. Educational debt was not significantly associated with job satisfaction. Significant predictors of job satisfaction included: being female (aOR = 1.28, 95% CI 1.08, 1.52); working <30 (aOR = 1.80, 95% CI 1.14, 2.84), 30-39 (aOR = 1.47, 95% CI 1.02, 2.11), or 40-49 (aOR = 1.42, 95% CI 1.02, 1.98) versus ≥50 h per week; earning an annual income of <$50,000 (aOR = 0.60, 95% CI 0.38, 0.94) or ≥ $150,000 (aOR = 2.05, 95% CI 1.30, 3.23) versus $100,000-$149,999; working in an independent community pharmacy (aOR = 3.72, 95% CI 2.54, 5.44), health system (aOR = 3.81, 95% CI 2.78, 5.22), clinic-based pharmacy (aOR = 4.39, 95% CI 2.18, 8.83), academia (aOR = 5.20, 95% CI 1.97, 13.73), benefits administration (aOR = 3.64, 95% CI 1.71, 7.74), long-term home and home health/infusion (aOR = 1.71, 95% CI 1.10, 2.67), mass merchandiser community (aOR = 0.79, 95% CI 0.62, 0.99), or manufacturer and wholesale distributor (aOR = 3.46, 95% CI 1.97, 6.08) versus chain community pharmacy. Conclusions: Overall, Virginia pharmacists reported high job satisfaction. Pharmacists working in chain community pharmacy reported lower satisfaction relative to other settings. Being female, having a high annual income, and working for less hours was associated with improved job satisfaction.

The cost-effectiveness of pharmacist-physician collaborative care models vs usual care on time in target systolic blood pressure range in patients with hypertension: a payer perspective.

BACKGROUND: Hypertension is highly prevalent in the United States, affecting nearly half of all adults (43%). Studies have shown that pharmacist-physician collaborative care models (PPCCMs) for hypertension management significantly improve blood pressure (BP) control rates and provide consistent control of BP. Time in target range (TTR) for systolic BP is a novel measure of BP control consistency that is independently associated with decreased cardiovascular risk. There is no evidence that observed improvement in TTR for systolic BP with a PPCCM is cost-effective. OBJECTIVE: To compare the cost-effectiveness of a PPCCM with usual care for the management of hypertension from the payer perspective. METHODS: We used a decision analytic model with a 3-year time horizon based on published literature and publicly available data. The population consisted of adult patients who had a previous diagnosis of high BP (defined as office-based BP ≥ 140/90 mmHg) or were receiving antihypertensive medications. Effectiveness data were drawn from 2 published studies evaluating the effect of PPCCMs (vs usual care) on TTR for systolic BP and the impact of TTR for systolic BP on 4 cardiovascular outcomes (nonfatal myocardial infarction [MI], stroke, heart failure [HF], and cardiovascular disease [CVD] death). The model incorporated direct medical costs, including both programmatic costs (ie, direct costs for provider time) and downstream health care utilization associated with acute cardiovascular events. One-way sensitivity and threshold analyses examined model robustness. RESULTS: In base-case analyses, PPCCM hypertension management was associated with lower downstream medical expenditures (difference: -$162.86) and lower total program costs (difference: -$108.00) when compared with usual care. PPCCM was associated with lower downstream medical expenditures across all parameter ranges tested in the deterministic sensitivity analysis. For every 10,000 hypertension patients managed with PPCCM vs usual care over a 3-year time horizon, approximately 27 CVD deaths, 29 strokes, 21 nonfatal MIs, and 12 incident HF diagnoses are expected to be averted. CONCLUSIONS: This is the first study to evaluate the cost-effectiveness of PPCCM compared to usual care on TTR for systolic BP in adults with hypertension. PPCCM was less costly to administer and resulted in downstream health care savings and fewer acute cardiovascular events relative to usual care. Although further research is needed to evaluate the long-term costs and outcomes of PPCCM, payer coverage of PPCCM services may prevent future health care costs and improve patient cardiovascular outcomes. DISCLOSURES: No funding was received for the completion of this research. The authors have nothing to disclose. Study results were presented as an abstract at the AMCP 2021 Virtual, April 12-16, 2021.

Lessons learned: Assessing team creation by personality inventories in pharmacy students.

BACKGROUND: Proper team formation is critical for team performance and dynamics in the setting of team-based learning (TBL). Faculty should stratify students to ensure an even allocation of learner resources; however, the ideal method of team creation for TBL in pharmacy education has yet to be determined. A study aimed to assess team formation stratified by personality strengths on student performance for graded team activities, peer evaluations, and student perceptions of team dynamics compared to randomization of teams the previous semester with the same cohort. This Live and Learn piece will describe lessons learned throughout this project and research considerations for future studies on TBL team creation. IMPACT: The study design compared team stratification by strengths vs. randomization, which resulted in similar distribution of CliftonStrengths domains with a variation of two teams between the semesters. Due to homogeneity in student strengths and negligible difference in purposeful team creation by strengths vs. randomization, the study was limited in its methodology and findings. RECOMMENDATIONS: Through the description of this experience, the authors have outlined suggestions for designing studies to explore team creation methods, specifically capturing preliminary data, including a control group, and recognizing the influence of randomization. DISCUSSION: Future studies to identify the optimal method for team formation may include alternate stratification approaches and should be performed over multiple cohorts from varying institutions. It is equally plausible that randomization consistently generates teams with equitable resource distribution and team formation has no overall impact on TBL effectiveness.

Differences in Exclusive Breastfeeding Rates in US Hospitals According to Baby-Friendly Hospital Initiative Designation and Area Deprivation Index Category.

Background: Disparities in breastfeeding persist placing a greater burden of disease on non-Hispanic black and Hispanic women and infants. Targeted implementation of the Baby-Friendly Hospital Initiative (BFHI) in areas at risk for poor breastfeeding outcomes has been shown to improve disparities in breastfeeding. The area deprivation index (ADI), a measure of the relative socioeconomic disadvantage of a neighborhood, may be useful in exploring the accessibility of BFHI hospitals in highly deprived areas and the differences in exclusive breastfeeding (EBF) rates in hospitals with and without the BFHI designation across deprivation categories. Objective: To evaluate the geographical distribution of BFHI and non-BFHI hospitals across ADI categories and explore the differences in EBF rates in BFHI and non-BFHI hospitals across ADI categories. Methods: Hospital EBF rates obtained from the Joint Commission included 414 BFHI and 1,532 non-BFHI hospitals. State ADI rank scores were determined for each hospital's census block group. Descriptive statistics were used to describe the geographic distribution of BFHI hospitals across three ADI categories (low, medium, and high). EBF rates across ADI categories and BFHI designations were compared using multiway analysis of variance. Results: The distribution of BFHI was similar across all ADI categories, ranging from 18% to 24%. EBF rates were 4.9% lower in highly deprived areas compared to areas with lower deprivation (p < 0.01). BFHI was associated with significantly higher EBF rates across all ADI categories (6.9%-11.2%, p < 0.01). Conclusion: ADI may be a useful tool for targeting the implementation of BFHI in hospitals in highly deprived areas to reduce breastfeeding disparities.

CMS Mega-Rule Update and the Status of Pharmacy-Related Deficiencies in Nursing Homes.

The scope, frequency, and nursing home characteristics associated with pharmacy-related deficiency citations following the Centers for Medicare and Medicaid Services 2016 "Mega-Rule" update are described. A retrospective analysis of data from Nursing Home Compare and LTCfocus.org was conducted on pharmacy-related deficiencies (including pharmacy services, drug regimen review, unnecessary medications, medication errors, and labeling/storage). The most commonly cited pharmacy-related deficiencies (N = 11,678) were related to labeling/storage (comprising 25.1% of pharmacy-related deficiencies), unnecessary psychotropic medications (20.5%), and routine pharmacy services (16.8%). In multivariable analysis, nursing home characteristics significantly associated with receiving any pharmacy-related deficiency included less geographic competition (adjusted odds ratio [aOR]: 0.68), registered nurse hours (aOR: 0.66), occupancy (aOR: 0.67), for-profit status (aOR: 1.27), and Midwest (aOR: 1.50) or West (aOR: 2.95) location. Given the frequency of pharmacy-related citations and the lack of standardization in pharmacists' roles in nursing homes, further research is needed to better understand how pharmacist services can affect inspection compliance.

Sex and Age Differences in Ambulatory Blood Pressure Monitoring Tolerability.

BACKGROUND: Clinical practice guidelines endorse using ambulatory blood pressure monitoring (ABPM) for the diagnosis and management of hypertension. However, ABPM is not always tolerated by patients, and differences between individuals according to age and sex remain unexplored. METHODS: This is a post hoc analysis of a prospective, single-arm clinical trial (NCT03920956) that evaluated the feasibility of an ABPM service provided at 2 community pharmacies. Tolerability was assessed using a previously published survey, which included 7 yes/no questions and 8 answered on a scale of 0-10. Descriptive statistics and Chi-square analyses were used to summarize the data for the patient surveys and to describe sex and age differences in device tolerability. RESULTS: Of the 52 subjects enrolled, 50 (96%) completed the survey; half were female with a mean (SD) age of 57.5 years (15.8). Chi-square analyses showed that compared with their male counterparts, females were more likely to find the monitor cumbersome to wear (76.2% vs. 40%, P = 0.014). Subjects under 55 years of age were more likely to be disturbed by the noise of the monitor during driving (38.1% vs. 4.2%, P = 0.005) and at other times (35.0% vs. 8.3%, P = 0.029), and to find the monitor embarrassing to wear (33.3% vs. 7.1%, P = 0.019). CONCLUSIONS: Although ABPM was generally well-tolerated overall, we did identify age and sex differences in tolerability. These factors should be considered to ensure patient acceptance and tolerability of ABPM.

Medication Adherence Trajectories: A Systematic Literature Review.

BACKGROUND: Traditional adherence measures such as proportion of days covered (PDC) and medication possession ratio (MPR) are limited in their ability to explain patient medication adherence over time. Group-based trajectory modeling (GBTM) is a new methodological approach that visually describes the dynamics of long-term medication adherence and classifies adherence behavior into groups. OBJECTIVES: To describe and compare trajectories of medication nonadherence reported in the medical literature, including identifying consistent trends in adherence trajectories and disease and patient characteristics that predict trajectory group membership. METHODS: A systematic literature review was conducted in April 2020 in PubMed and CINAHL using MeSH terms and key words in appropriate combinations. Citations were screened for relevance using predefined inclusion and exclusion criteria and evaluated according to variables associated with group-based trajectory models. RESULTS: 21 articles met the study criteria and were reviewed. Generally, studies identified 4 to 6 trajectory groups that described longitudinal medication adherence behavior. Most commonly identified trajectories were labeled as (a) consistent, high adherence, (b) declining adherence, (c) early and consistent nonadherence, and (d) initial nonadherence followed by an increase. Several predictors, including socioeconomic status, disease characteristics, and therapy initiation were routinely associated with group membership. CONCLUSIONS: This review suggests that adherence trajectories and predictors of specific group membership may be similar across diverse disease states. GBTM describes longitudinal, dynamic patterns of medication adherence that may facilitate the development of targeted interventions to promote adherence. Implications for value-based payment systems are discussed in this review. DISCLOSURES: No outside funding supported this study. The authors have no conflicts of interest to declare.

Utilizing widely available podcasts to create a reflection activity for pharmacy students.

BACKGROUND AND PURPOSE: Creative strategies can be employed to encourage development of affective domain skills. The purpose of this article is to describe and assess the creation of a written self-reflection assignment utilizing podcasts. Educational activity and setting: Second year pharmacy students (N = 122) in a skills laboratory course completed two written reflections that asked them to: (1) examine and reflect on personal beliefs, biases, motivations and emotions that were challenged while listening to a podcast; and (2) identify knowledge, skills, and abilities of a pharmacist that may impact the situation presented in the podcast. Students chose from a list of podcasts curated by faculty and completed two 450 to 600-word reflections. Students completed a pre-post modified Questionnaire for Reflective Thinking (mQRT). A one-tailed, paired t-test was used to assess the mQRT. The post-questionnaire survey also included questions related to student perceptions of the reflections. Descriptive statistics were used to summarize student perceptions. FINDINGS: Out of 122 students, 116 (95.1%) completed both the pre- and post-mQRT and survey. The majority of students responded affirmatively that the reflections made them think about healthcare in a different way (91.4%) and challenged their beliefs/biases (81.9%). Students reported applying information from previous course material to the podcast concepts (75%) and vice versa (77.6%). SUMMARY: Assignments using podcasts are a unique way of engaging student learners. These assignments may help to assess affective educational outcomes and be a way to increase self-reflection, self-awareness, and metacognition in pharmacy students.

Development and feasibility of a community pharmacy-driven 24-hour ambulatory blood pressure monitoring service.

BACKGROUND: Although 24-hour ambulatory blood pressure monitoring (ABPM) is recommended by practice guidelines, access to ABPM is poor in the United States. Other countries have increased ABPM access by making it available in community pharmacies. It is not known if a similar approach is feasible in the United States. OBJECTIVE: The objective of this study was to develop and evaluate the feasibility of a community pharmacy-driven ABPM service in the United States. SETTING: Two independent community pharmacies. PRACTICE DESCRIPTION: The ABPM service was developed through a collaboration between an academic partner and the clinical service leads of each pharmacy. Eligible patients were those referred by their provider or self-referred for white coat, masked, or sustained hypertension (HTN), symptoms of hypotension, or requiring confirmation of an initial diagnosis of HTN. The service was appointment-based, and the pharmacist sent the ABPM results and interpretation to the referring provider via facsimile. PRACTICE INNOVATION: This is the first description of a community pharmacy-driven ABPM service in the United States. EVALUATION: Descriptive statistics were used to summarize the data for the baseline demographics, ABPM findings, and a 9-question patient satisfaction survey. RESULTS: A total of 52 patients with a mean (SD) age of 56.6 (16.1) years, 50% women, 75% white, and 71.2% with a prior diagnosis of HTN were enrolled. Forty-six patients (88.5%) had successful ABPM readings with the most common blood pressure phenotypes being nocturnal HTN (91.3%), nondipper (52.1%), sustained HTN (41.3%), normotensive (23.9%), and white coat HTN (19.6%). Overall, 88% of the patients strongly agreed or agreed that they were very satisfied with their experience using the ABPM service. CONCLUSION: A community pharmacy-driven ABPM service is feasible in the United States and may be one approach to improve access to ABPM.

The Inclusion of Economic Endpoints as Outcomes in Clinical Trials Reported to ClinicalTrials.gov.

BACKGROUND: As medication expenditures rise, payers are increasingly demanding evidence of economic value for new medications. The 2015 Professional Society for Health Economics and Outcomes Research (ISPOR) Task Force on Cost-Effectiveness Analysis Alongside Clinical Trials noted that clinical trials are increasingly including health care utilization endpoints to address this rising interest in economic information. OBJECTIVES: To (a) describe the prevalence of economic endpoints in clinical trials submitted to ClinicalTrials.gov and (b) examine associations between trial characteristics and the inclusion of economic endpoints. METHODS: This retrospective review of ClinicalTrials.gov data extracted the characteristics of clinical trials that were submitted to ClinicalTrials.gov from January 2004 to December 2018; studied a drug and/or biological; and had a recruitment status of not yet recruiting, recruiting, active but not recruiting, or completed. Studies were classified as containing an economic endpoint based on 2 independent evaluations of the inclusion of endpoints relevant to costs, resource utilization, cost-effectiveness, productivity, absenteeism, presenteeism, or unemployment. Descriptive statistics were used to summarize trial characteristics, and chi-square analyses were used to evaluate differences in characteristics between trials with and without economic endpoints. RESULTS: Of the 104,885 trials included in the study, 1,437 (1.37%) included an economic endpoint; among later phase (phase 2/3, 3, 4) trials, 939 (2.54%) included economic endpoints. Compared with studies that did not include economic endpoints, those that did were less often industry funded (48.0% vs. 52.0%, P < 0.001) and were for a high-spend specialty condition (24.1% vs. 27.4%, P < 0.001). The proportion of trials that included economic endpoints increased by a small but significant amount over the time period studied, from 1.2% (2004-2008) to 1.6% (2014-2018; P < 0.001). CONCLUSIONS: A small but growing number of clinical trials are including economic endpoints. This finding may reflect continued industry concerns surrounding the cost and logistical challenges of piggybacking economic data collection alongside clinical trials and/or manufacturers' preferences for modeling for value demonstration. Future research is needed to better understand barriers to the inclusion of economic endpoints as well as the degree to which incorporating health care resource utilization collected during clinical trials into early economic modeling may reduce payer concerns about model transparency and bias. DISCLOSURES: No outside funding supported this study. Patterson reports past employment by Indivior, unrelated to this study. Mitchell has nothing to disclose. The research included in this study was presented as a nonreviewed student pharmacist poster at AMCP Nexus 2019; October 30-November 1, 2019; National Harbor, MD.

Outpatient Breastfeeding Champion Program: Breastfeeding Support in Primary Care.

Background: Breastfeeding support offered by trained professionals can increase breastfeeding success. The Outpatient Breastfeeding Champion (OBC) program creates a network of Breastfeeding Champions (typically nurses) who are trained to identify and resolve common breastfeeding issues and refer to lactation professionals as needed. The objective of this study was to evaluate the impact the OBC program on nurses' attitudes toward breastfeeding and self-confidence in providing breastfeeding care. Materials and Methods: The OBC program was implemented in 11 medical offices within a health care system. Nurses were surveyed before (n = 9) and immediately after (n = 9) participating in OBC training sessions, and 6 months following the implementation of the OBC training (n = 15). Data were collected on their breastfeeding attitude and self-confidence in providing breastfeeding care, and the responses at the different time points were compared using Wilcoxon Rank-Sum tests. Results: Nurses' attitudes toward breastfeeding (p = 0.049) and self-confidence in managing breastfeeding position and attachment (p = 0.09) were higher immediately after completion of the OBC training than they were before training. There was no significant difference in either response between immediately after completion and 6 months following training. Conclusion: This study presents a model of breastfeeding care that extends the reach of an International Board Certified Lactation Consultant to improve breastfeeding support in the primary care setting. Nurses' more positive breastfeeding attitudes and self-confidence in providing breastfeeding care following training suggest that the use of a breastfeeding training program may improve the breastfeeding support provided by nurses, which could be sustained over time.

Ultra-short duration direct acting antiviral prophylaxis to prevent virus transmission from hepatitis C viremic donors to hepatitis C negative kidney transplant recipients.

We conducted an adaptive design single-center pilot trial between October 2017 and November 2018 to determine the safety and efficacy of ultra-short-term perioperative pangenotypic direct acting antiviral (DAA) prophylaxis for deceased hepatitis C virus (HCV)-nucleic acid test (NAT) positive donors to HCV negative kidney recipients (D+/R-). In Group 1, 10 patients received one dose of SOF/VEL (sofusbuvir/velpatasvir) pretransplant and one dose on posttransplant Day 1. In Group 2A (N = 15) and the posttrial validation (Group 2B; N = 25) phase, patients received two additional SOF/VEL doses (total 4) on Days 2 and 3 posttransplant. Development of posttransplant HCV transmission triggered 12-week DAA therapy. For available donor samples (N = 27), median donor viral load was 1.37E + 06 IU/mL (genotype [GT]1a: 70%; GT2: 7%; GT3: 23%). Overall viral transmission rate was 12% (6/50; Group 1:30% [3/10]; Group 2A:13% [2/15]; Group 2B:4% [1/25]). For the 6 viremic patients, 5 (83%) achieved sustained virologic response (3 with first-line DAA therapy; and two after retreatment with second-line DAA). At a median follow-up of 8 months posttransplant, overall patient and allograft survivals were 98%, respectively. The 4-day strategy reduced viral transmission to 7.5% (3/40; 95% confidence interval [CI]: 1.8%-20.5%) and could result in avoidance of prolonged posttransplant DAA therapy for most D+/R - transplants.