Guidance for Pharmacy Curricula to Incorporate Health, Wellness, and Health Inequities Stemming From Climate Change: The Report of the 2022-2023 AACP Argus Commission.

The 2022-2023 American Association of College of Pharmacy Argus Commission was charged to provide guidance to schools, curriculum committees, and faculty on how to incorporate health, wellness, and health inequities stemming from climate change into pharmacy curricula. The Argus Commission does not advocate for major changes in the curriculum or standards but suggests a concerted effort across the Academy to enhance the awareness of graduating students of the potential impact of climate change on health both now and in the future. Various examples, along with recommendations and suggestions, are provided of how the impact of climate change on health is currently being integrated into curricula in member schools, as well as a list of resources faculty can use to enhance their awareness of issues related to climate change and health. The Commission was also charged to provide guidance to the American Association of College of Pharmacy regarding future fundraising and business development opportunities. Recommendations in that regard are also included in this report.

Development of an Entrustment-Supervision Assessment Tool for Pharmacy Experiential Education Using Stakeholder Focus Groups.

Objective To devise a pharmacy-specific, expanded entrustable professional activities (EPA) entrustment-supervision scale that would frame preceptor ratings in a prospective and retrospective manner for use in experiential learning settings.Methods A series of focus group sessions were conducted to solicit expert opinion on how to develop and refine two entrustment-supervision scales. Purposive sampling was used to identify experts from different professional groups (physicians, pharmacy experiential administrators, and pharmacy practice faculty) who had extensive knowledge regarding EPAs and at least one publication related to EPAs. Panelists were invited to participate via email. Three focus sessions were conducted via videoconferencing between June and September 2019. The primary outcome was development of a pharmacy-specific EPA entrustment-supervision assessment tool. Secondary outcomes were individual entrustment-supervision statements across five levels of the entrustment-supervision scale.Results The focus group consisted of four pharmacy practice faculty, two experiential administrators, and one academic physician. Four concepts emerged from the focus group discussion: need for more granularity in entrustment-supervision scales; limitations due to differences in licensure requirements across the United States; present and ongoing use of expanded scales by schools and colleges of pharmacy; and uncertainty regarding how to rate entrustment-supervision when a student exhibits unprofessional behavior.Conclusion A pharmacy-specific, expanded EPA entrustment-supervision scale will be useful to support longitudinal assessment of learners in experiential settings where an EPA framework is utilized. Determining when to use a prospective versus retrospective perspective requires further evaluation.

Entrustable Professional Activities (EPAs) for Global Health.

PURPOSE: As global health education and training shift toward competency-based approaches, academic institutions and organizations must define appropriate assessment strategies for use across health professions. The authors aim to develop entrustable professional activities (EPAs) for global health to apply across academic and workplace settings. METHOD: In 2019, the authors invited 55 global health experts from medicine, nursing, pharmacy, and public health to participate in a multiround, online Delphi process; 30 (55%) agreed. Experts averaged 17 years of global health experience, and 12 (40%) were from low- to middle-income countries. In round one, participants listed essential global health activities. The authors used in vivo coding for round one responses to develop initial EPA statements. In subsequent rounds, participants used 5-point Likert-type scales to evaluate EPA statements for importance and relevance to global health across health professions. The authors elevated statements that were rated 4 (important/relevant to most) or 5 (very important/relevant to all) by a minimum of 70% of participants (decided a priori) to the final round, during which participants evaluated whether each statement represented an observable unit of work that could be assigned to a trainee. Descriptive statistics were used for quantitative data analysis. The authors used participant comments to categorize EPA statements into role domains. RESULTS: Twenty-two EPA statements reached at least 70% consensus. The authors categorized these into 5 role domains: partnership developer, capacity builder, data analyzer, equity advocate, and health promoter. Statements in the equity advocate and partnership developer domains had the highest agreement for importance and relevance. Several statements achieved 100% agreement as a unit of work but achieved lower levels of agreement regarding their observability. CONCLUSIONS: EPAs for global health may be useful to academic institutions and other organizations to guide the assessment of trainees within education and training programs across health professions.

Global Health Learning Outcomes by Country Location and Duration for International Experiences.

Objective. To determine the impact of country income classification and experience duration on learning outcomes for student pharmacists participating in international advanced pharmacy practice experiences (APPEs). Methods. A mixed-methods, longitudinal study evaluated 81 fourth-year student pharmacists participating in an international APPE through one of three US universities. A pre-post survey was administered to evaluate students' self-perceived growth across 13 competencies established by the Consortium of Universities for Global Health (CUGH). The survey included four additional open-ended questions. Student pharmacists were also invited to participate in a focus group. Paired and independent t tests and multiple linear regression were conducted. Qualitative survey and focus group data underwent a two-cycle, open-coding process using conventional content analysis. Results. Students who completed their APPE in a low- to middle-income country had greater growth in all CUGH competency statements compared to those who completed their APPE in a high-income country. Completing the APPE in a low- to middle-income country and prior travel for non-vacation purposes were significant predictors of student growth. Students who went to a low- to middle-income country demonstrated increased cultural sensitivity, more patient-centered care, and skill development, while students who went to a high-income country displayed increased knowledge regarding differences in health care system components, pharmacy practice, pharmacy education, and an appreciation for alternative patient care approaches. Conclusion. Learning outcomes differed between students who completed an APPE in a high-income rather than a low- to middle-income country, with both types of locations providing valuable educational opportunities and professional and personal development.

Co-curricular assessment plan for developing pharmacy professionals (RxPro) after the first professional year.

INTRODUCTION: To measure changes in student professionalism from co-curricular activities. METHODS: A prospective cohort study followed first-year pharmacy students at The University of Texas at El Paso School of Pharmacy. Students completed one co-curricular activity each semester. Learning was assessed using the RxPro VALUE rubric and Professionalism Assessment Tool (PAT) at the beginning and end of the first professional year. The RxPro VALUE rubric included six domains (connections to experience, lifelong learning, diversity of communities and cultures, civic identity and commitment, empathy, and reflection and self-assessment) and was rated from 0 (not yet applied) to 4 (exemplary). The PAT contained 33-items in five domains (reliability, responsibility, and accountability; lifelong learning and adaptability; relationships with others; upholding principles of integrity and respect; and citizenship and professional engagement) and was rated from 1 (knows) to 5 (teaches) (maximum score = 165). RESULTS: Mean scores on the RxPro VALUE rubric increased (p < 0.05) from baseline to end of year in five domains: connections to experience (1.44 vs. 2.07), diversity of communities and cultures (1.75 vs. 2.3), civic identity and commitment (1.34 vs. 2.33), empathy (1.44 vs. 2.37), and reflection and self-assessment (1.53 vs 2.19). No significant changes were seen in PAT scores from baseline (M = 114.19, standard deviation = 32.832) to end of year (M = 119.56, standard deviation = 29.63, p = 0.35). CONCLUSIONS: The RxPro VALUE rubric detected growth in professional behaviors among first-year doctor of pharmacy students, while no significant change was observed in the PAT.

Validating a Budget Impact Model Using Payer Insight and Claims Data: A Framework and Case Study.

BACKGROUND: There is a paucity of studies validating budget impact models. The lack of such studies may contribute to the underuse of budget impact models by payers in formulary decision making. OBJECTIVE: To assess the face validity, internal verification, and predictive validity of a previously published model that assessed the budgetary impact of antidiabetic formulary changes. METHODS: 4 experts with diverse backgrounds were selected and asked questions regarding the face validity of the structure/conceptual model, input data, and results from the budget impact model. To assess internal verification, structured "walk-throughs," unit tests, extreme condition tests, traces, replication tests, and double programming techniques were used. The predictive validity of the model was evaluated by comparing the predicted and realized budget using mean absolute scaled error. "Realized" budgetary impact of the formulary changes was calculated by taking the difference between realized budget in the year after the formulary changes and the budget had there been no formulary changes (i.e., the counterfactual). The counterfactual budget was modeled using the best fit autoregressive integrated moving average model. RESULTS: When assessing the face validity of the model, the 4 experts brought up issues such as how to incorporate other health insurance, recent policy changes, cost inflation, and potential impacts on insulin use. The 6 internal verification techniques caught mistakes in equations, missing data, and misclassified data. The realized budget was found to be lower than the predicted budget, with 13% error and an absolute scaled error of 2.60. After removing the model assumption that past utilization trends would continue, the model's predictive accuracy improved (the absolute scaled error dropped below 1 to 0.48). The "realized" budgetary impact was found to be greater than the predicted budgetary impact, largely because of lower-than-expected utilization. CONCLUSIONS: The budget impact model overpredicted utilization in the year after the formulary changes. Discoveries through the validation process improved the accuracy and transparency of the model. DISCLOSURES: This project was supported by grant number F32HS024857 from the Agency for Healthcare Research and Quality (AHRQ). The content is solely the responsibility of the authors and does not necessarily represent the official views of AHRQ. AHRQ had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or design to submit the manuscript for publication. The findings discussed in this manuscript represent the views of the authors and do not necessarily reflect the views of the Department of Defense, the Defense Health Agency, nor the Departments of the Army, Navy, and Air Force. Hung reports a grant from the AHRQ, during the conduct of the study, and personal fees from CVS Health and BlueCross BlueShield Association, outside the submitted work. Mullins reports grants and personal fees from Bayer and Pfizer and personal fees from Boehringer Ingelheim, Janssen/J&J, Regeneron, and Sanofi-Aventis, outside the submitted work. Mullins, Slejko, and Shaya are employed by the University of Maryland School of Pharmacy. Haines and Lugo have nothing to disclose. Part of this content was previously presented as a poster at the 2017 AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 27-30, 2017; Denver, CO, and as poster and oral presentations at the 2017 AMCP Nexus Meeting; October 16-19, 2017; Dallas, TX. Part of this content was published as Hung's PhD dissertation.

Using a Budget Impact Model Framework to Evaluate Antidiabetic Formulary Changes and Utilization Management Tools.

BACKGROUND: Traditional budget impact models predict the financial consequences of a new drug entering the market. This study provides an example of applying the budget impact framework to a new research question of interest to managed care organizations-what is the budget impact of our formulary and utilization management (UM) policy changes? OBJECTIVE: To predict the 3-year annual budgetary impact of TRICARE's antidiabetic formulary and UM policy changes using TRICARE claims data. METHODS: A budget impact model was built in Microsoft Excel using health plan claims data for a 3-year time horizon. Model outcomes included spending on antidiabetic medications and medications used for side effect treatment. In sensitivity analyses, medical costs from inpatient, outpatient, and emergency room visits were also estimated. Model inputs included health plan antidiabetic medication utilization, as well as publicly available drug cost, rebate, dispensing fee, and patient cost-sharing estimates. Type of enrollee and pharmacy were also incorporated into the model. Sensitivity analyses varied estimates for utilization switch rates between preferred and nonpreferred agents, drug costs, rebates, and dispensing fees, as well as predicted impact from implementation delays. RESULTS: For the 623,827 affected by the formulary and UM policy changes, the model predicted annual savings that increased from $24 million in the first year to $43 million in the third year after the changes. The majority of savings came from drug acquisition costs, as opposed to rebates, copays, and dispensing fees. Sensitivity analyses found savings across all varied parameters and scenarios except an unlikely scenario when 0% of utilization switched from nonpreferred to preferred agents. The model also predicted that the formulary and UM policy changes would lead to $529,439 in savings from medical visit costs in Year 3. CONCLUSIONS: This budget impact model predicted cost savings from the payer's formulary and UM policy changes. DISCLOSURES: This project was supported by grant number F32HS024857 from the Agency for Healthcare Research and Quality (AHRQ), which contracted with the University of Maryland School of Pharmacy to conduct this study. The content is solely the responsibility of the authors and does not necessarily represent the official views of the AHRQ, which had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or design to submit the manuscript for publication. The findings discussed in this manuscript represent the views of the authors and do not necessarily reflect the views of the Department of Defense, the Defense Health Agency, nor the Departments of the Army, Navy, and Air Force. Hung reports a grant from the AHRQ, during the conduct of the study, and personal fees from CVS Health and BlueCross BlueShield Association, outside the submitted work. Mullins reports grants and personal fees from Bayer and Pfizer and personal fees from Boehringer-Ingelheim, Janssen/J&J, Regeneron, and Sanofi, outside the submitted work. Mullins, Slejko, and Shaya are employed by the University of Maryland School of Pharmacy. Haines and Lugo have nothing to disclose. Part of this content was previously presented as a poster at the 2017 AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 27-30, 2017; Denver, CO, and as poster and oral presentations at the 2017 AMCP Nexus Meeting; October 16-19, 2017; Dallas, TX. Part of this content was published as Hung's PhD dissertation.

Persistence with injectable antidiabetic agents in members with type 2 diabetes in a commercial managed care organization.

OBJECTIVE: While many patients with type 2 diabetes require insulin to achieve glycemic goals, little is known about patients' persistence with insulin or other injectable antidiabetic therapies. The objective of this study was to evaluate persistence with injectable antidiabetic agents in patients with type 2 diabetes who were naïve to these treatments. METHODS: The study cohort was obtained using administrative and pharmacy claims data from a commercial managed care organization of approximately 1.2 million members with pharmacy benefits. The inclusion criteria were members with type 2 diabetes who had at least one pharmacy claim for insulin glargine, insulin detemir, exenatide, or isophane insulin human (NPH insulin) from January 1, 2006 through June 30, 2006. The first claim for any of these injectable therapies was considered the index prescription. Members were excluded if they filled a prescription (a) for any injectable antidiabetic medication from July 2005 through December 2005; or (b) for short/rapid-acting or mixed insulins during 2006, either prior to the index date or within 30 days following the index date. The primary outcome was persistence with the index drug, defined as number of months between the initiation of therapy (i.e., index date) and either the end of therapy (date of last fill plus days supply) or study period of 12 months. The secondary outcome was the percentage of patients with claims for new antidiabetic agents added after index date. Multivariate regression with life data (survival analysis) was performed with number of months of persistence as the dependent variable. RESULTS: The cohort consisted of 1769 members with a mean (SD) age of 53.2 (12.5) years and 47.4% were men. Mean (SD) months of persistence for members on insulin glargine, insulin detemir and exenatide were similar at 7.8 (4.1), 7.8 (4.4), and 7.6 (4.4), respectively. Members taking NPH insulin had statistically lower persistence at 5.6 (4.5) months (P < 0.001). Overall persistence was 28.7% for injectable antidiabetics at 1 year among treatment-naïve patients. In a multivariate regression model, patients who were younger (P = 0.025) and who initially received NPH insulin (P < 0.001) were less likely to persist. There was no association between persistence and sex, initial copayment, or number of oral antidiabetic medications at time of index prescription. Members in the exenatide and NPH insulin groups were less likely to receive new antidiabetic agents compared with the insulin glargine group (P < 0.001). Limitations include the use of pharmacy claims to proxy the type of diabetes and patients with gestational diabetes may have been included. Missing or inaccurate claims data, the use of samples and hospitalizations may have occurred and would result in an underestimation of persistence. CONCLUSIONS: Persistence was low for injectable antidiabetics at 1 year among treatment-naïve patients. Patients who received insulin glargine, insulin detemir, or exenatide were more likely to persist than patients receiving NPH insulin. Older patients were more likely to persist, but sex, copayment and number of oral antidiabetic medications at initiation of the injectable antidiabetic were not associated with persistence.

Improving the use of anticoagulant therapies in acutely ill medical patients.

PURPOSE: Assessment of risk for the development of venous thromboembolism (VTE), selection of VTE prophylaxis in medical patients, strategies for improving prescribing practices to prevent VTE, and the impact of pharmacist-managed anticoagulation services are described; case studies are used to illustrate each topic. SUMMARY: Assessing risk for VTE is more complicated for acutely ill medical patients than for surgical patients. The risk of VTE in medical patients increases with the number of VTE risk factors the patient has. A number of regimens have demonstrated efficacy in reducing the rate of VTE in medically ill patients. Head-to-head studies suggest that enoxaparin 40 mg daily is at least as effective as unfractionated heparin (UFH) 5000 units three times daily for preventing VTE in acute medically ill patients. Because of greater efficacy, enoxaparin may be preferred over UFH in certain patient populations at particularly high risk for VTE. Although the efficacy of VTE prophylaxis is well documented, most patients at risk still do not receive this therapy. A combination of strategies is more effective than a single strategy for modifying prescribing practices to ensure that optimal VTE prophylaxis is provided when indicated. Pharmacist-managed anticoagulation services improve the appropriate use of anticoagulant agents, shorten hospital length of stay, and reduce mortality, drug-related complications, hospital readmissions for bleeding and thrombosis, and costs. CONCLUSION: Pharmacists can improve clinical and economic outcomes in acutely ill medical patients who are at risk for VTE through the use of various strategies, including anticoagulation management services.

Developing a business-practice model for pharmacy services in ambulatory settings.

A business-practice model is a guide, or toolkit, to assist managers and clinical pharmacy practitioners in the exploration, proposal, development and implementation of new clinical pharmacy services and/or the enhancement of existing services. This document was developed by the American College of Clinical Pharmacy Task Force on Ambulatory Practice to assist clinical pharmacy practitioners and administrators in the development of business-practice models for new and existing clinical pharmacy services in ambulatory settings. This document provides detailed instructions, examples, and resources on conducting a market assessment and a needs assessment, types of clinical services, operations, legal and regulatory issues, marketing and promotion, service development and exit plan, evaluation of service outcomes, and financial considerations in the development of a clinical pharmacy service in the ambulatory environment. Available literature is summarized, and an appendix provides valuable citations and resources. As ambulatory care practices continue to evolve, there will be increased knowledge of how to initiate and expand the services. This document is intended to serve as an essential resource to assist in the growth and development of clinical pharmacy services in the ambulatory environment.