Real-world total cost of care by line of therapy in relapsed/refractory diffuse large B-cell lymphoma.

AIMS: There are multiple recently approved treatments and a lack of clear standard-of-care therapies for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). While total cost of care (TCC) by the number of lines of therapy (LoTs) has been evaluated, more recent cost estimates using real-world data are needed. This analysis assessed real-world TCC of R/R DLBCL therapies by LoT using the IQVIA PharMetrics Plus database (1 January 2015-31 December 2021), in US patients aged ≥18 years treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or an R-CHOP-like regimen as first-line therapy. METHODS: Treatment costs and resources in the R/R setting were assessed by LoT. A sensitivity analysis identified any potential confounding of the results caused by the impact of the COVID-19 pandemic on healthcare utilization and costs. Overall, 310 patients receiving a second- or later-line treatment were included; baseline characteristics were similar across LoTs. Inpatient costs represented the highest percentage of total costs, followed by outpatient and pharmacy costs. RESULTS: Mean TCC per-patient-per-month generally increased by LoT ($40,604, $48,630, and $59,499 for second-, third- and fourth-line treatments, respectively). Costs were highest for fourth-line treatment for all healthcare resource utilization categories. Sensitivity analysis findings were consistent with the overall analysis, indicating results were not confounded by the COVID-19 pandemic. LIMITATIONS: There was potential misclassification of LoT; claims data were processed through an algorithm, possibly introducing errors. A low number of patients met the inclusion criteria. Patients who switched insurance plans, had insurance terminated, or whose enrollment period met the end of data availability may have had truncated follow-up, potentially resulting in underestimated costs. CONCLUSION: Total healthcare costs increased with each additional LoT in the R/R DLBCL setting. Further improvements of first-line treatments that reduce the need for subsequent LoTs would potentially lessen the economic burden of DLBCL.

Cost-Utility Analysis of a Medication Adherence-Enhancing Educational Intervention for Glaucoma.

OBJECTIVE: To evaluate the cost utility of a glaucoma medication-enhancing intervention compared to standard of care over a lifetime from the United States Department of Veterans Affairs (VA) payer perspective. DESIGN: Model-based cost-utility analysis of a glaucoma medication-enhancing intervention from a randomized clinical trial. SUBJECTS: Veterans with glaucoma, or suspected glaucoma who were prescribed topical glaucoma medications, had their visual field assessed within the last 9 months, and endorsed poor glaucoma medication adherence. METHODS: Veterans were randomized either to a behavioral intervention to promote adherence or to a standard of care (control) session about general eye health. A decision analytic model was developed to simulate lifelong costs and quality-adjusted life years (QALYs) for an intervention tested in a randomized clinical trial at a single VA eye clinic. Costs included direct medical costs that the VA payer would incur, as informed initially by the clinical trial and then by published estimates. Health-state quality of life was based on published utility values. Scenario analyses included addition of booster interventions, a 3% decline in chance of staying medication adherent annually, and the combination of the two. Analyses were also conducted in the following subgroups: those with companion versus not, and those with once-daily versus more than once-daily dosing frequency. MAIN OUTCOME MEASURES: Incremental cost-effectiveness ratio (ICER). RESULTS: Compared to standard of care, the intervention dominated resulting in lower costs ($23 339.28 versus $23 504.02) and higher QALYs (11.62 versus 11.58). Among the 4 subgroups, the intervention dominated for 3 of them. In the fourth subgroup, those with more than once-daily dosing, the ICER was $2625/QALY. Compared to standard of care, an intervention with booster interventions led to an ICER of $3278/QALY. Assuming both a 3% annual loss in chance of continuing to be adherent and addition of booster interventions, the ICER increased to $71 371/QALY. CONCLUSIONS: From a VA payer perspective over a lifetime, the glaucoma medication-enhancing behavioral intervention dominated standard of care in terms of generating cost savings and greater QALYs. FINANCIAL DISCLOSURES: Proprietary or commercial disclosure may be found after the references.

Assessing Student Perceptions of Blended and Online Learning Courses in Pharmacoeconomics, Management, and Leadership.

Objective. Blended learning combines traditional face-to-face education with online instruction. This learner-centered approach has been shown to improve student engagement, critical thinking, and performance outcomes. The objective of this study was to assess and trend student pharmacist perceptions of blended and online learning used to teach pharmacy management, leadership, and economics within a Doctor of Pharmacy (PharmD) curriculum.Methods. Qualitative methods were employed using in-depth, semistructured interviews. Second- and third-year student pharmacists were recruited by purposeful and snowball sampling and interviewed to a point of saturation. The interview guide was based on social cognitive theory. Themes identified through initial deductive thematic analysis were categorized by the three domains of social cognitive theory: cognitive, behavioral, and environmental factors. The coding team additionally analyzed the transcripts using inductive thematic analysis to ensure no themes outside of social cognitive theory were missed.Results. Twenty students were interviewed. Themes reveal perceptions that blended learning facilitated greater understanding of course material, increased motivation among learners, provided more flexibility in workload completion, and was a more enjoyable way to learn compared to traditional didactic instruction. Furthermore, blended learning offered additional distinct advantages over traditional and online-only pedagogies.Conclusion. Student pharmacists perceived blended and online learning positively and acceptable for the delivery of a pharmacy course on management, leadership, and economics over traditional didactic instruction. Blended learning may enhance innovation, leadership, management, and economics content delivery and the student learning experience.

Medication Adherence Among Adults With Comorbid Chronic Conditions Initiating Oral Anticancer Agent Therapy for Multiple Myeloma.

PURPOSE: Increased use of oral anticancer agents (OAAs) has empowered adults with multiple myeloma (MM) to manage their oncolytic therapy, but such a shift may result in issues with medication use, particularly among patients being concurrently treated for pre-existing, multiple chronic conditions. METHODS: This retrospective cohort study used 2013-2018 commercial and Medicare claims data to assess medication use in adults with MM. To be included, adults (18 years and older) must have been diagnosed with and had 2+ claims for an OAA, had continuous enrollment for 12 months before and after OAA initiation, and have been previously diagnosed with and had prescription fills for 2+ select chronic conditions. The proportion of days covered metric assessed medication adherence and was compared for 12 months before and after the OAA initiation by Wilcoxon signed-rank tests, McNemar's tests, and difference-in-differences models. RESULTS: The mean OAA adherence in the first year of therapy was 58.3% (standard deviation: 24.5) and 65.1% (standard deviation: 27.01) for commercial and Medicare patients, respectively. Adherence and the proportion adherent (proportion of days covered ≥ 80%) to comorbid therapies generally declined in the first year after OAA initiation. Changes in medication use were particularly noticeable among those on antihypertensive therapy: adjusted analyses uncovered a 2.5% (Medicare) and 5.2% (commercial) difference in adherence to these medications between those initially adherent and nonadherent to OAA therapy (both P < .05). CONCLUSION: Initiating OAA therapy in adults with MM may complicate an already complex treatment regimen, resulting in poor overall medication adherence in patients with multiple comorbid conditions.

Social determinants of health and adult influenza vaccination: a nationwide claims analysis.

BACKGROUND: The health and economic benefits of the annual influenza vaccine are well documented, yet vaccination rates in the United States missed the Healthy People 2020 goal and remain a focus of Healthy People 2030 efforts. By identifying underlying reasons for low annual influenza vaccination, social elements that need targeting may be identified and could guide future interventions or policy development to achieve vaccination goals and improve overall public health. OBJECTIVE: To determine the influence of certain social determinants of health on adherence to annual influenza vaccination in American adults. METHODS: This was a retrospective cohort analysis using data from IBM MarketScan Commercial Claims and Encounters Database and national Medicare 5% sample data from 2013 to 2016. Study eligibility criteria included adults (aged 18 years and older) who were continuously enrolled for 3 influenza seasons between 2013 and 2016. Receipt of the influenza vaccine was counted over 3 consecutive influenza seasons, and select social determinants were extracted from publicly available sources. Patient characteristics, health resource utilization, and selected social determinants of health were included in bivariate and multivariate logistic regression analyses to determine their association with annual influenza vaccination. RESULTS: 6,694,571 adults across employer-sponsored and Medicare coverage groups were analyzed, of which 14.7% of Medicare-enrolled adults and 9.2% of commercially enrolled adults were vaccinated in all 3 seasons. Higher proportions of vaccine adherence (ie, all 3 seasons) were observed among females (9.6% vs 8.7% [commercial], 15.0% vs 14.4% [Medicare]), the immunocompromised (11.8% vs 8.3% [commercial], 15.9% vs 13.6% [Medicare]), rural residents (10.5% vs 9.0% [commercial], 15.4% vs 14.6% [Medicare]; all P < 0.0001), and those enrolled in a high-deductible health plan (10.3%). Multivariable logistic regression models indicated that the odds of vaccine adherence tended to be higher in areas of higher poverty (OR=1.012; 95% CI = 1.01-1.02 [commercial], OR=1.01; 95% CI = 1.01-1.01 [Medicare]) yet lower in areas with higher proportions of Democratic voters (OR=0.998; 95% CI = 0.998-0.998 [commercial], OR = 0.996; 95% CI = 0.996-0.997 [Medicare]). Among commercially insured adults, the odds of vaccine adherence were higher in areas of higher health literacy (OR=1.036; 95% CI = 1.036-1.037), but this effect was not observed among Medicare members. Conversely, the odds of vaccine adherence increased as the proportion of those residing in areas of limited Internet access increased (OR=1.007; 95% CI = 1.004-1.010) among Medicare members only. CONCLUSIONS: Key social determinants of health are important factors of vaccine adherence and can guide policy and intervention efforts toward addressing potential hesitancy. A deeper assessment of other contributing social factors is needed in seasonal influenza and other vaccines to better interpret the vaccine-seeking behaviors of adults. DISCLOSURES: This study received no outside funding. Gatwood, Hagemann, Hohmeier, and Chiu declare vaccine-related grant funding from Merck & Co. and GlaxoSmithKline for vaccine research unrelated to the current study. Ramachandran declares vaccine-related grant funding from Glaxo-SmithKline for research unrelated to the current study. Shuvo and Behal have nothing to disclose. Findings described in this study were presented as a poster and podium at the Academy of Managed Care Pharmacy Nexus 2020 Virtual meeting, October 19-23, 2020.

Use of Rapid Assessment Procedures when analyzing qualitative data in pharmacy research.

Qualitative research analytics and methodology are a useful part of many research projects. However, qualitative data analysis may be time intensive causing delays in results. This is especially problematic in time-sensitive projects where there an urgent need for results and a rapidly evolving situation being studied, such as during health crisis or early stages of project implementation. An emerging body of literature around the use of Rapid Assessment Procedures (RAP) suggests that this method of qualitative assessment provides more efficient coding and categorizing of data without comprising rigor. The objectives of this manuscript are to: 1) describe how RAP can be used in pragmatic healthcare research studies and 2) provide an example of when RAP was applied to a qualitative research study in the healthcare setting. RAP includes 5 core features: 1) use in combination with quantitative outcomes or process data (mixed methods approach), 2) quick timeline from start to finish (weeks to months), 3) population of interest participation in planning and implementing the research, 4) team approach to research process, and 5) iterative cycle of data collection and analysis. Use of RAP provides key stakeholders and decision makers the ability to generate solutions to problems faster than ever before without compromising rigor, a method needed now more than ever. The progression of healthcare and clinical management is moving at an unprecedented rate, and RAP allows researchers to stay ahead by providing quicker results for better outcomes.

Early Patient-Centered Outcomes Research Experience With the Use of Telehealth to Address Disparities: Scoping Review.

BACKGROUND: Health systems and providers across America are increasingly employing telehealth technologies to better serve medically underserved low-income, minority, and rural populations at the highest risk for health disparities. The Patient-Centered Outcomes Research Institute (PCORI) has invested US $386 million in comparative effectiveness research in telehealth, yet little is known about the key early lessons garnered from this research regarding the best practices in using telehealth to address disparities. OBJECTIVE: This paper describes preliminary lessons from the body of research using study findings and case studies drawn from PCORI seminal patient-centered outcomes research (PCOR) initiatives. The primary purpose was to identify common barriers and facilitators to implementing telehealth technologies in populations at risk for disparities. METHODS: A systematic scoping review of telehealth studies addressing disparities was performed. It was guided by the Arksey and O'Malley Scoping Review Framework and focused on PCORI's active portfolio of telehealth studies and key PCOR identified by study investigators. We drew on this broad literature using illustrative examples from early PCOR experience and published literature to assess barriers and facilitators to implementing telehealth in populations at risk for disparities, using the active implementation framework to extract data. Major themes regarding how telehealth interventions can overcome barriers to telehealth adoption and implementation were identified through this review using an iterative Delphi process to achieve consensus among the PCORI investigators participating in the study. RESULTS: PCORI has funded 89 comparative effectiveness studies in telehealth, of which 41 assessed the use of telehealth to improve outcomes for populations at risk for health disparities. These 41 studies employed various overlapping modalities including mobile devices (29/41, 71%), web-based interventions (30/41, 73%), real-time videoconferencing (15/41, 37%), remote patient monitoring (8/41, 20%), and store-and-forward (ie, asynchronous electronic transmission) interventions (4/41, 10%). The studies targeted one or more of PCORI's priority populations, including racial and ethnic minorities (31/41, 41%), people living in rural areas, and those with low income/low socioeconomic status, low health literacy, or disabilities. Major themes identified across these studies included the importance of patient-centered design, cultural tailoring of telehealth solutions, delivering telehealth through trusted intermediaries, partnering with payers to expand telehealth reimbursement, and ensuring confidential sharing of private information. CONCLUSIONS: Early PCOR evidence suggests that the most effective health system- and provider-level telehealth implementation solutions to address disparities employ patient-centered and culturally tailored telehealth solutions whose development is actively guided by the patients themselves to meet the needs of specific communities and populations. Further, this evidence shows that the best practices in telehealth implementation include delivery of telehealth through trusted intermediaries, close partnership with payers to facilitate reimbursement and sustainability, and safeguards to ensure patient-guided confidential sharing of personal health information.

The Tennessee Medicaid medication therapy management program: early stage contextual factors and implementation outcomes.

BACKGROUND: First investigated in the 1990s, medication therapy management (MTM) is an evidence-based practice offered by pharmacists to ensure a patient's medication regimen is individualized to include the safest and most effective medications. MTM has been shown to a) improve quality of patient care, b) reduces health care costs, and c) lead to fewer medication-related adverse effects. However, there has been limited testing of evidence-based, a-priori implementation strategies that support MTM implementation on a large scale. METHODS: The study has two objectives assessed at the organizational and individual level: 1) to determine the adoption, feasibility, acceptability and appropriateness of a multi-faceted implementation strategy to support the MTM pilot program in Tennessee; and 2) to report on the contextual factors associated with program implementation based on the Consolidated Framework for Implementation Research (CFIR). The overall design of the study was a hybrid type 2 effectiveness-implementation study reporting outcomes of Tennessee state Medicaid's (TennCare) MTM Pilot program. This paper presents early stage implementation outcomes (e.g., adoption, feasibility, acceptability, appropriateness) and explores implementation barriers and facilitators using the CFIR. The study was assessed at the (a) organizational and (b) individual level. A mixed-methods approach was used including surveys, claims data, and semi-structured interviews. Interview data underwent initial, rapid qualitative analysis to provide real time feedback to TennCare leadership on project barriers and facilitators. RESULTS: The total reach of the program from July 2018 through June 2020 was 2033 MTM sessions provided by 17 Medicaid credentialed pharmacists. Preliminary findings suggest participants agreed that MTM was acceptable (µ = 16.22, SD = 0.28), appropriate (µ = 15.33, SD = 0.03), and feasible (µ = 14.72, SD = 0.46). Each of the scales had an excellent level of internal (> 0.70) consistency (feasibility, α = 0.91; acceptability, α = 0.96; appropriateness, α = 0.98;). Eight program participants were interviewed and were mapped to the following CFIR constructs: Process, Characteristics of Individuals, Intervention Characteristics, and Inner Setting. Rapid data analysis of the contextual inquiry allowed TennCare to alter initial implementation strategies during project rollout. CONCLUSION: The early stage implementation of a multi-faceted implementation strategy to support delivery of Tennessee Medicaid's MTM program was found to be well accepted and appropriate across multiple stakeholders including providers, administrators, and pharmacists. However, as the early stage of implementation progressed, barriers related to relative priority, characteristics of the intervention (e.g., complexity), and workflow impeded adoption. Programmatic changes to the MTM Pilot based on early stage contextual analysis and implementation outcomes had a positive impact on adoption.

Association of dyskalemias with short-term health care utilization in patients with advanced CKD.

BACKGROUND: Patients with advanced chronic kidney disease (CKD) are at high risk for dyskalemias, which may induce arrhythmias that require immediate emergent or hospital care. The association of dyskalemias with short-term hospital/emergency room (ER) visits in advanced CKD is understudied. OBJECTIVE: To assess the association of dyskalemias with short-term hospital/ER visits in an advanced CKD population. METHODS: From among 102,477 US veterans transitioning to dialysis from 2007 to 2015, we identified 21,366 patients with 2 predialysis outpatient eGFR < 30 ml/min/1.73m2 90-365 days apart (with the second eGFR serving as the index date) and at least 1 potassium (K) in the baseline period (1 year before index) and 1 outpatient K (oK) in the follow-up (1 year after the index but before dialysis initiation). We examined the association of time-varying hypokalemia (K < 3.5 mEq/L) and hyperkalemia (K > 5.5 mEq/L) vs referent (3.5-5.5 mEq/L) with separate hospital and ER visits within 2 calendar days following each oK value over the 1-year follow-up period from the index. We used generalized estimating equations with binary distribution and logit link to model the exposure-outcome relationship adjusted for various confounders. We conducted various subgroup and sensitivity analyses to test the robustness of our results. RESULTS: Over the 1-year follow-up, 125,266 oK measurements were observed, of which 6.8% and 3.7% were classified as hyper- and hypokalemia, respectively. In the multivariable-adjusted model, hyperkalemia (adjusted odds ratio [aOR] = 2.04; 95% CI = 1.88-2.21) and hypokalemia (aOR = 1.66; 95% CI = 1.48-1.86) were associated with significantly higher odds of hospital visits. Similarly, hyperkalemia (aOR = 1.83; 95% CI = 1.65-2.03) and hypokalemia (aOR = 1.24; 95% CI = 1.07-1.44) were associated with significantly higher odds of ER visits. Results were robust to subgroups and sensitivity analyses. CONCLUSIONS: In patients with advanced CKD, dyskalemias are associated with higher risk of hospital/ER visits. Interventions targeted at lowering the risk of dyskalemias might help in reducing the health care utilization and associated economic burden among patients with advanced CKD experiencing dyskalemias. DISCLOSURES: This study was supported by grant 5U01DK102163 from the National Institute of Health (NIH) to Kamyar Kalantar-Zadeh and Csaba P. Kovesdy and by resources from the US Department of Veterans Affairs. The data reported here have been supplied in part by the United States Renal Data System (USRDS). Support for VA/CMS data were provided by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Health Services Research and Development, VA Information Resource Center (project numbers SDR 02-237 and 98-004). Opinions expressed in this article are those of the authors and do not necessarily represent the opinion of the Department of Veterans Affairs or the funding institution. Kovesdy has received honoraria from Akebia, Ardelyx, Astra Zeneca, Bayer, Boehringer-Ingelheim, Cara Therapeutics, Reata, and Tricida unrelated to this study. Kalantar-Zadeh has received honoraria and/or support from Abbott, Abbvie, ACI Clinical (Cara Therapeutics), Akebia, Alexion, Amgen, American Society of Nephrology, Astra-Zeneca, Aveo, BBraun, Chugai, Cytokinetics, Daiichi, DaVita, Fresenius, Genentech, Haymarket Media, Hofstra Medical School, International Federation of Kidney Foundations, International Society of Hemodialysis, International Society of Renal Nutrition & Metabolism, Japanese Society of Dialysis Therapy, Hospira, Kabi, Keryx, Kissei, Novartis, OPKO, National Institutes of Health, National Kidney Foundations, Pfizer, Regulus, Relypsa, Resverlogix, Dr Schaer, Sandoz, Sanofi, Shire, Veterans Affairs, Vifor, UpToDate, and ZS-Pharma, unrelated to this study. Gatwood has received research support from AstraZeneca, Merck & Co., and GlaxoSmithKline unrelated to this study. Obi has received research support from Relypsa/Vifor Pharma Inc. The remaining authors declare that they have no relevant financial interests.

Amazon Pharmacy: distraction or disruption?

After years of anticipation about Amazon's rumored entry into pharmacy, Amazon Pharmacy launched in November 2020. What is yet to be understood is whether this new Amazon offering is a true market disruption capable of upending the pharmacy industry. This commentary describes the epic rise of Amazon from bookseller to retail giant, leading to its entry into the retail pharmacy space. Amazon Pharmacy's business model is described and its potential for industry disruption discussed.

Incorporation of a mock pharmacy and therapeutics committee as an entrustable professional activity supporting task.

INTRODUCTION: Entrustable professional activities (EPAs) denote activities and tasks students should be able to perform by graduation irrespective of their practice setting. Formulary decision-making includes several core EPA related skills, such as utilization of drug information, written, and verbal skills. The objective of this study was to describe an EPA supporting task aimed at improving utilization of evidence-based medicine skills and its impact on student self-perceived confidence, rating of skills needed, and competence. METHODS: Teams comprised of six to seven students were assigned a drug and instructed to complete the following activities: (1) background literature search, (2) drug monograph, (3) five-min presentation to simulate a live pharmacy and therapeutics (P&T) committee meeting, and (4) vote on a formulary drug in each drug class. Students completed a pre/post five-point Likert scale self-efficacy survey and a perceived importance survey. A scoring rubric assessed monograph and presentation elements (max points 30). Survey items were analyzed using Wilcoxon signed-rank test. Descriptive statistics were used for assignment grades. RESULTS: One hundred ninety students completed the pre/post self-efficacy and perceived importance survey. Confidence showed statistically significant improvement (P < .001) in nine target skill areas. In ranking importance, all 12 assessed skills exhibited a statistically significant increase following the activity. CONCLUSIONS: A mock P&T activity represents an innovative way to evaluate an EPA supporting task that allows students to improve their evidence-based analysis, written, and verbal communication skills.

Alignment of diagnosis and pharmacy claims data coding of medication adherence among patients with diabetes or hypertension.

BACKGROUND: ICD-10-CM codes exist that facilitate provider designation of patients as "nonadherent to therapy"; however, it is unclear whether this label accurately reflects patient behavior according to widely accepted medication adherence metrics using pharmacy claims data. OBJECTIVE: To determine the extent to which patients are accurately coded for and have calculated rates of nonadherence using ICD-10-CM codes and claims, respectively. METHODS: This was a retrospective cohort study using commercial insurance and Medicare Advantage claims data from 2015 to 2016. The analysis focused on adults aged 18 years and older who had been diagnosed with and were being treated for hypertension and/or diabetes and had been coded as nonadherent by a provider during an outpatient encounter. Adherence (proportion of days covered [PDC]) to oral antihypertensive and/or antidiabetic therapy was calculated 6 months before and after the first nonadherence diagnosis identified in outpatient encounters, using 2 distinct calculation methods. Inferential statistics and multivariable logistic regression were used to determine predictors of coding agreement and changes in adherence after the nonadherence diagnosis controlling for available patient characteristics. RESULTS: A total of 1,142 patients who had been coded as nonadherent were identified, of which between 5.3% and 22.0% (depending on metric and condition) had PDCs before the nonadherence code deeming them adherent according to claims, conflicting with nonadherence diagnosis codes documented by their providers. Mean PDCs increased significantly (20.5%-24.3%, all P < 0.001) among both conditions following the nonadherent code, as did the proportion adherent (PDC > 80%), irrespective of disease (all P < 0.01). The odds of being correctly labeled nonadherent according to claims decreased with age (diabetes odds ratio [OR]: 0.82, 95% CI = 0.694-0.976; hypertension OR: 0.86, 95% CI = 0.773-0.944) but were higher among those taking more medications (diabetes OR: 2.97, 95% CI = 1.658-5.326; hypertension OR: 3.0, 95% CI = 2.095-4.305). Following the nonadherence coding, the odds of being adherent increased with age in both models (diabetes OR: 1.17, 95% CI = 1.012-1.363; hypertension OR: 1.13, 95% CI = 1.048-1.223) yet decreased with increasing medications (diabetes OR: 0.25, 95% CI = 0.138-0.468; hypertension OR: 0.47, 95% CI = 0.368-0.592) and were lower if the patient was observed to be nonadherent before the index encounter (diabetes OR: 0.33, 95% CI = 0.146-0.760; hypertension OR: 0.25, 95% CI = 0.152-0.423). CONCLUSIONS: In general, providers are properly classifying patients as nonadherent using ICD-10-CM codes, but additional assessment is needed to determine the reasons for the remaining mismatch between claims- and diagnosis-based nonadherence. In addition, the correct claims-based metric needs to be established to improve alignment with provider interpretation of patient medication use. DISCLOSURES: No outside funding supported this study. Gatwood reports grants from GlaxoSmithKline, Merck & Co., and AstraZeneca, outside the submitted work. Kovesdy reports consulting fees from Amgen, Sanofi, Fresenius Medical Care, Keryx, Bayer, Abbott, Abbvie, Dr. Schar, Astra-Zeneca, Takeda, Tricida, and Reata and grants from Shire, outside the submitted work. The other authors have nothing to disclose. Findings described in this article were presented as a poster at the American College of Clinical Pharmacy Annual Meeting in New York City, October 2019.

The role of social determinants in timely herpes zoster vaccination among older American adults.

CDC recommends that U.S. adults ≥50 years receive the herpes zoster (HZ) vaccine; but few are vaccinated at the recommended age. Little is known about how social determinants of health (SDH) influence timely vaccination. This retrospective observational study included U.S. adults aged ≥50 years who were vaccinated against HZ between 2014 and 2016 from IBM MarketScan commercial claims and Medicare supplemental databases. The cohort was classified into three groups based on age of vaccination: earlier (50-59 years), timely (60-64 years), and later (65+ years). Select SDH data from publicly-available sources were linked and included in multinomial logistic regression assessing the impact of SDH on timely vaccination. The final cohort comprised 549,544 individuals, 49.5% of whom were vaccinated at the age of 60-64. Odds of later HZ vaccination increased with higher poverty (OR: 1.035, 95% CI: 1.031-1.038), more democratic voters (OR: 1.011, 95% CI: 1.010-1.012), and lack of Internet access (OR: 1.028, 95% CI: 1.024-1.032), but decreased with higher health literacy (OR: 0.971, 95% CI: 0.970-0.973). Conversely, higher health literacy and lower poverty were associated with higher odds of earlier vaccination. Being male, not receiving a seasonal influenza vaccine, and higher healthcare utilization were associated with later vaccination. Individuals on an EPO/PPO vs. HMO plan, or who resided in regions other than the Northeast were more likely to receive the vaccine earlier. This study demonstrates the influence of SDH on time of HZ vaccination, but further research is needed to fully understand the impact of SDH on vaccination.

Community pharmacist workflow and medication therapy management delegation: An assessment of preferences and barriers.

OBJECTIVES: The role of community pharmacists continues to evolve to meet the changing medication-related needs of patients in the United States, requiring a fundamental shift in the pharmacist's workflow and tasks including medication dispensing and medication therapy management (MTM). To compare community pharmacists' current and idealized time allocation. Barriers to, and potential facilitators of, typical and specific pharmacist functions are also reported, with an emphasis on MTM practices. A secondary objective included interpreting how pharmacists perceived the value of social determinants of health to the MTM process. METHODS: Community pharmacists practicing in Tennessee were surveyed online with 3 distinct foci: time allocation and delegation, MTM barriers, and the perceived value of health-related and social data to the MTM process. For the first 2 sections, the respondents provided responses in 2 different scenarios: (1) current workflow and (2) an idealized workflow. Paired Wilcoxon signed-rank and chi-square tests compared the responses to workday items, and Spearman correlations assessed the relationships between preferences and perceived barriers. RESULTS: The pharmacists reported spending the largest share of time verifying product (32.8% [SD 19.28]), and most indicated that they spent no time in either point-of-care testing (POCT) or physical patient assessment. In an ideal work environment, more patient-focused roles would be preferred (e.g., health screening, POCT, MTM, and vaccinations), with more than 80% indicating that they would delegate register activities, data entry, and product verification to technicians. In performing MTM, the pharmacists indicated that they would prefer delegating more data collection and patient management activities to technicians to reserve time for patient assessment and care plan creation. Key barriers to MTM included a lack of time, staff support, and patients' willingness to participate. CONCLUSION: Ideally, pharmacists would prefer to do no prescription filling or selling or register activities. Facilitating community pharmacy practice evolution will require focusing on building teams around support personnel.

Pneumococcal vaccination in older adults: An initial analysis of social determinants of health and vaccine uptake.

OBJECTIVES: To examine the potential influence of social determinants of health on pneumococcal vaccination in older American adults. METHODS: This study used nationwide, US Medicare claims data from 2013 to 2016 to assess uptake of pneumococcal vaccination among adults in the first year after turning age 65. Patients were followed from the point of being 65 years of age and initially enrolled in traditional fee-for-service Medicare or a Medicare Advantage plan through the subsequent year and observed for pneumococcal vaccination in outpatient clinics and pharmacies. Publicly-available data on select social determinants of health were incorporated and guided by the World Health Organization vaccine hesitancy matrix. Logistic regression determined predictors of vaccination while controlling clinical and demographic characteristics. RESULTS: A total of 307,488 and 74,995 adults aged 65 years were identified from Medicare Advantage and Medicare fee-for-service claims, respectively, and 21.1% of Medicare Advantage and 38.2% of Medicare fee-for-service patients received a pneumococcal vaccine in the first year after turning 65. Those residing in urban areas had a higher likelihood of pneumococcal vaccination in both the Medicare Advantage (OR: 1.31; 95% CI: 1.267-1.344) and Medicare fee-for-service (OR: 1.53; 95% CI: 1.450-1.615) cohorts. Additionally, residing in areas of higher health literacy or communities with more democratic voters were consistently associated with a higher odds of pneumococcal vaccination regardless of Medicare type. Results also pointed to a synergistic relationship between receiving the influenza vaccine and also being vaccinated against pneumococcal disease. CONCLUSION: Social determinants of health, including local health literacy, poverty, residing in more liberal areas, and access to information, may be influencing the pneumococcal vaccine-related decisions of older adults. However, additional factors associated with the vaccine hesitancy matrix and more granular data (e.g., zip code-level) are needed to fully determine the impact in this and other vaccines recommended in older adults.

Medication nonadherence, mental health, opioid use, and inpatient and emergency department use in super-utilizers.

OBJECTIVES: To examine whether mental health conditions, opioid use, and medication nonadherence are associated with inpatient and emergency department (ED) use among Medicare super-utilizers from medically underserved areas. STUDY DESIGN: Retrospective panel study. METHODS: The study included Medicare super-utilizers (≥3 hospitalizations or ≥2 hospitalizations with ≥2 ED visits in 6 months) served by a health system in a medically underserved area in the South from February 2013 to December 2014 with at least 1 filled prescription for hypertension, type 2 diabetes, cardiovascular, and/or chronic obstructive pulmonary disease/asthma medications. We used random effects negative binomial models to assess whether mental health diagnosis, opioid use, and medication nonadherence were associated with preventable and overall hospitalizations and ED visits stratified by age (18-64 vs ≥65 years). RESULTS: Overall chronic disease medication nonadherence was associated with more frequent hospitalizations and ED visits for both younger (hospitalizations: incidence rate ratio [IRR], 1.31; 95% CI, 1.16-1.47; ED visits: IRR, 1.33; 95% CI, 1.14-1.55) and older (hospitalizations: IRR, 1.34; 95% CI, 1.20-1.49; ED visits: IRR, 1.18; 95% CI, 1.02-1.38) beneficiaries. Mental health diagnosis was significantly associated with higher hospitalizations and ED visits among both age groups. Although associations between opioid medication use and inpatient and ED use were inconsistent and not significant in most cases, we found that 7 or more days' supply of opioids was associated with lower preventable hospitalizations in Medicare beneficiaries 65 years or older. CONCLUSIONS: The study findings highlight the importance of improving medication adherence and addressing behavioral health needs in Medicare super-utilizers.

Application of a Graphical Depiction of Longitudinal Study Designs to Managed Care Pharmacy Research.

Managed care pharmacists apply real-world evidence (RWE) to support activities such as pipeline forecasting, clinical policy development, and contracting for pharmaceutical products. Managed care pharmacy researchers strive to produce studies that can be applied in practice. While asking the right research question is necessary, it is not sufficient. As with all studies, consumers of RWE look for internal and external validity, as well as sources of bias, to determine how the study findings can be applied in their work. To date, however, some of the safeguards that exist for clinical trials-such as public registration of study protocols-are lacking for RWE. Several leading professional organizations have initiatives dedicated to improving the credibility and reliability of such research. One component common to these initiatives is enhanced transparency and completeness of methodologic reporting. Graphical representations of study designs can improve the reporting and design of research conducted in health care databases, specifically by enhancing the transparency and clarity of often complex studies. As such, Schneeweiss et al. (2019) proposed a graphical framework for longitudinal study designs in health care databases. Herein, we apply this framework to 2 studies published in the Journal of Managed Care & Specialty Pharmacy that represent common research designs and report how application of the framework revealed deficiencies in reporting. We advocate for adoption of this framework in the effort to increase the usability of RWE studies using health care databases by managed care pharmacy. DISCLOSURES: No funding was provided for this work. Gatwood has received research funding from Merck & Co., AstraZeneca, and GlaxoSmithKline, unrelated to this work. Schneeweiss is a consultant to Aetion, of which he also owns equity. He is the principal investigator of investigator-initiated grants to the Brigham and Women's Hospital from Bayer, Genentech, Boehringer Ingelheim, and Vertex. Wang reports support from investigator-initiated grants from Novartis, Boehringer Ingelheim, and Johnson & Johnson to Brigham and Women's Hospital, unrelated to this work. Happe and Brown have nothing to disclose.

Medication Adherence, Health Care Utilization, and Costs Among Patients Initiating Oral Oncolytics for Multiple Myeloma or Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

BACKGROUND: Oral oncolytic therapies have improved survival in hematologic cancers, such as chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and multiple myeloma (MM), which are now being managed like chronic conditions. However, compared with other cancers, there is a lack of studies assessing adherence, health care resource utilization, and costs in patients with these cancers. OBJECTIVE: To assess factors associated with adherence to oral oncolytic therapies, health care utilization, and costs in patients with CLL/SLL or MM. METHODS: A retrospective database study was conducted using the IBM MarketScan Commercial Claims and Medicare Supplement databases. Adults (aged ≥ 18 years) diagnosed with and prescribed an oral oncolytic for CLL/SLL (ibrutinib or idelalisib) or MM (thalidomide, lenalidomide, or pomalidomide) between 2013 and 2016 and with continuous eligibility 6 months before and 12 months after oral oncolytic initiation were identified. Adherence to oral oncolytics was measured using the proportion of days covered (PDC) metric. Multiple linear regression and multivariable logistic regression were used to identify adherence predictors. Count models assessed the relationship between adherence and resource utilization, and generalized linear models assessed the relationship between adherence and health care costs. RESULTS: A total of 701 and 2,385 patients were identified with CLL/SLL or MM, respectively. Mean PDC (SD) for CLL/SLL and MM patients was 75.3 (22.5) and 57.6 (26.5), respectively. For CLL/SLL patients, those aged ≥ 65 years (beta [B] = -4.00) had lower medication use. Among MM patients, multiple predictors of higher medication use emerged: aged ≥ 65 years (B = 3.44), higher than average outpatient resource utilization (B = 3.53), insurance plan other than preferred provider organization (PPO; B = -2.58), previous cancer therapy (B = -2.81), higher number of concurrent unique therapeutic classes (B = -0.35), and higher comorbidity burden (B = -2.55). Patients with CLL/SLL and enrolled in plans other than a PPO were more likely to be adherent (OR = 1.41, 95% CI = 1.01-1.98), whereas patients who were aged ≥ 65 years, were residents of the southern United States, and had visited the emergency department in the baseline period were less likely to be adherent. For MM patients, those aged ≥ 65 years (OR = 1.68, 95% CI = 1.38-2.04) and with higher than average outpatient services utilization (OR = 1.24, 95% CI = 1.01-1.52) were more likely to be adherent, whereas those enrolled in plans other than a PPO, previously treated with cancer therapy, and with higher comorbidity burden were less likely to be adherent. In both cohorts, adherent patients had significantly lower odds of health care utilization and incurred lower medical costs, but higher prescription costs, following oncolytic initiation; however, total costs were not significantly lower in those adherent. CONCLUSIONS: Factors were identified that influenced adherence at the patient, treatment, and health system levels. These factors can be used to identify patients requiring interventions for improving medication-taking behavior and associated health care burden. DISCLOSURES: This study received no outside funding. Dashputre was recently employed by Novartis; K. Gatwood has received speaker fees from Jazz Pharmaceuticals; and J. Gatwood has received research funding from Merck & Co. and GlaxoSmithKline, unrelated to this study..

Racial and Regional Disparities in Outcomes Among Veterans Initially Adherent to Oral Antidiabetic Therapies: an Observational Cohort Study.

BACKGROUND: Adherence to prescribed medications is connected with, but is not a guarantee of, improved disease management and health outcomes. It remains unclear whether underlying health disparities exist among patients adherent to therapy and whether differences in outcomes vary by race and residential areas of the country. OBJECTIVE: To determine the extent of racial and regional variation in outcomes within 5 years of oral antidiabetic drug initiation among veterans adherent to therapy. DESIGN: Retrospective cohort study of 83,265 US Veterans Health Administration data, 2002-2014 PATIENTS: US veterans with uncomplicated diabetes and taking oral antidiabetic agents MAIN MEASURES: Veterans initially adherent to oral antidiabetic therapy were followed for up to 5 years, and comparisons focused on differences between non-Hispanic White and non-Hispanic Black veterans across geographic region and residential type (urban or rural). Outcomes included composite cardiovascular events, composite cerebrovascular events, or all-cause mortality using Poisson and adjusted Cox proportional hazards models. KEY RESULTS: Cardiovascular event and all-cause mortality rates differed by race and region, while urban/rural differences were evident for cerebrovascular events and all-cause mortality. For non-Hispanic Blacks, the mortality rate was half that compared to non-Hispanic Whites (6.5 [95% CI 5.8-7.2] versus 13.3 [95% CI 12.9-13.8], p < 0.0001). Compared to the Northeast, all other regions had higher adjusted hazards for cardiovascular or cerebrovascular events (with a single exception), but no regional differences in all-cause mortality were observed. Models with interactions demonstrated that racial differences in cardiovascular events and all-cause mortality were isolated to the Midwest (HR 1.99 [95% CI 1.301-3.06; HR 1.64 [95% CI 1.210-2.215]) and South (HR 1.69 [85% CI 1.347-2.131]; HR 1.27 [95% CI 1.095-1.470]). CONCLUSIONS: Despite adherence to therapy, differences in outcomes are likely among veterans with diabetes based on race and geography. Localized analyses may uncover specific social determinants contributing to differences in outcomes.

The Tennessee medication therapy management program: A hybrid type 2 effectiveness-implementation trial study protocol.

BACKGROUND: Pharmacist-led medication therapy management (MTM) programs are considered evidence-based and have clearly defined core components. Despite this, MTM programs are often implemented without fidelity due to notable implementation barriers, such as physician-pharmacist relationships and pharmacist access to patient medical records. To improve MTM implementation, the Tennessee Medicaid program developed a MTM intervention that incorporates implementation strategies to address some of the known barriers to implementation (e.g., formalizing pharmacist-physician relationships through collaborative practice agreements, ensuring pharmacists' access to medical records). OBJECTIVES: The purpose of this hybrid type 2 effectiveness-implementation study is to (1) assess the effectiveness of the MTM pilot program in Tennessee (e.g., medication adherence, healthcare utilization, quality and cost of care) and (2) assess the implementation of the MTM pilot program (e.g., feasibility, appropriateness, acceptability, penetration). METHODS: The Tennessee MTM pilot program is being assessed as a hybrid type 2 effectiveness-implementation study with a quasi-experimental design. A mixed methods approach (QUAN + QUAL) for the purpose of complementarity (e.g., answering related research questions). Data will include surveys, interviews, MTM platform encounter information, and medical and pharmacy claims. Initial analyses will include data between January 2018 and December 2019. CONCLUSION: The study will further add to the evidence base of MTM interventions by testing an intervention that addresses known barriers to implementation and simultaneously collecting data on effectiveness and implementation to speed up MTM translation. The Tennessee MTM program is expected to serve as a guide to other states seeking to expand pharmacist-delivered clinical services to their Medicaid members, particularly those intending to incorporate MTM into programs seeking to improve primary care delivery. Further, by improving the implementation of MTM, the pilot program is expected to improve the reliability of MTM program benefits including healthcare quality and cost and patient outcomes.