Limited real-world evidence exists on the patterns of symptomatic treatment use for Alzheimer’s disease and related dementias (ADRD). Using data from the Merative® MarketScan Research Databases, we analyzed treatment patterns in ADRD patients aged ≥ 65 from 2011 to 2021. Initial treatment choices, subsequent changes, and factors influencing these changes were evaluated over an 18-month period. Among 74,212 acetylcholinesterase inhibitor (AChEI) and 15,917 memantine initiators, 56

Background: Non-adherence to anti-hypertensive medications is prevalent, leading to increased hospital costs and preventable deaths and disabilities. Managing patient perceptions of adherence difficulties may be key to improving adherence. Objective: This study examined the potential negative effect of patients' perceived difficulties with anti-hypertensive medication taking on adherence, along with whether and how that effect could be reduced through patient knowledge of and commitment to adherence. Method: 10,867 adult U.S. residents diagnosed with essential hypertension and prescribed anti-hypertensive medications participated in a cross-sectional online survey using self-reported behaviors and perceptions. Stepwise regressions and mean difference analyses were performed. Results: Perceived adherence difficulty was negatively associated with adherence behaviors (b = -.443, p < .001). This association was reduced by the moderating effects of adherence knowledge (b = .035, p < .001) and commitment to adherence (b = .008, p = .037), and their direct effects on adherence behaviors (b = .075, p < .001; b = .095, p < .001, respectively). Some differences by patient race-ethnicity and income were observed. Conclusions: Perceived adherence difficulty inhibits medication adherence but is countered by adherence knowledge and commitment to adherence. To improve adherence, healthcare strategies should strengthen patient knowledge and commitment by developing medication routines, engaging in self-care and awareness, and receiving tailored counseling on disease management, among others.

Purpose: To describe medication adherence and persistence of HIV PrEP overall and compare between sex and age groups of commercially insured individuals in the United States.Methods: We conducted a national retrospective cohort study of the Merative MarketScan Claims Database from 2011 to 2019 to describe adherence and persistence of PrEP overall and compared between sex and age groups. High adherence was defined as >= 80% of proportion of days covered and persistence was measured in days from initiation to the first day of a 60-day treatment gap.Results: A total of 29 689 new PrEP users identified. Overall adherence was high (81.9%; 95% confidence interval [CI]: 81.5%-82.3%). Females were more adherent than males (adjusted odds ratio [aOR] 1.87; 95% CI: 1.50-2.34), while those >= 45-years were less adherent than individuals <45-years (aOR 0.87: 95% CI: 0.81-0.93). More than half of individuals discontinued therapy within the first year (median 238.0 days; interquartile range 99.0-507.0 days). Females were less persistent than males (hazard ratio [HR] 1.49; 95% CI: 1.34-1.65), and people >= 45-years old were more persistent (i.e., lower risk of discontinuation) than those <45-years (HR 0.43; 95% CI: 0.33-0.55).Conclusions: These findings show adherence to daily PrEP is high among commercially insured individuals but the majority still discontinue in the first year. Future research should investigate what factors influence PrEP discontinuation among this population and ways to reduce barriers to therapy maintenance to ensure the population-level benefits of PrEP treatment.

Objective: To describe national annual rates of nonoccupational postexposure prophylaxis (nPEP) in the United States.Design: Retrospective cohort study of commercially insured individuals in the Merative MarketScan Database from January 1, 2010 to December 31, 2019.Methods: Patients at least 13 years old prescribed nPEP per recommended Centers for Disease Control and Prevention guidelines were identified using pharmacy claims. Rates of use were described overall and stratified by sex, age group, and region. These rates were qualitatively compared to the diagnosis rates of human immunodeficiency virus (HIV) observed in the data. Joinpoint analysis identified inflection points of nPEP use.Results: Eleven thousand, three hundred and ninety-seven nPEP users were identified, with a mean age of 33.7 years. Most were males (64.6%) and lived in the south (33.2%) and northeast (32.4%). The rate of nPEP use increased 515%, from 1.42 nPEP users per 100 000 enrollees in 2010 to 8.71 nPEP users per 10 000 enrollees in 2019. The comparative nPEP use rates among subgroups largely mirrored their HIV diagnosis rates, that is, subgroups with a higher HIV rate had higher nPEP use. In the Joinpoint analysis significant growth was observed from 2012 to 2015 [estimated annual percentage change (EAPC): 45.8%; 95% confidence interval (CI): 29.4 - 64.3] followed by a more moderate increase from 2015 to 2019 (EAPC 16.0%; 95% CI: 12.6-19.6).Conclusions: nPEP use increased from 2010 to 2019, but not equally across all risk groups. Further policy interventions should be developed to reduce barriers and ensure adequate access to this important HIV prevention tool.

The COVID pandemic exposed the critical role T cells play in initial immunity, the establishment and maintenance of long term protection, and of durable responsiveness against novel viral variants. A growing body of evidence indicates that adding measures of cellular immunity will fill an important knowledge gap in vaccine clinical trials, likely leading to improvements in the effectiveness of the next generation vaccines against current and emerging variants. In depth cellular immune monitoring in Phase II trials, particularly for high risk populations such as the elderly or immune compromised, should result in better understanding of the dynamics and requirements for establishing effective long term protection. Such analyses can result in cellular immunity correlates that can then be deployed in Phase III studies using appropriate, scalable technologies. Measures of cellular immunity are less established than antibodies as correlates of clinical immunity, and some misconceptions persist about cellular immune monitoring usefulness, cost, complexity, feasibility, and scalability. We outline the currently available cellular immunity assays, review their readiness for use in clinical trials, their logistical requirements, and the type of information each assay generates. The objective is to provide a reliable source of information that could be leveraged to develop a rational approach for comprehensive immune monitoring during vaccine development.

Testing guidelines for initiation of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) have been developed to ensure appropriate use of PrEP, such as among those with renal dysfunction or at high risk of seroconversion. While many studies have looked at the trends of use of PrEP in the United States, little is known about compliance with these guidelines, the quality of care of PrEP at a national level, or what provider-level factors are associated with high-quality care. We conducted a retrospective claims analysis of providers of commercially insured new users of PrEP between January 1, 2011, and December 31, 2019. Of the 4200 providers, quality of care was low, with only 6.4% having claims for ≥60% of guideline-recommended testing for their patients in the testing window for all visits. More than half of the providers did not have claims for HIV testing at initiation of PrEP and ≥40% did not for sexually transmitted infections at both initiation and follow-up visits. Even when extending the testing window, quality of care remained low. Logistic regression models found no association between provider type and high quality of care, but did find that providers with one PrEP patient were more likely to have higher quality of care than those with multiple patients for all tests [adjusted odds ratio 0.47 (95% confidence interval: 0.33-0.67)]. The study findings suggest further training and interventions, such as integrated test ordering through electronic health records, are needed to increase quality of care for PrEP and ensure appropriate monitoring of patients.

COVID-19 vaccine clinical development was conducted with unprecedented speed. Immunity measurements were concentrated on the antibody response which left significant gaps in our understanding how robust and long-lasting immune protection develops. Better understanding the cellular immune response will fill those gaps, especially in the elderly and immunocompromised populations which not only have the highest risk for severe infection, but also frequently have inadequate antibody responses. Although cellular immunity measurements are more logistically complex to conduct for clinical trials compared to antibody measurements, the feasibility and benefit of doing them in clinical trials has been demonstrated and so should be more widely adopted. Adding significant cellular response metrics will provide a deeper understanding of the overall immune response to COVID-19 vaccination, which will significantly inform vaccination strategies for the most vulnerable populations. Better monitoring of overall immunity will also substantially benefit other vaccine development efforts, and indeed any therapies that involve the immune system as part of the therapeutic strategy.

Long-term adherence to medications is not well understood and poses a significant challenge for many chronically ill persons. Past research provides insights on adherence in short durations such as a day or several weeks, even though chronically ill patients are required to take medications for periods as long as a lifetime. To fill this important knowledge gap, we study the temporal unfolding of prolonged medication-taking experiences among thirty adults, mostly African American, with chronic hypertension in the U.S. Specifically, we take an extended, experience-centered, narrative approach to examine retrospective patient accounts of adherence efforts over spans of one year to more than four decades. Applying Gergen and Gergen's concept of narrative forms (1983), we find four distinct narrative arcs, or patterned sequences of medication consumption, that we term Out of the Gate, Existential Turn, Fits and Starts, and Slow Climb, along with individual and social elements that shape and shift practices in the context of time.

Misuse of prescription opioids contributes to the ongoing crisis of opioid-related overdose and deaths in the United States. The failure of patients and caregivers to safely dispose of unused opioids contributes to the problems. In 2018, Public Law 115-271 provided U.S. Food and Drug Administration (FDA) authority to mandate a Risk Evaluation and Mitigation Strategy (REMS) for safe disposal packaging or safe disposal solutions for opioid analgesic medications. FDA has been collaborating with stakeholders to determine whether a new REMS is needed. A new or revised opioid REMS could substantially affect opioid packaging, pharmacist roles and services, and dispensing activities such as education, counseling, and product distribution. The pharmacy profession has provided limited input to FDA regarding a potential new or revised opioid REMS. In this commentary, we aim to (1) provide awareness and raise questions on pertinent issues regarding opioid use and safe home disposal, (2) offer considerations for regulators on needed research in the development and assessment of a new REMS, and (3) highlight actions for pharmacist engagement in patient care services to promote safe use and safe home disposal of opioids. Consideration of a potential mandate regarding enhanced safety packaging or safe disposal solutions for opioids presents opportunities to revisit professional roles and engage proactively with FDA and other stakeholders. We hope this commentary stimulates timely feedback by pharmacy leaders, researchers, and practitioners on whether and how options for safe home disposal of opioids should be included in a REMS in contemplation of potential benefits, unintended consequences, expanded professional roles, timeline, assessment of program effectiveness, and adequate compensation. We support a shared opioid REMS that funds the counseling of patients and caregivers on safe opioid use and safe home opioid disposal options and provides appropriate education and products to facilitate that disposal.

Background Educational outreach programs that focus on safe opioid prescribing and awareness of state prescription monitoring programs may modify clinicians’ prescribing behavior. The objective of this study was to evaluate the secondary effects of an opioid-focused academic detailing (AD) program on non-opioid controlled substance prescribing in primary care. Methods A quasi-experimental pre-post study of primary care clinicians exposed and unexposed to the AD program was conducted using data from the Illinois Prescription Monitoring Program from December 2017 to February 2019. Outcomes were mean monthly prescriptions for benzodiazepines (BZD), non-BZD sedative-hypnotics, and carisoprodol, per clinician. A difference-in-differences (DID) approach utilizing repeated-measures mixed-effects linear regression models was used to compare changes in outcomes six-months before and after the program. Results Mean monthly BZD prescriptions declined in both groups of clinicians (AD-exposed n = 151; controls n = 399) after implementation of the AD program. Although the mean monthly number of BZD prescriptions decreased in both groups after the AD program, BZD prescribing in the AD-exposed group declined at a slower rate following the AD program (DID = 0.73; 95% CI: 0.14, 1.31). The AD-exposed group had a 0.06 (95% CI: −0.11, −0.01) lower rate of mean monthly carisoprodol prescriptions compared to the control group following the AD program. There was no change in the rate of mean monthly non-BZD sedative-hypnotic prescriptions between the two groups. Conclusions The higher relative rate of BZD prescribing in the AD-exposed group compared to the control group following the AD program may be reflective of an unintended consequence of opioid-focused AD programs as clinicians learn to be cautious about opioid prescribing. Our findings may suggest the need for incorporation of targeted education on appropriate BZD prescribing into opioid-focused AD programs as a featured component. These findings warrant further consideration and investigation before large-scale implementation of opioid-focused educational outreach programs.

Objectives Marketing authorization holder (MAH)-sponsored patient support programs (PSPs) are a major source of adverse event (AE) reports. The impact of reports from PSPs on the ability to detect AE signals is unclear. We compared signal detection performance using data from PSPs vs. non-PSP sources, and between PSPs providing clinical services vs. PSPs not providing clinical services. Methods Data were obtained from an internal safety database for a global pharmaceutical company 2015-2017. We assessed whether signals were detected for the reference drug-AE pairs using data from PSPs vs. non-PSP sources, and among different PSP services. The performance was evaluated by four measures including area under the receiver operating characteristic curve (AUC) and time-to-signal detection. Results While the majority of reports were from PSPs, non-PSP sources were better and faster at detecting signals (AUC 0.63 vs. 0.41,p= 0.035; HR 3.52,p= 0.014) compared to PSPs. Within PSPs, PSPs providing clinical services were marginally better at detecting signals (AUC 0.60 vs. 0.41,p= 0.053) but not faster compared to PSPs not providing clinical services. Conclusion Reports of AEs from PSPs had worse signal detection performance compared to non-PSP sources. Pharmacovigilance experts should be mindful when using databases that contain reports from PSPs for signal detection.

Objective: Self-reported behavior change is used to evaluate the effectiveness of educational outreach interventions delivered to clinicians, such as academic detailing (AD). However, self-reported changes in behavior are often not corroborated with data on actual behavior change. To assess alignment between self-reported practice change intentions and actual opioid prescribing behavior among primary care clinicians after an AD intervention. Methods: We used a difference-in-differences approach to compare pre-post changes in opioid prescribing using data from the Illinois Prescription Monitoring Program. An opioid-focused AD intervention was delivered to primary care clinicians from a large health system in the Chicago metropolitan area from June 2018 to August 2018. Immediately after the AD intervention, clinicians were administered a single-item self-reported practice change measure. Clinicians were categorized into 2 groups on the basis of their responses: (1) intention to change and (2) no-to-moderate intention to change. Outcomes were mean total opioid prescriptions and high-dose opioid prescriptions (>= 90 morphine milligram equivalents) per clinician per month. Repeated measures linear regression models were used to compare changes in opioid prescribing outcomes between the 2 groups in the 6 months before and after the AD intervention. Results: A total of 149 clinicians were included for analysis. An intention to change was reported by 72 clinicians and no-to-moderate intention to change was reported by 77 clinicians. In the 6 months after the AD intervention, there were 1.48 (95% CI -2.48 to -0.47) fewer total opioid prescriptions and 0.50 (-0.69 to -0.31) fewer high-dose opioid prescriptions per clinician per month in the intention to change group than in the no-to-moderate intention to change group. Conclusion: This study showed considerable alignment between self-reported practice change intentions and actual changes in opioid prescribing behavior. Future opioid-focused educational outreach interventions should consider using standardized single-item practice change measures as an immediate indicator of future behavior change. (C) 2020 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.

Background Completeness of adverse event (AE) reports is an important component of quality for good pharmacovigilance practices. We aimed to evaluate the impact of incorporating a measure of completeness of AE reports on quantitative signal detection. Methods An internal safety database from a global pharmaceutical company was used in the analysis. vigiGrade, an index score of completeness, was derived for each AE report. Data from various patient support programs (PSPs) were categorized based on average vigiGrade score per PSP. Performance of signal detection was compared between: (1) weighting and not weighting by vigiGrade score; and, (2) well documented and poorly documented PSPs using sensitivity, specificity, area under the receiver operating characteristics curve (AUC) and time-to-signal detection. Results The ability to detect signals did not differ significantly when weighting by vigiGrade score [sensitivity (50% vs. 45%, p = 1), specificity (82.8% vs. 82.8%, p = 1), AUC (0.66 vs. 0.63, p = 0.051) or time-to-signal detection (HR 0.81, p = 0.63)] compared to not weighting. Well documented PSPs were better at detecting signals than poorly documented PSPs (AUC 0.66 vs. 0.52; p = 0.041) but time-to-signal detection did not differ significantly (HR 1.54, p = 0.42). Conclusion Completeness of AE reports did not significantly impact the ability to detect signals when weighting by vigiGrade score or restricting the database based on the level of completeness. While the vigiGrade helps provide quality assessments of AE reports and prioritize cases for review, our findings indicate the tool might not be useful for quantitative signal detection when used by itself.

BACKGROUNDUnderstanding barriers to safe opioid prescribing in primary care is critical amid the epidemic of prescription opioid abuse, misuse, and overdose in the US. Educational outreach strategies, such as academic detailing (AD), provide a forum for identification of barriers to, and strategies to facilitate, safe opioid prescribing in primary care.AIMTo identify barriers to safe opioid prescribing among primary care providers (PCPs) through AD.DESIGN AND SETTINGQualitative analysis of data was collected through an existing AD intervention to improve safe opioid prescribing in primary care. The AD intervention was delivered from June 2018 to August 2018 to licensed PCPs with prescriptive authority within a large independent health system in the metropolitan Chicagoland area.METHODThe AD intervention involved visits by trained detailers to PCPs who contemporaneously documented details from each visit via field notes. Using qualitative analysis, field notes were analysed to identify recurring themes related to opioid prescribing barriers.RESULTSDetailer-entered field notes from 186 AD visits with PCPs were analysed. Barriers to safe opioid prescribing were organised into six themes: 1) gaps in knowledge; 2) lack of prescription monitoring programme (PMP) utilisation; 3) patient pressures to prescribe opioids; 4) insurance coverage policies; 5) provider beliefs; and 6) health system pain management practices.CONCLUSIONBarriers to safe opioid prescribing in primary care, identified through AD visits among this large group of PCPs, support the need for continued efforts to enhance pain-management education, maximise PMP utilisation, and increase access to, and affordability of, non-opioid treatments.

OBJECTIVES:To develop and test the usability and feasibility of a customizable mobile application (app) designed to help educate patients about their oral anticancer medications (OAMs) and regimens.SETTING:Outpatient cancer center and oncology pharmacy for urban, Midwestern academic health system.PRACTICE DESCRIPTION:Clinically-supervised educational intervention to support patients learning about OAMs.PRACTICE INNOVATION:With input from patient partners, our interdisciplinary team designed the first known tablet-based educational app that can interface with a patient's electronic medical record. The app is based on learning style and adherence theories and is customizable for individually prescribed OAMs. The app can accommodate multiple learning styles through text at 6th-grade reading level, pictures, animations, and audio voiceovers. Functionalities include interactive educational modules on 11 OAMs and case-based patient stories on common barriers to OAM adherence.EVALUATION:Early phase testing provided the opportunity to observe the user interface with the app and app functionality. Data were summarized descriptively from observations and comments of patient subjects.RESULTS:Thirty patient subjects provided input-19 in phase 1 usability testing and 11 in phase 2 feasibility testing. Comments provided by patient subjects during usability testing were largely positive. Responses included self-identification with patient stories, usefulness of drug information, preferences for text messages, and app limitations (e.g., perceived generational digital divide in technology use and potential patient inability to receive text messages). Using their feedback, modifications were made to the prototype app. Responses in feasibility testing demonstrated the app's usefulness across a wide range of ages. Highest opinion ratings on app usefulness were stated by patients who were newer to OAM therapy.CONCLUSION:User feedback suggests the potential benefit of the app as a tool to help patients with cancer, particularly after the first months for those starting new OAM regimens. Processes and lessons learned are transferable to other settings.

The consumer journey has drawn interest from marketers as an avenue to strengthen sales through managing touchpoints. However, a firm-centric view has produced limited models of the journey, particularly on consumers’ usage experiences over extended periods in everyday settings. We attempt to redress this limitation by studying the situated experiences of disadvantaged consumers endeavoring to comply with medication therapies for chronic hypertension. Our broad aim is to understand more fully the influences on and nature of the journey. We find that compliance is a liminal state of provisional actions shaped contextually by life spheres of meso-structural conditions, micro-individual factors, and interpretive sense-making practices. We contribute a novel, integrated, and nuanced journey framework beyond the detached, steadily progressive model predominant in the literature. Our paper ends with practice, theory, and policy implications for marketing and healthcare, including touchpoint strategies.

Objective. To determine pharmacy students’ impressions of their faculty’s interactions with diverse student and patient populations. Methods. Three student focus groups were convened. Eighty-four page transcripts were coded, and emergent themes were identified by qualitative analysis. Results. Students defined diversity as multidimensional beyond traditional categories. Emergent themes were faculty awareness or lack of awareness of cultural diversity, disparate cultural perspectives and preferences within student groups, teaching/learning approaches to prepare students to be more culturally competent, and student group dynamics. First- and second-year students emphasized student-to-student interactions, while third- and fourth-year students emphasized a lack of preparation for the realities of contemporary practice based on instructional methods. Conclusion. Students perceived the majority of their pharmacy faculty to be culturally sensitive and aware, but microaggression and discrimination from faculty and student peers were experienced. Study implications can potentially improve curricular offerings, cultural awareness of faculty and students, and care to diverse patient populations.