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The articles in the June issue serve not only to inform senior care pharmacists on the importance of evidence-based approaches to reduce unnecessary aspirin use, but they also underscore the urgent need for the large and rapid increase in older adult representation in clinical trials and clinical research in general. A striking analysis performed in the United States that examined the trial populations used for Medicare coverage determinations found that while the average age of a Medicare enrollee was 70.8 years old (74.7 years old for older Medicare participants), the average age of the clinical trial population patients used in technology assessments for Medicare coverage determinations was 60.1 years. Hence, the US Medicare system, one of the largest national health care purchasers for older patients in the world, has relied on non-representative data to inform medical coverage decisions.

Obesity rates for older people have increased around the world1 with rates tripling over the past four decades.² While previously considered a phenomenon of developed countries, the increased prevalence of obesity is now established in developing countries as well.³ Factors stimulating this epidemic include modifications in the global food supply chain, rise in consumption and availability of energy-dense, low-nutrient foods, sedentary occupations, expanding urbanization, changes in transportation means, as well as environmental components.³ The increasing prevalence of obesity in older people in the United States over time has been well documented by federal agencies. Over the time periods 1999-2002, 2003-2006, and 2007-2010, a linear increase in the prevalence of obesity among older men in all age groups was observed. The obesity prevalence among men 65 to 74 years of age increased from about 31.6% in 1999-2002 to 41.5% in 2007-2010. In men older than 74 years of age, obesity prevalence increased from 17.7% in 1999-2002 to 26.5% in 2007-2010. Of interest is that, in women, the change over the same time period was not statistically significant for the older age groups (40.3% obesity in 65- to 74-year-old women and 28.7% in women older than 74 years of age in the 2007-2010 analysis period).⁴.

PurposeThe aim of this study was to assess the cost effectiveness of letermovir prophylaxis with the option for subsequent pre-emptive therapy (PET) for the prevention of cytomegalovirus (CMV) infection compared with a PET-only scenario in adult allogeneic hematopoietic stem cell transplant (allo-HCT) recipients in the United States over a 10-year time horizon.Materials and methodsA publicly available decision tree model was constructed using a commercial third-party payer perspective to simulate an allo-HCT recipient's clinical trajectory in the first-year post-transplant, followed by entry to a Markov model to simulate years 2 through 10. Clinical inputs and utility estimates were derived from published literature. Costs were derived from published literature and US Department of Veterans Affairs Federal Supply Schedule drug pricing. Outcomes assessed included life expectancy, quality-adjusted life-years (QALYs), direct medical costs, and the incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analyses (PSA) were performed to test the robustness of the findings.ResultsCompared with PET alone, letermovir prophylaxis was projected to increase life-years per person (4.99 vs. 4.70 life-years), and increase QALYs (3.29 vs. 3.08) and costs (US$83.411 vs. US$70,698), yielding an ICER of US$59,356 per QALY gained. One-way sensitivity analyses indicated our model was sensitive to mortality (ICER: $164,771/QALY) and utility (letermovir ICER: $117,447/QALY; PET ICER: $107,290/QALY) in the first-year post-transplant. In 57.1% of the PSA simulations, letermovir was a cost-effective option using a willingness-to-pay threshold of US$100,000 per QALY.ConclusionsLetermovir prophylaxis is cost effective compared with PET alone with a willingness-to-pay threshold of US$100,000 per QALY gained. Sensitivity analysis results indicate future research is required to understand the impact of mortality and quality of life in the first-year post-transplant to arrive at a conclusive decision on letermovir adoption.

BackgroundIn the US, medical costs for cancer patients have grown from $27 billion in 1990 to $174 billion in 2020. The increased financial strain that cancer patients and survivors endure is referred to as financial toxicity.ObjectiveTo quantify the relationship between indicators of financial toxicity and health utilization and quality of life in patients ever diagnosed with cancer.MethodsAdult cancer patients and survivors in 2017 were identified using the Medical Expenditure Panel Survey. Multiple logistic regression models were used to quantify the relationship between three financial toxicity exposures (concern for keeping an income, paying large medical bills, and going into debt or borrowing money) and two discrete outcomes of being able to purchase prescriptions and often worrying that cancer would worsen or come back.ResultsThis study assessed 609 respondents. After survey weighting was applied, that represented 16,215,673 individuals. Patients who reported concern for keeping an income were at 2.91 (95% Confidence Interval [CI], 1.16 to 7.31) and 2.97 (95% CI, 2.01 to 2.67) times increased odds to report avoiding purchase of prescriptions and worry of cancer status, respectively, versus those who did not. Patients who reported worry about paying large medical bills were at 4.46 (95% CI, 2.15 to 9.24) and 2.80 (95% CI, 1.98 to 3.96) times increased odds to report avoiding purchase of prescriptions and worry of cancer status, respectively, versus those who did not. Patients who reported borrowing money or going into debt were at 3.04 (95% CI, 1.19 to 7.76) and 2.42 (95% CI, 1.54 to 3.18) times increased odds to report avoiding purchase of prescriptions and worry of cancer status, respectively, versus those who did not.ConclusionsFinancial toxicity is associated with decreased prescription utilization and quality of life in the form of excessive worry among cancer patients including cancer survivors.

Background: Understanding medication use patterns for patients with COVID-19 will provide needed insight into the evolution of COVID-19 treatment over the course of the SARS-CoV-2 pandemic and aid clinical management considerations. Objectives: To systematically determine most frequently used medications among COVID-19 patients overall and by hospitalization status. Secondary objective was use measurement of medications considered potential therapeutic options. Methods: Retrospective cohort study was performed using data from the University of California COVID Research Data Set (UC CORDS) patients between March 10, 2020, and December 31, 2020. Main outcomes were percentages of patients prescribed medications, overall, by age group, and by comorbidity based on hospitalization status for COVID-19 patients. Use percentage by month of COVID-19 diagnosis was measured. Cumulative count of potential therapeutic options was measured over time. Results: Dataset included 22 896 unique patients with COVID-19 (mean [SD] age, 42.4 [20.4] years; 12 154 [53%] women). Most frequently used medications in patients overall were acetaminophen (21.2%), albuterol (14.9%), ondansetron (13.9%), and enoxaparin (10.8%). Dexamethasone use increased from fewer than 50 total hospitalized patients through April who had received the medication, to more than 500 patients by mid-August. Cumulative count of enoxaparin users was the largest throughout the study period. Conclusion and Relevance: In this retrospective cohort study, across age and comorbidity groups, predominant utilization was for supportive care therapy. Dexamethasone and remdesivir experienced large increases in use. Conversely, hydroxychloroquine and azithromycin use markedly dropped. Medication utilization rapidly shifted toward more evidence-concordant treatment of patients with COVID-19 as rigorous study findings emerged.

Measuring the population-level relationship between compromised mental health and diabetes care remains an important goal for clinicians and health care decision-makers. We evaluated the impact of self-reported unmet psychological need on health care resource utilization and total health care expenditure in people with type 2 diabetes. Patients who reported unmet psychological needs were more likely than those who did not to incur a higher annual medical expenditure, have greater resource utilization, and have a higher risk of all-cause mortality.

The randomized controlled trial (RCT) is the gold standard for evaluating the causal effects of medications. Limitations of RCTs have led to increasing interest in using real-world evidence (RWE) to augment RCT evidence and inform decision making on medications. Although RWE can be either randomized or nonrandomized, nonrandomized RWE can capitalize on the recent proliferation of large healthcare databases and can often answer questions that cannot be answered in randomized studies due to resource constraints. However, the results of nonrandomized studies are much more likely to be impacted by confounding bias, and the existence of unmeasured confounders can never be completely ruled out. Furthermore, nonrandomized studies require more complex design considerations which can sometimes result in design-related biases. We discuss questions that can help investigators or evidence consumers evaluate the potential impact of confounding or other biases on their findings: Does the design emulate a hypothetical randomized trial design? Is the comparator or control condition appropriate? Does the primary analysis adjust for measured confounders? Do sensitivity analyses quantify the potential impact of residual confounding? Are methods open to inspection and (if possible) replication? Designing a high-quality nonrandomized study of medications remains challenging and requires broad expertise across a range of disciplines, including relevant clinical areas, epidemiology, and biostatistics. The questions posed in this paper provide a guiding framework for assessing the credibility of nonrandomized RWE and could be applied across many clinical questions.

Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real-world evidence (RWE) in the evaluation of new treatments or products. RWE studies often rely on real-world data (RWD), including data extracted from healthcare records or data captured by mobile phones or other consumer devices. Global assessments of RWD sources are not helpful in assessing whether any specific RWD element is fit for any specific purpose. Instead, evidence generators and evidence consumers should clearly identify the specific health state or clinical phenomenon of interest and then consider each step between that clinical phenomenon and its representation in a research database. We propose specific questions regarding potential error or bias affecting each of those steps: Would a person experiencing this clinical phenomenon present for care in this setting or interact with this recording device? Would this clinical phenomenon be accurately recognized or assessed? How might the recording environment or tools affect accurate and consistent recording of this clinical phenomenon? Can data elements from different sources be harmonized, both technically (same format) and semantically (same meaning)? Can the original data elements be consistently reduced to a useful clinical phenotype? Addressing these questions requires a range of clinical, organizational, and technical expertise. Transparency regarding each step in the creation of RWD is essential if evidence consumers are to rely on RWE studies.

Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real-world evidence in the evaluation of new treatments or products. Real-world clinical trials or pragmatic trials often differ from traditional clinical trials in the use of open-label or nonblinded treatments delivered by real-world clinicians in community practice settings. Blinding and standardization of treatment may sometimes be necessary for internal validity, but they may also obscure or distort meaningful differences between treatments. When investigators consider whether blinding of clinicians, patients, or assessors is necessary, we suggest they consider several specific questions: Will clinicians, patients, and assessors have expectations or preferences regarding benefits or adverse effects? How might those expectations affect treatment uptake, treatment adherence, or assessment of outcomes? Will expectations differ in the settings where trial results will be applied? How would blinding of treatment reduce biases? How would blinding obscure true differences between treatments? How would procedures necessary for blinding reduce acceptability or increase risk of trial participation? When investigators consider how strictly treatments should be standardized, we suggest they consider several specific questions: How would treatment effectiveness or safety vary according to clinician experience or expertise? What level of experience or expertise is available in potential trial settings and settings where trial results would be applied? Is some level of standardization necessary for valid inference? Considering any special vulnerabilities of the study population, is some level of standardization necessary to assure participant safety?

Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real-world evidence (RWE) in the evaluation of new treatments or products. The RWE label has been used to refer to a variety of departures from the methods of traditional randomized controlled trials. Recognizing this complexity and potential confusion, the National Academies of Science, Engineering, and Medicine convened a series of workshops to clarify and address questions regarding the use of RWE to evaluate new medical treatments. Those workshops identified three specific dimensions in which RWE studies might differ from traditional clinical trials: use of real-world data (data extracted from health system records or data captured by mobile devices), delivery of real-world treatment (open-label treatments delivered in community settings by community practitioners), and real-world treatment assignment (including nonrandomized comparisons and variations on random assignment such as before-after or stepped-wedge designs). For any RWE study, decisions regarding each of these dimensions depends on the specific research question, characteristics of the potential study settings, and characteristics of the settings where study results would be applied.

In the United States, pharmacists' scope of practice continues to expand, with increasing opportunities for pharmacists in all practice settings to enhance health in society. In ambulatory care, pharmacists remain integral members on the healthcare team and have demonstrated positive impacts on patient care. Sharing similar characteristics as pharmacists in the community setting, a deeper look into common elements of a successful ambulatory care practice that can be applied in the community pharmacy setting is warranted. Key success factors identified from ambulatory care include (1) maximizing a pharmacist's unique knowledge base and skill set, (2) forming collaborations with physicians and other providers, (3) demonstrating outcomes and value, and (4) maintaining sustainability. Opportunities exist for pharmacists in the community setting to utilize these success factors when developing, implementing, and/or expanding direct patient care services that improve accessibility to quality care and population health.

BackgroundUse of angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) has been postulated to reduce cancer risk by inhibition of tumor progression, vascularization, and metastasis. The renin-angiotensin system is upregulated in colorectal cancers; however, the association of ACEi and ARB use with colorectal cancer risk is not well understood.MethodsThe study population was 142,812 Women's Health Initiative participants free of colorectal cancer who reported on ACEi and ARB use at baseline; 2,216 incident colorectal cancers were diagnosed during 10 years of follow-up. Cox regression models estimated adjusted HRs and 95% confidence intervals for associations relative to nonuse among normotensive women, untreated hypertensive women, and hypertensive women treated with other antihypertensive medications.ResultsHRs among women who used any ACEi or ARB compared with nonuse in the three referent groups ranged between 0.97 and 1.01. Findings were similar for increased ACEi/ARB duration and for medications examined as separate classes or individually.ConclusionsIn this large prospective study of women, no associations of ACEi or ARB use with colorectal cancer risk were observed.ImpactChoice of drug in the large population of aging women who will be prescribed ACEi and ARB should be made without factoring in any benefit on colorectal cancer risk.

Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real-world evidence (RWE) in the evaluation of new treatments or products. The RWE label has been used to refer to a variety of departures from the methods of traditional randomized controlled trials. Recognizing this complexity and potential confusion, the National Academies of Science, Engineering, and Medicine convened a series of workshops to clarify and address questions regarding the use of RWE to evaluate new medical treatments. Those workshops identified three specific dimensions in which RWE studies might differ from traditional clinical trials: use of real-world data (data extracted from health system records or data captured by mobile devices), delivery of real-world treatment (open-label treatments delivered in community settings by community practitioners), and real-world treatment assignment (including nonrandomized comparisons and variations on random assignment such as before-after or stepped-wedge designs). For any RWE study, decisions regarding each of these dimensions depends on the specific research question, characteristics of the potential study settings, and characteristics of the settings where study results would be applied.

Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real-world evidence in the evaluation of new treatments or products. Real-world clinical trials or pragmatic trials often differ from traditional clinical trials in the use of open-label or nonblinded treatments delivered by real-world clinicians in community practice settings. Blinding and standardization of treatment may sometimes be necessary for internal validity, but they may also obscure or distort meaningful differences between treatments. When investigators consider whether blinding of clinicians, patients, or assessors is necessary, we suggest they consider several specific questions: Will clinicians, patients, and assessors have expectations or preferences regarding benefits or adverse effects? How might those expectations affect treatment uptake, treatment adherence, or assessment of outcomes? Will expectations differ in the settings where trial results will be applied? How would blinding of treatment reduce biases? How would blinding obscure true differences between treatments? How would procedures necessary for blinding reduce acceptability or increase risk of trial participation? When investigators consider how strictly treatments should be standardized, we suggest they consider several specific questions: How would treatment effectiveness or safety vary according to clinician experience or expertise? What level of experience or expertise is available in potential trial settings and settings where trial results would be applied? Is some level of standardization necessary for valid inference? Considering any special vulnerabilities of the study population, is some level of standardization necessary to assure participant safety?

BACKGROUND: The Centers for Medicare & Medicaid Services (CMS) is the single largest payer for health care in the United States and the largest payer by spending globally. Medicare Part B, with more than 50 million beneficiaries, currently has no broad mechanisms in place for promoting cost-effective care of injectable drugs. OBJECTIVE: To conduct a real-world utilization and cost analysis comparing botulinum toxins in movement disorders. METHODS: The 2017 Medicare Provider Utilization and Payment Data: Physician and Other Supplier dataset from CMS was used for this claims level analysis. Neurologists, ophthalmologists, or physiatrists who injected predominantly for movement disorders (defined as blepharospasm, cervical dystonia, sialorrhea, and/or spasticity) were included along with their patients. Botulinum toxins with FDA indications spanning these 3 specialties were included. RESULTS: A total of 891 physicians (406 ophthalmologists, 338 neurologists, and 147 physiatrists) along with their 29,954 botulinum toxin (27,441 onabotulinumtoxinA and 2,513 incobotulinumtoxinA) patients were included in the analysis. The average total drug cost per patient per year (PPPY) was significantly lower for incobotulinumtoxinA versus onabotulinumtoxinA ($2,099 vs. $3,115; P < 0.001), for an average savings of 32.6%. Annual average out-of-pocket costs were also significantly less expensive for incobotulinumtoxinA versus onabotulinumtoxinA ($486 vs. $719; P < 0.001), for an average savings of 32.4%. Across 74,346 total injection visits, there was no significant difference in dosing between the agents, with an average dosing ratio of 0.94 incobotulinumtoxinA to 1.0 onabotulinumtoxinA. Injections PPPY were 2.42 for onabotulinumtoxinA and 2.29 for incobotulinumtoxinA. Average reported wastage was 64% higher for onabotulinumtoxinA than it was for incobotulinumtoxinA. A budget impact analysis estimated that increasing incobotulinumtoxinA use in the movement disorder space to attain an overall 20% botulinum toxin market share would save Medicare $32.9 million over a 3-year period versus current use. CONCLUSIONS: IncobotulinumtoxinA was shown to be a less costly alternative than onabotulinumtoxinA with similar dosing in real-world practice in this large national Medicare population. Policies to increase use of agents that promote cost-effective evidence-based care should be further explored and implemented for this fundamental federal payer. DISCLOSURES: This research received no external funding. Kazerooni was an employee of Merz Pharmaceuticals at the time of the analysis. Watanabe received no compensation or funding for this research project. Watanabe is a member of the National Academies of Sciences, Engineering, and Medicine Forum on Drug, Discovery, Development, and Translation. This information, content, and conclusions are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by the U.S. government or the National Academies of Sciences, Engineering.

INTRODUCTION:The scope of pharmacy practice has evolved over the last few decades to focus on the optimization of medication therapy. Despite this positive impact, the lack of reimbursement remains a significant barrier to the implementation of innovative pharmacist practice models. SUMMARY:We describe the successful development, implementation and outcomes of three types of pharmacist collaborative care models: (1) a pharmacist with physician oversight, (2) pharmacist-interprofessional teams and (3) physician-pharmacist teams. The outcome measurement of these pharmacist care models varied from the design phase to patient volume measurement and to comprehensive quality dashboards. All of these practice models have been successfully funded by affiliated health systems or grants. CONCLUSIONS:The expansion of pharmacist services delivered by clinical faculty has several benefits to affiliated health systems: (1) significant improvements in patient care quality, (2) access to experts in specialty areas, and (3) the dissemination of outcomes with national and international recognition, increasing the visibility of the health system.

The increasing number of pharmacists in the US has generated concern regarding potential oversupply. A 2018 analysis from the National Center for Health Workforce Analysis (NCHWA) in the US projected a best case scenario of an oversupply of more than 18,000 pharmacists in the year 2030. In this commentary, the limitations of this general health labor force analysis by the NCHWA are described. The goal of this work was to provide a more nuanced examination of the pharmacist labor demand in the US. Data from the US Bureau of Labor Statistics (BLS) and the US Medical Expenditure Panel Survey (MEPS) were utilized to examine, annually over a ten year period ending in 2017, the number of pharmacists, the ratio of pharmacists to persons living in the US, the ratio of pharmacists to older adults living in the US, and the ratio of medications to pharmacists. The number of pharmacists grew from 266,410 in 2008 to 309,330 in 2017. As anticipated, despite a growing US population, the ratio of people living in the US per pharmacist dropped unabated from 1141 to 1053 from 2008 to 2017, respectively. However, the reverse trend was observed for the ratio of persons 65 years or older per pharmacist. This ratio increased from 146.1 older adults to each pharmacist in 2008 to 164.3 in 2017. The accelerating demographic shift to an older population is also reversing an overall trend in the number of medications to pharmacist that will continue for the foreseeable future. While the ratio of medications to pharmacist dropped overall from 2008 to 2016, it has begun to rise again from 2016 to 2017. Beyond the increasing number of medications attributable to a rapidly aging population, there is a growing demand for clinical care from pharmacists due to the maturing environment of complex, costly medications for chronic disease treatment. As the portion of total health expenditure is increasingly devoted to medications and the US health delivery system continues its movement to community-based care, the demand for pharmacist care will require a larger number of pharmacists trained for advanced-practice care.

background: Cholinesterase (ChE) inhibitors enhance central cholinergic function and are considered as standard treatments to ameliorate symptoms relating to Alzheimer's disease. Though anticholinergic medications directly antagonize the effects of ChE inhibitors, they are commonly prescribed among hospitalized adults. objective: To determine the impact of high anticholinergic burden (ACB) on length of stay (LOS) and 30-day readmission rates among hospitalized patients receiving concomitant ChE inhibitors. methods: This was a retrospective cohort study conducted at a tertiary care academic medical center involving hospitalized patients on medical floors who received any Food and Drug Administration-approved ChE inhibitors during their hospital stay from October 1, 2022, to September 30, 2023. The primary outcome of the study was to compare hospital LOS among patients with high (ACB≥ 3) versus low (ACB < 3) ACB. The secondary outcome was to assess the impact of ACB burden on 30-day readmission rates. results: Among hospitalized adults, patients with high ACB exposure had a significantly longer hospital LOS (median: 5.50 vs 4.25 days; P < 0.001) than patients with low ACB exposure, after adjusting for covariates. Analysis of secondary outcome revealed that though the high ACB group had a higher 30-day readmission rate compared with the lower ACB group (6.8% vs. 2.2%), the difference was not statistically significant (OR = 3.46, 95% CI 0.85-14.08; P = 0.083). conclusion: A high ACB exposure among older individuals taking concurrent ChE inhibitors is associated with a longer hospital stay. [ABSTRACT FROM AUTHOR]

Background Oral anticoagulants (OACs) are recommended for nonvalvular atrial fibrillation (NVAF) patients with moderate-to high-stroke risk. Objective To examine nationally reflective OAC usage in incident NVAF patients longitudinally. Design Three-year retrospective cohort analysis. Setting Medicare Part D recipients in the contiguous United States.Participants52,465 Medicare beneficiaries with incident NVAF in 2010 with two or more atrial fibrillation diagnoses seven or more days apart. Main outcome measure Stroke risk via congestive heart failure, hypertension, age greater than or equal to 75, diabetes, stroke, vascular disease, age 65-74, sex category (CHA2DS2-VASc) score. Primary outcome was proportion of patients receiving one or more OACs post-NVAF diagnoses. Results Of 48,980 high-risk patients, 32.7% received one or more OAC within 60 days of diagnosis. By close of 2011, 48% had one or more OAC. OAC use increased to 52.9% by close of 2012. Conclusions Fewer than 33% of high-risk NVAF patients received OACs within 60 days of diagnosis in 2010. Despite increased use over time, oral anticoagulation was below 53% at study end. Use of OACs declined with CHA2DS2-VASc greater than 6. Expanded efforts are warranted to augment OAC use in high stroke-risk patients.

BACKGROUND:Public attention and recent US Congressional activity has intensified focus on escalating medication prices. However, the actual cost of medication use extends beyond the up-front cost of purchasing medicines. It also encompasses the additional medical costs of morbidity and mortality resulting from nonoptimized medication regimens, including medication nonadherence. OBJECTIVES:Applying the most current nationally representative data sources, our goal was to estimate the cost of prescription drug-related morbidity and mortality in the United States. METHODS:Total costs of nonoptimized prescription drug use and average pathway costs for a patient who experienced a treatment failure (TF), a new medical problem (NMP), or a TF and NMP were modeled in Microsoft Excel (Microsoft Corporation, Redmond, WA) and TreeAge Pro Healthcare, v2014 (TreeAge Software, Inc, Williamstown, MA), respectively. RESULTS:The estimated annual cost of prescription drug-related morbidity and mortality resulting from nonoptimized medication therapy was $528.4 billion in 2016 US dollars, with a plausible range of $495.3 billion to $672.7 billion. The average cost of an individual experiencing TF, NMP, or TF and NMP after initial prescription use were $2481 (range: $2233, $2742), $2610 (range: $2374, $2848) and $2572 (range: $2408, $2751), respectively. CONCLUSIONS:The estimated annual cost of drug-related morbidity and mortality resulting from nonoptimized medication therapy was $528.4 billion, equivalent to 16% of total US health care expenditures in 2016. We propose expansion of comprehensive medication management programs by clinical pharmacists in collaborative practices with physicians and other prescribers as an effective and scalable approach to mitigate these avoidable costs and improve patient outcomes.

BackgroundPrevious estimates of the economic burden of Crohn's disease (CD) varied widely from $2.0 to $18.2 billion per year (adjusted to 2015 $US). However, these estimates do not reflect recent changes in pharmaceutical treatment options and guidelines.ObjectiveThe goal of this study was to update cost estimates of Crohn's disease based on a representative sample of the US population from the most recent 11 years (2003-2013) of the Medical Expenditure Panel Survey (MEPS). A secondary aim described expenditure trends in respondents with and without Crohn's disease pre-post FDA approvals of new biologics and the American College of Gastroenterology Crohn's disease treatment guidelines.MethodsAverage annual expenditures (total, prescription, inpatient, and outpatient) were evaluated using a pooled cross-sectional design. Respondent data from the most recent 11 years (2003-2013) of MEPS were analyzed. Two-part generalized linear models with power-link were used to estimate the average annual expenditures per patient adjusted to multiple covariates. Confidence intervals (CI) were estimated using bootstrap methods. Difference-in-differences estimations were performed to compare the changes in health care expenditures pre-post FDA approvals of new biologics and the American College of Gastroenterology Crohn's disease treatment guidelines.ResultsThe annual aggregate economic burden of CD was $6.3 billion in the US. Respondents with CD had higher total (+$6442; 95% CI: $4864 to $8297), prescription (+$3283; 95% CI: $2289 to $4445), inpatient (+$1764; 95% CI: $748 to $3551), and outpatient (+$1191; 95% CI: $592 to $2160) expenditures compared to respondents without CD. In the difference-in-differences estimation, respondents with CD had significantly higher total (P = 0.001) and prescription (P

The article discusses the need to urgently resolve diverse population and older adult exclusion in clinical trials and research to improve drug evaluation in these groups as of 2024. Topics covered include the consequences of exclusion in trials, the barrier of institutional structures to inclusivity, and the process of trial recruitment and compensation for these people. Also noted are recommendations made for this effort and their implementation.

ObjectiveTo compare the prevalence of falls and fall-related concerns of medication users versus nonusers in U.S. seniors.DesignCross-sectional study.SettingThe National Health and Aging Trends Study.ParticipantsU.S. nationally representative sample of Medicare beneficiaries in 2011.OutcomesComparing subjects who used medications with subjects who did not in the past month, the outcomes were percentages of subjects who experienced 1) a fall in the past month, 2) worry about falling in the past month, 3) being limited by this worry in the past month, 4) a fall in the past year.ResultsA greater percentage of medication users experienced falls and fall-related outcomes, compared with non-medication users. Among medication users, 10.29% had a past month fall, compared with 5.42% of non-medication users; 27.69% of medication users worried in the past month about falling, compared with 9.15% of non-medication users; 40.96% of medication users were limited by this worry, compared with 21.21%; 22.82% of medication users had a fall in the past year, compared with 13.15% of non-medication users.ConclusionSeniors who use medications are more likely to fall and to be concerned about falling. Pharmacist involvement in fall prevention continues to be essential.

Health technology assessment is a form of health policy research that provides policymakers with information relevant to decisions about policy alternatives. Findings from cost-effectiveness analysis (CEA) are one of the important aspects of health technology assessment. Nevertheless, the more advanced method of value of information (VOI), which is recommended by the International Society for Pharmacoeconomics and Outcomes Research and Society for Medical Decision Making Modeling Good Research Practices Task Force, has rarely been applied in CEA studies in Asia. The lack of VOI in Asian CEA studies may be due to limited understanding of VOI methods and what VOI can and cannot help policy decision makers accomplish. This concept article offers audiences a practical primer in understanding the calculation, presentation, and policy implications of VOI. In addition, it provides a rapid survey of health technology assessment guidelines and literature related to VOI in Asia and discusses the future directions of VOI use in Asia and its potential barriers. This article will enable health economists, outcomes researchers, and policymakers in Asia to better understand the importance of VOI analysis and its implications, leading to the appropriate use of VOI in Asia.

Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30% of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable.

ObjectiveThe complete capture of all values for each variable of interest in pharmacy research studies remains aspirational. The absence of these possibly influential values is a common problem for pharmacist investigators. Failure to account for missing data may translate to biased study findings and conclusions. Our goal in this analysis was to apply validated statistical methods for missing data to a previously analyzed data set and compare results when missing data methods were implemented versus standard analytics that ignore missing data effects.DesignUsing data from a retrospective cohort study, the statistical method of multiple imputation was used to provide regression-based estimates of the missing values to improve available data usable for study outcomes measurement. These findings were then contrasted with a complete-case analysis that restricted estimation to subjects in the cohort that had no missing values. Odds ratios were compared to assess differences in findings of the analyses. A nonadjusted regression analysis ("crude analysis") was also performed as a reference for potential bias.SettingVeterans Integrated Systems Network that includes VA facilities in the Southern California and Nevada regions.PatientsNew statin users between November 30, 2006, and December 2, 2007, with a diagnosis of dyslipidemia.Main outcome measureWe compared the odds ratios (ORs) and 95% confidence intervals (CIs) for the crude, complete-case, and multiple imputation analyses for the end points of a 25% or greater reduction in atherogenic lipids.ResultsData were missing for 21.5% of identified patients (1665 subjects of 7739). Regression model results were similar for the crude, complete-case, and multiple imputation analyses with overlap of 95% confidence limits at each end point. The crude, complete-case, and multiple imputation ORs (95% CIs) for a 25% or greater reduction in low-density lipoprotein cholesterol were 3.5 (95% CI 3.1-3.9), 4.3 (95% CI 3.8-4.9), and 4.1 (95% CI 3.7-4.6), respectively. The crude, complete-case, and multiple imputation ORs (95% CIs) for a 25% or greater reduction in non-high-density lipoprotein cholesterol were 3.5 (95% CI 3.1-3.9), 4.5 (95% CI 4.0-5.2), and 4.4 (95% CI 3.9-4.9), respectively. The crude, complete-case, and multiple imputation ORs (95% CIs) for 25% or greater reduction in TGs were 3.1 (95% CI 2.8-3.6), 4.0 (95% CI 3.5-4.6), and 4.1 (95% CI 3.6-4.6), respectively.ConclusionThe use of the multiple imputation method to account for missing data did not alter conclusions based on a complete-case analysis. Given the frequency of missing data in research using electronic health records and pharmacy claims data, multiple imputation may play an important role in the validation of study findings.

Global support and standardization of regulation for biosimilars approval owes much of its legacy to the World Health Organization (WHO), since the first guidance by the organization on the matter was released in 2009. Since then, and with over a decade of research, the 2022 revision provides opportunities for time and financial savings to pharmaceutical manufacturers aiming to prove similarity of a potential biosimilar product to some reference product, particularly by clarifying that the use of a non-local reference product as a comparator in certain studies is permissible. This declaration has important implications, particularly in the emerging biological markets of the Middle East and North Africa region, where WHO guidelines have been integral to the regulatory framework of over a dozen countries for more than a decade. This article aims to review the impact of this revision on these countries and relevant policies on non-local comparator usage. Since 2022, this revision has been adopted only in Egypt. Many North African countries are yet to adopt a first draft of the formalized guidance. This analysis revealed that, although many of these countries reference the WHO guidelines, hesitation remains in terms of sourcing comparator products outside the US or European countries. This likely translates to slow regional development and cooperation of functioning, sustainable biosimilars markets. Future studies will be necessary to evaluate the continued development of guidance within these countries and changes in comparator sourcing norms as more time is allowed for their policies to mature and adapt to new standards. [ABSTRACT FROM AUTHOR]

BackgroundStatins remain a fundamental component of pharmacologic therapy for hyperlipidemia. Health benefits of statin therapy are jeopardized when adherence is reduced.ObjectivesTo (a) assess the association between copayment and copayment type on statin adherence using 2 different thresholds of adherence and (b) identify the incremental change in statin adherence associated with presence of copayment and copayment type.MethodsWe executed a retrospective cohort study of new users of statins with dyslipidemia from the Veterans Health Administration (VHA) within the Veterans Integrated Service Network 22 who initiated a statin between November 30, 2006, and December 2, 2007. We used exposure categories of Any Copayment versus No Copayment, indicating a patient had a copayment or had no copayment in order to obtain medications, respectively. As a separate analysis, we varied the exposures to the standard VHA copayment categories: (a) Service-Connected (SC) Copayment (patients with service-related injury), (b) Non-Service-Connected (NSC) Copayment (patients without a service-related injury), and (c) No Copayment. Using each set of exposures, we conducted separate multiple logistic regression analyses using 2 different adherence outcomes based on medication possession ratio (MPR) threshold: (1) adherence defined as MPR ≥ 0.8 and (2) adherence defined as MPR ≥ 0.9. We then proceeded with multiple linear regression models to determine the incremental change in MPR associated with the 2 sets of exposures. Subjects were required to be enrolled in VHA services for at least 2 years prior to index date and throughout the 1-year study period.ResultsA total of 4,886 subjects were identified for analysis based on the inclusion and exclusion criteria. Patients who did not pay a copayment for their statin medications were more likely to have adherence rates of ≥ 0.8 MPR and ≥ 0.9 MPR relative to the No Copayment Group with odds ratios (OR) of 1.19 (95% CI = 1.03-1.37) and 1.28 (95% CI = 1.11-1.48), respectively. The second analysis applied the VHA exposure categories of SC Copayment, NSC Copayment, and No Copayment. Using the 0.8 MPR or greater adherence threshold, the No Copayment group was associated with an increased likelihood of adherence versus the SC Copayment category as reference group with an OR of 1.31 (95% CI = 1.10-1.58). The NSC Copayment was associated with a nonsignificant increase in odds of adherence at the 0.8 MPR level or greater with OR of 1.12 (95% CI = 0.98-1.39). Using the 0.9 MPR level or greater, adherence threshold findings were similar. The No Copayment group produced an OR of 1.42 (95% CI = 1.17-1.71) compared with the SC Copayment group. The NSC Copayment group was associated with a nonsignificant increase in odds of adherence at the 0.9 MPR level or greater with an OR of 1.12 (95% CI = 0.97-1.38).The No Copayment group was associated with an increase in MPR of 0.02 (95% CI = 0.002-0.035) versus the Any Copayment category. Using the VHA copayment categories, we observed an increase in MPR for the No Copayment group versus the SC Copayment group of 0.03 (95% CI = 0.01-0.05). The NSC Copayment group was associated with a nonsignificant increase in MPR versus the SC Copayment group of 0.02 (95% CI = -0.003-0.036).ConclusionsPatients without out-of-pocket payments for their statins were more likely to adhere to therapy. Patients who pay a copayment for their statin medications were also compared with each other based on whether they (a) received any of their nonstatin prescriptions without a copayment or (b) paid a copayment on all of their prescriptions including statins. Our findings suggest that, among those that pay for their statins, patients are less adherent to their statins if other medications they are prescribed are copayment free. Thus, patient consumption behavior may be influenced by the relative cost of medications in patient prescription lists. Additional counseling on the necessity of adherence should be given to patients paying a copayment for their statin prescriptions.

OBJECTIVES: Aims were to quantify the association of pre-COVID-19 pandemic telehealth use and separately: 1) likelihood of an emergency department (ED) visit, 2) likelihood of a telehealth visit in older people during the pandemic. DESIGN: A retrospective cohort study to measure odds ratios (ORs) of telehealth usage before the pandemic and likelihood of an ED visit and telehealth visit during the study period. SETTING AND PATIENTS: Adults 65 years of age and older (N = 39,214) in the University of California COVID Research Data Set (UC CORDS). MAIN OUTCOMES: Primary outcome was occurrence of one or more ED visits. Secondary outcome was occurrence of one or more telehealth visits. RESULTS: A telehealth visit before the pandemic was associated with reduced likelihood of an ED visit with an OR of 0.33 (95% confidence interval [CI] 0.20-0.55). Pre-pandemic telehealth was associated with an increased likelihood of telehealth use during the pandemic with an OR of 4.66 (95% CI 3.52-6.18). CONCLUSION: Older people who utilized telehealth before the pandemic were less likely to receive emergency care and were more likely to use telehealth during the pandemic. Approaches to enhance and measure telehealth access for older people are necessary. [ABSTRACT FROM AUTHOR]

Background: Health care professionals can have a dramatic impact by assisting patients with tobacco cessation but most have limited training. Purpose: To evaluate the effectiveness of a 4-hour tobacco cessation training program. Methods: A team of multidisciplinary health care professionals created a veteran-specific tailored version of the Rx for Change program. The curriculum was administered through local trainings at 5 Veterans Affairs facilities. Participants completed pre- and posttraining surveys to assess key knowledge-based competency components, perceived ability to implement the 5 A's of treatment (Ask, Advise, Assess, Assist, Arrange), and self-efficacy for overall ability to assist patients with quitting. Results: A total of 205 out of 291 health care professionals completed pre- and posttraining surveys. Participants reported significant improvement in their overall ability and ability to implement the 5 A's of tobacco treatment (P < 0.0001). No significant differences were found between health care disciplines on overall ability posttraining. Conclusion: The training increased clinicians' knowledge and perceived self-efficacy. The analysis is the first evaluation that supports a face-to-face, multidisciplinary training model across a large health care system. Translation to Health Education Practice: With increased evaluation of this training model, Health Educators of large health care systems should provide multidisciplinary, tobacco cessation trainings to health care professionals.

OBJECTIVE: Amidst rising opioid overdose deaths in the United States, the US Centers of Disease Control and Prevention (CDC) recognized the need for national guidelines on pain management and released the 2016 CDC Opioid Prescribing Guideline. Opioids are associated with increased sedation, falls, respiratory depression, fractures, and other adverse events which lead to hospitalization in older adults. This study sought to identify emerging trends in opioid prescriptions among the older adult population in response to updated guidelines, using national data provided by the Medical Expenditure Panel Survey (MEPS). METHODS: A retrospective cohort study was conducted using 2017 and 2021 MEPS Household Component and Prescribed Medicine survey responses from adults aged 65 and older, which disclose pain limitation severity reported by the patient's SF-12v2 quality-of-health survey, and de-identified opioid prescriptions recorded by medical professionals. WHO analgesic ladder definitions were used to classify strong and weak opioids from generic medicine codes provided by MEPS, and chi-squared tests were performed to compare associations between pain limitation responses and strong or weak opioid prescription counts prescribed by year, using R Studio (Boston, MA) with an a < 0.05. RESULTS: For strong opioid fills between 2017 and 2021 categorized by pain limitation, a chi-square test of independence reveals a significant relationship between the year filled and pain limitation response (X2 = 14.1, P = .00692) For weak opioid prescriptions between 2017 and 2021, a chi-square test of independence demonstrates a significant relationship between pain limitation response and year filled (X2 = 11.8, P = .01924). CONCLUSION: Decreased opioid prescriptions for lower pain categories suggest potential shifts in prescribing practices or regulatory influence, with implications for pain management in older adults. This mirrors CDC findings for the general population and warrants additional investigation of this effect in other clinical settings and types of pain. [ABSTRACT FROM AUTHOR]