Factors associated with COVID-19 Infection among a national population of individuals with schizophrenia or schizoaffective disorder in the United States.

BACKGROUND: Individuals with schizophrenia are a vulnerable and under-served population who are also at risk for severe morbidity and mortality following COVID-19 infection. Our research was designed to identify factors that put individuals with schizophrenia at increased risk of COVID-19 infection. METHODS: This study was a retrospective cohort analysis of medical and pharmacy claims among 493,796 individuals residing in the United States with schizophrenia or schizoaffective disorder, between January 1, 2019 and June 30, 2020. A confirmed diagnosis of COVID-19 infection by September 30, 2020 was regressed on demographics, social determinants, comorbidity, and pre-pandemic (December 2019 - February 2020) healthcare utilization characteristics. RESULTS: A total of 35,249 (7.1%) individuals were diagnosed with COVID-19. Elevated odds of COVID-19 infection were associated with age, increasing consistently from 40-49 years (OR: 1.16) to 80+ years (OR:5.92), male sex (OR: 1.08), Medicaid (OR: 2.17) or Medicare (OR: 1.23) insurance, African American race (OR: 1.42), Hispanic ethnicity (OR: 1.23), and higher Charlson Comorbidity Index. Select psychiatric comorbidities (depressive disorder, adjustment disorder, bipolar disorder, anxiety, and sleep-wake disorder) were associated with elevated odds of infection, while alcohol use disorder and PTSD were associated with lower odds. A pre-pandemic psychiatry (OR:0.56) or community mental health center (OR:0.55) visit were associated with lower odds as was antipsychotic treatment with long-acting injectable antipsychotic (OR: 0.72) and oral antipsychotic (OR: 0.62). CONCLUSIONS: Among individuals with schizophrenia, risk of COVID-19 infection was substantially higher among those with fewer economic resources, with greater medical and psychiatric comorbidity burden, and those who resided in African American or Hispanic communities. In contrast, individuals actively engaged in psychiatric treatment had substantially lower likelihood of infection. These results provide insights for healthcare providers that can translate into improved identification of at-risk individuals and interventions to reduce the risk and consequences of COVID-19 infection.

Barriers to Esketamine Nasal Spray Treatment Among Adults With Treatment-Resistant Depression.

Background: Under a risk evaluation and mitigation strategy program, esketamine nasal spray CIII requires self administration at a certified treatment center. Our objective was to identify factors associated with esketamine initiation and continuation.Methods: A retrospective observational cohort study was conducted among US adults who met treatment-resistant depression (TRD) criteria. Cases (n = 966) initiated esketamine between October 11, 2019, and February 28, 2022, and were compared to controls (n = 39,219) with TRD but no esketamine use. Outcomes included initiation, induction (8 administrations within 45 days), and interruptions (30-day treatment gap). Comorbid psychiatric conditions were identified using International Classification of Diseases, Tenth Revision, Clinical Modification, codes.Results: Cases resided significantly closer to treatment centers (8.9 vs 20.3 miles). Compared to 0-9 miles, initiation rate decreased by 11.9%, 50.8%, 68.1%, 75.9%, and 92.8% for individuals residing 10-19, 20-29, 30-39, 40-49, and 50+ miles from a center. After adjustment, factors associated with increased likelihood of initiation were posttraumatic stress disorder, major depressive disorder with suicidal ideation, and male sex, while increasing distance, substance use disorder, Medicaid, Charlson Comorbidity Index (CCI), and older age were associated with lower likelihood. Factors associated with lower likelihood of completing induction were Medicaid, low socioeconomic status (SES), CCI, and Hispanic communities. Factors associated with increased likelihood of interruption were alcohol use disorder, distance, and minority communities, while generalized anxiety disorder and Medicaid were associated with lower likelihood.Conclusions: Travel distance, insurance, low SES, and minority communities are potential barriers to treatment. Alternative care models may be needed to ensure adequate access to care.J Clin Psychiatry 2024;85(2):23m15102.

Adherence to augmentation therapy for the treatment of major depressive disorder.

BACKGROUND: Inadequate response to antidepressant medication is common. Often, adjunctive pharmacotherapy or psychotherapy is recommended. OBJECTIVE: To measure adherence to adjunctive pharmacotherapy and psychotherapy among individuals with major depressive disorder (MDD). METHODS: Retrospective cohort study of individuals with MDD on antidepressant monotherapy who added adjunctive pharmacotherapy and/or psychotherapy. Medication adherence was measured by proportion of days covered (PDC) with optimal adherence defined as PDC≥0.80 and psychotherapy adherence defined by count of visits (optimal 8+ visits). Factors associated with optimal adherence were assessed by logistic regression. RESULTS: Among 218,192 individuals with adjunctive therapy, 185,349 added pharmacotherapy and 32,843 added psychotherapy. In the subsequent 12 months, 36.2% and 54.9% achieved optimal adherence to adjunctive pharmacotherapy and psychotherapy, respectively. Adherence to adjunctive pharmacotherapy was associated with adding psychotherapy, index antidepressant adherence, medical comorbidities, and MDD severity codes. Adherence to adjunctive psychotherapy was associated with adding another medication, previous psychiatry visit and psychiatric comorbidities. CONCLUSION: Adjunctive psychotherapy appears under-utilized and adherence to adjunctive therapy was low. Low adherence to adjunctive therapy reinforces challenges in managing MDD. That a second adjunctive therapy enhanced adherence to the initial adjunctive therapy indicates an opportunity to explore alternative adjunctive therapies.

Social determinants and distance from certified treatment centers are associated with initiation of esketamine nasal spray among patients with challenging-to-treat major depressive disorder.

Indicated for treatment-resistant depression or major depression with suicidal ideation, esketamine (ESK) is self-administered under supervision at certified treatment centers. Our study was to determine if social determinants of health and distance were associated with ESK utilization. We conducted a retrospective cohort study among 308 US adults initiating ESK between October 11, 2019 and December 31, 2020 and 1540 propensity-score matched controls with treatment-resistant depression or major depression with suicidal ideation. Adjusting for demographics, prior health care utilization and comorbidities, social determinant variables and distance were regressed separately on each outcome: ESK initiation, failure to complete induction (8 treatments in 45 days), and discontinuation within 6 months. ESK initiation was associated with higher population density (odds ratio [OR]: 2.12), American Indian, Alaska Native, Native Hawaiian, Other Pacific Islander (OR: 3.19), and mental health (OR: 1.55) and primary care providers (OR: 1.55) per capita. Lower likelihood of ESK initiation was associated with living > 7.2 miles from a treatment center (OR: 0.75), living in rural areas (OR: 0.64), and percent non-Hispanic African American (OR: 0.58) and Hispanic (OR: 0.40). Health care providers should tailor patient engagement strategies to mitigate potential barriers to initiating and continuing appropriate treatment. Failing to complete induction was associated with substance use disorder and longer distance to treatment center was associated with discontinuation (hazard ratio: 1.48), as was percent Asian population (hazard ratio: 1.37). Prior psychiatric care and residence in counties with high rates of primary care providers per capita, unemployment, and high school graduation were associated with both higher likelihood of completing induction and lower likelihood of discontinuation.

Real-World Evidence of Aripiprazole Tablets with Sensor: Treatment Patterns and Impacts on Psychiatric Healthcare Resource Utilization.

Purpose: Maintaining adherence to antipsychotic (AP) medication is often challenging. Aripiprazole tablets with sensor (AS) contain an ingestible event marker and communicate with wearable patches and a smartphone app to provide objective medication ingestion data. This study evaluated real-world treatment patterns of AS usage and its impact on psychiatric healthcare resource utilization (HCRU). Patients and Methods: This retrospective, observational cohort study identified individuals who initiated AS between 1/1/2019 and 6/30/2020 with 3 months baseline and 6 months of follow-up data using a commercial medical and pharmacy claims database (Clarivate). Controls were propensity score-matched (4:1) to AS initiators based on age (±2 years), sex, diagnosis (major depressive disorder [MDD], schizophrenia, bipolar I disorder [BP-I], other), insurance, and baseline oral AP use (yes/no). Days of AP supply were evaluated using a general regression model. The frequency of psychiatric HCRU during follow-up was compared between groups using a zero-inflated regression model. Results: Most AS initiators were diagnosed with MDD (61.2%) and were women (61.2%); mean age was 37.7 years (standard deviation: 14.1). Most AS initiators (53.1%) continued treatment for >60 days (mean days of supply = 77). After adjusting for covariates, AS initiators had 41% more days of AP supply during follow-up compared with controls (P <0.0001) and significantly lower adjusted odds ratios (ORs) for psychiatric outpatient visits (adjusted OR = 0.80; P <0.05), emergency department visits (adjusted OR = 0.11; P <0.05), inpatient visits (adjusted OR = 0.42; P <0.05), and other medical services (adjusted OR = 0.25; P <0.05). Conclusion: Participants who implemented AS had significantly more days of AP supply and fewer psychiatric care visits. These preliminary results suggest AS usage can help build regular medication-taking habits and holds promise for reducing psychiatric HCRU. Additional studies with larger sample sizes are warranted to inform clinical practice and coverage decisions.

Association between Surgical Technical Skills and Clinical Outcomes: A Systematic Literature Review and Meta-Analysis.

Background: A systematic literature review and meta-analysis was conducted to assess the association between intraoperative surgical skill and clinical outcomes. Methods: Peer-reviewed, original research articles published through August 31, 2021 were identified from PubMed and Embase. From the 1,513 potential articles, seven met eligibility requirements, reporting on 151 surgeons and 17,932 procedures. All included retrospective assessment of operative videos. Associations between surgical skill and outcomes were assessed by pooling odds ratios (OR) using random-effects models with the inverse variance method. Eligible studies included pancreaticoduodenectomy, gastric bypass, laparoscopic gastrectomy, prostatectomy, colorectal, and hemicolectomy procedures. Results: Meta-analytic pooling identified significant associations between the highest vs. lowest quartile of surgical skill and reoperation (OR: 0.44; 95% confidence interval [CI]: 0.23, 0.83), hemorrhage (OR: 0.66; 95% CI, 0.65, 0.68), obstruction (OR: 0.33; 95% CI, 0.30, 0.35), and any medical complication (OR: 0.23, 95% CI, 0.19, 0.27). Nonsignificant inverse associations were noted between skill and readmission, emergency department visit, mortality, leak, infection, venous thromboembolism, and cardiac and pulmonary complications. Conclusions: Overall, surgeon technical skill appears to predict clinical outcomes. However, there are surprisingly few articles that evaluate this association. The authors recommend a thoughtful approach for the development of a comprehensive surgical quality infrastructure that could significantly reduce the challenges identified by this study.

Warnings without guidance: patient responses to an FDA warning about ezetimibe.

BACKGROUND: In January 2008, the Food and Drug Administration (FDA) communicated concerns about the efficacy of ezetimibe, but did not provide clear clinical guidance, and substantial media attention ensued. We investigated the proportion of patients who discontinued therapy and switched to a clinically appropriate alternative after the FDA communication. METHODS: Using claims data from a national pharmacy benefits manager, we created a rolling cohort of new users of ezetimibe between January 2006 and August 2008 and created a supply diary for each patient in the year after cohort entry. A patient was identified as nonpersistent if a gap of 90 days was seen in the diary. Using segmented linear regression, we compared rates of nonpersistence before and after the FDA communication and assessed patient-level characteristics associated with discontinuation. Among nonpersistent patients, we determined whether a patient made a clinically appropriate switch in the subsequent 90 days by adding a new cholesterol-lowering medication or by increasing the dose of an existing one. We used a weighted t test to compare the rates of appropriate switching before and after the communication. RESULTS: Among 867,027 new ezetimibe users, 407,006 (46.9%) were nonpersistent in the first year. After the FDA communication, the monthly level of ezetimibe nonpersistence increased by 5.7 percentage points (P<0.0001). Younger patients, those who lived in low-income zip codes, and female patients were less likely to discontinue therapy (P<0.0001 for all). Among nonpersistent patients, rates of clinically appropriate switching increased from 10.8% before to 16.5% after the FDA warning (P = 0.004). CONCLUSIONS: A substantial increase in ezetimibe nonpersistence rates was seen after an FDA communication regarding its efficacy and following associated media attention, and a small proportion of patients made a clinically appropriate switch after discontinuation. Further consideration is needed to deliver messages that promote appropriate use of chronic therapy rather than simply reduce use.

Targeting cardiovascular medication adherence interventions.

OBJECTIVES: To determine whether adherence interventions should be administered to all medication takers or targeted to nonadherers. DATA SOURCES AND STUDY SELECTION: Systematic search (Medline and Embase, 1966-2009) of randomized controlled trials of interventions to improve adherence to medications for preventing or treating cardiovascular disease or diabetes. DATA EXTRACTION: Articles were classified as (1) broad interventions (targeted all medication takers), (2) focused interventions (targeted nonadherers), or (3) dynamic interventions (administered to all medication takers; real-time adherence information targets nonadherers as intervention proceeds). Cohen's d effect sizes were calculated. DATA SYNTHESIS: We identified 7,190 articles; 59 met inclusion criteria. Broad interventions were less likely (18%) to show medium or large effects compared with focused (25%) or dynamic (32%) interventions. Of the 33 dynamic interventions, 6 used externally generated adherence data to target nonadherers. Those with externally generated data were less likely to have a medium or large effect (20% vs. 34.8% self-generated data). CONCLUSION: Adherence interventions targeting nonadherers are heterogeneous but may have advantages over broad interventions. Dynamic interventions show promise and require further study.

Measuring Response to Adjunctive Therapy Among Individuals with Major Depressive Disorder.

Background: Incomplete or inadequate response to first-line antidepressant therapy (ADT) for major depressive disorder (MDD) is common. Response to adjunctive therapy is less understood. Objective: To estimate response to adjunctive pharmacotherapy or psychotherapy among individuals with MDD on an antidepressant using the PHQ-9 questionnaire. Methods: This was a retrospective cohort analysis using medical and pharmacy insurance claims among individuals with MDD or ADT who initiated adjunctive pharmacotherapy, psychotherapy, or both (dual). Eligible individuals initiated adjunctive therapy between 7/1/2014-12/31/2018. Symptom severity was measured by PHQ-9 score in the 6-month baseline and 12-month follow up. Multivariate logistic regression identified factors associated with improved symptom severity. Results: Most (81.8%) of the 2389 participants initiated adjunctive pharmacotherapy, followed by psychotherapy (12.7%) and dual adjunctive (5.5%). Only 30.2% had both a baseline and follow-up PHQ-9 score. Among those with mild or more severe PHQ-9 baseline scores, 36.7% had the same or worse MDD severity during follow-up. Among those with moderate or more severe baseline scores, 28.1% had the same or worse MDD severity during follow-up. Conclusion: Most individuals with moderate-to-severe MDD did not receive a follow-up questionnaire, suggesting incomplete monitoring of treatment response. Among those with a PHQ-9 following initiation of adjunctive therapy, many continued to report impactful symptoms. Future studies should explore alternate treatment approaches and methods to support the utilization of the PHQ-9 for monitoring treatment response.

Implications of Payment for Acute Myocardial Infarctions as a 90-Day Bundled Single Episode of Care: A Cost of Illness Analysis.

OBJECTIVES: Evaluate the cost of illness associated with the 90-day period following acute myocardial infarction (AMI) and the implication of care pathway (percutaneous coronary intervention [PCI] vs medical management [MM]), in order to assess the potential financial risk incurred by providers for AMI as an episode of care. PERSPECTIVE: Reimbursement payment systems for acute care episodes are shifting from 30-day to 90-day bundled payment models. Since follow-up care and readmissions beyond the early days/weeks post-AMI are common, financial risk may be transferred to providers. SETTING: AMI hospitalization Centers for Medicare & Medicaid Services (CMS) standard analytical files between 10/1/2015 and 9/30/2016 were reviewed. METHODS: Included patients were Medicare beneficiaries with a primary diagnosis of AMI subsequently treated with either PCI or MM. Payments were standardized to remove geographic variation and separated into reimbursements for services during the hospitalization and from discharge to 90 days post-discharge. Results were stratified by Medicare Severity Diagnosis Related Groups (MS-DRGs) individually and grouped between patients treated with MM and PCI. Risk-adjusted likelihood of utilization of post-acute nursing care and all-cause readmission was assessed by logistic regression. RESULTS: A total of 96,546 patients were included in the analysis. The highest total mean payment (US$32,714) was for MS-DRG 248 (PCI with non-drug-eluting stent with major complication or comorbidity). Total payments were similar between MM and PCI patients, but MM patients incurred the majority of costs in the post-acute period after discharge, with the converse true for PCI patients. MM without catheterization was associated with a twofold increase in risk of requiring post-acute nursing care and 90-day readmission versus PCI (odds ratio [95% confidence interval]: 2.01 [1.92-2.11] and 2.17 [2.08-2.27]). Smaller hospital size, diabetes, peripheral arterial disease, prior AMI, and multivessel disease were predictors of higher healthcare utilization. CONCLUSIONS: MS-DRGs associated with the lowest reimbursements (and presumably, lowest costs of inpatient care) incur the highest post-discharge expenditures. As the CMS Bundled Payment for Care Improvement and similar programs are implemented, there will be a need to account for heterogeneous post-discharge care costs. Video abstract (MP4 274659 KB).

Around 805,000 heart attacks occur annually in the US. With an average age over 65 years, many heart attack patients qualify for Medicare health insurance. Under Medicare, hospitals (or 'providers') receive reimbursements for the cost of care associated with 'acute care episodes' (e.g., heart attacks) as a 'bundled' payment. The bundled reimbursements are typically based on pre-defined prices, with hospitals paying the difference if actual costs exceed these. Reimbursements are typically given for care costs from the initial heart attack through to hospital discharge and care in the 30-day post-discharge period. However, recently introduced reimbursement models such as BPCI Advanced have moved to expand this to 90 days. Since follow-up care and additional cardiovascular readmissions are common beyond 30 days, extension of the reimbursement period to 90 days could increase financial risk to hospitals/providers if these additional costs are not included in reimbursements. To assess the potential impact of this, we investigated the cost of illness for heart attack and the implication of type of care: medical management (standard medication given after heart attack) vs. percutaneous coronary intervention (PCI; standard medication plus a non-surgical procedure to widen heart blood vessels). We found that 90-day costs after heart attack are substantial regardless of type of care. We found that post-discharge costs were generally high, but higher for medically managed patients than those receiving PCI. Our analysis also suggests Medicare disease classifications associated with lowest payments for heart attack (and presumably, lowest hospitalization costs) are associated with the highest post-discharge expenditures. Overall, our study suggests that new payment models should account for variable post-discharge care costs, and new therapies are needed to reduce additional events, readmissions, and associated costs in heart attack patients.

Impact of the COVID-19 Pandemic on Healthcare Resource Utilization in Individuals with Major Depressive Disorder.

Objective: To estimate the impact COVID-19 pandemic on healthcare resource utilization (HCRU) among individuals with major depressive disorder (MDD). Method: A retrospective cohort study was conducted to compare HCRU in the twelve months prior to and six months following pandemic onset among 1,318,709 individuals with MDD and propensity-score matched controls. Outcomes were monthly rates of all-cause and MDD-specific outpatient, inpatient, and prescription medication HCRU. Piecewise random effects models were used to adjust for patient-level clustering, trends over time, and pre-pandemic factors. Results: In the first month following onset, outpatient HCRU declined with primary care visits down 25.1%. Following this initial decline, outpatient HCRU increased, exceeding pre-pandemic rates within three months. By April 2020, three quarters of all psychotherapy sessions were delivered by telehealth, followed by psychiatry (62.3%), and primary care visits (30.1%). The use of telehealth remained highest for psychotherapy and psychiatry (representing 67.6% and 54.2% of visits, respectively, in September 2020). All-cause partial-day hospitalizations declined 50.5% and remained depressed through July 2020 (down 18.3%). Beginning in the first month post-onset, prescription medication HCRU increased for all antidepressant and antipsychotic medication classes: serotonin modulators ( + 11.8%), bupropion ( + 10.4%), SSRIs ( + 9.0%), SNRIs ( + 8.6%), and atypical antipsychotics ( + 7.5%). Conclusions: Following pandemic onset, individuals with MDD realized an immediate, but short-lived, reduction in primary care HCRU. Telehealth use remained elevated through the first six months. The most significant and sustained reduction in HCRU was noted for partial-day hospitalizations and all-cause ED visits.

Predicting Poor Outcomes Among Individuals Seeking Care for Major Depressive Disorder.

Objective: To develop and validate algorithms to identify individuals with major depressive disorder (MDD) at elevated risk for suicidality or for an acute care event. Methods: We conducted a retrospective cohort analysis among adults with MDD diagnosed between January 1, 2018 and February 28, 2019. Generalized estimating equation models were developed to predict emergency department (ED) visit, inpatient hospitalization, acute care visit (ED or inpatient), partial-day hospitalization, and suicidality in the year following diagnosis. Outcomes (per 1000 patients per month, PkPPM) were categorized as all-cause, psychiatric, or MDD-specific and combined into composite measures. Predictors included demographics, medical and pharmacy utilization, social determinants of health, and comorbid diagnoses as well as features indicative of clinically relevant changes in psychiatric health. Models were trained on data from 1.7M individuals, with sensitivity, positive predictive value, and area-under-the-curve (AUC) derived from a validation dataset of 0.7M. Results: Event rates were 124.0 PkPPM (any outcome), 21.2 PkPPM (psychiatric utilization), and 7.6 PkPPM (suicidality). Among the composite models, the model predicting suicidality had the highest AUC (0.916) followed by any psychiatric acute care visit (0.891) and all-cause ED visit (0.790). Event-specific models all achieved an AUC >0.87, with the highest AUC noted for partial-day hospitalization (AUC = 0.938). Select predictors of all three outcomes included younger age, Medicaid insurance, past psychiatric ED visits, past suicidal ideation, and alcohol use disorder diagnoses, among others. Conclusions: Analytical models derived from clinically-relevant features identify individuals with MDD at risk for poor outcomes and can be a practical tool for health care organizations to divert high-risk populations into comprehensive care models.

Mental Health Care Provider's Perspectives Toward Adopting a Novel Technology to Improve Medication Adherence.

Objective: To understand perspectives of mental health care providers regarding barriers and drivers of adopting a medication ingestible event monitoring (IEM) system in clinical practice. Methods: Between April and October 2019, a cross-sectional, online survey was conducted among 131 prescribing clinicians and 119 non-prescribing clinicians providing care to patients with major depressive disorder, bipolar disorder, and schizophrenia. Results: Most prescribing clinicians were physicians (79.4%) while most non-prescribing clinicians (52.9%) were licensed clinical social workers, followed by counselors (30.8%), clinical psychologists (13.4%), and case managers (2.5%). Most respondents (93.2%) reported that clinicians can influence adherence, that the IEM technology was in their patients' best interest (63.6%), and a willingness to beta test the technology (54.8%). Support was positively associated with prescribing clinicians (OR: 2.2; 95% CI: 1.1, 4.5), belief that antipsychotics reduce the health, social, or financial consequences of the condition (OR: 3.8; 95% CI: 1.3, 11.0), concern for patients' well-being without monitoring (OR: 3.3; 95% CI: 1.2, 8.7), and belief the technology will enhance clinical alliance (OR: 3.1; 95% CI: 1.5, 6.3) or improve patient engagement (OR: 3.0; 95% CI: 1.5, 6.2). Support was inversely related to concerns about appropriate follow-up actions (OR: 0.4; 95% CI: 0.2, 0.9) and responsibilities (OR: 0.3; 95% CI: 0.1, 0.8) when using the technology. Conclusions: Our results suggest that IEM sensor technology adoption will depend upon additional evidence that patients will actively engage in the use of the technology, will benefit from the technology through improved outcomes, and that the additional burden placed upon providers is minimal compared to the potential benefit.

Changes in drug utilization during a gap in insurance coverage: an examination of the medicare Part D coverage gap.

BACKGROUND: Nations are struggling to expand access to essential medications while curbing rising health and drug spending. While the US government's Medicare Part D drug insurance benefit expanded elderly citizens' access to drugs, it also includes a controversial period called the "coverage gap" during which beneficiaries are fully responsible for drug costs. We examined the impact of entering the coverage gap on drug discontinuation, switching to another drug for the same indication, and drug adherence. While increased discontinuation of and adherence to essential medications is a regrettable response, increased switching to less expensive but therapeutically interchangeable medications is a positive response to minimize costs. METHODS AND FINDINGS: We followed 663,850 Medicare beneficiaries enrolled in Part D or retiree drug plans with prescription and health claims in 2006 and/or 2007 to determine who reached the gap spending threshold, n = 217,131 (33%). In multivariate Cox proportional hazards models, we compared drug discontinuation and switching rates in selected drug classes after reaching the threshold between all 1,993 who had no financial assistance during the coverage gap (exposed) versus 9,965 multivariate propensity score-matched comparators with financial assistance (unexposed). Multivariate logistic regressions compared drug adherence (≤ 80% versus >80% of days covered). Beneficiaries reached the gap spending threshold on average 222 d ±79. At the drug level, exposed beneficiaries were twice as likely to discontinue (hazard ratio [HR]  = 2.00, 95% confidence interval [CI] 1.64-2.43) but less likely to switch a drug (HR  = 0.60, 0.46-0.78) after reaching the threshold. Gap-exposed beneficiaries were slightly more likely to have reduced adherence (OR  = 1.07, 0.98-1.18). CONCLUSIONS: A lack of financial assistance after reaching the gap spending threshold was associated with a doubling in discontinuing essential medications but not switching drugs in 2006 and 2007. Blunt cost-containment features such as the coverage gap have an adverse impact on drug utilization that may conceivably affect health outcomes.

Physician perceptions about generic drugs.

BACKGROUND: With constrained health-care resources, there is a need to understand barriers to cost-effective medication use. OBJECTIVE: To study physician perceptions about generic medications. METHODS: Physicians used 5-point Likert scales to report perceptions about cost-related medication nonadherence, the efficacy and quality of generic medications, preferences for generic use, and the implications of dispensing medication samples. Descriptive statistics were used to assess physician perceptions and logistic regression models were used to evaluate predictors of physician perceptions. RESULTS: Among the invited sample, 839 (30.4%) responded and 506 (18.3%) were eligible and included in the final study population. Over 23% of physicians surveyed expressed negative perceptions about efficacy of generic drugs, almost 50% reported negative perceptions about quality of generic medications, and more than one quarter do not prefer to use generics as first-line medications for themselves or for their family. Physicians over the age of 55 years were 3.3 times more likely to report negative perceptions about generic quality, 5.8 times more likely to report that they would not use generics themselves, and 7.5 times more likely to state that they would not recommend generics for family members (p < 0.05 for all). Physicians reported that pharmaceutical company representatives are the most common (75%) source of information about market entry of a generic medication. Almost half of the respondents expressed concern that free samples may adversely affect subsequent affordability, yet two thirds of respondents provide free samples. CONCLUSIONS: A meaningful proportion of physicians expressed negative perceptions about generic medications, representing a potential barrier to generic use. Payors and policymakers trying to encourage generic use may consider educational campaigns targeting older physicians.

The epidemiology of prescriptions abandoned at the pharmacy.

BACKGROUND: Picking up prescriptions is an essential but previously unstudied component of adherence for patients who use retail pharmacies. Understanding the epidemiology and correlates of prescription abandonment may have an important effect on health care quality. OBJECTIVE: To evaluate the rates and correlates of prescription abandonment. DESIGN: Cross-sectional cohort study. SETTING: One large retail pharmacy chain and one large pharmacy benefits manager (PBM) in the United States. MEASUREMENTS: Prescriptions bottled at the retail pharmacy chain between 1 July 2008 and 30 September 2008 by patients insured by the PBM were identified. Pharmacy data were used to identify medications that were bottled and either dispensed or returned to stock (RTS) or abandoned. Data from the PBM were used to identify previous or subsequent dispensing at any pharmacy. The first (index) prescription in a class for each patient was assigned to 1 of 3 mutually exclusive outcomes: filled, RTS, or RTS with fill (in the 30 days after abandonment, the patient purchased a prescription for a medication in the same medication class at any pharmacy). Outcome rates were assessed by drug class, and generalized estimating equations were used to assess patient, neighborhood, insurance, and prescription characteristics associated with abandonment. RESULTS: 10 349 139 index prescriptions were filled by 5 249 380 patients. Overall, 3.27% of index prescriptions were abandoned; 1.77% were RTS and 1.50% were RTS with fill. Patients were least likely to abandon opiate prescriptions. Prescriptions with copayments of $40 to $50 and prescriptions costing more than $50 were 3.40 times and 4.68 times more likely, respectively, to be abandoned than prescriptions with no copayment (P < 0.001 for both comparisons). New users of medications had a 2.74 times greater probability of abandonment than prevalent users (P < 0.001), and prescriptions delivered electronically were 1.64 times more likely to be abandoned than those that were not electronic (P < 0.001). LIMITATION: The study included mainly insured patients and analyzed data collected during the summer months only. CONCLUSION: Although prescription abandonment represents a small component of medication nonadherence, the correlates to abandonment highlight important opportunities to intervene and thereby improve medication taking. PRIMARY FUNDING SOURCE: CVS Caremark.

Revealed preference for community and mail service pharmacy.

OBJECTIVE: To determine revealed pharmacy preference and predictors among patients enrolled in a pharmacy benefit that offered a 90-day supply of prescriptions via mail service and community pharmacy channels, with no differences in out-of-pocket costs. DESIGN: Retrospective cohort study. SETTING: United States in 2008-09. PATIENTS: 324,968 commercially insured participants enrolled in plans that required use of mail service pharmacy for maintenance medications. INTERVENTION: Implementation of a pharmacy benefit design with optional use of either mail service or community pharmacy for 90-day supply prescriptions. MAIN OUTCOME MEASURES: Selection rates of mail service and community pharmacy and adjusted odds ratios for predicting community pharmacy for selected characteristics. RESULTS: In the first 4 months of the benefit design, 31.8% of participants previously mandated to use mail service pharmacy elected to fill 90-day prescriptions at community pharmacies. Selection of community pharmacy ranged from a low of 23.7% (previous mail service pharmacy users) to 66.3% (previous community pharmacy users). Among those initiating therapy, 44.3% selected community pharmacy for their new prescriptions, and among those with no previous mail use, 68% selected community pharmacy for new prescriptions. Preference for community/mail service pharmacy was dependent on numerous characteristics, including age, gender, household income, region, driving distance (time), and concomitant medication use. CONCLUSION: Patient behavior indicates that certain patients prefer to access prescription medications via mail service and others through community pharmacy channels. Restrictive benefit designs that incentivize patients to use less preferable pharmacy channels may adversely affect patient convenience, which could have the unintended consequence of reducing medication use and adherence.

Are caregivers adherent to their own medications?

OBJECTIVE: To explore caregiver adherence to chronic medications and predictors of appropriate medication use. DESIGN: Descriptive, nonexperimental, cross-sectional study. SETTING: United States in May 2009. PARTICIPANTS: 2,000 adults randomly selected from a large national consumer panel. INTERVENTION: Web-based survey of community pharmacy patients. MAIN OUTCOME MEASURE: Self-reported medication adherence. RESULTS: 21% of those invited (3,775) responded to the survey invitation. Of the 2,000 individuals who were eligible to participate, 38% described themselves as caregivers. Among caregivers, 45% agreed that they were more likely to forget their own medications than medications for their caregivees. Caregivers were 10% more likely to forget to take their medications, 11% more likely to stop taking medications if they felt well, and 13% more likely to forget to refill their medications than noncare-givers (P < 0.001 for all). In fully adjusted models, caregivers had 36% greater odds (95% CI 0.52-0.79) of reporting that they were nonadherent compared with noncare-givers and increased medication use among caregivees was associated with worse adherence among caregivers (P < 0.05). CONCLUSION: Medication nonadherence was common in this population, and caregivers were more likely to report poor medication adherence than noncaregivers. Considering that caregivers often engage health professionals, physicians and pharmacists may choose to screen for caregiving status. Pharmacists are uniquely positioned to intervene to enhance appropriate medication adherence.

Prescriber Attitudes, Experiences, and Proclivities Toward Digital Medicine and How They Influence Adoption of Digital Medicine Platforms.

BACKGROUND: Psychiatric prescribers (prescribers) typically assess medication adherence by patient or caregiver self-report. Despite likely clinical benefit of a new digital medicine technology, the role of specific prescriber attitudes, behaviors, and experiences in the likelihood of adoption is unclear. OBJECTIVE: To identify prescriber characteristics that may affect adoption of the ingestible event marker (IEM) platform. DESIGN: A survey of prescribers treating seriously mentally ill patients was conducted. Factor analysis was performed on 11 items representing prescriber characteristics believed to be related to endorsement of the IEM platform. Four factors were extracted. Regression analysis was used to test the strength of the relationships between the factors and likelihood of adoption of the IEM platform. RESULTS: A total of 131 prescribers completed the survey. Most (84%) agreed that visits allow enough time to monitor adherence. Factor analysis revealed four underlying dimensions: 1) perspectives on the value of adherence; 2) concerns about measuring adherence; 3) views toward digital health technologies; and 4) views on payer role/reimbursement. Factors 1 and 3 were related to gender, the belief that computerization benefits prescribers, the presence of office support staff, and the belief that new digital medicine (DM) technology will be cost prohibitive. Willingness to adopt the IEM platform was related to gender (p < 0.05) and perspectives on the value of adherence (p < 0.05), with those scoring higher on that measure also being more likely to adopt. CONCLUSION: Psychiatric prescribers are concerned about medication adherence, perceive current monitoring tools to be problematic, and are open to using digital technologies to improve accuracy of adherence assessment. Relationships among prescriber characteristics, beliefs, and experiences should be considered when developing educational materials, particularly when the goal is to encourage adoption and use of the IEM platform.

Vasculogenic Erectile Dysfunction: The Impact of Diet and Lifestyle.

Vasculogenic erectile dysfunction has been aptly called the "canary in the coal mine" for cardiovascular disease because it almost always precedes other manifestations of atherosclerotic cardiovascular disease, including myocardial infarction and stroke. It is common, associated with the presence of modifiable cardiovascular risk factors, and impacted by diet and lifestyle choices. This concise review provides an update on the use of dietary and other lifestyle interventions to improve vasculogenic erectile dysfunction and atherosclerotic cardiovascular disease.