The COVID-19 pandemic's impact on all-cause mortality disparities in Medicare: By race, income, chronic health, mental/behavioral health, disability.

BACKGROUND: The Medicare-enrolled population is heterogeneous across race, ethnicity, age, dual eligibility, and a breadth of chronic health, mental and behavioral health, and disability-related conditions, which may be differentially impacted by the COVID-19 pandemic. OBJECTIVE: To quantify changes in all-cause mortality prior-to and in the first year of the COVID-19 pandemic across Medicare's different sociodemographic and health-condition subpopulations. METHODS: This observational, population-based study used stratified bivariate regression to investigate Medicare fee-for-service subpopulation differences in pre-pandemic (i.e., 2019 versus 2016) and pandemic-related (2020 versus 2019) changes in all-cause mortality. RESULTS: All-cause mortality in the combined Medicare-Advantage (i.e., managed care) and fee-for-service beneficiary population improved by a relative 1% in the ten years that preceded the COVID-19 pandemic, but then escalated by a relative 15.9% in 2020, the pandemic's first year. However, a closer look at Medicare's fee-for-service subpopulations reveals critical differences. All-cause mortality had actually been worsening prior to the pandemic among most psychiatric and disability-related condition groups, all race and ethnicity groups except White Non-Hispanic, and Medicare-Medicaid dual-eligible (i.e., low-income) beneficiaries. Many of these groups then experienced all-cause mortality spikes in 2020 that were over twice that of the overall Medicare fee-for-service population. Of all 61 chronic health conditions studied, beneficiaries with schizophrenia were the most adversely affected, with all-cause mortality increasing 38.4% between 2019 and 2020. CONCLUSION: This analysis reveals subpopulation differences in all-cause mortality trends, both prior to and in year-one of the COVID-19 pandemic, indicating that the events of 2020 exacerbated preexisting health-related inequities.

Transparency, health equity, and strategies in state-based protocols for remdesivir allocation and use.

BACKGROUND: The Emergency Use Authorization (EUA) of remdesivir for coronavirus disease 2019 raised questions on transparency of applied strategy, and how to equitably allocate and prioritize eligible patients given limited supply of the medication. The absence of federal oversight highlighted the critical role by states in health policymaking during a pandemic. OBJECTIVE: To identify public state-based protocols for remdesivir allocation and clinical guidance for prioritizing remdesivir use and assess approaches and inclusion of language promoting equitable access or mitigating health disparities. METHODS: We identified remdesivir allocation strategies and clinical use guidelines for all 50 states in the U.S. and the District of Columbia accessible on state health department websites or via internet searches. Public protocols dated between May 1, 2020 and September 30, 2020 were included in the study. We reviewed strategies for allocation and clinical use, including whether protocols contained explicit language on equitable access to remdesivir or mitigating health disparities. RESULTS: A total of 38 states had a remdesivir allocation strategy, with 33 states (87%) making these public. States used diverse allocation strategies, and only 10 (30%) of the 33 states included language on equitable allocation. A total of 30 states had remdesivir clinical use guidelines, where all were publicly accessible. All guidelines referenced recommendations by federal agencies but varied in their presentation format. Of the 30 states, 12 (40%) had guidelines that included language on equitable use. Neither an allocation strategy or clinical use guideline were identified (public or non-public) for 10 states and the District of Columbia during the study period. CONCLUSIONS: The experience with the remdesivir EUA presents an opportunity for federal and state governments to develop transparent protocols promoting fair and equal access to treatments for future pandemics.

Patient factors associated with oral generic olanzapine initiation and substitution among Medicaid beneficiaries: a new user cohort study.

OBJECTIVE: Generic drugs typically are less expensive than branded products; however, several factors can limit generic drug utilization. This study assesses the associations of patient factors with generic olanzapine initiation and substitution. METHODS: A retrospective new user cohort study was conducted using the 2011-2012 Medicaid administrative claims data. Beneficiaries continuously enrolled during the 6 month washout period prior to their initial oral brand or generic olanzapine prescription were included and followed up to 12 months. Among brand olanzapine new users, time to generic substitution and competing risk outcomes was estimated using the Fine-Gray cumulative incidence function. Patient demographic and health service utilization factors were assessed in the multivariate cause-specific hazards model. RESULTS: Among olanzapine new users, 70.7% patients initiated generic treatment. Beneficiaries aged ≥21, and living in the Midwest and West regions were more likely to initiate generic olanzapine. Among brand new users, 28.2% switched to generic olanzapine, 23.6% switched to an alternative atypical antipsychotic treatment and 38.0% discontinued within 12 months. Beneficiaries who resided in urban areas (adjusted hazard ratio [AHR) = 0.53, 95% CI = 0.37-0.75) and had prior hospitalizations (AHR = 0.85, 95% CI = 0.75-0.96) had lower rates of generic substitution, whereas those with emergency department (ED) visits (AHR = 1.06, 95% CI = 1.02-1.10) had a higher rate of generic substitution. In addition, beneficiaries in different age subgroups also had different rates of generic substitution in different regions. CONCLUSION: Medicaid beneficiaries' age, geographic region, prior hospitalization and ED utilization were associated with generic olanzapine initiation and substitution. Tailored educational outreach targeting these patient subgroups might improve generic olanzapine utilization.

Patient and caregiver opinions about an FDA-developed generic drug educational handout: A pilot cross-sectional survey.

OBJECTIVE: To examine patient and caregiver opinions and "receptivity" regarding generic drug educational material in terms of content, format and design, delivery channel, and level of satisfaction. METHODS: Interviewer-administered surveys were conducted with patients and caregivers who were clients of a regional medication management program or pharmacy services clinic to gather perceptions about generic drugs and input on a generic drug educational handout developed by the U.S. Food and Drug Administration (FDA). Survey questions were developed by the investigators and pretested before use. Data were analyzed using descriptive statistics, and responses to open-ended questions were assessed using qualitative content analysis. Survey psychometrics were examined using exploratory factor analysis (EFA). RESULTS: Of the 100 survey participants, most (93%) had positive perceptions about generic drug safety and effectiveness after reading the handout. Most participants were satisfied or very satisfied with the handout's content (87%) as well as format and design (92%). However, more than 20% of participants were still unsure about the benefits and risks of generic drugs compared with those of brand drugs, and more than 15% were still unsure about which benefits and risks mattered most to them. The participants' preferred source for the handout was a pharmacy (49%) or doctor's office (27%). In an EFA of the survey instrument, 2 factors emerged related to the educational handout's content: (1) generic drug information, a 7-item factor (Cronbach alpha = 0.882); and (2) personal relevance, a 3-item factor (Cronbach alpha = 0.692). CONCLUSION: The findings indicate an overall positive "receptiveness" toward generic drug informational materials from patients and caregivers, which highlights the feasibility and importance of educational outreach programs about generic drugs targeted toward this population. Future studies may focus on more diverse populations and tailor materials to the needs of specific patient and caregiver subgroups and health literacy levels.

Oral generic tacrolimus initiation and substitution in the Medicaid population: a new user cohort study.

OBJECTIVE: Although existing studies have compared clinical efficacy and pharmacokinetics of generic with brand tacrolimus, little is known about generic tacrolimus utilization patterns or factors predicting generic substitution. This study examines associations between patient-level factors and generic tacrolimus initiation or substitution among new users of oral generic or brand-name tacrolimus. METHODS: This new user retrospective cohort study identified 374 beneficiaries who initiated generic or brand tacrolimus treatment, using 100% Medicaid administrative claims data from 11 states in 2011-2012. Outcomes were generic tacrolimus initiation and substitution within 12 months of treatment initiation. Multivariable logistic regression and Cox proportional hazards models were used to identify factors associated with generic tacrolimus initiation and substitution. RESULTS: Two-thirds of oral tacrolimus new users initiated generic tacrolimus. Patients who were older age and black were significantly more likely to initiate generic tacrolimus (adjusted odds ratio [AOR] = 1.02, 95% confidence interval [CI] = 1.001-1.03; AOR = 2.54, 95% CI = 1.40-4.62; respectively). Patients with more concomitant prescriptions, more comorbidities, or higher initial daily dosage had significantly lower likelihoods of initiating generic tacrolimus (AOR = 0.93, 95% CI = 0.87-0.99; AOR = 0.87, 95% CI = 0.77-0.99; AOR = 0.96, 95% CI = 0.93-0.993). Among brand tacrolimus new users, 23.6% substituted with generics within 12 months, and an addition of prior hospitalization or unit of initial daily dosage increment was associated with 35% (subdistribution hazard ratio [SHR] = 1.35, 95% CI = 1.02-1.76) or 2% (SHR = 1.02, 95% CI = 1.00-1.04) increase in likelihood of generic substitution, respectively. CONCLUSIONS: Understanding associations between patient-level factors with generic tacrolimus initiation and substitution could help practitioners and policymakers monitor treatment effect and facilitate generic tacrolimus utilization.

Generic escitalopram initiation and substitution among Medicare beneficiaries: A new user cohort study.

OBJECTIVES: To examine patterns of generic escitalopram initiation and substitution among Medicare beneficiaries. METHODS: This retrospective new user cohort used a 5% random sample of 2013-2015 Medicare administrative claims data. Fee-for-service Medicare beneficiaries continuously enrolled in Parts A, B, and D during a 6-month washout period prior to their initial generic or brand oral escitalopram prescriptions were included (n = 12,351). The primary outcomes were generic escitalopram treatment initiation, and among brand escitalopram initiators, generic substitution within 12 months. Patient demographics, health service utilization, and prescription level factors were measured and assessed. RESULTS: Among all escitalopram initiators, about 88.2% Medicare beneficiaries initiated generic escitalopram. Beneficiaries who were younger age, male, residing in non-Northeast regions or urban area, in the Part D plan deductible benefit phase, and filling prescriptions at community/retail pharmacies were more likely to initiate generic treatment. Among brand escitalopram initiators (n = 1,464), about 20.7% switched to generic escitalopram, 31.2% switched to another alternative antidepressant, 25.1% discontinued treatment, and 8.7% were lost to follow up or passed away within 12 months after brand initiation. Factors associated with generic escitalopram substitution included region (Midwest vs. Northeast, adjusted hazard ratio (HR) = 1.46, 95% CI = 1.04-2.05), pre-index hospitalization (HR = 1.31; 95% CI = 1.16-1.48) and lower escitalopram average daily dosage (HR = 0.97; 95% CI = 0.95-0.99). CONCLUSIONS: In 2013-2015, almost 90% Medicare beneficiaries initiated generic escitalopram treatment. Among brand escitalopram initiators, about 1 in 5 patients switched to generic escitalopram within 1 year, as compared to 1 in 4 or 1 in 3 who discontinued current or switched to alternative treatment, respectively. Medicare beneficiary's geographic region was independently associated with generic escitalopram initiation and substitution. Findings from this study not only provide up-to-date evidence in generic escitalopram use patterns among Medicare population, but also can guide educational and practice interventions to further increase generic escitalopram use.

Association of Formulary Exclusions and Restrictions for Opioid Alternatives With Opioid Prescribing Among Medicare Beneficiaries.

Importance: Although there are many pharmacologic alternatives to opioids, it is unclear whether the structure of Medicare Part D formularies discourages use of the alternatives. Objectives: To quantify the coverage of opioid alternatives and prevalence of prior authorization, step therapy, quantity limits, and tier placement for these drugs, and test whether these formulary exclusions and restrictions are associated with increased opioid prescribing to older adults at the county level. Design, Setting, and Participants: County fixed-effect models were estimated using a panel of counties across the 50 US states and the District of Columbia over calendar years 2015 and 2016. Data analysis was conducted from July 1 to September 23, 2019. The sample included 2721 counties in 2015 and 2671 counties in 2016 with sufficient data on Medicare Part D formulary design and opioid prescribing. Main Outcomes and Measures: County-level opioid prescribing rate (number of opioid claims divided by the number of overall claims) and counts of excluded opioid alternatives and opioid alternatives with prior authorization, step therapy, quantity limits, and high-tier placements. Results: A total of 30 nonopioid analgesics were examined across 28 997 Medicare plans in 2015 and 30 390 plans in 2016. Medicare plans did not cover a mean of 7% of these drugs (interquartile range, 10%; lower to upper limit, 0%-23%). Among covered nonopioids, prior authorization and step therapy were uncommon, with fewer than 5% affected by prior authorization and 0% by step therapy. However, 13% of covered nonopioids had quantity limits (interquartile range, 10%; lower to upper limit, 0%-31%) and 22% were in high-cost tiers (interquartile range, 38%; lower to upper limit, 0%-50%). Increases in the number of nonopioids excluded on Medicare plans in a county were associated with increased opioid prescribing (effect size relative to mean, 2.2%-3.7%; P = .004). Conversely, increases in the number of opioids not covered on Medicare plans in a county was found to be associated with decreased opioid prescribing (effect size relative to mean, 0.8%-1.5%; P = .02). None of the utilization management strategies (prior authorization, step therapy, and quantity limits) examined or high-cost tier placements of nonopioids were associated with increased opioid prescribing. Conclusions and Relevance: Lack of Medicare coverage for pharmacologic alternatives to opioids may be associated with increased opioid prescribing.

Generic levothyroxine initiation and substitution among Medicare and Medicaid populations: a new user cohort study.

PURPOSE: Generic levothyroxine has been approved and available since 2004 but its substitution remains controversial. Therefore, the objective was to examine patterns of and identify factors associated with initiation and substitution of generic levothyroxine treatment. METHODS: This was a retrospective observational study, including new users of brand and generic levothyroxine in 2013-2015 Medicare (n = 15,877) or 2011-2012 Medicaid (n = 9390) administrative claim databases. The primary outcomes included (1) generic levothyroxine initiation, and (2) among brand-new users, generic levothyroxine substitution in 12 months. The factors associated with generic levothyroxine initiation and substitution were measured. RESULTS: Among all levothyroxine new users, Medicare beneficiaries had a higher proportion of generic levothyroxine initiation than Medicaid beneficiaries (66.40% vs. 44.04%, respectively). Medicare beneficiaries' demographic factors, and health service utilizations were associated with generic levothyroxine initiation. Medicaid beneficiaries who were male and residing in the northeast region and rural areas were more likely to initiate generic levothyroxine. Among brand levothyroxine new users, the generic substitution rate was higher in the Medicare than the Medicaid cohort (18.26 vs. 3.88%). Medicare brand levothyroxine new users' demographic factors and health service utilizations were associated with generic levothyroxine substitution. Medicaid brand levothyroxine new users who were residing in the northeast region, with more prior hospitalization, and initiating a lower dosage of brand levothyroxine, had higher rates of generic substitution. CONCLUSION: Patient demographic factors and health service utilizations are associated with generic levothyroxine initiation and substitution. Educational outreach programs targeted to increase generic levothyroxine use and prescription savings should be tailored based on different patient populations.

Healthcare provider opinions about a generic drug educational newsletter.

BACKGROUND: Increasing the prescribing and dispensing of generic drugs, compared to branded drugs, may increase patient access to affordable drug treatments. Healthcare providers have information needs regarding generic drugs, but available, tailored education materials designed for provider use are lacking. OBJECTIVES: To examine healthcare provider opinions and receptivity regarding generic drug educational materials in content, format and design, delivery channel, and level of satisfaction. METHODS: A national online survey was conducted in summer 2018 to gather practicing healthcare prescribers' (i.e., physicians, nurse practitioners, physician assistants) and pharmacists' opinions on an educational newsletter developed through a collaboration between the investigators and the U.S. Food and Drug Administration (FDA). Survey data were analyzed using descriptive statistics. Quantitative analyses were performed using SPSS version 24 (IBM, Armonk, NY), while responses to open-ended questions were assessed using qualitative content analysis in Excel. RESULTS: A total of 208 surveys were completed. Overall, participants expressed positive opinions about the newsletter's content and format/design. About 69% of prescribers and 60% of pharmacists stated the newsletter gave information that will help them better serve patients. While 15% of surveyed pharmacists stated that they did not have resources to help them get information on generic drug availability and cost, more prescribers (37%) responded similarly. Both prescribers and pharmacists preferred to receive this newsletter via email from the FDA or a professional association. CONCLUSIONS: Findings indicate the feasibility of educational outreach programs about generic drugs targeted towards healthcare providers. There is room for improvement in making prescribers and pharmacists aware of resources for learning about generic drug availability and cost. Future studies may test alternate versions of the newsletter that have been tailored to the needs of specific provider specialties or provider practices serving specific patient sub-groups, as well as preferred dissemination frequency.

Communicating benefits and risks of generic drugs to consumers: Patient and caregiver opinions of two FDA-developed educational materials.

BACKGROUND: Increasing prescribing and dispensing of generic drugs, compared to brand drugs, may increase patient access to affordable medications. However, little is known about patients' and caregivers' needs and receptiveness regarding the design of educational materials about generic drugs. METHODS: The research used focus groups of patients and caregivers who were students or employees of one university in the Southeastern U.S. to gather input on the optimal content, format and design, delivery channel, and level of satisfaction for two existing, FDA-developed educational materials about generic drugs (infographic and brochure). RESULTS: Participants stated a need for the materials to modernize their graphics, emphasize generic drug cost-savings for consumers, reduce scare tactics when discussing adverse events, and be disseminated directly from physician's offices and pharmacies. Despite an overall positive impression of the materials, participants wanted more consumer-oriented materials that were tailored to fit the needs of different types of patients/caregivers, including older adults. CONCLUSIONS: This paper discusses how these findings relate to theories of multimedia learning and guidelines for designing health educational materials, as well as implications for the development of tailored generic drug educational materials for use in public health campaigns to improve access to medication therapy.

Association between Higher Generic Drug Use and Medicare Part D Star Ratings: An Observational Analysis.

BACKGROUND: Increasing generic drug use, due to potential for cost savings and drug access, is a viable consideration for Medicare prescription drug plans to achieve high star ratings and improve quality of plan offerings for Medicare beneficiaries. OBJECTIVE: To examine the association between contract-level proportion of generic drugs dispensed (pGDD) and Medicare Part D star ratings. METHODS: This was a retrospective study of linked 2011 Medicare Part D star rating data with contract-level pGDD data. A total of 477 individual Medicare prescription contracts were included, representing 75% of total Prescription Drug Plans and more than 65% of total Medicare Advantage Prescription Drug Plans available by the end of 2010. Primary outcomes were Medicare Part D summary and domain star ratings (1-5 indicating lowest to highest performance), incorporating a range of quality measures for access, cost, beneficiary satisfaction, and health services outcomes and processes. Ordinal logistic regression models were used to examine associations between pGDD and Medicare Part D summary and domain star ratings, controlling for contract type and number of beneficiary enrollment. RESULTS: Higher pGDD was associated with higher summary star ratings (adjusted odds ratio 1.08 with 95% confidence interval 1.04-1.12) and higher "member experience with drug plan" domain ratings (adjusted odds ratio 1.07 with 95% confidence interval 1.03-1.11). CONCLUSIONS: Prescription formulary benefit design targeting increasing generic drug use appears to be associated with improved member experience and higher plan star ratings. Consideration may be given to incorporating pGDD into Medicare Part D star rating measures to improve quality of prescription plans.

The Association Between Patient Sociodemographic Characteristics and Generic Drug Use: A Systematic Review and Meta-analysis.

BACKGROUND: Generic drugs are bioequivalent and cost-effective alternatives to brand drugs. In 2014, $254 billion was saved because of the use of generic drugs in the United States. OBJECTIVE: To critically assess evidence on the association between patient characteristics and generic drug use in order to inform the development of educational outreach for improving generic drug use among patients. METHODS: We systematically searched the literature between January 2005 and December 2016 using PubMed, Web of Science, Ovid MEDLINE, Google Scholar, and EBSCO IPA-MEDLINE for potentially relevant studies. The titles and abstracts of identified articles were assessed independently by 2 reviewers. Titles and abstracts that were not written in English, were published before 2005, were not empirical, did not contain sociodemographic data, or were not policy or methodologically relevant to generic drug use were excluded. Data were pooled in a meta-analysis using the RStudio software to assess the association of patient-related factors with generic drug use. RESULTS: Our searches resulted in 11 articles on patient-level factors, and 6 of these articles had sufficient information to conduct meta-analyses in the domains of patients' gender, age, race/ethnicity, and income. Quantitative analysis indicated that no differences in generic drug use existed between subgroups of patients defined by gender, age, or race/ethnicity. However, patients with lower income (i.e., < 200% federal poverty level [FPL]) were more likely to use generic drugs than those with higher income (≥ 200% FPL; pooled OR = 1.32, 95% CI = 1.15-1.52). Heterogeneity was high (I 2 > 75%) for all analyses but income. CONCLUSIONS: Patients with lower income were more likely to use generic drugs, whereas evidence was heterogeneous regarding an association between generic drug use and gender, age, or race/ethnicity. Educational outreach targeting patients with higher incomes to understand their perspectives in generic drugs may help improve generic drug use within that population. DISCLOSURES: Funding for this study was made possible, in part, by the U.S. Food and Drug Administration through grant U01FD005486. Hansen has provided expert testimony for Daiichi Sankyo. No other authors have declared a potential conflict of interest. Views expressed in written materials or publications and by speakers do not necessarily reflect the official policies of the U.S. Department of Health and Human Services, nor does any mention of trade names, commercial practices, or organization imply endorsement by the U.S. government. Study concept and design were contributed by Howard, Harris, Kiptanui, Hansen, and Qian. Frank, Mishuk, Howard, Harris, and Kiptanui collected the data, and data interpretation was performed by Mishuk and Hansen, along with Qian, Harris, and Kiptanui. The manuscript was written and revised primarily by Mishuk, along with Qian and Hansen.

Maryland Multipayor Patient-centered Medical Home Program: A 4-Year Quasiexperimental Evaluation of Quality, Utilization, Patient Satisfaction, and Provider Perceptions.

OBJECTIVE: To evaluate impact of the Maryland Multipayor Patient-centered Medical Home Program (MMPP) on: (1) quality, utilization, and costs of care; (2) beneficiaries' experiences and satisfaction with care; and (3) perceptions of providers. DESIGN: 4-year quasiexperimental design with a difference-in-differences analytic approach to compare changes in outcomes between MMPP practices and propensity score-matched comparisons; pre-post design for patient-reported outcomes among MMPP beneficiaries. SUBJECTS: Beneficiaries (Medicaid-insured and privately insured) and providers in 52 MMPP practices and 104 matched comparisons in Maryland. INTERVENTION: Participating practices received unconditional financial support and coaching to facilitate functioning as medical homes, membership in a learning collaborative to promote education and dissemination of best practices, and performance-based payments. MEASURES: Sixteen quality, 20 utilization, and 13 cost measures from administrative data; patient-reported outcomes on care delivery, trust in provider, access to care, and chronic illness management; and provider perceptions of team operation, team culture, satisfaction with care provided, and patient-centered medical home transformation. RESULTS: The MMPP had mixed impact on site-level quality and utilization measures. Participation was significantly associated with lower inpatient and outpatient payments in the first year among privately insured beneficiaries, and for the entire duration among Medicaid beneficiaries. There was indication that MMPP practices shifted responsibility for certain administrative tasks from clinicians to medical assistants or care managers. The program had limited effect on measures of patient satisfaction (although response rates were low) and on provider perceptions. CONCLUSIONS: The MMPP demonstrated mixed results of its impact and indicated differential program effects for privately insured and Medicaid beneficiaries.

Influencers of generic drug utilization: A systematic review.

INTRODUCTION: With an increase in prescription drug spending and rising drug costs there is a need to encourage the use of generic prescription drugs. However, maximizing generic drug use is not possible without the public's positive perception and meeting their informational needs about generic drugs. Thus, improving the public's confidence in, and knowledge of generic drugs on the market is critical. The objective of this systematic review is to examine and evaluate the studies focusing on the nature and extent of key factors influencing generic drug use in the United States in order to help guide policy, education and practice interventions. MATERIALS AND METHODS: Using multiple search engines and key word screening criteria, empirical studies published in English between January 1, 2005 and December 31, 2015 were identified. A qualitative synthesis of the evidence identified domains of key factors that influenced generic drug use across studies. RESULTS: Over 3000 citations met the key word screening criteria; 67 of these met inclusion criteria for the systematic review. Seven domains of factors that influence generic drug utilization were identified: 1) patient-related factors, 2) formulary management or cost containment, 3) healthcare policies, 4) promotional activities, 5) educational initiatives, 6) technology, and 7) physician-related factors. CONCLUSION: Patients, physicians, pharmacists, formulary managers, and policymakers play an important role in generic drug use. Understanding the factors influencing generic drug use can help guide future policy, education, and practice interventions to increase generic drug use.

Assessing Physician and Patient Perceptions of Generic Drugs via Facebook: A Feasibility Study.

Background: Social media offer a novel avenue to engage with and recruit research participants. Facebook in particular is a promising option given its popularity and widespread use. Objective: To explore the feasibility of using Facebook to recruit physicians and patients to participate in a survey to assess their perceptions about generic venlafaxine extended release (ER) tablet indicated for depression. Methods: Web-based surveys were developed to gauge physicians' prescribing experiences with and patients' perceptions of generic venlafaxine ER tablet. The surveys included questions specific to venlafaxine ER tablets, such as perceived safety and efficacy of the drug and overall comfort level with either prescribing or taking the drug. Survey links were then posted and advertised on Facebook to recruit physicians and patients. Results: Advertisement for physicians reached 1898 Facebook users and advertisement for patients reached 1144 users during a 10-day advertising period. However, only 14 and 35 users clicked on the survey for physicians and patients, respectively. No physician completed the physician survey while 3 patients completed the patient survey. Conclusions: The findings of this study suggest that Facebook may not be an effective method to recruit physicians. Facebook holds promise to recruit patients, but additional recruitment efforts, such as incentives, are needed.

Disclosure of industry payments to prescribers: industry payments might be a factor impacting generic drug prescribing.

PURPOSE: Pharmaceutical companies paid at least $3.91bn to prescribers in 2013, yet evidence indicating whether industry payments shift prescribing away from generics is limited. This study examined the association between amount of industry payments to prescribers and generic drug prescribing rates among Medicare Part D prescribers. METHODS: A cross-sectional analysis was conducted among 770 095 Medicare Part D prescribers after linking the 2013 national Open Payments data with 2013 Medicare Provider Utilization and Payment data. The exposure variable was the categorized amount of total industry payments to prescribers (i.e., meals, travel, research, and ownership). The outcome was prescriber's annual generic drug prescribing rate. Multivariable generalized linear regression models were used to examine the association between the amount of industry payments and prescriber's annual generic drug prescribing rates, controlling for prescriber's demographic and practice characteristics. RESULTS: In this sample, over one-third (38.0%) of Medicare Part D prescribers received industry payments in 2013. The mean annual generic drug prescribing rate was highest among prescribers receiving no payments and lowest among those receiving more than $500 of industry payments (77.5% vs. 71.3%, respectively; p < 0.001). The receipt of industry payments was independently associated with prescribers' generic drug prescribing rate; higher payments corresponded with lower generic drug prescribing rates. Other prescriber characteristics associated with higher annual generic drug prescribing rate included male sex, non-northeast region, specialty, and patient volume. CONCLUSIONS: Receipt of industry payments was associated with a decreased rate of generic drug prescribing. How this affects patient care and total medical costs warrants further study. Copyright © 2017 John Wiley & Sons, Ltd.

Depression among older adults after traumatic brain injury: a national analysis.

OBJECTIVE: Sequelae of traumatic brain injury (TBI) include depression, which could exacerbate the poorer cognitive and functional recovery experienced by older adults. The objective of this study was to estimate incidence rates of depression after hospital discharge for TBI among Medicare beneficiaries aged at least 65 years, quantify the increase in risk of depression after TBI, and evaluate risk factors for incident depression post-TBI. METHODS: Using a retrospective analysis, the authors studied Medicare beneficiaries at least 65 years old hospitalized for TBI during 2006 to 2010 who survived to hospital discharge and had no documented diagnosis of depression before the study period (N = 67,347). RESULTS: The annualized incidence rate of depression per 1,000 beneficiaries was 62.8 (95% confidence interval [CI]: 61.6, 64.1) pre-TBI and 123.9 (95% CI: 121.6, 126.2) post-TBI. Annualized incidence rates were highest immediately after hospital discharge and declined over the 12 months post-TBI. TBI increased the risk of incident depression in men (hazard ratio: 1.95; 95% CI: 1.84, 2.06; Wald χ(2) = 511.4, df = 1, p <0.001) and in women (hazard ratio: 1.69; 95% CI: 1.62, 1.77; Wald χ(2) = 589.3, df = 1, p <0.001). The strongest predictor of depression post-TBI for both men and women was discharge to a skilled nursing facility (men: odds ratio, 1.91; 95% CI, 1.77, 2.06; Wald χ(2) = 277.1, df = 1, p <0.001; women: odds ratio, 1.72; 95% CI, 1.63, 1.83; Wald χ(2) = 324.2, df = 1, p <0.001). CONCLUSION: TBI significantly increased the risk of depression among older adults, especially among men and those discharged to a skilled nursing facility. Results from this study will help increase awareness of the risk of depression post-TBI among older adults.

Patterns of Depression Treatment in Medicare Beneficiaries with Depression after Traumatic Brain Injury.

There are no clinical guidelines addressing the management of depression after traumatic brain injury (TBI). The objectives of this study were to (1) describe depression treatment patterns among Medicare beneficiaries with a diagnosis of depression post-TBI; (2) compare them with depression treatment patterns among beneficiaries with a diagnosis of depression pre-TBI; and (3) quantify the difference in prevalence of use. We conducted a retrospective analysis of Medicare beneficiaries hospitalized with TBI during 2006-2010. We created two cohorts: beneficiaries with a new diagnosis of depression pre-TBI (n=4841) and beneficiaries with a new diagnosis of depression post-TBI (n=4668). We searched for antidepressant medications in Medicare Part D drug event files and created variables indicating antidepressant use in each 30-day period after diagnosis of depression. We used provider specialty and current procedural terminology to identify psychotherapy in any location. We used generalized estimating equations to quantify the effect of TBI on receipt of depression treatment during the year after diagnosis of depression. Average monthly prevalence of antidepressant use was 42% among beneficiaries with a diagnosis of depression pre-TBI and 36% among those with a diagnosis post-TBI (p<0.001). Beneficiaries with a diagnosis of depression post-TBI were less likely to receive antidepressants compared with a depression diagnosis pre-TBI (adjusted odds ratio [OR] 0.87; 95% confidence interval [CI] 0.82, 0.92). There was no difference in receipt of psychotherapy between the two groups (OR 1.08; 95% CI 0.93, 1.26). Depression after TBI is undertreated among older adults. Knowledge about reasons for this disparity and its long-term effects on post-TBI outcomes is limited and should be examined in future work.

A Systematic Review of the Benefits and Risks of Anticoagulation Following Traumatic Brain Injury.

OBJECTIVE: To synthesize the existing literature on benefits and risks of anticoagulant use after traumatic brain injury (TBI). DESIGN: Systematic review. A literature search was performed in MEDLINE, International Pharmaceutical Abstracts, Health Star, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) on October 11, 2012, and updated on September 2, 2013, using terms related to TBI and anticoagulants. MAIN MEASURES: Human studies evaluating the effects of post-TBI anticoagulation on venous thromboembolism, hemorrhage, mortality, or coagulation parameters with original analyses were eligible for the review. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline was followed throughout the conduct of the review. RESULTS: Thirty-nine eligible studies were identified from the literature, of which 23 studies with complete information on post-TBI anticoagulant use and patient outcomes were summarized in this review. Meta-analysis was unwarranted because of varying methodological design and quality of the studies. Twenty-one studies focused on the effects of pharmacological thromboprophylaxis (PTP) post-TBI on venous thromboembolism and/or progression of intracranial hemorrhage, whereas 2 randomized controlled trials analyzed coagulation parameters as the result of anticoagulation. CONCLUSION: Pharmacological thromboprophylaxis appears to be safe among TBI patients with stabilized hemorrhagic patterns. More evidence is needed regarding effectiveness of PTP in preventing venous thromboembolism as well as preferred agent, dose, and timing for PTP.