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1.
Am J Alzheimers Dis Other Demen ; 35: 1533317520922380, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32383387

RESUMO

OBJECTIVE: To identify characteristics associated with an increased risk of cardiovascular events in patients diagnosed with Alzheimer disease (AD) and treated with antidementia medications. METHODS: Demographics, diagnoses, and medication usage of 30 433 Medicare patients were analyzed using 2006 to 2013 claims data and a combined model of screening, ranking and stepwise logistic regressions to evaluate factors associated with composite outcomes of 6 cardiovascular events. RESULTS: Incidence rate of at least 1 cardiovascular event was 25.1%. Fifty-five factors were identified from the 10 381 candidate variables by the combined model with a c-statistic of 67% and an accuracy of 75%. Factors associated with increased risk of cardiovascular events include history of heart rhythm disorders, alteration of consciousness (odds ratio [OR]: 1.25; 95% confidence interval [CI]: 1.14-1.36), and usage of ß-blockers (OR: 1.19; 95% CI: 1.13-1.27). CONCLUSIONS: Clinicians should consider the increased risk of cardiovascular events in patients with AD with heart rhythm disorders and on ß-blockers.

2.
Am J Cardiol ; 2020 Apr 10.
Artigo em Inglês | MEDLINE | ID: mdl-32359718

RESUMO

It remains unknown whether the comparative effectiveness of direct oral anticoagulants (DOACs) and warfarin differs between atrial fibrillation patients with and without a history of stroke or transient ischemic attack (TIA). Using 2012 to 2014 Medicare claims data, we identified patients newly diagnosed with AF in 2013 to 2014 who initiated apixaban, dabigatran, rivaroxaban, or warfarin. We categorized patients based on a history of stroke or TIA. We constructed Cox proportional hazard models that included indicator variables for treatment groups, a history of stroke or TIA, and the interaction between them, and controlled for demographics and clinical characteristics. DOACs were generally more effective than warfarin in stroke prevention; however, there were important differences between subgroups defined by a history of ischemic stroke. In particular, the superiority of dabigatran compared with warfarin in ischemic stroke prevention was more pronounced in patients with a history of stroke or TIA (hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.48 to 0.85) than in patients with no history of stroke or TIA (HR 0.94; 95% CI 0.75 to 1.16; p value for interaction = 0.034). There was no difference in the risk of stroke between apixaban, dabigatran, and rivaroxaban in patients with no history of stroke or TIA. However, in patients with a history of stroke or TIA, the risk of stroke was lower with dabigatran (HR 0.64; 95% CI 0.48 to 0.85) and rivaroxaban (HR 0.70; 95% CI 0.56 to 0.87), compared with apixaban (p value for both interactions <0.05). In conclusion, the comparative effectiveness of DOACs differs substantially between patients with and without a history of stroke or TIA; specifically, apixaban is less effective in patients with a history of stroke or TIA.

3.
JAMA ; 323(9): 854-862, 2020 03 03.
Artigo em Inglês | MEDLINE | ID: mdl-32125403

RESUMO

Importance: Most studies that have examined drug prices have focused on list prices, without accounting for manufacturer rebates and other discounts, which have substantially increased in the last decade. Objective: To describe changes in list prices, net prices, and discounts for branded pharmaceutical products for which US sales are reported by publicly traded companies, and to determine the extent to which list price increases were offset by increases in discounts. Design, Setting, and Participants: Retrospective descriptive study using 2007-2018 pricing data from the investment firm SSR Health for branded products available before January 2007 with US sales reported by publicly traded companies (n = 602 drugs). Net prices were estimated by compiling company-reported sales for each product and number of units sold in the US. Exposures: Calendar year. Main Outcomes and Measures: Outcomes included list and net prices and discounts in Medicaid and other payers. List prices represent manufacturers' price to wholesalers or direct purchasers but do not account for discounts. Net prices represent revenue per unit of the product after all manufacturer concessions are accounted for (including rebates, coupon cards, and any other discount). Means of outcomes were calculated each year for the overall sample and 6 therapeutic classes, weighting each product by utilization and adjusting for inflation. Results: From 2007 to 2018, list prices increased by 159% (95% CI, 137%-181%), or 9.1% per year, while net prices increased by 60% (95% CI, 36%-84%), or 4.5% per year, with stable net prices between 2015 and 2018. Discounts increased from 40% to 76% in Medicaid and from 23% to 51% for other payers. Increases in discounts offset 62% of list price increases. There was large variability across classes. Multiple sclerosis treatments (n = 4) had the greatest increases in list (439%) and net (157%) prices. List prices of lipid-lowering agents (n = 11) increased by 278% and net prices by 95%. List prices of tumor necrosis factor inhibitors (n = 3) increased by 166% and net prices by 73%. List prices of insulins (n = 7) increased by 262%, and net prices by 51%. List prices of noninsulin antidiabetic agents (n = 10) increased by 165%, and net prices decreased by 1%. List price increases were lowest (59%) for antineoplastic agents (n = 44), but discounts only offset 41% of list price increases, leading to 35% increase in net prices. Conclusions and Relevance: In this analysis of branded drugs in the US from 2007 to 2018, mean increases in list and net prices were substantial, although discounts offset an estimated 62% of list price increases with substantial variation across classes.


Assuntos
Custos de Medicamentos/tendências , Honorários Farmacêuticos/tendências , Custos e Análise de Custo , Honorários Farmacêuticos/legislação & jurisprudência , Medicaid/economia , Estudos Retrospectivos , Estados Unidos
6.
JAMA Netw Open ; 3(2): e1921357, 2020 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-32074287

RESUMO

Importance: Less than half of US patients with a diagnosis of atrial fibrillation (AF) receive oral anticoagulation. Objectives: To identify patients with similar patterns of adherence to regimens of warfarin and direct oral anticoagulants (DOACs) in the first year after AF diagnosis and to evaluate associations between patient characteristics and membership in latent classes of adherence. Design, Setting, and Participants: This retrospective cohort study used 2013 to 2016 Medicare claims data to identify 7491 patients with a new diagnosis of AF in 2014 to 2015 who initiated warfarin after AF diagnosis and 9478 patients with a new diagnosis of AF in 2014 to 2015 who initiated DOAC treatment after AF diagnosis, for a total of 16 969 Medicare beneficiaries. Participants were followed up for 12 months after AF diagnosis. Statistical analysis was performed from February 1 to November 30, 2018. Exposures: Treatment with warfarin or DOAC after AF diagnosis. Main Outcomes and Measures: The main outcome was the proportion of days that patients received warfarin or DOAC, measured in 30-day intervals after AF diagnosis. Independent variables included patient demographic characteristics, socioeconomic status, region of residence, and clinical characteristics. Latent class mixed models were used to identify latent classes of warfarin and DOAC adherence, and polytomous logistic regression was used to assess the association between patient characteristics and membership in each latent class. Results: Among the 7491 patients receiving warfarin (4348 women), the mean (SD) age was 76.0 (10.0) years; among the 9478 patients receiving DOAC (5496 women), the mean (SD) age was 77.0 (8.5) years. Four latent classes of patients were identified based on warfarin adherence: late initiators (980 [13%]), early initiators who discontinued therapy at months 1 to 3 (1297 [17%]) or at months 5 to 10 (735 [10%]), and continuously adherent patients (4479 [60%]). Four latent classes of patients were also identified based on DOAC adherence: patients who initiated DOAC in months 1 to 5 (1368 [14%]) or months 6 to 11 (800 [8%]), patients with suboptimal and decreasing adherence (2267 [24%]), and continuously adherent patients (5043 [53%]). Membership in latent classes of warfarin adherence was significantly associated with sex, eligibility for Medicaid and income subsidy, region of residence, CHA2DS2-VASc (cardiac failure or dysfunction, hypertension, age 65-74 [1 point] or ≥75 years [2 points], diabetes, and stroke, transient ischemic attack or thromboembolism [2 points]-vascular disease, and sex category [female]) risk score, and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile international normalized ratio, elderly, and drugs or alcohol) score. Membership in latent classes of DOAC adherence was significantly associated with race/ethnicity, region of residence, HAS-BLED score, and use of antiarrhythmic medications. Conclusions and Relevance: This study found that, among patients who initiated anticoagulation therapy, 40% of those who initiated warfarin therapy and 47% of those who initiated DOAC treatment did not continuously adhere to therapy in the first year after AF diagnosis. Identifying longitudinal patterns of warfarin and DOAC adherence and the factors associated with them provides suggestions for the design of targeted strategies to mitigate suboptimal oral anticoagulation use.

7.
J Natl Med Assoc ; 112(1): 103-108, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32035755

RESUMO

BACKGROUND: Atrial fibrillation (AF) is the most common heart rhythm disorder and is associated with a 5-fold increased risk of ischemic stroke. Racial/ethnic minorities and women with AF have higher rates of stroke compared to white individuals and men respectively. Oral anticoagulation reduces the risk of stroke, yet prior research has described racial/ethnic and sex-based variation in its use. We sought to examine the initiation of any oral anticoagulant (warfarin or direct-acting oral anticoagulants, DOACs) by race/ethnicity and sex in patients with incident, non-valvular AF. Further in those who initiated any anticoagulant, we examined DOAC vs. warfarin initiation by race/ethnicity and sex. METHODS: We used claims data from a 5% sample of Medicare beneficiaries to identify patients with incident AF from 2012 to 2014, excluding those without continuous Medicare enrollment. We used logistic regression to assess the association between race/ethnicity (white, black, Hispanic), sex, and oral anticoagulant initiation (any, warfarin vs. DOAC), adjusting for sociodemographics, medical comorbidities, stroke and bleeding risk. RESULTS: The cohort of 42,952 patients with AF included 17,935 women, 3282 blacks, and 1958 Hispanics. Overall OAC initiation was low (49.2% whites, 48.1% blacks, 47.5% Hispanics, 48.1% men, and 51.5% women). After adjusting, blacks (odds ratio (OR) 0.84; 95% CI, 0.78-0.91) were less likely than whites to initiate any oral anticoagulant with no difference observed between Hispanics and whites (OR 0.92; 95% CI, 0.83-1.01). Women were less likely than men to initiate any oral anticoagulant, OR 0.59 (95% CI 0.55-0.64). Among initiators of oral anticoagulation, DOAC use was low (35.8% whites, 29.3% blacks, 40.0% Hispanics, 41.6% men, and 42.4% women). After adjusting, blacks were less likely to initiate DOACs than whites, OR 0.75 (95% CI 0.66-0.85); the odds of DOAC initiation did not differ between Hispanic and white patients or between men and women. CONCLUSION: In a national cohort of Medicare beneficiaries with newly-diagnosed AF, overall oral anticoagulant initiation was lower in blacks and women, with no difference observed by Hispanic ethnicity. Among oral anticoagulant initiators, blacks were less likely to initiate novel DOACs, with no differences identified by Hispanic ethnicity or sex. Identifying modifiable causes of treatment disparities is needed to improve quality of care for all patients with AF.

8.
J Manag Care Spec Pharm ; 26(2): 154-159, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32011961

RESUMO

BACKGROUND: Statutory rebates and preferred drug lists (PDLs) may result in differential use of biosimilars and generics between Medicaid fee-for-service (FFS) and managed care organizations (MCOs), particularly for branded drugs with large price increases subject to large inflation rebates, which are not retained by MCOs. OBJECTIVE: To compare the use of 2 biosimilar/generics of branded drugs whose list price tripled in 2008-2018 across states with only FFS Medicaid, with MCOs not subject to statewide PDLs, with MCOs subject to statewide PDLs, and with MCOs where drug benefits have been carved out. METHODS: Using 2018 Medicaid drug utilization data, we extracted reimbursement records in Q1-Q3 2018 for insulin glargine 100 IU/mL and glatiramer. We calculated the market share of the biosimilar insulin glargine and generic glatiramer among the corresponding drugs. We compared the market share of these products across 4 state groups: states with only FFS Medicaid, states with MCOs not subject to statewide PDLs for each drug, states with MCOs subject to PDLs, and states with MCOs where drug benefits have been carved out into FFS. We evaluated the correlation between state-level penetration of MCOs and share of biosimilar/generic products. RESULTS: Nationally, the market share of these biosimilar/specialty generics was higher among MCOs than FFS (60.5% vs. 3.7% for biosimilar insulin glargine; 59.4% vs. 5.7% for generic glatiramer; all P < 0.001). The market share of these products was highest in states where MCOs were not subject to statewide PDLs for these drugs (59.1% for biosimilar insulin glargine, 52.8% for glatiramer) compared with states with MCOs subject to PDLs (2.4%, 18.0%); states with only FFS Medicaid (0.9%, 1.7%); or states where drug benefits have been carved out of MCOs (0.0%, 1.0%; all P < 0.001). There was a significant correlation between state-level MCO penetration and share of generic/biosimilar products (R = 0.50 for biosimilar insulin glargine and 0.57 for glatiramer; all P < 0.001). CONCLUSIONS: For 2 drug classes with large price increases, use of biosimilars/generics was greater in MCOs than FFS Medicaid, specifically in states without PDL requirements for MCOs. These findings may reflect financial incentives for MCOs to use drugs with lower list prices because they do not benefit from statutory Medicaid rebates. DISCLOSURES: No outside funding supported this study. Hernandez was funded by the National Heart, Lung and Blood Institute (grant number K01HL142847). The authors have nothing to disclose.

9.
J Gen Intern Med ; 35(4): 1276-1284, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31907790

RESUMO

BACKGROUND: As healthcare reimbursement shifts from being volume to value-focused, new delivery models aim to coordinate care and improve quality. The patient-centered medical home (PCMH) model is one such model that aims to deliver coordinated, accessible healthcare to improve outcomes and decrease costs. It is unclear how the types of delivery systems in which PCMHs operate differentially impact outcomes. We aim to describe economic, utilization, quality, clinical, and patient satisfaction outcomes resulting from PCMH interventions operating within integrated delivery and finance systems (IDFS), government systems including Veterans Administration, and non-integrated delivery systems. METHODS: We searched PubMed, the Cochrane Library, and Embase from 2004 to 2017. Observational studies and clinical trials occurring within the USA that met PCMH criteria (as defined by the Agency for Healthcare Research and Quality), addressed ambulatory adults, and reported utilization, economic, clinical, processes and quality of care, or patient satisfaction outcomes. RESULTS: Sixty-four studies were included. Twenty-four percent were within IDFS, 29% were within government systems, and 47% were within non-IDFS. IDFS studies reported decreased emergency department use, primary care use, and cost relative to other systems after PCMH implementation. Government systems reported increased primary care use relative to other systems after PCMH implementation. Clinical outcomes, processes and quality of care, and patient satisfaction were assessed heterogeneously or infrequently. DISCUSSION: Published articles assessing PCMH interventions generally report improved outcomes related to utilization and cost. IDFS and government systems exhibit different outcomes relative to non-integrated systems, demonstrating that different health systems and populations may be particularly sensitive to PCMH interventions. Both the definition of PCMH interventions and outcomes measured are heterogeneous, limiting the ability to perform direct comparisons or meta-analysis.

10.
Res Social Adm Pharm ; 2020 Jan 14.
Artigo em Inglês | MEDLINE | ID: mdl-31959565

RESUMO

BACKGROUND: Chronic disease represents a significant burden to the United States (US) health care system, with approximately 50% of all adults in the US having one or more chronic disease conditions. Pharmacist-led chronic disease management interventions are of special interest since 80% of medical treatments involve the use of prescription drugs. Moreover, community pharmacists are among the most accessible health care professionals to provide care for populations with chronic diseases. The impact of care provided by community pharmacists isn't well defined, with interventions taking on diverse forms with varied effects on outcomes. OBJECTIVE: The purpose of this review is to summarize evidence from secondary literature on community pharmacist-led chronic disease management interventions and the impact on clinical, utilization, and economic outcomes. METHODS: We conducted a systematic search of systematic reviews, meta-analyses, and narrative reviews using MEDLINE via PubMed, EMBASE.com and Cochrane Library databases published between January 1, 2007 and October 17, 2017. The following data were extracted: citation details, review type, number of primary studies included, disease state, description of the intervention, outcomes assessed, and results. RESULTS: Our search strategy retrieved 2296 titles and abstracts of which 15 references met our inclusion criteria. Selected articles covered 7 main diseases -diabetes, asthma, chronic obstructive pulmonary disease (COPD), hypertension, heart failure, hyperlipidemia, and human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). Community pharmacist-led interventions mostly consisted of patient consultations and education. In diabetes, interventions achieved significant reductions in hemoglobin A1c, total cholesterol, and low-density lipoprotein (LDL). Reviews also reported favorable reductions in blood pressure, improved medication adherence and reduced readmission rates in patients with heart failure, improved lung function in patients with respiratory conditions, and increased medication adherence in those with HIV/AIDs. Literature reporting economic and utilization outcomes were limited and mostly focused on pharmacy interventions in diabetes. In some cases, community pharmacy services demonstrated a decrease in medical and health care costs in patients with diabetes. CONCLUSION: We found that community pharmacists can improve clinical outcomes in a wide array of chronic diseases, including diabetes, hyperlipidemia, HIV/AIDS, cardiovascular and respiratory diseases. More robust studies are needed to further assess the impact of specific interventions on economic and utilization outcomes.

11.
Enferm Infecc Microbiol Clin ; 38(1): 11-15, 2020 Jan.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31060865

RESUMO

INTRODUCTION: NDM-1 carbapenemase is spreading rapidly all over the world, but this metallo-beta-lactamase has just been detected for the first time in an Acinetobacter baumannii (Ab) isolate of the ST85 clone in Spain. The aim of this study was to characterize a NDM-1-producing carbapenem-resistant A. baumannii (CR-Ab) isolate submitted to the Andalusian PIRASOA [infection prevention program] referral laboratory. METHODS: Carbapenemases were detected by PCR and Sanger DNA sequencing. Whole genome sequencing was performed by NGS (Miseq, Illumina). Resistance genes were identified with RESfinder, while MLSTfinder was used for sequence typing (ST). The genetic location of blaNDM-1 was determined by nuclease S-1/PFGE/hybridization with specific probe. RESULTS: The isolate was susceptible to amikacin and tigecycline and belonged to the ST85 clone. blaOXA-94 and blaNDM-1 were identified by PCR and Sanger DNA sequencing, respectively. The resistance genes aadB, blaADC-25, blaNDM-1, blaOXA-94, msr(E), mph(E) and floR,sul2 were identified by NGS. The chromosome of the isolate contained a defective Tn125 transposon with blaNDM-1 flanked by the insertion sequences ISAbA125 and ISAba14. The blaNDM-1 gene was only detected in the chromosomal DNA. CONCLUSION: This is the first time that blaNDM-1 has been detected and characterized in a blaOXA-94-producing CR-Ab isolate belonging to the ST85 clone in Spain.

13.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31813643

RESUMO

INTRODUCTION: To characterize a carbapenem-resistant Enterobacter cloacae complex isolate recovered from a patient from Ukraine. METHODS: The isolate was sent to a regional reference laboratory for molecular characterization by whole genome sequencing. Susceptibility assays, carbapenemase identification, imipenem hydrolysis and clonality were performed. RESULTS: The isolate showed resistance or reduced susceptibility to all ß-lactam agents tested. Genome analysis led to the identification of an NDM-1-producing E. cloacae complex strain that was assigned to a new multilocus sequence type, ST932. The blaNDM-1 enzyme was located in a conjugative IncX3 plasmid of ca. 50kb. In addition, blaCMH-3, a recently described AmpC ß-lactamase sequence, which has not previously been reported in Europe, was also detected and its genetic environment was studied. CONCLUSION: To our knowledge, this is the first reported case in Europe of an E. cloacae complex strain that produces both blaNDM-1 and blaCMH-3.

14.
Artigo em Inglês | MEDLINE | ID: mdl-31808136

RESUMO

BACKGROUND: In patients with atrial fibrillation (AF) who survive an anticoagulant-related intracranial hemorrhage (ICH), the benefits of restarting oral anticoagulation (OAC) remain unclear. OBJECTIVE: In this study, we sought to determine the effectiveness and safety associated with resumption of OAC in atrial fibrillation patients who survive an ICH. METHODS: Using 2010-2016 Medicare claims data, we identified patients with non-valvular AF who experienced an OAC-related ICH and survived at least 6 weeks after the ICH (n = 1502). The primary outcomes included the composite of ischemic stroke and transient ischemic attack (TIA), thromboembolism (TE), a composite of ischemic stroke/TIA and TE, recurrent ICH, and all-cause mortality. We constructed Cox proportional hazard models to evaluate the association between post-ICH OAC resumption, which was measured in a time-dependent manner, and the risk of primary outcomes, while controlling for a comprehensive list of covariates. RESULTS: Among patients who survived an ICH, 69% reinitiated OAC within 6 weeks of the event, and among those who resumed OAC, 83% restarted warfarin. There was no significant difference in the risk of ischemic stroke/TIA (hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.62-1.21), TE (HR 0.85, 95% CI 0.55-1.32), and ischemic stroke/TIA/TE (HR 0.81, 95% CI 0.61-1.07) between post-ICH OAC use and non-use. Post-ICH OAC use was associated with a lower risk of recurrent ICH (HR 0.62, 95% CI 0.41-0.95) and all-cause mortality (HR 0.48, 95% CI 0.37-0.62) compared with non-OAC use. CONCLUSIONS: In AF patients who survived an ICH, restarting OAC was not associated with a greater risk of recurrent ICH. Evidence from randomized controlled studies is needed to further clarify the clinical benefit of restarting OAC in this high-risk population. Further evaluation of which individuals benefit from restarting OAC is also needed to provide more clinical guidance.

16.
Res Social Adm Pharm ; 2019 Dec 09.
Artigo em Inglês | MEDLINE | ID: mdl-31864886

RESUMO

BACKGROUND: Direct-to-consumer advertising (DTCA) of prescription drugs impacts patients' requests for medications, and clinician prescribing. However, the impact of DTCA during the Super Bowl has not been previously described. OBJECTIVE: Evaluate the impact of prescription drug DTCA during the Super Bowl on drug utilization using 2014-2016 Medicare data. METHODS: Efinaconazole was advertised during Super Bowls XLIX (02/01/2015) and L (02/07/2016). The number of prescriptions for efinaconazole and for a comparator drug, tavaborole, were calculated in 31-day intervals from July 2014-December 2016. Interrupted time-series analysis models were created to test changes in trends of prescriptions for efinaconazole and tavaborole. RESULTS: Following Super Bowl XLIX, the number of prescriptions per 100,000 Medicare beneficiaries increased by 91% for efinaconazole, and 275% for tavaborole. After Super Bowl L, the number of prescriptions increased significantly for efinaconazole (p-value<0.001), but not for tavaborole (p = 0.70). Interrupted time-series analyses estimated that, in the absence of DTCA during Super Bowl XLIX, prescriptions for efinaconazole would have increased by 40%, instead of the observed 91%. For tavaborole, prescriptions would have increased by 90% instead of 275%. CONCLUSIONS: DTCA during the Super Bowl resulted in sharp increases in utilization of the prescription drug advertised, which supports further regulation of DTCA.

17.
Value Health ; 22(11): 1266-1274, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31708063

RESUMO

BACKGROUND: In 2012, Medicare incorporated medication adherence targeting oral antidiabetic medications, renin-angiotensin system (RAS) antagonists, and statins as highly weighted components in its Star Ratings Program. In the same year, health plans began receiving quality bonus payments for higher star ratings. OBJECTIVE: We aimed to assess how these policy changes affected adherence to targeted and other chronic disease medications in the United States. METHODS: We performed interrupted time series analyses to assess monthly changes in medication adherence from 2010 to 2016 using health plans' Medicare claims submitted to a large pharmacy benefits manager. We conducted 2 sets of analyses. The first examined whether policy changes affected adherence to the 3 targeted therapy classes, and the second assessed the association between policy changes and adherence to 5 chronic disease classes not targeted by star ratings. For the second analysis, we further compared adherence between members who concomitantly used and did not use targeted medications. RESULTS: For star-ratings analyses, we studied 240 811 members on oral antidiabetic medications, 500 958 on RAS antagonists, and 471 135 on statins. Adherence for all star rating-targeted and nontargeted medications increased after 2012 (P < .001). Oral antidiabetic, statin, and RAS antagonist adherence was, respectively, 11.2%, 3.7%, and 8.1% higher than adherence without policy changes (P < .001). Nontargeted antihypertensive and antihyperlipidemic adherence trends were higher among those concomitantly on star rating-targeted medications compared with those who were not (P < .001). CONCLUSIONS: As policy makers strive to identify optimal quality measures for improving healthcare delivery, it is important to consider that incentives can promote improved performance in both targeted measures and related outcomes.

18.
JAMA Netw Open ; 2(9): e1910626, 2019 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-31483473

RESUMO

Importance: Drug safety communications released by the US Food and Drug Administration (FDA) are often based on limited evidence on safety signals after approval. Varenicline may serve as a relevant case study because it was the target of several FDA communications in 2008 and 2009; ultimately, the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) dismissed safety concerns on increased suicidal thoughts and aggressive and erratic behavior on December 16, 2016. Objective: To examine the association between FDA drug safety communications and the use of varenicline. Design, Setting, and Participants: Retrospective, longitudinal, cross-sectional study of Veterans Health Administration (VHA) outpatient data from October 1, 2001, through December 31, 2018, and Medicaid drug state use data from July 1, 2006, through September 30, 2018, on varenicline prescribing. Main Outcomes and Measures: Prescribing records for varenicline and nicotine replacement therapy (NRT) in the VHA were extracted, and the number of unique varenicline and NRT users in the VHA per quarter was measured. An interrupted time series analysis was performed to describe the association between FDA safety warnings and the use of varenicline and NRT. To test the generalizability of the findings, similar analyses were conducted using the number of prescriptions reimbursed for varenicline by Medicaid every quarter in 2006-2018. Results: After its addition to the VHA national drug formulary in January 2007, varenicline use presented a steady increase, reaching a peak of 32 581 quarterly unique users in the first quarter of 2008. Within 12 months of the February 1, 2008, public health advisory, quarterly varenicline use in VHA patients decreased by 68.7% (from 32 581 to 10 182 patients; P < .001 for slope change), and NRT use increased by 32.1% (from 55 728 to 73 629 patients; P < .001 for slope change). In Medicaid prescriptions, varenicline use decreased by 38.0% (from 109 308 to 67 761 prescriptions; P < .001 for slope change) within 12 months of the 2008 public health advisory. Twelve months after the publication of the EAGLES trial, which showed no significant increase in psychiatric/behavioral effects with varenicline relative to NRT, use of varenicline increased by 42.7% in VHA patients (from 9251 to 13 199 patients; P = .01 for slope change) and by 26.0% in Medicaid prescriptions (112 063 to 141 122; P = .26 for slope change ). Conclusions and Relevance: With use of varenicline as a case study, early communications from the FDA and VHA followed by a labeling change appeared to be associated with a considerable decrease in drug use, which may have been associated with negative public health consequences.

19.
Artigo em Inglês | MEDLINE | ID: mdl-31523759

RESUMO

INTRODUCTION: The objective of this study was to compare the risk of stroke in atrial fibrillation (AF) with adherent use of oral anticoagulation (OAC), non-adherent use, and non-use of OAC. METHODS: Using 2013-2016 Medicare claims data, we identified patients newly diagnosed with AF in 2014-2015 and collected prescriptions filled for OAC in the 12 months after AF diagnosis (n = 39,272). We categorized participants each day into three time-dependent exposures: adherent use (≥ 80% of the previous 30 days covered with OAC), non-adherent use (0-80% covered with OAC), and non-use (0%). We constructed Cox proportional hazards models to estimate the association between time-dependent exposures and time to stroke, adjusting for demographics and clinical characteristics. RESULTS: The sample included 39,272 patients. Study participants spent 35.0% of the follow-up period in the adherent use exposure category, 10.9% in the non-adherent category, and 54.0% in the non-use category. OAC adherent use [hazard ratio (HR) 0.62; 95% confidence interval (CI) 0.52-0.74] and non-adherent use (HR 0.74; 95% CI 0.57-0.95) were associated with lower hazards of stroke than non-use. Adherent use of DOAC (HR 0.54; 95% CI 0.42-0.69) and warfarin (HR 0.70; 95% CI 0.56-0.89) was associated with lower risk of stroke than non-use, but the risk of stroke did not statistically differ between DOAC and warfarin adherent use (HR 0.77; 95% CI 0.56-1.04). DISCUSSION: Although adherence to OAC reduces stroke risk by nearly 40%, newly diagnosed AF patients in Medicare adhere to OAC on average only one third of the first year after AF diagnosis.

20.
J Manag Care Spec Pharm ; 25(9): 995-1000, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31456493

RESUMO

The shift to a value-based health care system has incentivized providers to implement strategies that improve population health outcomes while minimizing downstream costs. Given their accessibility and expanded clinical care models, community pharmacists are well positioned to join interdisciplinary care teams to advance efforts in effectively managing the health of populations. In this Viewpoints article, we discuss the expanded role of community pharmacists and potential barriers limiting the uptake of these services. We then explore strategies to integrate, leverage, and sustain these services in a value-based economy. Although community pharmacists have great potential to improve population health outcomes because of their accessibility and clinical interventions that have demonstrated improved outcomes, pharmacists are not recognized as merit-based incentive eligible providers and, as a result, may be underutilized in this role. Additional barriers include lack of formal billing codes, which limits patient access to services such as hormonal contraception; fragmentation of Medicare, which prevents alignment of medical and pharmaceutical costs; and continued fee-for-service payment models, which do not incentivize quality. Despite these barriers, there are several opportunities for continued pharmacist involvement in new care models such as patient-centered medical homes (PCMH), accountable care organizations, and other value-based payment models. Community pharmacists integrated within PCMHs have demonstrated improved hemoglobin A1c, blood pressure control, and immunization rates. Likewise, other integrated, value-based models that used community pharmacists to provide medication therapy management services have reported a positive return on investment in overall health care costs. To uphold these efforts and effectively leverage community pharmacist services, we recommend the following: (a) recognition of pharmacists as providers to facilitate full participation in performance-based models, (b) increased integration of pharmacists in emerging delivery and payment models with rapid cycle testing to further clarify the role and value of pharmacists, and (c) enhanced collaborative relationships between pharmacists and other providers to improve interdisciplinary care. DISCLOSURES: This article was funded by the National Association of Chain Drug Stores. The authors have no potential conflicts of interest to report.


Assuntos
Serviços Comunitários de Farmácia/organização & administração , Serviços Comunitários de Farmácia/normas , Conduta do Tratamento Medicamentoso/organização & administração , Conduta do Tratamento Medicamentoso/normas , Farmacêuticos/organização & administração , Farmacêuticos/normas , Organizações de Assistência Responsáveis/organização & administração , Organizações de Assistência Responsáveis/normas , Redução de Custos/normas , Planos de Pagamento por Serviço Prestado/normas , Custos de Cuidados de Saúde/normas , Humanos , Medicare/organização & administração , Medicare/normas , Equipe de Assistência ao Paciente/organização & administração , Equipe de Assistência ao Paciente/normas , Atenção Primária à Saúde/organização & administração , Atenção Primária à Saúde/normas , Papel Profissional , Estados Unidos
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