Search

ObjectiveThe Veterans Health Administration (VHA) and the Centers for Medicare and Medicaid Services (CMS) each created initiatives to reduce off-label use of antipsychotics in patients with dementia in nursing homes. Although CMS has reported antipsychotic reductions, the impact on prescribing of antipsychotic and other CNS-active medications in the VHA remains unclear. The authors evaluated national trends in antipsychotic and other CNS-active medication prescribing for nursing home patients with dementia in the VHA.MethodsThe study sample was all veterans with dementia residing in VHA nursing homes for more than 30 days (N=35,742). Using an interrupted time-series design, the quarterly prevalences of antipsychotic, antidepressant, antiepileptic, anxiolytic, opioid, and memory medication prescribing were evaluated from FY2009 through FY2018.ResultsAntipsychotic prescribing in VHA nursing homes declined from FY2009 to FY2018 (from 33.7% to 27.5%), with similar declines in anxiolytic prescribing (from 33.5% to 27.1%). During this period, prescribing of antiepileptics, antidepressants, and opioids increased significantly (antiepileptics: from 26.8% to 43.3%; antidepressants: from 56.8% to 63.4%; opioids: from 32.6% to 41.2%). Gabapentin served as the main driver of antiepileptic increases (from 11.1% to 23.5%). Increases in antidepressant prescribing included sertraline, mirtazapine, and trazodone. From FY2009 to FY2018, the overall prescribing of non-antipsychotic psychotropic medications grew from 75.0% to 81.1%.ConclusionsAntipsychotic and anxiolytic prescribing for VHA nursing home residents with dementia declined, although overall prescribing of other psychotropic and opioid medications increased. Policies focused primarily on reducing antipsychotic use without considering use in the context of other medications may contribute to growth in alternative medication classes with even less evidence of benefit and similar risks.

BACKGROUND: There has been a reduction in BZD prescribing in the Veterans Affairs (VA) health care system since 2013. It is unknown whether the decline in VA-dispensed BZDs has been offset by Medicare Part D prescriptions. OBJECTIVES: To examine (1) whether, accounting for Part D, declines in BZD prescribing to older Veterans remain; (2) patient characteristics associated with obtaining BZDs outside VA and facility variation in BZD source (VA only, VA and Part D, Part D only). DESIGN: Retrospective cohort study with mixed effects multinomial logistic model examining characteristics associated with BZD source. PATIENTS: A total of 1,746,278 Veterans aged ≥65 enrolled in VA and Part D, 2013–2017. MAIN MEASURES: BZD prescription prevalence and source. KEY RESULTS: From January 2013 to June 2017, the quarterly prevalence of older Veterans with Part D filling BZD prescriptions through the VA declined from 5.2 to 3.1% (p

PURPOSE: Unlike in many community-based settings, benzodiazepine (BZD) prescribing to older veterans has decreased. We sought to identify health care system strategies associated with greater facility-level reductions in BZD prescribing to older adults. METHODS: We completed an explanatory sequential mixed methods study of health care facilities in the Veterans Health Administration (N = 140). Among veterans aged ≥75 years receiving long-term BZD treatment, we stratified facilities into relatively high and low performance on the basis of the reduction in average daily dose of prescribed BZD from October 1, 2015 to June 30, 2017. We then interviewed key facility informants (n = 21) who led local BZD reduction efforts (champions), representing 11 high-performing and 6 low-performing facilities. RESULTS: Across all facilities, the age-adjusted facility-level average daily dose in October 2015 began at 1.34 lorazepam-equivalent mg/d (SD 0.17); the average rate of decrease was −0.27 mg/d (SD 0.09) per year. All facilities interviewed, regardless of performance, used passive strategies primarily consisting of education regarding appropriate prescribing, alternatives, and identifying potential patients for discontinuation. In contrast, champions at high-performing facilities described leveraging ≥1 active strategies that included individualized recommendations, administrative barriers to prescribing, and performance measures to incentivize clinicians. CONCLUSIONS: Initiatives to reduce BZD prescribing to older adults that are primarily limited to passive strategies, such as education and patient identification, might have limited success. Clinicians might benefit from additional recommendations, support, and incentives to modify prescribing practices.

BACKGROUND/OBJECTIVES Benzodiazepines (BZDs) are widely prescribed to older adults. Although prescribing has declined in the U.S. Department of Veterans Affairs (VA), Medicare introduced BZD coverage in 2013. It is unknown whether declines in the VA have been widespread among older adults in the United States. DESIGN Observational study in traditional fee‐for‐service Medicare, commercial insurance, and the VA. SETTING United States, 2013–2017. PARTICIPANTS Adults aged 55 and older in traditional Medicare (234,290,693 person‐months), commercial insurance (337,827,125 person‐months), and the VA (256,590,369 person‐months). MEASUREMENTS (1) Change in BZD and BZD‐opioid co‐prescribing modeled by Poisson regression over time; and (2) standardized ratios of BZD and BZD‐opioid co‐prescribing, using Medicare as the reference. RESULTS From April 2013 to December 2017, the monthly percentage of adults aged 55 and older who received BZDs fell from 10.4% to 9.3% in Medicare, 6.6% to 6.5% in commercial insurance, and 5.7% to 3.0% in the VA. Monthly BZD‐opioid co‐prescribing over the same time fell from 4.0% to 3.0% in Medicare, 2.3% to 2.0% in commercial, and 2.2% to .6% for the VA. Age‐ and sex‐adjusted rates of decline for BZD and BZD‐opioid co‐prescribing were statistically significant for all systems. Annual BZD rate reductions were .98 (Medicare), .99 (commercial), and .87 (VA; P < .001 for all); co‐prescribing rate reductions were .95, .99, and .75 (P < .001 for all). Using standardized ratios accounting for demographic and clinical characteristics, both prescribing and co‐prescribing were lowest for the VA relative to Medicare (standardized BZD ratio = .40; 95% confidence interval [CI] = .39–.40; standardized BZD‐opioid co‐prescribing ratio = .35; 95% CI = .35–.35). Prescribing in commercial insurance was also lower (BZD = .65; 95% CI = .65–.65; BZD‐opioid co‐prescribing = .65; 95% CI = .65–.65). CONCLUSION BZD prescribing has declined much more to older adults receiving care through the VA than Medicare or commercial insurance. Other systems may learn from strategies implemented in the VA.

OBJECTIVE To describe how use of antidepressants, benzodiazepines, and other anxiolytic/sedative-hypnotics among older adults (age ≥ 65 years) has changed over time among visits to primary care providers and psychiatrists. METHODS Data were from the National Ambulatory Medical Care Survey (years 2003-2005 and 2010-2012), a nationally representative cross-section of outpatient physician visits. Analysis focused on visits to primary care providers (n = 14,282) and psychiatrists (n = 1,095) at which an antidepressant, benzodiazepine, or other anxiolytic/sedative-hypnotic was prescribed, which were stratified by demographic and clinical characteristic (including ICD-9-CM diagnosis) and compared across study intervals. Odds of medication use were calculated for each stratum, adjusting for demographic and clinical characteristics. RESULTS The visit rate by older adults to primary care providers where any of the medications were prescribed rose from 16.4% to 21.8% (adjusted odds ratio [AOR] = 1.43, P < .001) while remaining steady among psychiatrists (75.4% vs 68.5%; AOR = 0.69, P = .11). Primary care visits rose for antidepressants (9.9% to 12.3%; AOR = 1.28, P = .01) and other anxiolytic/sedative-hypnotics (3.4% to 4.7%; AOR = 1.39, P = .01), but the largest growth was among benzodiazepines (5.6% to 8.7%; AOR = 1.62, P < .001). Among patients in primary care, increases primarily occurred among men, non-Hispanic white patients, and those with pain diagnoses as well as those with no mental health or pain diagnoses. CONCLUSIONS From 2003 to 2012, use of the most common psychotropic medications among older adults seen in primary care increased, with concentration among patients with no mental health or pain diagnosis. As the population of older adults grows and receives mental health treatment in primary care, it is critical to examine the appropriateness of psychotropic use.

Late-life veteran suicide is a public health concern, and may overlap with recent high-risk medication use. We identified use in the 6 months prior to attempt and assessed salient risk factors. 13,872 veterans aged 50 years and older that attempted suicide were compared with demographically-matched controls utilizing VHA healthcare in a similar time period. Medications potentially related to suicide risk were included. Other variables were psychiatric and medical diagnoses, fatality of attempt and means. Compared with controls, veterans who attempted were nearly 3 times more likely to have been prescribed benzodiazepines and opioids, even when controlling for other diagnoses. Those taking 3 or more high-risk medications were between 7 and 11 times more likely to attempt than controls, with a higher risk of death particularly by drug overdose. These findings begin to uncover the complex contribution of prescription medications and polypharmacy to late-life veteran suicide, with implications for prevention. Part of a symposium sponsored by the Aging, Alcohol and Addictions Interest Group.

As the nation’s largest integrated healthcare system, the Veterans Health Administration (VHA) is faced with challenges in caring for a growing number of older adult Veterans with comorbid medical, mental health, neurocognitive, and behavioral care needs. These Veterans can pose significant risk of harm to self or others and can lead to inefficient, ineffective, or inappropriate use of VHA resources. Using an implementation science framework, this presentation will describe the development and expansion of the Care of Patients with Complex Problems (CP)^2 Program, outcomes, and implications. A national needs assessment of 138 VHA medical centers estimated 42% of inpatient beds are occupied by Veterans with complex problems, with 38% indicating access to inpatient care related challenges. Through leadership feedback and group consensus, an interdisciplinary task force and a VHA senior leadership steering committee selected one of six promising practices to launch the (CP)^2 Program. The key components of the program include: dissemination of promising practices; a national learning collaborative and webinar series (participation averaging 200 staff/month); and centralized technical assistance. Three medical centers were invited to participate in the initial launch of the program with a regional dissemination of the promising practice model that supports transitioning Veterans from inpatient care to more appropriate and less costly community settings. Following promising outcomes (i.e. reductions in costs and hospital readmissions) and over 30 briefings/stakeholder meetings, support was garnered for a national training and expanded dissemination of the model. Implications for practice, development of VHA/community partnerships, and lessons learned were identified.

OBJECTIVES: Despite evidence for many potential risks, use of benzodiazepines (BZD) among older adults is common. The authors evaluated the available evidence for BZD effectiveness and tolerability for use in older adults in three psychiatric conditions for which BZD are commonly prescribed: insomnia, anxiety disorders, and behavioral and psychological symptoms of dementia. DESIGN: Electronic databases including PubMed/MEDLINE were searched to identify articles that included: 1) patients ≥50 years of age; 2) focused on patients diagnosed with insomnia, anxiety disorders, or behavioral and psychological symptoms of dementia; and 3) were either a randomized, placebo-controlled trial or a randomized trial comparing a BZD with either another psychotropic medication or psychotherapy. RESULTS: A total of 31 studies met the inclusion criteria. Of the three clinical indications evaluated, treatment of insomnia had the greatest available evidence for use of BZD among older adults, with 21 of 25 trials demonstrating improvement in sleep outcomes with use of BZD. Only one trial was found to meet eligibility criteria for BZD use in anxiety disorders, demonstrating benefit over placebo. A total of 5 studies for use in behavioral disturbances in dementia were included; of which only one trial demonstrated improvement over placebo. CONCLUSION: The results of this systematic review suggest that BZD prescribing to older adults is significantly in excess of what the available evidence would suggest is appropriate. Future trials should focus on efforts to reduce both acute and chronic BZD use among older adults while improving access to effective non-pharmacologic treatment alternatives.

The impact of STAR-VA on psychotropic drug use among residents with behavioral symptoms of dementia was evaluated through a difference-in-differences framework. STAR-VA residents enrolled 2013-2017 were evaluated longitudinally pre-post intervention. The primary outcome was the number of as needed administrations with an indication of ‘anxiety’ or ‘agitation’. The analytical cohort included 214 training cases and 1,870 controls from untrained sites meeting eligibility criteria. STAR-VA cases were less white (48% vs. 54%), less black (11% vs. 14%), and had significantly longer median length of stay (830 vs. 261 days), respectively. STAR-VA cases had on average 3.5 as needed doses/month of psychotropic medication before the intervention and 1.7 after, controls averaged 1.8 doses/month. After adjustment for person-time-fixed effects, enrollment was associated with 55% (95% CI:30, 68) reduction or an average 0.8 as needed psychotropic doses/month. Findings demonstrate effectiveness in decreasing as-needed psychotropic drug use among CLC residents, supporting continued implementation of STAR-VA.

Objective:National data from Veterans Health Administration (VHA) electronic medical records were used to examine rates of mental illness and service use among older veterans since mental health care transformation efforts were implemented in 2005.Methods:Data were extracted from VHA electronic medical records for each fiscal year from 2005 through 2013 for veterans ages 65 and older. Among those receiving any health care services, the number and proportion treated for a confirmed mental illness and the utilization of non–mental health care services were identified.Results:In 2013, 2.6 million older veterans utilized services in VHA, 14% of whom had a confirmed mental illness, which was a 57% increase from 2005. Older veterans with confirmed mental illness accounted for a sizable and growing proportion of non–mental health service utilization.Conclusions:Preparing the workforce to address the mental health needs of older veterans and nonveterans is essential.

OBJECTIVE This study used a private insurance claims database to examine the use of diverse classes of psychotropic medications among patients without a psychiatric diagnosis. METHODS MarketScan claims data for 2009 were used to identify privately insured individuals who filled a prescription for at least one psychotropic medication (5.1 million patients). Bivariate and multivariate analyses were used to compare the proportion of patients with and without a psychiatric diagnosis who received a prescription for six different classes of psychotropic medications. The analyses were adjusted for potential medical indications and severity of comorbid general medical illness. RESULTS Altogether, 58% of individuals who were prescribed a psychotropic medication in 2009 had no psychiatric diagnosis during the year. The proportion of patients who were prescribed a psychotropic medication without a psychiatric diagnosis was highest among individuals aged 50 to 64 (69%) and among individuals who did not receive any mental health specialty care (67%). The odds of being prescribed psychotropic medication without a psychiatric diagnosis were 2.9 times higher among patients aged 50 to 64 than among younger patients. Diagnoses signifying potential medical indications for use and severity of comorbid medical conditions were only weakly related to absence of a psychiatric diagnosis and did not alter these age trends. CONCLUSIONS In a large private claims database, a majority of recipients of psychotropic medication, especially older patients and those not utilizing mental health specialty care, lacked a clear indication for such use. This phenomenon deserves further study and may reflect less than desirable care.

Objectives To establish the rate of new and continuation of benzodiazepine use in older adults seen by nonpsychiatrist physicians and to identify subpopulations at risk of new and continuation benzodiazepine use. Design Cross-sectional analysis. Setting National Ambulatory Medical Care Survey (2007–10). Participants Adults visiting office-based nonpsychiatrist physicians (n = 98,818) who were prescribed a benzodiazepine (new or continuation). Measurements Percentage of benzodiazepine visits of all outpatient encounters according to patient age and corresponding annual visit rate per 1,000 population. Analysis was then limited to adults aged 65 and older, demographic, clinical, and visits characteristics were used to compare visits of benzodiazepine users with those of nonusers and visits of continuation users with those of new users. Results The overall proportion of benzodiazepine visits ranged from 3.2% (95% confidence interval (CI) = 2.7–3.7) of those aged 18 to 34 to 6.6% (95% CI = 5.8–7.6) of those aged 80 and older, and the proportion of continuation visits increased with age, rising to 90.2% (95% CI = 86.2–93.1) of those aged 80 and older. The population-based visit rate ranged from 61.7 (95% CI = 50.7–72.7) per 1,000 persons in the youngest adults to 463.7 (95% CI = 385.4–542.0) in those aged 80 and older. Only 16.0% (95% CI = 13.5–18.8) of continuation users had any mental health diagnosis. Of all benzodiazepine users, fewer than 1% (95% CI = .4–1.8) were provided or referred to psychotherapy, and 10.0% (95% CI = 7. 2–13.3) were also prescribed an opioid. Conclusion In the United States, few older adult benzodiazepine users receive a clinical mental health diagnosis, and almost none are provided or referred to psychotherapy. Prescribing to older adults continues despite decades of evidence documenting safety concerns, effective alternative treatments, and effective methods for tapering even chronic users.

Increasing numbers of aging Veterans with complex and interacting medical, mental health, neurocognitive, and/or behavioral concerns are receiving care in Veterans Health Administration (VHA) facilities. VHA recognized that Veterans with complex care needs may not receive well-integrated care across inpatient care settings (medical/ surgical, mental health, skilled nursing, rehabilitation). A national, interdisciplinary VHA Task Force was established to recommend evidence-based strategies to achieve safe and effective care for this population. The Task Force noted a number of systemic challenges for caring for these patients, including silos of medical, mental health, or geriatric care; gaps in staff competencies; and inconsistent coordination of care across services and settings. Task Force recommendations focused on patient/family-centered models emphasizing care in place when possible, prevention, strengthening of interdisciplinary and integrated medical and mental health care, and attention to staff skills development. Plans for implementing recommendations and conducting systematic evaluation are underway.

Background Development of the commercial genomics sector within the biotechnology industry relied heavily on the scientific commons, public funding, and technology transfer between academic and industrial research. This study tracks financial and intellectual property data on genomics firms from 1990 through 2004, thus following these firms as they emerged in the era of the Human Genome Project and through the 2000 to 2001 market bubble. Methods A database was created based on an early survey of genomics firms, which was expanded using three web-based biotechnology services, scientific journals, and biotechnology trade and technical publications. Financial data for publicly traded firms was collected through the use of four databases specializing in firm financials. Patent searches were conducted using firm names in the US Patent and Trademark Office website search engine and the DNA Patent Database. Results A biotechnology subsector of genomics firms emerged in parallel to the publicly funded Human Genome Project. Trends among top firms show that hiring, capital improvement, and research and development expenditures continued to grow after a 2000 to 2001 bubble. The majority of firms are small businesses with great diversity in type of research and development, products, and services provided. Over half the public firms holding patents have the majority of their intellectual property portfolio in DNA-based patents. Conclusions These data allow estimates of investment, research and development expenditures, and jobs that paralleled the rise of genomics as a sector within biotechnology between 1990 and 2004.

Introduction Polymerase chain reaction (PCR) was a seminal genomic technology discovered, developed, and patented in an industry setting. Since the first of its core patents expired in March, 2005, we are in a position to view the entire lifespan of the patent, examining how the intellectual property rights have impacted its use in the biomedical community. Given its essential role in the world of molecular biology and its commercial success, the technology can serve as a case study for evaluating the effects of patenting biological research tools on biomedical research. Case description Following its discovery, the technique was subjected to two years of in-house development, during which issues of inventorship and publishing/patenting strategies caused friction between members of the development team. Some have feared that this delay impeded subsequent research and may have been due to trade secrecy or the desire for obtaining lucrative intellectual property rights. However, our analysis of the history indicates that the main reasons for the delay were benign and were primarily due to difficulties in perfecting the PCR technique. Following this initial development period, the technology was made widely available, but was subject to strict licensing terms and patent protection, leading to an extensive litigation history. Discussion and evaluation PCR has earned approximately $2 billion in royalties for the various rights-holders while also becoming an essential research tool. However, using citation trend analysis, we are able to see that PCR's patented status did not preclude it from being adopted in a similar manner as other non-patented genomic research tools (specifically, pBR322 cloning vector and Maxam-Gilbert sequencing). Conclusion Despite the heavy patent protection and rigid licensing schemes, PCR seems to have disseminated so widely because of the practices of the corporate entities which have controlled these patents, namely through the use of business partnerships and broad corporate licensing, adaptive licensing strategies, and a "rational forbearance" from suing researchers for patent infringement. While far from definitive, our analysis seems to suggest that, at least in the case of PCR, patenting of genomic research tools need not impede their dissemination, if the technology is made available through appropriate business practices.

Polymerase chain reaction (PCR) was a seminal genomic technology discovered, developed, and patented in an industry setting. Since the first of its core patents expired in March, 2005, we are in a position to view the entire lifespan of the patent, examining how the intellectual property rights have impacted its use in the biomedical community. Given its essential role in the world of molecular biology and its commercial success, the technology can serve as a case study for evaluating the effects of patenting biological research tools on biomedical research. Following its discovery, the technique was subjected to two years of in-house development, during which issues of inventorship and publishing/patenting strategies caused friction between members of the development team. Some have feared that this delay impeded subsequent research and may have been due to trade secrecy or the desire for obtaining lucrative intellectual property rights. However, our analysis of the history indicates that the main reasons for the delay were benign and were primarily due to difficulties in perfecting the PCR technique. Following this initial development period, the technology was made widely available, but was subject to strict licensing terms and patent protection, leading to an extensive litigation history. PCR has earned approximately $2 billion in royalties for the various rights-holders while also becoming an essential research tool. However, using citation trend analysis, we are able to see that PCR's patented status did not preclude it from being adopted in a similar manner as other non-patented genomic research tools (specifically, pBR322 cloning vector and Maxam-Gilbert sequencing). Despite the heavy patent protection and rigid licensing schemes, PCR seems to have disseminated so widely because of the practices of the corporate entities which have controlled these patents, namely through the use of business partnerships and broad corporate licensing, adaptive licensing strategies, and a "rational forbearance" from suing researchers for patent infringement. While far from definitive, our analysis seems to suggest that, at least in the case of PCR, patenting of genomic research tools need not impede their dissemination, if the technology is made available through appropriate business practices.

Edwin Southern developed a blotting technique for DNA in 1973, thereby creating a staple of molecular biology laboratory procedures still used after several decades. It became a seminal technology for studying the structure of DNA. The story of the creation and dissemination of this technology, which was not patented and was freely distributed throughout the scientific community, stands as a case study in open science. The Southern blot was developed at a time when attitudes about commercial intrusion into health research were beginning to change and the practical value of molecular genetics was becoming apparent to industry. Interest from industry in fundamental molecular biological techniques meant that scientists began to think about commercial uses of their work even in otherwise "basic" research. The unpatented Southern blot is contrasted with later patented technologies, particularly microarray methods, which were created in the same environment by many of the same people, but which followed significant changes to UK policies encouraging commercialization of academic research and a norm shift friendlier to such commercialization within academic molecular biology. Professor Southern's personal experience illuminates how the technologies evolved, and his views provide insight into how scientists' attitudes about commercialization have changed.