Publications

2017

Thorpe, Joshua M, Carolyn T Thorpe, Walid F Gellad, Chester B Good, Joseph T Hanlon, Maria K Mor, John R Pleis, Loren J Schleiden, and Courtney Harold Van Houtven. (2017) 2017. “Dual Health Care System Use and High-Risk Prescribing in Patients With Dementia: A National Cohort Study.”. Annals of Internal Medicine 166 (3): 157-63. https://doi.org/10.7326/M16-0551.

BACKGROUND: Recent federal policy changes attempt to expand veterans' access to providers outside the Department of Veterans Affairs (VA). Receipt of prescription medications across unconnected systems of care may increase the risk for unsafe prescribing, particularly in persons with dementia.

OBJECTIVE: To investigate the association between dual health care system use and potentially unsafe medication (PUM) prescribing.

DESIGN: Retrospective cohort study.

SETTING: National VA outpatient care facilities in 2010.

PARTICIPANTS: 75 829 veterans with dementia who were continuously enrolled in Medicare from 2007 to 2010; 80% were VA-only users, and 20% were VA-Medicare Part D (dual) users.

MEASUREMENTS: Augmented inverse propensity weighting was used to estimate the effect of dual-system versus VA-only prescribing on 4 indicators of PUM prescribing in 2010: any exposure to Healthcare Effectiveness Data and Information Set (HEDIS) high-risk medication in older adults (PUM-HEDIS), any daily exposure to prescriptions with a cumulative Anticholinergic Cognitive Burden (ACB) score of 3 or higher (PUM-ACB), any antipsychotic prescription (PUM-antipsychotic), and any PUM exposure (any-PUM). The annual number of days of each PUM exposure was also examined.

RESULTS: Compared with VA-only users, dual users had more than double the odds of exposure to any-PUM (odds ratio [OR], 2.2 [95% CI, 2.2 to 2.3]), PUM-HEDIS (OR, 2.4 [CI, 2.2 to 2.8]), and PUM-ACB (OR, 2.1 [CI, 2.0 to 2.2]). The odds of PUM-antipsychotic exposure were also greater in dual users (OR, 1.5 [CI, 1.4 to 1.6]). Dual users had an adjusted average of 44.1 additional days of any-PUM exposure (CI, 37.2 to 45.0 days).

LIMITATION: Observational study design of veteran outpatients only.

CONCLUSION: Among veterans with dementia, rates of PUM prescribing are significantly higher among dual-system users than with VA-only users.

PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.

Gellad, Walid F, Xinhua Zhao, Carolyn T Thorpe, Joshua M Thorpe, Florentina E Sileanu, John P Cashy, Maria Mor, et al. (2017) 2017. “Overlapping Buprenorphine, Opioid, and Benzodiazepine Prescriptions Among Veterans Dually Enrolled in Department of Veterans Affairs and Medicare Part D.”. Substance Abuse 38 (1): 22-25. https://doi.org/10.1080/08897077.2016.1267071.

BACKGROUND: Buprenorphine is a key tool in the management of opioid use disorder, but there are growing concerns about abuse, diversion, and safety. These concerns are amplified for the Department of Veterans Affairs (VA), whose patients may receive care concurrently from multiple prescribers within and outside VA. To illustrate the extent of this challenge, we examined overlapping prescriptions for buprenorphine, opioids, and benzodiazepines among veterans dually enrolled in VA and Medicare Part D.

METHODS: We constructed a cohort of all veterans dually enrolled in VA and Part D who filled an opioid prescription in 2012. We identified patients who received tablet or film buprenorphine products from either source. We calculated the proportion of buprenorphine recipients with any overlapping prescription (based on days supply) for a nonbuprenorphine opioid or benzodiazepine, focusing on veterans who received overlapping prescriptions from a different system than their buprenorphine prescription (Part D buprenorphine recipients receiving overlapping opioids or benzodiazepines from VA and vice versa).

RESULTS: There were 1790 dually enrolled veterans with buprenorphine prescriptions, including 760 (43%) from VA and 1091 (61%) from Part D (61 veterans with buprenorphine from both systems were included in each group). Among VA buprenorphine recipients, 199 (26%) received an overlapping opioid prescription and 11 (1%) received an overlapping benzodiazepine prescription from Part D. Among Part D buprenorphine recipients, 208 (19%) received an overlapping opioid prescription and 178 (16%) received an overlapping benzodiazepine prescription from VA. Among VA and Part D buprenorphine recipients with cross-system opioid overlap, 25% (49/199) and 35% (72/208), respectively, had >90 days of overlap.

CONCLUSIONS: Many buprenorphine recipients receive overlapping prescriptions for opioids and benzodiazepines from a different health care system than the one in which their buprenorphine was filled. These findings highlight a previously undocumented safety risk for veterans dually enrolled in VA and Medicare.

Stroupe, Kevin T, Lauren Bailey, Walid F Gellad, Katie Suda, Zhiping Huo, Rachael Martinez, Muriel Burk, Francesca Cunningham, and Bridget M Smith. (2017) 2017. “Veterans’ Pharmacy and Health Care Utilization Following Implementation of the Medicare Part D Pharmacy Benefit.”. Medical Care Research and Review : MCRR 74 (3): 328-44. https://doi.org/10.1177/1077558716643887.

We examined associations between enrollment in Medicare Part D pharmacy benefits and changes in medication acquisition from Department of Veterans Affairs (VA) pharmacies. We included all women and a random 10% sample of men who were VA enrollees, ≥65 years old as of January 1, 2004, and alive through December 2007. We used difference-in-differences models with propensity score weighting to examine changes in medication acquisition between 2005 (before Part D was implemented) and 2007 (after Part D implementation) for veterans who were or were not Part D enrolled. Of 231,716 veterans meeting inclusion criteria, 49,881 (21.5%) were enrolled. While 30-day medication supplies decreased from 26.2 to 23.4 for enrolled veterans, they increased from 36.6 to 37.4 for nonenrolled veterans (difference-in-differences: -4.0, p < .001). Reductions in 30-day supplies were greater among veterans who were required to pay VA copayments for some or all medications and who used VA and Medicare outpatient services.

2016

Radomski, Thomas R, Chester B Good, Carolyn T Thorpe, Xinhua Zhao, Zachary A Marcum, Peter A Glassman, John Lowe, Maria K Mor, Michael J Fine, and Walid F Gellad. (2016) 2016. “Variation in Formulary Management Practices Within the Department of Veterans Affairs Health Care System.”. Journal of Managed Care & Specialty Pharmacy 22 (2): 114-20. https://doi.org/10.18553/jmcp.2016.14251.

BACKGROUND: All Department of Veterans Affairs Medical Centers (VAMCs) operate under a single national drug formulary, yet substantial variation in prescribing and spending exists across facilities. Local management of the national formulary may differ across VAMCs and may be one cause of this variation.

OBJECTIVE: To characterize variation in the management of nonformulary medication requests and pharmacy and therapeutics (P&T) committee member perceptions of the formulary environment at VAMCs nationwide.

METHODS: We performed an online survey of the chief of pharmacy and an additional staff pharmacist and physician on the P&T committee at all VAMCs. Respondents were asked questions regarding criteria for use for nonformulary medications, specific procedures for ordering nonformulary medications in general and specific lipid-lowering and diabetes agents, the appeals process, and the formulary environment at their VAMCs. We compared responses across facilities and between chiefs of pharmacy, pharmacists, and physicians.

RESULTS: A total of 212 chief pharmacists (n = 80), staff pharmacists (n = 78), and physicians (n = 54) responded, for an overall response rate of 49%. In total, 107/143 (75%) different VAMCs were represented. The majority of VAMCs reported adhering to national criteria for use, with 38 (36%) being very adherent and 69 (65%) being mostly adherent. There was substantial variation between VAMCs regarding how nonformulary drugs were ordered, evaluated, and appealed. The nonformulary lipid-lowering drugs ezetimibe, rosuvastatin, and atorvastatin were viewable to providers in the order entry screen at 67 (63%), 67 (63%), and 64 (60%) VAMCs, respectively. The nonformulary diabetes medication pioglitazone was only viewable at 58 (55%) VAMCs. In the remaining VAMCs, providers could not order these nonformulary drugs through the normal order-entry process. For questions about the formulary environment, physician respondent perceptions differed from those of staff pharmacists and chief pharmacists. Compared with pharmacy chiefs and staff pharmacists, physicians were less likely to agree that providers at their VAMC prescribed too many nonformulary medications (47% and 44% vs. 12%, P < 0.001), more likely to agree that providers must jump through too many hoops to prescribe nonformulary medication (5% and 3% vs. 25%, P < 0.001), and more likely to agree that providers make an effort to convert new patients from nonformulary to formulary lipid-lowering (65% and 73% vs. 94%, P <0.02) and diabetic medications (49% and 50% vs. 88%, P < 0.001).

CONCLUSIONS: Although the Department of Veterans Affairs (VA) operates under a single national formulary, we found significant differences among VAMCs regarding their management of nonformulary medication requests. We also found differences among formulary leaders regarding their perception of the environment in which their VAMC's formulary is managed. These findings have important implications not just for VA, but for any organization that develops, implements, and manages drug formularies across multiple facilities.

Chidi, Alexis P, Shari Rogal, Cindy L Bryce, Michael J Fine, Chester B Good, Larissa Myaskovsky, Vinod K Rustgi, Allan Tsung, and Kenneth J Smith. (2016) 2016. “Cost-Effectiveness of New Antiviral Regimens for Treatment-Naïve U.S. Veterans With Hepatitis C.”. Hepatology (Baltimore, Md.) 63 (2): 428-36. https://doi.org/10.1002/hep.28327.

UNLABELLED: Recently approved, interferon-free medication regimens for treating hepatitis C are highly effective, but extremely costly. We aimed to identify cost-effective strategies for managing treatment-naïve U.S. veterans with new hepatitis C medication regimens. We developed a Markov model with 1-year cycle length for a cohort of 60-year-old veterans with untreated genotype 1 hepatitis C seeking treatment in a typical year. We compared using sofosbuvir/ledipasvir or ombitasvir/ritonavir/paritaprevir/dasabuvir to treat: (1) any patient seeking treatment; (2) only patients with advanced fibrosis or cirrhosis; or (3) patients with advanced disease first and healthier patients 1 year later. The previous standard of care, sofosbuvir/simeprevir or sofosbuvir/pegylated interferon/ribavirin, was included for comparison. Patients could develop progressive fibrosis, cirrhosis, or hepatocellular carcinoma, undergo transplantation, or die. Complications were less likely after sustained virological response. We calculated the incremental cost per quality-adjusted life year (QALY) and varied model inputs in one-way and probabilistic sensitivity analyses. We used the Veterans Health Administration perspective with a lifetime time horizon and 3% annual discounting. Treating any patient with ombitasvir-based therapy was the preferred strategy ($35,560; 14.0 QALYs). All other strategies were dominated (greater costs/QALY gained than more effective strategies). Varying treatment efficacy, price, and/or duration changed the preferred strategy. In probabilistic sensitivity analysis, treating any patient with ombitasvir-based therapy was cost-effective in 70% of iterations at a $50,000/QALY threshold and 65% of iterations at a $100,000/QALY threshold.

CONCLUSION: Managing any treatment-naïve genotype 1 hepatitis C patient with ombitasvir-based therapy is the most economically efficient strategy, although price and efficacy can impact cost-effectiveness. It is economically unfavorable to restrict treatment to patients with advanced disease or use a staged treatment strategy. (Hepatology 2016;63:428-436).

Cunningham, Francesca E, Kwan Hur, Diane Dong, Donald R Miller, Rongping Zhang, Xiangming Wei, Madeline McCarren, et al. (2016) 2016. “A Comparison of Neuropsychiatric Adverse Events During Early Treatment With Varenicline or a Nicotine Patch.”. Addiction (Abingdon, England) 111 (7): 1283-92. https://doi.org/10.1111/add.13329.

AIMS: We compared the risk of mental health episodes requiring hospitalization (primary aim) or out-patient clinic visits (secondary aim) associated with varenicline versus the nicotine patch (NP) in an era prior to psychiatric boxed warnings.

DESIGN: Retrospective cohort.

SETTING: Department of Veterans Affairs (VA), USA.

PARTICIPANTS: VA patients with or without psychiatric comorbidities and a new prescription for varenicline (15 255) were propensity score-matched (1 : 2) to new users of NP (123 054) between 1 May 2006 and 30 September 2007, resulting in 11 774 and 23 548 patients in the varenicline and NP groups, respectively.

MEASUREMENTS: The primary outcomes were hospitalizations with a primary discharge diagnosis of a range of mental health disorders: depression, schizophrenia, bipolar disorder, suicide attempt, post-traumatic stress disorder, other psychosis and drug-induced mental disorders. Secondary outcomes were out-patient clinic visits with a primary diagnosis of the above list of mental health disorders.

FINDINGS: Background characteristics of the treatment groups were similar after matching. There was no statistically significant difference in risk of hospitalization for any of the studied mental health disorders with varenicline compared with NP. Among secondary outcomes there was an increased risk of out-patient clinic visits for schizophrenia among patients who received varenicline [hazard ratio (HR) = 1.27; 95% confidence interval (CI) = 1.07, 1.51], this increase being evident only in those with a pre-existing mental health disorder.

CONCLUSION: In US VA patients studied prior to the boxed warning being implemented, use of varenicline for smoking cessation was not associated with a detectable increase compared with nicotine patches in hospitalization for any mental health outcomes. There was an increased rate of out-patient attendances with a primary diagnosis of schizophrenia amounting to five per 100 person years of treatment. This increase was found only in patients with a pre-existing mental health disorder.