Publications

2015

Thorpe, Carolyn T, Walid F Gellad, Chester B Good, Sijian Zhang, Xinhua Zhao, Maria Mor, and Michael J Fine. (2015) 2015. “Tight Glycemic Control and Use of Hypoglycemic Medications in Older Veterans With Type 2 Diabetes and Comorbid Dementia.”. Diabetes Care 38 (4): 588-95. https://doi.org/10.2337/dc14-0599.

OBJECTIVE: Older adults with diabetes and dementia are at increased risk for hypoglycemia and other adverse events associated with tight glycemic control and are unlikely to experience long-term benefits. We examined risk factors for tight glycemic control in this population and use of medications associated with a high risk of hypoglycemia in the subset with tight control.

RESEARCH DESIGN AND METHODS: This retrospective cohort study of national Veterans Affairs (VA) administrative/clinical data and Medicare claims for fiscal years (FYs) 2008-2009 included 15,880 veterans aged ≥ 65 years with type 2 diabetes and dementia and prescribed antidiabetic medication. Multivariable regression analyses were used to identify sociodemographic and clinical predictors of hemoglobin A1c (HbA1c) control (tight, moderate, poor, or not monitored) and, in patients with tight control, subsequent use of medication associated with a high risk of hypoglycemia (sulfonylureas, insulin).

RESULTS: Fifty-two percent of patients had tight glycemic control (HbA1c <7% [53 mmol/mol]). Specific comorbidities, older age, and recent weight loss were associated with greater odds of tight versus moderate control, whereas Hispanic ethnicity and obesity were associated with lower odds of tight control. Among tightly controlled patients, 75% used sulfonylureas and/or insulin, with higher odds in patients who were male, black, or aged ≥ 75 years; had a hospital or nursing home stay in FY2008; or had congestive heart failure, renal failure, or peripheral vascular disease.

CONCLUSIONS: Many older veterans with diabetes and dementia are at high risk for hypoglycemia associated with intense diabetes treatment and may be candidates for deintensification or alteration of diabetes medications.

Lund, Brian C, Margaret Carrel, Walid F Gellad, Elizabeth A Chrischilles, and Peter J Kaboli. (2015) 2015. “Incidence- Versus Prevalence-Based Measures of Inappropriate Prescribing in the Veterans Health Administration.”. Journal of the American Geriatrics Society 63 (8): 1601-7. https://doi.org/10.1111/jgs.13560.

OBJECTIVES: To describe variations in potentially inappropriate prescribing (PIP) and characterize the extent to which switching to an incidence-based indicator would affect health system quality rankings.

DESIGN: Observational study.

SETTING: Veterans Health Administration in 2011.

PARTICIPANTS: Older adults receiving outpatient primary care.

MEASUREMENTS: PIP was defined according to the National Committee for Quality Assurance High-Risk Medications in the Elderly list. Ranks were separately assigned for prevalent and incident PIP at the regional, network, and healthcare system levels.

RESULTS: National PIP prevalence was 12.3% (167,766/1,360,251), and incidence was 5.8% (78,604/1,360,251). PIP prevalence ranged from 3.5% to 33.1% across healthcare systems (interquartile range (IQR) = 9.2-15.5%). PIP incidence ranged from 1.2% to 14.9% (IQR = 4.1-7.2%). Rank order in PIP prevalence and incidence was correlated (Spearman correlation; ρ = 0.934, P < .001), although substantial changes in ranks were seen for some healthcare systems, with seven of 139 (5.0%) systems shifting more than 30 rank positions and 21 (15.1%) systems shifting 16 to 30 positions.

CONCLUSION: Prevalence- and incidence-based indicators of prescribing quality were strongly correlated. Transitioning to incidence-based indicators would not produce an initial disruption in quality rankings for most healthcare systems and might yield more-salient measures for tracking healthcare quality.

Zullig, Leah L, Walid F Gellad, Jivan Moaddeb, Matthew J Crowley, William Shrank, Bradi B Granger, Christopher B Granger, Troy Trygstad, Larry Z Liu, and Hayden B Bosworth. (2015) 2015. “Improving Diabetes Medication Adherence: Successful, Scalable Interventions.”. Patient Preference and Adherence 9: 139-49. https://doi.org/10.2147/PPA.S69651.

Effective medications are a cornerstone of prevention and disease treatment, yet only about half of patients take their medications as prescribed, resulting in a common and costly public health challenge for the US health care system. Since poor medication adherence is a complex problem with many contributing causes, there is no one universal solution. This paper describes interventions that were not only effective in improving medication adherence among patients with diabetes, but were also potentially scalable (ie, easy to implement to a large population). We identify key characteristics that make these interventions effective and scalable. This information is intended to inform health care systems seeking proven, low resource, cost-effective solutions to improve medication adherence.

2014

Soni, Amy, Sherrie L Aspinall, Xinhua Zhao, Chester B Good, Francesca E Cunningham, Gurkamal Chatta, Vida Passero, and Kenneth J Smith. (2014) 2014. “Cost-Effectiveness Analysis of Adjuvant Stage III Colon Cancer Treatment at Veterans Affairs Medical Centers.”. Oncology Research 22 (5-6): 311-9. https://doi.org/10.3727/096504015X14424348426152.

The objective of this study was to evaluate the real-world cost effectiveness of adjuvant stage III colon cancer chemotherapy regimens, given that previous analyses have been based on data from clinical trials. The study was designed using integrated decision tree and Markov model, which was developed to evaluate the cost effectiveness of 5-fluorouracil/leucovorin (5-FU/LV), capecitabine, and the combination of each with oxaliplatin. The analysis was performed from a US Veterans Affairs perspective via retrospectively collected data, over a 5-year model time horizon. Outcome and cost data were used to calculate cost per quality adjusted life year (QALY), and one-way and probabilistic sensitivity analyses were performed. In the base case analysis, capecitabine and capecitabine plus oxaliplatin both cost more and were less effective than other regimens, and 5-FU/LV plus oxaliplatin, compared to 5-FU/LV alone, resulted in a cost of $25,997 per QALY gained. Model results were generally robust to parameter variation. Capecitabine plus oxaliplatin could be economically reasonable if full dosing occurred ≥76% of the time (base case 42%). In a real-world setting, the addition of oxaliplatin to 5-FU/LV is more effective but also more costly than 5-FU/LV alone. If full dosing of capecitabine-containing regimens can be assured, they may also be cost-effective strategies.

Glassman, Peter A, Paul L Schneider, and Chester B Good. (2014) 2014. “An Ethical Framework for Pharmacy Management: Balancing Autonomy and Other Principles.”. Journal of Managed Care & Specialty Pharmacy 20 (4): 334-8. https://doi.org/10.18553/jmcp.2014.20.4.334.

Decisions to control pharmaceutical costs can cause conflicts as to what medications are covered. Such conflicts have ethical implications, however implicit, and given this fact, an ethical framework can help address them. In the following commentary, we discuss the more traditional, individual-level ethical considerations likely familiar to most clinicians. We, then, discuss population-level ethical constructs that clinicians may not as readily embrace. We also present a hypothetical cancer-care case to illustrate how imbalances in ethical foci between individual- and population-level constructs may lead to conflicts among health care actors and promote shifts in pharmaceutical decision making away from providers and toward payers, paradoxically reducing provider autonomy and hence patient autonomy. Finally, we propose a more comprehensive ethical framework to help converge individual, payer, and societal interests when making pharmaceutical use decisions. Pharmacists play a crucial role as pharmacy benefits managers and should be familiar with individual- and population-based ethical constructs.

Gellad, Walid F, Phillip Choi, Margaret Mizah, Chester B Good, and Aaron S Kesselheim. (2014) 2014. “Assessing the Chiral Switch: Approval and Use of Single-Enantiomer Drugs, 2001 to 2011.”. The American Journal of Managed Care 20 (3): e90-7.

OBJECTIVES: A "chiral switch" occurs in the pharmaceutical market when a drug made up of 2 enantiomer forms is replaced with a purified single-enantiomer version, often in the context of a patent expiration. We studied the prevalence of chiral switching in the United States over the past decade, including trends in use of, and expenditures on, these products in Medicaid.

STUDY DESIGN: Retrospective analysis.

METHODS: We used US Adopted Names prefixes (lev/levo/ar/es/dex/dextro) to identify all single-enantiomer drugs approved from 2001 to 2011. From publicly available US Food and Drug Administration (FDA) approval documents, we extracted the characteristics of the pivotal premarket trials for the single enantiomers. Specifically, we evaluated whether the single enantiomer was directly compared with the precursor racemic drug and whether there was evidence of superior efficacy. We used quarterly drug expenditure data from each state Medicaid program to chart trends in use of, and spending on, the single-enantiomer products and their racemic precursors during the study period.

RESULTS: From 2001 to 2011, the FDA approved 9 single-enantiomer products: dexlansoprazole, levoleucovorin, levocetirizine, armodafinil, arformoterol, eszopiclone, escitalopram, dexmethylphenidate, and esomeprazole. Of those 9 drugs, 3 had at least 1 pre-approval randomized trial that included the racemic precursor as a direct comparator, but there was no evidence of superiority of the single enantiomer over the racemic at comparable doses. Between 2001 and 2011, US Medicaid programs spent approximately $6.3 billion on these 9 single-enantiomer drugs.

CONCLUSIONS: Recently approved single-enantiomer drugs showed no evidence of superior efficacy over the older racemic precursors in the pivotal trials leading to their approval, and in a majority of cases, they were not directly compared.