Publications

2025

Kim, Katherine Callaway, Julie M Donohue, Eric T Roberts, Chester B Good, Lindsay M Sabik, and Katie J Suda. (2025) 2025. “Prescriber-Level Responses to the 2018-2019 Valsartan, Irbesartan, and Losartan Recalls and Drug Shortages: A National Study.”. Medical Care. https://doi.org/10.1097/MLR.0000000000002209.

BACKGROUND: Global shortages for 3 angiotensin receptor-II blockers (ARBs)-valsartan, losartan, and irbesartan-occurred in 2018-2019 after recalls due to ingredient impurities. Provider-level responses to the ARB shortages in the United States and spillovers to other antihypertensive classes are unknown.

OBJECTIVE: To estimate changes in provider-level prescribing for ARBs and non-ARB antihypertensives up to 18 months after the 2018-2019 recalls and shortages.

RESEARCH DESIGN: National cohort study of prescribers using all-payer pharmacy claims. Mixed interrupted time series models quantified changes in prescribing postshortages and heterogeneous changes by specialty, region, medical school graduation cohort, sex, and level of prerecall prescribing.

PATIENTS AND METHODS: Active providers exposed to the 2018-2019 valsartan, irbesartan, and losartan shortages (defined as top-25th percentile for these drugs in 2017).

MEASURES: Within-class changes in prescribing for ARBs (recalled and nonrecalled). Between-class substitutions to non-ARB antihypertensives (ACE-Is, alpha- and beta-adrenergic blockers, calcium channel blockers, diuretics, and other agents).

RESULTS: Among 138,032 prescribers who met the inclusion criteria, per-prescriber fills for valsartan decreased by 57%-59% after it was recalled in July 2018. We observed concurrent increases for losartan and irbesartan fills and no change in overall ARB prescribing. There were no significant changes in fills for ACE-Is or for other antihypertensives. Absolute decreases in valsartan fills were greatest among providers with higher levels of prescribing at baseline. However, relative changes did not differ by prescriber characteristics.

CONCLUSIONS: In this prescriber level, national study, substitutions to other ARBs mitigated decreases in valsartan fills after it was recalled. There were no spillovers to non-ARB anti-hypertensives. The availability of close substitutes during drug shortages may mitigate gaps in access for prescribers and their patients.

Miner, Tate William, Katherine Callaway Kim, Scott Rothenberger, Shanzeh Chaudhry, Mina Tadrous, and Katie J Suda. (2025) 2025. “Impact of Implementation of World Health Organization National Action Plans on Antibiotic Rates: A Time Series Analysis of 37 Countries.”. Infection Control and Hospital Epidemiology, 1-4. https://doi.org/10.1017/ice.2025.10293.

We conducted an interrupted time series analysis to assess changes in antibiotic sales in 37 countries that implemented National Action Plans (NAPs) between 2013 and 2018. Overall, NAP implementation was not associated with changes in antibiotic sales two years later, with country-specific effects ranging from a 38.3% decrease to 65.3% increase.

Etemadi, Ali, Parth Kumar, Timothy S Anderson, and Tara I Chang. (2025) 2025. “Acute Elevated Blood Pressure in the Inpatient Setting.”. Heart (British Cardiac Society). https://doi.org/10.1136/heartjnl-2025-325845.

Elevated blood pressure (BP) in the inpatient setting is frequently encountered by most healthcare providers. While there is general consensus on the management of acute BP elevations when associated with end-organ damage, these cases of true hypertensive emergency are relatively infrequent. In contrast, asymptomatic acute BP elevations are considerably more frequent, yet there is little consensus on their appropriate management. Contributing factors include concerns about missing true emergencies, the barriers affecting the accuracy of inpatient BP measurements and a lack of consistent data on the short- and long-term impact of inpatient BP elevations. Practice varies widely, even between departments within the same hospital, and includes observation, intravenous antihypertensives, oral agents and adjustments to existing regimens. Some clinicians also choose to discharge patients on intensified therapy based on inpatient BP values. However, despite the high prevalence of elevated BP in the inpatient setting, evidence remains heterogeneous and fragmented. This review aims to synthesise current knowledge and provide a practical, holistic framework for evaluating and managing elevated BP in the inpatient setting.

Palatucci, John S, Sujoy Chakravarty, Evan S Cole, Jose Nova, Taiisa Kelly, Julie M Donohue, Everette James, and Joel C Cantor. (2025) 2025. “Medicaid Enrollment Following the ACA Eligibility Expansion Among Persons Using Homelessness Services: An Interrupted Time-Series Analysis.”. Research Square. https://doi.org/10.21203/rs.3.rs-6247440/v1.

Background Persons experiencing homelessness bear high rates of morbidity, injury, and mortality. Medicaid offers an opportunity to provide support, but barriers persist to enrolling and maintaining enrollment among this vulnerable population. The objective of this study was to determine the initial and longer-term effects of the Affordable Care Act (ACA) Medicaid eligibility expansion on Medicaid enrollment among persons observed to be unhoused or housing insecure through recorded housing services utilization. Methods We applied interrupted time-series analyses of linked administrative data from two expansion states - New Jersey (NJ) and Pennsylvania (PA); Homeless Management Information System data were linked to monthly Medicaid enrollment files of non-elderly adults (aged 18-64) utilizing shelter, street outreach and other housing assistance from January 2011 to December 2016. The study outcome was a binary measure of Medicaid enrollment status in month of Homelessness Management Information System service exit overall and stratified by race/ethnicity. Results ACA Medicaid eligibility expansion was associated with a level change in the likelihood of enrollment of 7.5 percentage points (pp) in NJ and 8.5 pp in PA. The trend in enrollment post-expansion also increased by 0.6 pp/month in NJ. Compared to no homeless-related service use in the year, being recorded with one month with a shelter stay or other homelessness assistance services in the year was associated with a higher likelihood of Medicaid enrollment (14.8 pp higher in NJ and 6.9 pp higher in PA), and likelihood of enrollment was highest when two or more months with homelessness assistance services were used in the year (18.6 pp higher in NJ and 12.8 pp higher in PA). However, the effect of the policy change attenuated back to the pre-ACA trend in both states by the end of 2016. Results were similar across race/ethnicity stratifications. Conclusions We found significant increases in the likelihood of Medicaid enrollment after the ACA Medicaid expansions in the months immediately following the expansion. Additional months with homeless shelter stay or other housing services for unhoused persons were associated with a higher likelihood of Medicaid enrollment; this suggests the need for further investigation into the potential of leveraging staff-client relationships at homelessness assistance programs during future health policy initiatives.

Cupler, Zachary A, Kristina L Hruska, Nicole M Beyer, Loren J Schleiden, Keri L Rodriguez, Liam Rose, Aimee N Pickering, Carolyn T Thorpe, and Thomas R Radomski. (2025) 2025. “VA Clinicians’ Perspectives on Low-Value Health Service Use in the Veterans Health Administration: A Qualitative Study.”. Journal of General Internal Medicine. https://doi.org/10.1007/s11606-025-09838-3.

BACKGROUND: Low-value health services adversely affect outcomes and unnecessarily increase the cost of care. Approximately 10% of Veterans receive at least one of 29 low-value services delivered or paid for by the Veterans Health Administration (VA) annually. However, determinants of and potential solutions to reduce low-value service delivery are poorly understood.

OBJECTIVE: To characterize the drivers of and approaches to reduce low-value service delivery across VA Medical Centers (VAMCs) from the perspective of VA clinicians.

DESIGN: Qualitative study using semi-structured interviews conducted from October 2022 to November 2023.

PARTICIPANTS: 65 VA clinicians, including 32 generalists and 33 medical and surgical specialists, at 46 VAMCs.

APPROACH: We used deductive analysis based on a priori categories and definitions structured by the Theoretical Domains Framework to identify predominant themes related to drivers of low-value service delivery. We used inductive analysis to identify clinician-suggested approaches to reduce low-value services.

KEY RESULTS: We identified three overarching domains as drivers of low-value service delivery at VA: 1) environmental context and resources; 2) social influence; and 3) belief about consequences. Regarding key subthemes, social pressure from Veterans emerged among generalists and specialists. Generalists were more likely to identify referral parameters or requirements compared to specialists, while specialists were more like to identify negative consequences compared to generalists. We identified four overarching domains as approaches to reduce low-value service delivery at VA, which were consistently identified by both generalists and specialists: 1) improving quality and access to VA health care; 2) dissemination of best practices; 3) optimizing use of the electronic health record; and 4) instilling an organizational culture on value.

CONCLUSIONS: We identified the most salient drivers of and approaches to reduce low-value services from the perspective of VA clinicians. These findings may inform the design of future de-implementation interventions and policy to reduce VA-delivered low-value services.

Schapira, Marilyn M, Sumedha Chhatre, Patience M Dow, Charles E Leonard, Peter Groeneveld, Jason M Prigge, Christopher Roberts, et al. (2025) 2025. “The Impact of Opioid Use Associated With Curative-Intent Cancer Surgery on Safe Opioid Prescribing Practice Among Veterans: An Observational Study.”. Cancer 131 (18): e70009. https://doi.org/10.1002/cncr.70009.

BACKGROUND: Opioid exposure during cancer therapy may increase long-term unsafe opioid prescribing. This study sought to determine the rates of coprescription of benzodiazepine and opioid medications and new persistent opioid use after surgical treatment of early-stage cancer.

METHODS: A retrospective cohort study was conducted among a US veteran population via the Veterans Affairs Corporate Data Warehouse database. Participants were opioid-naive persons aged ≥21 years with a new diagnosis of stage 0-III cancer between January 1, 2015, and December 31, 2016. Outcomes were days of coprescription of benzodiazepines and opioids in the 13 months posttreatment and new persistent opioid use. The exposure was total morphine milligram equivalents (MMEs) attributed to treatment and prescribed from 30 days before through 14 days after the index surgical procedure.

RESULTS: Among 9213 veterans, coprescription of benzodiazepines and opioids occurred in 366 patients (4.0%) and new persistent opioid use in 981 patients (10.6%). In a linear model adjusting for patient, clinical, and geographic factors, persons in the highest quartile compared to no opioid exposure had increased days with coprescription of benzodiazepines and opioids (mean difference, 1.0; 95% CI, 0.3-1.7). In a discrete time survival analysis, persons in the highest quartile of MME exposure compared to none had a greater risk of new persistent opioid use (hazard ratio, 1.6; 95% CI, 1.3-1.9).

CONCLUSIONS: More than one of 10 opioid-naive veterans undergoing curative-intent surgical treatment for cancer developed new persistent opioid use. Optimizing cancer treatment pain management strategies to mitigate long-term opioid-related health risks is crucial.

Dow, Patience M, Christopher M Santostefano, Landon D Hughes, Elizabeth G Stettenbauer, Theresa I Shireman, Julie M Donohue, Lisa Peterson, and Jaclyn M W Hughto. (2025) 2025. “Medicaid Prescription Cap Policies and Acute Care Use and Mortality Among Enrollees With Opioid Use Disorder.”. Drug and Alcohol Dependence 276: 112856. https://doi.org/10.1016/j.drugalcdep.2025.112856.

BACKGROUND: Twelve state Medicaid programs limit the monthly number of covered prescriptions. Such cap policies may force enrollees to forego essential medications with important health consequences. We aimed to determine the impact of cap policies on acute care use and all-cause mortality among enrollees with opioid use disorder (OUD).

METHODS: Using 2016-2019 T-MSIS Analytical Files, we propensity-score matched enrollees with OUD in 12 states with cap policies and 26 states without cap policies. Outcomes measured over 12 months included emergency department (ED) visits, hospitalization, and all-cause mortality and were analyzed via generalized linear regression models. We conducted subgroup analyses by use of medications for OUD (MOUD) and comorbidity level and sensitivity analyses to examine the role of cap policy characteristics.

RESULTS: Unadjusted risks were 64.0 % vs. 62.5 % for ED visits, 27.6 % vs. 27.5 % for hospitalizations, and 3.2 % vs. 2.7 % for mortality in cap states and non-cap states, respectively. After adjustment, hospitalization risk was higher (RR=1.89, 99.5 %CI:1.13,3.16) in cap states than non-cap states whereas ED visits and mortality did not differ. There were largely no outcome differences by cap status in subgroups. Strict prescription limits allowing 3-4 prescriptions monthly (RR=1.90, 95 %CI:1.09,3.30) and lack of MOUD exemptions (RR=2.23, 95 %CI:1.32,3.78) were associated with increased hospitalization risk relative to non-cap states.

CONCLUSIONS: Medicaid prescription cap policies were associated with increased hospitalization risk, but there were no differences in ED use or all-cause mortality. Cap policies may undermine the health of individuals with OUD and could be counterproductive to state efforts to curb Medicaid spending.

Donahoe, Travis, Noa Krawczyk, Julie M Donohue, Dylan Nagy, and Paul J Joudrey. (2025) 2025. “Restrictive State Opioid Treatment Program Regulations Constrain Local Access To Methadone Maintenance Treatment.”. Health Affairs (Project Hope) 44 (9): 1173-80. https://doi.org/10.1377/hlthaff.2025.00341.

State regulations governing opioid treatment programs (OTPs) vary widely in their restrictiveness, but how they affect geographic access to methadone maintenance treatment for opioid use disorder remains poorly understood. In this study of comprehensive data on methadone shipments to OTPs in 2019, we found that ZIP codes just across the border in states with low restrictiveness in OTP regulations had more than twice the OTP density and methadone shipments compared with nearby and otherwise similar ZIP codes in states with high restrictiveness. These findings suggest that restrictive state OTP regulations constrain geographic access to methadone maintenance treatment and that easing such restrictions is a viable strategy to expand access.