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We described insulin glargine (originator) and insulin glargine-yfgn (biosimilar) treatment patterns, assessed effectiveness and safety outcomes, and identified reasons for switching back to the originator product from the biosimilar. This retrospective study included 328,463 Veterans 18 years of age and older who received one or more outpatient prescriptions for insulin glargine and/or insulin glargine-yfgn between 1 June 2021 and 31 December 2022. Patients were assigned to subgroups based on the initial prescription during the study period, prevalent versus incident use for originator insulin glargine, and prior versus no prior use of the originator before the biosimilar (i.e., prevalent originator non-switcher (n = 189,734), originator switch to biosimilar (n = 81,010), incident originator non-switcher (n = 49,401), and incident biosimilar (n = 8318)). There were no differences in the outcome of mean HbA1c (7.9% for all subgroups). There were also no differences in the unadjusted rates of hospitalization and/or emergency room visits for hyper- and hypoglycemia between the prevalent originator non-switcher and originator switched to biosimilar subgroups (p = 0.09 and 0.38, respectively) or the incident originator non-switcher and incident biosimilar subgroups (p = 0.054 and 0.61, respectively). Finally, none of the HbA1c or hyperglycemia outcomes adjusted for baseline characteristics were statistically different. Adjusted analyses for rates of hospitalization and/or emergency room visits for hypoglycemia could not be performed due to the low number of events. Overall, patients who received insulin glargine-yfgn had similar effectiveness and safety outcomes as patients who received the originator.

Background: Real-world data on use of PCSK9 inhibitors (PCSK9-Is), with or without statins and/or ezetimibe, and associated outcomes, can inform more effective prescribing. The objective was to evaluate clinical effectiveness and safety of PCSK9-Is within the Veterans Health Administration (VHA). Methods: In this retrospective cohort study, we included Veterans who had at least one outpatient prescription for alirocumab and/or evolocumab filled within VHA between August 21, 2015, and September 30, 2020. Analyses included 4 mutually exclusive subgroups: PCSK9-I alone, PCSK9-I+statin, PCSK9-I+ezetimibe, and PCSK9-I+statin+ezetimibe subgroups. Primary outcomes included medication possession ratio, persistence, and low-density lipoprotein (LDL). Results: Among Veterans in the analytical cohort (n = 2428), 36.2% were on PCSK9-I monotherapy; 24.0% received a PCSK9-I+statin; 27.4% were on a PCSK9-I+ezetimibe; and 12.4% received triple therapy, that is, PCSK9-I+statin+ezetimibe. The mean medication possession ratio (standard deviation [SD]) for PCSK9-I monotherapy was 83.8% (13.3) compared to 84.3% (11.2) with PCSK9-I+statin therapy, 87.1% (10.1) with PCSK9-I+ezetimibe therapy, and 85.8% (11.7) with triple therapy. The percentage of patients who discontinued PCSK9-I in the monotherapy subgroup was 12.3% vs 9.5%, 6.6%, and 7.4% in the concomitant statin, ezetimibe, and triple-therapy subgroups, respectively (p = .002 among the groups). Mean LDL level was greater in the PCSK9-I monotherapy subgroup (85.6 mg/dL) compared with the concomitant statin (66.5 mg/dL), ezetimibe (65.7 mg/dL), and triple-therapy subgroups (68.1 mg/dL). Conclusions: Veterans showed good adherence and/or persistence with PCSK9-I regimens. On average, those receiving concomitant therapy with a statin and/or ezetimibe achieved significantly lower LDL levels.

Abstract The objective of this study was to evaluate the association between fluoroquinolone (FQ) use and the occurrence of aortic aneurysm/dissection (AA/AD), acute myocardial infarction (AMI), ventricular arrhythmias (VenA), and all‐cause mortality vs other commonly used antibiotics. We conducted a self‐controlled case series analysis of patients who experienced the outcomes of AA/AD, AMI, and VenA, based on diagnosis codes from emergency department visits and hospitalizations within Veterans Health Administration, and death in FY2014‐FY2018. These Veterans also received outpatient prescriptions for FQs. Conditional Poisson regression models were used to estimate the association between FQs and each of the outcomes vs antibiotics of interest (ie amoxicillin or amoxicillin/clavulanate, azithromycin, doxycycline, cefuroxime or cephalexin, or sulfamethoxazole‐trimethoprim), adjusted for time‐varying covariates. Using a 30‐day risk period after each antibiotic prescription, adjusted incidence rate ratios (aIRRs) for FQs vs each comparator antibiotic were not statistically different for outcomes of VenA or AMI. For AA/AD, incidence was higher during FQ risk periods vs amoxicillin [aIRR 1.50 (95% CI 1.01, 2.25)] and azithromycin [aIRR 2.15 (95% CI 1.27, 3.64)] risk periods. A significantly increased risk of mortality was observed with FQs vs each antibiotic of interest. FQs were associated with an increased risk of AA/AD vs amoxicillin and azithromycin and an increased risk of all‐cause mortality vs multiple antibiotics commonly used for outpatient infections. Although the differences in event rates are small, FQ use should be limited to serious infections without appropriate alternatives.

Abstract Background Facilitating appropriate and safe prescribing of opioid medications for chronic pain management in primary care is a pressing public health concern. Interdisciplinary team-based models of primary care are exploring the expansion of clinical pharmacist roles to support disease management for chronic conditions, e.g. pain. Our study aims to 1) identify roles clinical pharmacists can assume in primary care team based chronic pain care processes and 2) understand the barriers to assuming these expanded roles. Methods Setting: Veterans Health Administration (VA) has implemented an interdisciplinary team-based model for primary care which includes clinical pharmacists. Design: We employed an inductive two part qualitative approach including focus groups and semi-structured interviews with key informants. Participants: 60 members of VA primary care teams in two states participated in nine preliminary interdisciplinary focus groups where a semi-structured interview guide elucidated provider experiences with screening for and managing chronic pain. To follow up on emergent themes relating to clinical pharmacist roles, an additional 14 primary care providers and clinical pharmacists were interviewed individually. We evaluated focus group and interview transcripts using the method of constant comparison and produced mutually agreed upon themes. Results Clinical pharmacists were identified by primary care providers as playing a central role with the ongoing management of opioid therapy including review of the state prescription drug monitoring program, managing laboratory screening, providing medication education, promoting naloxone use, and opioid tapering. Specific barriers to clinical pharmacists role expansion around pain care include: limitations of scopes of practice, insufficient institutional support (low staffing, dedicated time, insufficient training, lack of interdisciplinary leadership support), and challenges and opportunities for disseminating clinical pharmacists’ expanded roles. Conclusions Expanding the role of the clinical pharmacist to collaborate with providers around primary care based chronic pain management is a promising strategy for improving pain management on an interdisciplinary primary care team. However, expanded roles have to be balanced with competing responsibilities relating to other conditions. Interdisciplinary leadership is needed to facilitate training, resources, adequate staffing, as well as to prepare both clinical pharmacists and the providers they support, about expanded clinical pharmacists’ scopes of practice and capabilities.

The term “clinical inertia” is used to describe the failure to manage a chronic condition aggressively enough to bring it under control. The underlying mechanisms for clinical inertia remain poorly understood. To describe one potential mechanism for clinical inertia, seen through the lens of clinician responses to a computerized hypertension reminder. Cohort study. A total of 509 hypertensive patients from 2 primary care clinics in urban Veterans Health Administration (VA) Medical Centers. All patients had elevated blood pressure (BP) values that triggered a computerized reminder. Given a set of possible responses to the reminder, clinicians asserted at least once for each patient that medication adjustments were unnecessary because the BP was “usually well controlled”. Using recent BP values from the electronic medical record, we assessed the accuracy of this assertion. In most instances (57%), recent BP values were not well controlled, with the systolic BP (56%) much more likely to be elevated than the diastolic BP (13%). Eighteen percent of recent systolic BP values were 160 mmHg or greater. When clinicians asserted that the BP was “usually well controlled”, objective evidence frequently suggested otherwise. This observation provides insight into one potential mechanism underlying clinical inertia. [ABSTRACT FROM AUTHOR]

OBJECTIVE:: We tested whether interval exposure to an automated drug alert system that included approximately 2000 drug–drug interaction alerts increased recognition of selected interacting drug pairs. We also examined other perceptions about computerized order entry.RESEARCH DESIGN:: We administered cross-sectional surveys in 2000 and 2002 that included more than 260 eligible clinicians in each time period.SUBJECTS:: We studied clinicians practicing in ambulatory settings within a Southern California Veterans Affairs Healthcare System and who responded to both surveys (97 respondents).MEASURES:: We sought to measure (1) recognition of selected drug–drug and drug–condition interactions and (2) other benefits and barriers to using automated drug alerts.RESULTS:: Clinicians correctly categorized similar percentages of the 7 interacting drug–drug pairs at baseline and follow-up (53% vs. 54%, P = 0.51) but improved their overall recognition of the 3 contraindicated drug–drug pairs (51% vs. 60%, P = 0.01). No significant changes from baseline to follow-up were found for the 8 interacting drug–condition pairs (60% vs. 62%, P = 0.43) or the 4 contraindicated drug–condition pairs (52% vs. 56%, P = 0.24). More providers preferred using order entry at follow-up than baseline (63% vs. 45%, P < 0.001). Signal-to-noise ratio remained the biggest reported problem at follow-up and baseline (54 vs. 57%, P = 0.75). In 2002, clinicians reported seeing a median of 5 drug alerts per week (representing approximately 12.5% of prescriptions entered), with a median 5% reportedly leading to an action.CONCLUSIONS:: Interval exposure to automated drug alerts had little to no effect on recognition of selected drug–drug interactions. The primary perceived barrier to effective utilization of drug alerts remained the same over time. [ABSTRACT FROM AUTHOR]

OBJECTIVE:: The objective of this study was to contrast experiences and opinion of providers in military treatment facilities, where a single formulary is used, with those of community providers where multiple formularies and preferred lists are commonly encountered. STUDY DESIGN:: We conducted cross-sectional surveys. SETTING:: The study was conducted at military and community practices that serve military beneficiaries. PARTICIPANTS:: We studied randomly selected clinicians, stratified by military treatment facility (MTF) size or number of military beneficiaries served. The final samples included 566 eligible MTF and 557 private clinicians, with 69% and 38% response rates, respectively. OUTCOME MEASURES:: We wanted to determine experiences with and opinions of formularies and/or preferred lists and related policies. RESULTS:: Sixty-three percent of military providers were very familiar with formulary content and 60% with nonformulary request procedures; 67% thought their formulary was up-to-date and 84% felt Pharmacy & Therapeutics (P&T) committees were responsive to providers. In contrast, 23% of community providers felt very familiar with (multiple) formulary content and 10% with nonformulary request procedures. Only 15% perceived that formularies were current and 34% thought P&T committees were responsive to providers. Statistically significant differences remained after analysis of potential bias. CONCLUSIONS:: Community providers were less aware and less satisfied with pharmacy benefits management policies than military providers, likely as a result of their daily interactions with multiple, unrelated pharmacy management systems. Addressing the problems expressed by community providers is imperative for pharmacy benefits managers. [ABSTRACT FROM AUTHOR]

BACKGROUND Clinicians' perceptions about decision support systems may impact the effectiveness of these technologies.OBJECTIVE To explore clinicians' baseline knowledge of common drug interactions and experiences with automated drug alerts within a provider order entry system as a means to better understand the potential benefits and barriers to using this technology.RESEARCH DESIGN Cross-sectional survey.SUBJECTS The study population comprised 263 clinicians practicing within a Southern California Veterans Affairs health care system that used VA's Computerized Patient Record System (CPRS). Response rate was 64%.MEASURES A 67-item survey (19 questions) was developed to elicit information including: (1) computer use for patient-related activities; (2) recognition of drug interactions; and (3) benefits and barriers to using automated drug alerts.RESULTS Clinicians correctly categorized 44% (range 11-64%) of all drug-drug pairs, 53% of interacting combinations, and 54% of contraindicated pairs. Providers also correctly categorized 55% (range 24-87%) of 11 drug-disease pairs and 62% of interacting combinations, and 53% of contraindicated pairs. Nearly 90% of clinicians thought drug alerts would be helpful to identify interactions yet 55% of clinicians perceived that the most significant barrier to utilizing existing alerts was poor signal to noise ratio, meaning too many nonrelevant warnings.CONCLUSIONS Automated drug interaction alerts have the potential to dramatically increase clinicians' recognition of selected drug interactions. However, perceived poor specificity of drug alerts may be an important obstacle to efficient utilization of information and may impede the ability of such alerts to improve patient safety. [ABSTRACT FROM AUTHOR]

Background Drug–drug interactions (DDIs) are common and can result in patient harm. Electronic health records warn clinicians about DDIs via alerts, but the clinical decision support they provide is inadequate. Little is known about clinicians’ real-world DDI decision-making process to inform more effective alerts.Objective Apply cognitive task analysis techniques to determine informational cues used by clinicians to manage DDIs and identify opportunities to improve alerts.Design Clinicians submitted incident forms involving DDIs, which were eligible for inclusion if there was potential for serious patient harm. For selected incidents, we met with the clinician for a 60 min interview. Each interview transcript was analysed to identify decision requirements and delineate clinicians’ decision-making process. We then performed an inductive, qualitative analysis across incidents.Setting Inpatient and outpatient care at a major, tertiary Veterans Affairs medical centre.Participants Physicians, pharmacists and nurse practitioners.Outcomes Themes to identify informational cues that clinicians used to manage DDIs.Results We conducted qualitative analyses of 20 incidents. Data informed a descriptive model of clinicians’ decision-making process, consisting of four main steps: (1) detect a potential DDI; (2) DDI problem-solving, sensemaking and planning; (3) prescribing decision and (4) resolving actions. Within steps (1) and (2), we identified 19 information cues that clinicians used to manage DDIs for patients. These cues informed their subsequent decisions in steps (3) and (4). Our findings inform DDI alert recommendations to improve clinicians’ decision-making efficiency, confidence and effectiveness.Conclusions Our study provides three key contributions. Our study is the first to present an illustrative model of clinicians’ real-world decision making for managing DDIs. Second, our findings add to scientific knowledge by identifying 19 cognitive cues that clinicians rely on for DDI management in clinical practice. Third, our results provide essential, foundational knowledge to inform more robust DDI clinical decision support in the future.