Formulary Change Research Articles

Real-world experience with biosimilar infliximab-adba and infliximab-dyyb among infliximab-naïve patients with inflammatory bowel disease in the Veterans Health Administration.

The Veterans Health Administration (VHA) listed the infliximab (IFX) biosimilar, IFX-dyyb (Inflectra), on the Veterans Affairs National Formulary (VANF) in May 2017. In September 2018, biosimilar IFX-abda (Renflexis) became the VANF IFX product. The recommended formulary changes from one IFX biosimilar to another provided a unique opportunity to study IFX utilization patterns in IFX-naïve Veterans with Inflammatory Bowel Disease (IBD). This study aimed to describe IFX and healthcare utilization during the 365 days after initiation with IFX reference product (RP) or biosimilars IFX-dyyb and IFX-adba. This descriptive study was performed using the VHA Corporate Data Warehouse. All Veterans initiated on IFX-RP (Remicade) or biosimilars IFX-dyyb and IFX-adba between September 1, 2016 and December 30, 2019 were included and followed for 365 days. Veterans enrolled in the VHA for at least 365 days with no evidence of IFX before their index date were considered IFX-naïve. Continuous data on IFX use, laboratory measurements, and healthcare utilization were reported with means, 95% confidence interval (CI), medians, and interquartile ranges. Frequency, proportions, and 95% CIs were presented for categorical variables. Statistical tests included ANOVA and Kruskal-Wallis for continuous outcomes, Poisson regression for count-based outcomes (i.e., healthcare utilization visits), and Chi-square for dichotomous outcomes. The study identified 1763 IFX-naïve patients with IBD, and 785, 441, and 537 was indexed to RP, IFX-dyyb, and IFX-adba, respectively. Statistical differences were observed in IFX utilization measures related to dosing, adherence, and persistence. The proportion of days covered (PDC) during the 365-day follow-up period varied among the IFX groups: IFX-RP at 66%, IFX-dyyb at 60%, and IFX-abda at 69% (P value < .001). Persistence with the index IFX product during the 365-day follow-up period also varied: IFX-RP at 43%, IFX-dyyb at 32%, and IFX-abda at 51% (P value < .001). Healthcare utilization and laboratory findings were similar among the IFX groups. IFX utilization and laboratory patterns were clinically similar among the IFX biosimilars and RP groups, suggesting that providers did not modify their practice with biosimilars. Statistically significant differences in IFX utilization patterns are explained by formulary dynamics when the VANF product switched from IFX-dyyb to IFX-abda.

Prescribing Trends for Oral Vancomycin and Fidaxomicin after Guideline and Formulary Changes in Ontario, Canada: An Interrupted Time-Series Analysis.

Clostridioides difficile is a pathogen causing diarrheal illness, which can be treated with vancomycin or fidaxomicin. To evaluate changes in monthly prescription volumes for oral vancomycin and fidaxomicin in Ontario community pharmacies following implementation of the 2017 and 2021 updates to guidelines from the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) and after a 2019 provincial formulary change for vancomycin. An interrupted time-series analysis was conducted from November 2015 to October 2021 using monthly projected prescription volumes obtained from IQVIA's Compuscript database. Level and slope (trend) changes in prescribing were assessed using segmented linear regression. The volume of vancomycin prescriptions increased by 74 prescriptions per month (95% confidence interval [CI] 16 to 132) following implementation of the 2017 guideline update and by 73 prescriptions per month (95% CI 13 to 133) after the 2019 formulary change; however, no statistically significant changes were observed after implementation of the 2021 guideline update. No significant trend changes were observed for fidaxomicin. Guidelines and formulary changes were correlated with increased volume of vancomycin prescriptions.

Budget impact analysis of biosimilar natalizumab in the US.

Biosimilars provide an opportunity for a more sustainable and cost-effective treatment for multiple sclerosis (MS). This study evaluated the potential financial impact of implementing a formulary change from reference to biosimilar natalizumab (NTZ) from the US commercial payer perspective. The budget impact of transitioning to biosimilar NTZ for the treatment of relapsing-remitting MS (RRMS) was estimated over a 3-year time horizon based on real-world dosing. Additional scenario analyses were conducted by varying the price differential of biosimilar NTZ. The target population was estimated from a 1-million-member hypothetical commercial health plan. Model inputs were drug acquisition costs and treatment-related and patient coinsurance costs. Budget impact and cost savings per member per year were calculated by assuming a biosimilar uptake of 10% in year 1 to 20% in year 3. Over 3 years, 255 patients were estimated to be treated with high-efficacy disease-modifying therapies for RRMS. The inclusion of biosimilar NTZ onto a formulary would result in cumulative cost savings to payers of $452,611 over 3 years, with mean savings per treated member per year of $1179, $1769, and $2359 in years 1, 2, and 3, respectively. One-way sensitivity analyses indicated that budget impact results were most sensitive to drug acquisition costs of both reference and biosimilar NTZ. Adoption of biosimilar NTZ can yield considerable cost savings to US health plans that could result in increased treatment access for patients with RRMS.

Real-world treatment patterns and outcomes of zanubrutinib in chronic lymphocytic leukemia and small lymphocytic leukemia (CLL/SLL).

11158 Background: Zanubrutinib (zanu) is a next-generation selective Bruton’s tyrosine kinase inhibitor (BTKi) with superior efficacy over first generation ibrutinib (ibru) in CLL/SLL patients (pts). Herein we present real-world treatment patterns based on a formulary change from ibrutinib to zanubrutinib in pts with CLL/SLL in an integrated community oncology practice. Methods: We retrospectively analyzed CLL/SLL pts 18 years and older who received at least 3 months of zanubrutinib from October 1, 2018 to September 15, 2023 at Kaiser Permanente Northern California. Treatment patterns, treatment-emergent adverse events (TEAEs: AEs reported during BTKi use), treatment-limiting adverse events (TLAEs: AEs leading to BTKi discontinuation), and mortality were reported. Results: A total of 281 pts received zanu (median age: 71 years; 64% male); 190 pts switched from ibru (ibru-zanu), and 91 pts received zanu only. Most pts were White (75%) followed by Black (10%). Compared with ibru-zanu pts, zanu-only pts were older (median age 74 vs 69 years) and had more comorbidities but were comparable in sex, race, and insurance type. The primary reasons for switching to zanu were formulary change (73%) and progression (15%). Median follow-up time after initiation of first BTKi was longer in the ibru-zanu group (Table). Similar TEAE rates were seen with use of both BTKi therapies, with lower TLAE rates with zanu (Table). Most common TLAE were atrial fibrillation and fatigue for ibru, and cytopenias and rash/bruising for zanu. Cardiac TLAE and non-TLAE rates overall were higher with ibru than zanu, and the rates decreased while on zanu after switching from ibru (Table). Dose modification occurred in 34 pts on ibru and 50 pts on zanu (18 ibru-zanu pts, 32 zanu-only pts), with reductions primarily for grade 1-2 AEs. Of the 281 pts who received zanu, 79% remain on treatment at the end of data collection; 13 pts died (8 from infection, including 5 from COVID), with no reports of treatment-related deaths. Conclusions: In the real-world setting post-formulary change, zanu is effective and safe in pts with or without prior ibru use. Zanu use had lower cardiotoxicity and TLAE rates than ibru though data was limited by a difference in follow-up time. Similar results were seen in zanu-only pts despite being older and having more comorbidities, with discontinuation most often due to grade &lt;3 AEs. [Table: see text]

A population-based time-series analysis of opioid agonist treatment dispensed during pregnancy.

Identifying effective opioid treatment options during pregnancy is a high priority due to the growing prevalence of opioid use disorder across North America. We assessed the temporal impact of three population-level interventions on the use of opioid agonist treatment (OAT) during pregnancy in Ontario, Canada. This was a population-based time-series analysis to identify trends in the monthly prevalence of pregnant people dispensed methadone and buprenorphine. The impact of adding buprenorphine/naloxone to the public drug formulary, the release of pregnancy-specific guidance and the start of the COVID-19 pandemic were assessed. The study was conducted in Ontario, Canada between 1 July 2013 and 31 March 2022, comprising people who delivered a live or stillbirth in any Ontario hospital during the study period. We identified any prescription for methadone or buprenorphine dispensed between the estimated conception date and delivery date and calculated the monthly prevalence of OAT-exposed pregnancies among all pregnant people in Ontario. Overall, rates of OAT during pregnancy have declined since mid-2018. Methadone-exposed pregnancies decreased from 0.46% of all pregnancies in Ontario in 2015 to a low of 0.16% in 2022. In the primary analysis, none of the interventions had a statistically significant impact on overall OAT rates; however, in the stratified analyses, there was a small increase in buprenorphine after the formulary change [0.006%, 95% confidence interval (CI) = 0.0032-0.0081, P < 0.0001] and a decrease in buprenorphine after the release of the 2017 guidelines (-0.005%, 95% CI = -0.0080 to -0.0020, P = 0.001) and the start of the COVID-19 pandemic (-0.003%, 95% CI = -0.0054 to -0.0006, P = 0.015). Despite changes in guidance and funding, opioid agonist treatment during pregnancy has been declining in Ontario, Canada since 2018.

Inhaler Formulary Change in COPD and the Association with Exacerbations, Health Care Utilization, and Costs.

Prescription formularies specify which medications are available to patients. Formularies change frequently, potentially forcing patients to switch medications for nonclinical indications (nonmedical switching). Nonmedical switching is known to impact disease control and adherence. The consequences of nonmedical switching have not been rigorously studied in COPD. We conducted a cohort study of Veterans with COPD on inhaler therapy in January 2016 when formoterol was removed from the Department of Veterans Affairs (VA) national formulary. A 2-point difference-in-differences analysis using multivariable negative binomial and generalized linear models was performed to estimate the association of the formulary change with patient outcomes in the 6 months before and after the change. Our primary outcome was the number of COPD exacerbations in 6 months, with secondary outcomes of total health care encounters and encounter-related costs in 6 months. We identified 10,606 Veterans who met our inclusion criteria, of which 409 (3.9%) experienced nonmedical switching off formoterol. We did not identify a change in COPD exacerbations (-0.04 exacerbations; 95% confidence interval [CI] -0.12, 0.03) associated with the formulary change. In secondary outcome analysis, we did not observe a change in the number of health care encounters (-0.12 visits; 95% CI -1.00, 0.77) or encounter-related costs ($369; 95% CI -$1141, $1878). Among COPD patients on single inhaler therapy, nonmedical inhaler switches due to formulary discontinuation of formoterol were not associated with changes in COPD exacerbations, encounters, or encounter-related costs. Additional research is needed to confirm our findings in more severe disease and other settings.

A national heart failure initiative is associated with improved use of quadruple guideline-directed medical therapy

Abstract Background Heart Failure (HF) is projected to impact over 8 million people in the US by 2030. The 2022 AHA/ACC/HFSA Guideline for the Management of HF recommend four foundational medication classes for treating HFrEF patients: RAAS inhibitors, preferably angiotensin receptor/neprilysin inhibitor (ARNi), evidence-based beta-blockers (EBBB), sodium-glucose cotransporter-2 inhibitor (SGLT2i) and mineralocorticoid receptor antagonist (MRA) referred to as Quadruple Guideline-Directed Medical Therapy (Q-GDMT). Q-GDMT has shown an estimated 73% relative and 26% absolute reduction in all-cause mortality over 2 years. Yet, despite remarkable clinical potential, these therapies are patently underutilized in clinical practice. It is unknown whether an implementation science strategy may enhance adherence to Q-GDMT for HF. Methods IMPLEMENT-HF (IHF) is a national HF quality improvement initiative composed of a multidisciplinary learning collaborative and resource repository across seven U.S regions. IHF promotes adherence to Q-GDMT by focusing on early adoption and rapid adherence to prescribing at hospital discharge and within 30 days post discharge. Multi-disciplinary participation in the learning collaborative includes pharmacy, provider groups, nursing, quality, social services, outpatient clinics and others. Shared interventions to promote Q-GDMT include formulary changes (e.g., adding SGLT2i), optimizing electronic health record tools (disease-specific order sets, dot phrases), clinician education, and user-friendly patient resources to address medication access. IHF sites receive educational materials, including webinars, learning modules, pocket guideline booklets, and reminder cards to reinforce Q-GDMT. IHF participating hospitals collect Q-GDMT data at discharge and at 30 days post discharge in Get With The Guidelines®-Heart Failure (GWTG-HF). These data were analyzed from baseline (Q1 Q2 2021 aggregate) through Q3 2022. Results Data from 71 IHF participating sites of 13,858 HFrEF patient hospitalization episodes (median age 69, 34% females, median LVEF 24%), demonstrated Q-GDMT prescription at discharge increased from 14% at baseline to 47% in Q3 2022 (p value &amp;lt;0.001). 30-day post discharge data from 52 IHF sites demonstrated an increase in Q-GDMT from 9% at baseline to 58% in Q3 2022 (p value &amp;lt;0.001) as seen in Figure 1. Conclusions Among sites participating in IHF, the use of an implementation science strategy suggest a rapid increase in prescribing Q-GDMT for eligible HFrEF patients at discharge and 30-days post discharge. This multi-region quality improvement initiative demonstrates the potential for this learning collaborative model to drive improvement in adherence to Q-GDMT prescribing, using shared implementation strategies to overcome barriers. Ongoing study will assess continued compliance and clinical outcomes with Q-GDMT beyond the timeframe of this analysis.Quadruple Medication Therapy baseline-Q3

Alogliptin and Heart Failure Outcomes in Patients With Type 2 Diabetes

Background: In 2016, the FDA issued a warning for saxagliptin and alogliptin regarding an increased risk of heart failure (HF), potentially limiting the use of effective medications in type 2 diabetes. Current data and guideline recommendations regarding HF risk are conflicting, especially with alogliptin. In March 2019, the Memphis Veterans Affairs Medical Center made a formulary change from saxagliptin to alogliptin, creating an opportunity to evaluate a large number of patients receiving alogliptin. Objective: To evaluate the risk of HF with alogliptin use in type 2 diabetes patients. Methods: A retrospective chart review of patients prescribed alogliptin was performed. The primary outcome was the composite number of HF hospital admissions and ED visits. Secondary outcomes included exacerbation rates among established HF patients, incidence of new-onset HF, incidence of alogliptin discontinuation due to HF, comparison of HF exacerbations between saxagliptin and alogliptin in patients with prior saxagliptin use, and evaluation of concomitant cardiotoxic medications. Results: 455 patients were included. A composite of 28 hospital admissions and ED visits occurred for a HF exacerbation. Fourteen patients (26.4%) of 53 patients with established HF had an exacerbation, whereas 5 patients (1.2%) of 402 patients with no history of HF had an exacerbation. Eight patients (2%) developed new-onset HF. Alogliptin was discontinued in 4 patients (0.9%) due to HF. No statistically significant difference in HF exacerbations was found between patients on alogliptin who previously received saxagliptin (4.8% vs 4.2%, P = 0.726). Conclusions: Alogliptin may increase the risk of HF exacerbation in patients with established HF.

Medicare Part D Coverage Restrictions and Patient Cost-Sharing for Opioids Commonly Used for Cancer Pain, 2015-2021.

Nation-wide rapid declines in prescription opioid dispensing gave rise to concerns regarding restricted access to effective pain management for patients with cancer-related pain. One important mechanism for such restrictions could be through more restrictive insurance coverage for opioids. This study aims to assess recent changes in Medicare Part D formulary designs for opioids commonly used for cancer-related pain. We used data from the 2015-2021 Medicare Prescription Drug Plan (PDP) Formulary Files to assess formulary changes for six opioid-dose combinations commonly used for cancer-related pain. We estimated % of PDPs adopting prior authorization, quantity limits (and limits adopted), and a higher cost-sharing tier for each opioid-dose combination. We further estimated median and mean out-of-pocket (OOP) costs across all PDPs for a 30-day supply of the drug. Trends in proportions were tested using the Cochrane-Armitage test; trends in continuous measures were tested using the Jonckheere-Terpstra test. Proportion of PDPs adopting prior authorization increased from close to 0% to about 50% for two long-acting opioids (P < .001). Distribution of quantity limits across PDPs shifted over time to being more restrictive for all opioids considered (P < .001). For four of the six opioids, the proportion of PDPs adopting tier 3 or above increased from below or about 50% to well over 70% (P < .001). For the same four opioids, median OOP costs doubled to quadrupled (P < .001). Medicare PDP coverage has become increasingly restrictive for opioids commonly used for cancer-related pain, with multifold increases in patient OOP costs over the past 7 years. These changes pose concerns for patients with cancer needing opioid therapies for pain control and call for strategies to effectively exempt cancer-related pain from insurance and pharmacy rules intended to apply to opioids for noncancer chronic pain.

Use of an Innovative Pharmaceutical Class Scoring Tool for Prioritized Annual Formulary Review.

Background: Though The Joint Commission requires health systems perform annual formulary review, guidance for how to perform this review is lacking. Published methods include comprehensive review of all pharmaceutical classes; however, this approach may not be the most efficient or effective option for a health system with a large formulary. Objective: To create a prioritization system for annual formulary review through development of a pharmaceutical class scoring tool. Methods: Drug information pharmacists developed the scoring tool, which used external and internal data to score pharmaceutical classes in 4 categories: safety, efficacy, cost, and utilization. The primary outcome, number of formulary changes resulting from pharmaceutical class review, was compared between the highest-scoring and lowest-scoring class to assess the tool's ability to prioritize high-yield class reviews. Results: The tool calculated scores for 91 pharmaceutical classes, altogether containing 962 medications. After review of the highest-scoring class, corticosteroids, 2 formulary changes were made: one dosage form was removed from formulary, and one medication was restricted to outpatient use only. Zero formulary changes resulted from review of the lowest-scoring class, pharmaceutical adjuvants. Conclusions: The tool described in this study prioritized annual formulary review efforts by identifying a pharmaceutical class with meaningful formulary optimization opportunities as the highest-scoring class, while correctly identifying a class with no optimization opportunities as the lowest-scoring class.

Utilization of Cholinesterase Inhibitors for Alzheimer Disease in Canada

&#x0D; Due to upcoming Canadian market approvals of biologics for Alzheimer disease, a utilization study was conducted to assess the current utilization patterns and funding criteria for cholinesterase inhibitors (ChEIs) in selected Canadian jurisdictions from 2017 to 2020.&#x0D; Most jurisdictions list ChEIs as exception status, special authorization, or limited use drugs except Manitoba; as of 2018, Manitoba lists donepezil and galantamine as regular benefits and rivastigmine as an exception status drug. Additionally, British Columbia and New Brunswick fund galantamine and rivastigmine after a patient is deemed intolerant to donepezil.&#x0D; The following are insights from the utilization analysis.&#x0D; &#x0D; Across Canada, there has been a decrease in the number of beneficiaries and claims for all ChEIs from 2017 to 2020 in all jurisdictions except Manitoba:&#x0D; &#x0D; There was a 12% reduction in number of beneficiaries and a 17% reduction in the number of total claims from 2017 to 2020.&#x0D; In Manitoba, there was an increase in the number of ChEI beneficiaries that peaked in 2018, which corresponds to the formulary changes for donepezil and galantamine during this period.&#x0D; &#x0D; &#x0D; Across Canada, donepezil had the highest market share among all ChEIs each year from 2017 to 2020, which increased from 71.2% in 2017 to 75.8% in 2020. Galantamine had the second-highest market share each year. The market shares for both galantamine and rivastigmine decreased over time, indicating there is a preference for prescribing donepezil to patients with Alzheimer disease.&#x0D; &#x0D; The greater use of donepezil may be explained by prescriber preferences or coverage criteria for ChEIs (e.g., donepezil is considered first line in British Columbia and New Brunswick).&#x0D; &#x0D; &#x0D; The cumulative costs of all ChEIs paid for by public drug plans across Canada in 2020 was $20,659,136, a decrease of 43% from $36,325,781 in 2017, which corresponds with the decrease in the total number of ChEI beneficiaries.&#x0D; &#x0D; Donepezil had the highest national total costs, followed by galantamine, then rivastigmine, which corresponds to the market share for each of these drugs. However, on a cost-per-beneficiary basis, donepezil was associated with the lowest cost estimates in each year from 2017 to 2020.&#x0D; &#x0D; &#x0D; &#x0D; &#x0D;

A cross-sectional analysis of persistence to disease-modifying therapies in treatment naïve and experienced patients with relapsing multiple sclerosis at a health-system specialty pharmacy

BackgroundPatients with relapsing multiple sclerosis (RMS) are maintained on disease-modifying therapy (DMT) to prevent disease progression. Reported persistence rates to DMTs are varied and concerningly low. Limited data exists on long-term persistence rates and reasons for DMT discontinuation in patients with RMS. This study evaluated long-term DMT persistence, rates and reasons for DMT discontinuation or switch, specialty pharmacist involvement in DMT treatment transitions, and predictors associated with non-persistence in treatment naïve and experienced patients. MethodsWe performed a single-center retrospective, cross-sectional review of patients with RMS and ≥3 fills of DMT from a health-system specialty pharmacy (May-October 2017). Patients were followed for 3 years to determine DMT persistence, defined as the time a patient remained on index DMT. Descriptive statistics were used to summarize sample characteristics and outcomes. The Kaplan-Meier estimation method was used to estimate the probability of remaining persistent and we used the Cox proportional hazards regression model to analyze the primary outcome. Rates and reasons for DMT discontinuation were identified via pharmacy claims and confirmed via chart review of the electronic health record. ResultsThe study included 540 patients, of which 41 (7.6%) were treatment naïve. Over 3 years, 193 (36%) patients remained on index DMT. The probability of remaining persistent for 3 years was 0.51 (95% confidence interval [CI] 0.47–0.56) and median time on index DMT was 642 days (interquartile range 317–1096). For the 347 patients that did not continue index DMT: 91 (26%) discontinued, 136 (39%) switched to a new DMT, 92 (27%) transferred care to a new specialty pharmacy or provider, 21 (6%) were lost to follow-up, and 7 (2%) died. Common reasons for DMT discontinuation or switch were insurance formulary change, side effects, clinical decline, and stable disease. Specialty pharmacists initiated 6 (7%) DMT discontinuations and 49 (36%) DMT switches. A strong non-linear relationship existed between age and risk of non-persistence (p = 0.003). Patients on an injectable index DMT were 1.5 times more likely to be non-persistent than those on an oral DMT (95% CI 1.1–2.1, p = 0.012) and patients with non-commercial insurance were 1.4 times more likely to be non-persistent (95% CI 1.02–2.0, p = 0.040). ConclusionsLong-term persistence to DMTs is low, with many patients switching or discontinuing DMT treatment. Specialty pharmacists identify the need for DMT discontinuation or switch and are uniquely positioned to assist during therapy transitions.

Postintubation Sedation After a Formulary Change From Succinylcholine to Rocuronium in a Critical Care Transport Organization

ObjectiveRocuronium is increasingly used as a first-line neuromuscular blocker (NMB) in rapid sequence intubation by transport teams. Prior work has shown that rocuronium is associated with a delay in postintubation sedation compared with intubation with succinylcholine. MethodsBoston MedFlight is a consortium-based transport organization. In 2017, the intubation protocol and formulary for Boston MedFlight was changed to replace succinylcholine with rocuronium. We performed a retrospective review of patients intubated by the critical care transport teams from January 2017 through December 2019. ResultsWe analyzed data for 264 intubations, 92 with succinylcholine and 172 with rocuronium. Ketamine and etomidate were the most common induction agents. The mean time from NMB administration to the first dose of sedation was 9.2 minutes (95% confidence interval, 5.4-23.7) for the succinylcholine cohort and 14.8 minutes (95% confidence interval, 8.4-38.0; P < .001) for the rocuronium cohort. After neuromuscular blockade, the total hourly weight-adjusted fentanyl dose was significantly lower for patients intubated with rocuronium compared with succinylcholine. ConclusionsIntubation with rocuronium was associated with a longer time until the administration of sedation and decreased postneuromuscular blockade fentanyl administration compared with intubation with succinylcholine. These findings suggest opportunities for improvement in sedation and analgesia practices after rocuronium rapid sequence intubation.

Statin Administration for ST-Elevation Myocardial Infarction During Rotor Wing Transport

ObjectiveThe aim of this study was to evaluate the feasibility of statin administration by a critical care transport medicine (CCTM) team during rotor wing transport for ST-elevation myocardial infarction patients to a percutaneous intervention–capable center. MethodsWe conducted a retrospective study at a single CCTM program after an intervention focused on statin administration for ST-elevation myocardial infarction that included a formulary change and a single brief educational presentation to flight physicians. A comparison group of flight nurse practitioners underwent training after the study period and were used as a control. Two authors completed an independent chart review to collect data. Descriptive statistics and chi-square or Mann-Whitney U testing were used to compare groups. ResultsStatin administration (or documentation of statin administration before CCTM crew arrival or contraindication to statin administration) occurred during 15 of 19 (79%) transports staffed by trained providers and 3 of 18 (17%) transports staffed by untrained providers (P < .001 by chi-square test). Scene times were not significantly different between transports by trained and untrained providers. ConclusionIn summary, we demonstrate the feasibility and safety of a protocol for statin administration in the CCTM setting.

Abstract 13791: Trends in the Use of Oral Anticoagulation for Nonvalvular Atrial Fibrillation in a Large Integrated Health Care System 2011-2020

Introduction: Direct Oral anticoagulants (DOACs) have demonstrated superiority or noninferiority to vitamin K antagonists (VKAs) for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). The uptake of DOACs into clinical medicine has been variable and may be influenced by many factors. Objective: To determine how the prescription (Rx) pattern for DOACs has evolved since their introduction and to evaluate the temporal effects of factors which may impact DOAC Rx. Methods: We performed a retrospective review of patients with NVAF within the Geisinger Health System from 2011-2020. We evaluated longitudinal yearly trends in anticoagulant use and new/initial Rx of DOAC vs VKA in NVAF. We examined subgroups based on clinical and demographic indices. Key points in the timeline regarding DOAC availability and medical society or institutional guidelines were incorporated to determine whether changes DOAC Rx were temporally associated with these events. Results: We identified 34, 936 patients with NVAF. The average age of the was 74.3 years, 48% were female and 98% white. The average CHA 2 DS 2 Vasc score was 2.5. There was a linear increase in overall and new Rx for DOACs with 77.7% of all new Rx for DOAC in 2020. The greatest increase in new DOAC Rx coincide with timepoints of DOAC incorporation into ACC/AHA Guidelines, approval of Xa reversal agent and institutional formulary change. Apixaban was the most common DOAC Rx since 2015 and now accounts for 70.9% of all new anticoagulation Rx and 91.3% of new DOAC Rx at our institution. Conclusions: There was a linear increase in DOACs use for NVAF over time and apixaban has become the most prescribed DOAC at our institution. Society guidelines, approval of reversal agents and institutional formulary changes appear to be temporally associated with increased Rx of DOACs for NVAF.

Applying Best Practice to Converting Blood Collection Tube Suppliers: Overcoming Laboratory Supply Shortages

Abstract Introduction/Objective Changing blood tube suppliers is a complex process that requires systematic validation. It can serve to expand a laboratory’s options during a supply shortage, and can lead to cost savings. Just prior to the pandemic, our laboratory underwent a large-scale conversion of blood tube suppliers after successful validation of serum, plasma, and whole blood tubes for blood bank, chemistry, immunology, hematology, coagulation, molecular diagnostics, and flow cytometry. Methods/Case Report First, we designed a patient consent form for collecting extra blood samples. Per CLSI standards, validation of blood tubes is needed for each testing methodology but not for each analyte. Hence, we selected high-impact assays to represent each testing methodology used by our instrument platforms. We designed comparison studies to test the new blood tubes for result accuracy, precision and specimen stability that covered an assay’s reportable range. Allowable error limits were set based on Westgard and CAP guidelines. Spiked specimens were used when positive patient samples were not feasible. We also took the opportunity to optimize the blood tube sizes, e.g., converting the lavender-top tubes from 2 ml (vendor A) to 3 ml (vendor B). We then confirmed with our reference labs the acceptability of the new vendor’s products, and administered an electronic survey to solicit staff feedback. Finally, we coordinated supply chain, formulary changes and test catalog updates. Results (if a Case Study enter NA) Data analyses showed 100% acceptable performance of the new supplier’s blood tubes. The survey showed that our phlebotomists supported the new products, citing their ease of use and good vacuum. Our hematology technologists provided favorable feedback on the larger lavender-top tubes that reduced the number of insufficient samples. On the economic front, this supplier conversion has yielded a 26% cost savings. Conclusion To our knowledge, our study is the most comprehensive of all blood collection device comparison analyses published. Our validation strategies that were designed to comply with best practice standards have led to our confidence in the interchangeability of the new and old blood tube products. This initiative serves to elucidate a protocol to add vendor options that can be replicated by other laboratories to mitigate blood tube supply shortages and backorders. It has helped us control supply costs without compromising quality.

Сопоставимость отчетов о ходе торговли на Макарьевско-Нижегородской ярмарке с 1813 по 1917 гг.

The article considers comparability of Nizhny Novgorod (Makaryev) Fair reports of 1813-1917. Reports for the mentioned period are not fully available; moreover, formulary of sources changed. Scientific originality of the study lies in the fact that reports of Nizhny Novgorod Fair Administration and Nizhny Novgorod Stock Exchange Committee are for the first time subjected to source study analysis. The research findings are as follows: the author proves that the reports were prepared according to the established procedure, which makes it possible to compare data from different years, in spite of formulary changes and new report forms.

Impact of Payor-Initiated Switching of Inhaled Corticosteroids on Lung Function

To evaluate the impact of a payor-initiated formulary change in inhaled corticosteroid coverage on lung function in patients with asthma and on provider prescribing practices. This formulary change, undertaken in August 2016 by a Medicaid payor in Kentucky, eliminated coverage of beclomethasone dipropionate, a metered dose inhaler (MDI), in favor of mometasone furoate, available as MDI and dry powder inhaler (DPI). A retrospective chart review was conducted on children with asthma ages 6-18years covered by the relevant payor from a university-based pediatric practice who were seen before the formulary change (February to July 2016) and after (February to July 2017). Spirometry data from each visit was compared using the paired Student t test. Fifty-eight patients were identified who were initially on beclomethasone dipropionate and had spirometry available at both visits. Those who switched from an MDI to a DPI (n=24) saw a decline in median predicted forced expiratory volume in 1second from 98.5% to 91% (P=.013). A decline was also seen in forced expiratory flow at 25%-75%, from 89.5% predicted to 76% predicted (P=.041). No significant changes were observed in children remaining on an MDI. Seven patients discontinued inhaled corticosteroid therapy. This study suggests insurance formulary changes leading to use of a different inhaler device may have a detrimental impact on pediatric lung function, which may be a surrogate measure for overall asthma control. This could be due to a lack of adequate timely educational intervention as well as the inability of some children to use DPIs.

Navigating uncharted waters: Developing a standardized approach for evaluating and implementing biosimilar products at a comprehensive cancer center.

The processes for formulary implementation and electronic health record (EHR) integration of biosimilar products at a comprehensive cancer center are described. Implications for research protocols are also discussed. The existing literature focuses on practical considerations for formulary addition of biosimilar products, but there is a lack of guidance on how to implement the change, particularly within the EHR. Before building the ordering tools for biosimilars, the clinical and informatics teams should determine the role of biosimilars at the institution, identify drug-specific product characteristics that affect medication build, and characterize implications of future formulary changes or drug shortages. Leveraging an orderable record provides the ability to include logic that maps to multiple products and also allows for future implementation of changes within the medication record rather than requiring "swaps" at the treatment protocol level. The institutional review board should coordinate changes in affected research protocols and consent forms and work with principal investigators to amend protocols when necessary. Pharmacy leaders should develop processes to oversee inventory during the transition period and minimize the risk of errors. The development of a standardized approach for evaluating and implementing biosimilar products improves efficiency and collaboration among the various team members responsible for the products' integration into existing workflows, including implications for clinical research. Implementing biosimilars for agents used to treat cancer will pose new challenges and require additional considerations. Partial implementation of biosimilars continues to pose multiple challenges in the provision of patient care.

Switching between GLP-1 receptor agonists in clinical practice: Expert consensus and practical guidance.

BackgroundGlucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) are an established treatment for patients with type 2 diabetes (T2D). Differences between GLP‐1RAs in pharmacokinetics, dosing regimens and clinical effects, including cardiovascular (CV) outcomes, mean there may be benefits to switching from one to another. However, clinical guidance on switching is lacking and data from clinical trials are limited. This article provides a clinical perspective and consensus on the benefits of switching between GLP‐1RAs, the triggers for switching and how best to manage this in clinical practice. Once weekly (OW) semaglutide is used as an example to illustrate how the authors might switch to a different GLP‐1RA in clinical practice.MethodsLiterature was searched and perspectives from 10 healthcare professionals with experience in switching patients with T2D to OW semaglutide from another GLP‐1RA were collated.ResultsMedical triggers for switching to another GLP‐1RA included HbA1c targets not being met, a desire for additional weight loss, poor adherence, patients moving to increased CV risk status and adverse effects with the current GLP‐1RA. Non‐medical triggers for switching included patient preference, cost, formulary changes and insurance mandates. Once the decision to switch is made, an individualised approach is recommended, based on considerations that include reimbursement requirements, treatment duration with (and dose of) previous GLP‐1RA, the patient's experience initiating the prior GLP‐1RA, any concomitant treatment and clinical characteristics. When switching, it is important to emphasise that treatment burden will not increase and that if gastrointestinal adverse effects occur, they are typically transient. Any transient gastrointestinal adverse effects that may occur (or recur) when switching to another GLP‐1RA can be reduced by slow up‐titration and advising patients to reduce food portion sizes and fat intake.ConclusionSwitching from one GLP‐1RA to another, such as OW semaglutide, can provide clinical benefits and may delay the need for treatment intensification.