Use of electronic health record data to examine administrations of pro re nata analgesics during hip fracture post-acute care.

PURPOSE: Medications prescribed to older adults in US skilled nursing facilities (SNF) and administrations of pro re nata (PRN) "as needed" medications are unobservable in Medicare insurance claims. There is an ongoing deficit in our understanding of medication use during post-acute care. Using SNF electronic health record (EHR) datasets, including medication orders and barcode medication administration records, we described patterns of PRN analgesic prescribing and administrations among SNF residents with hip fracture. METHODS: Eligible participants resided in SNFs owned by 11 chains, had a diagnosis of hip fracture between January 1, 2018 to August 2, 2021, and received at least one administration of an analgesic medication in the 100 days after the hip fracture. We described the scheduling of analgesics, the proportion of available PRN doses administered, and the proportion of days with at least one PRN analgesic administration. RESULTS: Among 24 038 residents, 57.3% had orders for PRN acetaminophen, 67.4% PRN opioids, 4.2% PRN non-steroidal anti-inflammatory drugs, and 18.6% PRN combination products. The median proportion of available PRN doses administered per drug was 3%-50% and the median proportion of days where one or more doses of an ordered PRN analgesic was administered was 25%-75%. Results differed by analgesic class and the number of administrations ordered per day. CONCLUSIONS: EHRs can be leveraged to ascertain precise analgesic exposures during SNF stays. Future pharmacoepidemiology studies should consider linking SNF EHRs to insurance claims to construct a longitudinal history of medication use and healthcare utilization prior to and during episodes of SNF care.

COVID-19 Vaccines: Moderna And Pfizer-BioNTech Use Varied By Urban, Rural Counties.

We investigated county-level variation in mRNA COVID-19 vaccine use among Medicare beneficiaries throughout the United States. There was greater use of Pfizer-BioNTech vaccines than Moderna vaccines in urban areas for first and booster doses.

Comparative safety and cardiovascular effectiveness of sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists in nursing homes.

AIM: Studies examining the safety and effectiveness of sodium-glucose cotransporter-2 inhibitors (SGLT2is) versus glucagon-like peptide-1 receptor agonists (GLP-1RAs) among community-dwelling adults may not generalize to nursing home (NH) residents, who are typically older and more multimorbid. We compared the safety and cardiovascular effectiveness of SGLT2is and GLP-1RAs among US NH residents. MATERIALS AND METHODS: Eligible individuals were aged ≥66 years with type 2 diabetes mellitus and initiated an SGLT2i or GLP-1RA in an NH between 2013 and 2018. Safety outcomes included fall-related injuries, hypoglycaemia, diabetic ketoacidosis (DKA), urinary tract infection or genital infection, and acute kidney injury in the year following treatment initiation. Cardiovascular effectiveness outcomes included death, major adverse cardiovascular events and hospitalization for heart failure. Per-protocol adjusted hazard ratios (HR) were calculated using stabilized inverse probability of treatment and censoring weighted cause-specific hazard regression models accounting for 127 covariates. RESULTS: The study population included 7710 residents (31.08% SGLT2i, 68.92% GLP-1RA). Compared with GLP-1RA initiators, SGLT2i initiators had higher rates of DKA (HR 1.95, 95% confidence limits 1.27, 2.99) and death (HR 1.18, 95% confidence limits 1.02, 1.36). Rates of urinary tract infection or genital infection, acute kidney injury, major adverse cardiovascular events, and heart failure were also elevated, while rates of fall-related injuries and hypoglycaemia were reduced, but all estimates were imprecise and highly compatible with no difference. CONCLUSIONS: SGLT2is do not have superior, and may have inferior, effectiveness compared with GLP-1RAs for cardiovascular and mortality outcomes in NH residents. Residents initiating SGLT2is should be monitored closely for DKA.

Sliding Scale Insulin Use in Nursing Homes Before and After Onset of the COVID-19 Pandemic.

OBJECTIVE: To characterize sliding-scale insulin (SSI) use in US nursing homes (NHs) before and after the COVID-19 pandemic. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: A total of 129,829 US NH residents on SSI (01/2018-06/2022) across 12 NH chains with a common electronic health record system. METHODS: Among all residents with at least 1 administration of SSI documented in the electronic medication administration record, we described resident demographics, frequency of SSI monotherapy vs combination therapy with another diabetes medication, number of daily capillary blood glucose readings ("fingersticks"), and hypoglycemia (capillary blood glucose <70 mg/dL) and hyperglycemia after first SSI use. We used interrupted time series analysis (ITS) with segmented linear regression models to examine whether the monthly prevalence of SSI use changed at and after the onset of the COVID-19 pandemic (March 2020). RESULTS: There were 129,829 unique NH residents with SSI use [51% women, average age 71.3 (SD 11.7) years]. Of these, 36% of residents received SSI monotherapy and 64% received SSI combination therapy. Residents on SSI received an average of 3.96 (SD 1.41) fingersticks per day. Overall, 26% of SSI users experienced a hypoglycemic event within 30 days of the first SSI dose. The ITS analysis identified a step decrease in the rate of SSI use following the onset of the COVID-19 pandemic (43 fewer SSI users per 1000 insulin users) but no change in overall trend over time from before the onset of the pandemic. CONCLUSIONS AND IMPLICATIONS: SSI use and fingerstick burden are high in NH residents. Hypoglycemia occurred commonly among residents on SSI. Future research should compare the safety and effectiveness of SSI monotherapy vs other diabetes medication regimens to guide person-centered prescribing decisions in NHs.

COVID-19 and Influenza Vaccine Coadministration Among Older U.S. Adults.

INTRODUCTION: Coadministering COVID-19 and influenza vaccines is recommended by public health authorities and intended to improve uptake and convenience; however, the extent of vaccine coadministration is largely unknown. Investigations into COVID-19 and influenza vaccine coadministration are needed to describe compliance with newer recommendations and to identify potential gaps in the implementation of coadministration. METHODS: A descriptive, repeated cross-sectional study between September 1, 2021 to November 30, 2021 (Period 1) and September 1, 2022 to November 30, 2022 (Period 2) was conducted. This study included community-dwelling Medicare beneficiaries ≥ 66 years who received an mRNA COVID-19 booster vaccine in Periods 1 and 2. The outcome was an influenza vaccine administered on the same day as the COVID-19 vaccine. Adjusted ORs and 99% CIs were estimated using logistic regression to describe the association between beneficiaries' characteristics and vaccine coadministration. Statistical analysis was performed in 2023. RESULTS: Among beneficiaries who received a COVID-19 vaccine, 78.8% in Period 1 (N=6,292,777) and 89.1% in Period 2 (N=4,757,501), received an influenza vaccine at some point during the study period (i.e., before, after, or on the same day as their COVID-19 vaccine), though rates were lower in non-White and rural individuals. Vaccine coadministration increased from 11.1% to 36.5% between periods. Beneficiaries with dementia (aORPeriod 2=1.31; 99%CI=1.29-1.32) and in rural counties (aORPeriod 2=1.19; 99%CI=1.17-1.20) were more likely to receive coadministered vaccines, while those with cancer (aORPeriod 2=0.90; 99%CI=0.89-0.91) were less likely. CONCLUSIONS: Among Medicare beneficiaries vaccinated against COVID-19, influenza vaccination was high, but coadministration of the 2 vaccines was low. Future work should explore which factors explain variation in the decision to receive coadministered vaccines.

Methodological guidance for the use of real-world data to measure exposure and utilization patterns of osteoporosis medications.

Observational studies of osteoporosis medications can provide critical real-world evidence (RWE) that fills knowledge gaps left by clinical trials. However, careful consideration of study design is needed to yield reliable estimates of association. In particular, obtaining valid measurements of exposure to osteoporosis medications from real-world data (RWD) sources is complicated due to different medication classes, formulations, and routes of administration, each with different pharmacology. Extended half-lives of bisphosphonates and extended dosing of denosumab and zoledronic acid require particular attention. In addition, prescribing patterns and medication taking behavior often result in gaps in therapy, switching, and concomitant use of osteoporosis therapies. In this review, we present important considerations and provide specialized guidance for measuring osteoporosis drug exposures in RWD. First, we compare different sources of RWD used for osteoporosis drug studies and provide guidance on identifying osteoporosis medication use in these data sources. Next, we provide an overview of osteoporosis pharmacology and how it can influence decisions on exposure measurement within RWD. Finally, we present considerations for the measurement of osteoporosis medication exposure, adherence, switching, long-term exposures, and drug holidays using RWD. Ultimately, a thorough understanding of the differences in RWD sources and the pharmacology of osteoporosis medications is essential to obtain valid estimates of the relationship between osteoporosis medications and outcomes, such as fractures, but also to improve the critical appraisal of published studies.

Benefits and Harms of Standard Versus Reduced-Dose Direct Oral Anticoagulant Therapy for Older Adults With Multiple Morbidities and Atrial Fibrillation.

Background Dose reduction of direct oral anticoagulant (DOAC) medications is inconsistently applied to older adults with multiple morbidities, potentially due to perceived harms and unknown benefits of standard dosing. Methods and Results Using 2013 to 2017 US Medicare claims linked to Minimum Data Set records, we conducted a retrospective cohort study. We identified DOAC initiators (apixaban, dabigatran, rivaroxaban) aged ≥65 years with nonvalvular atrial fibrillation residing in a nursing home. We estimated inverse-probability of treatment weights for DOAC dose using propensity scores. We examined safety (hospitalization for major bleeding) and effectiveness outcomes (all-cause mortality, thrombosis [myocardial infarction, stroke, systemic embolism, venous thromboembolism]). We estimated hazard ratios (HRs) and 95% CIs using cause-specific hazard-regression models. Of 21 878 DOAC initiators, 48% received reduced dosing. The mean age of residents was 82.0 years, 66% were female, and 31% had moderate/severe cognitive impairment. After estimating inverse-probability of treatment weights, standard dosing was associated with a higher rate of bleeding (HR, 1.18 [95% CI, 1.03-1.37]; 9.4 versus 8.0 events per 100 person-years). Standard-dose therapy was associated with the highest rates of bleeding among those aged >80 years (9.1 versus 6.7 events per 100 person-years) and with a body mass index <30 kg/m2 (9.4 versus 7.4 events per 100 person-years). There was no association of dosing with mortality (HR, 0.99 [95% CI, 0.96-1.06]) or thrombotic events (HR, 1.16 [95% CI, 0.96-1.41]). Conclusions In this nationwide study of nursing home residents with nonvalvular atrial fibrillation, we found a higher rate of bleeding and little difference in effectiveness of standard versus reduced-dose DOAC treatment. Our results support the use of reduced-dose DOACs for many older adults with multiple morbidities.

Racial and ethnic disparities in COVID-19 booster vaccination among U.S. older adults differ by geographic region and Medicare enrollment.

Introduction: COVID-19 booster vaccines are highly effective at reducing severe illness and death from COVID-19. Research is needed to identify whether racial and ethnic disparities observed for the primary series of the COVID-19 vaccines persist for booster vaccinations and how those disparities may vary by other characteristics. We aimed to measure racial and ethnic differences in booster vaccine receipt among U.S. Medicare beneficiaries and characterize potential variation by demographic characteristics. Methods: We conducted a cohort study using CVS Health and Walgreens pharmacy data linked to Medicare claims. We included community-dwelling Medicare beneficiaries aged ≥66 years who received two mRNA vaccine doses (BNT162b2 and mRNA-1273) as of 8/1/2021. We followed beneficiaries from 8/1/2021 until booster vaccine receipt, death, Medicare disenrollment, or end of follow-up (12/31/2021). Adjusted Poisson regression was used to estimate rate ratios (RRs) and 95% confidence intervals (CIs) comparing vaccine uptake between groups. Results: We identified 11,339,103 eligible beneficiaries (mean age 76 years, 60% female, 78% White). Overall, 67% received a booster vaccine (White = 68.5%; Asian = 67.0%; Black = 57.0%; Hispanic = 53.3%). Compared to White individuals, Black (RR = 0.78 [95%CI = 0.78-0.78]) and Hispanic individuals (RR = 0.72 [95% = CI 0.72-0.72]) had lower rates of booster vaccination. Disparities varied by geographic region, urbanicity, and Medicare plan/Medicaid eligibility. The relative magnitude of disparities was lesser in areas where vaccine uptake was lower in White individuals. Discussion: Racial and ethnic disparities in COVID-19 vaccination have persisted for booster vaccines. These findings highlight that interventions to improve vaccine uptake should be designed at the intersection of race and ethnicity and geographic location.

Comparative Risks of Potential Adverse Events Following COVID-19 mRNA Vaccination Among Older US Adults.

Importance: Head-to-head safety comparisons of the mRNA vaccines for SARS-CoV-2 are needed for decision making; however, current evidence generalizes poorly to older adults, lacks sufficient adjustment, and inadequately captures events shortly after vaccination. Additionally, no studies to date have explored potential variation in comparative vaccine safety across subgroups with frailty or an increased risk of adverse events, information that would be useful for tailoring clinical decisions. Objective: To compare the risk of adverse events between mRNA vaccines for COVID-19 (mRNA-1273 and BNT162b2) overall, by frailty level, and by prior history of the adverse events of interest. Design, Setting, and Participants: This retrospective cohort study was conducted between December 11, 2020, and July 11, 2021, with 28 days of follow-up following the week of vaccination. A novel linked database of community pharmacy and Medicare claims data was used, representing more than 50% of the US Medicare population. Community-dwelling, fee-for-service beneficiaries aged 66 years or older who received mRNA-1273 vs BNT162b2 as their first COVID-19 vaccine were identified. Data analysis began on October 18, 2022. Exposure: Dose 1 of mRNA-1273 vs BNT162b2 vaccine. Main Outcomes and Measures: Twelve potential adverse events (eg, pulmonary embolism, thrombocytopenia purpura, and myocarditis) were assessed individually. Frailty was measured using a claims-based frailty index, with beneficiaries being categorized as nonfrail, prefrail, and frail. The risk of diagnosed COVID-19 was assessed as a secondary outcome. Generalized linear models estimated covariate-adjusted risk ratios (RRs) and risk differences (RDs) with 95% CIs. Results: This study included 6 388 196 eligible individuals who received the mRNA-1273 or BNT162b2 vaccine. Their mean (SD) age was 76.3 (7.5) years, 59.4% were women, and 86.5% were White. A total of 38.1% of individuals were categorized as prefrail and 6.0% as frail. The risk of all outcomes was low in both vaccine groups. In adjusted models, the mRNA-1273 vaccine was associated with a lower risk of pulmonary embolism (RR, 0.96 [95% CI, 0.93-1.00]; RD, 9 [95% CI, 1-16] events per 100 000 persons) and other adverse events in subgroup analyses (eg, 11.0% lower risk of thrombocytopenia purpura among individuals categorized as nonfrail). The mRNA-1273 vaccine was also associated with a lower risk of diagnosed COVID-19 (RR, 0.86 [95% CI, 0.83-0.87]), a benefit that was attenuated by frailty level (frail: RR, 0.94 [95% CI, 0.89-0.99]). Conclusions and Relevance: In this cohort study of older US adults, the mRNA-1273 vaccine was associated with a slightly lower risk of several adverse events compared with BNT162b2, possibly due to greater protection against COVID-19. Future research should seek to formally disentangle differences in vaccine safety and effectiveness and consider the role of frailty in assessments of COVID-19 vaccine performance.

Evaluation of post-acute care and one-year outcomes among Medicare beneficiaries with hip fractures: a retrospective cohort study.

BACKGROUND: Post-acute care (PAC) services after hospitalization for hip fracture are typically provided in skilled nursing facilities (SNFs), inpatient rehabilitation facilities (IRFs), or at home via home health care (HHC). Little is known about the clinical course following PAC for hip fracture. We examined the nationwide burden of adverse outcomes by PAC setting in the year following discharge from PAC for hip fracture. METHODS: This retrospective cohort included Medicare Fee-for-Service beneficiaries > 65 years who received PAC services in U.S. SNFs, IRFs, or HHC following hip fracture hospitalization between 2012 and 2018. Individuals who had a fall-related injury (FRI) during PAC or received PAC services in multiple settings were excluded. Primary outcomes included FRIs, all-cause hospital readmissions, and death in the year following discharge from PAC. Cumulative incidences and incidence rates for adverse outcomes were reported by PAC setting. Exploratory analyses examined risk ratios and hazard ratios between settings before and after inverse-probability-of-treatment-weighting, which accounted for 43 covariates. RESULTS: Among 624,631 participants (SNF, 67.78%; IRF, 16.08%; HHC, 16.15%), the mean (standard deviation) age was 82.70 (8.26) years, 74.96% were female, and 91.30% were non-Hispanic White. Crude incidence rates (95%CLs) per 1000 person-years were highest among individuals receiving SNF care for FRIs (SNF, 123 [121, 123]; IRF, 105 [102, 107]; HHC, 89 [87, 91]), hospital readmission (SNF, 623 [619, 626]; IRF, 538 [532, 544]; HHC, 418 [414, 423]), and death (SNF, 167 [165, 169]; IRF, 47 [46, 49]; HHC, 55 [53, 56]). Overall, rates of adverse outcomes generally remained higher among SNF care recipients after covariate adjustment. However, inferences about the group with greater adverse outcomes differed for FRIs and hospital readmissions based on risk ratio or hazard ratio estimates. CONCLUSIONS: In this retrospective cohort study of individuals hospitalized for hip fracture, rates of adverse outcomes in the year following PAC were common, especially among SNF care recipients. Understanding risks and rates of adverse events can inform future efforts to improve outcomes for older adults receiving PAC for hip fracture. Future work should consider calculating risk and rate measures to assess the influence of differential time under observation across PAC groups.

Trends in COVID-19-Related Medication Use in US Nursing Homes, 2018-2022.

OBJECTIVES: Little is known about how COVID-19 treatment patterns have evolved over time in nursing homes (NHs) despite the devastating effects of COVID-19 in this setting. The aim was to describe changes in COVID-19-related medication use over time among NH residents in the United States. DESIGN: Retrospective cohort study. SETTING AND PARTICIPANTS: This study used electronic health records (EHR) from 11 different US NH corporations between January 1, 2018, and March 31, 2022. METHODS: The use of medications approved for COVID-19-related conditions or known to be used off-label for COVID-19 during the study period is identified. We described trends in the use of each drug and combined use per 1000 NH residents over calendar time [quarters (Q)]. RESULTS: A total of 59,022 unique residents with the use of an eligible medication were identified. Hydroxychloroquine use sharply increased from 9.8 in 2020Q1 to 30.2 orders per 1000 individuals in 2020Q2. Dexamethasone use increased sharply from 14.8 in 2020Q2 to a peak of 121.9 orders per 1000 individuals in 2020Q4. Azithromycin use increased from 44.1 in 2019Q3 to a peak of 99.9 orders per 1000 individuals in 2020Q4, with a drop in 2020Q3 of 51.3 per 1000 individuals in 2020Q3. Concurrent use of azithromycin and hydroxychloroquine increased sharply from 0.3 in 2020Q1 to 10.6 orders per 1000 residents in 2020Q2 and then drastically decreased to 0.6 per 1000 residents in 2020Q3. Concurrent use of dexamethasone and azithromycin rose considerably from 0.7 in 2020Q2 to 28.2 orders per 1000 residents in 2020Q4. CONCLUSIONS AND IMPLICATIONS: As in other settings, COVID-19-related medication use in NHs appears to have changed in response to the shifting evidence base and availability of medications during the pandemic. Providers should continue to diligently modify their prescribing as new evidence accrues.

Adoption of sodium-glucose cotransporter-2 inhibitors among prescribers caring for nursing home residents.

BACKGROUND: Sodium-glucose cotransporter-2 inhibitor (SGLT2I) use has increased among community-dwelling populations, but little is known about how clinicians have prescribed them for US nursing home (NH) residents. We described the adoption of SGLT2Is by prescribers caring for long-stay NH residents by clinician specialty and over time, compared with sulfonylureas, an older diabetes medication class. METHODS: We conducted a retrospective cohort study of prescribers of SGLT2Is and sulfonylureas for all long-stay US NH residents aged 65 years or older (2017-2019). Using 100% of Medicare Part D claims linked to prescriber characteristics data, we identified all dispensings of SGLT2Is and sulfonylureas for long-stay NH residents and their associated prescribers. We described the distribution of prescriber specialties for each drug class over time as well as the number of NH residents prescribed SGLT2s versus sulfonylureas. We estimated the proportions of prescribers who prescribed both drug classes versus only sulfonylureas or only SGLT2Is. RESULTS: We identified 36,427 unique prescribers (SGLT2I: N = 5811; sulfonylureas: N = 35,443) for 117,667 NH residents between 2017 and 2019. For both classes, family medicine and internal medicine physicians accounted for most prescriptions (75%-81%). Most clinicians (87%) prescribed only sulfonylureas, 2% prescribed SGLT2Is only, and 11% prescribed both. Geriatricians were least likely to prescribe only SGLT2Is. We observed an increase in the number of residents with SGLT2I use from n = 2344 in 2017 to n = 5748 in 2019. CONCLUSIONS: Among NH residents, most clinicians have not incorporated SGLT2Is into their prescribing for diabetes, but the extent of use is increasing. Family medicine and internal medicine physicians prescribed the majority of diabetes medications for NH residents, and geriatricians were the least likely to prescribe only SGLT2Is. Future research should explore provider concerns regarding SGLT2I prescribing, particularly adverse events.

Post-Acute Care Setting After Hip Fracture Hospitalization and Subsequent Opioid Use in Older Adults.

OBJECTIVE: Pain management in post-acute care (PAC) requires careful balance, with both opioid use and inadequate pain treatment linked to poor outcomes. We describe opioid use among older adults following discharge from PAC for hip fracture in skilled nursing facilities (SNFs) and inpatient rehabilitation facilities (IRFs). DESIGN: Retrospective cohort. SETTING AND PARTICIPANTS: Medicare beneficiaries with Medicare Provider Analysis (MedPAR) claims, aged 66 years and older with a hip fracture hospitalization between 2012 and 2018 followed by PAC in SNFs or IRFs and then discharge to the community. METHODS: Individuals were followed from PAC discharge for up to 1 year to assess opioid use. Covariate-standardized risk ratios (RR) and risk differences (RD) for opioid use within 7 days of PAC discharge were estimated via parametric g-formula with modified Poisson regression, and hazard ratios (HRs) for any post-PAC opioid use and long-term opioid use via Fine-Gray sub-distribution hazards regression. RESULTS: Of 101,021 individuals, 80% (n = 80,495) were discharged from SNFs and 20% (n = 20,526) from IRFs. Opioids were dispensed to 50,433 patients (50%) overall and the 1-year cumulative incidence was notably higher in IRF (68%) than SNF (46%) patients. The adjusted risk of discharge from PAC with an opioid was 41% lower after SNFs versus IRFs [RR: 0.59; 95% confidence limits (CLs): 0.57-0.61; and RD: -0.16; 95% CLs: -0.17 to -0.15]. The adjusted rate of any opioid use in the year after PAC discharge was 44% lower (HR: 0.56; 95% CLs: 0.54-0.57) and of long-term opioid use was 17% lower (HR: 0.83; 95% CLs: 0.80-0.87) after SNFs versus IRFs. CONCLUSIONS AND IMPLICATIONS: Opioid use is highly prevalent upon discharge from PAC after hip fracture, with lower use after SNF versus IRF care. Future research should assess the benefits and harms of post-PAC opioid prescribing and whether care practices during PAC can be improved to optimize long-term opioid use.

Comparative safety of sulfonylureas among U.S. nursing home residents.

BACKGROUND: The comparative safety of sulfonylureas (SUs) in nursing home (NH) residents remains understudied despite widespread use. We compared the effects of three SU medications and initial SU doses on adverse glycemic and cardiovascular events among NH residents. METHODS: This national retrospective cohort study linked Medicare claims with Minimum Data Set 2.0 assessments for long-stay NH residents aged ≥65 years between January 2008 and September 2010. Exposures were the SU medication initiated (glimepiride, glipizide, or glyburide) and doses (standard or reduced). One-year outcomes were hospitalizations or emergency department visits for severe hypoglycemia, heart failure (HF), stroke, and acute myocardial infarction (AMI). After the inverse probability of treatment and inverse probability of censoring by death weighting, we estimated hazard ratios (HR) using Cox regression models with robust 95% confidence intervals (CI). RESULTS: The cohort (N = 6821) included 3698 new glipizide, 1754 glimepiride, and 1369 glyburide users. Overall, the mean (standard deviation) age was 81.4 (8.2) years, 4816 (70.6%) were female, and 5164 (75.7%) were White non-Hispanic residents. The rates of severe hypoglycemia were 30.3 (95% CI 22.3-40.1), 49.0 (95% CI 34.5-67.5), and 35.9 (95% CI 22.2-54.9) events per 1000 person-years among new glipizide, glimepiride, and glyburide users, respectively (glimepiride versus glipizide HR 1.6, 95% CI 1.0-2.4, p = 0.04; glyburide versus glipizide HR 1.2, 95% CI 0.7-1.9, p = 0.59). The rates of severe hypoglycemia were 27.1 (95% CI 18.6-38.0) and 42.8 (95% CI 33.6-53.8) events per 1000 person-years among new users of reduced and standard SU doses, respectively (HR 2.2, 95% CI 1.4-3.5, p < 0.01). Rates of HF, stroke, and AMI were similar between medications and doses. CONCLUSIONS: Among long-stay NH residents, new use of glimepiride and standard SU doses resulted in higher rates of severe hypoglycemic events. Cardiovascular outcomes may not be affected by the choice of SU medication or dose.

Data resource profile: COVid VAXines effects on the aged (COVVAXAGE).

Background: To improve the assessment of COVID-19 vaccine use, safety, and effectiveness in older adults and persons with complex multimorbidity, the COVid VAXines Effects on the Aged (COVVAXAGE) database was established by linking CVS Health and Walgreens pharmacy customers to Medicare claims. Methods: We deterministically linked CVS Health and Walgreens customers who had a pharmacy dispensation/encounter paid for by Medicare to Medicare enrollment and claims records. Linked data include U.S. Medicare claims, Medicare enrollment files, and community pharmacy records. The data currently span 01/01/2016 to 08/31/2022. "Research-ready" files were created, with weekly indicators for vaccinations, censoring, death, enrollment, demographics, and comorbidities. Data are updated quarterly. Results: As of November 2022, records for 27,086,723 CVS Health and 23,510,025 Walgreens unique customer IDs were identified for potential linkage. Approximately 91% of customers were matched to a Medicare beneficiary ID (95% for those aged 65 years or older). In the final linked cohort, there were 38,250,873 unique beneficiaries representing ~60% of the Medicare population. Among those alive and enrolled in Medicare as of January 1, 2020 (n = 33,721,568; average age = 73 years, 74% White, 51% Medicare Fee-for-Service, and 11% dual-eligible for Medicaid), the average follow-up time was 130 weeks. The cohort contains 16,021,055 beneficiaries with evidence a first COVID-19 vaccine dose. Data are stored on the secure Medicare & Medicaid Resource Information Center Health & Aging Data Enclave. Data access: Investigators with funded or in-progress funding applications to the National Institute on Aging who are interested in learning more about the database should contact Dr Vincent Mor [Vincent_mor@brown.edu] and Dr Kaleen Hayes [kaley_hayes@brown.edu]. A data dictionary can be provided under reasonable request. Conclusions: The COVVAXAGE cohort is a large and diverse cohort that can be used for the ongoing evaluation of COVID-19 vaccine use and other research questions relevant to the Medicare population.

Electronic Health Records to Rapidly Assess Biosimilar Uptake: An Example Using Insulin Glargine in a Large U.S. Nursing Home Cohort.

Large healthcare administrative databases, like Medicare claims, are a common means to evaluate drug policies. However, administrative data often have a lag time of months to years before they are available to researchers and decision-makers. Therefore, administrative data are not always ideal for timely policy evaluations. Other sources of data are needed to rapidly evaluate policy changes and inform subsequent studies that utilize large administrative data once available. An emerging area of interest in both pharmacoepidemiology and drug policy research that can benefit from rapid data availability is biosimilar uptake, due to the potential for substantial cost savings. To respond to the need for such a data source, we established a public-private partnership to create a near-real-time database of over 1,000 nursing homes' electronic health records to describe and quantify the effects of recent policies related to COVID-19 and medications. In this article, we first describe the components and infrastructure used to create our EHR database. Then, we provide an example that illustrates the use of this database by describing the uptake of insulin glargine-yfgn, a new exchangeable biosimilar for insulin glargine, in US nursing homes. We also examine the uptake of all biosimilars in nursing homes before and after the onset of the COVID-19 pandemic. We conclude with potential directions for future research and database infrastructure.

Corrigendum: When to Start and Stop Bone-Protecting Medication for Preventing Glucocorticoid-Induced Osteoporosis.

[This corrects the article DOI: 10.3389/fendo.2021.782118.].