Anti-spike antibody durability after SARS-CoV-2 vaccination in adolescent solid organ transplant recipients.

BACKGROUND: Adolescent solid organ transplant recipients (aSOTRs) who received three doses of the COVID-19 mRNA vaccine experience high seroconversion rates and antibody persistence for up to 3 months. Long-term antibody durability beyond this timeframe following three doses of the SARS-CoV-2 mRNA vaccine remains unknown. We describe antibody responses 6 months following the third vaccine dose (D3) of the BNT162b2 mRNA vaccination among aSOTRs. METHODS: Participants in a multi-center, observational cohort who received the third dose of the vaccine were analyzed for antibodies to the SARS-CoV-2 spike protein receptor-binding domain (Roche Elecsys anti-SARS-CoV-2-S positive: ≥0.8, maximum: >2500 U/mL). Samples were collected at 1-, 3-, and 6-months post-D3. Participants were surveyed at each timepoint and at 12-months post-D3. RESULTS: All 34 participants had positive anti-RBD antibody titers 6 months post-D3. Variations in titers occurred between 3 and 6 months post-D3, with 8/28 (29%) having decreased antibody levels at 6 months compared to 3 months and 2/28 (7%) reporting increased titers at 6 months. The remaining 18/28 (64%) had unchanged antibody titers compared to 3-month post-D3 levels. A total of 4/34 (12%) reported breakthrough infection within 6 months and 3/32 (9%) reported infection after 6-12 months following the third dose of the SARS-CoV-2 mRNA vaccine. CONCLUSIONS: The results suggest that antibody durability persists up to 6 months following three doses of the SARS-CoV-2 mRNA in aSOTRs. Demography and transplant characteristics did not differ for those who experienced antibody weaning. Breakthrough infections did occur, reflecting immune-evasive nature of novel variants such as Omicron.

Omicron Infections in Vaccinated Pediatric Solid Organ Transplant Recipients.

SARS-CoV-2 infection during the Omicron period was frequent amongst a cohort of vaccinated pediatric solid organ transplant recipients (pSOTRs) despite robust anti-receptor-binding domain (anti-RBD) antibody response, suggesting poor neutralizing capacity against Omicron subvariants. Breakthrough infections among pSOTRs were overall limited in severity.

Glucagon-like peptide-1 receptor agonists use for type 2 diabetes mellitus in end-stage renal disease.

BACKGROUND: Management of type 2 diabetes mellitus (T2DM) in patients with end-stage renal disease (ESRD) remains a challenge given limited data. Although current guidelines recommend use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for the treatment of T2DM in patients with concomitant chronic kidney disease, supporting safety and efficacy evidence is lacking for patients with ESRD or hemodialysis. OBJECTIVE: This retrospective study was conducted to evaluate the efficacy and safety of GLP-1 RAs for the treatment of T2DM in patients with ESRD. DESIGN, SETTING, AND PARTICIPANTS: This is a single-centered, multifacility retrospective cohort analysis. Patients were included if they had a diagnosis of T2DM and ESRD and were prescribed a GLP-1 RA. Patients were excluded if the GLP-1 RA was prescribed solely for weight loss. OUTCOME MEASURES: The primary outcome was change in A1C. Secondary outcomes included (1) incidence of acute kidney injury (AKI), (2) change in weight, (3) change in estimated glomerular filtration rate, (4) ability to discontinue basal or bolus insulin, and (5) incidence of emergent hypoglycemia. RESULTS: There were 46 unique patients and 64 individual GLP-1 RA prescriptions included. The mean reduction in A1C was 0.8%. There were 10 incidences of AKI, although none occurred in the semaglutide cohort. Emergent hypoglycemia occurred in 3 patients who were all prescribed concomitant insulin. CONCLUSION: Results from this retrospective review provide additional real-world data on use of GLP-1 RAs in this unique population. Prospective studies to control for confounding factors are warranted given that GLP-1RAs are a safer alternative to insulin in this high-risk population.

Clinical pharmacy specialists providing consistent comprehensive medication management with increased efficiency through telemedicine during the COVID19 pandemic.

INTRODUCTION: The Veterans Affairs (VA) has been at the forefront of harnessing the skills of clinical pharmacy specialists (CPS) in patient-aligned care teams (PACT) to improve patient care outcomes and create access for veterans. With the unfortunate arrival of Coronavirus disease 2019 (COVID19), PACT CPS were duty-bound to expand telehealth services at an accelerated rate. The purpose of this quality improvement analysis is to compare CPS efficiency as well as some objective patient metrics to assess for a change in the quality of care. This is the first study to compare the efficiency and quality of care by CPS in the VA pre-COVID19 and during the COVID19 pandemic. METHODS: This is a retrospective review of PACT CPS comprehensive medication management from 3/10/19 to 11/30/19 and 3/10/20 to 11/30/20. Data points focused on clinic encounters, patient accountability to appointments, disease state expansion, and markers of disease-state management. Given diabetes and hypertension are the main disease states managed by most PACT CPS', the study evaluated changes in hemoglobin A1c (HbA1c) and blood pressure (BP) between the two cohorts as well. Data were analyzed using GraphPad Software or Microsoft Excel. A student T-test was used for continuous data and Chi-squared or Fishers Exact for nominal data. RESULTS: The total number of PACT CPS encounters increased 32% in 2020, and the number of unique patients increased by 12%. There were a statistically significant increase in telephone and direct-to-consumer (DCT) video visits. The rates of no shows and cancellations significantly decreased between 2019 and 2020. There was no difference in the average change in HbA1c or average blood pressure between the two study groups. CONCLUSIONS: When PACT CPS services transitioned from primarily face-to-face visits to all virtual care, the consistency of care improved, and the quality of care was not compromised.

Implementation and Effect of a Pharmacist-to-Pharmacist Transitions of Care Initiative on Ambulatory Care Sensitive Conditions.

BACKGROUND: One of the most vulnerable times in a patient's encounter with a health care system is during transitions of care (TOC), defined by the Joint Commission as the movement of a patient from one health care provider or setting to another. The use of a clinical pharmacist as a member of the care transitions team has received focused attention and shown improved benefit. OBJECTIVE: To determine the effect of a large-scale pharmacist-to-pharmacist TOC model where inpatient clinical pharmacists identify patients during a hospital stay, provide evidence-based care and education, and then coordinate follow-up with an outpatient clinical pharmacist who provided comprehensive medication management (CMM) under a scope of practice. METHODS: This was a multisite, single health care system, quasi-experimental, matched interrupted time series design study conducted at an integrated Veterans Affairs (VA) health care system. Patients admitted with a primary or secondary diagnosis of diabetes, hypertension, chronic obstructive pulmonary disease (COPD) and heart failure (HF) were included for enrollment. Clinical pharmacists rounding on inpatient medical teams provided evidence-based recommendations to optimize medications while coordinating follow-up by an outpatient clinical pharmacy specialist within 10 days of discharge for CMM. The primary endpoint of this study was to determine the effect on the composite all-cause 30-day acute care utilization rate (emergency department [ED] visit or hospital readmission) for patients discharged with a primary or secondary diagnosis of diabetes, hypertension, COPD, and HF compared with a comparator group of patients with similar discharge diagnosis before implementation of the TOC program. RESULTS: 484 patients (242 in each group, with 366 heart failure, 66 COPD, 10 hypertension, and 42 diabetes) were included for analysis. For the primary outcome of composite 30-day, all-cause acute care utilization rates, no statistically significant difference was identified, with 26.9% of patients in the intervention group and 28.9% in the historical group readmitted or seen in the ED within 30 days of discharge (P = 0.6852). Outcomes for the HF index acute care utilization rate (i.e., admission for the same disease state discharged with), including 30-day index readmissions (P = 0.0014), 30-day index ED visits (P = 0.0047), and 90-day index readmissions for HF (P < 0.0001) were significantly reduced. CONCLUSIONS: Our study is one of the first to identify at-risk patients using rounding clinical pharmacists in the acute care arena and coordination of care systematically with a clinical pharmacy specialist practicing under a scope of practice targeted for CMM. Although the overall primary endpoint was not met, a reduction in acute care utilization rates for HF at 30 and 90 days can be achieved. DISCLOSURES: No outside funding supported this research. The authors report no conflicts of interest.

Old Friends With New Faces: Are Sodium Channel Blockers the Future of Adjunct Pain Medication Management?

Providers are being asked to decrease the emphasis and overutilization of long-term opioid therapy, but many are left without proper guidance on appropriate utilization of nonopioid therapies. Furthermore, therapeutic options are quite limited and many providers lack confidence in distinguishing available alternatives. When first-line therapy has failed in a patient, there is an apparent lack of knowledge on how to proceed with choosing subsequent therapy. To choose among alternative agents, an understanding of pharmacology, pharmacokinetics, and efficacy in targeting various pain conditions is necessary. This article focuses on the use of the carboxamide class of sodium channel blockers (carbamazepine, oxcarbazepine, eslicarbazepine) for adjunct pain medication management including research updates in pharmacology, pharmacokinetics, and current evidence for pain along with promising areas of research. It is an evidence update for clinical use of sodium channel blockers, clarifies misconceptions regarding their use, and highlights emerging research for improved pain targets that justifies additional study. We performed a complete review of the literature using the search terms, "oxcarbazepine," "carbamazepine," and "eslicarbazepine" in conjunction with "pharmacokinetics," "adverse effects," "pharmacology," "voltage-gated sodium channel subtype," "neuropathic pain," "inflammatory pain," "metabolism," "epoxide metabolite formation," "drug interactions," "CYP450 interactions," "pain phenotype," and "chronic pain management." Databases searched included PubMed and Google Scholar. Package inserts were used for drug structure illustration, adverse reactions, and bioavailability. Pharmacology and pharmacokinetic data were taken from randomized controlled trials evaluating this area as well as in vitro published results. For validity, only peer-reviewed literature was included. Evidence for sodium channel blockers in chronic pain management was limited. This review focuses on highlighting the data available for the use of sodium channel blockers for certain pain syndromes as well as underutilized potential. Emerging literature on sodium channel subtypes and their connection to neuropathic, inflammatory, and mechanical pain transmission is elucidated. The authors also scrutinize literature surrounding the pharmacokinetics of oxcarbazepine and eslicarbazepine to provide clearer guidance to the significance of any drug interactions and refute assumptions made on the basis of structural similarity to carbamazepine and its known undesirable drug interactions. Side effect profiles are outlined and compared, emphasizing the differences between agents. Sodium channel blocker doses used in certain pain syndromes are outlined with a call for further research to better understand their place in chronic pain management. Identification of sodium channel subtypes with links to specific pain conditions and the ability to target them hints at the potential for truly individualized therapy. Sodium channel inhibitors are underutilized on the basis of available evidence, and emerging research has identified this area as promising for additional clinical trials to better guide clinical practice. PERSPECTIVE: This article provides a review of the pharmacology, evidence for pain management, and pharmacokinetics of oxcarbazepine, carbamazepine, and eslicarbazepine. There is a disparity in evidence using sodium channel blockers for pain and this article highlights the potential that is currently underutilized. The authors believe this will catalyze interest for further studies.