RESUMEN
BACKGROUND: REGEN-COV is a non-Food and Drug Adminstration approved monoclonal antibody combination of casirivimab/imdevimab. Casirivimab/imdevimab was previously used for the treatment of SARS-CoV-2 infection (COVID-19), under an emergency use authorization, and has demonstrated a reduction in hospitalizations and death. With the ability to administer this monoclonal antibody combination subcutaneously in an outpatient setting, limited community pharmacies became a treatment location for patients. OBJECTIVES: The objective of this study was to describe an innovative service and evaluate the safety of administering REGEN-COV, a monoclonal antibody combination of casirivimab and imdevimab, in a community pharmacy setting as treatment for COVID-19. PRACTICE DESCRIPTION: This study was conducted in a community pharmacy during traditional business hours. PRACTICE INNOVATION: A novel service of monoclonal antibody administration for the treatment of COVID-19 was implemented in a community pharmacy in response to community needs during the pandemic. EVALUATION METHODS: A retrospective, observational study was conducted from September 1, 2021 to December 31, 2021. Patients were required to have a positive SARS-CoV-2 test and meet all inclusion and exclusion criteria. Patients were assessed for adverse drug reactions at the time of monoclonal antibody administration and 60-minutes after administration. Patients were contacted by phone to complete a survey to assess patient reported adverse drug reactions post administration, number of patients hospitalized, and number of patients able to return to normal daily activities. RESULTS: Of the 93 patients included in this study, adverse effects were reported in 4.3% of patients at administration and 9.7% at follow-up. Included patients receiving this service generated $32,688.68 in revenue for the community pharmacy. CONCLUSION: Community pharmacists can administer casirivimab/imdevimab safely and effectively in an outpatient setting with low adverse events. This innovative monoclonal antibody administration service should be used as an example for a Call to Action of expansion of pharmacist scope of practice.
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COVID-19 , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Farmacias , Humanos , Estudios Retrospectivos , SARS-CoV-2 , Anticuerpos MonoclonalesRESUMEN
INTRODUCTION: In this PCI era, non-invasive management for patients presenting with non-ST elevation acute coronary syndrome continues to be relevant in several clinical circumstances. The duration of anticoagulation in non-invasively treated group is not clear. The use of heparin can be associated with fatal side effects. Thus, defining the optimal duration of therapy has significant implications for patient safety and cost. METHODS: Literature search was conducted using Medline (PubMed and Ovid SP), Embase, Cochrane Central Register of Controlled Clinical Trials (CENTRAL) and Cochrane Database of Systematic Review (CDSR) from the inception of these databases till present (August 2013). Only studies on humans and in English language were included. We included only published clinical trials which used UFH or LMWH as the anticoagulation agent. RESULTS: Initial search revealed 548 studies with 182 meeting inclusion criteria for full review. The duration of therapy was reported in 20 of 182 studies with an average treatment duration of 2-8 days. There was a trend towards increased bleeding without significant improvement in cardiovascular outcomes when anticoagulation was continued for more than 5-7 days. No single trial directly analyzed the composite end point outcome or adverse events in correlation with the duration of anticoagulation. CONCLUSION: There is a lack of good quality evidence to define the optimal duration of anticoagulation in the management of NSTE ACS. Well-designed, methodologically rigorous database studies are required to determine the shortest duration of therapy which achieves the benefits of anticoagulants while minimizing the costs and risks associated with prolonged anticoagulant use.
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Síndrome Coronario Agudo/tratamiento farmacológico , Anticoagulantes/uso terapéutico , Coagulación Sanguínea/efectos de los fármacos , Heparina de Bajo-Peso-Molecular/uso terapéutico , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/epidemiología , Anticoagulantes/efectos adversos , Anticoagulantes/farmacología , Coagulación Sanguínea/fisiología , Ensayos Clínicos como Asunto/métodos , Hemorragia/epidemiología , Hemorragia/prevención & control , Heparina/efectos adversos , Heparina/farmacología , Heparina/uso terapéutico , Heparina de Bajo-Peso-Molecular/efectos adversos , Heparina de Bajo-Peso-Molecular/farmacología , HumanosRESUMEN
BACKGROUND: Much debate exists on the optimal medication for posttraumatic seizure prophylaxis after traumatic brain injury (TBI). There is some evidence that levetiracetam (LEV) could be neuroprotective and provide long-term benefits in this patient population. OBJECTIVE: The primary objective was to compare the Glasgow Outcome Scale-Extended (GOS-E) 6 months or more after severe TBI. Secondary end points were presence of early seizures (0 to 7 days post-TBI) or late seizures (8 days post-TBI to phone interview), use of anticonvulsant medication when interviewed, medication-related hospital complications, and a summary of phenytoin (PHT) and LEV dosing regimens. METHODS: This was an IRB-approved, single-center, prospective cohort analysis. Patients were identified by cross-referencing a list of patients receiving LEV or PHT, with a list of patients with ICD-9 code consistent with TBI. After study inclusion, patients were contacted by telephone, and the GOS-E was administered. Data for secondary end points were gathered by retrospective chart review. RESULTS: In all, 19 patients were included in the final analysis. There was no difference in the GOS-E score assessed ≥6 months after injury (5.07±1.69 vs 5.60±2.07, P=0.58). There was no difference in the secondary end points of early seizures (P=0.53) or late seizures (P=0.53). However, the PHT group experienced a higher rate of hospital days with recorded fever (0.20±0.22 vs 0±0; P=0.014). CONCLUSIONS: Long-term functional outcome in patients who experienced a TBI was not affected by treatment with PHT or LEV; however, patients treated with PHT had a higher incidence of fever during hospitalization.