Purpose: Evaluate whether a 15-minute lecture intervention will improve adverse drug reaction reporting quality on standard MedWatch forms.
Methods: Seventy-eight 4th-year medical students were randomized to intervention 'Group-A' or non-intervention 'Group-B' on the first day of a required five-day clinical pharmacology rotation. Group-A participants attended a 15-minute lecture on completing a MedWatch form with quality information considered by the Food and Drug Administration as critical to adequate adverse drug reaction reporting. Group-B participants did not attend this lecture. Both groups then watched a standardized patient interview of a recognizable adverse drug reaction and completed MedWatch forms. Four Safety Evaluators from the Food and Drug Administration (FDA) rated student responses in a blinded fashion for the primary efficacy variable of Overall Impression and six informational domins using a standardized data quality analysis form that was developed within the Office of Postmarketing Drug Risk Assessment of the FDA.
Results: Seventy-eight MedWatch forms were evaluated (Group-A = 40, Group B = 38). Overall MedWatch information quality scores for the intervention group were significantly higher than the non-intervention group (p < 0.004).
Conclusions: As little as a 15-minute intervention can significantly improve the quality of adverse drug reaction reporting by 4th-year medical students. Academic medical centers should consider incorporating adverse drug reaction reporting curriculum into the clinical training of medical students.
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http://dx.doi.org/10.1002/pds.797 | DOI Listing |
Proc Natl Acad Sci U S A
January 2025
Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN 47405.
Dysregulation of GABAergic inhibition is associated with pathological pain. Consequently, enhancement of GABAergic transmission represents a potential analgesic strategy. However, therapeutic potential of current GABA agonists and modulators is limited by unwanted side effects.
View Article and Find Full Text PDFPLoS One
January 2025
Worldwide Health Economics and Outcomes Research, Bristol Myers Squibb, Princeton, NJ, United States of America.
Background: Belatacept is approved for the prophylaxis of organ rejection in Epstein-Barr virus (EBV)-seropositive kidney transplant recipients and is associated with a risk of post-transplant lymphoproliferative disorder (PTLD).
Methods: Data from the Organ Procurement and Transplantation Network were used to examine patterns of belatacept use, describe patient characteristics, and estimate risk of PTLD in EBV-seropositive, kidney-only transplant recipients receiving belatacept- or calcineurin inhibitor (CNI)-based immunosuppression as part of US Food and Drug Administration-mandated safety monitoring.
Results: During the study period (June 15, 2011-June 14, 2016), 94.
Medicine (Baltimore)
January 2025
Department of Hematology, Tongde Hospital of Zhejiang Province, Hangzhou, P.R. China.
Rationale: Carbapenem-resistant Klebsiella pneumoniae (CRKP) bloodstream infections are a severe complication resulting from granulocyte deficiency following chemotherapy for hematologic malignancies and have a high mortality rate. However, reports of disseminated organ infections secondary to bloodstream infections are rare.
Patient Concerns And Diagnoses: We report 2 cases of patients with acute lymphoblastic leukemia who both developed CRKP bloodstream infections during the granulocyte deficiency stage following chemotherapy, with 1 case of secondary bacterial liver abscess and 1 case of secondary septic arthritis.
Medicine (Baltimore)
January 2025
Pediatrics Department, Affiliated Hospital of Gansu University of Chinese Medicine, Lanzhou, Gansu, China.
This retrospective study aims to assess the adjunctive efficacy of warm needle moxibustion and gua sha care in the treatment of eszopiclone tablets on sleep quality and psychological stress in insomnia patients. Data of 138 insomnia patients from Gansu Baoshihua hospital between January and December 2022 were collected. Patients were bifurcated into 2 groups: those solely treated with eszopiclone (n = 71) and those administered a combined regimen of eszopiclone, warm needle moxibustion, and gua sha (n = 67).
View Article and Find Full Text PDFMedicine (Baltimore)
January 2025
Department of Traditional Chinese Medicine, Shanghai Fourth People's Hospital Affiliated to Tongji University of Medicine, Shanghai, China.
Based on network pharmacology and molecular docking methods, this study explored its active compounds and confirmed its potential mechanism of action against Hand-foot skin reaction induced by tumor-targeted drugs. Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform and UniProt Database were used to obtain the active ingredients and target proteins of Spatholobi Caulis. All hand-foot skin reaction (HFSR)-related targets were obtained with the help of the Human Gene Database, Online Mendelian Inheritance in Humans (OMIM), DisGeNET and DrugBank databases.
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