Research Information System
Thesis Type: Expertise In Medicine
Institution Of The Thesis: Gazi Üniversitesi, Tıp Fakültesi, Turkey
Approval Date: 2020
Thesis Language: Turkish
Student: AYÇA PINAR NAS
Supervisor: ANIL TAPISIZ
Abstract:Although antimicrobial agents have a critical role in treatment of infectious diseases by reducing mortality and morbidity in children, the incidence of drugrelated adverse events are too high to be underestimated. Therefore, our aim is to evaluate the drug used in children receiving inpatient parenteral antimicrobial therapy, to categorize the adverse events that occur, to determine the causality relationship between the drugs used according to the criteria determined by the World Health Organization (WHO); thereby to increase the awareness of pharmacovigilance and to emphasize the importance of reporting adverse events in a systematic and orderly way. In this study, 573 hospitalized pediatric patients in Gazi University Faculty of Medicine, whose parenteral antimicrobial treatment was started by the Department of Pediatric Infectious Diseases, were investigated and analyzed for undesirable and unintended adverse events retrospectively between December 2018 and April 2020. All patients who received antimicrobial agents for at least 24 hours were included. Exclusion criteria included prophylactic antibiotic use, antibiotics used for noninfectious indications, chemotherapeutic drugs, topical or inhaled antibiotics, and antituberculosis regimens. Adverse events were classified by the systems, and WHO 82 causality assessment scale was used to determine the causality. By the evaluation of the data, the incidence of adverse events due to parenteral antimicrobial drugs was found to be 46.5%. Adverse events were determined as hematological system findings, gastrointestinal system findings and dermatological findings in order of frequency . Reasons affecting the adverse event occurrence were evaluated by logistic regression analysis. Days of therapy, presence of concomitant disease and number of antimicrobial drugs proved to be at a significant risk for adverse events (p <0.05). Nevertheless unintended and undesired adverse events due to antimicrobial drugs can be reduced with the widespread use of rational drugs and the establishment of advanced pharmacovigilance systems.