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Pedijatrijska je populacija specifična po svojim razvojnim karakteristikama. Nedostaje kliničkih ispitivanja koja bi potvrdila sigurnost primjene lijekova kod pedijatrijske populacije i oni se propisuju ‘izvan odobrenja’ ili off-label što često za posljedicu ima nuspojave. Ovaj rad daje analitički pregled spontano prijavljenih nuspojava lijekova u pedijatrijskoj populaciji zaprimljenih u Hrvatsku agenciju za lijekove i medicinske proizvode do 31. prosinca 2021. Cilj rada bio je odrediti i okarakterizirati prijavljene nuspojave. Analizirano je 8 375 prijava sumnji na nuspojave. Prijave sumnji na nuspojave analizirane su prema spolu i dobi pacijenta, prijavitelju, godini zabilježene nuspojave, klasifikaciji nuspojave prema organskim sustavima koje navodi MedDRA, ozbiljnosti nuspojave, prema anatomsko-terapijsko-kemijskoj klasifikaciji lijekova suspektne djelatne tvari i djelatnih tvari u istodobnoj primjeni. Dobiveni rezultati ovog diplomskog rada nadopunit će postojeće informacije i dokaze o nuspojavama u pedijatrijskoj populaciji te doprinjeti smanjenju učestalosti istih. The pediatric population is specific for its developmental characteristics. There is a lack of clinical trials that confirm the safety of drugs in pediatric population. Consequently, drugs are prescribed ‘out of approval’ or off-label which often results in side effects. This paper provides an analytical overview of spontaneously reported adverse drug reactions in pediatric population received by the Croatian Agency for Medicinal Products and Medical Devices by the 31st of December 2021. The objective of the thesis was to identify and characterize reported adverse reactions. The analysis included 8,375 reports of suspected adverse reactions. The received reports of suspected side effects were analyzed according to the gender and age of the patient, the applicant, the year of the recorded side effect, the classification of side effects according to the organ systems listed by MedDRA, the severity of side effects, according to the anatomical-therapeutic-chemical classification of drugs, the suspected active substance and active substances in simultaneous use. The obtained results of this thesis supplement the existing information and evidence of side effect in the pediatric population and contribute to reducing their frequency. |
