Analiza sigurnosnog profila TNF-alfa inhibitora na temelju zaprimljenih prijava sumnji na nuspojave u 2018. i 2019. godini

master's thesis

• Title (english): Analysis of the safety profile of TNF-alpha inhibitors based on the received reports of suspected side effects in 2018 and 2019
• Author: Lucija Kanižaj
• Mentor: Maja Ortner Hadžiabdić (mentor)
• Committee member: Maja Ortner Hadžiabdić (predsjednik povjerenstva)
• Committee member: Lidija Bach-Rojecky (član povjerenstva)
• Committee member: Nikica Mirošević Skvrce (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Centre for applied pharmacy); Zagreb
• Defense date and country: 2021-01-07, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Cilj ovog rada bio je analizirati nuspojave TNF- α inhibitora prijavljene Agenciji za lijekove i medicinske
proizvode u razdoblju od 1. siječnja 2018. do 31. prosinca 2019. godine, te povećati svijest o sigurnosnom profilu ovih
lijekova i mjerama minimalizacije rizika, posebice dodatnim mjerama. Prijave sumnji na nuspojave analizirane su u
odnosu na ukupan broj zaprimljenih prijava sumnji na nuspojave u zadanom razdoblju, zatim prema vrsti prijavitelja
nuspojave, prema dobi i spolu pacijenta, suspektnom lijeku, najčešćim lijekovima u istodobnoj primjeni, ozbiljnosti
reakcije, prijavljenim nuspojavama prema pripadnosti klasifikaciji organskih sustava Medicinskog rječnika za
regulatorne poslove (MedDRA), prema najčešće prijavljenim nuspojavama, te prema najozbiljnijim nuspojavama.
Ukupno je zaprimljeno 246 prijava, najviše za pacijente između 18 i 64 godine (74,4%) te za pacijente ženskog spola
(60,6%). Najčešći prijavitelji su bili liječnici (86,2%). Najviše prijava je zaprimljeno na infliksimab i adalimumab, dok
su lijekovi u istodobnoj primjeni s TNF-α inhibitorima najčešće pripadali skupini imunosupresiva i analgetika.
61% prijava je ispunjavalo neki kriterij ozbiljnosti, najčešće „druga medicinski važna stanja“. Najviše nuspojava
je zaprimljeno za opće poremećaje i poremećaje na mjestu primjene, a najčešća reakcija je nedjelotvornost lijeka. Od
ozbiljnih nuspojava najčešće su bile infekcije. Dobiveni rezultati i sveukupno znanje o sigurnosnom profilu TNF- α
inhibitora i mjerama minimalizacije rizika omogućuju dodatnu edukaciju zdravstvenih radnika o lakšoj prevenciji,
otkrivanju i liječenju mogućih nuspojava kako bi se očuvala kvaliteta života pacijenata.

Abstract (english)

The aim of this study was to analyze the side effects of TNF-α inhibitors reported to the Agency for Medicinal
Products and Medical Devices of Croatia in the period from 1 January 2018 to 31 December 2019, and to raise
awareness of the safety profile of these drugs and risk minimization measures, especially additional measures. Reports
of suspected adverse reactions were analyzed in relation to the total number of suspected reports of adverse reactions
in the given period, then by reporter qualification, by age and sex of the patient, suspected drug, most common
concomitant drugs, severity of reaction, reported adverse reactions by MedDRA organic classification (the Medical
Dictionary for Regulatory Affairs), the most commonly reported side effects, and the most serious side effects. A total
of 246 applications were received, mostly for patients between the ages of 18 and 64 (74,4 %) and for female patients
(60,6 %). The most common reporters were physicians (86,2 %). Most reports were received on infliximab and
adalimumab, while drugs co-administered with TNF-α inhibitors most often belonged to the group of
immunosuppressants and analgesics. 61 % of applications met some criterion of severity, most often "other medically
important conditions". Most side effects have been received for general and on-site reactions, and the most common
reaction is drug ineffectiveness. Of the serious side effects, infections were the most common. The obtained results
and overall knowledge about the safety profile of TNF-α inhibitors and risk minimization measures enable additional
education of healthcare professionals on easier prevention, detection and treatment of possible side effects in order to
preserve the quality of life of patients.

• Keywords: TNF-α inhibitori; nuspojave; sigurnosni profil; mjere minimizacije rizika
• Keywords (english): TNF-α inhibitors; side effects; safety profile; risk minimization measures
• Language: croatian
• URN:NBN: urn:nbn:hr:163:814332
• Study programme: Title: Pharmacy; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2021-11-17 09:52:09