Nuspojave u osoba starije životne dobi koje nastaju primjenom lijekova izvan uvijeta odobrenja za stavljanje lijeka u promet

master's thesis

• Author: Carmen Pacadi
• Mentor: Nikica Mirošević Skvrce (mentor)
• Mentor: Iva Mucalo (mentor)
• Committee member: Renata Jurišić Grubešić (predsjednik povjerenstva)
• Committee member: Nikica Mirošević Skvrce (član povjerenstva)
• Committee member: Maja Ortner Hadžiabdić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Centre for applied pharmacy); Zagreb
• Defense date and country: 2021-10-21, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Cilj istraživanja: Cilj ovog istraživanja je odrediti učestalost i okarakterizirati spontano
prijavljene nuspojave Hrvatskoj agenciji za lijekove i medicinske proizvode (HALMED) u
2012. i 2016. godini kod osoba starijih od 65 godina, koje su nastale zbog primjene lijekova
izvan uvjeta odobrenja. Dodatno, cilj je odrediti uzrok nastanka tih nuspojava.
Materijali i metode: Retrospektivno opservacijsko istraživanje spontano prijavljenih sumnji
na nuspojave HALMED-u u 2012. i 2016. godini kod osoba starijih od 65 godina. Sažetak opisa
svojstava lijeka korišten je kao referentni dokument za određivanje povezanosti nuspojave s
primjenom lijeka izvan uvjeta odobrenja. Nuspojave povezane s primjenom lijeka izvan uvjeta
odobrenja analizirane su prema dobi bolesnika, prijavitelju, ozbiljnosti nuspojave, organskom
sustavu prema MedDRA-i (System Organ Class, SOC), Anatomsko terapijsko kemijskoj
(ATK) klasifikaciji, broju korištenih lijekova i komorbiditeta. Statistička obrada podataka
provedena je računalnim programom IBM SPSS v. 20.0.
Rezultati: Ukupno je obrađeno 196 prijava nuspojava HALMED-u kod osoba starijih od 65
godina. Njih 48 (24,5 %) je bilo povezano s primjenom lijeka izvan uvjeta odobrenja od kojih
je većina bila uzrokovana medikacijskim pogreškama (N=39). Identificirano je 69 ozbiljnih
prijava nuspojava kod osoba starijih od 65 godina, a njih 19 je uzrokovano primjenom lijeka
izvan uvjeta odobrenja. Prema ATK klasifikaciji lijekova, nuspojave koje su nastale primjenom
lijekova izvan uvjeta odobrenja najčešće su bile uključene kod lijekova koji djeluju na krvožilni
sustav (ATK skupina C). Poremećaji kože i potkožnog tkiva (15,9 %) te poremećaji probavnog
sustava (13,6 %) bile su najčešće prijavljene nuspojave nastale primjenom lijekova izvan uvjeta
odobrenja. U 66,7 % prijava nuspojava nastalih primjenom lijekova izvan uvjeta odobrenja
radilo se o nuspojavama tipa A, a u 33,3 % prijava o nuspojavama tipa B.
Zaključak: Rezultati ove studije nadopunit će već postojeće dokaze o učestalosti i
karakteristikama nuspojavama kod osoba starije životne dobi. Osim toga, omogućit će razvoj
strategije za prevenciju nuspojava nastalih primjenom lijekova izvan uvjeta odobrenja.

Abstract (english)

Aim of the research: The aim of this study was to determine the frequency and characterize
spontaneously reported adverse drug reactions (ADRs) to Croatian Agency for Medicinal
Products and Medical Devices (HALMED) in 2012 and 2016 in persons over 65 years of age,
related to the use of the medicinal products outside the terms of the marketing authorisation.
Additionally, the aim was to determine the cause of these ADRs.
Materials and methods: A retrospective observational study of spontaneously reported
suspected ADRs to HALMED in 2012 and 2016 in persons over 65 years of age. The Summary
of Product Characteristics was used as a reference document to determine the association of the
ADRs with the use of the medicinal product outside the terms of the marketing authorization.
ADRs were analyzed according to patient age, reporter's qualification, seriousness of ADR,
MedDRA system organ class (SOC), Anatomical Therapeutic Chemical (ATC) classification,
number of used drugs, and number of comorbidities. Statistical evaluation data was performed
using IBM SPSS v. 20.0 statistical software.
Results: A total of 196 reports of ADRs to HALMED in persons over 65 years of age were
included in the analysis. Out of the 48 (24,5 %) ADR reports associated with the use of the
medicinal product outside the terms of the marketing authorization, majority were due to
medication errors (N = 39). There were 69 serious ADR reports in persons over 65 years of age,
and 19 of them were caused by the use of the medicinal product outside the terms of the
marketing authorization. Therapeutic drug classes the most frequently involved in ADRs
caused by the use of the medicinal product outside the terms of the marketing authorization
included cardiovascular system agents (ATC code C). Skin and subcutaneous tissue disorders
(15,9 %) and gastrointestinal disorders (13,6 %) were the most commonly reported ADRs
aroused from the medicinal product use outside the terms of the marketing authorization. In
66,7 % of ADR reports arising from the use of drugs outside the terms of the marketing
authorization were ADRs type A, and in 33,3 % of ADR reports were ADRs type B.
Conclusion: The results of this study will complement existing evidence on the frequency and
characteristics of ADRs in elderly patients. In addition, it will allow the development of a
strategy to prevent ADRs that arise from the use of medicinal products outside the terms of the
marketing authorization.

• Keywords: osobe starije životne dobi; nuspojave lijekova; HALMED
• Keywords (english): elderly; adverse drug reactions; HALMED
• Language: croatian
• URN:NBN: urn:nbn:hr:163:785444
• 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: 2022-03-16 11:38:14