Stavovi i znanja ljekarnika o spontanome prijavljivanju nuspojava u Republici Hrvatskoj

professional thesis

• Author: Marija Tabak
• Mentor: Siniša Tomić (mentor)
• Committee member: Srećko Marušić (član povjerenstva)
• Committee member: Siniša Tomić (član povjerenstva)
• Committee member: Vesna Bačić Vrca (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; Zagreb
• Defense date and country: 2016, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Podaci prikupljeni tijekom predmarketinške faze razvoja lijeka ne mogu predvidjeti sve nuspojave koje se mogu pojaviti nakon što lijek dođe u promet. Zbog toga spontano prijavljivanje nuspojava od strane pacijenata i zdravstvenih djelatnika je od temeljne važnosti za praćenje sigurnosti lijekova. Međutim, neprijavljivanje nuspojava od strane zdravstvenih djelatnika je evidentirano u brojnim zdravstvenim sustavima te nije ograničeno samo na ljekarnike.
Cilj istraživanja: Ispitati stavove i čimbenike koji utječu na spontano prijavljivanje nuspojava od strane javnih i bolničkih ljekarnika u Republici Hrvatskoj.
Ispitanici i metode: Istraživanjem je obuhvaćeno 314 ljekarnika koji su dobrovoljno pristali na sudjelovanje. Podaci su prikupljani anonimnim online upitnikom.
Rezultati: Ovo istraživanje ukazuje da ni ljekarnici u Republici Hrvatskoj ne prijavljuju sve nuspojave koje uoče: 41,72% (131) ispitanika u godini dana nije prijavilo ni jednu nuspojavu, dok je 71,88% (225) ispitanika odgovorilo da ne prijavljuje sve nuspojave na koje posumnjaju. Značajno više prijavljivača je bilo među ljekarnicima koji rade u sklopu privatnih ljekarničkih lanaca (p<0,01). Kao najčešći razlozi neprijavljivanja nuspojava hrvatski ljekarnici su naveli: nesigurnost da je lijek uzrokovao nuspojavu, činjenicu da je nuspojava već dobro poznata za taj lijek, nedostupnost potpune medikacijske povijesti bolesnika, nedostatak vremena i zaboravnost. Kada usporedimo rezultate ovog ispitivanja s ispitivanjem provedenim od 2006.-2009. među hrvatskim ljekarnicima, strah od otkrivanja identiteta prijavitelja i nedovoljno znanja o prijavljivanju nuspojava se više ne navode među najčešćim razlozima neprijavljivana. Ispitanici pokazuju pozitivan stav prema prijavljivanju nuspojava. 88,22% ispitanika smatra da je prijavljivanje nuspojava dio profesionalne dužnosti ljekarnika. Najviše ispitanika je navelo da bi prijavljivali više nuspojava kada bi postojao jednostavniji način za prijavu nuspojava, te kada bi bili bolje educirani.
Zaključak: Rezultati ove studije doprinose razumijevanju stavova i čimbenika koji utječu na spontano prijavljivanje nuspojava od strane javnih i bolničkih ljekarnika u Republici Hrvatskoj. Identifikacija stavova i čimbenika vezanih uz prijavljivanja omogućuje obrazovne strategije koje bi izravno bile usmjerene na promjenu stavova, kao i razvoj alata za daljnje poticanje prijavljivanja. Ovo ispitivanje sugerira da postoji potreba za kontinuiranom edukacijom ljekarnika o važnosti i načinu prijavljivanja nuspojava.

Abstract (english)

Pre-marketing phases of drug development (non-clinical and clinical trials) do not guarantee that all adverse drug reactions (ADRs) are discovered. Post-marketing safety surveillance is important for detection of any rare or delayed ADRs over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. A voluntary reporting system of ADRs is fundamental to drug safety monitoring; however, the under-reporting is its major limitation and it is not limited only to pharmacists.
Objectives: This study was designed to investigate attitudes and factors affecting voluntary reporting of adverse drug reactions by Croatian pharmacists.
Subjects and Methods: A 314 pharmacists voluntarily participated in this study. Data were collected by anonymous online questionnaire.
Results: It was found among responders that 41.72% (131) did not report any ADR in the period of one year, and that 71.88% (225) of responders do not report every ADR that encounter. Significantly more reporters of ADR were among the pharmacists who worked within the private pharmacy chains (p <0.01). The main factors that discouraged ADR reporting were uncertainty that drug caused ADR, ADR is well known for the drug, unavailability of patients' medical histories, lack of time or forgetfulness. When comparing results of this study with the investigation carried out among Croatian pharmacists from 2006 to 2009, the fear of revealing the identity of reporter and lack of knowledge are not listed among the most common constraints for non-reporting. Respondents show a positive attitude towards reporting ADR. 88.22% of respondents considered the reporting of ADRs to be integral part of professional role as a pharmacist. Simplified mode of reporting ADRs and further education were indicated by most responders as factors that would encourage ADR reporting.
Conclusion: The study’s findings contribute to an increased understanding of individual attitudes and factors that influence voluntary reporting of adverse drug reactions by Croatian pharmacists. Findings can be used for developing educational strategies focused on attitudes modification, as well as the development of tools to enhance reporting. Results suggest that there is a need for continuous education of pharmacists on the importance of ADR reporting.

• Keywords: nuspojave lijekova
• Keywords (english): adverse drug reactions
• Language: croatian
• URN:NBN: urn:nbn:hr:163:895590
• Study programme: Title: Clinical pharmacy; Study programme type: university; Study level: postgraduate specialist; Academic / professional title: sveučilišni/a magistar/sveučilišna magistra kliničke farmacije (sveučilišni/a magistar/sveučilišna magistra kliničke farmacije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2016-08-29 09:00:33