| Abstract | Cilj: Ispitati osnovna znanja o farmakovigilanciji, stavove i praksu zaposlenika ljekarne o procesu prijavljivanja sumnji na nuspojave lijekova u Republici Hrvatskoj.
Materijali i metode: U istraživanju su sudjelovali farmaceutski tehničari, magistri farmacije, magistri farmacije na specijalističkom studiju, magistri farmacije s doktoratom znanosti te magistri farmacije sa specijalizacijom. Stavovi i znanja zaposlenika ljekarne su ispitani anketnim upitnikom koji je sadržavao 28 pitanja podijeljenih u 3 dijela, a korišten je prevedeni alat istraživanja Raymond Li i suradnika.
Rezultati: U istraživanju je sudjelovalo ukupno 158 ispitanika iz cijele Republike Hrvatske. Većina ispitanika bile su ženskog spola, a više od pola (72,8%) ispitanika bilo je mlađe od 40 godina. Gotovo trećina ispitanika nikada nije prijavila sumnju na nuspojavu lijeka.
Statistički značajna razlika pronađena je između magistara farmacije i farmaceutskih tehničara koji nikada nisu prijavili nijednu sumnju na nuspojavu lijeka te u znanju definicije štetnih događaja. Ukupno, 18,6% magistara nikada nije prijavilo nuspojavu, u usporedbi sa 65,6% farmaceutskih tehničara, p<0,001, a definiciju štetnog događaja znalo je 24,1% magistara naspram 7,0% tehničara, p=0,032. Najmanji udio ispitanika, 31,0%, je prepoznao definiciju štetnog događaja te hepatotoksičnost kao najčešći razlog povlačenja lijeka s tržišta, koje je prepoznalo samo 35,4% ispitanika. Gotovo svi ispitanici, 96,8% i 95,6%, prepoznali su da se sve nuspojave bez obzira na ozbiljnost moraju prijaviti te da i zdravstveni djelatnici i potrošači prijavljuju nuspojave.
Farmaceuti su se češće u potpunosti slagali s tvrdnjom da je prijavljivanje sumnji na nuspojave lijekova dio ljekarničke skrbi te da bi svi članovi tima trebali prijavljivati sumnje, u usporedbi s farmaceutskim tehničarima. Farmaceutski tehničari su izrazili manje zadovoljstvo svojom razinom znanja o prijavljivanju nuspojava, u usporedbi s magistrima farmacije.
Zaključak: Istraživanjem je utvrđeno da stopa prijavljivanja sumnji na nuspojave lijekova od strane zaposlenika ljekarni u Hrvatskoj nije visoka iako većina ispitanika zna da imaju profesionalnu obvezu i smatra da posjeduje odgovarajuće znanje i obuku o farmakovigilanciji. Na temelju dobivenih rezultata može se zaključiti da je potrebno uložiti dodatan napor u edukaciju i motivaciju zdravstvenih djelatnika s obzirom na to da gotovo jedna trećina ispitanika ne prijavljuje sumnje na nuspojave lijekova. |
| Abstract (english) | Objectives: To determine the basic knowledge of pharmacovigilance, the attitudes and practices of pharmacy practitioners regarding the process of adverse drug reaction reporting in the Republic of Croatia.
Respondents and methods: Pharmaceutical technicians, masters of pharmacy, masters of pharmacy on specialist studies, masters of pharmacy with a doctorate and masters of pharmacy with specialization participated in the research. The attitudes and knowledge of pharmacy practitioners were examined by a survey which contained 28 questions divided into 3 parts for the preparation of which previously published questionnaire was used (Raymond Li et al). After collecting the data from the survey, a statistical analysis was performed.
Results: A total of 158 pharmacy practitioners from the entire Republic of Croatia participated in the research. Most of pharmacy practitioners the were female, and more than half (72.8%) of the respondents were under 40 years of age. Almost a third of the pharmacy practitioners never reported an adverse drug reaction. Two statistically significant differences were found between masters of pharmacy and pharmacy technicians who never reported any suspicion of a drug side effect and in the knowledge of the definition of adverse events. Overall, 18.6% of masters never reported an adverse event, compared to 65.6% of pharmacy technicians, p<0.001, and the definition of an adverse event was known by 24.1% of masters vs. 7.0% of technicians, p=0.032. The smallest share of pharmacy practitioners, 31.0%, recognized the definition of an adverse event and hepatotoxicity as the most common reason for removing a drug from the market, which was recognized by only 35.4% of pharmacy practitioners. Almost all pharmacy practitioners, 96.8% and 95.6%, recognized that all adverse drug reaction must be reported and that both health professionals and consumers report adverse drug reaction. Pharmacists were more likely to fully agree with the statement that reporting adverse drug reaction is part of pharmacy care and that all team members should report adverse drug reaction, compared to pharmacy technicians. Pharmacy technicians expressed less satisfaction with their level of knowledge about adverse drug reaction reporting, compared to masters of pharmacy.
Conclusions: The research found that the rate of adverse drug reaction reporting by pharmacy practitioners in Croatia is not high, although the majority of respondents know that they have a professional obligation and believe that they have adequate knowledge and training on pharmacovigilance. Based on the obtained results, it can be concluded that it is necessary to invest additional effort in the education and motivation of healthcare professionals, considering that almost one third of pharmacy practitioners do not report adverse drug reaction. |
