Yusuf Ergün1, Tansel Bekiroğlu Ergün2, Eylem Toker2, Esengül Ünal3, Mine Akben2. 1. Clinical Pharmacology Unit, Department of Pharmacology, School of Medicine, Kahramanmaraş Sütçü İmam University, Kahramanmaraş. 2. Department of Midwifery, Kahramanmaraş School of Health, Kahramanmaraş Sütçü İmam University, Kahramanmaraş. 3. Department of Family Medicine, School of Medicine, Kahramanmaraş Sütçü İmam University, Kahramanmaraş, Turkey.
Abstract
BACKGROUND: Pharmacovigilance and spontaneous reporting of adverse drug reactions (ADRs) have pivotal roles in drug safety. This study aimed to evaluate the knowledge, attitude and practice of health professionals towards pharmacovigilance in a university hospital in Turkey. METHODS: An observational, cross-sectional study via a 25-item self-administered questionnaire was conducted among physicians (n=161) and nurses (n=321). RESULTS: Although 66% (320/482) of the subjects were aware of the 'pharmacovigilance' term, the awareness of the Turkish Pharmacovigilance Center was as low as 30% (161/482). Similarly, 41% (198/482) of the subjects did not know the pharmacovigilance contact point of the hospital. Defining and determining new ADRs and improving patient safety were associated with the importance of spontaneous reporting by the subjects. According to the physicians, unawareness of the national pharmacovigilance system was the first discouraging factor, as was the unawareness of the need for spontaneous reporting of ADRs for the nurses. Although the frequency with which the nurses encountered ADRs was lower than that of the physicians, their claimed reporting ratio (21%; 68/321) was more than the physicians (8%; 12/161). CONCLUSIONS: There is significant potential under-reporting of ADRs, which seems to be the result of several factors, including the lack of the knowledge of the national pharmacovigilance system.
BACKGROUND: Pharmacovigilance and spontaneous reporting of adverse drug reactions (ADRs) have pivotal roles in drug safety. This study aimed to evaluate the knowledge, attitude and practice of health professionals towards pharmacovigilance in a university hospital in Turkey. METHODS: An observational, cross-sectional study via a 25-item self-administered questionnaire was conducted among physicians (n=161) and nurses (n=321). RESULTS: Although 66% (320/482) of the subjects were aware of the 'pharmacovigilance' term, the awareness of the Turkish Pharmacovigilance Center was as low as 30% (161/482). Similarly, 41% (198/482) of the subjects did not know the pharmacovigilance contact point of the hospital. Defining and determining new ADRs and improving patient safety were associated with the importance of spontaneous reporting by the subjects. According to the physicians, unawareness of the national pharmacovigilance system was the first discouraging factor, as was the unawareness of the need for spontaneous reporting of ADRs for the nurses. Although the frequency with which the nurses encountered ADRs was lower than that of the physicians, their claimed reporting ratio (21%; 68/321) was more than the physicians (8%; 12/161). CONCLUSIONS: There is significant potential under-reporting of ADRs, which seems to be the result of several factors, including the lack of the knowledge of the national pharmacovigilance system.