Abstract

ABSTRACT

Statistics show that about 6% of hospital admissions are due to adverse drug reactions (ADRs) and over 50% of them could have been avoided. In accordance with European and national regulatory changes related to the pharmacovigilance system since 2012, the issue of medical professionals’ awareness on the given topic is extremely important. The annual reports of the BDA website for the period 2000- 2012 refer to the low average of ADRs reporting among health professionals and it proves thatmedical specialists in Bulgaria do not realize the importance and necessity of ADRs reporting in order to ensure and maintain safe and effective medicinal products. A pilot study has been undertaken in order to investigate medical professionals’ awareness in Bulgaria about the importance of adverse drug reactions reporting. Pharmacovigilance is defined as a system for collecting, monitoring, researching and evaluating information by the healthcare professionals, marketing authorisation holders and patients. In this survey undertaken in 2013 among 143 health professionals regarding pharmacovigilance system, a significant awareness of 61.5% of the respondents was found. More than half of the surveyed health professionals are familiar with the reporting rules and regulations, regardless the low frequency of reporting for the country, published in the annual reports of the Bulgarian Drug Agency (BDA) The highest share of pharmacovigilance knowledge is among the pharmacists, followed by assistant pharmacists and the medical doctors. Regarding the procedure for adverse drug reactions reporting the proportion of respondents who answered correctly was 85.3% or 122 participants in the study indicated that this is by completing the “Yellow card” provided by the BDA.

Keywords: Pharmacovigilance, health professionals, adverse drug reactions,awareness.