Adverse drug reaction reporting by patients in Bulgaria

Adverse drug reaction reporting by patients in Bulgaria

Oral presentation

Deyan Rashkov1, Emanuyl Yordanov1, Emil Hristov1, Sava Ognyanov1, Tzvetomir Deliysky1, Kalina Andreevska2, Hristo Byrgazlyev 3, Daniela Grekova2, Zlatka Dimitrova1
1Faculty of Chemistry and Pharmacy, University of Sofia “St. Kliment Ohridski”, Sofia 2Faculty of Pharmacy, Medical University of Plovdiv 3Medical college, University “Prof. Asen Zlatarov”, Bourgas

Adverse drug reactions (ADRs) are a serious public health concern. Although the most common adverse reactions to medicines may be identified in clinical trials, rarer ones might only be recognised when numerous patients have used the medicine in normal clinical practice, over the long term, or even after the end of treatment—and only if reported. By collecting reports on suspected adverse drug reactions after medicines are made available to patients and evaluating these data, regulatory authorities can identify whether harms outweigh benefits and take necessary action to protect patient safety. In spite of the fact that spontaneous reporting is crucial for signal detection, under-reporting is common. It is estimated that only 1% to 10% of serious adverse reactions are reported. Methods: A questionnaire was prepared to investigate knowledge and attitude of patients regarding ADR reporting. The questionnaire was given to 274 patienrts. The study was conducted from May 2017 till September 2017 in Sofia, the capital of Bulgaria. We have used a documentary and statistic methods Results: we have found that a larger percentage of patients would report the ADR mainly to physicians and other healthcare professionals and are not aware of the existence of the yellow card. Conclusion: The results of the survey reveal the need for closer links with patient organizations. When conducting direct contact with the patients themselves in the pharmacies, it is advisable to train them about ADRs and their reporting. Patient education and awareness can also involve media.