The aspects of pharmacovigilance in the Republic of Moldova

Abstract

Introduction According to the World Health Organization, pharmacovigilance is the science that deals with the detection, evaluation and prevention of adverse drug reactions. Increased interest in adverse reaction research continues to be the topical issue of the studies for reducing their incidence. In order to prevent and reduce the risk of adverse drug reactions and to improve the public health system, mechanisms for monitoring and evaluating the safety of medicines in medical practice are vital. This implies the existence of a well-organized pharmacovigilance system, pharmacovigilance being the key element in the medical offices and in the public health program. Purpose. The evaluation of the collection, management and monitoring of adverse reactions in the pharmacovigilance activity. Material and methods. The communication sheets of the adverse reactions received by the Pharmacovigilance Departement within the Medicines and Medical Devices Agency during the period from 2018 to 2019 were researched and evaluated. All communication sheets (93 sheets) - were received, analyzed, recorded in the database of adverse drug reactions and other suspected pharmaceutical products. Results. During the period from 2018 to 2019, 93 sheets of communication of adverse reactions were analyzed, among which 12 cases of inefficiency of the drug preparation. According to the data obtained regarding the group of patients we had examined there is a predominance of women vs. men (55% and 60%), which corresponds to the data of the researched literature. The predominant age is suitable for work: 30-50 years, with a share of 46% specific for both groups studied. Based on the obtained data, we found that it was a higher incidence of oral drugs administration (62%) and the predominance of solid pharmaceutical forms (tablets-36%, capsules-8%, powder-3%). The most commonly reported adverse reactions were of the following groups of drugs: antituberculosis drugs–85%, antibiotics–48^, perfusion solutions–22%, nonsteroidal anti¬inflammatory drugs -18%, contrast agents– 15%, antiretrovirals– 11%. Conclusions. The importance of avoiding and detecting adverse reactions is a goal of the future, which requires everyone's contribution to solving it, through the receptivity of reports, the active encouragement of medical workers and patients.