Particularităţile farmacovigilenţei în Republica Moldova

Abstract

Introducere. Pentru a preveni şi diminua riscul apariţiei reacţiilor adverse (RA) la medicamente se impune necesitatea unui sistem de farmacovigilenţă bine organizat, acesta constituind un element cheie al practicii medicale şi farmaceutice [1]. Scopul lucrării. Evaluarea monitorizării reacţiilor adverse în cadrul activităţii de farmacovigilenţă a R. Moldova în anul 2016. Material şi metode. Au fost cercetate şi evaluate fişele- comunicare ale reacţiilor adverse recepţionate de către Secţia farmacovigilenţă a Agenţiei Medicamentului. Rezultate. în 2016 au fost recepţionate 277 fişe- comunicare a reacţiilor adverse, dintre care 12 cazuri de ineficienţă a preparatului medicamentos. Majoritatea bolnavilor au manifestat reacţii alergice la preparatele antituberculoase, cu o pondere de 33% şi medicamentele predestinate tratamentului infecţiei HIV-SIDA, cu 13%. Cel mai frecvent raportate au fost cazurile de RA la: antituberculoase - 116, antibiotice - 30, substanţe de contrast - 15, antihipertensive - 7, soluţii perfuzabile - 27, antiretrovirale - 11. Majoritatea RA raportate au fost apreciate, ca fiind de gravitate medie (67,55%), iar cele grave constituind -17,21%, fapt ce reflectă că mai mult de jumătate din RA comportă im caracter periculos pentru starea sănătăţii pacientului. Concluzii. Majoritatea bolnavilor au manifestat RA la preparatele antituberculoase şi retrovirale. Reacţiile adverse raportate au fost apreciate, ca fiind de gravitate medie şi grave.

Introduction. For the prevention and reduction of the risk of appearance of adverse reactions (AR) of drugs, the necessity of the well organized system of pharmacovigilance is imposed, that constitutes one of the most important elements of the medical and pharmaceutical practice [1]. The aim of the study. The evaluation of the surveillance system for adverse reactions in the activity of pharmacovigilance of R. Moldova in 2016. Material and methods. The investigation and evaluation of communication files of the adverse reactions collected by the Section of pharmacovigilance of the Drug Agency. Results. In 2016, 277 communication files of adverse reactions were collected, including 12 cases of inefficiency of drugs. Most patients showed the allergic reactions to antituberculosis drugs, with the rate of 33% and drugs predestinated to treatment of HIV-SIDA infection with 13%. The most frequent cases of AR were: antituberculosis-116, antibiotics-30, substances of contrast-15, antihypertensive-7, infusion solutions-27, antiretroviral-11. Most of the cases of AR was appreciated with medium gravity (67,55%) and the severe cases (17,21%), this reflected that more than half of AR cases had a dangerous character for the health of the patient. Conclusions. Most of patients manifested AR for antituberculosis and retroviral drugs. Reported adverse reactions were appreciated with a medium and advanced severity.