부산대학교 도서관

Pharmacovigilance as a science and group of activities related to detection, collection, analysis, understanding and prevention of adverse drug reactions (ADRs) is an essential activity in the regulatory system of drugs of any country. Defining increased patient safety as the main purpose of ADR reporting, a well-designed national pharmacovigilance system achieves its ultimate goal, i.e., protection of public health. In organizational and technical terms, the Republic of Serbia has a well-developed system of pharmacovigilance, created on the basis of a proven reliable system of the former SFR Yugoslavia, and carried out by the National Agency for Medicines and Medical Devices of Serbia (ALIMS), which conducts all organized activities aimed at strengthening the national system of ADR monitoring and reporting. Unlike the neighboring Croatia and Montenegro with similar pharmacovigilance systems, Serbia has only recently approached the WHO standard of 200 reports per million inhabitants despite a significant increase of 180 ADR reports per million inhabitants in 2019 (1251 in total). Considering this, our study aimed to provide a critical insight into the practice of pharmacovigilance in Serbia by pharmacoepidemiologic analysis of a ten-year period of ADR monitoring and reporting activities. Key words: Adverse drug reactions; Adverse drug reaction monitoring and reporting; Suspected drug; Adverse events following immunization Farmakovigilancija kao znanost i skupina aktivnosti vezanih za otkrivanje, prikupljanje, analizu, razumijevanje i sprjecavanje nuspojava lijekova (NPL) predstavlja vaznu aktivnost u regulatornom sustavu lijekova bilo koje zemlje. Definiranjem povecane sigurnosti bolesnika kao glavne svrhe prijavljivanja nuspojava, dobro osmisljen nacionalni sustav farmakovigilancije postize svoj krajnji cilj, a to je zastita javnog zdravlja. U organizacijskom i tehnickom smislu Republika Srbija ima dobro razvijen sustav farmakovigilancije utemeljen na provjerenom sustavu bivse SFR Jugoslavije, a provodi ga Nacionalna agencija za lijekove i medicinska sredstva Srbije (ALIMS), koja organizira sve aktivnosti usmjerene na jacanje nacionalnog sustava pracenja i izvjescivanja o NPL. Za razliku od susjedne Hrvatske i Crne Gore sa slicnim sustavima farmakovigilancije, Srbija se tek nedavno priblizila standardu Svjetske zdravstvene organizacije od 200 izvjestaja na milijun stanovnika unatoc znacajnom povecanju od 180 izvjesca o nezeljenim reakcijama na milijun stanovnika u 2019. godini (ukupno 1251). S obzirom na to, ovaj je rad imao za cilj pruziti kriticki uvid u praksu farmakovigilancije u Srbiji kroz farmakoepidemiolosku analizu desetogodisnjeg razdoblja pracenja i izvjescivanja o nezeljenim reakcijama na lijekove. Kljucne rijeci: Nuspojave lijekova; Pracenje i izvjescivanje o nuspojavama lijekova; Lijek pod sumnjom; Nuspojave jepiva
Introduction Ever since the well-known thalidomide tragedy in the middle of the last century caused the birth of a large number of newborns with severe congenital malformations around the world [...]