ADVERSE DRUG REACTIONS IN CRIMEA REPUBLIC IN 2013

Abstract

In this article authors analyze patterns of ADRs registered in Crimea Republic in 2013. Data of ADR-reporting forms sent in 2013 by Crimean 21 doctors to Regional office of pharmacovigilance used. Information was recorded in local electronic database called “ARCADe”. 1129 reports from 89 clinics had been analyzed. Most frequently ADRs were found in patients from 46 to 60 years old (22%) and in first year babies (8%). Among adults females suffered from MP ADRs more than males (61%), but among children boys dominated (58%). Most frequent type of serious ADR (37%) was life-threating ones and those, which led to hospitalization. Two reports informed about lethal reactions caused by Ceftriaxone and combination “Pitofenon+Metamizole-sodium”. Causality
assessment revealed that bigger part of ADRs had belonged to “probable” type
(43%). During risk factors analysis, we found complicated allergy anamnesis
(10%) and polypharmacy (5% of cases). In 22% and 17% of reports, suspended MPs
were prescribed for respiratory diseases and cardiologic pathologies treatment
(respectively), and in 10% of cases for therapy of infections. Leading clinical
presentation of ADR was skin rashes with different manifestations, severity
and localization (50%), symptoms of involvement of CNS (11%), GIT and blood
circulation system (7% both) were registered less frequently. In 5% of reports, we
found descri ption of angioneurotic edema and in 1% - symptoms of anaphylactic
shock. 68% of ADRs required additional prescri ption of drugs for correction
of reaction`s symptoms. 39% of ADRs were caused by systemic antimicrobial
products, 13% and 11% by MP influencing on functions of heart and CNS
(respectively). In antibiotics group Cephalosporins prevailed and Ceftriaxone
caused most of ADRs, “Zidovudine+Lamivudine” combination was leading in
antiretroviral drugs, among cardiological drugs ACE inhibitors prevailed but
leading drug was Amplodi pine, and among NSAIDs most reactions were caused
by Metamizole-sodium and its combinations. Conclusions. In 2013, the patterns of
ADRs in Crimea region did not change and were the same as in previous years.
Pharmacovigilance activity is high and amount of received reports satisfies WHO
requirements. Found patterns will ease formation of local and national strategy
for prevention of ADRs