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Safety and Risk of Pharmacotherapy

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No 3 (2014)

EDITORIAL

 
4 491

REVIEWS AND ORIGINAL ARTICLES

5-10 615
Abstract

The article presents the history of the exploration of arrow poisons, used in Asia, Africa and South America. The active ingredients of these poisons
were widely used and continue to apply currently in traditional and official medicine. Methodology for development of new drugs based on arrow poisons has determined tendencies of drug design in modern pharmacology. 

11-14 585
Abstract

The article presents recommendations for doctors, pharmacists, developers and manufacturers on how to prepare and report to the regulatory of
the Russian Federation individual case safety reports of adverse drug reactions,
unefficiency or adverse drug interactions

15-19 555
Abstract

In this article authors analyze the influence of a label on drug
package on the risk of medication errors and propose methods of their prevention.
Analysis of the corresponding data published by regulators EMA and FDA has
provided an opportunity to find examples of phonetic and graphic similarities
with drugs identification

20-26 581
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

27-30 538
Abstract

The article presents the results of pharmacoeconomic studies of
adverse reactions of developed drugs in Russian Federation

31-37 565
Abstract

The article presents the results of analysis of the use of drugs in the first trimester of pregnancy from the point of view of safety to the fetus

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ISSN 2312-7821 (Print)
ISSN 2619-1164 (Online)