of their changes in comparison with previous years is very important for effective pharmacovigilance (PV) (eg, taking of regulatory acts, update of instructions for use, revealing of medical mistakes). Patients (or Materials) and Methods: To analyze structure of ADR, we used search in ARCADe (Adverse Reactions in Crimea Autonomy DatabasE). Results: In 2012, Regional PV office of State Expert Center of Ukraine in Simferopol (Crimea Autonomic Republic) received 1135 spontaneous reports about ADR

more »

... rom 123 hospitals. As in 2006-2011 period, most frequently ADR were registered in 1-st year children (98 cases) and 46 to 60 year-old adults (259). Sixty-five percent of reports informed about ADR in females, 35% in males. Two reactions were lethal (both in children, uncertain causality), 72 were life-threating, 102 resulted in hospitalization of patient, and 181 in temporary disability. Most of drugs were used per os (575), others were prescribed intramuscularly (190), intravenously (239) , or in topical forms (69 reports). A total of 133 patients had allergy in anamnesis, 73 from them had medicinal allergy. A total of 328 patients took only 1 product (monotherapy), when other took combinations of drugs, from them 113 patients 5 medicines and more. Most frequently drugs were prescribed for treatment of respiratory diseases (269), heart diseases (176), and infections (148). A total of 563 reports informed about skin rush, 115 about dyspeptic disorders, 96 about central neural system symptoms, 53 about fever, 53 about hemopoiesis depression, 37 and 15 about angioneurotic edema and anaphylactic shock, respectively. In 71%, ADRs needed medical correction-prescription of additional drugs. The structure of ADR data according to groups is following: 41% of reactions were caused by systemic antimicrobial agents (ATC J01-J07), 12% by cardiovascular drugs (C01-C10), 8.3% by drugs influencing on CNS, and 7.5% by nonsteroidal anti-inflammatory drugs. The top 3 of products use of which resulted in ADR includes: ceftriaxone (62 cases), zidovudine/ lamivudine combination (52 cases), and ceftazidime (37 cases). The most frequent errors found during analysis were ignoring of allergic anamnesis, off-label use (ignoring of age limits, pregnancy, lactation, contraindications), overdosage, and breaches of treatment regimen. Conclusion: Regular analysis of ADR data received from doctors allows to define specific patterns of reactions development, pharmacologic groups of high risk of complications and most frequent medical errors. Knowledge of them let clinical pharmacologists, regulatory agency, and educational societies to focus on the issues really important for effective and safe pharmacotherapy.