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THE SIGNIFICANCE OF SERIOUS ADVERSE DRUG REACTIONS (ADRs) AMONG ALL REPORTED ADRs IN CROATIA (CROSBI ID 608743)

Prilog sa skupa u zborniku | sažetak izlaganja sa skupa | međunarodna recenzija

Jankovic, Iva ; Mirosevic, Nikica ; Ortner Hadziabdic, Maja ; Jadrijevic-Mladar Takac, Milena ; Tomic, Siniša ; Macolic-Sarinic, Viola ; Duggan, Catherine ; Bates, Ian THE SIGNIFICANCE OF SERIOUS ADVERSE DRUG REACTIONS (ADRs) AMONG ALL REPORTED ADRs IN CROATIA. 2007

Podaci o odgovornosti

Jankovic, Iva ; Mirosevic, Nikica ; Ortner Hadziabdic, Maja ; Jadrijevic-Mladar Takac, Milena ; Tomic, Siniša ; Macolic-Sarinic, Viola ; Duggan, Catherine ; Bates, Ian

engleski

THE SIGNIFICANCE OF SERIOUS ADVERSE DRUG REACTIONS (ADRs) AMONG ALL REPORTED ADRs IN CROATIA

INTRODUCTION Serious adverse drug reactions (ADRs) constitute major concerns, including both individual consequences (eg. deaths and hospitalizations) and public health expense. Several studies have been conducted to assess the importance and economic consequences of adverse drug reactions1-4. However, such work has not been previously undertaken in Croatia. AIM To describe and quantify serious ADRs among all spontaneously reported ADRs in Croatia during 2005. METHODS We performed a retrospective observational study of the ADRs in Croatia reported to the Department for Pharmacovigilance, National Agency for Medicinal Products and Medical Devices for the period from March to December 2005. Data concerning the suspected ADRs were coded using MedDRA adverse drug reaction terminology. All drugs were classified using the British National Formulary (BNF) code system. ADRs were considered serious* if one of the criteria according to the Uppsala Monitoring Centre (UMC) definition were met. This database was than searched for both, actual and potential DDIs. Actual and potential DDIs were detected with a computerized interaction detection system Drug-Reax (Thomson, Micromedex). Descriptive statistics and logistic regression using SPSS 14.0. were undertaken. RESULTS The results showed that among all the reported ADRs 32.3% refered to serious ADRs (Figure 1). The majority of these serious ADRs (70.9%) were caused by drugs used for cardiovascular system (28.2%), infections (26.2%) and central nervous system conditions (16.5%). The following drugs caused the most serious ADRs: antibacterials (24.5%), drugs affecting the renin-angiotensin system and the other antihypertensive drugs (10.8%), and cytotoxic drugs (6.9%). From this database of ADRs, polypharmacy was associated with an increased risk of experiencing a serious ADR (B=1.2 ; R2=0.025 ; p=0.08). The relationship between serious ADRs, and drug interactions were explored as well. From all serious ADRs 11.7% were due to actual interactions and 27.2% due to potential interactions (Figure 2). CONCLUSIONS This study has highlighted the importance of reporting incidences that have an effect on patient outcome. Further work is planned to thoroughly evaluate this data and to compare with subsequent years reports.

adverse drug reaction; drug-drug interaction

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Podaci o prilogu

2007.

objavljeno

Podaci o matičnoj publikaciji

Podaci o skupu

67th FIP Congress

poster

31.08.2007-06.09.2007

Peking, Kina

Povezanost rada

nije evidentirano