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

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

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, ostalo

Skup
67th FIP Congress

Mjesto i datum
Peking, Kina, 31.08.2007. - 06.09.2007

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
adverse drug reaction; drug-drug interaction

Sažetak
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.

Izvorni jezik
Engleski

POVEZANOST RADA