engleski

The Significance of Serious Adverse Drug Reactions (ADRs) among all Reported ADRs in Croatia

Serious adverse drug reactions (ADRs) constitute major concerns, including both individual consequences (e.g. deaths and hospitalizations) and public health expense. Several studies have been conducted to asses the importance and economic consequences of adverse drug reactions. However, such work has not been previously undertaken in Croatia. Aim was to describe and quantify serious ADRs among all spontaneously reported ADRs in Croatia during 2005. 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 and the drug involved were coded using the Medical Dictionary for Regulatory Activities (MedDRA) adverse drug reaction terminology. All drugs were classified using the British National Formulary (BNF) code system, and subsequently entered into a database ADRs were considered serious of one of the following criteria were met according to the Uppsala Monitoring Center (UMC) definition the ADR is life threatening it led to hospitalization/prolonged stay in hospital ; caused congenital malformation, permanent disability, or medically serious condition according to the CIOMS V (Council for International Organization for Medical Sciences). Descriptive statistics and logistic regression using SPSS 14.0 were undertaken. The result showed that among all the reported ADRs 32.3% referred to serious ADRs (103 cases). 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 rennin-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, patient demographics and drug interactions were explored as well. Two recorded serious ADRs were associated with death the use of lisinopril in a 68 year old male which caused Quinck's oedema, and a combination of salmeterol and fluticasone in a 11 year old girl with status asthmaticus. This study has highlightened 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 reactions; ADRs in Croatia

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