Abstracts are summaries of the overall goal of an offering and the specific ideas or concepts that will be presented, including outcomes and implications for practice. Please limit abstracts to a 450-word count; this does not include the title or the author block, which is entered in a different field of the submission process.
Abstracts must be submitted only in English consisting of five paragraphs with the following headings:
Abstracts should be submitted using the online submission system before the final submission deadline of May 20, 2025. After the submission deadline, all abstracts will be automatically considered to be fully submitted and will proceed to peer review.
Up to 15 authors can be submitted for an abstract (including the presenting author). The presenting author is selected first; other authors can be added only when the presenting author is submitted. However, the author order can be changed if needed by swapping the names in the list of the authors. The first name is always considered to be the main author, and the presenting author should be underlined.
All accepted abstracts will be published in Drug Safety, ISoP official journal. It is highly recommended to check the abstract for correct spelling, punctuation, grammar, and formal structure before submitting.
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Title: Risk Factors for Developing Serious Adverse Drug Reactions
Introduction: Serious adverse drug reactions (ADRs) constitute major concerns in terms of both individual outcomes (e. g. deaths and hospitalizations) and public health expenses. Several studies have been conducted to assess the importance and economic consequences of ADRs. [1-4] However, such work has not been previously undertaken in Croatia.
Aim: To identify risk factors associated with developing a serious ADR.
Methods: We performed a retrospective observational study of the ADRs reported to the Croatian Agency for Medicinal Products and Medical Devices for the period from March 2005 to December 2006. All drugs were classified using the Anatomical Therapeutic Chemical (ATC) classification code system and subsequently entered into a database. ADRs were considered serious if one of the following criteria were met according to the ICH E2A guidelines: the ADR is life-threatening; it led to hospitalization/prolonged stay in hospital; caused congenital malformation; permanent disability; or a medically serious condition. Descriptive statistics and logistic regression using SPSS 14.0 were undertaken.
Results: The results showed that among all the reported ADRs (n = 898), 26.1% referred to serious ADRs (n = 234). The majority of these serious ADRs (59.4%) were caused by drugs belonging to N (25.7%), J (18.5%), and, C (15.2%) ATC groups. From this database of ADRs, polypharmacy was associated with an increased risk of experiencing a serious ADR (B = 1.226; R2 = 0.026; p 0.005). The relationships between serious ADRs, patient demographics, and drug interactions were also explored.
Conclusions: This study has identified factors that contributed to developing serious ADRs reported to Croatian Agency for Medicinal Products and Medical Devices. These data will be used for the development of national risk management plans.