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 400-word count and use font Time New Roman (size 12 pts); 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:

• Background / Introduction
• Objective/Aim
• Methods
• Results
• Conclusion
• References/Further sources of information

Abstracts should be submitted using the online submission system before the final submission deadline of 1^st of April 2024. 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.

Please check that references are cited in the text. There is a possibility that references will be deleted during production if they are not cited in the text.

The organizer reserves the right to edit abstracts, if necessary, prior to the publication in Drug Safety.

This year’s Meeting intends to provide original and high-quality sessions focused on educational content that is free from commercial influence or bias. We request all presenters to cooperate with this by declaring during the abstract submission process that the abstract is unpublished and original material and fill the conflict of interest form.

• Abstracts already published elsewhere or based on full papers that have already been published will not be considered for inclusion.
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• Pharmaceutical products should include the generic name and in parenthesis the brand name.
• ISoP requests that a high standard of science is followed concerning publications and presentations at all its Annual Meetings and training courses. However, ISoP as a whole its Executive Committee (EC) appointed Scientific Committees, or its members, do not take any responsibility for the completeness or correctness of data or references given by authors in publications and presentations at official scientific meetings. It is not within the remit of ISoP, the EC, or Scientific Committees in particular, to seek clarification or detailed information from authors about data in submitted abstracts. Moreover, it is not within the scope of ISoP and its committees to monitor compliance with any legal obligations, e. g. reporting requirements or regulatory actions.

• One table can be included with each abstract and the table must not contain more than 4 columns and 10 rows.

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Submitter/Author(s) will be asked to select from the following:

• Oral Presentation
• Poster Presentation

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.

• Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998; 279: 1200-5
• Einarson TR. Drug-related hospital admissions. Ann Pharmacother 1993; 27: 832-40
• Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA, et al. The costs of adverse drug events in hospitalized patients. JAMA 1997; 277: 307-11
• Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol 1998; 45: 301-8