{
  "abstract": "Background and Importance Pharmacovigilance is a key component of good clinical practice, particularly in the post-marketing phase when rare or unexpected adverse drug reactions (ADRs) may occur. Systematic ADR reporting is essential for patient safety in complex hospital care, where the risk is increased by polypharmacy and novel therapies used. Clinical pharmacists are well positioned to detect and report suspected ADRs, supporting early identification of safety signals, high-risk drugs, and vulnerable patient groups.Aim and Objectives To describe and analyse the spectrum, frequency, and clinical relevance of suspected ADRs reported by a clinical pharmacist over twelve years in oncology patients in a tertiary care hospital, focusing on trends, most implicated drugs, and patient outcomes.Material and Methods A retrospective analysis was conducted of all suspected ADRs in oncology patients that were identified and reported by a clinical pharmacist to the Czech State Institute for Drug Control between November 2013 and April 2025. Collected data included patient demographics, cancer type, drug and therapy category, ADR type and severity, clinical outcomes, and annual reporting trends. Descriptive statistics were applied for the analysis.Results A total of 217 ADRs were reported: 62% in females, 38% in males. The most affected age group was 60–79 years (62%). Main therapies were chemotherapy (38%), immunotherapy (31%), biological therapy (21%), and other (9%). Most implicated drugs were nivolumab, ipilimumab, carboplatin, paclitaxel, oxaliplatin, and pembrolizumab. Common ADRs included allergic reactions/drug intolerance (35%), diarrhoea/colitis (13%), exanthema (8%), nephrotoxicity (6%), hematotoxicity (6%), hepatotoxicity (6%), pneumonitis (3%), and neurotoxicity (2%). About 40% of ADRs were serious (hospitalisation, life-threatening events, death); most patients fully recovered. An increasing proportion of immunotherapy-related ADRs was observed in recent years.Conclusion and Relevance Twelve years of systematic ADR reporting by a clinical pharmacist generated valuable real-world pharmacovigilance data in oncology patients. Allergic and immune-related reactions were the most frequent and clinically significant. Continuous monitoring and systematic reporting should be an integral part of clinical pharmacy practice, especially in the post-marketing phase. Despite demonstrated benefits, underreporting persists due to limited access to patient/product data, time constraints, and insufficient awareness of post-marketing safety monitoring.References and/or Acknowledgements Thanks to co-authors for their support and collaboration.Supported by Charles University grant SVV 260 785.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "University Hospital Hradec Kralove, Hospital Pharmacy, Hradec Kralove, Czech Republic"
      ],
      "name": "M Novosadova"
    },
    {
      "affiliations": [
        "University Hospital Hradec Kralove, Hospital Pharmacy, Hradec Kralove, Czech Republic",
        "Faculty of Pharmacy In Hradec Kralove, Department of Clinical and Social Pharmacy, Hradec Kralove, Czech Republic"
      ],
      "name": "P Rozsivalova"
    },
    {
      "affiliations": [
        "State Institute for Drug Control, Department of Pharmacovigilance, Prague, Czech Republic"
      ],
      "name": "E Jirsova"
    },
    {
      "affiliations": [
        "University Hospital Hradec Kralove, Quality Management Department, Hradec Kralove, Czech Republic"
      ],
      "name": "D Havlicek"
    },
    {
      "affiliations": [
        "University Hospital Hradec Kralove, Department of Oncology and Radiotherapy, Hradec Kralove, Czech Republic"
      ],
      "name": "J Kopecky"
    }
  ],
  "title": "5PSQ-002 Twelve years of clinical pharmacist-led adverse drug reaction reporting in oncology patients at a university hospital",
  "uid": "d45f718b-88ae-55dd-80cb-61d247d54eec"
}