Analysis of adverse drug reactions in hospitalized patients reported to pharmacovigilance center in a teaching hospital

Year 2020, Volume: 45 Issue: 2, 556 - 561, 30.06.2020

Zakir Khan , Emine Öz , Olcay Kıroğlu , Yusuf Karataş

https://doi.org/10.17826/cumj.671198

Cited By: 1

Abstract

Purpose: This study was carried out to assess the rate and pattern of adverse drug reactions (ADRs) reporting in hospitalized patients at a teaching hospital.
Materials and Methods: A retrospective cross-sectional study was conducted in Balcalı Hospital at Adana, Turkey for one year. The reports were examined on the basis of demographics, ADRs type, causality, severity, seriousness, drug characteristics, and outcomes. WHO-UMC/ Naranjo algorithm scale, Hartwig and Siegel severity scale and pharmacovigilance contact point (PVCP) criteria were used to assess the causality, severity, and seriousness of ADRs respectively.
Results: A total of 61105 hospitalized patients were admitted to the hospital and only 20 spontaneous ADRS were submitted to (PVCP) with an incidence rate of 0.03%. Of these, 18 eligible ADRs reporting forms were reviewed according to inclusion criteria. ADRs related to antibiotics (38.8%) were most frequently reported followed by antineoplastic agents (22.2%). Most of the ADRs were related to skin (33.3%). In causality assessment, almost 50% of the reported ADRs were possible and 55.5% were moderate in severity. Moreover, about 83.3% of the ADRs were found to be serious according to PVCP criteria. Among the total patients, 55.5% have recovered from the reactions. ADRs were reported by physicians (66.7%) followed by an assistant doctor (16.7%).
Conclusion: This study shows that ADRs are a significant problem in hospitalized patients. Monitoring and management of severe and serious types of ADRs would be valuable for improved patient care.

Keywords

Adverse drug reactions, antibiotics, pharmacovigilance, hospital, Turkey

Bir eğitim hastanesinde farmakovijilans merkezine yönlendirilen yatan hastalardaki advers ilaç reaksiyonlarının analizi

Abstract

Amaç: Bu çalışma, bir eğitim hastanesinde yatan hastalarda rapor edilen advers ilaç reaksiyonlarının (ADR) oranını ve şeklini değerlendirmek için yapılmıştır.
Gereç ve Yöntem: Adana, Balcalı Hastanesi'nde bir yıllık retrospektif kesitsel bir çalışma yapıldı. ADR'lerin nedensellik, şiddet ve ciddiyetini değerlendirmek için WHO-UMC / Naranjo algoritma skalası, Hartwig ve Siegel şiddet skalası ve farmakovijilans temas noktası (PVCP) kriterleri kullanıldı.
Bulgular: Toplam 61105 yatan hastadan 20 spontan ADRS vakası PVCP’ye sunulmuş olup insidansı %0.03’ e denk düşmektedir. Bunlardan 18 tanesi ADR bildirim formu dahil edilme kriterlerine göre uygun bulunmuştur. Antibiyotiklerle ilişkili ADR'ler (% 38.8) en sık bildirilirken antineoplastik ajanlar (% 22.2) idi. ADR'lerin çoğu deri ile ilişkiliydi (% 33.3). Nedensellik değerlendirmesinde, bildirilen ADR'lerin neredeyse %50'si mümkündür ve % 55.5'i orta ciddiyettedir. Ayrıca, ADR'lerin yaklaşık % 83.3'ünün PVCP kriterlerine göre ciddi olduğu bulunmuştur. Toplam hastalar arasında% 55.5'i reaksiyonlardan iyileşmiştir. ADR'ler doktorlar (% 66.7) ve ardından asistan doktor (% 16.7) tarafından rapor edilmiştir.
Sonuç: Bu çalışma hastanede yatan hastalarda ADR'lerin önemli bir problem olduğunu göstermektedir. Şiddetli ve ciddi tipte ADR'lerin izlenmesi ve yönetimi, daha iyi hasta bakımı için değerli olacaktır.

Keywords

Adverse drug reactions, antibiotics, pharmacovigilance, hospital, Turkey

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