Akademik Veri Yönetim Sistemi
Cukurova Medical Journal, cilt.45, sa.2, ss.556-561, 2020 (ESCI)
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.