Incident safety reports on generic and branded docetaxel medications in a teaching hospital
DOI:
https://doi.org/10.30968/jhphs.2025.164.1223Abstract
Objective: To compare incident reporting associated with generic and branded docetaxel in a Brazilian teaching hospital, and to analyze the pharmacovigilance notifications involving this drug in a teaching hospital. Methods: A cross-sectional study was conducted in a high complexity Brazilian university hospital. Data from patients aged 18 years or older were included. Incidents associated with docetaxel 80 mg reported in the hospital’s pharmacovigilance database from January 1st, 2018, to December 31st, 2020, were analyzed. Reports of adverse drug reactions (ADR), therapeutic ineffectiveness, medication errors, and quality deviations (QD) were considered. Additionally, the underreporting rate of late ADRs was calculated. For descriptive analysis it was used the number of cases and percentages for categorical variables; and mean and standard deviation (SD) for continuous variables. Results: 124 incident reports related to chemotherapeutic agents were recorded. Among these, 34 (27.4%) were associated with docetaxel. Two involved the generic medication, while 32 were associated with the branded medication. Despite having a well-established multidisciplinary team in the oncology department, the most frequent reporters were nurses (26/34). The reports described 35 incidents: 21 ADR (10 immediate and 11 delayed) and 14 QD. Nine immediate ADR, 11 delayed ADR, and 12 QD reports were related to branded medication. The underreporting rate was 93.0%. Conclusion: Underreporting hindered the comparison of incidentes associated with generic and branded docetaxel in the pharmacovigilance database. The lack of medication safety communication decreases signal detection and compromises decision-making rely on real-world data. In this regard, the findings suggest the need for educational interventions for healthcare professionals to improve attitudes towards pharmacovigilance.
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