Preventability of adverse drug reactions to anticancer drugs: insights from the database of the Regional Drug Information and Pharmacovigilance Center

Abstract Background Adverse drug reactions (ADRs) are common events in cancer therapy and may result in prolonged hospitalization or death. In Vietnam, there is a paucity of studies assessing the severity and preventability of ADRs using data from the regional pharmacovigilance system. This study was therefore carried out to characterize these ADRs, determine their severity, and assess their preventability. Methods A retrospective, cross-sectional study of ADR reports related to anticancer drugs submitted to the Ho Chi Minh City Regional Drug Information and Pharmacovigilance Center, Ho Chi Minh City, Vietnam, was conducted between January 1 and December 31, 2023. Causality between suspected drugs and ADRs was assessed using the World Health Organization–Uppsala Monitoring Centre (WHO-UMC) causality assessment system; eligible reports were further evaluated for preventability using the World Health Organization Preventability (WHO P-method). Results A total of 291 reports were included in the analysis after excluding reports related to drug quality and those not associated with anticancer drugs. The results showed that female patients (212/291, 72.9%) experienced ADRs more frequently than male patients (76/291, 26.1%), with the 40–64 age group accounting for 54.3% (158/291) of cases. Causality assessment using the WHO scale identified 253 reports (86.9%), corresponding to 433 drug–ADR pairs, as having a causal relationship between the suspected drug and the ADR. These reports were subsequently evaluated for preventability, and 2 reports (0.8%) were determined to be preventable. The most common anticancer drugs causing ADRs were carboplatin (92/433, 21.2%) and paclitaxel (87/433, 20.1%). Non-serious ADRs accounted for 70.8% (179/253), whereas 18.2% (46/253) required hospitalization or prolonged hospital stay and 6.3% (16/253) resulted in death. Two cases (0.8%) were deemed preventable, attributed to a history of drug hypersensitivity (cisplatin) and therapeutic duplication (epirubicin). Conclusion Most anticancer drug–related ADRs in this study were non-serious, although a considerable proportion still resulted in hospitalization or death. The identification of preventable ADRs highlights the need for ongoing monitoring and evaluation to inform appropriate preventive strategies and enhance patient safety in cancer treatment.