Adverse Drug Reaction Profile of Anticancer Agents in a Tertiary Care Hospital: An Observational Study.

BACKGROUND

Anti-cancer agents are known to be toxic, leading to a number of adverse drug reactions (ADRs). ADRs not only increase the financial burden on the patient/healthcare system but also decrease the quality of life. Understanding the burden of ADR will help strengthen the knowledge on patient safety and implement intervention strategies to reduce it.

OBJECTIVES

The objectives of the study are as follows: 1. To study the pattern of adverse drug reactions of anticancer agents of patients admitted in the oncology ward. 2. To assess the causality, severity, and preventability of the adverse drug reactions observed.

METHODS

This was a cross-sectional, observational study carried out in 200 adult patients in the daycare center for chemotherapy. Details of ADRs noted in the previous and current cycles were noted. Causality assessment was done using Naranjo and WHO scales. For severity and preventability assessment, Hartwig Siegel and Modified Schumock Thorton scale were used, respectively.

RESULTS

Out of the total 732 ADRs encountered, alopecia was the most common ADR. The average number of ADRs observed per patient was 3.66 + 1.59 (mean + SD). The maximum number of ADRs were seen in Paclitaxel-carboplatin 3 weekly regimen. Nausea and alopecia were the most common ADRs reported with most regimens. On causality assessment, 95 (12.97%) were definitely related according to Naranjo's Causality scale, while 15.71% were certainly related according to the WHO scale. Of all the ADRs recorded, 47.81% were of moderate intensity, while 52.18% were of mild intensity. The majority of ADRs, i.e., 87.59%, were not preventable.

CONCLUSION

Alopecia was the most common ADR reported. Most of the ADRs could be causally related to drugs. These ADRs were mild to moderate in severity and were not preventable. There is a need to identify the underlying factors that predispose patients to these ADRs and target them in future research.