Frequency, nature, severity and preventability of adverse drug reactions arising from cancer chemotherapy in a teaching hospital

Abstract

Background: An adverse drug reaction (ADR) is defined by the World Health Organization (WHO) as “Any response to a drug which is noxious, unintended and occurs at doses used in man for prophylaxis, diagnosis or therapy”. Cancer chemotherapy is associated with the occurrence of ADRs, which is a worldwide problem. Monitoring and reporting of these ADRs are essential to safeguard the patient and to manage it accordingly. The outcome would create alertness and prevent their recurrence. Hence, we have undertaken a hospital-based study to study the frequency and nature of ADRs due to chemotherapeutic agents. Methods: A total of 500 patients developed ADRs due to cancer chemotherapy from 13th April 2018 to 18th September 2019. Demographics of the patient, drugs taken, and ADRs encountered were recorded in a predesigned form. Results: A total of 665 ADRs were recorded from 500 patients. Anemia was the most common ADR encountered followed by nausea/vomiting and leucopenia. Leukemia (s) were common cancer observed followed by lung and breast cancers. The most common drugs implicated were cisplatin, paclitaxel, carboplatin, and doxorubicin. Naranjo's scale showed 92% of ADRs as probable and 7% as possible. Severity scale showed 80.2% of ADRs were of moderate (level 3 and 4) severity, 11.6% of mild (level 1 and 2) severity, and 8.2% of level 5 severity. A total of 26.8% of ADRs were deemed preventable and 73.2% were not preventable. Conclusions: Our study provides safety data regarding the usage of anti-cancer drugs. Hence, it creates alertness among the treating doctors to prevent its recurrence.

Keywords

• adrs
• cancer chemotherapy
• india
• preventability
• severity
• teaching hospital