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 13 th April 2018 to 18 th 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.

Adverse drug reaction profile of anticancer agents in a tertiary care centre of rural Maharashtra: a cross-sectional study

“…The scrutiny of causal association using the Naranjo Scale of Causality assessment showed that 73.4% ADR fell in the category of 'Probable' and 26.5 % were 'Possible' (Table 2). These finding are similar to studies by Chopra et al and Ramasubbu et al 16,34 With the use of this same scale, two other studies reported 100% and 61% of probable scores for causality. 35,36 These findings suggest that one should be watchful of the common ADRs of the drugs prescribed, which fall under the category of probable and possible.…”

Exploration and Evaluation of Adverse Drug Reactions Documented in a Tertiary-Care Hospital in Chennai: An In-Depth Retrospective Observational Study

“…According to the Naranjo causality assessment scale, 77% of the ADRs were categorized as probable, 22% as possible, 4% as certain, and 3% as doubtful. The number of reactions classified into probable categories is similar to other studies conducted previously by Gupta and Kumar [24], Ramasubbu et al [25], and Patel et al [26]. In our study, ADRs due to IV fluids were classified as certain as all the reactions occurred immediately after drug administration without any confounding factor.…”

Drug-related problems among esophageal, gastric and colorectal cancer patients at the National and referral hospital in Kenya

“…Previous research has shown that cancer patients receiving chemotherapy are at a significantly increased risk of experiencing adverse drug reactions. 53–56 The present study showed that the combination of chemotherapy and radiotherapy and chemotherapy-treated esophageal and gastric cancer patients had the highest percentage of adverse drug reactions, respectively. In addition, chemotherapy (37%) had the highest proportion of adverse drug reactions in colorectal cancer patients.…”

“…62 In contrast, most adverse drug reactions in cancer patients were reported to be non-preventable ADRs. 53,67 Since most ADRs weredefinitely preventable in our setting, preventive measures should be adopted throughout chemotherapy treatment to lessen the frequency of adverse drug reactions and the severity of such reactions among patients with gastrointestinal cancer.…”