Pharmacovigilance in cancer chemotherapy in regional cancer center of Eastern India: prospective observational study

Abstract

Background: Globally cancer is the leading cause of morbidity and mortality with annual death rate of 12%. According Indian Council of Medical Research, more than 1300 Indians die every day due to cancer. Chemotherapy is one of the multimodal approaches for treatment of cancer and regimens are much complex and cancer patients are more susceptible to adverse drug reaction with little tolerance due to diminished immunity. The present study was done to evaluate the prevalence of various adverse drug reactions with different cancer chemotherapy regimens, their nature and severity as well as their causality assessment as per WHO scale.Methods: This prospective observational study was conducted from July 2015 to June 2016. Patients receiving cancer chemotherapy from regional cancer centre, Cuttack were observed during the study period for the adverse drug reactions. Those ADRs were analysed for causality assessment, severity and preventability.Results: It was observed that after the initiation of chemotherapy, ADRs were observed in 92 (88.46%) patients. Among these 329 observed ADRs, during the study period, female predominance was observed in the age group 51-60yrs. Most common ADRs observed were nausea and vomiting 57 (17.37%), alopecia 46 (13.98%) and neutropenia 38 (11.55%). ADRs were most commonly seen with the haematological systems (37.68%) followed by gastrointestinal system amounting 25.22% of the total ADRs. Platinum Compound (58.35%), followed by antibiotics, antimetabolites, were the most common group of drugs causing different adverse drug reactions. On causality assessment, as per WHO-UMC criteria 68.38% were probable and 31.62% ADRs were possible. Severity assessment showed majority of the ADRs were moderate 228 (69.31%) followed by mild 67 (20.36%) and severe 34 (10.33%). It was observed that majority 212 (64.45%) of the ADRs were not preventable, 72 (21.88%) were definitely preventable and 45 (13.67%) were probably preventable.Conclusions: Cancer chemotherapy has definitely improved the quality of life, but associated ADRs need early diagnosis, prompt management and routine reporting. Thus, pharmacovigilance will definitely reduce morbidity and mortality, so also the financial burden for the patients and society.

A Prospective Observational Study on Evaluation of Chemotherapy Induced Adverse Drug Reactions in Cancer Patients in a Tertiary Care Hospital

“…This is in accordance with study by Surendiran et al 23 The mechanism of chemotherapy induced nausea and vomiting is through activation of chemoreceptor trigger zone. 24,25 In relation to the organ system, our results are consistent with the previous studies, 16 where the reactions affecting gastrointestinal tract were found to be among the most frequently affected ADRs.…”

“…It is consistent with the study done by Rademaker M et al 14 The reason for this increased risk includes gender related differences in pharmacokinetics, immunological and hormonal factors. 15,16 Women generally have lower body mass, reduced hepatic clearance and metabolize drugs at different rates compared to men. 17 This variation can also be due to difference in medications and treatment guidelines followed in different setups.…”

Adherence to Chemotherapy and Associated Factors Among Patients With Cancer in Amhara Region, Northeastern Ethiopia, 2022. A Cross-Sectional Study

“…Despite the availability of cancer treatment options, patients are vulnerable to adverse drug reactions for a variety of reasons, including poor drug adherence and clinical conditions. 11 As a result, poor chemotherapy adherence leads to drug resistance, recurrence, and poor quality of life in patients, negatively impacting the nation's health costs and ultimately resulting in mortality. 12 Chemotherapy adherence is strongly related to patientrelated factors, therapy-related factors, condition-related factors, healthcare system factors, and socioeconomic factors.…”

<p>Chemotherapy-Related Adverse Drug Reaction and Associated Factors Among Hospitalized Paediatric Cancer Patients at Hospitals in North-West Ethiopia</p>

“…14,17 Although cancer treatment options exist, patients become vulnerable to ADR due to various reasons, including poor adherence to drugs and clinical conditions. 18 For a number of formerly fatal malignancies, such as lymphomas and leukemias, chemotherapy treatment is curative. Although anti-cancer drugs are well studied and highly beneficial for better treatment outcomes, when compared to other classes of medications, they are associated with various forms of adverse drug reactions (ADRs).…”