Abstract

PHARMACOVIGILANCE STUDY OF ANTI-CANCER DRUGS IN CANCER HOSPITALS: A PROSPECTIVE OBSERVATIONAL STUDY

Bola Shankar Vusurumarthi*, Dinesh Mayakuntla*, Durga Devi Vusurumurthy, Dr. Venkata Ramarao Nallani and Professor Rama Rao Nadendla

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Abstract

Aim: To Identify, Analyze and Report the Adverse drug reactions that occurs due to Chemotherapy and targeted agents. Method: This is a Prospective Observational study which was carried out in and around Guntur over a period of 6 months i.e. October 2020 to March 2021. About 150 study participants were analyzed for demographic profile, Organ-system wise distribution of ADR‟s, Common and rare ADR‟s encountered, Grade-wise severity assessment of ADR‟s and to determine incidence and prevalence of different types of Cancer in different age groups, Genders, a sample size of 1000 subjects were included. Results: A total of 948 Chemotherapy-induced ADR‟s were detected with different grades from a total of 150 patients during the study period. The common drugs involved in causing ADR‟s were Microtubule damaging agents, Platinum compounds, Anti-metabolites. Haematological system (91.3%; n=137) was the most frequently involved organ system with Anemia, Thrombocytopenia being most common manifestations. According to the severity assessment scale (CTCAE 4.0) it was found that most of the reactions were of Grade-I (Mild, 51.5%) followed by Grade-II (Moderate, 44.6%) and very few people were found with Grade-III (Severe, 3.7%) and Grade-IV (Life threatening, 0.2%). The Epidemiological results of this study revealed that there was a higher incidence of different types of Cancers among people with age of 51-60 years and females were highly affected when compared to males. Conclusion: ADR‟s pose additional worse outcomes in patients treated with Chemotherapy since they have a negative impact on the patient‟s QOL and in addition escalates cost of therapy. So, to ensure the preventability of ADR‟s in many cases, timely reporting of ADR‟s and effective ADR monitoring system (Onco - pharmacovigilance) could be the need of hour with the involvement of Oncologists, Radiotherapists and Onco –surgeons.

Keywords: Chemotherapy, Onco-pharmacovigilance, CTCAE, Severity, Adverse drug reactions, prospective observational study, Pharmacovigilance, Causality and Side effects.