Retrospective Observational Study to Evaluate Causality, Preventability and Severity of Adverse Drug Reaction Associated with Anticancer Drugs in a Tertiary Care Hospital in Northern India.

BACKGROUND: Chemotherapy has high efficacy, but it is associated with several adverse drug reactions (ADRs). OBJECTIVES: A retrospective observational study to explore the prevalence, causality, and preventability of ADRs of anticancer agents was conducted. METHODS: The study was carried out at Punjab Institute of Medical Sciences Jalandhar, Punjab after obtaining IEC approval. The data was collected from cancer patients undergoing treatment at the hospital. The causality assessment of the collected data was done by using WHO causality assessment criteria. The preventability and severity of the reported ADRs were also assessed. RESULTS: From 50 medical records, a total of 47 ADRs were recorded among 25 patients, out of which 16 were females and the rest were males. The cancer cases observed were breast carcinoma, leukaemia, lung, colon, and ovarian cancer. The highest number of ADRs were observed with alkylating agents, followed by taxanes, antimetabolites, kinase inhibitors, and monoclonal antibodies. The most affected organ systems were the gastrointestinal system, blood, and lymphatic system. According to the causality assessment, the majority of the ADRs were of the "possible" category. Preventability analysis showed that 85.11% of ADRs were unavoidable reactions, while 14.89% of ADRs were possibly avoidable. Severity analysis of ADRs showed that 87.23% of ADRs were mild and 12.77% were of moderate severity. The majority of the ADRs were unavoidable and mild to moderate in severity. CONCLUSION: Since the majority of the ADRs were of the unavoidable category, it indicates that the treatment regimens are acceptable as per the current clinical management of cancer patients.

A survey on the knowledge, attitude and the practice of pharmacovigilance among the health care professionals in a teaching hospital in northern India.

OBJECTIVE: To assess the pharmacovigilance awareness among the healthcare professionals in a teaching hospital in Northern India. MATERIAL AND METHODS: A questionnaire which was suitable for assessing the basic Knowledge, Attitude and the Practice (KAP) of pharmacovigilance was designed and distributed among 100 doctors of the Punjab Institute of Medical Sciences (PIMS) Hospital, Jalandhar, Punjab, India. RESULTS: Among the 100 doctors, 61 responded. The data was analyzed by using the SPSS statistical software. Although 77% of the subjects knew the term 'pharmacovigilance', only 59% were aware of the existence of the National Pharmacovigilance Program. 23% volunteered to reports Adverse Drug Reactions (ADRs), but more than 60% doctors did not know how and where to report the ADRs. CONCLUSION: There is a need for a regular training and the reenforcement for the ADR reporting among the health care personnel. The perception of the reporting process being tedious, the lack of time, a poor knowledge on the reporting mechanism and inadequate expertise seemed to be the main reasons for not reporting the ADRs. A majority of the respondents suggested regular training sessions on a priority basis for the success of the pharmacovigilance program and for the better clinical management of the patients in general.