Background: Many adverse drug reactions (ADRs), interactions and specific toxicities are known once drug is exposed to a larger population. Spontaneous reporting adverse events (AEs) are fundamental to a robust pharmacovigilance (PhV). Increasing physician awareness about the pharmacovigilance and ADR reporting can significantly contribute the safety of medicines. Objective of the study was to assess the knowledge, attitude and practices related to PhV among medical professionals at a tertiary care teaching hospital.Methods: Postgraduate students (PGs) and medical teachers at a Medical College and tertiary care hospital were evaluated for their knowledge, attitude and practice of pharmacovigilance with the help of a structured questionnaire. Suggestions for improving the effectiveness of the pharmacovigilance practices were also sought.Results: One-hundred and fifty doctors [91 (60.7%) PGs and 59 (39.3%) medical teachers] participated. Overall, 48.7% were males. 96% believed that PhV is important in medical practice but only 79.3% knew the definition of pharmacovigilance. Only 24.7% were aware of the existing nationwide pharmacovigilance program whereas the international collaborating center was known to 26% of the participants. 96% believed that it is the duty of a treating physician to report an ADR while 36.7% felt that ADR reporting should be the responsibility of a separate team. Surprisingly, 54% felt that financial aid should be provided for ADR reporting. 42.7% have not reported any ADR whilst only 16% have reported more than 10 ADRs in their career. To create an ADR database (79.3%) was the common expectation from the PhV center. 98.7% suggested continued medical education (CME) and trainings to improve the effectiveness of PhV in Indian setting.Conclusions: Regardless of a fair attitude towards PhV, the practice of ADR reporting is poor probably because of lack of sufficient knowledge about PhV. Motivating the physicians through CMEs and trainings so as to improve and strengthen the pharmacovigilance practices is the current need in India.

Background: Adverse drug reactions (ADRs) associated with the use of anticancer drugs are a worldwide problem and cannot be overlooked. They range from nausea, vomiting or any other mild reaction to severe myelosuppression. The study was planned to evaluate the pattern of adverse drug events to anti-cancer agents in a tertiary care hospital. Methods: This observational prospective study was carried out in a tertiary care hospital from 1st January 2011 to 31st December 2011. A total of 213 patients who fulfilled the inclusion criteria were enrolled in the study. Out of them, 8 patients were withdrawn from the study as they subsequently underwent radiotherapy. The adverse events observed during the treatment were noted and analyzed by using applicable statistics. Results: Out of 205 patients, 98 were males and 107 were females. Breast cancer was the commonest type of cancer evident. A total 523 anti-cancer drugs were prescribed for the patients with alkylating agents being the most common. 635 adverse events (ADRs) were observed in patients with vomiting and nausea as the most common adverse drug reactions (ADREs). Majority of the ADRs (89%) had a latent onset (occurring 2 or more days after exposure to the drug). Few events were serious in nature (9%); fatal events were uncommon (0.31%). WHO causality was 'possible' for 94% of the events. ADRs were more frequently observed in females in the age group of 46-60 years; mood swings were significantly higher in women, while vomiting was found to be significantly common in men. Conclusions: The study showed that chemotherapy has a high potential to cause ADRs. Thus, there is a need for vigilant ADR monitoring to prevent morbidity and mortality due to ADRs.

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