Pharmacovigilance analysis in a rural tertiary care hospital in North India: a retrospective study

Atal Sood, Vivek Sood, Himani Prajapati, Aradhna Sharma, Rekha Bansal, Vikram Mahajan


Background: The main motive of PvPI (Pharmacovigilance Programme of India) is to collect valuable data so that signals can be generated from reported adverse drug events (ADEs). It also tries to establish their causality so that ADEs can be labelled as adverse drug reactions (ADRs) beyond any doubt.

Methods: This retrospective observational study done in rural set up tertiary care teaching hospital collected data through voluntary reporting in ADR form of PvPI for period of 6 month. Causality assessment was done using WHO causality assessment scale.

Results: In 150 reported cases, majority ADRs were due to tuberculosis, cancer and HIV treatments. Gastrointestinal tract and central nervous system were the major organs involved. Most ADRs occurred within first day of drug intake. Around 15% required hospitalization. 55% ADRs were probable and 41% were possible in nature. Vertigo and depression was most frequent ADR in MDR therapy. Rashes, pruritis, fever and joint pain was frequent in antiretroviral therapy. Dysguesia, dizziness, nausea, vomiting and constipation was frequent in patients taking anticancer drugs. Platins and antibiotics used for cancer therapy cause most cancer treatment ADRs.

Conclusions: ADRs add to hospitalization expenses, insurance costs and increase in work loss days besides addition to patient suffering. Prior knowledge can help in better prescriptions and prevent valuable resource loss. Reasons for under-reporting of ADRs can be complacency, ignorance, lack of financial incentives for reporting, fear of litigation, claims of compensation and lack of time in busy hospital schedules.


Pharmacovigilance in India, ADE, DOTS plus ADR, Antiretroviral therapy ADR, Chemotherapy ADR

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