Adverse drug reaction monitoring in a teaching hospital Mandya

Abstract

Objectives: 1. To assess and analyse adverse drug reactions (ADRs) according to reporting and presentation. 2. To describe causality and severity analysis. Materials and methods: After taking approval from the Institutional ethical committee study was undertaken over a period of one year. A prospective observational study was conducted to monitor the ADRs in all the clinical departments and emergency units of the hospital. The ADRs forms were distributed to all the departments and informed them to report any suspected adverse drug reactions. ADRs were monitored both actively and passively. Reported forms were collected by active surveillance and Causality assessment was done by pharmacologist using Naranjo’s & WHO scale and severity by Hartwig’s scale respectively. Results: Total 85 ADRs were reported over a period of year. Most of the ADRs were reported from the ART centers 70.6%. The most common system involved in ADR was haematological system about 29.4% of overall reaction followed by 24.7% dermatological. Zidovudine induced anaemia was the most common ADR. Causality assessed using Naranjo’s scale showed that most of reported ADRs were probable 49.4%, 27.1% were doubtful and 23.5% were possible. Conclusion: Study showed that there was under reporting of ADRs. Most of the cases were reported from ART center. There is a need to improve awareness among the clinicians to emphasize their role in voluntary reporting of ADRs, on generating quality reports, critically monitor the ADRs so as to prevent them further. Keywords: Adverse drug reaction, Causality assessment, Naranjo scale, WHO scale and Hartwig’s scale.