Publication:

Study of adverse drug reactions in a tertiary care teaching hospital

Background Adverse drug reactions (ADRs) are the recognized dangers of drug treatment and can arise with several groups of drugs. The purpose of this study was to identify and assess ADRs in inpatients of a tertiary care teaching hospital in Potheri.

Methods A prospective spontaneous reporting was carried out in a tertiary care teaching hospital, Potheri for a period of eight months. The causality assessment of the reported ADRs was done using the Naranjo causality assessment scale. The severity of ADRs was classified as mild, moderate or severe according to the modified Hartwig and Siegel scale.

Results A total of 62 ADRs were reported with male preponderance (51.6%). Majority of ADRs was from General Medicine and General Surgical departments in which the most affected organ systems were the skin (69.4%) and the gastrointestinal system (8.1%). The most frequent drugs causing ADRs were antibiotics (53.2%) in which type B reactions were more compared to type A. The severity assessment showed that most of them were mild reactions (51.6%). Causality assessment revealed that 61.3% of the reactions were probable, possible (30.6%), definite (8.1%) and no reactions were unlikely.

Conclusions The study accomplished that ADRs are widespread and a few of them raised the healthcare expenditure due to the increased hospital stay. The reporting of ADRs to regional pharmacovigilance centres should be encouraged to ensure drug safety.