Applied Drug Research, Clinical Trials and Regulatory Affairs - Online First

Incidences of adverse drug reactions were reported through spontaneous reporting at an ADR monitoring unit in a tertiary care hospital.

This study was conducted to describe the distribution pattern of adverse drug reaction (ADR).

The objective of this study was to monitor and report the adverse drug reactions (ADRs) occurring in a tertiary care hospital and to evaluate the incidence, causality, severity, and preventability of adverse drug reactions.

A prospective, observational study was conducted at a tertiary care hospital in Punjab for 6 months. All patients admitted to the hospital above 18 years of age were included in the study.

A total of 103 ADRs were observed over the study period of 6 months. The majority of them were females (60), comprising of 58.25%. The therapeutic class of drug associated with most of the ADRs was antibiotics 18 (17.5%). Maximum number of ADRs occurred in the general medicine ward with frequency of 27 (26.2%) and were of type b 58 (56.3%). Causality was assessed using the Naranjo scale, and most of the ADRs came out to be probable 64 (62.1%) in nature. Severity was assessed using Hartwig’s severity assessment scale, and most of the cases, 66 (64.1%), were moderate in intensity. ADR preventability was assessed using the Schumock and Thornton preventability scale, and it was observed that most of the cases, 82 (79.6%), were not preventable.

This study seeks to strengthen the ADR database through analysis of spontaneous reporting patterns of ADRs from various clinical departments of a tertiary care teaching hospital, thereby increasing awareness and improving the reporting culture among health care practitioners. It can be concluded that continuous medication monitoring and a well-organized and committed pharmacovigilance system led by a clinical pharmacist in a hospital setting would undoubtedly lower the incidence of adverse drug reactions.