A PROSPECTIVE STUDY ON CAUSALITY OF ADVERSE DRUG REACTIONS AT A TERTIARY CARE HOSPITAL

*Drisya T., A. R. Shabaraya and Sudhamshu K. Tantry

ABSTRACT

The use of drugs is increasing day by day with the occurrence of new diseases, use of multiple drugs can lead to a
variety of adverse drug reactions. Knowing the causality of ADRs caused by various classes of drugs helps to
achieve better therapeutic regimen and deliver optimum patient care. This study aimed to assess causality (WHOUMC
scale and Naranjo scale) of ADRs. A prospective observational study was conducted over a period of 6
months at Srinivas Institute of Medical Science and Research Centre, Mukka, Dakshina Kannada. Data was
collected in the reported ADR data collection form, which were then assessed for causality using WHO-UMC and
Naranjo’s algorithm scales. Out of the total 100 ADRs collected, it was found that incidence (60 ADRs) was higher
in geriatric patients (above 60 years). Commonly reported ADR was constipation (35). The maximum number of
ADRs were found in females (54%), while compared to males (46%). 71% of the type A reactions (Augmented)
and 29% type B (bizarre) reactions were reported. The class of drugs which commonly caused ADRs were
antibiotics (58). General medicine department had highest number of reported ADRs (32). Assessment of ADR
causality revealed majority of the ADRs were Probable (Naranjo- 72 ADRs. WHO – 72 ADRs). To minimize the
incidence and prevent further complications and occurrence, proper monitoring of adverse reactions is required.
Spontaneous reporting of ADR will help to improve the patient’s safety and health and also it may help the
physician to avoid those drugs which may cause fatal reactions. Hence, importance should be given in spontaneous
reporting of ADR, to ensure the safety of the patient.

Keywords: ADR, Causality, WHO, Naranjo.