Assessment of Adverse Drug Reactions Reported in a Tertiary Care Teaching Hospital in South India.

The aim of the study was to detect, document, assess and report the suspected adverse drug reactions.  A prospective-observational study on adverse drug reactions was conducted in a 1000 bedded multi-specialty hospital. Suspected ADRs were analyzed for causality, severity and preventability using appropriate validated scales. A total of 65 ADRs were identified in 2280 admissions during the study period. Severity of the suspected ADRs assessed using Modified Hartwig and Siegel Scale. The study revealed that 2(1.6%) suspected ADRs were severe, 5(8%) ADRs were moderate and 58(90.4%) ADRs were mild in severity. Causality assessment was done by using WHO and Naranjo scale. The assessment by Naranjo scale showed that 16 (24.8%) ADRs were possibly drug-related, whereas 43(65.6%) were classified as probably and 6(9.6%) ADRs were definitely related to the drug, while the assessment done by using WHO scale revealed that 16(24.8%) ADRs were possibly drug-related,18 (27.2%) ADRs were probably drug-related, whereas 7(9.6%) were classified as certainly related to drug. Nine patients (13.8%) were admitted due to an Adverse. Preventability of suspected ADRs assessed by using Modified Schumock and Thornton scale, revealed that 17(26%) ADRs were definitely preventable while 1 (2%) ADRs were probably preventable and 47(72%)of the drug reactions were not preventable. Intervention was required in all ADRs as it indirectly contributed to affect the patient’s Quality Of Life. Our ability to anticipate and prevent such ADRs can be facilitated by the establishment of standardized approaches and active reporting of suspected ADRs.