The Profile of Voluntary Reported Adverse Drug Reactions at a Tertiary Care Hospital: A Fifteen Month Prospective Study 1504-1509
Dr. Amit Dang,
Director, Geronimo Healthcare Solutions Private
Objectives: The present study was undertaken to provide the health professionals who were working at a tertiary care hospital, with a simple method to report Adverse Drug Reactions (ADRs) and to monitor, document and to evaluate them according to the set criteria.
Method and Materials: This study was conducted over a period of 15 months from 1st Janâ€™ 2008 to 31st March 2009 at Goa Medical College and Hospital (Goa, India). The evaluation of the data was done for various parameters, which included patient demographics and drug and reaction characteristics. An assessment was also done for the outcome, causality and the severity of the drug reactions.
Results: A total of 265 ADRs were reported. Among the drugs, the Ăź-lactam antibiotics were implicated the maximum number of times (54, 20.37%), followed by fluoroquinolones (35, 13.20%), antiretrovirals (33, 12.45%) and antiepileptics (31, 11.69%). Females showed more ADRs (142, 54%) than males (123, 46%). The skin was involved in about 57.73% (153) of the ADRs, while the CNS and the vascular system were involved in 8.67% (23) and 8.30% (22) of the ADRs. Most of the ADRs were categorized as â€śType IIâ€ť (203, 77%) against â€śType Iâ€ť (62, 23%) by Rawlins and Thompsonâ€™s classification. The causality assessment was done by the Naranjo Algorithm and 62.26% (165) were seen to fall in the â€śprobable categoryâ€ť as compared to 29.05% (77) in the â€śhighly probableâ€ť one. Out of all the ADRs which were reported, 34.71% (148) were â€śsevereâ€ť, in accordance with the Modified Hartwig and Siegelâ€™s scale.
Conclusion: The present work was a humble attempt to set up a well organized ADR reporting system at our government hospital. The systematic tracking and monitoring of ADRs can shed light on their extensiveness and their patterns of occurrence.