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A Prospective Observational Study on Adverse Drug Reactions in General Medicine Department of a Tertiary Care Teaching Hospital


Affiliations
1 Department of Pharmacy Practice, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
2 Department of General Medicine, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
3 Department of Pharmacology, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
     

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Present study was carried out to estimate the incidence of ADRs reported in general medicine department, to evaluate the causality, severity and preventability of ADRs caused by any drugs. A prospective observational study was carried out for a period of 8 months. Patients admitted during the study period were included as per the study criteria and monitored for ADRs. The clinical system, spectrum of ADRs noted and assessment of ADRs was done by causality, preventability and severity. The different scales are applied for assessment of causality, severity and preventability. Data was analysed by using descriptive statistics. A total number of 270 patients were included. 55 ADRs were observed in 52 patients. Higher incidence of suspected ADRs were exhibited with the age group of 61-70 years. The hospital stay extended for more than nine days in 32 (61.5%) patients who experienced ADR. The causality assessment by WHO Probability Scale, showed that out of 55 ADRs, majority were probable 38 (69.09%), whereas 11 (22%) reactions were possible and 6 (10.91%) reactions were certain. Based on Naranjo’s scale, 29 (52.73%) reactions were probable and 26 (47.27%) reactions were possible. Majority of 29 (53%) reactions were moderate in severity. Proper monitoring of adverse reactions is useful to minimize the incidence of ADRs and prevent further occurrence of the same. The regular monitoring of ADRs can reduce the morbidity and can improve the patients compliance which in turn can produce better therapeutic outcome.

Keywords

Adverse Drug Reaction, Causality, Severity, Preventability, Naranjo’s Scale.
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  • A Prospective Observational Study on Adverse Drug Reactions in General Medicine Department of a Tertiary Care Teaching Hospital

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Authors

N. M. Rayees
Department of Pharmacy Practice, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
Sampath Kumar
Department of General Medicine, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
K. C. Bharath Raj
Department of Pharmacy Practice, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
K. S. Rajesh
Department of Pharmacy Practice, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
Juno J. Joel
Department of Pharmacy Practice, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
K. Prasanna Shama
Department of Pharmacology, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
M. P. Gururaja
Department of Pharmacology, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
U. P. Nandakumar
Department of Pharmacy Practice, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India

Abstract


Present study was carried out to estimate the incidence of ADRs reported in general medicine department, to evaluate the causality, severity and preventability of ADRs caused by any drugs. A prospective observational study was carried out for a period of 8 months. Patients admitted during the study period were included as per the study criteria and monitored for ADRs. The clinical system, spectrum of ADRs noted and assessment of ADRs was done by causality, preventability and severity. The different scales are applied for assessment of causality, severity and preventability. Data was analysed by using descriptive statistics. A total number of 270 patients were included. 55 ADRs were observed in 52 patients. Higher incidence of suspected ADRs were exhibited with the age group of 61-70 years. The hospital stay extended for more than nine days in 32 (61.5%) patients who experienced ADR. The causality assessment by WHO Probability Scale, showed that out of 55 ADRs, majority were probable 38 (69.09%), whereas 11 (22%) reactions were possible and 6 (10.91%) reactions were certain. Based on Naranjo’s scale, 29 (52.73%) reactions were probable and 26 (47.27%) reactions were possible. Majority of 29 (53%) reactions were moderate in severity. Proper monitoring of adverse reactions is useful to minimize the incidence of ADRs and prevent further occurrence of the same. The regular monitoring of ADRs can reduce the morbidity and can improve the patients compliance which in turn can produce better therapeutic outcome.

Keywords


Adverse Drug Reaction, Causality, Severity, Preventability, Naranjo’s Scale.

References