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A Prospective Study of Adverse Drug Reactions Monitoring in a Tertiary Care Hospital, Rewa (MP)


Affiliations
1 Department of Pharmacology, S.S. Medical College, Rewa, (MP), India
2 Department of Medicine, S.S. Medical College, Rewa, (MP), India
     

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Aims and Objectives: The aim of study is to determine the pattern of suspected ADRs reported in ICU and ward admitted patients in a tertiary care hospital.

Material and methods: Study was conducted in the department of Pharmacology and department of Medicine, SS Medical College and SGM Hospital, Rewa, MP, during October 2014 to September 2015. Total 130 cases were enrolled in study that presented with suspected ADRs during study period, after taking written informed consent. Clinical evaluation and scrutiny of data was done to assess pattern, extent and duration of the suspected adverse drug reactions, affected organ system and involvement of therapeutic drugs classes as a part of the drug reaction.

Results: The result of this study showed that maximum (25%) patients belonged to the 18-25 years of age group, of these 55% was males and 45% were females. Mean (± SD) age of these patients was 34.84 ± 20.99 years. Among the reported suspected ADRs; maximum (26%) were skin rashes, followed by pruritus (15%), nausea, vomiting and rigor each occur 7%; Fever 6%, Apnea, oral ulcers and headache 3%. The most commonly affected organ system was skin and mucous membrane (44%), followed by central nervous system (11%), gastrointestinal system (10%), respiratory system (7%), and cardiovascular system (5%) in decreasing order. Of these; majority of suspected ADRs were associated with use of antimicrobials (68%), followed by NSAIDs (9%); Hematinics (5%); Antihypertensive, Antianginal, Antiepileptics, Hypoglycemis, Corticosteroids and Ionotrops (2%).

Conclusions: The Hospital-based monitoring of suspected ADRs is convenient but it is under reported and the limitation of these studies is that they do not yield the exact incidence of suspected ADRs associated with particular drug use.


Keywords

Drugs, Adverse Drug Reaction, Morbidity, Organ System.
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  • A Prospective Study of Adverse Drug Reactions Monitoring in a Tertiary Care Hospital, Rewa (MP)

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Authors

B. Raj
Department of Pharmacology, S.S. Medical College, Rewa, (MP), India
P. Singh
Department of Pharmacology, S.S. Medical College, Rewa, (MP), India
P. More
Department of Medicine, S.S. Medical College, Rewa, (MP), India
M. Indurkar
Department of Pharmacology, S.S. Medical College, Rewa, (MP), India
V. Pandey
Department of Pharmacology, S.S. Medical College, Rewa, (MP), India

Abstract


Aims and Objectives: The aim of study is to determine the pattern of suspected ADRs reported in ICU and ward admitted patients in a tertiary care hospital.

Material and methods: Study was conducted in the department of Pharmacology and department of Medicine, SS Medical College and SGM Hospital, Rewa, MP, during October 2014 to September 2015. Total 130 cases were enrolled in study that presented with suspected ADRs during study period, after taking written informed consent. Clinical evaluation and scrutiny of data was done to assess pattern, extent and duration of the suspected adverse drug reactions, affected organ system and involvement of therapeutic drugs classes as a part of the drug reaction.

Results: The result of this study showed that maximum (25%) patients belonged to the 18-25 years of age group, of these 55% was males and 45% were females. Mean (± SD) age of these patients was 34.84 ± 20.99 years. Among the reported suspected ADRs; maximum (26%) were skin rashes, followed by pruritus (15%), nausea, vomiting and rigor each occur 7%; Fever 6%, Apnea, oral ulcers and headache 3%. The most commonly affected organ system was skin and mucous membrane (44%), followed by central nervous system (11%), gastrointestinal system (10%), respiratory system (7%), and cardiovascular system (5%) in decreasing order. Of these; majority of suspected ADRs were associated with use of antimicrobials (68%), followed by NSAIDs (9%); Hematinics (5%); Antihypertensive, Antianginal, Antiepileptics, Hypoglycemis, Corticosteroids and Ionotrops (2%).

Conclusions: The Hospital-based monitoring of suspected ADRs is convenient but it is under reported and the limitation of these studies is that they do not yield the exact incidence of suspected ADRs associated with particular drug use.


Keywords


Drugs, Adverse Drug Reaction, Morbidity, Organ System.

References