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Pattern and Frequency of Spontaneously Reported Suspected ADRs in Admitted Patients at a Tertiary Care Hospital of Central India: A Pharmacovigilance Study


Affiliations
1 Associate Professor, Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
2 Assistant Professor, Department of Physiology, S.S. Medical College, Rewa, Madhya Pradesh, India
3 AYUSH Medical Officer, Department of Ayush, Medical Officer, PHC, Devtalab, Rewa, Madhya Pradesh, India
4 Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
5 Professor & Head, Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
6 3rd year PG Resident, Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
     

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Background: ADRs constitute an enormous burden for society and it is one of the leading causes of death. ADRs are poorly and inadequately reported and up to 57% of ADRs are unrecognized by attending physicians.

Aims & Objectives: The aim of this study is to assess the frequency, clinical pattern and spectrum of suspected ADRs in admitted patients.

Material & Methods: This study was conducted, in a multidisciplinary tertiary care hospital, in which a total of 54 cases with suspected ADRs were enrolled. Data was collected by a researcher through telephonic conversation by healthcare professionals from the admitted patients of hospital in CDSCO - ADR reporting form. The data were analyzed by Microsoft word - excel version 2007. All the multiple responses were presented in terms of numbers and percentage.

Results: In the present study, maximum patients (31.48%) belonged to 26-40 years age group, of these maximum patients (35.18%) belonged to lower middle socioeconomic status. Majority of patients (68.51%) were residents of rural areas. Skin & mucous membranes and gastrointestinal system were most frequently (37.18%) involved organ systems; most frequent ADR (17.58%) was skin rashes, followed by pruritus (13.56%). Majority (56.78%) of suspected ADRs were associated with antimicrobials. Among antimicrobials, ceftriaxone + sulbactam is associated with majority (34.51%) of suspected ADRs.

Conclusion: ADR monitoring is the key component of effective drug regulation systems, clinical practice and public health programmes. Hospital based ADR monitoring and reporting programmes aim to identify and quantify the risks associated with the use of the drugs.


Keywords

Pharmacovigilance Program of India, PvPI, Adverse Drug Event, Adverse Drug Reaction, Central Drugs Standard Control Organization, CDSCO.
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  • Pattern and Frequency of Spontaneously Reported Suspected ADRs in Admitted Patients at a Tertiary Care Hospital of Central India: A Pharmacovigilance Study

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Authors

Prabhakar Singh
Associate Professor, Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
Amita Singh
Assistant Professor, Department of Physiology, S.S. Medical College, Rewa, Madhya Pradesh, India
Arpita Singh
AYUSH Medical Officer, Department of Ayush, Medical Officer, PHC, Devtalab, Rewa, Madhya Pradesh, India
Vivek Pandey
Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
Bhupendra Raj
Professor & Head, Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
Ankita Dixit
3<sup>rd</sup> year PG Resident, Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India

Abstract


Background: ADRs constitute an enormous burden for society and it is one of the leading causes of death. ADRs are poorly and inadequately reported and up to 57% of ADRs are unrecognized by attending physicians.

Aims & Objectives: The aim of this study is to assess the frequency, clinical pattern and spectrum of suspected ADRs in admitted patients.

Material & Methods: This study was conducted, in a multidisciplinary tertiary care hospital, in which a total of 54 cases with suspected ADRs were enrolled. Data was collected by a researcher through telephonic conversation by healthcare professionals from the admitted patients of hospital in CDSCO - ADR reporting form. The data were analyzed by Microsoft word - excel version 2007. All the multiple responses were presented in terms of numbers and percentage.

Results: In the present study, maximum patients (31.48%) belonged to 26-40 years age group, of these maximum patients (35.18%) belonged to lower middle socioeconomic status. Majority of patients (68.51%) were residents of rural areas. Skin & mucous membranes and gastrointestinal system were most frequently (37.18%) involved organ systems; most frequent ADR (17.58%) was skin rashes, followed by pruritus (13.56%). Majority (56.78%) of suspected ADRs were associated with antimicrobials. Among antimicrobials, ceftriaxone + sulbactam is associated with majority (34.51%) of suspected ADRs.

Conclusion: ADR monitoring is the key component of effective drug regulation systems, clinical practice and public health programmes. Hospital based ADR monitoring and reporting programmes aim to identify and quantify the risks associated with the use of the drugs.


Keywords


Pharmacovigilance Program of India, PvPI, Adverse Drug Event, Adverse Drug Reaction, Central Drugs Standard Control Organization, CDSCO.

References