A Retrospective Study on Adverse Drug Reactions of Anticancer Drugs in a Tertiary Care Hospital in Northeast India
Introduction: Anticancer drugs account to high susceptibility towards Adverse Drug Reactions (ADRs) due to their narrow therapeutic window and increased toxicity, which makes pharmacovigilance studies essential. Aim: To determine the nature and severity of ADRs in cancer patients based on the r...
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| Format: | Article |
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JCDR Research and Publications Private Limited
2021-11-01
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| Series: | Journal of Clinical and Diagnostic Research |
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| Online Access: | https://jcdr.net/articles/PDF/15687/51095_CE[Ra1]_F(SHU)_PF1(AG_SS)_PFA(AG_KM)_PN(KM).pdf |
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| author | Swagata Datta Christina Zosangpuii Geetanjali Ningthoujam Shyamasakhi Devi Paonam Tarinita Devi Leisangthem Meena Devi Nameirakpam Surjit Singh Nameirakpam |
| author_facet | Swagata Datta Christina Zosangpuii Geetanjali Ningthoujam Shyamasakhi Devi Paonam Tarinita Devi Leisangthem Meena Devi Nameirakpam Surjit Singh Nameirakpam |
| author_sort | Swagata Datta |
| collection | DOAJ |
| description | Introduction: Anticancer drugs account to high susceptibility
towards Adverse Drug Reactions (ADRs) due to their narrow
therapeutic window and increased toxicity, which makes
pharmacovigilance studies essential.
Aim: To determine the nature and severity of ADRs in cancer
patients based on the reports received from the Department
of Radiation Oncology to the Pharmacovigilance centre of a
tertiary care hospital.
Materials and Methods: A retrospective, descriptive study was
conducted in the Regional Institute of Medical Sciences (RIMS),
Imphal, Manipur, India on the patients who developed ADRs
due to anticancer drugs during the period from January 2018 to
December 2020. These ADRs were assessed for causality using
World Health Organisation- Uppsala Monitoring Centre (WHOUMC) criteria. The data was analysed using Statistical Package
for the Social Sciences (SPSS) version 21.0 and frequencies
and percentages were determined for each variable.
Results: A total of 913 ADRs were reported from 334
patients. Total 62.57% females developed ADRs and age
group of 51-60 years (31.14%) were affected the most.
Bronchogenic carcinoma (20.9%) was found to be the most
common cancer and haematological system (31.11%) was
mostly affected. Most common ADRs observed were alopecia
(16.32%) followed by anorexia and anaemia. Carboplatin
(23.21%) followed by Cisplatin, Paclitaxel, Docetaxel were
the most common drugs causing different ADRs. On causality
assessment, as per WHO-UMC criteria 67.25% ADRs were
‘probable’ and 32.75% were ‘possible’. Severity assessment
using modified Hartwig and Siegel scale showed 56.41%
ADRs as mild, 41.95% moderate and 1.64% severe reaction.
Preventability assessment using Schumock-Thornton scale
showed 44.69% ADRs were ‘not preventable’ whereas
41.62% ADRs were ‘definitely preventable’ and 13.69% were
‘probably preventable’.
Conclusion: The use of anticancer drugs is associated with
various adverse effects. However, early detection of the ADRs
may help to modify the doses or the drug regimen to minimise
the adverse effects. |
| first_indexed | 2024-12-22T20:22:32Z |
| format | Article |
| id | doaj.art-6ca465feca664cac942b6ecbd4ea439a |
| institution | Directory Open Access Journal |
| issn | 2249-782X 0973-709X |
| language | English |
| last_indexed | 2024-12-22T20:22:32Z |
| publishDate | 2021-11-01 |
| publisher | JCDR Research and Publications Private Limited |
| record_format | Article |
| series | Journal of Clinical and Diagnostic Research |
| spelling | doaj.art-6ca465feca664cac942b6ecbd4ea439a2022-12-21T18:13:48ZengJCDR Research and Publications Private LimitedJournal of Clinical and Diagnostic Research2249-782X0973-709X2021-11-011511010510.7860/JCDR/2021/51095.15687A Retrospective Study on Adverse Drug Reactions of Anticancer Drugs in a Tertiary Care Hospital in Northeast IndiaSwagata Datta0Christina Zosangpuii1Geetanjali Ningthoujam2Shyamasakhi Devi Paonam3Tarinita Devi Leisangthem4Meena Devi Nameirakpam5Surjit Singh Nameirakpam6Postgraduate Trainee, Department of Pharmacology, Regional Institute of Medical Sciences, Imphal, Manipur, IndiaPostgraduate Trainee, Department of Pharmacology, Regional Institute of Medical Sciences, Imphal, Manipur, IndiaPostgraduate Trainee, Department of Pharmacology, Regional Institute of Medical Sciences, Imphal, Manipur, IndiaAssociate Professor, Department of Pharmacology, Regional Institute of Medical Sciences, Imphal, Manipur, IndiaAssociate Professor, Department of Pharmacology, Regional Institute of Medical Sciences, Imphal, Manipur, IndiaProfessor and Head, Department of Pharmacology, Regional Institute of Medical Sciences, Imphal, Manipur, IndiaPharmacovigilance Associate, Department of Pharmacology, Regional Institute of Medical Sciences, Imphal, Manipur, India.Introduction: Anticancer drugs account to high susceptibility towards Adverse Drug Reactions (ADRs) due to their narrow therapeutic window and increased toxicity, which makes pharmacovigilance studies essential. Aim: To determine the nature and severity of ADRs in cancer patients based on the reports received from the Department of Radiation Oncology to the Pharmacovigilance centre of a tertiary care hospital. Materials and Methods: A retrospective, descriptive study was conducted in the Regional Institute of Medical Sciences (RIMS), Imphal, Manipur, India on the patients who developed ADRs due to anticancer drugs during the period from January 2018 to December 2020. These ADRs were assessed for causality using World Health Organisation- Uppsala Monitoring Centre (WHOUMC) criteria. The data was analysed using Statistical Package for the Social Sciences (SPSS) version 21.0 and frequencies and percentages were determined for each variable. Results: A total of 913 ADRs were reported from 334 patients. Total 62.57% females developed ADRs and age group of 51-60 years (31.14%) were affected the most. Bronchogenic carcinoma (20.9%) was found to be the most common cancer and haematological system (31.11%) was mostly affected. Most common ADRs observed were alopecia (16.32%) followed by anorexia and anaemia. Carboplatin (23.21%) followed by Cisplatin, Paclitaxel, Docetaxel were the most common drugs causing different ADRs. On causality assessment, as per WHO-UMC criteria 67.25% ADRs were ‘probable’ and 32.75% were ‘possible’. Severity assessment using modified Hartwig and Siegel scale showed 56.41% ADRs as mild, 41.95% moderate and 1.64% severe reaction. Preventability assessment using Schumock-Thornton scale showed 44.69% ADRs were ‘not preventable’ whereas 41.62% ADRs were ‘definitely preventable’ and 13.69% were ‘probably preventable’. Conclusion: The use of anticancer drugs is associated with various adverse effects. However, early detection of the ADRs may help to modify the doses or the drug regimen to minimise the adverse effects.https://jcdr.net/articles/PDF/15687/51095_CE[Ra1]_F(SHU)_PF1(AG_SS)_PFA(AG_KM)_PN(KM).pdf: modified hartwig and siegel scalepharmacovigilanceschumock-thornton scaleworld health organisation- uppsala monitoring centre criteria |
| spellingShingle | Swagata Datta Christina Zosangpuii Geetanjali Ningthoujam Shyamasakhi Devi Paonam Tarinita Devi Leisangthem Meena Devi Nameirakpam Surjit Singh Nameirakpam A Retrospective Study on Adverse Drug Reactions of Anticancer Drugs in a Tertiary Care Hospital in Northeast India Journal of Clinical and Diagnostic Research : modified hartwig and siegel scale pharmacovigilance schumock-thornton scale world health organisation- uppsala monitoring centre criteria |
| title | A Retrospective Study on Adverse Drug Reactions of Anticancer Drugs in a Tertiary Care Hospital in Northeast India |
| title_full | A Retrospective Study on Adverse Drug Reactions of Anticancer Drugs in a Tertiary Care Hospital in Northeast India |
| title_fullStr | A Retrospective Study on Adverse Drug Reactions of Anticancer Drugs in a Tertiary Care Hospital in Northeast India |
| title_full_unstemmed | A Retrospective Study on Adverse Drug Reactions of Anticancer Drugs in a Tertiary Care Hospital in Northeast India |
| title_short | A Retrospective Study on Adverse Drug Reactions of Anticancer Drugs in a Tertiary Care Hospital in Northeast India |
| title_sort | retrospective study on adverse drug reactions of anticancer drugs in a tertiary care hospital in northeast india |
| topic | : modified hartwig and siegel scale pharmacovigilance schumock-thornton scale world health organisation- uppsala monitoring centre criteria |
| url | https://jcdr.net/articles/PDF/15687/51095_CE[Ra1]_F(SHU)_PF1(AG_SS)_PFA(AG_KM)_PN(KM).pdf |
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