A 5 year retrospective analysis of pharmacovigilance study, completeness and quality of suspected adverse drug reaction forms at adverse drug reaction monitoring center Port Blair.
In India, Adverse Drug Reaction (ADRs) related morbidity and mortality is one of the leading health problem. ADRs result in diminished quality of life, prolonged hospital stay, morbidity and mortality. The present study was planned to scrutinise suspected ADRs forms and evaluate completeness with qu...
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University of Basrah
2021-12-01
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| Series: | The Medical Journal of Basrah University |
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| Online Access: | https://mjbu.uobasrah.edu.iq/article_170074_5918ab276fd9f29198ab0ebfcd094c7d.pdf |
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| author | Priyanka Hotha C. Dinesh M. Naidu Nimisha Elezebeth Zachariah |
| author_facet | Priyanka Hotha C. Dinesh M. Naidu Nimisha Elezebeth Zachariah |
| author_sort | Priyanka Hotha |
| collection | DOAJ |
| description | In India, Adverse Drug Reaction (ADRs) related morbidity and mortality is one of the leading health problem. ADRs result in diminished quality of life, prolonged hospital stay, morbidity and mortality. The present study was planned to scrutinise suspected ADRs forms and evaluate completeness with quality assessment of ADR reports at AMC Port Blair. The study was a 5 year retrospective observational study. The collected data was evaluated based on patients’ demographic, adverse drug reaction and drug characteristics with completeness and quality of reactions. A total of 877 ADRs from 715 offending drugs in 671 patients were reported. In India, 9.5% hospital admissions were because of ADRs. 52% female experienced ADRs which was more than male. The occurrence of ADRs in adult patients was high. Antibiotics (39%) was most commonly prescribed class of drug followed by NSAID (10.9%). Majority of ADRs (45%) were observed in the skin followed by musculoskeletal system (12.7%). In our study, 60.2% of patients recovered in the outcome parameters. 83.6% of drugs withdrew for management of ADRs. Rechallenge was made only in 12.3% patients, 71.6% of patients had non-serious reactions and 71.7% ADRs were probable. We received the highest completeness score in 2020 which was 0.98. ADRs remain as a challenge in modern healthcare. The health system should promote spontaneous reporting of ADRs. The proper documentation and periodic reporting to ADR monitoring centres (AMC) reduce the incidence of new ADRs and maintain the public confidence toward safe use of drugs. This good quality reporting increases the potential for signal generation. |
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| language | English |
| last_indexed | 2024-12-24T01:38:55Z |
| publishDate | 2021-12-01 |
| publisher | University of Basrah |
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| series | The Medical Journal of Basrah University |
| spelling | doaj.art-1d4642485d484948b53ed3e3381067f22022-12-21T17:22:05ZengUniversity of BasrahThe Medical Journal of Basrah University0253-07592413-44142021-12-013929210310.33762/mjbu.2021.130470.1077170074A 5 year retrospective analysis of pharmacovigilance study, completeness and quality of suspected adverse drug reaction forms at adverse drug reaction monitoring center Port Blair.Priyanka Hotha0C. Dinesh M. Naidu1Nimisha Elezebeth Zachariah2Department of Pharmacology, Assistant Professor, University College of Medical Sciences, Delhi, India.Professor & Head, Department of Pharmacology Andaman & Nicobar Islands Institute of Medical Sciences (ANIIMS), Port Blair, India.Pharmacovigilance associate, Department of Pharmacology, Andaman & Nicobar Islands Institute of Medical Sciences (ANIIMS), Port Blair, India.In India, Adverse Drug Reaction (ADRs) related morbidity and mortality is one of the leading health problem. ADRs result in diminished quality of life, prolonged hospital stay, morbidity and mortality. The present study was planned to scrutinise suspected ADRs forms and evaluate completeness with quality assessment of ADR reports at AMC Port Blair. The study was a 5 year retrospective observational study. The collected data was evaluated based on patients’ demographic, adverse drug reaction and drug characteristics with completeness and quality of reactions. A total of 877 ADRs from 715 offending drugs in 671 patients were reported. In India, 9.5% hospital admissions were because of ADRs. 52% female experienced ADRs which was more than male. The occurrence of ADRs in adult patients was high. Antibiotics (39%) was most commonly prescribed class of drug followed by NSAID (10.9%). Majority of ADRs (45%) were observed in the skin followed by musculoskeletal system (12.7%). In our study, 60.2% of patients recovered in the outcome parameters. 83.6% of drugs withdrew for management of ADRs. Rechallenge was made only in 12.3% patients, 71.6% of patients had non-serious reactions and 71.7% ADRs were probable. We received the highest completeness score in 2020 which was 0.98. ADRs remain as a challenge in modern healthcare. The health system should promote spontaneous reporting of ADRs. The proper documentation and periodic reporting to ADR monitoring centres (AMC) reduce the incidence of new ADRs and maintain the public confidence toward safe use of drugs. This good quality reporting increases the potential for signal generation.https://mjbu.uobasrah.edu.iq/article_170074_5918ab276fd9f29198ab0ebfcd094c7d.pdfadverse drug reaction,,,،,؛adverse drug monitoring centre,,,،,؛completeness score,,,،,؛pharmacovigilance |
| spellingShingle | Priyanka Hotha C. Dinesh M. Naidu Nimisha Elezebeth Zachariah A 5 year retrospective analysis of pharmacovigilance study, completeness and quality of suspected adverse drug reaction forms at adverse drug reaction monitoring center Port Blair. The Medical Journal of Basrah University adverse drug reaction,, ,،,؛adverse drug monitoring centre,, ,،,؛completeness score,, ,،,؛pharmacovigilance |
| title | A 5 year retrospective analysis of pharmacovigilance study, completeness and quality of suspected adverse drug reaction forms at adverse drug reaction monitoring center Port Blair. |
| title_full | A 5 year retrospective analysis of pharmacovigilance study, completeness and quality of suspected adverse drug reaction forms at adverse drug reaction monitoring center Port Blair. |
| title_fullStr | A 5 year retrospective analysis of pharmacovigilance study, completeness and quality of suspected adverse drug reaction forms at adverse drug reaction monitoring center Port Blair. |
| title_full_unstemmed | A 5 year retrospective analysis of pharmacovigilance study, completeness and quality of suspected adverse drug reaction forms at adverse drug reaction monitoring center Port Blair. |
| title_short | A 5 year retrospective analysis of pharmacovigilance study, completeness and quality of suspected adverse drug reaction forms at adverse drug reaction monitoring center Port Blair. |
| title_sort | 5 year retrospective analysis of pharmacovigilance study completeness and quality of suspected adverse drug reaction forms at adverse drug reaction monitoring center port blair |
| topic | adverse drug reaction,, ,،,؛adverse drug monitoring centre,, ,،,؛completeness score,, ,،,؛pharmacovigilance |
| url | https://mjbu.uobasrah.edu.iq/article_170074_5918ab276fd9f29198ab0ebfcd094c7d.pdf |
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