Incidence of adverse reaction of drugs used in COVID-19 management: a retrospective, observational study
Background An urgent need for coronavirus infectious disease (COVID-19) treatment has resulted in off-label drug use. Although previous studies had investigated the adverse drug reaction (ADR) of the medications for COVID-19 in their respective local settings, the safety profile in a Malaysian setti...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2021-12-01
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| Series: | Journal of Pharmaceutical Policy and Practice |
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| Online Access: | http://dx.doi.org/10.1186/s40545-021-00370-3 |
| _version_ | 1797401270250635264 |
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| author | Jia Yin Lee Abby Shoon Yeun Ang Nurdalila Mohd Ali Li Min Ang Azura Omar |
| author_facet | Jia Yin Lee Abby Shoon Yeun Ang Nurdalila Mohd Ali Li Min Ang Azura Omar |
| author_sort | Jia Yin Lee |
| collection | DOAJ |
| description | Background An urgent need for coronavirus infectious disease (COVID-19) treatment has resulted in off-label drug use. Although previous studies had investigated the adverse drug reaction (ADR) of the medications for COVID-19 in their respective local settings, the safety profile in a Malaysian setting remains unknown. Our study aims to establish the incidence of ADR for drugs used in COVID-19 management in a Malaysian tertiary hospital. Methods This retrospective observational study enrolled patients started on drugs for COVID-19 in Sungai Buloh Hospital from 1 March 2020 to 31 May 2020. The clinical staging of COVID-19 patients was decided by the treating physician in accordance with the Clinical Management of Confirmed COVID-19 Case in Adults (Annex 2E). Suspected ADRs were evaluated with a trigger tool of pre-defined laboratory values or the adverse events listed in the registered product insert. Causality assessment was conducted when an ADR was suspected using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system, and only cases classified as certain, probable and possible ADR were considered. Data analysis was completed with descriptive, univariate and multivariate analysis. Results The study (N = 1,080) identified 217 patients (20.1%) who experienced ADR, with 246 adverse events detected. Most events were related to the gastrointestinal (43.5%), hepatobiliary (36.2%) and cardiac (16.3%) systems. The most commonly suspected drugs were atazanavir (52.7%), chloroquine (36.8%) and lopinavir/ritonavir (34.6%). The independent risk factors of ADR were female (adjusted odds ratio (OR): 1.53; 95% CI 1.06–2.20; P = 0.024), diagnosis of COVID-19 stage 3 (adjusted OR: 2.58; 95% CI 1.20–5.55; P = 0.015) and stage 4 (adjusted OR: 4.17; 95% CI 1.79–9.73; P = 0.001), and the number of COVID-19 drugs (adjusted OR: 3.34; 95% CI 2.51–4.44; P < 0.001). Only 49 adverse events (19.9%) were manually reported by healthcare professionals, with hyperbilirubinaemia (65.3%) and QT prolongation (28.6%) most frequently reported. Conclusion Medications used in COVID-19 management had resulted in one in five patients experiencing ADR. Our study has provided an overview on incidence of ADR for off-label use of medications used in COVID-19 management, which suggests a similar safety profile when used for FDA-approved indications. |
| first_indexed | 2024-03-09T02:07:32Z |
| format | Article |
| id | doaj.art-46c3dd806c924c158a112701b55189b8 |
| institution | Directory Open Access Journal |
| issn | 2052-3211 |
| language | English |
| last_indexed | 2024-03-09T02:07:32Z |
| publishDate | 2021-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Pharmaceutical Policy and Practice |
| spelling | doaj.art-46c3dd806c924c158a112701b55189b82023-12-07T15:28:04ZengTaylor & Francis GroupJournal of Pharmaceutical Policy and Practice2052-32112021-12-0114110.1186/s40545-021-00370-312315284Incidence of adverse reaction of drugs used in COVID-19 management: a retrospective, observational studyJia Yin Lee0Abby Shoon Yeun Ang1Nurdalila Mohd Ali2Li Min Ang3Azura Omar4Department of Pharmacy,Department of Pharmacy,Department of Pharmacy,Department of Pharmacy,Department of Pharmacy,Background An urgent need for coronavirus infectious disease (COVID-19) treatment has resulted in off-label drug use. Although previous studies had investigated the adverse drug reaction (ADR) of the medications for COVID-19 in their respective local settings, the safety profile in a Malaysian setting remains unknown. Our study aims to establish the incidence of ADR for drugs used in COVID-19 management in a Malaysian tertiary hospital. Methods This retrospective observational study enrolled patients started on drugs for COVID-19 in Sungai Buloh Hospital from 1 March 2020 to 31 May 2020. The clinical staging of COVID-19 patients was decided by the treating physician in accordance with the Clinical Management of Confirmed COVID-19 Case in Adults (Annex 2E). Suspected ADRs were evaluated with a trigger tool of pre-defined laboratory values or the adverse events listed in the registered product insert. Causality assessment was conducted when an ADR was suspected using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system, and only cases classified as certain, probable and possible ADR were considered. Data analysis was completed with descriptive, univariate and multivariate analysis. Results The study (N = 1,080) identified 217 patients (20.1%) who experienced ADR, with 246 adverse events detected. Most events were related to the gastrointestinal (43.5%), hepatobiliary (36.2%) and cardiac (16.3%) systems. The most commonly suspected drugs were atazanavir (52.7%), chloroquine (36.8%) and lopinavir/ritonavir (34.6%). The independent risk factors of ADR were female (adjusted odds ratio (OR): 1.53; 95% CI 1.06–2.20; P = 0.024), diagnosis of COVID-19 stage 3 (adjusted OR: 2.58; 95% CI 1.20–5.55; P = 0.015) and stage 4 (adjusted OR: 4.17; 95% CI 1.79–9.73; P = 0.001), and the number of COVID-19 drugs (adjusted OR: 3.34; 95% CI 2.51–4.44; P < 0.001). Only 49 adverse events (19.9%) were manually reported by healthcare professionals, with hyperbilirubinaemia (65.3%) and QT prolongation (28.6%) most frequently reported. Conclusion Medications used in COVID-19 management had resulted in one in five patients experiencing ADR. Our study has provided an overview on incidence of ADR for off-label use of medications used in COVID-19 management, which suggests a similar safety profile when used for FDA-approved indications.http://dx.doi.org/10.1186/s40545-021-00370-3adverse drug reactionsclinical pharmacydrug safetydrug monitoringpharmaceutical care |
| spellingShingle | Jia Yin Lee Abby Shoon Yeun Ang Nurdalila Mohd Ali Li Min Ang Azura Omar Incidence of adverse reaction of drugs used in COVID-19 management: a retrospective, observational study Journal of Pharmaceutical Policy and Practice adverse drug reactions clinical pharmacy drug safety drug monitoring pharmaceutical care |
| title | Incidence of adverse reaction of drugs used in COVID-19 management: a retrospective, observational study |
| title_full | Incidence of adverse reaction of drugs used in COVID-19 management: a retrospective, observational study |
| title_fullStr | Incidence of adverse reaction of drugs used in COVID-19 management: a retrospective, observational study |
| title_full_unstemmed | Incidence of adverse reaction of drugs used in COVID-19 management: a retrospective, observational study |
| title_short | Incidence of adverse reaction of drugs used in COVID-19 management: a retrospective, observational study |
| title_sort | incidence of adverse reaction of drugs used in covid 19 management a retrospective observational study |
| topic | adverse drug reactions clinical pharmacy drug safety drug monitoring pharmaceutical care |
| url | http://dx.doi.org/10.1186/s40545-021-00370-3 |
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