Unknown adverse drug reactions from spontaneous reports in a hospital setting: characterization, follow-up, and contribution to the pharmacovigilance system
Introduction: Post-marketing identification and report of unknown adverse drug reactions (ADRs) are crucial for patient safety. However, complete information on unknown ADRs seldom is available at the time of spontaneous ADR reports and this can hamper their contribution to the pharmacovigilance sys...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-07-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1211786/full |
| _version_ | 1797783968625459200 |
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| author | Francesca Filippi-Arriaga Cristina Aguilera Cristina Aguilera Cristina Aguilera Elena Guillén Elena Guillén Lucía Bellas Eulàlia Pérez Lourdes Vendrell Antònia Agustí Antònia Agustí Antònia Agustí Gloria Cereza Gloria Cereza |
| author_facet | Francesca Filippi-Arriaga Cristina Aguilera Cristina Aguilera Cristina Aguilera Elena Guillén Elena Guillén Lucía Bellas Eulàlia Pérez Lourdes Vendrell Antònia Agustí Antònia Agustí Antònia Agustí Gloria Cereza Gloria Cereza |
| author_sort | Francesca Filippi-Arriaga |
| collection | DOAJ |
| description | Introduction: Post-marketing identification and report of unknown adverse drug reactions (ADRs) are crucial for patient safety. However, complete information on unknown ADRs seldom is available at the time of spontaneous ADR reports and this can hamper their contribution to the pharmacovigilance system.Methods: In order to characterize the seriousness and outcome of unknown ADRs at the time of report and at follow-up, and analyze their contribution to generate pharmacovigilance regulatory actions, a retrospective observational study of those identified in the spontaneous ADR reports of patients assisted at a hospital (January, 2016-December, 2021) was carried out. Information on demographic, clinical and complementary tests was retrieved from patients’ hospital medical records. To evaluate the contribution to pharmacovigilance system we reviewed the European Union SmPCs, the list of the pharmacovigilance signals discussed by the Pharmacovigilance Risk Assessment Committee, and its recommendations reports on safety signals.Results: A total of 15.2% of the spontaneous reported cases during the study contained at least one unknown drug-ADR pair. After exclusions, 295 unknown drug-ADR pairs were included, within them the most frequently affected organs or systems were: skin and subcutaneous tissue (34, 11.5%), hepatobiliary disorders (28, 9.5%), cardiac disorders (28, 9.5%) and central nervous system disorders (27, 9.2%). The most frequent ADRs were pemphigus (7, 2.4%), and cytolytic hepatitis, sudden death, cutaneous vasculitis and fetal growth restriction with 6 (2%) each. Vaccines such as covid-19 and pneumococcus (68, 21.3%), antineoplastics such as paclitaxel, trastuzumab and vincristine (39, 12.2%) and immunosuppressants such as methotrexate and tocilizumab (35, 11%) were the most frequent drug subgroups involved. Sudden death due to hydroxychloroquine alone or in combination (4, 1.4%) and hypertransaminasemia by vincristine (n = 3, 1%) were the most frequent unknown drug-ADR pairs. A total of 269 (91.2%) of them were serious. Complementary tests were performed in 82.7% of unknown-ADR pairs and helped to reinforce their association in 18.3% of them. A total of 18 (6.1%) unknown drug-ADR pairs were evaluated by the EMA, in 8 (2.7%) the information was added to the drug’s SmPC and in 1 case the risk prevention material was updated.Conclusion: Identification and follow-up of unknown ADRs can be of great relevance for patient safety and for the enrichment of the pharmacovigilance system. |
| first_indexed | 2024-03-13T00:33:24Z |
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| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-13T00:33:24Z |
| publishDate | 2023-07-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pharmacology |
| spelling | doaj.art-ea0f91fb141c409dab7e56910bbe19c82023-07-10T09:22:42ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-07-011410.3389/fphar.2023.12117861211786Unknown adverse drug reactions from spontaneous reports in a hospital setting: characterization, follow-up, and contribution to the pharmacovigilance systemFrancesca Filippi-Arriaga0Cristina Aguilera1Cristina Aguilera2Cristina Aguilera3Elena Guillén4Elena Guillén5Lucía Bellas6Eulàlia Pérez7Lourdes Vendrell8Antònia Agustí9Antònia Agustí10Antònia Agustí11Gloria Cereza12Gloria Cereza13Clinical Pharmacology Service, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainClinical Pharmacology Service, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainDepartment of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, SpainImmunomediated Diseases and Innovative Therapies Group, Vall d’Hebron Research Institute, Barcelona, SpainDepartment of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, SpainDepartment of Clinical Pharmacology, Area Medicament, Hospital Clinic of Barcelona, Barcelona, SpainClinical Pharmacology Service, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainClinical Pharmacology Service, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainClinical Pharmacology Service, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainClinical Pharmacology Service, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainDepartment of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, SpainImmunomediated Diseases and Innovative Therapies Group, Vall d’Hebron Research Institute, Barcelona, SpainDepartment of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, SpainCatalan Centre of Pharmacovigilance, Directorate-General for Healthcare Planning and Regulation, Ministry of Health, Government of Catalonia, Barcelona, SpainIntroduction: Post-marketing identification and report of unknown adverse drug reactions (ADRs) are crucial for patient safety. However, complete information on unknown ADRs seldom is available at the time of spontaneous ADR reports and this can hamper their contribution to the pharmacovigilance system.Methods: In order to characterize the seriousness and outcome of unknown ADRs at the time of report and at follow-up, and analyze their contribution to generate pharmacovigilance regulatory actions, a retrospective observational study of those identified in the spontaneous ADR reports of patients assisted at a hospital (January, 2016-December, 2021) was carried out. Information on demographic, clinical and complementary tests was retrieved from patients’ hospital medical records. To evaluate the contribution to pharmacovigilance system we reviewed the European Union SmPCs, the list of the pharmacovigilance signals discussed by the Pharmacovigilance Risk Assessment Committee, and its recommendations reports on safety signals.Results: A total of 15.2% of the spontaneous reported cases during the study contained at least one unknown drug-ADR pair. After exclusions, 295 unknown drug-ADR pairs were included, within them the most frequently affected organs or systems were: skin and subcutaneous tissue (34, 11.5%), hepatobiliary disorders (28, 9.5%), cardiac disorders (28, 9.5%) and central nervous system disorders (27, 9.2%). The most frequent ADRs were pemphigus (7, 2.4%), and cytolytic hepatitis, sudden death, cutaneous vasculitis and fetal growth restriction with 6 (2%) each. Vaccines such as covid-19 and pneumococcus (68, 21.3%), antineoplastics such as paclitaxel, trastuzumab and vincristine (39, 12.2%) and immunosuppressants such as methotrexate and tocilizumab (35, 11%) were the most frequent drug subgroups involved. Sudden death due to hydroxychloroquine alone or in combination (4, 1.4%) and hypertransaminasemia by vincristine (n = 3, 1%) were the most frequent unknown drug-ADR pairs. A total of 269 (91.2%) of them were serious. Complementary tests were performed in 82.7% of unknown-ADR pairs and helped to reinforce their association in 18.3% of them. A total of 18 (6.1%) unknown drug-ADR pairs were evaluated by the EMA, in 8 (2.7%) the information was added to the drug’s SmPC and in 1 case the risk prevention material was updated.Conclusion: Identification and follow-up of unknown ADRs can be of great relevance for patient safety and for the enrichment of the pharmacovigilance system.https://www.frontiersin.org/articles/10.3389/fphar.2023.1211786/fullunknown adverse drug reactionadverse drug reaction reporting systemspharmacovigilancedrug safetysignal detectionhospital |
| spellingShingle | Francesca Filippi-Arriaga Cristina Aguilera Cristina Aguilera Cristina Aguilera Elena Guillén Elena Guillén Lucía Bellas Eulàlia Pérez Lourdes Vendrell Antònia Agustí Antònia Agustí Antònia Agustí Gloria Cereza Gloria Cereza Unknown adverse drug reactions from spontaneous reports in a hospital setting: characterization, follow-up, and contribution to the pharmacovigilance system Frontiers in Pharmacology unknown adverse drug reaction adverse drug reaction reporting systems pharmacovigilance drug safety signal detection hospital |
| title | Unknown adverse drug reactions from spontaneous reports in a hospital setting: characterization, follow-up, and contribution to the pharmacovigilance system |
| title_full | Unknown adverse drug reactions from spontaneous reports in a hospital setting: characterization, follow-up, and contribution to the pharmacovigilance system |
| title_fullStr | Unknown adverse drug reactions from spontaneous reports in a hospital setting: characterization, follow-up, and contribution to the pharmacovigilance system |
| title_full_unstemmed | Unknown adverse drug reactions from spontaneous reports in a hospital setting: characterization, follow-up, and contribution to the pharmacovigilance system |
| title_short | Unknown adverse drug reactions from spontaneous reports in a hospital setting: characterization, follow-up, and contribution to the pharmacovigilance system |
| title_sort | unknown adverse drug reactions from spontaneous reports in a hospital setting characterization follow up and contribution to the pharmacovigilance system |
| topic | unknown adverse drug reaction adverse drug reaction reporting systems pharmacovigilance drug safety signal detection hospital |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1211786/full |
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