Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical Care
For drug safety in pediatric patients, knowledge about adverse drug reactions (ADRs) is essential to balance benefits and risks, especially because of the high incidence of off-label drug use. However, underreporting of ADRs is a serious problem, leading to a deficit in knowledge affecting clinical...
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| Format: | Article |
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MDPI AG
2022-09-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/15/9/1148 |
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| author | Anne T. M. Dittrich Nori J. L. Smeets Emma F. M. de Jong Juliët L. Kämink Yvet Kroeze Jos M. Th. Draaisma Eugène P. van Puijenbroek D. Maroeska W. M. te Loo |
| author_facet | Anne T. M. Dittrich Nori J. L. Smeets Emma F. M. de Jong Juliët L. Kämink Yvet Kroeze Jos M. Th. Draaisma Eugène P. van Puijenbroek D. Maroeska W. M. te Loo |
| author_sort | Anne T. M. Dittrich |
| collection | DOAJ |
| description | For drug safety in pediatric patients, knowledge about adverse drug reactions (ADRs) is essential to balance benefits and risks, especially because of the high incidence of off-label drug use. However, underreporting of ADRs is a serious problem, leading to a deficit in knowledge affecting clinical practice. The aim of this study is to find a method by which we can improve the quantity of ADR reporting while maintaining or improving the quality of the ADR reports. This was done in several steps. First, health care providers were educated to increase awareness of ADRs. Thereafter, a novel active supporting system was introduced, where reporting ADRs was simplified; if clinical physicians suspected an ADR, they only had to send the name or hospital number of the patient, the observed ADR, and the suspected drug to a supportive team. This team collects all information needed about the possible ADR from the patient’s medical records and hospital charts. With this information, the supportive team fills in the forms necessary for reporting ADRs to the nationwide pharmacovigilance centre Lareb. With this system, the quantity of ADR reports from both inpatients and outpatients rose dramatically. Subsequently, the quality of the obtained ADR reports was measured using the ClinDoc and vigiGrade systems. This study shows there is no loss of quality of the ADR reports in the active reporting system compared to spontaneous reporting systems. Based on the data of the present study, we suggest that an active reporting system has the potential to increase our knowledge about ADRs in pediatric patients. |
| first_indexed | 2024-03-09T22:50:59Z |
| format | Article |
| id | doaj.art-148aef8c56994023940649287268e2a6 |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-09T22:50:59Z |
| publishDate | 2022-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-148aef8c56994023940649287268e2a62023-11-23T18:19:34ZengMDPI AGPharmaceuticals1424-82472022-09-01159114810.3390/ph15091148Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical CareAnne T. M. Dittrich0Nori J. L. Smeets1Emma F. M. de Jong2Juliët L. Kämink3Yvet Kroeze4Jos M. Th. Draaisma5Eugène P. van Puijenbroek6D. Maroeska W. M. te Loo7Department of Pediatrics, Radboud University Medical Centre, Radboud Institute for Health Sciences, Amalia Children’s Hospital, 6500 HB Nijmegen, The NetherlandsDepartment of Pharmacology and Toxicology, Radboud University Medical Centre, Radboud Institute for Health Sciences, 6500 HB Nijmegen, The NetherlandsDepartment of Pediatrics, Radboud University Medical Centre, Radboud Institute for Health Sciences, Amalia Children’s Hospital, 6500 HB Nijmegen, The NetherlandsDepartment of Pediatrics, Radboud University Medical Centre, Radboud Institute for Health Sciences, Amalia Children’s Hospital, 6500 HB Nijmegen, The NetherlandsDepartment of Pediatrics, Radboud University Medical Centre, Radboud Institute for Health Sciences, Amalia Children’s Hospital, 6500 HB Nijmegen, The NetherlandsDepartment of Pediatrics, Radboud University Medical Centre, Radboud Institute for Health Sciences, Amalia Children’s Hospital, 6500 HB Nijmegen, The NetherlandsNetherlands Pharmacovigilance Centre Lareb, 5237 MH ‘s-Hertogenbosch, The NetherlandsDepartment of Pharmacology and Toxicology, Radboud University Medical Centre, Radboud Institute for Health Sciences, 6500 HB Nijmegen, The NetherlandsFor drug safety in pediatric patients, knowledge about adverse drug reactions (ADRs) is essential to balance benefits and risks, especially because of the high incidence of off-label drug use. However, underreporting of ADRs is a serious problem, leading to a deficit in knowledge affecting clinical practice. The aim of this study is to find a method by which we can improve the quantity of ADR reporting while maintaining or improving the quality of the ADR reports. This was done in several steps. First, health care providers were educated to increase awareness of ADRs. Thereafter, a novel active supporting system was introduced, where reporting ADRs was simplified; if clinical physicians suspected an ADR, they only had to send the name or hospital number of the patient, the observed ADR, and the suspected drug to a supportive team. This team collects all information needed about the possible ADR from the patient’s medical records and hospital charts. With this information, the supportive team fills in the forms necessary for reporting ADRs to the nationwide pharmacovigilance centre Lareb. With this system, the quantity of ADR reports from both inpatients and outpatients rose dramatically. Subsequently, the quality of the obtained ADR reports was measured using the ClinDoc and vigiGrade systems. This study shows there is no loss of quality of the ADR reports in the active reporting system compared to spontaneous reporting systems. Based on the data of the present study, we suggest that an active reporting system has the potential to increase our knowledge about ADRs in pediatric patients.https://www.mdpi.com/1424-8247/15/9/1148drug safetyadverse drug reactionspharmacovigilanceactive reporting ADRsquality of ADR reports |
| spellingShingle | Anne T. M. Dittrich Nori J. L. Smeets Emma F. M. de Jong Juliët L. Kämink Yvet Kroeze Jos M. Th. Draaisma Eugène P. van Puijenbroek D. Maroeska W. M. te Loo Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical Care Pharmaceuticals drug safety adverse drug reactions pharmacovigilance active reporting ADRs quality of ADR reports |
| title | Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical Care |
| title_full | Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical Care |
| title_fullStr | Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical Care |
| title_full_unstemmed | Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical Care |
| title_short | Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical Care |
| title_sort | quality of active versus spontaneous reporting of adverse drug reactions in pediatric patients relevance for pharmacovigilance and knowledge in pediatric medical care |
| topic | drug safety adverse drug reactions pharmacovigilance active reporting ADRs quality of ADR reports |
| url | https://www.mdpi.com/1424-8247/15/9/1148 |
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