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The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase(®)
BACKGROUND: Spontaneous reporting is regarded as a cornerstone of pharmacovigilance (PV) but presents many limitations, including varying quality and completeness of information, which is essential for causality assessment. AIM: This study aimed to evaluate the completeness of adverse drug reaction...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
AOSIS
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9900287/ https://www.ncbi.nlm.nih.gov/pubmed/36744452 http://dx.doi.org/10.4102/phcfm.v15i1.3659 |
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author | Matlala, Mafora F. Lubbe, Martha S. Steyn, Hanlie |
author_facet | Matlala, Mafora F. Lubbe, Martha S. Steyn, Hanlie |
author_sort | Matlala, Mafora F. |
collection | PubMed |
description | BACKGROUND: Spontaneous reporting is regarded as a cornerstone of pharmacovigilance (PV) but presents many limitations, including varying quality and completeness of information, which is essential for causality assessment. AIM: This study aimed to evaluate the completeness of adverse drug reaction (ADR) reports in South Africa based on the vigiGrade completeness score. SETTING: The South African Health Products Regulatory Authority (SAHPRA). METHODS: A cross-sectional, descriptive study of all reports received by SAHPRA and submitted to VigiBase(®) in 2017 was conducted. A report with a vigiGrade score > 0.8 is considered well-documented. RESULTS: The mean completeness score for the 8438 reports received was 0.456 (s.d. = 0.221). Only 11.3% of reports had a completeness score > 0.8. The completeness of reports submitted by consumers professionals did not significantly differ from reports by physicians, pharmacists or other healthcare professionals (d ≤ 0.2). Reports of reactions that resulted in death (M = 0.572, s.e. = 0.007), disability (M = 0.491, s.e. 0.033) or were life threatening (M = 0.474, s.e. = 0.013) had a medium to large practically significant effect (0.5 ≥ d ≤ 0.8) on the completeness score compared with reports of congenital anomaly (M = 0.348, s.e. = 0.089). CONCLUSION: The completeness of reports submitted by consumers is comparable to those submitted by healthcare professionals. The completeness of reports was low and multiple measures to improve reporting are recommended. CONTRIBUTION: This study describes the completeness of ADR reports in South Africa and the results can be used to improve training. |
format | Online Article Text |
id | pubmed-9900287 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | AOSIS |
record_format | MEDLINE/PubMed |
spelling | pubmed-99002872023-02-07 The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase(®) Matlala, Mafora F. Lubbe, Martha S. Steyn, Hanlie Afr J Prim Health Care Fam Med Original Research BACKGROUND: Spontaneous reporting is regarded as a cornerstone of pharmacovigilance (PV) but presents many limitations, including varying quality and completeness of information, which is essential for causality assessment. AIM: This study aimed to evaluate the completeness of adverse drug reaction (ADR) reports in South Africa based on the vigiGrade completeness score. SETTING: The South African Health Products Regulatory Authority (SAHPRA). METHODS: A cross-sectional, descriptive study of all reports received by SAHPRA and submitted to VigiBase(®) in 2017 was conducted. A report with a vigiGrade score > 0.8 is considered well-documented. RESULTS: The mean completeness score for the 8438 reports received was 0.456 (s.d. = 0.221). Only 11.3% of reports had a completeness score > 0.8. The completeness of reports submitted by consumers professionals did not significantly differ from reports by physicians, pharmacists or other healthcare professionals (d ≤ 0.2). Reports of reactions that resulted in death (M = 0.572, s.e. = 0.007), disability (M = 0.491, s.e. 0.033) or were life threatening (M = 0.474, s.e. = 0.013) had a medium to large practically significant effect (0.5 ≥ d ≤ 0.8) on the completeness score compared with reports of congenital anomaly (M = 0.348, s.e. = 0.089). CONCLUSION: The completeness of reports submitted by consumers is comparable to those submitted by healthcare professionals. The completeness of reports was low and multiple measures to improve reporting are recommended. CONTRIBUTION: This study describes the completeness of ADR reports in South Africa and the results can be used to improve training. AOSIS 2023-01-18 /pmc/articles/PMC9900287/ /pubmed/36744452 http://dx.doi.org/10.4102/phcfm.v15i1.3659 Text en © 2023. The Authors https://creativecommons.org/licenses/by/4.0/Licensee: AOSIS. This work is licensed under the Creative Commons Attribution License. |
spellingShingle | Original Research Matlala, Mafora F. Lubbe, Martha S. Steyn, Hanlie The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase(®) |
title | The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase(®) |
title_full | The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase(®) |
title_fullStr | The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase(®) |
title_full_unstemmed | The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase(®) |
title_short | The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase(®) |
title_sort | completeness of adverse drug reaction reports in south africa: an analysis in vigibase(®) |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9900287/ https://www.ncbi.nlm.nih.gov/pubmed/36744452 http://dx.doi.org/10.4102/phcfm.v15i1.3659 |
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