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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...

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Autores principales: Matlala, Mafora F., Lubbe, Martha S., Steyn, Hanlie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: AOSIS 2023
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.
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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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