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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| Format: | Article |
| Language: | English |
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AOSIS
2023-01-01
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| Series: | African Journal of Primary Health Care & Family Medicine |
| Subjects: | |
| Online Access: | https://phcfm.org/index.php/phcfm/article/view/3659 |
| _version_ | 1797937161319743488 |
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| author | Mafora F. Matlala Martha S. Lubbe Hanlie Steyn |
| author_facet | Mafora F. Matlala Martha S. Lubbe Hanlie Steyn |
| author_sort | Mafora F. Matlala |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-04-10T18:41:24Z |
| format | Article |
| id | doaj.art-15cd490736d24042abd9a0b8a9636d93 |
| institution | Directory Open Access Journal |
| issn | 2071-2928 2071-2936 |
| language | English |
| last_indexed | 2024-04-10T18:41:24Z |
| publishDate | 2023-01-01 |
| publisher | AOSIS |
| record_format | Article |
| series | African Journal of Primary Health Care & Family Medicine |
| spelling | doaj.art-15cd490736d24042abd9a0b8a9636d932023-02-01T13:05:37ZengAOSISAfrican Journal of Primary Health Care & Family Medicine2071-29282071-29362023-01-01151e1e910.4102/phcfm.v15i1.36591003The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase®Mafora F. Matlala0Martha S. Lubbe1Hanlie Steyn2Medicine Usage in South Africa, Faculty of Health Sciences, North-West University, Potchefstroom, South Africa; and Pharmacovigilance Unit, South African Health Products Regulatory Authority, PretoriaMedicine Usage in South Africa, Faculty of Health Sciences, North-West University, PotchefstroomMedicine Usage in South Africa, Faculty of Health Sciences, North-West University, PotchefstroomBackground: 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.https://phcfm.org/index.php/phcfm/article/view/3659pharmacovigilanceadverse drug reactionsreportscompletenesssouth africaindividual case safety report. |
| spellingShingle | Mafora F. Matlala Martha S. Lubbe Hanlie Steyn The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase® African Journal of Primary Health Care & Family Medicine pharmacovigilance adverse drug reactions reports completeness south africa individual case safety report. |
| 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 r |
| topic | pharmacovigilance adverse drug reactions reports completeness south africa individual case safety report. |
| url | https://phcfm.org/index.php/phcfm/article/view/3659 |
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