| Title: |
Adverse drug reactions reported to a provincial public health sector pharmacovigilance programme in South Africa |
| Authors: |
Jones, J; Swart, A; Tommy, E; Cohen, K; Stewart, A; Voget, J; Blockman, M |
| Source: |
South African Medical Journal; Vol 110, No 12 (2020); 1226-1230 ; 2078-5135 ; 0256-9574 |
| Publisher Information: |
South African Medical Association |
| Publication Year: |
2020 |
| Collection: |
South African Medical Journal (SAMJ) |
| Subject Terms: |
Pharmacovigilance; Adverse drug reactions; Causality; Drug safety |
| Description: |
Background. There are limited data in South Africa (SA) on adverse drug reaction (ADR) patterns and common causative medicines, outside of HIV and tuberculosis treatment programmes. In SA, Western Cape Province has a pharmacovigilance programme that collects spontaneous reports of suspected ADRs from public sector healthcare facilities.Objectives. To describe reports received by the pharmacovigilance programme over a 4-year period (excluding those ascribed to medicines used to treat HIV and tuberculosis), as well as challenges faced in the implementation of such a system.Methods. Reports of suspected ADRs and deaths possibly related to ADRs received between January 2015 and December 2018 were reviewed. Causality was assessed by a pharmacist, with multidisciplinary team involvement for all deaths and complicated cases. Causality was categorised according to the World Health Organization-Uppsala Monitoring Centre system. Preventability was assessed using Schumock and Thornton criteria. Observations on preventability and challenges faced in the operation of a spontaneous reporting system were also noted.Results. We received 5 346 reports containing 6 023 suspected ADRs. There were 5 486 ADRs confirmed after causality assessment, in 5 103 reports. Cough, angio-oedema, movement disorders and uterine bleeding disorders were the most common ADRs. Enalapril, etonogestrel, amlodipine and hydrochlorothiazide were the most commonly implicated drugs. Seven deaths were reported; 3 of these reports of deaths had confirmed ADRs, and these ADRs were assessed as contributing to the deaths. Approximately 3.8% of commonly reported ADRs were preventable.Conclusions. Enalapril and etonogestrel were responsible for a significant proportion of ADRs reported to this provincial programme. Future work should include quantification of preventability aspects to better inform gaps in healthcare worker knowledge that can be addressed in order to improve patient care. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
http://samj.org.za/index.php/samj/article/view/13150/9597; http://samj.org.za/index.php/samj/article/view/13150 |
| DOI: |
10.7196/SAMJ.2020.v110i12.14721 |
| Availability: |
http://samj.org.za/index.php/samj/article/view/13150; https://doi.org/10.7196/SAMJ.2020.v110i12.14721 |
| Rights: |
Copyright of published material remains in the Authors’ name. This allows authors to use their work for their own non-commercial purposes without seeking permission from the Publisher, subject to properly acknowledging the Journal as the original place of publication. Authors are free to copy, print and distribute their articles, in full or in part, for teaching activities, and to deposit or include their work in their own personal or institutional database or on-line website. Authors are requested to inform the Journal/Publishers of their desire/intention to include their work in a thesis or dissertation or to republish their work in any derivative form (but not for commercial use).  Material submitted for publication in the SAMJ is accepted provided it has not been published or submitted for publication elsewhere. Please inform the editorial team if the main findings of your paper have been presented at a conference and published in abstract form, to avoid copyright infringement. |
| Accession Number: |
edsbas.E4209F47 |
| Database: |
BASE |