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Adverse Drug Reactions Reported to a National HIV & Tuberculosis Health Care Worker Hotline in South Africa: Description and Prospective Follow-Up of Reports

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Abstract

Introduction

The National HIV & Tuberculosis Health Care Worker (HCW) Hotline provides advice on the management of suspected adverse drug reactions (ADRs). We describe suspected ADRs reported to the hotline by HCWs, concordance with advice, and patient outcomes.

Methods

We reviewed suspected ADRs in HIV-infected patients, patients taking antiretrovirals and patients taking anti-tuberculosis therapy reported from May 2013 to October 2014. We performed causality assessment using the World Health Organization Uppsala Monitoring Centre (WHO-UMC) criteria. We included suspected ADRs categorized as certain, probable or possible in further analysis.

Results

We received 772 ADR reports, of which 87/772 (11.3 %) were classified as certain, 176/772 (22.8 %) as probable, 361/772 (46.8 %) as possible, and 148/772 (19.2 %) as unlikely or unassessable. The most frequent ADRs were rash, drug-induced liver injury (DILI) and kidney injury, comprising 110/624 (17.6 %), 87/624 (13.9 %), and 77/624 (12.3 %), respectively. The ADR was severe in 27.3 % of rashes, 36.4 % of kidney injury reports and 88.5 % of DILI reports. Most frequently implicated drugs, either alone or in combination with other potentially causative drugs, were efavirenz (rashes), efavirenz and anti-tuberculosis drugs (DILI) and tenofovir (kidney injury). In 383 cases with HCW follow-up, 254 (66.3 %) improved, 9 (2.3 %) had complete resolution, 32 (8.4 %) remained unchanged, 6 (1.6 %) deteriorated, 10 (2.6 %) died and 72 (18.8 %) had unknown outcome. Advice provided was followed in 93.2 % of these cases. Of 223 ADRs with preventability data, 40 (17.9 %) were preventable.

Conclusion

Queries about rashes, DILIs and kidney injuries were common. Detection and management of these ADRs should be included in HCW training. In cases with follow-up, concordance with advice was high, and HCWs reported improvement in the majority.

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Acknowledgments

The authors would like to acknowledge all the drug information pharmacists at the Medicines Information Centre who were involved in the data collection process.

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Authors and Affiliations

  1. Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa

    Christine Njuguna, Annemie Stewart, Johannes P. Mouton, Marc Blockman, Gary Maartens, Annoesjka Swart, Briony Chisholm, Jackie Jones & Karen Cohen

  2. National Department of Health, Pretoria, South Africa

    Mukesh Dheda

  3. Pharmaceutical Services, School of Health Sciences, University of KwaZulu-Natal, Durban, South Africa

    Mukesh Dheda

  4. US Centers for Disease Control and Prevention, Pretoria, South Africa

    Ehimario U. Igumbor

Authors
  1. Christine Njuguna
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  2. Annemie Stewart
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  3. Johannes P. Mouton
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  4. Marc Blockman
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  5. Gary Maartens
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  6. Annoesjka Swart
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  7. Briony Chisholm
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  8. Jackie Jones
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  9. Mukesh Dheda
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  10. Ehimario U. Igumbor
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  11. Karen Cohen
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Corresponding author

Correspondence to Karen Cohen.

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Funding

This research has been supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) through the US Centers for Disease Control and Prevention (CDC) under the terms of Cooperative Agreement Number GGH000371. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC.

Conflicts of interest

Christine Njuguna, Annemie Stewart, Johannes Mouton, Marc Blockman, Gary Maartens, Annoesjka Swart, Briony Chisholm, Jackie Jones, Mukesh Dheda, Ehimario Igumbor and Karen Cohen have no conflicts of interest that are directly relevant to the content of this study.

Ethical approval

The study was approved by the Faculty of Health Sciences Human Research Ethics Committee, University of Cape Town (UCT) and has been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments. The UCT Human Research Ethics Committee has Federal Wide Assurance (FWA) for the Protection of Human Subjects accreditation with the US Department of Health and Human Services.

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Njuguna, C., Stewart, A., Mouton, J.P. et al. Adverse Drug Reactions Reported to a National HIV & Tuberculosis Health Care Worker Hotline in South Africa: Description and Prospective Follow-Up of Reports. Drug Saf 39, 159–169 (2016). https://doi.org/10.1007/s40264-015-0359-8

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  • DOI: https://doi.org/10.1007/s40264-015-0359-8

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