Evidence map›Paper›PMID 26547719›Full record

ArticleDrug safety2016

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

Christine Njuguna, Annemie Stewart, Johannes P Mouton, Marc Blockman, Gary Maartens, Annoesjka Swart, Briony Chisholm, Jackie Jones, Mukesh Dheda, Ehimario U Igumbor and 1 more

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Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
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  3. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Christine NjugunaDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Annemie StewartDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Johannes P MoutonDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Marc BlockmanDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Gary MaartensDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Annoesjka SwartDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Briony ChisholmDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Jackie JonesDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Mukesh DhedaNational Department of Health, Pretoria, South Africa.
Ehimario U IgumborUS Centers for Disease Control and Prevention, Pretoria, South Africa.
Karen CohenDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa. karen.cohen@uct.ac.za.

Funding

Intramural CDC HHS CC999999PEPFARPHS HHS GGH000371
6 · The paper itself

Abstract

introductionThe 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.

methodsWe 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.

resultsWe 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.

conclusionQueries 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.

Indexed as

Acute Kidney InjuryAdverse Drug Reaction Reporting SystemsAnti-HIV AgentsAntitubercular AgentsChemical and Drug Induced Liver InjuryDrug-Related Side Effects and Adverse ReactionsHIV InfectionsHumansProspective StudiesTuberculosisAnti-HIV AgentsAntitubercular Agents

Identifiers

PMID26547719
PMCPMC4738009

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.