Christine Njuguna1, Annemie Stewart1, Johannes P Mouton1, Marc Blockman1, Gary Maartens1, Annoesjka Swart1, Briony Chisholm1, Jackie Jones1, Mukesh Dheda2,3, Ehimario U Igumbor4, Karen Cohen5. 1. Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa. 2. National Department of Health, Pretoria, South Africa. 3. Pharmaceutical Services, School of Health Sciences, University of KwaZulu-Natal, Durban, South Africa. 4. US Centers for Disease Control and Prevention, Pretoria, South Africa. 5. Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa. karen.cohen@uct.ac.za.
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.
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-infectedpatients, 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.
Authors: Charles Karari; Robin Tittle; Jeremy Penner; Jayne Kulzer; Elizabeth A Bukusi; Reson Marima; Craig R Cohen Journal: Telemed J E Health Date: 2011-05-25 Impact factor: 3.536
Authors: Johannes P Mouton; Ushma Mehta; Andy G Parrish; Douglas P K Wilson; Annemie Stewart; Christine W Njuguna; Nicole Kramer; Gary Maartens; Marc Blockman; Karen Cohen Journal: Br J Clin Pharmacol Date: 2015-07-06 Impact factor: 4.335
Authors: Briony S Chisholm; Karen Cohen; Marc Blockman; Hans-Friedemann Kinkel; Tamara J Kredo; Annoesjka M Swart Journal: AIDS Res Ther Date: 2011-01-26 Impact factor: 2.250