Targeted spontaneous reporting of suspected renal toxicity in patients undergoing highly active anti-retroviral therapy in two public health facilities in Uganda

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Helen NdagijeShanthi N Pal

Abstract

Although the national HIV control programme in Uganda has a well-established system for monitoring disease progression and treatment outcomes, monitoring of adverse drug reactions (ADRs) is inadequate. In order to address under-reporting of ADRs, the National Pharmacovigilance Centre, in collaboration with the HIV control programme, piloted a targeted spontaneous reporting (TSR) system as a complementary method to traditional spontaneous reporting. From April 2012 to March 2014, all cases of suspected renal toxicity in 10,225 patients on tenofovir-based regimens were monitored in the regional pharmacovigilance centres of Masaka and Mbale. The identification of renal toxicity was performed using serum creatinine, urinalysis, and other signs and symptoms of kidney injury. There was one suspected renal toxicity reported for every 200 patients on a tenofovir-based regimen. Some of the serious reactions reported were death in two cases and bone demineralisation in five patients. Most of patients had been on treatment for 2 years. Those that had been on tenofovir for more than 4 years had raised serum creatinine levels, emphasising the importance of monitoring for the risk of renal damage for longer. We also found that the reporting ...Continue Reading

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Citations

Jun 5, 2015·Expert Review of Clinical Pharmacology·Sten OlssonAlex Dodoo
Jan 13, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Haggar H AmpaduAlexander N O Dodoo
Apr 2, 2015·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Shanthi N PalElliot G Brown
Jun 11, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Beth RachlisPaula Braitstein
Jun 7, 2019·AIDS Research and Therapy·Takudzwa J MtisiGene D Morse

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