Development of a pharmacovigilance safety monitoring tool for the rollout of single low-dose primaquine and artemether-lumefantrine to treat Plasmodium falciparum infections in Swaziland: a pilot study

Malaria Journal

Research

Sisi Pan¹  Adam Soble¹  Nyasatu Ntshalintshali¹  Eric Vittinghoff²  Andy Stergachis³  Eugenie Poirot⁴  Roland Gosling⁴  Joelle Brown⁴  Jimee Hwang⁵  Sarah Darteh⁶  Cheryl Pace⁷  Simon Kunene⁸  Sibonakaliso Vilakati⁸  Nomcebo Mkhonta⁸  Calisile Malambe⁸  Gugu Maphalala⁹  Asen Mwandemele^1,10 

[1] Clinton Health Access Initiative, Mbabane, Swaziland;Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA;Departments of Pharmacy and Global Health, Schools of Pharmacy and Public Health, University of Washington, Seattle, USA;Global Health Group, University of California San Francisco, San Francisco, CA, USA;Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA;Global Health Group, University of California San Francisco, San Francisco, CA, USA;President’s Malaria Initiative, Malaria Branch, U.S. Centers for Disease Control and Prevention, Atlanta, GA, USA;International Center for AIDS Care and Treatment Programs, Mbabane, Swaziland;Liverpool School of Tropical Medicine, Liverpool, UK;National Malaria Control Programme, Manzini, Swaziland;Swaziland Health Laboratory Services, Mbabane, Swaziland;University of Namibia, Windhoek, Namibia;

关键词: Elimination;    Glucose-6-phosphate dehydrogenase deficiency;    G6PD;    Malaria;    Pharmacovigilance;    Plasmodium falciparum;    Primaquine;    Safety;   

DOI  :  10.1186/s12936-016-1410-7

 received in 2016-02-16, accepted in 2016-06-21,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundCountries remain reluctant to adopt the 2012 World Health Organization recommendation for single low-dose (0.25 mg/kg) primaquine (SLD PQ) for Plasmodium falciparum transmission-blocking due to concerns over drug-related haemolysis risk, especially among glucose-6-phosphate dehydrogenase-deficient (G6PDd) people, without evidence demonstrating that it can be safely deployed in their settings. Pharmacovigilance methods provide a systematic way of collecting safety data and supporting the rollout of SLD PQ.MethodsThe Primaquine Roll Out Monitoring Pharmacovigilance Tool (PROMPT), comprising: (1) a standardized form to support the surveillance of possible adverse events following SLD PQ treatment; (2) a patient information card to enhance awareness of known adverse drug reactions of SLD PQ use; and (3) a database compiling recorded information, was developed and piloted. Data on patient characteristics, malaria diagnosis and treatment are collected. Blood samples are taken to measure haemoglobin (Hb) and test for G6PD deficiency. Active follow-up includes a repeat Hb measurement and adverse event monitoring on or near day 7. A 13-month prospective pilot study in two hospital facilities in Swaziland alongside the introduction of SLD PQ generated preliminary evidence on the feasibility and acceptability of PROMPT.ResultsPROMPT was well received by nurses as a simple, pragmatic approach to active surveillance of SLD PQ safety data. Of the 102 patients enrolled and administered SLD PQ, none were G6PDd. 93 (91.2 %) returned on or near day 7 for follow-up. Four (4.6 %) patients had falls in Hb ≥25 % from baseline, none of whom presented with signs or symptoms of anaemia. No patient’s Hb fell below 7 g/dL and none required a blood transfusion. Of the 11 (11 %) patients who reported an adverse event over the study period, three were considered serious and included two deaths and one hospitalization; none were causally related to SLD PQ. Four non-serious adverse events were considered definitely, probably, or possibly related to SLD PQ.ConclusionImproved pharmacovigilance to monitor and promote the safety of the WHO recommendation is needed. The successful application of PROMPT demonstrates its potential as an important tool to rapidly generate locally acquired safety data and support pharmacovigilance in resource-limited settings.

【 授权许可】

CC BY   
© The Author(s) 2016