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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…

Overview of attention for article published in Malaria Journal, July 2016
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Title
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
Published in
Malaria Journal, July 2016
DOI 10.1186/s12936-016-1410-7
Pubmed ID
Authors

Eugenie Poirot, Adam Soble, Nyasatu Ntshalintshali, Asen Mwandemele, Nomcebo Mkhonta, Calisile Malambe, Sibonakaliso Vilakati, Sisi Pan, Sarah Darteh, Gugu Maphalala, Joelle Brown, Jimee Hwang, Cheryl Pace, Andy Stergachis, Eric Vittinghoff, Simon Kunene, Roland Gosling

Abstract

Countries 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. The 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. PROMPT 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. Improved 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.

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X Demographics

The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 102 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 102 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 18 18%
Researcher 16 16%
Student > Bachelor 13 13%
Student > Ph. D. Student 8 8%
Student > Doctoral Student 6 6%
Other 17 17%
Unknown 24 24%
Readers by discipline Count As %
Medicine and Dentistry 22 22%
Nursing and Health Professions 15 15%
Pharmacology, Toxicology and Pharmaceutical Science 7 7%
Social Sciences 6 6%
Economics, Econometrics and Finance 5 5%
Other 18 18%
Unknown 29 28%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 28 July 2016.
All research outputs
#16,023,298
of 24,380,741 outputs
Outputs from Malaria Journal
#4,461
of 5,820 outputs
Outputs of similar age
#233,138
of 371,461 outputs
Outputs of similar age from Malaria Journal
#93
of 139 outputs
Altmetric has tracked 24,380,741 research outputs across all sources so far. This one is in the 32nd percentile – i.e., 32% of other outputs scored the same or lower than it.
So far Altmetric has tracked 5,820 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 7.0. This one is in the 19th percentile – i.e., 19% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 371,461 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 34th percentile – i.e., 34% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 139 others from the same source and published within six weeks on either side of this one. This one is in the 28th percentile – i.e., 28% of its contemporaries scored the same or lower than it.