Primaquine Roll Out Monitoring Pharmacovigilance Tool (PROMPT)
Why is pharmacovigilance important when using primaquine to prevent malaria transmission?
For malaria-eliminating countries, interrupting the transmission of the malaria parasite Plasmodium falciparum or Plasmodium vivax is the ultimate goal. While primaquine is the only drug approved by the World Health Organization (WHO) for preventing the onward transmission of P. falciparum malaria, few countries follow the WHO recommendation of administering single low-dose primaquine (SLD PQ), in conjunction with an artemisinin-based combination therapy. This decision is based largely on concerns about the risk of hemolysis, an adverse effect of SLD PQ usage in people with G6PD deficiency, a common enzyme deficiency among people living in malaria-endemic settings. Pharmacovigilance enables rapid detection and treatment of adverse events such as hemolysis, should they arise after SLD PQ use, to support the roll out of SLD PQ in malaria-eliminating countries.
What is the Primaquine Roll Out Monitoring Pharmacovigilance Tool and why is it useful?
In response to persistent safety concerns about treatment with SLD PQ, the Malaria Elimination Initiative developed the Primaquine Roll Out Monitoring Pharmacovigilance Tool (PROMPT). PROMPT is a step-by-step tool that facilitates active pharmacovigilance surveillance data collection and safety monitoring of SLD PQ. It is used over eight-days, during which an individual is treated for uncomplicated P. falciparum malaria and monitored for any adverse events. With this information, NMCPs can rapidly detect and treat hemolytic adverse events across multiple health facilities, should they arise after SLD PQ usage. In addition, national data can be combined with data from other countries to strengthen global research on the safety of SLD PQ for the treatment of P. falciparum malaria and inform new risk mitigation strategies.
Who should use this tool and how?
PROMPT should be used by healthcare providers in settings that are rolling out SLD PQ to monitor the potential side effects after administering the treatment. NMCPs can also benefit from collecting and aggregating this data to monitor the overall risk and determine risk mitigation strategies of SLD PQ.
The MEI requests that national malaria programs and implementing partners contact us when using any of the tools in the Malaria Elimination Toolkit. Support in implementing the tool may also be available.
- PROMPT Checklist for Day 0 and Day 7
- PROMPT Patient Data Collection Form
- Patient Information Card
- PROMPT Database