Safety Monitoring Experience of Single-low Dose Primaquine Co-administered With Artemether-lumefantrine Among Providers and Patients in Routine Healthcare Practice: a Qualitative Study in Eastern Tanzania

Abstract

\n Background: Primaquine is a gametocytocidal drug recommended by the WHO in a single-low dose combined with artemisinin-based combination therapy (ACT) for the treatment and prevention of Plasmodium falciparum malaria transmission. Safety monitoring concern and the lack of universal validated and approved primaquine pharmacovigilance tool is a challenge for a national rollout in many countries. This study aimed explored acceptance, reliability and perceived effectiveness of the primaquine roll out monitoring pharmacovigilance tool (PROMPT). Methods: This study was conducted in three dispensaries in the Coastal region of Eastern Tanzania. The study held six in-depth interviews with healthcare providers and six participatory focus group discussions with malaria patients (3) and parents/guardians of sick children (3). Participants were purposively sampled. Thematic analysis was conducted with the aid of NVivo qualitative analysis software.Results: The respondents’ general acceptance and perceived effectiveness of the single-low dose primaquine and PROMPT was good. Screening procedure for treatment eligibility and explaining to patients about the possible adverse events was considered very useful for safety reasons. Crushing and dissolving of primaquine tablet to get the appropriate dose, particularly in children, was reported by all providers to be challenging. Transport cost and poor access to the health facility were the main reasons for a patient failing to return to the clinic for a scheduled follow-up visit. Treatment was perceived to be safe by both providers and patients and reported no case of a severe adverse event. Some providers were concern with the haemoglobin drop observed on day seven. Conclusion: Single-low dose primaquine was perceived to be safe and acceptable among providers and patients. PROMPT demonstrated to be a reliable and user-friendly tool among providers. Further validation of the tool by involving the National Malaria Control Program is pivotal to address key challenges and facilitate the adoption of primaquine in the national policy.