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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.
Mosha, Dominic; Kakolwa, Mwaka A; Mahende, Muhidin K; Masanja, Honorati; Abdulla, Salim; Drakeley, Chris; Gosling, Roland; Wamoyi, Joyce.
Affiliation
  • Mosha D; Ifakara Health Institute, Plot 463, Kiko Ave, Mikocheni, P.O Box 78373, Dar es Salaam, Tanzania. dfmosha@hotmail.com.
  • Kakolwa MA; Ifakara Health Institute, Plot 463, Kiko Ave, Mikocheni, P.O Box 78373, Dar es Salaam, Tanzania.
  • Mahende MK; Ifakara Health Institute, Plot 463, Kiko Ave, Mikocheni, P.O Box 78373, Dar es Salaam, Tanzania.
  • Masanja H; Ifakara Health Institute, Plot 463, Kiko Ave, Mikocheni, P.O Box 78373, Dar es Salaam, Tanzania.
  • Abdulla S; Ifakara Health Institute, Plot 463, Kiko Ave, Mikocheni, P.O Box 78373, Dar es Salaam, Tanzania.
  • Drakeley C; Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK.
  • Gosling R; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
  • Wamoyi J; Global Health Group, Malaria Elimination Initiative, University of California, San Francisco, CA, USA.
Malar J ; 20(1): 392, 2021 Oct 09.
Article in En | MEDLINE | ID: mdl-34627236
ABSTRACT

BACKGROUND:

Primaquine is a gametocytocidal drug recommended by the World Health Organization (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 concerns and the lack of a universal validated and approved primaquine pharmacovigilance tool is a challenge for a national rollout in many countries. This study aimed to explore the 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 costs 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 concerned with the haemoglobin drop observed on day 7.

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 Programme is pivotal to addressing key challenges and facilitating primaquine adoption in the national policy.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Primaquine / Malaria, Falciparum / Artemether, Lumefantrine Drug Combination / Antimalarials Type of study: Observational_studies / Prevalence_studies / Qualitative_research / Risk_factors_studies Limits: Adult / Child / Female / Humans / Male / Middle aged Country/Region as subject: Africa Language: En Journal: Malar J Journal subject: MEDICINA TROPICAL Year: 2021 Document type: Article Affiliation country:

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Primaquine / Malaria, Falciparum / Artemether, Lumefantrine Drug Combination / Antimalarials Type of study: Observational_studies / Prevalence_studies / Qualitative_research / Risk_factors_studies Limits: Adult / Child / Female / Humans / Male / Middle aged Country/Region as subject: Africa Language: En Journal: Malar J Journal subject: MEDICINA TROPICAL Year: 2021 Document type: Article Affiliation country: