ABSTRACT
BACKGROUND: Public health initiatives for improving adherence to primaquine based regimens and enhancing effective pharmacovigilance are needed to support the efforts for malaria elimination in real world conditions. METHODS: A multicomponent patient-oriented strategy using a Smart Safety Surveillance (3S) approach including: (1) educational materials for treatment counselling and identification of warning symptoms of haemolytic anaemia; (2) an mHealth component using Short Message Service (SMS) treatment reminders and (3) development and implementation of follow-up phone surveys three days after treatment completion, using a web-based platform linked to the local information system of malaria. Adherence was measured using the Morisky Medication Adherence Scale. Self-reported events were registered using a structured questionnaire and communicated to the Brazilian Health Regulatory Agency. RESULTS: Educational materials were disseminated to 5594 patients, of whom 1512 voluntarily entered the mHealth component through the local information system; 7323 SMS were sent, and 1062 participants completed a follow-up survey after treatment. The mean age of patients was 37.36 years (SD 13.65), 61.24% were male, 98.54% were infected with. Plasmodium vivax and 95.90% received a short regimen of chloroquine plus primaquine (CQ + PQ 7 days), as per malaria case management guidelines in Brazil. From the 1062 surveyed participants 93.31% were considered adherent to the treatment. Most of the patients (95.20%) reported at least one adverse event. Headache, lack of appetite and nausea/vomiting were the most frequently reported adverse events by 77.31%, 70.90% and 56.78% of the patients respectively. A quarter of the patients reported anxiety or depression symptoms; 57 (5.37%) patients reported 5 to 6 warning symptoms of haemolytic anaemia including jaundice and dark urine in 44 (4.14%). Overall, three patients presenting symptoms of haemolytic anaemia attended a hospital and were diagnosed with G6PD deficiency, and one had haemolysis. All of them recovered. CONCLUSIONS: Under real world conditions, a multicomponent patient-oriented strategy using information and communication technologies allowed health care providers to reinforce treatment adherence and enhance safety surveillance of adverse events associated with regimens using primaquine. Active monitoring through phone surveys also reduced under-reporting of ADRs. This approach is low-cost, scalable and able to support prioritized activities of the national malaria programme.
Subject(s)
Antimalarials/therapeutic use , Pharmacovigilance , Telemedicine/statistics & numerical data , Treatment Adherence and Compliance/statistics & numerical data , Brazil , HumansABSTRACT
Objective: To describe the clinical-epidemiological profile of Multisystem Inflammatory Syndrome in Children (MIS-C) cases and to identify factors associated with MIS-C deaths in Brazil, 2020. Methods: Cross-sectional study, based on MIS-C national monitoring database in Brazil, 2020. Simple and multiple logistic regression was performed to estimate crude and adjusted odds ratios (OR). Results: The median age of cases (n=652) was 5 years, 57.1% were male, 52.0% were brown race/color and 6.4% died. The odds of death was greater among those who presented O2 saturation <95% (ORa=4.35 95%CI 1.69;11.20) and altered result of urea (ORa=5.18 95%CI 1.91;14.04); lower in the absence of cutaneous lesion such as rash (ORa=0.23 95%CI 0.09;0.62), with the use of anticoagulants (ORa=0.32 95%CI 0.12;0.89) and of immunoglobulins (ORa=0.38 95%CI 0.15;1.01). Conclusion: Fatality rates was higher among cases that presented O2 saturation<95% and altered urea, and lower among those with cutaneous lesion, who used immunoglobulins and anticoagulants.
Objetivo: Caracterizar o perfil clínico-epidemiológico da síndrome inflamatória multissistêmica pediátrica temporalmente associada à COVID-19 (SIM-P) e identificar fatores associados aos óbitos de SIM-P no Brasil, 2020. Métodos: Estudo seccional, utilizando dados do monitoramento nacional da SIM-P. Empregou-se regressão logística para estimar razões de chances (ORs, odds ratios) brutas e ajustadas. Resultados: Os casos (n=652) apresentaram idade mediana de 5 anos; 57,1% eram do sexo masculino e 52,0% de raça/cor da pele parda; 6,4% evoluíram a óbito. A chance de óbito foi significativamente maior nos que apresentaram saturação de O2<95% (ORa=4,35 IC95% 1,69;11,20) e resultado alterado de ureia (ORa=5,18 IC95% 1,91;14,04); e menor na ausência de manchas vermelhas pelo corpo (ORa=0,23 IC95% 0,09;0,62), com uso de anticoagulantes (ORa=0,32 IC95% 0,12;0,89) e imunoglobulinas (ORa=0,38 IC95% 0,15;1,01). Conclusão: A letalidade foi maior entre casos que apresentaram saturação de O2<95% e ureia alterada; e menor nos que apresentaram manchas vermelhas, usaram imunoglobulinas e anticoagulantes.
