Use of artesunate in the treatment of severe imported malaria in France: review of the effectiveness and real-life safety in two French university hospitals.

BACKGROUND: Intravenous artesunate (AS) is the first-line treatment for patients with severe imported malaria (SIM) worldwide. However, after 10 years of use in France, AS hasn't yet received marketing authorization.The purpose of this study was to assess the real-life effectiveness and safety of AS in the treatment of SIM in two Hospitals in France. METHODS: We performed a bicenter retrospective and observational study. All patients treated with AS for SIM between 2014 and 2018 and 2016-2020 were included. The effectiveness of AS was evaluated by parasite clearance, number of deaths, and the length of hospital stay. The real-life safety was assessed by related adverse events (AE) and monitoring of biological blood parameters during the hospital stay and follow-up period. RESULTS: 110 patients were included during the six-year study period. 71.8% of patients were parasite-negative of their day 3 thick and thin blood smears after AS treatment. No patients discontinued AS due to an AE and no serious AE were declared. Two cases of delayed post-artesunate hemolysis occurred and required blood transfusions. CONCLUSION: This study highlights effectiveness and safety of AS in non-endemic areas. Administrative procedures must be accelerated in order to obtain full registration and facilitate access to AS in France.

[Drug distribution systems in hospitals]. / Le circuit du médicament à l'hôpital.

Any drug generally made and marketed by drug companies must respect the quality standards conferred by New Drug Approval regarding both safety and efficacy. Once prescribed by a doctor, inside a hospital, the drug, or more precisely the decision of its prescription will follow a complex circuit, involving numerous intermediates (human and technical) leading to drug dispensation and follow-up. Regulatory guidelines and rules harmonise and standardise this drug pathway in hospitals. Any weakness in this distribution system will be the source of nosocomial drug iatrogeny. The present review aims at describing the different steps and stages from the prescription to an individual patient to drug administration and follow-up. The evaluation of this system will be mentioned in the perspective of optimisation. The computerised system is essential allowing tracking of a drug, and providing help for decision-making (by confrontation with data bases) and a research tool (i.e, pharmacoepidemiology). Different experiences of assessment of the performance of such a drug distribution system inside hospitals will be presented, trying to check the quality reference: the right drug, the right patient, the right moment, in good conditions. The challenge is to optimise and secure all steps of the process. This goal needs assessment and quality control of the different phases, opening the discussion between hospital policy and regulatory and technical considerations.