Amba Mireille Ngale, Ntambwe Erick Kamangu, Biongo Aline Engo, Ntamabyaliro Nsengi, Kahunu Gauthier Mesia, Mabiala Joseph Bodi, Ndosimao Celestin Nsibu, Lutete Gaston Tona, Miremont-Salamé Ghada, Fourrier-Réglat Annie
Clinical Pharmacology Unit, Faculty of Medicine, University of Kinshasa, Kinshasa, DR, Congo.
Service de Pharmacologie Médicale, Centre Hospitalier Universitaire de Bordeaux, Bordeaux-DROM Regional Pharmacovigilance Centre, INSERM, U1219, Bordeaux, F-33000, France.
BMC Pharmacol Toxicol. 2025 May 22;26(1):108. doi: 10.1186/s40360-025-00941-z.
Since 2012, DRC adopted WHO recommendations for the malaria treatment with artemisinin-based drugs. Medication errors are defined as "a failure in the treatment process that results in, or has the potential to result in, harm to the patient". Medication errors are a major public health problem and one of the leading causes of death in the United States. The impact of medical errors can have severe consequences on children due to physiological features of children.
To identify, describe, and propose actionable strategies to address medication errors during malaria treatment in children with adverse effects in the DRC.
This is a cross-sectional study of the ADR reports of children (< 18 years old) in the DRC recorded in VigiBase, the WHO pharmacovigilance database, from 2010 to February 2018. Five treatment process criteria (choice of treatment, dosage, duration, timing and route of administration) were selected to identify medication errors.
Medication errors accounted for 65,9% of the 851 cases retrieved from VigiBase. Children aged 2-11 years represented 55.2% of the study population. The choice of treatment, duration and dosage were the main prescription criteria for deviations.
The availability of alternative formulations, self-medication and inadequate dosage forms are factors contributing to medication errors. The information available in VigiBase did not allow us to evaluate the overall process of malaria management. Pharmacovigilance must be consolidated to raise awareness among consumers and providers and to ensure more effective monitoring.
Non-compliance with national guidelines for the management of malaria is important in DRC. Our study amply demonstrates the need to strengthen the four pillars of the WHO's third global challenge, "Medication without harm", to reduce medication errors. This study advocates a significant mobilisation of resources for the training of health professionals and the strengthening of pharmacovigilance. Field studies on the management of malaria in children should be conducted to quantify drug errors.
自2012年以来，刚果民主共和国采用了世界卫生组织关于使用青蒿素类药物治疗疟疾的建议。用药错误被定义为“治疗过程中的失误，导致或有可能导致对患者的伤害”。用药错误是一个重大的公共卫生问题，也是美国主要的死亡原因之一。由于儿童的生理特征，医疗错误对儿童的影响可能会产生严重后果。
识别、描述并提出可采取的策略，以解决刚果民主共和国儿童疟疾治疗过程中出现不良反应的用药错误问题。
这是一项横断面研究，研究对象为2010年至2018年2月记录在世卫组织药物警戒数据库VigiBase中的刚果民主共和国18岁以下儿童的药品不良反应报告。选择五个治疗过程标准（治疗选择、剂量、疗程、给药时间和途径）来识别用药错误。
从VigiBase检索到的851例病例中，用药错误占65.9%。2至11岁的儿童占研究人群的55.2%。治疗选择、疗程和剂量是出现偏差的主要处方标准。
替代制剂的可用性、自我用药和剂型不足是导致用药错误的因素。VigiBase中提供的信息无法让我们评估疟疾管理的整体过程。必须加强药物警戒，以提高消费者和提供者的认识，并确保进行更有效的监测。
在刚果民主共和国，不遵守国家疟疾管理指南的情况很严重。我们的研究充分表明，需要加强世界卫生组织第三次全球挑战“无害用药”的四大支柱，以减少用药错误。本研究主张大力动员资源，用于培训卫生专业人员和加强药物警戒。应开展关于儿童疟疾管理的实地研究，以量化用药错误。
