Medication errors in malaria management in children: insights from pharmacovigilance data in the Democratic Republic of Congo.

Abstract

Introduction: 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.

Objectives: To identify, describe, and propose actionable strategies to address medication errors during malaria treatment in children with adverse effects in the DRC.

Methods: 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.

Results: 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.

Discussion: 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.

Conclusion: 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.