gms | German Medical Science

Background: The unintended incorrect route of drug administration (IRODA) of a medicinal product, e.g., intravenous instead of oral, can lead to serious adverse drug reactions (ADR). Individual cases of such IRODA in children and adolescents have been described in the literature [1] but no larger case series investigation.

The aim of our analysis was thus to identify ME reports describing a IRODA of a medicinal product in children and adolescents in the European ADR database EudraVigilance (EV) and the medication error (ME) case collection of the Federal Institute for Drugs and Medical Devices (BfArM). The identified reports will be investigated concerning various parameters.

This analysis is thematically related to the research project MEKIH [2].

Materials and Methods: All ME reports relating to children and adolescents reported until September 13, 2023 were extracted from EV, using specific coding terms of MedDRA 26.0 terminology. Additional reports from EV and the ME case collection, which were identified in the MEKIH project were considered. ME reports related to vaccines, hyposensitizations, or deliberately altered pharmaceutical dosage forms were excluded.

All ME reports were evaluated, e.g. for patient data, drug related data and information about the ME, and assessed regarding their clinical consequences according to the NCC MERP 'Index for Categorizing Medication Errors Algorithm' into nine categories, ranked from A to I, with I indicating the highest severity [3]. Thereby, information on the necessity of monitoring, interventions, inpatient consequences, and the duration of a potential impairment was collected.

Results: Currently, about 60 reports were analyzed. These can be divided into two subgroups: i) ME reports, in which a IRODA was chosen and executed (e.g. an oral solution was unintentionally used for injection) and, ii) ME reports, in which the correct route of drug administration was intended but not exerted (e.g. the intravenous administration was not carried out correctly leading to a paravasal administration).

According to the NCC MERP Algorithm, approximately 40% of the cases fall into category E, which leads to temporary harm to the patient and requires intervention, while 30% fall into category F, which leads to temporary harm to the patient requiring initial or extended hospitalization.

Conclusion: Our analysis so far indicates a temporary impairment in most of the patients in most patients. In general, impairment of patients may often lead to an increased demand for medical care.

Analyzing this topic of IRODA could help to identify associated factors and consequently develop dedicated approaches for their reduction and prevention.