Paediatric drugs · 2026
Unintentional Incorrect Route of Drug Administration: An Analysis of Spontaneous Reports of Medication Errors in Children and Adolescents from Germany.
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Domgörgen Severin, Kayser Claudia, Toni Irmgard, Ströbel Armin, Neubert Antje, Sachs Bernhardt, Dubrall Diana
Аннотация
BACKGROUND AND OBJECTIVE: Administering a drug unintentionally via an incorrect route, for example intravenously instead of orally, can lead to serious adverse drug reactions. Although individual cases of incorrect routes of drug administration (IRDA) in children and adolescents have been described in the literature, a systematic analysis of a larger number of cases is lacking. The aim of this exploratory study was to analyse unintentional IRDA errors related to chemically defined drugs in two spontaneous reporting databases focusing on the drugs, dosage forms, patients involved and the clinical consequences.
METHODS: In this exploratory study, spontaneous reports from the European adverse drug reaction database EudraVigilance and the medication error case collection of the Federal Institute for Drugs and Medical Devices (BfArM) were used. Reports on vaccines, desensitisation treatments and manipulated dosage forms were excluded. The National Coordinating Council for Medication Error Reporting and Prevention "Index for Categorizing Medication Errors Algorithm" was used to collect data on interventions, monitoring, clinical consequences and duration of impairment.
RESULTS: A total of 59 IRDA reports were identified across both databases. Within these reports, the most frequently identified IRDAs were intravenous instead of oral administration (22.0%), inhalation instead of oral administration (8.5%), and intramuscular instead of subcutaneous administration (8.5%). Most of the IRDAs led to temporary harm requiring interventions or hospitalisation. Liquid dosage forms were involved in 82.5% of the IRDA reports. Furthermore, a higher number of reports for infants (<1 year) [n = 13] compared with other age groups was found.
CONCLUSIONS: The findings may provide starting points for deriving measures to prevent IRDA errors. For example, liquid dosage forms may increase the risk of unintentional administration via the wrong route because they lack procedural barriers that prevent route switching. Nevertheless, given the relatively small number of reports, these findings should be considered exploratory and require further validation.
METHODS: In this exploratory study, spontaneous reports from the European adverse drug reaction database EudraVigilance and the medication error case collection of the Federal Institute for Drugs and Medical Devices (BfArM) were used. Reports on vaccines, desensitisation treatments and manipulated dosage forms were excluded. The National Coordinating Council for Medication Error Reporting and Prevention "Index for Categorizing Medication Errors Algorithm" was used to collect data on interventions, monitoring, clinical consequences and duration of impairment.
RESULTS: A total of 59 IRDA reports were identified across both databases. Within these reports, the most frequently identified IRDAs were intravenous instead of oral administration (22.0%), inhalation instead of oral administration (8.5%), and intramuscular instead of subcutaneous administration (8.5%). Most of the IRDAs led to temporary harm requiring interventions or hospitalisation. Liquid dosage forms were involved in 82.5% of the IRDA reports. Furthermore, a higher number of reports for infants (<1 year) [n = 13] compared with other age groups was found.
CONCLUSIONS: The findings may provide starting points for deriving measures to prevent IRDA errors. For example, liquid dosage forms may increase the risk of unintentional administration via the wrong route because they lack procedural barriers that prevent route switching. Nevertheless, given the relatively small number of reports, these findings should be considered exploratory and require further validation.