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ADRED – Adverse drug reactions (ADR) leading to emergency department (ED) visits: Causality analysis and preventability rate of the ADRs

ADRED – Adverse drug reactions (ADR) leading to emergency department (ED) visits: Causality analysis and preventability rate of the ADRs - ADRED

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00008979
Enrollment
9000
Registered
2017-01-11
Start date
2015-09-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Y57 T88.0

Interventions

Group 1: Four emergency treatment centers are involved in recruiting patients. In the participating emergency departments during the study period, all patients are reviewed for a causal treatment for

Sponsors

Forschungsabteilung BfArM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with adverse drug reactions (ADRs), which needed a treatment in an emergency department. In these cases, it comes to enrollment after positive causality assessment of ADRs by the physician. Age =18 years. Capacity to consent and written informed consent of the patient.

Exclusion criteria

Exclusion criteria: Patients treated in the emergency center without UAW by using home medication. (after causality assessment by a health professional in the emergency room). Intentional ingestion of inappropriate drugs or doses, by the patients themselves, which have led to the adverse effect (eg. As with suicidal intent). Age <18 years

Design outcomes

Primary

MeasureTime frame
Primary target is the occurrence of at least one avoidable ADRs (Adverse Drug Reaction) per patient, which have led to hospital emergency treatment. The classification of ADRs as avoidable (medication errors) is being edited with a work of score called Schumock et al. (1992).

Secondary

MeasureTime frame
1) Possible causes of preventable ADRs, which have led to hospital emergency treatment: Medication errors types and causes (eg. As dose omission, incorrect application form, wrong patient et cetera.) 2) Possible causes of non-preventable ADRs, which have led to hospital emergency treatment: • Patient-related factors (gender, age, comorbidity et cetera.) • Pharmacogenetic causes of ADRs 3) consequences of ADRs: • Clinical course and severity of the clinical consequences • number of deaths within the observation period • Pharmacoeconomic implications of ADRs / medication errors

Countries

Germany

Contacts

Public ContactMarlen Schurig

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)Abteilung Forschung

marlen.schurig@bfarm.de0228 99307 3572

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 1, 2026