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

Recruiting

• Conditions: Y57; T88.0; Other and unspecified drugs and medicaments; Infection following immunization

• Registration Number: DRKS00008979
• Lead Sponsor: Forschungsabteilung BfArM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 9000

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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