Y57 T88.0
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)Abteilung Forschung