Ignite Creation Date:
2024-05-06 @ 1:06 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01734642
Status:
UNKNOWN
Last Update Posted:
2012-11-29
First Post:
2012-11-21
Brief Title:
Observational Study to Reduce Medication Errors
Sponsor:
Universita di Verona
Organization:
Universita di Verona
Study Overview
Official Title:
A Regional Project to Reduce Adverse Drug Reactions Due to Medication Errors in Hospital
Status:
UNKNOWN
Status Verified Date:
2012-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSME
Brief Summary:
A medication error is a failure in the treatment process that leads to or has the potential to lead to harm to the patient1 Medication errors are a common unfortunate occurrence in hospital They can occur in different phases of the therapeutic process prescribing distribution administration and monitoring and have significant impact on morbidity and mortality Prescribing faults and prescription errors are major problem among medication errors Prescription errors account for 70 of medication errors that could potentially result in adverse drug effects2 Overall it has been estimated prescription errors affect 7 of medication orders 2 of patient days and 50 of hospital admissions34 When harm arises from a medication error it is potentially preventable The medication errors project was devised to analyze and limit through educational audit and other tools as much as possible damages due to the therapeutic process The project will include 5 phases Preliminary phase organizational meetings Phase I Patient monitoring a monitor in collaboration with health professionals of involved units will review all patient charts and will register all adverse drug reactionsADRs All ADRs will be introduced by the monitor in a database Health professional will be invited to send the reports of observed ADRs Evaluation of ADRs a panel of experts will evaluate if the ADRs are due to medication errors or not Phase II educational audits directed to health professionals will be organized Tools to reduce the medication errors will be proposed Phase III the same procedure of the first phase Final phase IV analysis of data with publication of a scientific article
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None