- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01280422
Analysis of Drug-drug Interaction Alert Based on Multicenter Clinical Database
The doctor's overridden rate for Drug-drug interaction (DDI) alert systems was 85-95% in foreign and there was more than 90% overridden rate in Taiwan. Why DDI alerts systems which spent much time and money to establish could not use medicinal information to increase drug safety? One of the reasons which induced to override was that health care thought there were too much DDI alerts and high false alerts.
The difference between DDI alert systems from pharmacists to confirm drug-drug interaction was that pharmacists not only confirmed ordering drug at the same time but also checked the other drug information such as frequency, rote and refill etc. Therefore, DDI alert systems which were established by drug code alone would induce a lot of false alerts.
In order to study how much false alert rate in drug-drug interactions, this research selected most common drug-drug interaction which was antacids and antibiotics. Antacids were most self-payment so this research needed to analyze ROCDR (Establishing a Multi-Center, Longitudinal, Research-Oriented Clinical Data Repository for Clinical Research). The aim was to study how many drug-drug interactions and false alerts from antacids and antibiotics and analyze the difference in different department. Finally, proposing advice and assessment for building drug-drug interaction alerts system to strength drug information system and increase drug safety.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Taipei, Taiwan
- Taipei Medical University - WanFang Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Select DDI rules: antacids and antibiotics
- Database: ROCDR (multicenter clinical database)
The pharmacists defined six rules which were based on medical knowledge for true alerts or false-alert.
- True alert: Rule 1 and Rule 2
- "False-alert": Rule 3 or Rule 4
- "Other" (Unable to determine): Rule 5 or Rule 6
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Yu-Chuan Li, Taipei Medical University WanFang Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 99009
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