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Analysis of Drug-drug Interaction Alert Based on Multicenter Clinical Database

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ClinicalTrials.gov Identifier: NCT01280422
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : January 20, 2011
Information provided by:

Study Description
Brief Summary:

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.

Condition or disease
Drug Interaction Alert

Study Design

Study Type : Observational
Actual Enrollment : 67128927 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Analysis of Drug-drug Interaction Alert Based on Multicenter Clinical Database
Study Start Date : February 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

    1. True alert: Rule 1 and Rule 2
    2. "False-alert": Rule 3 or Rule 4
    3. "Other" (Unable to determine): Rule 5 or Rule 6

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280422

Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Principal Investigator: Yu-Chuan Li Taipei Medical University WanFang Hospital
More Information

Responsible Party: Yu-Chuan Li, Department of Dermatology, WanFang Hospital
ClinicalTrials.gov Identifier: NCT01280422     History of Changes
Other Study ID Numbers: 99009
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: January 20, 2011
Last Verified: January 2011

Keywords provided by Taipei Medical University WanFang Hospital: