- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04523259
Compatibility Problems and Prescribing Pattern of Injectable Drugs at the Hospital
Drug safety is always a national, as well as international, patient safety goal. Administration of injection, especially intravenous infusion, is an extremely complicated and dangerous process, which includes reconstitution, dilution, selection of diluent and volume, verification of concentration of final solution, check for stability, sterility and compatibilities, and the selection of intravenous (IV) set, peripheral or central route, and the rate of infusion. Due to its inherent complexity, errors occur easily during these procedures. Literatures indicated that the incidence of injection administration errors ranged from 13% to 84%, which included errors in dosage, diluents, and volumes; excessive administration rate; and incompatible IV admixture.
In the U.S.A., pharmacists provide comprehensive clinical services. They ensure the appropriateness of every step in the process from prescription and dosage verification, drug reconstitution and dilution, selection of diluents and concentration, to the rate of administration. Even more, they provide the final IV products that are ready to administer to the patients (IV admixture services). Therefore, many common administration errors can be avoided. In Taiwan, nevertheless, pharmacists have limited role in IV services due to our health-care system. There are no studies on the administration pattern of injections. There is still room for improvement in the assurance of injection safety.
To ensure the safety of injection, we not only have to oversee the accuracy of drugs and dosage, but also take the compatibilities among drugs and diluents seriously.
Because diluent is not a mandatory claim data, the National Health Insurance data base cannot provide the related information for drug compatibility epidemiology study. The application for reimbursement of injections is based on total amount used instead of daily usage; it is therefore difficult to find drug incompatibility problems in this data base. Hospital data base analysis, questionnaire survey and chart review are more feasible for such study.
This study will analyze the prescriptions of IV injection in the intensive-care units and pediatric units to determine the prescribing pattern. High risk IV admixtures and Y-site administrations will be explored by questionnaire survey and literature review. Laboratory experiments will be done on some indicator drugs to find the reasons, categories and severities of the compatibilities. A list of incompatible drugs shall be generated for computerized intervention. We hope the results of the study can be used as a reference for guideline, policy and procedure for health care system and government.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- nurses
Exclusion Criteria:
- not nurses
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug incompatibility assessed by questionnaire survey
Time Frame: 6 months
|
IV admixture
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Taiwan National Taiwan University Hospital, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 200911016R
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on IV Injection
-
The University of Texas Health Science Center,...ZARS Pharma Inc.UnknownPain on Propofol IV InjectionUnited States
-
The University of Texas Health Science Center,...CompletedPain on IV Injection of Propofol.United States
-
Keimyung University Dongsan Medical CenterCompletedIntravascular InjectionKorea, Republic of
-
Jeffrey Alan Klein, MDNot yet recruitingAnesthesia, Local | Injection Site Irritation | Injection Site Discomfort | Injection Site Bruising | Benzoic Acid Adverse ReactionUnited States
-
Galderma R&DCompletedInjection TechniquesSweden
-
Keimyung University Dongsan Medical CenterCompletedIntravascular InjectionKorea, Republic of
-
Erevna Innovations Inc.Completed
-
Microdermics Inc.CompletedIntradermal InjectionCanada
-
Kyungpook National University Chilgok HospitalRecruitingS1 Transforaminal Epidural InjectionKorea, Republic of
-
Chang Gung Memorial HospitalRecruiting