- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- nurses
Exclusion Criteria:
- not nurses
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Drug incompatibility assessed by questionnaire survey
Tidsramme: 6 months
|
IV admixture
|
6 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Taiwan National Taiwan University Hospital, National Taiwan University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 200911016R
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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