SIMulation of Medication Error induced by Clinical Trial drug labeling: the SIMME-CT study.
Int J Qual Health Care
; 28(3): 311-5, 2016 Jun.
Article
en En
| MEDLINE
| ID: mdl-26976831
ABSTRACT
OBJECTIVE:
To assess the impact of investigational drug labels on the risk of medication error in drug dispensing.DESIGN:
A simulation-based learning program focusing on investigational drug dispensing was conducted.SETTING:
The study was undertaken in an Investigational Drugs Dispensing Unit of a University Hospital of Lyon, France.PARTICIPANTS:
Sixty-three pharmacy workers (pharmacists, residents, technicians or students) were enrolled. INTERVENTION Ten risk factors were selected concerning label information or the risk of confusion with another clinical trial. Each risk factor was scored independently out of 5 the higher the score, the greater the risk of error. From 400 labels analyzed, two groups were selected for the dispensing simulation 27 labels with high risk (score ≥3) and 27 with low risk (score ≤2). Each question in the learning program was displayed as a simulated clinical trial prescription. MAIN OUTCOMEMEASURE:
Medication error was defined as at least one erroneous answer (i.e. error in drug dispensing). For each question, response times were collected.RESULTS:
High-risk investigational drug labels correlated with medication error and slower response time. Error rates were significantly 5.5-fold higher for high-risk series. Error frequency was not significantly affected by occupational category or experience in clinical trials.CONCLUSIONS:
SIMME-CT is the first simulation-based learning tool to focus on investigational drug labels as a risk factor for medication error. SIMME-CT was also used as a training tool for staff involved in clinical research, to develop medication error risk awareness and to validate competence in continuing medical education.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Drogas en Investigación
/
Etiquetado de Medicamentos
/
Errores de Medicación
/
Sistemas de Medicación en Hospital
Tipo de estudio:
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
Int J Qual Health Care
Asunto de la revista:
SERVICOS DE SAUDE
Año:
2016
Tipo del documento:
Article
País de afiliación:
Francia