SIMulation of Medication Error induced by Clinical Trial drug labeling: the SIMME-CT study

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 outcome measure: 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.

Keywords: investigational drugs; medication error; simulation.