title: 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.
  
  
  METHODS
  A simulation-based learning program focusing on investigational drug dispensing was conducted.
  
  
  METHODS
  The study was undertaken in an Investigational Drugs Dispensing Unit of a University Hospital of Lyon, France.
  
  
  METHODS
  Sixty-three pharmacy workers (pharmacists, residents, technicians or students) were enrolled.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Cecile
authors.initials: C
authors.lastname: Dollinger
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Vérane
authors.initials: V
authors.lastname: Schwiertz
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France Université Lyon 1, EMR UCBL/HCL 3738, Lyon, France.
authors.forename: Laura
authors.initials: L
authors.lastname: Sarfati
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Chloé
authors.initials: C
authors.lastname: Gourc-Berthod
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Marie-Gabrielle
authors.initials: MG
authors.lastname: Guédat
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Céline
authors.initials: C
authors.lastname: Alloux
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Vantard
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Noémie
authors.initials: N
authors.lastname: Gauthier
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: He
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Elena
authors.initials: E
authors.lastname: Kiouris
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Anne-Gaelle
authors.initials: AG
authors.lastname: Caffin
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Delphine
authors.initials: D
authors.lastname: Bernard
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France Université Lyon 1, EMR UCBL/HCL 3738, Lyon, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Ranchon
authors.affiliation: Clinical Oncology Pharmacy Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre Bénite, France Université Lyon 1, EMR UCBL/HCL 3738, Lyon, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Rioufol
mesh_terms: D003198:Computer Simulation; D004348:Drug Labeling / Q000706:statistics & numerical data*; D015507:Drugs, Investigational / Q000008:administration & dosage*; D005602:France; D006785:Hospitals, University; D006801:Humans; D008508:Medication Errors / Q000706:statistics & numerical data*; D008510:Medication Systems, Hospital / Q000458:organization & administration* / Q000592:standards / Q000706:statistics & numerical data*; D010595:Pharmacists / Q000706:statistics & numerical data; D064172:Pharmacy Residencies / Q000706:statistics & numerical data; D010596:Pharmacy Technicians / Q000706:statistics & numerical data; D012307:Risk Factors; D013339:Students, Pharmacy / Q000706:statistics & numerical data; D013997:Time Factors
chemical_list: D015507:Drugs, Investigational
keywords: investigational drugs; medication error; simulation