Medication Administered in Error Clinical Trial
Official title:
Effect of Bar-code-assisted Medication Administration on Medication Error Rates: a Controlled Randomized Multicentre Trial
Serious medication administration errors are common in hospitals. Various interventions were
developed to help prevention of such errors such as bar-code technology. Investigators aimed
to study the effect of bar-code-assisted medication administration (BCMA) system on the rate
of medication errors in two hospitals.
They will conduct a randomized controlled trial in 6 care units of two hospitals in Paris,
France. Each unit will be randomized in either the control group or the intervention group
using the bar-code system to help drug administration. The observation method will be used to
evaluate the error rates in the 2 groups at baseline and when BCMA will be implanted. Nurses
of the unit will be randomized to determine who will be observed during the administration
rounds.
Considering the results of a passed observational study in 4 units (Berdot, BMC Health Serv
Research 2012) and the results of the study by Poon and al. (NEJM 2010), investigators
estimated that 5.981 TOE (Total Opportunities for Errors) are needed to detect a relative
reduction of 45% of error rate.
The ADIM system (Aide a la Distribution Informatisee des Medicaments) consists of 2 machines
with photographic reconnaissance and readers: one for preparation assistance that can be
placed at the pharmacy or in the clinical service and one to assist the administration by the
nurse in the clinical service.
The system ADIM preparation consists of a working area with 2 reader devices (a RFID reader
and a bar code reader) and a touch screen . It allows selection from the list of patients,
the patient's prescription for which the preparation will be made. It is linked to the drug
data base.
The system ADIM administration is composed of a laptop with touch screen, 2 readers (a RFID
reader and a barcode reader) , the elements needed to care and a work plan and drawers
containing unit dose drugs for patients for a specific nurse. The nurse scans her/his badge,
the patient's wristband and each dose administered and prepared by the pharmacy. If the dose
is not prepared by the pharmacy, the nurse takes the dose in the automat cabinet. The nurse
scans the drug's barcode or select on the touch screen the drug and the required dose of the
drug. In case of discrepancy with the prescription, there is a visual alert. However, the
alert can be override by the nurse if she/he gives a justification.
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