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Use of barcodes to improve the medication process in the hospital
Prof. Pascal BONNABRY
Ljubljana, October 26, 2009
Slovenian Pharmaceutical Society
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
To err is humanUSA
• Serious adverse events in≈ 3% [2.9-3.7%] of hospitalizations
• ≈ 10% [8.8-13.6%] of adverse events led to death
• Extrapolation: 44’000 to 98’000 deathseach year in the USA (medication errors: 7’000)!
• 8th leading cause of death(motor vehicle accidents 43’500, breast cancer 42’000, AIDS 16’500)
Equivalent of a BOEING 747 crash every 2 days...
To err is human, IOM, 1999
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Counterfeit drugs
Source: Bobée JM, Sanofi-Aventis, 2009
% counterfeit drugs≈50 % of drugs illegally buyon the internet are counterfeit
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Potential interests of IT
• To improve• The safety
by improving the reliability of controls• five “R”
• authentication of drugs
• The traceabilityby facilitating the registration of logs
• The efficiencyby increasing the working performance
• The communicationby connecting the different steps of the processes
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Human reliability
« On the 6th day, God created man … »
… but God was tired, and hiscreation was not perfect …
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
The addition of two errors
Commission error AND Control failure
SelectionCalculationCounting
CheckDouble-check
Check-listElectronic
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Limited performance of controls
• Introduction of errors during unit dose dispensing
• Detection ability during human-performed control:
• Pharmacists: 87.7%• Nurses: 82.1%
Facchinetti NJ, Med Care 1999;37:39-43
Efficiency ≈ 85%(known value in the industry)
Do not be too confident with the double-checks !
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
The medication process
Pharmacy stock
Industry stock
Production stock
Raw-materialsanalysisProductionEnd-product
analysis
Ward stock
Prescription
Dispensation Production
Physical flowInformation flow
EPR
CytosTPNMP
Administrationto patients
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Electronic systemsto catch errors
Pharmacy stock
Industry stock
Production stock
Raw-materialsanalysisProductionEnd-product
analysis
Ward stock
Prescription
Dispensation Production
Physical flowInformation flow
EPR
CytosTPNMP
Administrationto patients
( )
Delivery
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Electronic systemsto avoid errors
Pharmacy stock
Industry stock
Production stock
Raw-materialsanalysisProductionEnd-product
analysis
Ward stock
Prescription
Dispensation Production
Physical flowInformation flow
EPR
CytosTPNMP
Administrationto patients
EDI
CPOE
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
• Error rate during manual distribution = 1 %
Pharmacy stockDistribution errors
Gschwind L, HUG, 2006
24%
21%55%
Count
OmissionSelection
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
• The consequences can be dramatic
Pharmacy stockDistribution errors
Le Monde, 3 janvier 2009
Paris, december 2008 A kid death associated to a distribution error of a drug
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
• Stock entry• Product ID location ID validation in software
Pharmacy stockManagement with barcodes
B. Hirschi, CHUV, 2009
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
• Stock exit• Product ID quantity validation in software
Pharmacy stockManagement with barcodes
B. Hirschi, CHUV, 2009
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Pharmacy stockImpact of barcoding on adverse drug events
Churchill WW, Brigham and Women’s Hospital, Boston
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Traceability of delivery
• Cold chain / narcotics• RFID delivery man barcode delivery sheet RFID nurse
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
DispensationError rates
• Nurses• 3,0 % dispensation errors• Control not tested
36%
35%
21%8%
Wrong drugWrong dosageWrong formOthers
• Pharmacy• 3,6 % dispensation errors• 79% detected during control
74%
20%6%
Selection error
Repartition error
Counting error
Selection errors ≈ 2%
Garnerin Ph, Eur J Clin Pharmacol 2007;63:769 Cina JL, Jt Comm J Qual Patient Saf 2006;32:73
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
DispensationAutomation
Barcodes are needed to secure the process
Centralised Decentralised
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
DispensationImpact on error rates
C. Du Pasquier, L. Riberdy, HUG, 2003
0
0.5
1
1.5
2
2.5
3
Erro
r rat
e [%
]
Total Omission Selection Counting Repartition
without Pyxiswith Pyxis
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
• 19% errors
Administration to patientsError rates
Observation study in 36 institutions Barker KN, Arch Intern Med 2002;162:1897
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Administration to patientsObjectives of bedside scanning
• Increase patient safety
• Increase patient satisfaction(safety feeling)
• Increase efficiency(documentation, stock management, billing,…)
• Increase nurses satisfaction
• Reduce costs(especially related to errors)
Foote SO, Nursing Economics 2008;26:207
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Administration to patientsBenefit of bedside scanning
• Positive impact
• Wrong drug - 75%
• Wrong dose - 62%
• Wrong patient - 93%
• Wrong administration time - 87%
Globally - 80%
Johnson, J Healthcare Inf Manag 2002;16:1
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Administration to patientsBenefit of bedside scanning
Dean B, Qual Saf Health Care 2007;16:279
• CPOE + Barcoding in surgical ward• Prescribing errors: 3.8 2 %
• Patient identity checked: 17 81 %
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Administration to patientsCytostatics
Database
Drug
Patient
NursePhysicians
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
ProductionWeighing system
• Cytostatics – CATO®
• Direct calculation from the prescription• Operator guided step by step• Weighing control• Identity control by barcode
(version 2)• Traceability
www.cato.eu
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
ProductionWeighing system
• Batch production
Computerizedprotocols
Weighing
Identity / validityof raw material
Final productIdentity, batch expiry dateOperator identity
Raw materialidentityexpiry date
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
ProductionTraceability
• Cytostatics
Who ?What ?When ?
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
ProductionTraceability
• Batch production
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Prerequisite to successfulscanning
• Electronic management of processes (CPOE, stocks, …)
• Technical infrastructure (hard-, soft-)
• Actors identification (caregivers, patients, drugs)
• Acceptability (patients, caregivers)
• Adaptation to processes
• Project leadership
• Financing
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Electronic patient record
Handwritten → electronic traceability
C. Lovis, HUG
CPOE
Laboratory
Radiology
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Global process management
Prescription and electronic patient record Bedside scanning
Automation of dispensation
RetranscriptionX
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Global process managementCytostatics
Electronicprescription
Bedsidescanning
Preparation withweighing control
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Actors identification
The patient
The caregiver
The drugIdentification ?
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Actors identification
The patient
The caregiver
The drug
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Acceptability by patients
Cléopas A, Qual Saf Health Care 2004;13:344
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Acceptability by caregivers
MAS-NAS = Medication Administration System – Nurses Assessment of Satisfaction
Likert scale 1 - 6 [max satisfaction] Hurley AC, JONA 2007;37:343
• Nurses satisfaction
+ 1 point on a 6 point likert scale
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Adaptation to processes
• Reasons for workaround• Process
• Training requirements• Process flow (administration of drug before scanning, shortage of time)
• Technology• Hardware (performance of scanners)
• Software (delays in response)
• Barcode (difficulties in reading)
• Resistance• Communication• Changing role• Negative perception of IT
Van Onzenoort HA, Am J Health-Syst Pharm 2008;65:644Nanji KC, J Am Med Inform Assoc 2009;16:645
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Drug identification
Unit dose
Secondary package
Hospital package
• Hierarchy
GS1 = international standard
Box
Pallet
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Unit dose identification
Reconditionedby the pharmacy
Identifiedby the industry
?
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Unit doses identification
Panadol 500 mgparacétamol
n°lot 420607Exp. 08.2009
SafetyID product(minimal)
Easily human readable
TraceabilityBatch numberExpiry date(ideal)
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Unit dose identificationUSA - FDA
• Product identification mandatory(batch number and expiry date encouraged)
• Mandatory since April 26, 2006
• Prevention of 500’000 adverse events / year ?
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Unit dose identificationUSA - FDA
• Adoption of barcode medication administration
Schneider PJ, Am J Health-Syst Pharm 2007;64:S10
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Unit dose identificationEurope - EAHP
• Unit doses blisters, with each single dose containing the wholeinformation• Trade name• Active substance• Dosage• Expiry date• Batch number• Barcode
• Including product ID, expiry date and batch number• Use of a recognized international standard (i.e GS1)• Datamatrix
EAHP, 2007
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Secondary package
SafetyID product(minimal)
TraceabilityBatch numberExpiry date(Serial number)(ideal)
EAN-13
or
GS1-128 Datamatrix
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Data carrier
Linear barcode
Datamatrix
RFID
Number of information
Limited space
Distance of lecture
Active storage of information(i.e. temperature)
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Conclusion
• Barcoding can improve the safety and the traceability of drug use at each step of the process
• The implementation requires• an exhaustive identification of drugs without reducing the human
readability (industry)• the development of information technologies in the medication
process (hospital)
• Each institution should define the room for such technologies and set priorities
• The implementation is a real challenge and resources must be dedicated to these projects
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Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Perspective
• Will we be able to be as effective as supermarkets?
Pascal BONNABRY Barcoding in the hospital, October 26, 2009
Thank you for your attention
This presentation can be downloaded:
http://pharmacie.hug-ge.ch/ens/conferences.html