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24/11/2017
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HIGH-RISK MEDICATIONS: HOW TO IMPROVE THE SAFETY ?
Pr Pascal BONNABRYHead of pharmacy
Pfizer BelgiumNovember 23, 2017
A simple story
Insuline – heparineStorage error (insuline → fridge)
Selection error (look-alike)
Control failure
Late clinical detection(hypoglycaemic coma or massive bleeding)
Potentially severe consequences for the patient
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The addition of 2 errors
Commission error AND Control failure
How errors occur ?
SelectionDilution
Calculation…
CheckDouble-check
…
Order of magnitude of dispensing errors by healthcare professionals ?
A. 0.01%
B. 0.1%
C. 1%
D. 10%
Quiz
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Order of magnitude of dispensing errors by healthcare professionals ?
A. 0.01%
B. 0.1%
C. 1%
D. 10%
Quiz - answer
74%
20%6%
Selection error
Repartition error
Counting error
Garnerin P, Eur J Clin Pharmacol 2007;63:769
Error rate = 3 %
Dispensing errors(simulation)
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n=500
mean = 114%
Atracurium Fentanyl Lidocaine Thiopental
Preparation errors(real-life)
Unused syringes in anaesthesiology>± 10%: 29% >± 50%: 8% >± 100%: 4%
Stucki C, Am J Health-Syst Pharm 2013;70:137
Performance of controls to catch errors ?Example: double-check of dispensed drugs ?
A. 70%
B. 85%
C. 95%
D. 99%
Quiz
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Performance of controls to catch errors ?Example: double-check of dispensed drugs ?
A. 70%
B. 85%
C. 95%
D. 99%
Quiz - answer
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
Limited performance of controls
Efficacy ≈ 85%(known value in the industry)
Do not be too confident with double-checks !
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“We cannot change the human condition,
but we can change the conditions under
which humans work.”
James Reason
“We cannot change the human condition,
but we can change the conditions under
which humans work.”
James Reason
Implement strategies to
How to improve the safety ?
Reduce the frequencyof errors
Increase the reliabilityof controls
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1. Avoid reliance on memory2. Simplify3. Standardize4. Use constraints and forcing functions5. Use protocols & checklists wisely6. Improve information access7. Reduce handoffs8. Increase feedback
Human factors principles to progress
http://www.who.int/patientsafety/research/online_course/en/
• Technology• Constraints• Forcing functions
High
• Standardisation• Redundancies• Check-lists
Medium
• Procedures• Education• Vigilance
Low
Hierarchy of risk reductionstrategies
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« Medications that bear a heightened risk of causing significant harm to individuals whenthey are used in error »
The Joint Commission
« Medications that bear a heightened risk of causing significant harm to individuals whenthey are used in error »
The Joint Commission
High-risk medicationHigh-risk medication
High-risk medication: list
www.ismp.org
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High-risk medications: short list
10 drugs responsible for 73% of deaths
Saedder E, Eur J Clin Pharmacol 2014;70:637
Review, 135 publications
Numerous actors & guidelines
2006-20082004-2006
… and many others
2008-2010
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Self-assessment tools
www.ismp.org www.cec.health.nsw.gov.au
Self-assessment tools: Switzerland
Drug selection / procurement
Logistics / stock management
Drug information
Prescription
Preparation/Administration
Monitoring
Education
Risk management
www.gsasa.ch > Qualité&Sécurité > Parenteralia Self Assessment Tool (PSAT)
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Self-assessment tools: Switzerland
www.gsasa.ch > Qualité&Sécurité > Parenteralia Self Assessment Tool (PSAT)
General principles to reduce harm
www.ihi.orgHow –to guide: prevent harm from high-alert medications
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General principles to reduce harm
www.ihi.orgHow –to guide: prevent harm from high-alert medications
General principles to reduce harm
www.ihi.orgHow –to guide: prevent harm from high-alert medications
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Define improvement objectives
Never eventsError during the management of anticoagulant treatments
Error during the administration of iv potassium
Insulin administration error
Oral methotrexate administration frequency error
Intrathecal administration of intravenous drugs
Infusion pumps programming error
...
www.ansm.sante.fr
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Concrete actionsPackaging design
Tall man letters
www.ismp.org
Concrete actionsDrug selection
List of critical drugs – risk analysis
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Concrete actionsStorage
Limit the storage(concentrated electrolytes)
Ideally, concentrated solutions of electrolytes must beremoved from wards
If not possible (i.e. intensive care), they must be storedexclusively in well identified locked rooms
The exchange of electrolytes between wards must beforbidden
…
Quick-alert N°13, 2010
BUT…Efficacy demonstrated ?
Realistic in practice ?
Workarounds ?
BUT…Efficacy demonstrated ?
Realistic in practice ?
Workarounds ?
Concrete actionsPrescription
Order-sets - anticoagulants
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Concrete actionsPrescription
Clinical pharmacy
www.easystem.eu/pharmaclass-prevenir-iatrogenie-medicamenteuse-evitable
Pharmaclass®
Prioritize interventions of clinicalpharmacists by selecting high-risk patients/medicationsImplement rules in a system connected to the electronic patient record:
Drug prescriptionsDiagnosticsLabsDemographic data...
Concrete actionsPreparation
Standardized dilutions and labelling
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Concrete actionsPreparation
Ready-to-administer – injectables (CIVAS)
Suxamethonium Diluted potassium
In-house production → Sub-contracting → Commercialisation
Concrete actionsPreparation
Ready-to-administer – oral forms
Morphine solution
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Concrete actionsAdministration
Check-list (cytotoxics)
0
25
50
75
100
No help Check-listn=62
Mean[IC 95%]
R. Balbaaki, HUG, 2006
86.4% 98.6%
Concrete actionsInformation technologies
Logisticinformation
system
EDI
Centralpharmacy
stock
Industrystock
Wardstock
Automateddispensing cabinets
Bedsidescanning
Robotizeddistribution
CPOE
Distribution with scanning
Clinicalinformation
system
Smart Pumps
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Heparin
Oral methotrexate
Heparin
Oral methotrexate
Examples of specific actionsExamples of specific actions
Main risks (22 identified)Using unverified patient weights to calculate dose
Miscalculating the dose or infusion rate
Preparing heparin infusion incorrectly
Mix-up between different concentrations
Programming the infusion pump incorrectly
…
www.ismp.org/NEWSLETTERS/acutecare/articles/20100408.asp
Heparin
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HeparinPrescription
Weight rangesNo calculationWeight rangesNo calculation
Weight from electronic recordUp-to-date information
Weight from electronic recordUp-to-date information
CPOEComplete and univoque
CPOEComplete and univoque
HeparinPreparation RTU vial
No dilutionRTU vial
No dilution
Differentiation from insulinSTOP look-alike
Differentiation from insulinSTOP look-alike
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HeparinAdministration
Rate based on the prescription rangeNo calculation
Rate based on the prescription rangeNo calculation
Oral methotrexate
www.nrls.npsa.nhs.uk/resources/?entryid45=59800
Error in administration frequency
Inadequate packaging (e.g. number of tablets, identification of dosages)
Confusion with folic acid (look-alike)
Failure in adequate monitoring
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Oral methotrexate
UK: 137 related events, 25 deaths (2004)
NHS, Towards the safer use of oral methotrexate, 2004
Oral methotrexatePrescription
A single frequencyNo 1x/day prescription
A single frequencyNo 1x/day prescription
Pop-up alertProvide information
Pop-up alertProvide information
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Oral methotrexateDispensing
Commercial 100 cpr Reconditioned 4 cpr
Warning 1/weekNurse informationWarning 1/week
Nurse information
Max 1 month treatmentOnly 4 days in case of error
Max 1 month treatmentOnly 4 days in case of error
Nominative dispensationCatch error after 4 daysNominative dispensationCatch error after 4 days
Oral methotrexatePatient information
https://pharmacie.hug-ge.ch/infomedic/utilismedic/metho_infopat.pdf
Warning 1/weekPatient information
Warning 1/weekPatient information
Side effectsPatient information
Side effectsPatient information
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Supporting tools are neededSupporting tools are needed
• Culture & knowledge: education
• Proactive: risk analysis (FMECA)
• Reactive: incident declaration and investigation
• Follow-up: indicators (audit, Trigger tool)
• Culture & knowledge: education
• Proactive: risk analysis (FMECA)
• Reactive: incident declaration and investigation
• Follow-up: indicators (audit, Trigger tool)
Which strategies are you actually following ?
A. Separate storage / identification of high-risk medications
B. Protocols / guidelines for prescription
C. Protocols / guidelines for administration
D. Specific education for healthcare workers
E. Standardization of dilution and labelling
F. Ready-to-use injectables
G. Information technologies
Quiz
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Take home messages
High-risk medication are responsible for the majority of serious incidentsMany recommendations are existing but theirimpact is seldom rigourously evaluatedRobust / high impact measures must beprioritizedEach hospital has to determine a strategicroadmap, with a continuous evolution over time
Like a spiderweb…… it has to be built progressively …
… to reduce the risk of an error passing through
Like a spiderweb…… it has to be built progressively …
… to reduce the risk of an error passing through
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THANK YOU FOR YOUR ATTENTION
Hospital pharmacists must be strongly involved in the implementation of solutions to improve the safetyof high-risk medications
Hospital pharmacists must be strongly involved in the implementation of solutions to improve the safetyof high-risk medications
