24/11/2017
HIGH-RISK MEDICATIONS:
HOW TO IMPROVE THE SAFETY ?
Pr Pascal BONNABRY Pfizer Belgium
Head of pharmacy November 23, 2017
A simple story
Insuline – heparine
Storage 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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How errors occur ?
The addition of 2 errors
Commission error AND Control failure
Selection
Dilution Check
Calculation Double-check
… …
Quiz
Order of magnitude of dispensing errors by
healthcare professionals ?
A. 0.01%
B. 0.1%
C. 1%
D. 10%
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Quiz - answer
Order of magnitude of dispensing errors by
healthcare professionals ?
A. 0.01%
B. 0.1%
C. 1%
D. 10%
Dispensing errors
(simulation)
Error rate = 3 %
6%
20%
74%
Selection error
Repartition error
Counting error
Garnerin P, Eur J Clin Pharmacol 2007;63:769
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Preparation errors
(real-life)
Unused syringes in anaesthesiology
>± 10%: 29% >± 50%: 8% >± 100%: 4%
n=500
mean = 114%
Atracurium Fentanyl Lidocaine Thiopental
Stucki C, Am J Health-Syst Pharm 2013;70:137
Quiz
Performance of controls to catch errors ?
Example: double-check of dispensed drugs ?
A. 70%
B. 85%
C. 95%
D. 99%
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Quiz - answer
Performance of controls to catch errors ?
Example: double-check of dispensed drugs ?
A. 70%
B. 85%
C. 95%
D. 99%
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
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
How to improve the safety ?
Implement strategies to
Increase the reliability
of controls
Reduce the frequency
of errors
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Human factors principles to
progress
1. Avoid reliance on memory
2. Simplify
3. Standardize
4. Use constraints and forcing functions
5. Use protocols & checklists wisely
6. Improve information access
7. Reduce handoffs
8. Increase feedback
http://www.who.int/patientsafety/research/online_course/en/
Hierarchy of risk reduction
strategies
• Technology
High • Constraints
• Forcing functions
• Standardisation
Medium • Redundancies
• Check-lists
• Procedures
Low • Education
• Vigilance
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High-risk medication
« Medications that bear a heightened risk of
causing significant harm to individuals when
they are used in error »
The Joint Commission
High-risk medication: list
www.ismp.org
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High-risk medications: short list
10 drugs responsible for 73% of deaths
Review, 135 publications
Saedder E, Eur J Clin Pharmacol 2014;70:637
Numerous actors & guidelines
2004-2006 2006-2008
2008-2010
… and many others
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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.org
How –to guide: prevent harm from high-alert medications
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General principles to reduce harm
www.ihi.org
How –to guide: prevent harm from high-alert medications
General principles to reduce harm
www.ihi.org
How –to guide: prevent harm from high-alert medications
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Define improvement objectives
Never events
Error 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 actions
Packaging design
Tall man letters
www.ismp.org
Concrete actions
Drug selection
List of critical drugs – risk analysis
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BUT…
Concrete actions Efficacy demonstrated ?
Storage Realistic in practice ?
Workarounds ?
Limit the storage
(concentrated electrolytes)
Ideally, concentrated solutions of electrolytes must be
removed from wards
If not possible (i.e. intensive care), they must be stored
exclusively in well identified locked rooms
The exchange of electrolytes between wards must be
forbidden
…
Quick-alert N°13, 2010
Concrete actions
Prescription
Order-sets - anticoagulants
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Concrete actions
Prescription
Clinical pharmacy
Prioritize interventions of clinical
pharmacists by selecting high-
risk patients/medications
Implement rules in a system
connected to the electronic patient
record:
Drug prescriptions
Diagnostics
Labs
Pharmaclass® Demographic data
...
www.easystem.eu/pharmaclass-prevenir-
iatrogenie-medicamenteuse-evitable
Concrete actions
Preparation
Standardized dilutions and labelling
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Concrete actions
Preparation
Ready-to-administer – injectables (CIVAS)
Suxamethonium Diluted potassium
In-house production → Sub-contracting → Commercialisation
Concrete actions
Preparation
Ready-to-administer – oral forms
Morphine solution
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Concrete actions
Administration
Check-list (cytotoxics)
Mean 86.4% 98.6%
[IC 95%] 100
75
50
25
0
n=62 No help Check-list
R. Balbaaki, HUG, 2006
Concrete actions
Information technologies
Automated
Robotized dispensing cabinets
distribution
CPOE
EDI Clinical
information
Industry Central Ward system
stock pharmacy stock
stock
Logistic
information
system Bedside Smart
Distribution scanning Pumps
with scanning
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Examples of specific actions
Heparin
Oral methotrexate
Heparin
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
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Weight ranges
Heparin No calculation
Prescription
Weight from electronic record
Up-to-date information
CPOE
Complete and univoque
Heparin
Preparation RTU vial
No dilution
Differentiation from insulin
STOP look-alike
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Heparin
Administration
Rate based on the prescription range
No calculation
Oral methotrexate
Error in administration frequency
Inadequate packaging (e.g. number of
tablets, identification of dosages)
Confusion with folic acid (look-alike)
Failure in adequate monitoring
www.nrls.npsa.nhs.uk/resources/?entryid45=59800
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Oral methotrexate
UK: 137 related events, 25 deaths (2004)
NHS, Towards the safer use of oral methotrexate, 2004
Oral methotrexate A single frequency
No 1x/day prescription
Prescription
Pop-up alert
Provide information
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Oral methotrexate Warning 1/week
Dispensing Nurse information
Max 1 month treatment
Only 4 days in case of error
Nominative dispensation
Catch error after 4 days
Commercial 100 cpr Reconditioned 4 cpr
Oral methotrexate
Patient information
Warning 1/week
Patient information
Side effects
Patient information
https://pharmacie.hug-ge.ch/infomedic/utilismedic/metho_infopat.pdf
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Supporting tools are needed
• Culture & knowledge: education
• Proactive: risk analysis (FMECA)
• Reactive: incident declaration and investigation
• Follow-up: indicators (audit, Trigger tool)
Quiz
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
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Take home messages
High-risk medication are responsible for the
majority of serious incidents
Many recommendations are existing but their
impact is seldom rigourously evaluated
Robust / high impact measures must be
prioritized
Each hospital has to determine a strategic
roadmap, with a continuous evolution over time
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 safety
of high-risk medications
[email protected]
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