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Global Patient Safety Considerations
with Pharmaceutical Product
Labeling Michael R Cohen
Institute for Safe Medication PracticesChairperson, International Medication Safety Network
www.intmedsafe.net
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Some important labeling and packaging problems
Dangerous abbreviationsLook-alike labelingInconsistent and unclear expression of strengthCluttered labelingHighly stylized label graphics
Overemphasis on company name and logosLack of contrast on glass ampulsInadequate prominence of reminders and warnings
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Dangerous abbreviations and dose designations
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New Zealand
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Look alike labeling
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Belize
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Canada
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United KingdomOral Generics
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Latin America - Colombia
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Australia
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Denmark
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Contrast on glass ampuls
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Spain
Note lack of label background – no contrast upon dark background
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Australia
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Serious medication errors with ampules of bupivacaine and tranexamic acid
• https://www.ejmanager.com/mnstemps/83/83-1444637751.pdf• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3371494/• https://www.apsf.org/newsletters/html/2010/spring/02_inject.htm• https://dokumen.tips/documents/01-danger-of-wrong-drug-administration-during-
subarachnoid-blockpdfpdfcompressor.html
Ampule labeling
Germany
Label position on ampuls and syringes
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US ampul label for comparison
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Readability of information on polypropylene ampules
New Zealand
Germany
Label position on ampuls and syringes
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US ampul label for comparison
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Expression of concentration and strength
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United States
Before and after – both are same strength
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USA
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Singapore
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New Zealand
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French label above
Spain
United Kingdom
France and French speaking African country
Greece
Spain
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How much heparin?
IU
Bar code?
Heparin in title is per liter while other heparin mention and electrolytes are per 500 mL
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Units not standardized to mEq or mmol
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Label reminders and warnings; communication of
important information
Neuromuscular Blockers
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New Zealand
Unknown Country
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Why warning paralyzing agent on US and Canadian labels only?
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Neuromuscular Blocker look-alike New Zealand
USA and Canada Neuromuscular Blocker
![DPD Colorimetric Testing for Chlorine Using vacuum ampuls ...Analyzing a Sample Absorbance The adjusted absorbances are the only values that are used in calculations. [.065] = .522974(x)](https://img.dokumen.tips/doc/110x75/5ed028af3dba1418324266fb/dpd-colorimetric-testing-for-chlorine-using-vacuum-ampuls-analyzing-a-sample.jpg?t=1686371092)
