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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