Application of Safety Principles to Labeling, Packaging and Nomenclature Decisions Michael R. Cohen, RPh, MS, ScD, FASHP Institute for Safe Medication Practices Huntingdon Valley, PA 19006

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Application of Safety Principles to
Labeling, Packaging and Nomenclature
DecisionsMichael R. Cohen, RPh, MS, ScD,
FASHPInstitute for Safe Medication
PracticesHuntingdon Valley, PA 19006

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Medication Errors Reporting ProgramOperated by
theUnited States Pharmacopeia in
cooperationwith the Institute for Safe
Medication PracticesReport medication errors in
confidence1 800 23 ERRORwww.ismp.org/www.usp.or
g(USP and ISMP are FDA MEDWATCH partners)
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Failure analysis

• A systematic assessment of how and where
  pharmaceutical trademarks may be vulnerable to
  confusion
• Set up process flow diagram
• Determine failure modes
• Rank likelihood of occurrence, severity of
  outcome
• Where effects of errors are judged unacceptable,
  action may be taken to minimize potential for
  errors

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Consider the Process Flow

• Who purchases?
• Where stored?
• Who prescribes?
• Ordering process?
• handwritten, verbal, telephone, computer
• Where used?

• How does it get to site?
• Who administers?
• Who/how monitored?
• Who adjusts therapy?
• Recording of administration?
• Reordering?

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Factors to consider - trademark and
nonproprietary name

• Looks similar when handwritten?
• Sounds similar when spoken?
• Are suffixes confused with medical terminology?
• Product strengths similar?
• Typical dosing schedule similar? (e.g., frequency
  of use)
• Product dose (or dose range) similar?
• Dosage units similar?
• Route of administration similar?

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Factors to consider - trademark and
nonproprietary name

• Dosage form similar (e.g., tab, cap, etc.)?
• Clinical indications similar between new and
  established products?
• Product instructions similar (e.g., take on empty
  stomach, etc.)?
• Products likely to be stored near one another
  (e.g., both refrigerated, next to each other on a
  shelf, etc.)?
• Packaging similar or from the same company?
• Bad outcome if error happens?

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Package/Label

• Is the drug packaging similar to a current
  formulary product?
• Manufacturer trade dress
• Size/shape of package
• Expression of drug concentration/strength
• (per total volume vs. per mL)

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Package/Label

• Presence of problem elements
• Inadequate type size, spacing, placement
• Confusing or ambiguous terminology
• Distracting logo, symbols, icons
• Color scheme problem
• Potential for storage confusion
• Potential for dosing confusion

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Package/Label

• Readability
• Brand name (trademark)
• Generic name
• Storage information
• Expiration date
• Lot number
• Bar codes
• Other information

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High risk patient populations

• Patients with renal/liver impairment
• Pregnant/breast feeding patients
• Neonates
• Elderly/chronically ill
• Patients on multiple medications
• Oncology patients
• etc.

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Other issues

• Bar coding
• Computeriztion
• Unit dose
• Unit of use
• Patient education materials

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Other issues

• Bar coding
• Computeriztion
• Unit dose
• Unit of use
• Patient education materials

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Final Recommendations

• Practitioner input - testing
• Work with group purchasing organizations, and
  safety agencies
• Follow medication error prevention literature
• Address issues raised by practitioners and
  respond appropriately