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Labeling of LDPE Containers: Options for Improving Identification for Prevention of Medication Errors Rick Schindewolf P

Labeling of LDPE Containers: Options for Improving Identification for Prevention of Medication Errors Rick Schindewolf Patrick Poisson. May 5, 2004. Cardinal Health.

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Labeling of LDPE Containers: Options for Improving Identification for Prevention of Medication Errors Rick Schindewolf P

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  1. Labeling of LDPE Containers:Options for Improving Identification for Prevention of Medication ErrorsRick SchindewolfPatrick Poisson May 5, 2004

  2. Cardinal Health • Cardinal Health is a Fortune 25 corporation that provides distribution, manufacturing, research and management solutions to the healthcare industry • Cardinal Health Woodstock produces approximately 1 billion sterile units annually using Blow/Fill/Seal technology for a variety of pharmaceutical partners • Cardinal Health Woodstock’s product portfolio includes NDA, ANDA, 510(k) and USP Monograph sterile aqueous products for respiratory, ophthalmic, topical and catheter flush applications

  3. Blow/Fill/Seal Technology • Advantages • Advanced Aseptic Process (USP XXV) for increased sterility assurance • Flexibility in container design • Cost effective approach to producing high volume sterile products (one raw material: plastic) • Limitations • LDPE is a semi-permeable material • Heat sensitive products • Labeling

  4. Current Industry Practice • Labeling and Packaging: General Industry Approach with LDPE UDVs • Emboss or deboss containers to display requisite labeling information • Product Name, Concentration, Manufacturer, Lot Number, Exp. Date, with critical phrases (i.e. “not for injection”, “for oral inhalation only”) • Packaged in secondary overwrap (multiple/single) printed with additional product information to provide protection against chemical contaminants (vapor permeation of hydrocarbons) and small volume water vapor loss

  5. Current Guidance Specific to LDPE • Draft Guidance Inhalation Drug Products Packaged in Semipermeable Container Closure Systems (July 2002) • LDPE vials are permeable to some volatile chemicals • Recommends against paper labels due to past evidence of chemical contamination • Recommends embossing/debossing or other means to display the requisite labeling information • Recommends protective secondary packaging (i.e. multi-laminate foil)

  6. Primary Vial Labeling • Embossing/Debossing Approach to Primary Vial Labeling • Advantages: • Provides immediate tamper evident identification of the product at the time of manufacturing • Eliminates the potential for chemical contamination that could occur with a paper label • Provides ease of label copy control in the manufacturing process • Limitations: • Clear LDPE does not provide a contrasting background to aid legibility • Does not provide bar code readable print • Vial size affects legibility of print - based on current content requirement

  7. Options for Improvement • Enhancements for Product Identification • Reduce content requirement to allow an increased text size • Addition of physical/tactile identifiers for generic product groups • Alternative label approaches (Sleeve Label) • Color code UDVs for generic product groups • Individual secondary overwrap of UDVs

  8. Options for Improvement 1. Increased text size • Limited surface area on container available for embossing/debossing due to mold cavity limitations • Text size can be significantly increased however some currently required information must be removed • Does not change container materials or process. No impact on product chemistry • Can be implemented in 8-10 weeks pending regulatory approval of label change • One time minimal cost investment in tooling

  9. Increase Text Size Concept

  10. Options for Improvement 2. Physical/tactile identifiers added to container design • Provides a easily recognizable/legible symbol on a container that represents a product type • Examples: A for Albuterol Sulfate, I for Ipratropium Bromide, C for Cromolyn Sodium, etc. • Currently being implemented on products manufactured by Cardinal Health for our customers • Does not change container materials or process. No impact on product chemistry • Can be implemented in 8-10 weeks pending regulatory approval of label change (CBE 30?) • One time minimal cost investment in tooling

  11. Symbol Concept w/ Increased Text Size

  12. Symbol Concept w/ Increased Text Size

  13. Symbol Concept w/ Increased Text Size Contrasted with standard vial design

  14. Options for Improvement 3. Sleeve Label • Redesign extended tab area to make amenable for non-paper label on non-product contacting surface • Cardinal Health has designed a LDPE vial (patent pending) capable of receiving a shrink wrap sleeve • Label provides contrasted background for enhanced legibility and provides bar code readable print • No changes to product contact surface of container. Shrink or pressure sensitive labelattached to vial appendage. No adhesives adjacent to product contact surfaces • Increase in manufacturing cost (equipment, labor, materials) • Implementation 12-14 months following regulatory approval (stability testing)

  15. Sleeve Label Concept

  16. Options for Improvement 4. Color Coding • Products could be color coded to aid in identification. Similar in approach to AAO recommendations for cap/label color for topical ophthalmic medicationsContainer Closure Systems for Packaging Human Drugs and Biologics (May 1999) • Provides a contrasting background to aid legibility of embossing/debossing • Could impact product chemistry (leachables & extractables) • Slight increase in product cost (raw materials) • Implementation 6-9 months following stability and regulatory approval (stability and extractable/leachable testing)

  17. Colored Vial Samples

  18. Options for Improvement 5. Individual Secondary Overwrap • Individual UDV secondary overwrap provides enhanced labeling opportunities including bar code readable print • Overwrap can/will be separated from product prior to use. Legibility/identification issues still exist at the time of use • Significant manufacturing cost increase (equipment, labor, raw materials) • Implementation 12-14 months following regulatory approval of packaging change (stability testing)

  19. Summary • Improvements in identification of LDPE containers to prevent medication errors can be made • Each alternative should be assessed based on impact to the product, speed of implementation, ease of regulatory approval and cost to the patient

  20. Recommendation • Increase label information font size on individual vials • Add tactile symbol for generic identification • Advantages 1. Quickest approach for immediate improvement in product recognition 2. No impact on product chemistry or stability 3. No impact on patient cost • Hospital dispensed UDVs - add sleeve label to accommodate bar coding

  21. Biotechnology and Sterile Life Sciences

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