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Commentary

Longstanding LVP Labeling and Packaging Problems Require Updates


March 31, 2021

By Merissa Andersen, PharmD, MPH

Large volume parenterals (LVPs) are premixed solutions of 100mL or greater that are provided in ready to use dosage forms. These premixed solutions are intended to reduce the potential for compounding errors and provide a sterile product labeled with ingredients and a barcode, but errors associated with packaging and labeling of the products have occurred for decades. For example, both Hospira and Baxter’s of DOBUTamine 1,000 mg/250 mL have been repeatedly mixed up with the 250 mg/250 mL strength. Both manufacturers’ DOPamine 800 mg/250 mL infusions have been mixed up with look-alike containers of 200 mg/250 mL (Baxter) and 400 mg/250 mL (Hospira).

In January 2007, the FDA held a public meeting with representatives from ISMP and USP to discuss how labels on intravenous (IV) products could be designed to minimized medication errors. These discussions included improved placement, style, and type of information required on LVP labels. These findings led to the April 2013 FDA Draft Guidance for Industry, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors, which was never finalized. Since this guidance, updated recommendations are necessary.  Today, errors are still associated with similar appearances of containers, problems with barcodes, and label clutter.

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compounding bag

 

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Since this report was published as a draft, ISMP continues to receive reports related to confusion of LVP labeling. Reports including look-alike LVPs with differing base solutions (for example, 0.45% sodium chloride, 0.9% sodium chloride, and D5W/0.45% sodium chloride) and difficulty scanning barcodes are commonplace. Several updated safe practice recommendations have been proposed. These include:

  • Label redesign, including style, font type, and the limited use of color to distinguish products;
  • Label placement on both the front and back of LVPs containing ISMP High-Alert Medications with the text not over lapping and to be readable in inverted positions, leaving space for application of a patient label;
  • Reconsideration of information deemed essential for the container label to reduce clutter;
  • Segmentation of any essential information required on the label below the product name (ie, storage, route of administration); and
  • Requiring the placement of two-dimensional barcodes using dark black lines on an opaque white background on both sides of the actual LVP and the overwrap.

In the meantime, health care practitioners can identify look-alike LVPs in their institution, clearly label storage locations, affix unique labels to a few products, base solutions or strengths. The Pharmacy and Therapeutics committee can evaluate whether all sizes and strengths of LVPs are necessary, and then limit the variety of LVPs by removing those with limited use or value from common storage locations or hospital inventory We hope to see changes from manufacturers in the future to improve safety, but until then remain diligent with the use of barcode scanning of the actual LVP to minimize the number of errors which may reach a patient.

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