Practitioners' Reporting News

Manufacturers Take Actions to Change Product Labeling & Packaging

Issued January 30, 2004

The following are descriptions of reports received through the USP Medication Errors Reporting (MER) Program. The manufacturer's reply is also included to illustrate the important role of reporting to national programs such as MER. The cases described here have initiated the manufacturers to take some action in relation to the report.

Potential error: The expiration date on Compazine® rectal suppositories, manufactured by GlaxoSmithKline, is difficult to read due to the aluminum foil packaging. Packages not adequately stamped or printed must be read in a variety of lighting situations throughout the facility by pharmacists and nurses, taking unnecessary time to identify the expiration dates. In some cases, the medication cannot be used due to inadequate markings. The importance of accuracy and safety of dispensing medications cannot be emphasized enough.
Reporting pharmacist's action/recommendation: Expiration dates and contrast on labels should be standardized.
GlaxoSmithKline reply/action taken: After evaluating the packaging process, GlaxoSmithKline concluded that the white laminated aluminum foil could be difficult to read. As corrective action, the white laminated aluminum foil was changed to a silver colored aluminum foil. Changes in the materials used to package Compazine suppositories should significantly improve the readability of all embossed information including lot number and expiration date.

USP received three reports regarding the similarity of American Pharmaceutical Partners dexamethasone and ketorolac vials. Each of these reports is summarized below followed by the manufacturer's reply.

Picture of similar labeling/packaging (provided by reporter)

REPORT 1
Error description: Dexamethasone 10 mg/mL was dispensed for ketorolac 60 mg/2 mL. The print and labeling on the vials uses the same color scheme. The labeling of the vials is too similar and is conducive to medication errors.
Reporting pharmacist's action/recommendation: The facility has stopped ordering the dexamethasone vials.

REPORT 2
Potential error: The hospital's nursing staff alerted the pharmacy about the look-alike potential for a medication error when working with these two products.
Reporting pharmacist's action/recommendation: The pharmacy immediately double checked the inventory to confirm that the right medications were in the right storage locations. The pharmacy used internal e-mail to notify staff about this potential for error. The ketorolac was relocated to a different part of the pharmacy. All dexamethasone and ketorolac orders are now highlighted to bring attention to the look-alike potential. The facility considered using a different manufacturer's product, but it was not possible at this time. The facility also posted a picture of the look-alike products at all automated dispensing machines that routinely stock these medications.

REPORT 3
Potential error: The pharmacist believes that this is an error waiting to happen in the facility's emergency department, as both dexamethasone and ketorolac are stocked in the automated dispensing cabinet. This labeling similarity presents a problem for pharmacists and technicians in dispensing, and for nurses in administering these medications.
Reporting pharmacist's action/recommendation: After identifying the similarities, the pharmacy separated the products into different drawers. The facility is planning to purchase a different generic brand of one of the products to avoid any confusion. The facility would like to see the labeling changed for one of these products.

American Pharmaceutical Partners reply/action taken: An internal investigation was conducted and the results did reflect that the two products had flip tops that were the same color, that they were both packaged in an amber 2 mL vial, and that the labels contained white lettering. It was also noted that the labels clearly reflected the product name of each drug, which was the differentiating factor. The company believes that good medical practice mandates that the drug name, strength of the drug, dose of the drug ordered, route of administration, and the expiration date be checked prior to preparation, after the preparation, and prior to the dispensing of the medication to the patient. American Pharmaceutical Partners is concerned about the safety of the patient first and foremost. It is because of this concern and to prevent any further confusion that the company has elected to change the color of the dexamethasone flip top cap. The new flip top cap color will be lavender. The company will continue to monitor for similar product complaints and will make the necessary labeling changes should they be warranted.

USP has received numerous reports regarding the similarity and illegibility of various respiratory plastic ampul products. One of these reports is summarized below followed by the manufacturer's reply.

Xopenex®

albuterol

Picture of similar labeling/packaging (provided by reporter)

Potential error: Xopenex®, manufactured by Sepracor, and albuterol solution for inhalation, manufactured by Alpharma, are both packaged in clear plastic ampuls. The drug name and strength are imprinted on the products. However, it is very difficult to read, as there is no color or lettering on the ampul.
Alpharma reply/action taken: Alpharma brands of inhalation products are identifiable by the color-coding of the outer boxes and foil wrapper (blue for albuterol and green for ipratropium). As the plastic ampul has been designed to provide a sterile product, the product name, lot number and expiration date are embossed in the plastic in raised letters that also provide a textured surface to assist in gripping the vial when opening by twisting off the top. The product cartons and foil packages are made to protect these products from light and are clearly marked with the product name and dose. Alpharma recommends keeping the products in the foil wrappers to prevent any possibility of product degradation from exposure to light and to help prevent errors in dispensing. To further distinguish the albuterol inhalation solution 0.083% from other products, Alpharma has elected to change the top of the plastic ampul to the shape of an "A."

Practitioners contributing to the MER Program are providing a valuable service to the healthcare community. By identifying and reporting actual and potential medication errors to MER, healthcare professionals are notifying three expert organizations (USP, the Institute for Safe Medication Practices, and the Food and Drug Administration) as well as the manufacturers and/or labelers of the product. As illustrated in the reports described above, manufacturers are then able to implement changes to their products that will possibly prevent or reduce medication errors from occurring.

Similar actual or potential errors can be submitted to the MER Program on-line at www.usp.org/patientSafety/mer/ or by calling 1-800-23-ERROR (1-800-233-7767) to request a reporting form.

Readers are advised that official USP cautions and warnings for drugs appear in the USP–NF or USP DI. Unless otherwise indicated, any advice or opinions expressed herein reflect solely the judgment of USP staff. Such statements are intended for further consideration and evaluation and may or may not be applicable to a particular practice. The USP Medication Errors Reporting Program is presented in cooperation with the Institute for Safe Medication Practices.