Practitioners' Reporting News

Cases Submitted to MER—New Reconstitution Volumes; Confusing/Incomplete Labeling; Illegible Order

Issued March 31, 2004

The following are various cases of medication error reports submitted through the USP Medication Errors Reporting (MER) Program between December 2003 — January 2004.

Case 1

Potential error: The instructions on identical 75 mL bottles of Augmentin® 400 mg/5 mL indicate different volumes to use for reconstitution. One indicates to use 70 mL and the other indicates to use 66 mL. Both containers have the same national drug code number. This change in reconstitution volumes could result in a wrong drug preparation and improper dose/quantity.


Front
Side
Photo of Augmentin packaging/labeling*

Reporting pharmacist's action/recommendation: All bottles of Augmentin were checked to see if additional containers with the different reconstitution instructions were in the inventory. Augmentin containers with the new reconstitution instructions were separated from the older product.

USP called GlaxoSmithKline regarding this issue and learned the following: The Augmentin 400 mg/5 mL and 200 mg/5 mL suspensions underwent a new formulation for flavoring, which required a different reconstitution volume. Therefore, practitioners may have product in stock with different reconstitution volumes on the labeling. The table below illustrates the new reconstitution volumes for the reformulated strengths of Augmentin suspensions. Practitioners should check their stock and take the necessary precautions immediately to ensure that all staff are aware of these changes for the reformulated batches.

Augmentin
Strength/Concentration		 Container
Size/Total
Volume		 Old
Reconstitution
Volume		 New Reconstitution
Volume for
Reformulated
Batches
400 mg/5 mL 50 mL 44 mL 50 mL
400 mg/5 mL 75 mL 66 mL 70 mL
400 mg/5 mL 100 mL 87 mL 90 mL
200 mg/5 mL 50 mL 47 mL 50 mL
200 mg/5 mL 75 mL 69 mL 75 mL
200 mg/5 mL 100 mL 91 mL 95 mL

Case 2

Potential error: The new packaging of Taxotere® is packaged as a vial of concentrate containing 80 mg in 2 mL, which must be further diluted with the enclosed diluent of 7.1 mL for a final concentration of 10 mg/mL (8 mL total volume). The new outer packaging states, "Taxotere Injection Concentrate 80 mg/2 mL." Although the new package has clear instructions on the back, the reporting pharmacist is concerned that this statement will lead practitioners to believe that the diluted product has a concentration of 40 mg/mL, rather than the actual 10 mg/mL; particularly for healthcare professionals who may not be familiar with this agent.

Reporting pharmacist's action/recommendation: Staff education and a brightly colored note where the product is stored to draw attention to the diluted concentration.

Case 3

Potential error: USP received several reports regarding the labeling on the unit-dose packaging of Tamiflu®. The unit-dose packaging does not indicate the strength of the medication. The capsule itself is imprinted with 75 mg, but in very small print. The box contains the strength, but the medication is often distributed as a unit-dose for each patient. Tamiflu is only available in one strength, but this information may not be known by every practitioner.


Photo of Tamiflu packaging/labeling*

Reporting pharmacists and pharmacy technician action/recommendation: One facility restricted access to Tamiflu to the pharmacy and indicated that the product will be relabeled when sent to the nursing units. Another facility scheduled a meeting with each nursing unit to alert them to this problem and intends to put the Tamiflu in a plastic baggie with a label indicating the proper dose to administer and the strength of each capsule. A third facility indicated that they manually repackage the product with the appropriate labeling, but acknowledged that this creates extra work for technicians and pharmacists alike.

Case 4

Error description: The order below was interpreted as FluMist™, but was actually an order for a flu shot. The error was discovered because the facility did not carry FluMist and the physician was called for a substitution.


Photo of illegible order for a flu shot*

Reporting pharmacist's action/recommendation: Route of administration should be included on every order.

Practitioners are encouraged to submit similar errors to the MER Program. MER is a nationwide program that makes it possible for health professionals who encounter actual or potential medication errors to report to USP confidentially and anonymously, if preferred. By sharing these experiences, pharmacists, nurses, physicians, and other healthcare practitioners contribute to improved patient safety and to the development of valuable educational services for the prevention of future errors. USP reviews each report for health hazards and forwards all information to the U.S. Food and Drug Administration (FDA) and the product manufacturer/labeler. USP will act as your liaison with the FDA and the manufacturer/labeler should you wish to submit a report confidentially.

Reports can be submitted online at www.usp.org/patientSafety/mer/ or by requesting a form at 1-800-23-ERROR (1-800-233-7767).

*All photos provided courtesy of the reporter or the Institute for Safe Medication Practices.


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.