Practitioners' Reporting News

Cases Submitted to MER—Misleading Labeling; Processing Problem; Potential Abbreviation Error; Poor Packaging Design

Issued March 31, 2004

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

Case 1

Error description: Fluzone® 0.25 mL prefilled syringes contains misleading information on the labeling. The labeling on the front exterior of the box indicates that the product is preservative-free. Due to this labeling statement, pharmacists are informing physicians that Fluzone contains no mercury. While Fluzone does not contain enough mercury to act as a preservative, the trace amount of mercury (less than 0.1 mcg/0.5 mL) could still be enough to trigger an allergic reaction. In fact, the "contraindication" section of the package insert does state, "use of this product is contraindicated in patients allergic to mercury." The "description" section of the package insert, as well as the back exterior of the box, addresses the mercury content; however, the information is not easily found.


Front

Back
Photo of Fluzone packaging/labeling*

Reporting pharmacist's action/recommendation: A table comparing different products was created, which was distributed to the pharmacy and medical staff. The table contains a warning that mercury is present in Fluzone. In addition, pharmacists who have dealt with this issue are available to help when a question arises.

Case 2

Error description: A patient was ordered digoxin 0.125 mg. A hole-puncher was used to place the order in the patient's chart. The hole-puncher had gone through the "0.1" portion of the dose. The "25 mg" portion of the dose could be seen and was interpreted as digoxin 0.25 mg. The patient suffered digitalis toxicity as a result of the dosing error, but fortunately recovered.

Case 3

Potential error: A pharmacist discovered the abbreviation "AChE" for acetylcholinesterase inhibitor. This abbreviation is so close to "ACE" for angiotensin-converting enzyme inhibitor that the pharmacist believes they could be confused for one another.

Case 4

Potential error: The lot number and expiration date on FiberCon® packaging appears only at the top of the blister packs. If the tablets are separated, the lot number, expiration date, and the complete drug name do not appear on the separated tablets. Even though there may be supplementary information on the box or in the package insert, unless the product is relabeled for dispensing, the nurse administering the medication will not know all the relevant information pertaining to the product.


Front
Back
Photo of FiberCon packaging/labeling*

Reporting pharmacist's action/recommendation: The pharmacist called the manufacturer to report the problem. The manufacturer referred the pharmacist to the package insert and original box. According to the pharmacist, the manufacturer did not seem to understand the need for the packaging to contain all the relevant information when separated.

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.