AMPULE LABELING

Too much transparency

A hospital pharmacist received a supply of clear glass ampules of dimercaprol (BAL IN OIL) 300 mg/3 mL manufactured by Akorn. Dimercaprol is an antidote given to treat arsenic, gold, mercury, and lead poisoning. When trying to scan the bar code to add the product to inventory, he found the scanner couldn't read the dark print on the clear glass (see photo). In addition, overlapping text visible through the glass may have interfered with its readability by the scanner. Looking at the ampule in the photo, a person would probably be equally unable to read the label.

An FDA draft guidance states that "product container labels and carton labeling should communicate information that is critical to the safe use of a medication from the initial prescription, to procurement, preparation and dispensing of the product to the time it is given to the patient." Poor label design can contribute to medication errors by making it difficult for healthcare professionals, caregivers, and/or patients to readily locate and understand critical safety information.

Figure. The label on this ampule is virtually unreadable.

For safety, ampule dosage forms should be avoided whenever possible. If manufacturers must make certain medications available in ampules, they should be required to identify the drug, strength, bar code, lot number, and so on in contrasting ink printed on a paper background, or via applied ceramic labeling, a process in which ceramic inks are printed directly onto the glass and then heated so the ink adheres to the glass. This process allows bar codes to be scanned correctly.1

Akorn is checking options to improve label readability. Healthcare professionals who encounter other poorly labeled products can report them to the Institute for Safe Medication Practices (ISMP) as directed at the end of this column.

REFERENCE

1. Glass Packaging Institute. Industry Resources. Glass labels. http://www.gpi.org/industry-resources/package-design/glass-labels. [Context Link]

POTASSIUM CHLORIDE

Unsafe in syringes

At least one outsourcing company (Nephron) has distributed potassium chloride (KCl) concentrate to hospitals in syringes (see photo below). These syringes were ordered by a hospital pharmacy technician and may have been meant for use only in the pharmacy as an additive to be diluted in a minibag or large-volume parenteral solution due to a shortage of commercially available premixed KCl infusion products. For safety reasons, the ISMP highly recommends not ordering or using additive syringes of KCl concentrate for injection. Instead, KCl should be provided in a sterile vial or already mixed in a minibag.

Although KCl syringes are intended for pharmacy use, they could inadvertently make it to patient-care areas and be erroneously administered to a patient via I.V. injection-a potentially fatal error. For example, in some hospitals without 24-hour pharmacy service, a nursing supervisor has the key to the pharmacy for after-hours access (a practice to be avoided because it elevates risk). The supervisor might find these syringes, not realize they're intended for use only after dilution, and take them to a patient-care unit.

Figure. Providing potassium chloride concentrate injection (10 mEq/5 mL) in a 10 mL syringe, as shown here, could lead to a fatal error.

Nurses shouldn't have access to the pharmacy after hours, and concentrated KCl shouldn't be available on patient-care units. Fatalities have been reported due to pharmacy-dispensed syringes of concentrated KCl that were inadvertently administered via I.V. push.1 Pharmacies and clinicians can minimize risks by avoiding use of KCl products in syringes.

REFERENCE

1. Knox CA, Liu W, Brushwood DB. Potassium chloride for injection concentrate: time for a risk evaluation and mitigation strategy. Am J Health Syst Pharm. 2014;71(3):238-242. [Context Link]