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  1. Cohen, Michael R. ScD, MS, RPh

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Shortage opens the door to foreign products

Because of the severe shortage of potassium chloride injection, the FDA is permitting Athenex Pharmaceuticals to import 20 mEq/10 mL ampules (2 mEq/mL) of the product, which is manufactured and marketed in Italy by Galenica Senese. As shown below, the ampule label expresses the potassium chloride concentration as 2 mEq/mL, with 20 mEq/10 mL in parentheses. This is the opposite of how the concentration is expressed on US potassium chloride vial labels according to USP standards. Also, the ampule label has no bar code, so alternate procedures are needed to verify product identification.


Finally, this product is in an ampule (rather than a vial) that, unlike a US product, does not have a black band or series of black bands above the neck constriction. In the US, concentrated potassium chloride is provided in vials, not ampules. Because concentrated potassium chloride is a high-risk drug, these vials feature a black cap and ferrule. A black line or lines on the neck of an ampule of concentrated potassium chloride would remind clinicians that the product is a high-risk drug. For complete information, including product access, photographs of the carton and ampule label, and comparison to the US product, visit http://www.ismp.org/ext/71.

Figure. Concentratio... - Click to enlarge in new windowFigure. Concentration on potassium chloride injection imported from Italy is prominently expressed per mL as 2 mEq/mL, followed by the amount per total volume in parentheses (20 mEq/10 mL). This is the opposite of how concentration is expressed on US labels.

The FDA is also permitting the importation of potassium chloride for injection concentrate, 20 mEq/10 mL (2 mEq/mL), by a French company, Laboratoire Aguettant. The French product is packaged in a plastic ampule and is labeled in French. English translation is provided on the carton label (and prescribing information), and a sticker with important information is on the carton. The strength is listed as "0,15 g/mL," which is equivalent to 2 mEq/mL. (On some foreign products, including this one, commas are used instead of decimal points to indicate numbers less than 1.) Like the Italian product, the ampule label does not contain a bar code. Additional information and a side-by-side comparison can be found at http://www.ismp.org/ext/79.


Because of the potential for confusion leading to medication errors for this high-alert drug, the Institute for Safe Medication Practices (ISMP) recommends that facilities ordering these foreign products store and utilize the ampules only within the pharmacy.



Concentrate on these overwraps

A hospital reported that Baxter DOBUTamine 1,000 mg per 250 mL (4,000 mcg/mL) premixed bags were erroneously placed in a bin holding DOBUTamine 250 mg per 250 mL (1,000 mcg/mL). The two different concentrations were noticed when new inventory was being stocked. Separately labeled bins are normally used to store each concentration.


Premixed DOBUTamine is available in bags holding three concentrations: 250 mg, 500 mg, and 1,000 mg per 250 mL. As the photo above shows, the overwraps for the three concentrations look nearly identical. Similar mix-ups have been reported by other hospitals.

Figure. Outerwraps o... - Click to enlarge in new windowFigure. Outerwraps on bags of premixed DOBUTamine in various concentrations look very similar.

If your facility stocks these products, staff should be alerted to the potential for mix-ups. ISMP recommends placing a prominent warning about this risk wherever the products are stored. Clinicians should always scan the bar code when selecting and administering products.



Don't make up names

An ED physician verbally requested "Neostick" from a bedside clinical pharmacist. The pharmacist misheard the request as "neostig" and retrieved neostigmine. In fact, the provider had wanted Neo-Synephrine, a former US brand of phenylephrine. A quick Google search reveals that "Neostick" is a popular slang term. ISMP occasionally receives medication error reports involving other made-up drug names, such as "ketofol" for ketamine and propofol combined in a syringe. Never use slang terms and contrived drug names and abbreviations.