Home E-Weekly May 1, 2018

Double Check the Labels on Your Compounded Drugs

Published: May 1, 2018

Tap Water Used with permission from ISMP TOO CLOSE FOR COMFORT The similarities between these two drug syringes makes them very easy to mix up if someone is in a hurry.

Drug shortages may be behind the increase in reports of look-alike compounded syringes according to the Institute for Safe Medication Practices (ISMP).

The recent drug shortage has hospitals and surgical facilities reaching out to unfamiliar compounders to obtain much needed medications. As the FDA does not have strict labeling requirements for compounded medications, facilities have been surprised by unexpected labeling on their usual prefilled syringes.

For example, some compounders do not use the standard USP labeling standards that require the strength per total volume be prominently displayed on the label with the strength per ml in parenthesis underneath. A facility reported finding the strength displayed differently on syringes of succinylcholine from two different compounders. One followed the standard labeling while the other displayed the strength per ml more prominently. This could lead to dosing errors if the strength per ml is mistaken for the strength per total volume.

Another compounder used the same color tamper-proof caps and syringe sizes for two different drugs, fentanyl and hydromorphone. Although the drug name is clearly displayed, someone in a hurry just looking at the cap color and syringe size could easily grab the wrong drug.

The "FDA should not allow products from compounders to follow different container labeling standards than commercial manufacturers, thus creating unsafe conditions," a recent ISMP newsletter says. The newsletter also calls on the FDA to convene an advisory committee to address the non-standard labeling and create guidance that requires all compounders to follow the same safety standards as commercial manufacturers.

JoEllen McBride, PhD

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