FDA News: Mixups between Insulin U-100 and U-500

The Institute for Safe Medication Practices (ISMP) recently described an increase in reports about mixups between insulin U-100 and insulin U-500. These errors could result in dangerous hypoglycemia or hyperglycemia. Mistakes have occurred when prescribers accidentally selected U-500 regular insulin from computer screens instead of U-100.

ISMP has identified several possible reasons for these kinds of errors. For example, sometimes the two dosage forms appear one line apart on the screen, which makes it easy to select the wrong one. Also, depending on the screen size, the prescriber may see only the first few words of the product listing, so the drug concentration may not be visible. And finally, since the use of U-500 insulin is not common at present, prescribers may just assume that the only regular insulin that's available is U-100 and not even look for the concentration on the screen. ISMP suggests that the use of U-500 insulin may be increasing due to the higher prevalence of obesity, the use of insulin pumps, and tight glucose control protocols in hospitalized patients.

ISMP says that the major suppliers of drug information systems have agreed to add the word "concentrated" on their selection screens, immediately following the drug name and preceding "U-500", which should help solve the problem. Until these updates appear in your system, here's what ISMP recommends.

• If U-500 isn't commonly used in your facility, consider listing it differently from other insulins, so it doesn't appear on the same screen as other insulin products.

• Consider adding a hard stop to all orders for U-500. This requires prescribers and pharmacists verify that the patient should be getting the U-500.

• Pharmacies should consider not stocking U-500 if they don't have patients who use it.

FDA Patient Safety News: April 2008

For more information, please see the FDA website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=74#7

For a related story, visit Diabetes Health at: http://www.diabeteshealth.com/read/2007/08/07/5361.html

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Tags: diabetes, fda, insulin, medical error, medication
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