[JasonJayhawk]

My sister is a pharmacist, and sent this newsletter from the ISMP (a group concerned with medicine safety). Being a southpaw, my eyes always open up when I see a product safety mentioned for left handers.



Subject: ISMP Medication Safety Alert! November16, 2006 Vol. 11, Issue 23
Provided to Premier members by Premier Group Purchasing Partners

ISMP Medication Safety Alert!

November 16, 2006
Volume 11, Issue 23


Educating the healthcare community
about safe medication practices

©2006 Institute for Safe Medication Practices
ISMP®, A Nonprofit Organization


Pharmaceutical industry and medical device companies:

Part of the solution?


In the past few months, there have been numerous, highly publicized, fatal errors reported in the media: one involved infants who died from heparin overdoses, which the hospital believes may have been avoided if the pharmaceutical company had provided distinctive labeling and packaging of various strengths of heparin; another involved a young mother who died after receiving an epidural analgesic intravenously, which might have been avoided if containers, tubing, and connectors for epidural medications were vastly different than intravenous medications. In fact, as we look back on the causes of fatal medication errors that have happened in the last decade, many can be traced to labeling and packaging issues, and problems with medical devices and how humans interact with them.


This is not to say that poor system design, environmental challenges, and miscommunication within healthcare facilities have not played a large role in medication errors. Still, we have ample evidence that organizations are redesigning systems and environments under their control, as well as improving team communication among all caregivers. But what about the pharmaceutical industry and medical device companies? About 40% of all reports submitted to the USP-ISMP Medication Errors Reporting Program are related to product or device problems. Yet, with few exceptions, we can’t say with confidence that the pharmaceutical industry and medical device companies have always stepped up to the plate despite increased attention to these issues. In fact, we repeatedly see evidence of new and existing products and devices that contribute to repeated medication errors.


Take the new OptiClik device from sanofi-aventis. Both LANTUS (insulin glargine [rDNA]) and APIDRA (insulin glulisine [rDNA origin] injection) are available in a 3 mL cartridge to be used with this device. The dose is displayed digitally in a small window near the dial used to set the dose (see figure 1 in the attached PDF version of the newsletter). While the dose is clearly visible in the window, the pen could be dialed to the wrong dose if it is oriented in the wrong direction, just like a left-handed practitioner or patient might hold it—upside down, with the needle to the right, away from the hand. (Twenty percent of people are left handed.) For instance, when the pen is oriented incorrectly, a dose that is actually “52” units looks like 25 units (see figure 2 in the PDF version of the newsletter). Many other doses can potentially be confused: what appears to be a dose of “10” units is actually “1” unit (01); a dose of “50” units is actually “5” units (05); a dose of “21” units is actually “12” units; a dose of “15” units is actually “51” units; a dose of “62” units is actually “29” units; and so on. The design of this pen is potentially dangerous, as the patient could receive a significant overdose or a subtherapeutic dose of insulin, a high-alert drug. Thus, we believe the device is unacceptable for clinical use under any circumstances unless these safety issues are fully resolved.


As is our usual practice when learning about risks and errors, we contacted sanofi-aventis about this problem and asked if they had received similar complaints. The person at the call center could not tell us if errors had been previously reported. Our complaint was forwarded to the quality department for review, but we have not received a return call. Unfortunately, this is a common response, as many companies are unwilling to share what they know about the problem we are reporting, or to tell us what they plan to do about it, if anything. In some cases, companies that we have contacted about problems have simply sent a letter to ISMP, thanking us for the information but stating that the company is in compliance with FDA regulations and that no additional action is required. Sadly, we’ve also received letters stating “Reading the label is Nursing 101” or similar comments, implying that the problem lies entirely with the healthcare provider or patient who did not use the product or device correctly.