Simple ideas usually work the best.
Lilly recently announced the launch of their color differentiation system for their U-100 insulin products in the United States (think Humalog® and Humalin®). Our thought? EXCELLENT idea! We're glad to see it and not a moment too soon. We know there are plenty of people with diabetes who have accidentally used the wrong type of insulin. Some have put long-acting insulin in pumps; others have given 15 units of Humalog instead of Lantus without realizing; etc. But beyond the normal mistakes people can make (young and older alike), remember that there are many people in the United States that have problems understanding the doctor's instructions. Health literacy can be as much of an obstacle to diabetes management as access to insulin in the United States. It's definitely a problem we should be working on equally while researching for a cure as part of the care to keep everyone healthy while we wait!
We give a thumbs up to these improved safety measures that will help patients use insulin correctly. Remember, it's important to always look at the label and read it correctly, follow your doctor's orders, etc. and we are glad for the extra recognition factor to assist in correctly identifying insulin. Lilly plans to introduce the color differentiation system in all insulin products, from vials to pens to individual packaging. This follows Lilly's 2004 introduction of bar coding of packaging and insulin vials. The color system will be introduced throughout 2008 with colors indicating both insulin 'family' and insulin 'type' (burgundy for Humalog; blue for Humalin; yellow for Regular; insulin mixes will have two colors).
What do you think are other ways to address the health literacy obstacle to diabetes management?
I learned of this last week, and while I think it is the right move, I still question whether it will make a meaningful difference. The main issue is that these plans only work if ALL manufacturers agree to adopt them. Novo Nordisk A/S has testified before the FDA on this topic and says it does support color-coding, but whether they agree with Lilly's corporate decision to unilaterally adopt a color scheme remains to be seen, as the regulators have not mandated anything officially. A case in point is the fact that Lilly adopted magenta (burgundy) as the color scheme for the crimp and cap intended for Humalog to communicate that it was a rapid-acting analogue back in 1996, but rivals Novo Nordisk and Sanofi Aventis subsequently introduced "me-too" rapid-acting analogues and did not adopt the same color scheme, which killed its widespread effectiveness (even if it did work for Lilly).
Regulators really should be chiming in here, and the FDA's failure to do so sets a poor precedent on its concern about patient safety, which explains why in April 2008, the Institute for Safe Medication Practices (ISMP) reported a marked increase in reports about mixups between insulin U-100 and insulin U-500 earlier this year, and made some recommendations for pharmacies to help avoid mixups, including having the major suppliers of drug information systems to add the word "concentrated" on their computerized selection screens, immediately following the drug name and preceding "U-500".
Would these warnings have even been needed if a universally-adopted color scheme had been adopted by the FDA? One has to wonder!
Posted by: Scott | 10/30/2008 at 05:03 AM