I won't infringe on Metric Today's copyright by posting their article. However, for anyone without access to Metric Today, here are links directly to the FDA's posting in the Federal Register, and the full text of their proposal: http://www.smartpdf.com/register/2009/nov/05/E9-26531.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM188992.pdf
I commented in December after downloading e-version of Metric Today. Note that FDA deadline is Feb 3, 2010, and I had trouble with their electronic comment system and had to send them a paper letter, so you may not want to wait until the last minute. This is a chance to fix the rule before it is published, and I urge interested members of our list to take a look and comment. The FDA wants a dosage delivery device included with OTC medicine and they want the units in the instructions and on the device to agree. However, they would still allow a hodge-podge of units to be used if they agree, and they would still allow teaspoons or tablespoons, although that makes it more likely parents would use household spoons, not measuring spoons, to measure. In my view, they should require, or at least STRONGLY recommend that only milliliters (mL) be used. I think it would suffice if that only applied to redesigned packaging, and they allowed some reasonable and bounded phaseout time for older packaging designs. ________________________________ From: James R. Frysinger <[email protected]> To: U.S. Metric Association <[email protected]> Sent: Fri, January 15, 2010 8:48:04 PM Subject: [USMA:46418] Re: A spoonful of medicine My copy arrived today. I scanned it and noticed the article but I have not read it yet. Thanks for the suggestion, John. Jim John M. Steele wrote: > There is also a good article in the Jan/Feb issue of Metric Today (p. 7). > The FDA is recommending a "dosage delivery device" with all OTC liquid >medications. It also seeks to reduce errors by requiring the units in the >directions to agree with the units on the device. It is a good first step, >but it could go further and be more effective in reducing errors. > It would still allow multiple systems of units, they just have to agree. >Devices showinng measurements in multiple units are more complex and therefore >more confusing. They should take the next step of specifying milliliters >(symbol: mL) and ONLY milliliters. > There are links in the article to locate the FDA proposal. Interested >members should read it and send comments to the FDA. > . > > ------------------------------------------------------------------------ > *From:* James R. Frysinger <[email protected]> > *To:* U.S. Metric Association <[email protected]> > *Sent:* Thu, January 14, 2010 10:35:23 AM > *Subject:* [USMA:46405] A spoonful of medicine > > > This LA Times article appeared in today's Tennessean (Nashville). It's good > to see this advice being published. > > Jim > > January 14, 2010 > > A spoonful of medicine may be too much, or not enough > > By Amina Khan > LOS ANGELES TIMES > > "Heaping" teaspoon or "level"? That's the nail-biting dilemma that usually > confronts amateur boulangeries as they mix baking soda or salt into their > cake batter. > > In medicine, though, the unreliability of your average spoon — and by average > spoon, we mean a tool more commonly used to stir sugar into coffee — can > create far more serious problems. > > In a study in the Jan. 5 issue of the Annals of Internal Medicine, > researchers asked student patients at the Cornell University health clinic to > pour out 5 milliliters of cold medicine into different-size kitchen spoons. > The researchers found that participants expressed confidence in their > measuring abilities, and yet "underdosed by 8.4 percent when using the > medium-size spoon and overdosed by 11.6 percent when using the larger spoon." > > That may sound minimal, but consider someone who's making that same mistake > three to five times a day for a seven-day regimen. That can add up. > Overdosing can mean nasty and troublesome side effects. Underdosing — on an > antibiotic, for example — can lead to drug-resistant bacteria, ultimately > rendering the medication ineffective. > > The lesson? Use a proper device — a measuring cap, a syringe or a dosing > spoon — to make that medicine go down. > > > And parents, before you pour any liquid into your kid's spoon (accurate or > not), make sure you have the proper dose for your child's age and weight. > > Source: > http://www.tennessean.com/article/20100114/FEATURES04/1140313/A+spoonful+of+medicine+may+be+too+much++or+not+enough > > -- James R. Frysinger > 632 Stony Point Mountain Road > Doyle, TN 38559-3030 > > (C) 931.212.0267 > (H) 931.657.3107 > (F) 931.657.3108 > -- James R. Frysinger 632 Stony Point Mountain Road Doyle, TN 38559-3030 (C) 931.212.0267 (H) 931.657.3107 (F) 931.657.3108
