New FDA Guidelines to Prevent Children’s OTC Medication Errors

In a recent Baltimore, Maryland pharmacy error injury lawyer blog, our attorneys discussed an FDA panel’s recent recommendation that dosing instructions be based primarily on children’s weight, and not age—as studies found that many parents administer the wrong drug dosage to their children because of confusing medication label instructions.

The FDA has recently released new guidelines that are expected to reduce the prevalence of medication error and overdoses with Children’s liquid over-the-counter (OTC) medication, which is administered and dispensed with cups, spoons and droppers.

The guidance was reportedly developed after past reports of medication errors revealed that labels often cause confusion with administration, the measuring devices provided in drug packages are often inconsistent with the labels, and parents often used devices from other drug products to dispense the medication that do not match the label instructions—leading to medication error.

According to the FDA recommendations:

• Dosage dispensing devices (cups, spoons, droppers) should be included with all OTC medications that are liquid and taken orally.
• Over-the-counter (OTC) drugs will reportedly now come with dispensing devices that are calibrated to match the exact units of measurement specified on the drug label—to avoid drug error or injury.
• Companies should make sure that the liquid dispensing devices are used only to measure the intended drug products.

• The markings on the dispensing devices should be visible when the liquid medication is added for measurement.

And as our Maryland medication mistake attorneys discussed previously, the FDA is also advising that liquid acetaminophen products will be changed to one concentration only, with age-appropriate dosages, to reduce medication dosing errors.

Lebowitz and Mzhen, LLC represent victims of medication error in the Washington, D.C. and Maryland. Call our attorneys today at 1-800-654-1949 to schedule your free consultation.

FDA Issues Guidelines for Liquid OTC Medicines, Health Day, May 4, 2011
FDA: Stricter over-the-counter labeling needed, Packaging Digest.com, May 17, 2011
Panel Calls for Label Changes on Acetaminophen Products, WSJ, May 19, 2011
Clearer kids’ dosing urged for acetaminophen-containing meds, CNN, May 18, 2011

Related Web Resources:

U.S. Food and Drug Administration: Medication Error Reports

Institute for Safe Medication Practices, (ISMP)

20 Tips to Help Prevent Medical Errors in Children: Patient Fact Sheet, Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services

Related Blog Posts:

Prescription Error Overdose Leads to Paralysis, Victim Hopeful for Recovery, Pharmacy Error Injury Lawyer Blog, May 19, 2011
FDA Redesigns Pharmacy Packet Inserts to Avoid Medication Error Injury, Pharmacy Error Injury Lawyer Blog, May 9, 2011
Study Finds Small Doses of Drugs From Syringes Could Cause Medication Error in Children, Pharmacy Error Injury Lawyer Blog, February 4, 2011

Contact Information