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FDA 101: Medication Errors

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FDA's Role continued...

Error Analyses:
FDA reviews about 1,400 reports of medication errors per month and analyzes them to determine the cause and type of error.

Guidances for Industry:
FDA is working on three new guidances—one on complete submission requirements for anaylsis of trade names, one about the pitfalls of drug labeling, and another on best test practices for naming drugs.

Public Education:
FDA spreads the message about medication error prevention through public health advisories, medication guides, and outreach partnerships with other organizations.

Examples of Medication Errors

Misuse of Tussionex Prescription Cough Medicine:
On March 11, 2008, FDA informed health care professionals about adverse events and deaths in children and adults who have taken Tussionex Pennkinetic Extended-Release Suspension (Tussionex). Tussionex is a long-acting prescription cough medicine.

Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems when too much medicine is given at one time or when the medicine is given more frequently than recommended. Tussionex should not be used in children less than 6 years old.

Reports indicate that health care professionals have prescribed Tussionex for patients younger than the approved aged group of 6 years old and older, more frequently than the labeled dosing interval of every 12 hours ("extended release"), and that patients have administered the incorrect dose due to misinterpretation of the dosing directions and the use of inappropriate measuring devices. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal breathing problems.

For more information, see FDA Issues Alert on Tussionex at

Overdoses of Cough and Cold Products in Children:
Roughly 7,000 children ages 11 and younger are treated in hospital emergency rooms each year because of overdoses of OTC cough and cold medication, according to a recent study by the Centers for Disease Control and Prevention. About two-thirds of those incidents occurred when children took medication without a parent's knowledge. Parents should keep medication out of children's reach and should never describe medication as "candy."