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FDA 101: Medication Errors

A medication error is any preventable event that may cause or lead to inappropriate medication use or harm to a patient. Since 2000, the Food and Drug Administration (FDA) has received more than 95,000 reports of medication errors. FDA reviews reports that come to MedWatch, the agency's adverse event reporting program.

"These reports are voluntary, so the number of actual medication errors is believed to be higher," says Carol Holquist, R.Ph., Director of the Division of Medication Error Prevention and Analysis in FDA's Center for Drug Evaluation and Research.

Recommended Related to FDA Center

FDA's MedWatch Safety Alerts: January 2010

After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor unexpected and undesirable side effects (adverse events) of that product. Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, by fax, or by phone. Online 1 Regular Mail:...

Read the FDA's MedWatch Safety Alerts: January 2010 article > >

FDA works with many partners to track medication errors, including the U.S. Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). "Every report received through the USP/ISMP Voluntary Medication Error Reporting Program (MERP) automatically gets sent to FDA's MedWatch program," says Mike Cohen, R.Ph., Sc.D., President of ISMP. "It takes a cooperative approach to monitor errors, evaluate them, and educate the public about strategies to keep errors from happening again."

Medication errors occur for a variety of reasons. For example, miscommunication of drug orders can involve poor handwriting, confusion between drugs with similar names, poor packaging design, and confusion of metric or other dosing units.

"Medication errors usually occur because of multiple, complex factors," says Holquist. "All parts of the health care system—including health professionals and patients—have a role to play in preventing medication errors."

FDA's Role

Drug Name Review:
To minimize drug name confusion, FDA reviews about 400 drug names a year that companies submit as proposed brand names. The agency rejects about one-third of the names that drug companies propose.

Drug Labels:
FDA regulations require all over-the-counter (OTC) drug products (more than 100,000) to have a standardized "drug facts label." FDA has also improved prescription drug package inserts for health care professionals.

Drug Labeling and Packaging:
FDA works with drug companies to reduce the risk of errors that may result from similar-looking labeling and packaging, or from poor product design.

Bar Code Label Rule:
In accordance with an FDA rule that went into effect in 2004, bar codes are required on product labels for certain drugs and biologics such as blood. When used with bar code scanner and computerized patient information systems, bar code technology can help ensure that the right dose of the right drug is given to the right patient at the right time.

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.

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