Medication error product labeling

A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems including prescribing order communication product labeling, packaging, and nomenclature compounding dispensing distribution administration education monitoring and use. 

Serious medication errors, including some leading to death, have resulted from the interpretation of the Cerebyx product labeling. The terminology on the label, which previously indicated the concentration as being 50 mg of phenytoin equivalents (PE) per milliliter, was misinterpreted as the total number of PEs per vial. Furthermore, health professionals were reportedly confused by the expression phenytoin equivalents, a prodrug concept introduced for this product. As a result, massive fosphenytoin overdoses were mistakenly administered. 

The FDA receives and reviews about 300 medication error reports each month and classifies them to determine the cause and type of error. Depending on the findings, the FDA can change the way it labels, names, or packages a drug product. In addition, once a problem is discovered, the FDA educates the public on an ongoing basis to prevent repeat errors. 

For nearly 33 years, the USP has been reporting programs for health care professionals to share experiences and observations about the quality and safe use of medications. This year, the USP Center for the Advancement of Patient Safety publishes its sixth annual report to the nation on medication errors reported to MED MARX (Table 6). It was observed that drug product packaging/labeling is one of the main courses of medication errors in hospitals. 

The Food and Drug Administration (FDA) implemented a final rule in April 2004 requiring bar coding on certain products administered to patient in hospitals in an effort to reduce medication errors. This rule applies to manufacturers, repackers, relablers, and private label distributors of the following products ... 

Colorants, other than titanium dioxide, are rarely used in plastic containers however, the use of colorants is required for the cap. The American Academy of Ophthalmology (AAO) recommended to the FDA that a uniform color coding system be established for the caps and labels of all topical ocular medications. Industry new drug applicants are required to either follow this system or provide an adequate justification for any deviations from the system. The AAO color codes, as revised and approved by the AAO Board of Trustees in June 1996, are shown in Table 4. The FDA and AAO have extended the cap color scheme to differentiate different classes of newer Rx drugs for the benefit of the patient who may be using more than one product. The intent is to help prevent errors in medication and improve patient compliance. It is important for the pharmacist to explain this color coding to the patient and/or caregiver since it can be defeated if the cap is not returned to the proper container after each use. 

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