Background
Medication errors resulting in patient injury and death are occurring at significantly high and unacceptable numbers. One way patient safety can be improved by information technology is through the use of machine–readable codes such as bar codes in a standardized format on all medication packages and containers. A scannable bar code can help guarantee that the right drug and dose are being administered to the correct patient.
In 2001, the National Coordinating Council for Medication Error Reporting and Prevention urged the FDA to collaborate with pharmaceutical manufacturers and other appropriate stakeholders to establish and implement uniform bar code standards down to the immediate unit–of–use package. Subsequently, the FDA issued a proposed rule, and following public comment, a final rule to require bar codes on the labels of certain human drug and biological products {see final rule in Federal Register.(February 26) 2004; 69:9119–917}. The Council's recommendations, as described below, not only encompass but go beyond the requirements put forth by the FDA in its 2004 final rule.
The Council proposes the following recommendations
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Bar code labels should be on all commercially available prescription and nonprescription drug, dietary supplement, and herbal products. The standard bar code should be included on:
- Immediate container labels in any dosage form (e.g., oral solids, oral liquids, injectables, inhalers, nasal sprays, topicals, and other forms of specialized product packaging).
- Intermediate container or carton.
- Shelf Keeping Unit (SKU).
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The data elements of a bar code should include:
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National Drug Code (NDC)
The unique product identifier in the bar code should be a uniform NDC number. This number has regulatory standing with the Food and Drug Administration (21 CFR Section 207.20) and is currently used by the pharmaceutical industry and by health care organizations in automated tracking of drug products. The Council understands that both 11–digit and 10–digit NDC number formats exist today and strongly encourages key stakeholders to come to agreement on a single uniform format for the NDC number.
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Lot/control/batch number and expiration date
The bar code should contain two secondary identifiers: the lot number and the expiration date. A unique lot number that is used in the event of a recall identifies each manufacturing batch. Inclusion of this lot number within the bar code will ensure that those lots subject to a recall can be readily identified. Inclusion of the expiration date within the bar code will ensure that the patient does not receive a medication that is beyond its expiration date.
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National Drug Code (NDC)
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Format parameters for the bar code should include:
- The three data elements of a bar code (i.e., NDC, lot number, expiration date) should be uniformly ordered.
- The three data elements should be bar coded using existing symbologies, such as reduced space symbology in the form of a composite bar code. For example, the NDC number can be encoded by a linear bar code with the lot number and expiration dates in the two–dimensional code.
- The bar code print density should be sufficiently consistent to allow an accurate scan each time.
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Labeling parameters should include:
- Standardized location of the bar code on the label.
- Only one bar code per label.
- Human readable drug name, strength/concentration, lot and expiration date per existing FDA regulation.
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Bar code down to the unit–of–use package The standard bar code should be included on all immediate unit–of–use packaging which may include single–unit, single dose, unit–dose, unit–of–use, multiple–unit, and multiple dose containers.
(Terms as defined in General Notices, The United States Pharmacopeia and the National Formulary (USP 30–NF 25), Volume 1, page 10, 2007.)
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Professional associations should develop relevant standards of practice including, but not limited to:
- Repackaging and labeling of extemporaneous preparations.
- Educating practitioners on the proper and optimal use of bar codes.
- Avoiding "work–around" processes.
- Health care organizations should adopt bar coding technology to support safe medication use. Single–Unit Container – A single–unit container is one that is designed to hold a quantity of drug product intended for administration as a single dose or a single finished device intended for use promptly after the container is opened. Preferably, the immediate container and/or the outer container or protective packaging shall be so designed as to show evidence of any tampering with the contents. Each single–unit container shall be labeled to indicate the identity, quantity and/or strength, name of the manufacturer, lot number, and expiration date of the article.
Single–Dose Container – A single–dose container is a single–unit container for articles intended for parenteral administration only. A single–dose container is labeled as such. Examples of single–dose containers include pre–filled syringes, cartridges, fusion–sealed containers, and closure–sealed containers when so labeled.
Unit–Dose Container – A unit–dose container is a single–unit container for articles intended for administration by other than the parenteral route as a single dose, direct from the container. Unit–of–Use Container – A unit–of–use container is one that contains a specific quantity of a drug product and that is intended to be dispensed as such without further modification except for the addition of appropriate labeling. A unit–of–use container is labeled as such.
Multiple–Unit Container – A multiple–unit container is a container that permits withdrawal of successive portions of the contents without changing the strength, quality, or purity of the remaining portion.
Multiple–Dose Container –– A multiple–dose container is a multiple–unit container for articles intended for parenteral administration only. Adopted by the National Coordinating Council for Medication Error Reporting and Prevention.
Actions/Decisions are those of the Council as a whole and may not reflect the views/positions of individual member organizations.