Abbott Laboratories Supports FDA's Final Bar Code Rule

ABBOTT PARK, Ill. -- Abbott Laboratories has reaffirmed its support of the U.S. Food and Drug Administration's (FDA) final bar coding rule, which will require bar codes on most drugs and biological products for human use within two years after the

rule's effective date. The vast majority of Abbott's bar-coded hospital

products will become part of Hospira, the independent global hospital products

business Abbott plans to launch in the first half of 2004.

In March 2003, the company completed an industry-leading effort to affix

unit-of-use bar codes to 100 percent of its hospital injectable

pharmaceuticals and intravenous (IV) solutions. The initiative encompassed

more than 1,000 products and has the ability to impact patient safety where it

is most critical, at the patient bedside. Additionally, virtually all of

Abbott's oral pharmaceuticals distributed in bottles to hospitals in the

United States already include bar codes. Abbott has also made progress in its

efforts to use bar code technology across hospital unit-dose packaging of

these oral medications.

The FDA's final rule is designed to enhance patient safety and help reduce

the number of medication errors in this country. At a minimum, the FDA will

require that bar codes contain the product's National Drug Code (NDC) number,

which identifies the company's name, the drug's name, and its strength and

dosage form.

"This mandate is an important part of a larger FDA initiative to address

the problem of medication errors; it's an effort we wholeheartedly support,"

said Christopher B. Begley, currently senior vice president of hospital

products at Abbott Laboratories and the named CEO of

Hospira. "Our company's bar coding initiative underscores our overall

commitment to patient safety, and we look forward to continuing to provide

innovative products and solutions that help improve medication management."

Bar codes can have a positive, significant impact in helping to reduce

medication errors and enhance patient safety. For example, bar codes on

medications allow the cross-checking of what healthcare professionals call

the "five rights" -- right patient, right drug, right dose, right route of

administration, and right time -- by scanning the patient's wristband, the

nurse's ID badge and the drug to be administered, and then matching them with

a computerized list of medications.

Addressing the challenge of affixing bar codes to smaller or odd-shaped

containers, Abbott is the first company to introduce Reduced Space

Symbology (RSS) technology commercially on its hospital injectable

pharmaceuticals and IV solutions. RSS technology allows for a miniaturized

bar code to be applied to single-unit containers as small as a pen cap.

Studies have shown that bar codes may dramatically reduce the risks

associated with improper dosing and/or administration of drugs, lowering

medication error rates by approximately 85 percent. Of note, the Veterans

Affairs (VA) Medical Center in Topeka, Kan., reduced its medication error

rate by 86.2 percent after it implemented a bar coding system. A hospital in

New Hampshire lowered its medication error rate by 80 percent.

In addition to its pioneering bar coding initiative, Abbott's hospital

products business recently launched Abbott MedNet, a drug library software

that provides clinical decision rules for up to 1,200 medications and is

designed to improve medication management at the hospital patient's bedside,

offering protection against IV-medication errors. Setting a new industry

standard, the software is the first to offer "best-practice" guidelines for

both hard and soft dose- and rate-setting limits for primary and secondary

infusion. MedNet is the newest addition to the company's Encoded Care

initiative, which highlights the technology-driven solutions that may help

customers enhance productivity and improve patient care. Also in the product

portfolio is LifeCare PCA3 Infusion System, a patient-controlled analgesia

(PCA) device -- the first of its kind to incorporate a built-in bar code

reader to identify and verify drug and dose concentrations automatically.

In August 2003, Abbott Laboratories announced it would create a new

company comprised of its global core hospital products business, which was

recently named Hospira. As a specialty pharmaceutical and medication delivery

company, Hospira's business will include: medication delivery systems, such as

medication management systems (including electronic pumps and the new MedNet

drug library software), infusion therapy and critical care products; and

specialty injectable pharmaceuticals, including generic acute-care injectables

and intensive care pharmaceuticals. Once the new company is launched, which

is expected to be in the first half of 2004, it will have approximately 14,000

employees worldwide, will be headquartered in Lake Forest, Ill., north of

Chicago, and will be among the largest manufacturers of hospital products in

the United States.

Abbott Laboratories is a global, broad-based healthcare company devoted

to the discovery, development, manufacture and marketing of pharmaceuticals,

nutritionals, and medical products, including devices and diagnostics. The

company employs more than 70,000 people and markets its products in more than

130 countries.

Source: Abbott Laboratories

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