Abbott Laboratories Supports FDA’s Final Bar Coding Rule

Abbott Park, Illinois, February 25, 2004 — Abbott Laboratories today 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 (I.V.) 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, Hospital Products, Abbott Laboratories and the named chief executive officer 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 health care 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 I.V. 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, Kansas, 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 I.V. 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, Illinois, north of Chicago, and will be among the largest manufacturers of hospital products in the United States.

Abbott Laboratories is a global, broad-based health care 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.

Reduced Space Symbology is a registered trademark of Uniform Code Council, Inc.