Healthcare Workers At Risk: Researchers at Utah's Huntsman Cancer Institute Demonstrate Biological Uptake of Chemotherapy Drugs.

Traditional assumptions about safe drug handling are challenged by a study published in the current edition of the American Journal of Health-System Pharmacy. This study confirms European findings that, despite existing protective measures, there persists widespread surface contamination with antineoplastic drugs in the workplace and employee exposure to carcinogenic or mutagenic particulates and vapors. Results show that the PhaSeal(r) System, now distributed in the U.S. by Denver-based Baxa Corporation can reduce or eliminate human exposure to cancer chemotherapy drugs.

Englewood, CO November 18 2003--In a study published in the current edition (dated Nov. 15, 2003) of the American Journal of Health-System Pharmacy, clinicians from the University of Utah report they reduced employee exposure and surface contamination in the chemotherapy infusion center of the Huntsman Cancer Institute by using PhaSeal(r), a closed system for hazardous drug preparation and administration distributed in the U.S. by Denver-based Baxa Corporation. The announcement is made by Greg Baldwin, Baxa Corp. chairman and CEO.

The study, entitled "Using a Closed-System Protective Device to Reduce Personnel Exposure to Antineoplastic Agents," documented the biological uptake of cyclophosphamide and ifosfamide in infusion center pharmacy and nursing staff despite their use of standard precautions and guidelines for safe handling. Six months following the adoption of the PhaSeal System, the presence of these two drugs in urine samples from center personnel was reduced to undetectable levels. The study also showed that drug contamination initially detected on infusion center surfaces was significantly reduced following implementation of the PhaSeal System.

"As a result of our study, we've now extended the use of the PhaSeal System from Huntsman to everywhere within the University of Utah Hospitals and Clinics where cancer chemotherapy is handled and prepared," says James Jorgenson, RPh, MS, one of the study's authors and Director of Pharmacy and Associate Dean for Professional Affairs at the University of Utah.

Baseline measurements of personnel exposure to the chemotherapy drugs cyclophosphamide and ifosfamide were made in January 2002 in the Huntsman Cancer Institute's chemotherapy infusion center and pharmacy. Surface contamination was measured by collecting wipe samples of selected facility and equipment surfaces. These measurements yielded positive results for all samples.

Urine samples were collected from infusion center pharmacy and nursing personnel at the same time. Test results indicated that there had been biological uptake of the two drugs in infusion center nursing and pharmacy staff.

"These positive results surprised us for two reasons," says Mr. Jorgenson. "First, Huntsman opened in November 2000, so it was virtually a brand new facility with state-of-the-art equipment and staff training. Second, the only chemotherapy exposure for the pharmacy technician who tested positive was checking in and shelving the daily drug order."

Following the baseline tests, the PhaSeal closed-loop drug containment system was implemented in the chemotherapy infusion center, while continuing the preparation and administration safeguards already in use. Six months later, in June 2002, the urine and surface wipe tests were repeated. These results demonstrated that after six months of PhaSeal use, the two chemotherapy drugs were no longer detectable in urine samples and surface contamination was significantly reduced.

A special assay method was designed for this study to detect both drugs in a single sample using mass-spectrometry with liquid chromatography.

About the Investigators
Authors of the study, all affiliated with the University of Utah, were: Catherine Wick, PharmD, Clinical Pharmacist; Mathew H. Slawson, PhD, Assistant Director, Center of Human Toxicology and Research Professor, Pharmacology and Toxicology; James A. Jorgenson, RPh, MS, Director of Pharmacy and Associate Dean for Professional Affairs; and Linda S. Tyler, PharmD, Pharmacy Manager for Drug Information Services and Professor (Clinical) Pharmacy Practice.

About Baxa Corporation
As a leading provider of devices and systems for the preparation, handling, packaging, and administration of liquid medications, Baxa manufactures and markets a wide range of healthcare products for use in hospitals, critical care units and alternate-site pharmacies. Headquartered in Englewood, Colorado, Baxa has subsidiaries and sales offices in Canada, the United Kingdom; Denmark, and Germany; and distribution partners worldwide. Further information is available at http://www.baxa.com.

About Carmel Pharma ab
The PhaSeal System is manufactured in Sweden by Carmel Pharma ab of Gorg, Sweden. Introduced in Europe in 1994, the PhaSeal System is now used in most Swedish hospitals, with its benefits documented by a significant body of scientific research on the health risks associated with the preparation and administration of cytotoxic drugs. The PhaSeal System is protected by a comprehensive patent portfolio in the U.S., European Union and Japan. For more information on Carmel Pharma, visit http://www.carmelpharma.se.

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Contacts:

Marian Robinson, Vice President, Marketing Baxa Corporation: 800.567.2292 ext. 2157 or 303.617.2157 -- Email: e-mail protected from spam bots

Maggie Chamberlin Holben, APR, Absolutely Public Relations: 303.984.9801 or 303.669.3558 -- Email: e-mail protected from spam bots