MD Anderson and PhaSeal®: A Leader in Science Leads Adoption of New Closed System Technology For Safe Handling of Hazardous Drugs
Traditional assumptions about safe drug handling are challenged by recent studies of U.S. and Canadian drug preparation facilities conducted by the M.D. Anderson Cancer Center and others. These studies confirm 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 System, now distributed in the U.S. by Baxa Corporation, can reduce or eliminate human exposure to cancer chemotherapy drugs. A case study covering M.D. Anderson's experience with the new PhaSeal System follows.
Englewood, CO (PRWEB) July 31, 2003 -- The story of the PhaSeal System in the
United States grows out of the history of pharmacy safety initiatives led by the
MD Anderson Cancer Center in Houston, Texas. Thanks to MD Anderson's leadership
in safety, a growing number of US hospitals are now adopting PhaSeal, the only
closed system for safe handling of hazardous drugs.
It was 1982 when
health professionals were first challenged to rethink workplace safety by
research conducted at MD Anderson. In studies that measured employee exposure to
antineoplastic drugs, Roger W. Anderson, PharmD, Director, Division of Pharmacy
at MD Anderson, and his colleagues observed mutagenicity in the urine of all
employees who had prepared drugs in traditional horizontal laminar-flow hoods.
In contrast, they found no urine mutagenicity in those who had used a new
technology called vertical-flow biological safety cabinets (BSCs). See
references 1 and 2.
Re-Examining Standards and Practices:
These
results prompted awareness among healthcare workers of a safety problem in the
nation's pharmacies. MD Anderson and other US hospitals decided to implement
BSCs in their drug preparation facilities. Professional organizations revised
their standards governing exposure to hazardous agents. Updated guidelines for
safe drug handling began to be established in the mid-1980's just as the next
generation of antineoplastic drugs swelled the application of chemotherapy to
treat cancer.
Awareness of new safety problems arose in the mid-1990's,
initially in Europe, when investigators adopted new, more sensitive methods of
chemical detection in the environment. Dutch toxicologist Paul Sessink,
pioneering the use of surface wipe tests with a new chemical analytical
monitoring technique, discovered widespread contamination with cytotoxic agents
in European drug preparation facilities. The fact was surprising, given the
universal acceptance of safe handling guidelines. But, as Dr. Sessink found, the
problem lay less with the guidelines than with the drug handling practices of
employees.
Discovering the PhaSeal Technology:
At about the same time,
a Swedish company, Carmel Pharma ab, was developing a series of disposable
containment devices under the brand name PhaSeal. Designed to isolate hazardous
drugs during preparation and administration, the new system was based on a novel
approach. Instead of containing workers within protective gear, the idea was to
contain the hazard within a closed system, thereby simplifying safe handling
practices for workers. The PhaSeal System soon became widely instituted
throughout Europe.
Dr. Anderson invited Dr. Sessink to present his
research in Houston early in 1997. It was at this meeting that Dr. Anderson and
his colleagues first learned about the science of the PhaSeal
System.
Defining the Problem in North America:
Later that year, Dr.
Thomas H. Connor and Dr. Anderson led a team to study surface contamination in
six cancer treatment centers in the US and Canada. Dr. Sessink's new analytical
monitoring tool was used and provided the investigators with better detection
capability than had been available in 1982.
Their published findings
confirmed the European experience that, despite published safeguards, the
workplace remained contaminated with hazardous chemotherapy drugs. They found
that worker exposure to carcinogenic or mutagenic particulates and vapors was
widespread. See reference 3.
Confirming the Efficacy of
PhaSeal:
Having discovered the scope of the problem in North America, Dr.
Anderson decided to evaluate the PhaSeal technology in MD Anderson's Ambulatory
Treatment Center for one year. It was determined that a planned rebuilding of
the Center's IV preparation area in the fall of 1999 offered an ideal
opportunity to measure the effectiveness of the PhaSeal System in containing
drug contamination in a clean, new environment. The new study, again led by Drs.
Connor and Anderson, tested the PhaSeal System in a completely rebuilt facility
equipped with brand-new BSCs and furnishings.
In their published study,
the MD Anderson team reported apparent containment of new surface contamination
when the PhaSeal System was used for drug preparation in BSCs. See reference 4.
"Our results showed that we can reduce or eliminate human exposure to cancer
chemotherapy drugs by using the PhaSeal System," commented Dr.
Connor.
The First to Implement PhaSeal:
The outcome of the PhaSeal
effectiveness study was the decision by MD Anderson in 2000 to implement the
PhaSeal System throughout the hospital. This made MD Anderson the first US
hospital to adopt the system. "We've put the PhaSeal System in place for all
doses prepared and administered in our hospital," Dr. Anderson said. "We're
convinced it will greatly enhance the safety of the workplace for our
employees."
A further study performed at MD Anderson by Dr. Susan Spivey
and Dr. Connor employed a fluorescent agent to visually compare leakage from
mock manipulations using a traditional needle/syringe technique versus the
PhaSeal closed system. This study, published in early 2003, supports previous
findings on PhaSeal's effectiveness. No release of the fluorescent test agent
was observed in any of the 75 documented manipulations involving the PhaSeal
System. See reference 5.
As it did with BSCs 20 years ago, the MD
Anderson Cancer Center has helped redefine workplace safety in the US by leading
the scientific evaluation of this new closed-system technology for containing
hazardous drugs. Today, more than 100 US hospitals are using the PhaSeal System,
according to Baxa Corporation, the exclusive US
distributor.
References:
1 Anderson RW, Puckett WH, Dana, WJ. Risk of
handling injectable antineoplastic agents. Am J Hosp Pharm. 1982;
39:1881-7.
2 Nguyen TV, Theiss JC, Matney TS et al. Exposure of pharmacy
personnel to mutagenic antineoplastic drugs. Cancer Res.
1982;
42:4792-6.
3 Connor TH, Anderson RW, Sessink PJ et al. Surface
contamination with antineoplastic agents in six cancer treatment centers in
Canada and the United States. Am J Health-Syst. Pharm. 199; 56:1427-32.
4
Connor TH, Anderson RW, Sessink PJ, Spivey S. Effectiveness of a closed-system
device in containing surface contamination with cyclophosphamide and ifosfamide
in an i.v. admixture area. Am J Health-Syst. Pharm. 2002; 59:68-72.
5
Spivey s, Connor TH. Determining sources of workplace contamination with
antineoplastic drugs and comparing conventional i.v. drug preparation with a
closed system. Hosp Pharm. 2003; 38 no. 2: 135-139.
About MD
Anderson:
MD Anderson, part of the University of Texas System, was created by
the legislature in 1941. One of the first three Comprehensive Cancer Centers
designated by the National Cancer Institute, it serves more than 60,000 patients
annually. Named the nation's top cancer hospital by US News & World Report
in 2002 and 2000, MD Anderson has ranked as one of the top two cancer centers
each year since 1990. More information is available at http://www.mdanderson.org.
About Carmel
Pharma:
Carmel Pharma ab manufactures the PhaSeal closed-system products at
its headquarters in Goteborg, Sweden. Active in the market since 1994, PhaSeal
is now used in most Swedish hospitals, and its benefits are backed by a
significant body of scientific research on the health risks related to
preparation and administration of cytotoxic drugs. The PhaSeal System is
protected by a comprehensive patent portfolio in the US, European Union and
Japan. More information is available at http://www.carmelpharma.se.
About Baxa
Corporation:
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, and Denmark, and distribution
partners worldwide. Further information is available at http://www.baxa.com.
Click
the following link to view a presentation by Jim Jorgenson "Using a Closed
System Device to Reduce Occupational Exposure to Hazardous Drugs." Jorgenson is
Director of Pharmacy for the Huntsman Cancer Institute and Associate Dean for
Professional Affairs at the University of Utah:
http://www.isips.org/presentations/PhaSeal/player.html
For
More Information, Contact:
Marian Robinson, Vice President, Marketing,
Baxa Corporation: 800.567.2292 ext. 2157, 303.617.2157, e-mail protected from
spam bots
Maggie Chamberlin Holben, APR, Absolutely Public Relations:
303.984.9801, 303.669.3558,
e-mail protected from spam bots
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Source : http://www.prweb.com/releases/2003/7/prweb74462.htm