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 closed system technology (CST) can reduce or eliminate human exposure to cancer chemotherapy drugs. A case study covering M.D. Anderson's experience with CST follows.
Englewood, CO (PRWEB) July 31, 2003 -- The story of closed system technology (CST) 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 CST 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 CST Technology:
At about the same time, a Swedish company was developing a series of disposable containment devices. 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. CST 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 CST.
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 CST:
Having discovered the scope of the problem in North America, Dr. Anderson decided to evaluate CST 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 CST in containing drug contamination in a clean, new environment. The new study, again led by Drs. Connor and Anderson, tested CST 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 CST 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 closed system technology," commented Dr. Connor.
The First to Implement CST:
The outcome of the study was the decision by MD Anderson in 2000 to implement CST throughout the hospital. This made MD Anderson the first US hospital to adopt the technology. "We've put closed systems 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 CST. This study, published in early 2003, supports previous findings on CST effectiveness. No release of the fluorescent test agent was observed in any of the 75 documented manipulations involving CST. 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 CST, according to Baxa Corporation.
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 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, marian.robinson@baxa.com
Maggie Chamberlin Holben, APR, Absolutely Public Relations: 303.984.9801, 303.669.3558,
maggie@absolutelypr.com
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