According to the Centers for Disease Control and Prevention (CDC), about 8 million US health care workers—including pharmacists, pharmacy technicians, nurses, providers, and environmental service workers—are potentially exposed to hazardous medications.1 The Occupational Safety and Health Administration (OSHA) has identified worker exposure to hazardous medications, which can occur during the drug preparation, administration, and disposal processes, as a problem of increasing health concern.2
Per USP General Chapter <800>, a closed system drug-transfer device (CSTD) mechanically prohibits both environmental contaminants from entering the system and the escape of hazardous medication or vapors from the system.3 The chapter states that CSTDs should be used when compounding hazardous medications and must be used when administering antineoplastic hazardous medications (when the dosage form allows).3 With the advent of USP <800>, implementing both CSTDs and an environmental wipe sampling program to verify containment are critical steps in the effort to ensure safe handling of hazardous medications.
Alaska Native Medical Center (ANMC) is a 167-bed hospital that provides comprehensive medical services to Alaska Native and American Indian people throughout Alaska. Outpatient oncology and infusion services are provided in an ambulatory infusion center, as well as on an inpatient basis. In our efforts to ensure compliance with USP <800>, the hospital recently began a process of identifying areas for improvement.
Identifying an Improvement Focus
In addition to requiring CSTD use during drug administration and recommending use during preparation, USP <800> recommends that environmental wipe sampling be routinely performed—for example, initially as a benchmark and every 6 months or more frequently as needed to verify containment.3 Also, medical surveillance be performed initially at baseline, periodically thereafter, and upon termination of employment.
Protecting the health of our employees and ensuring USP <800> compliance are critical concerns at ANMC. A multidisciplinary team, encompassing nursing, pharmacy, and environmental health, identified implementing both CSTDs and an environmental wipe sampling program as crucial strategies for achieving these goals. Specific areas identified as requiring improvement included:
- Identifying baseline detection of hazardous medications in pharmacy and nursing work areas
- Evaluating and implementing CSTDs for use by pharmacy and nursing
- Monitoring detection of hazardous medications on compounding and medication administration surfaces
Choosing and Implementing a CSTD
The multidisciplinary team evaluated five devices, judging them according to ease of use for pharmacy and nursing, the number of components required, and a literature review. After a device was chosen, the team developed a staff-training program—including hands-on compounding and administration using simulated hazardous medications—which is required for each employee who would use the device. A total of 75 staff members were initially trained. Compliance was assessed by direct observation of staff competencies, and noted in employee files for documentation purposes.
Surface Sampling Program
To develop an effective wipe sampling program, the team selected a test that detected the highest volume chemotherapies compounded at our facility: carboplatin and oxaliplatin. Sampling locations were determined in collaboration with environmental health using USP <797> recommendations. The testing areas included three locations in the pharmacy (the floor and counter in the negative pressure room and inside the negative pressure hood) and four areas in the infusion area (on the desk, on the floor by the patient chair, on the medication room counter, and on the floor in the patient restroom). The wipe sampling procedure was performed by our environmental health department in collaboration with pharmacy. Testing occurred in the pharmacy and nursing areas after periods of typical use.
Samples were sent to a third-party company for analysis. The results, which demonstrated the surface concentration of the marker drugs, were returned to the environmental health department and then analyzed by the multidisciplinary team.
Baseline wipe sampling revealed that most samples were under the quantitation limit, with the exception of two oxaliplatin samples—one taken from the pharmacy floor and another from the infusion center medication room counter. Follow-up sampling, which occurred 8 months after CSTD implementation, revealed levels below the quantitation level for all sites—a significant improvement from baseline. To document compliance, electronic reports are stored and are easily retrievable in the event of an audit. Moving forward, surface sampling is scheduled to occur every 6 months.
The improvement in the number of samples above the quantitation limit illustrates the value of implementing CSTDs in drug preparation and administration. Moreover, environmental wipe sampling was key to better understanding potential error points in our hazardous medication handling processes.
Maintaining high standards and creating a positive collaborative environment where employees are held accountable for maintaining safe practices was critical to ensuring a culture of safety at ANMC. Moving forward, we plan to identify other opportunities to increase USP <800> compliance. Future goals include performing a gap analysis of current practice and implementing changes based on the chapter and NIOSH’s 2016 List of Antineoplastic and Other Hazardous Drugs. In addition, we strive to ensure that safe practices are continuously maintained following the relocation and expansion to an 18-chair ambulatory infusion center.
- Hazardous Drug Exposures in Health Care. Centers for Disease Control and Prevention and National Institute for Occupational Safety and Health Web site. http://www.cdc.gov/niosh/topics/hazdrug/. Accessed November 18, 2016.
- Safety and Health Topics: Hazardous Drugs. United States Department of Labor and the Occupational Safety and Health Administration Web site. https://www.osha.gov/SLTC/hazardousdrugs/ Accessed November 18, 2016.
- Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. In: 2016 USP Compounding Compendium. Rockville, MD: USP Convention: 2016: 85-103.
Anne Marie Bott, PharmD, BCOP, BCPS, NCPS, is a commander in the United States Public Health Service and the Indian Health Service (IHS) Alaska area oncology pharmacist at the Alaska Native Medical Center in Anchorage, Alaska. She received her PharmD from Virginia Commonwealth University in 2005 and completed an IHS pharmacy practice residency in 2006.
Ashley Schaber, PharmD, MBA, BCPS, NCPS, is a commander in the United States Public Health Service and the inpatient pharmacy manager at Alaska Native Medical Center in Anchorage, Alaska. She received her PharmD from University of Georgia in 2006 and completed a pharmacy practice residency in 2007.
The authors would like to thank Jennifer Karpinski, Senior Editor at Pharmacy Purchasing & Products magazine, for writing and editing assistance on this article.
Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
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