In May 2009, the National Institute for Occupational Safety and Health (NIOSH) received a confidential employee request for a health hazard evaluation (HHE) at a Florida oncology clinic, concerning possible employee exposure to chemotherapy drugs.1 Thus, NIOSH investigators began an evaluation of the site’s cleaning procedures and employee work practices. A site visit was conducted in September of that year, which measured the face velocity of the Class 2 biological safety cabinet (BSC) where chemotherapy was mixed, and surface and hand samples were collected for platinum-containing chemotherapy agents. In addition, NIOSH investigators conducted health interviews with 14 of 54 employees and reviewed the OSHA Form 300 Log of Work-Related Injuries and Illnesses for 2006-2008.
A second evaluation of the facility occurred in November 2010, when surface wipe samples for platinum-containing chemotherapy drugs were collected (in similar locations to the first evaluation), as well as surface wipe samples for cyclophosphamide, ifosfamide, and doxorubicin at the start of the work day, prior to unpacking chemotherapy, and at the end of the work day, after the last chemotherapy treatment was completed.
Results of the NIOSH Investigation
The results of these evaluations highlight important findings:
- Platinum-containing chemotherapy drugs were detected in most surface wipe samples during both evaluations, but not on the two hand wipes collected in 2009 from nurses who had recently handled platinum-containing chemotherapy.
- Cyclophosphamide and ifosfamide were detected on surface wipe samples collected throughout the clinic, suggesting inadequate work practices and housekeeping. Doxorubicin was not detected on any surface wipe samples, but it should be noted that recovery may have been poor because the wipe samples were frozen for approximately 7 months awaiting development of an analytical method.
- The Class 2 BSC was certified biannually. An alarm that was malfunctioning during the first visit had been repaired by the second visit, and the BSC face velocity measured 275 feet per minute, meeting CDC recommendations of at least 100 feet per minute.
- Four of 14 employees interviewed reported health symptoms, including runny nose, sneezing, eye irritation, and headache that improved when they were not at work. One of the four reported a recurrent burning rash on his nose after handling chemotherapy drug waste. All employees interviewed reported sufficient training about the safe preparation, administration, and disposal of chemotherapy drugs, but three employees reported inadequate training on the potential short‐ and long-term health effects of chemotherapy exposure.
Investigators noted other interesting findings. Cyclophosphamide residue was found in the clinic pharmacy (on the floor in front of the BSC and the prepared drugs), in a treatment room (under an IV stand next to the first chair), and in the checkout area (on the desk surface). Although no spills or accidents were reported, it is possible that there may have been surface contamination or an undetected leak in an IV bag. The results from surface sampling in the treatment room were among the highest detected during the investigation, suggesting that cyclophosphamide was stable in that environment and that housekeeping procedures were not effectively removing this medication in one cleaning.
Moreover, cyclophosphamide was detected in all surface wipe samples collected in the checkout area, which is significant because chemotherapy drugs were not administered in the checkout area. This is particularly alarming, as employees working in this area do not wear PPE, and patients in the checkout area could unknowingly be exposed to chemotherapy agents outside of their treatment regimen. In addition, patients’ family members and the general public may be exposed. Although the source of chemotherapy in the checkout area was not identified, possible sources include contaminated paperwork, contaminated skin of employees, or patients themselves.
Based on inconsistent use of personal protective equipment (PPE) and the presence of chemotherapy residue in the clinic work area, NIOSH investigators concluded that employees were at risk of developing both acute and chronic health effects from exposure to chemotherapy. NIOSH recommended that the clinic improve employee work practices and housekeeping, start an employee medical surveillance program, provide annual training, and require the use of appropriate PPE when handling chemotherapy drugs.
Scope of the Problem
The Florida clinic’s deficiencies described in the NIOSH HHE report are not an aberration; many organizations struggle with reducing staff exposure to chemotherapy. Although safe handling guidelines have been established, adherence has been sporadic, and the problem of occupational exposure to hazardous drugs in hospitals persists. Measurable concentrations of some hazardous drugs have been documented in the urine of health care workers who prepare or administer these medications, even after safety precautions have been put in place. Likewise, environmental studies of patient care areas have documented measurable concentrations of drug contamination, even in facilities following recommended handling guidelines.2 Clearly, continued vigilance is required to reduce staff exposure to chemotherapy. NIOSH’s recommendations to the oncology clinic can be extrapolated and utilized to reduce hazardous drug exposure at other facilities that handle, prepare, and administer hazardous drugs.
Recommendations for Reducing Exposure
NIOSH suggested the clinic follow a hierarchy of controls approach to reduce staff exposure to hazardous drugs; this method groups actions by their likely effectiveness to reduce or remove chemotherapy contamination.1
Engineering controls reduce exposure to employees by removing the hazard from the process or placing a barrier between the hazard and the employee, and are extremely effective at protecting employees without placing the onus of primary responsibility on the employee.
Management-dictated work practices and policies to reduce or prevent exposures to hazardous drugs—also known as administrative controls—are effective contingent on employer commitment and staff acceptance. Routine monitoring and reinforcement are required to ensure that policies and procedures (P&Ps) are not circumvented. NIOSH suggests that safe hazardous drug handling P&Ps be reviewed with participation of administration and staff, and that on the basis of this review, a hazard communication program—ie, worker and employer right-to-know for all hazardous drugs used in an organization—be developed.
- Increase Training. Provide additional training on proper procedures for handling chemotherapy drugs to employees, including wearing PPE, using BSCs, cleaning and housekeeping requirements, disposal of chemotherapy drugs, and spill management. Training should include a hands-on requirement to demonstrate proficiency—for example, test kits using fluorescein dye can help assess employee technique during handling, preparing, and cleaning steps. Training should occur upon hire before beginning work duties and thereafter at least annually (or more often if deficiencies are identified). Competency testing should be performed to evaluate training effectiveness. Moreover, duty-specific training on the potential harmful effects of hazardous drug exposure is necessary.
- Implement a Medical Surveillance Program. Start a medical surveillance program for staff members who handle chemotherapy. Specific information on developing such a program is available at http://www.cdc.gov/niosh/docs/wp-solutions/2013-103/pdfs/2013-103.pdf.3 In addition, encourage employees to report all health concerns to their supervisors. These employees should be evaluated by health care providers who are knowledgeable about occupational diseases.
- Ensure Robust Cleaning Practices. Establish and clearly communicate cleaning P&Ps with janitorial staff or other staff cleaning areas where chemotherapy is handled. BSCs should be cleaned with a deactivating agent and disinfectant at the beginning and end of each shift, before and after each activity, and after spills. ASHP notes that strong oxidizing agents—such as sodium hypochlorite solution—may effectively deactivate many chemotherapy agents.4 Due to the corrosive nature of sodium hypochlorite on surfaces, using a thiosulfate-based solution after cleaning with sodium hypochlorite can help neutralize its effect. USP <797> requires a final cleaning with a residue-free disinfecting agent, such as sterile 70% isopropyl alcohol.5
- Implement Surface Sampling. Sample work surfaces periodically for chemotherapy drugs. Although NIOSH and OSHA have not established occupational exposure limits for surface levels of chemotherapy drugs, periodic sampling allows comparisons over time to assist in evaluating the effectiveness of employee work and cleaning practices, and administrative controls.
- Personal Protective Equipment
NIOSH considers PPE the least effective means for controlling employee exposures to hazardous drugs; proper use of PPE requires a comprehensive program and a high level of employee involvement and commitment to be effective. PPE should not be relied on as the only method of limiting employee exposures to hazardous drugs. (See reference 1 for specific PPE recommendations.)
As illustrated by the NIOSH investigation of the Florida oncology clinic, chemotherapy exposure remains a threat to health care workers handling, preparing, and administering these drugs. Therefore, ensuring that the appropriate engineering controls, administrative controls, and PPE are in place to protect employees is necessary to reduce the chance of hazardous drug exposure. Moreover, remaining abreast of guidelines, conducting appropriate staff training, and implementing effective cleaning practices and a medication surveillance program can assist in protecting health care workers from exposure.
- Couch J and West C. CDC and NIOSH Health Hazard Evaluation Report, June 2012 (HETA 2009-0148-3158). Chemotherapy Drug Exposures at an Oncology Clinic—Florida. http://www.cdc.gov/niosh/hhe/reports/pdfs/2009-0148-3158.pdf. Accessed September 28, 2015.
- DHHS (NIOSH) Publication No. 2004-165. Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf. Accessed September 28, 2015.
- DHHS (NIOSH) Publication No. 2013-103 (Supersedes 2007-117), November 2012. Workplace Solutions From NIOSH. Medical Surveillance for Healthcare Workers Exposed to Hazardous Drugs. http://www.cdc.gov/niosh/docs/wp-solutions/2013-103/pdfs/2013-103.pdf. Accessed September 28, 2015.
- American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs. Am J Health-Syst Pharm. 2006;63(12):1172-1193.
- USP Chapter <797>. Pharmaceutical Compounding—Sterile Preparations. Rockville, MD: United States Pharmacopeia and National Formulary, 2008.
Jennifer Karpinski is a senior editor at Pharmacy Purchasing & Products magazine, and can be reached at firstname.lastname@example.org.
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