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«Evaluation of Chemotherapy Drug Exposure in an Outpatient Infusion Center Christine West, RN, MSN/MPH, COHN-S Catherine Beaucham, MPH, CIH Report No. ...»

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Evaluation of Chemotherapy Drug Exposure

in an Outpatient Infusion Center

Christine West, RN, MSN/MPH, COHN-S

Catherine Beaucham, MPH, CIH

Report No. 2013-0019-3205

March 2014

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention

Page 1

Health Hazard Evaluation Report 2013-0019-3205

National Institute for Occupational Safety and Health

Contents

Highlights

Abbreviations

Introduction

Methods

Results and Discussion

Conclusions

Recommendations

Appendix A

Appendix B

References

The employer is required to post a copy of this report for 30 days at or near the workplace(s) of affected employees. The employer must take steps to ensure that the posted report is not altered, defaced, or covered by other material.

The cover photo is a close-up image of sorbent tubes, which are used by the HHE Program to measure airborne exposures. This photo is an artistic representation that may not be related to this Health Hazard Evaluation. Photo by NIOSH.

Health Hazard Evaluation Report 2013-0019-3205 Page 2 Highlights of this Evaluation The Health Hazard Evaluation Program received a request from a regional hospital. The employer was concerned about possible adverse health effects in employees from handling chemotherapy drugs in the outpatient cancer and infusion center.

What We Did ● We visited the infusion center in June 2013.

● We observed how employees received, stored, administered, and disposed chemotherapy We evaluated employee drugs.

exposure to chemotherapy ● We talked to employees about their w

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Page i Health Hazard Evaluation Report 2013-0019-3205 What the Employer Can Do ● Require employees to wear chemotherapy gowns and gloves whenever handling chemotherapy drugs.

● Advise employees to wear safety goggles rather than prescription glasses when cleaning up a drug spill or when chemotherapy drugs might splash.

● Ensure employees who receive the chemotherapy drug shipments are aware of the potential for contamination of outer surfaces of drug containers and protect themselves.

● Start a medical surveillance program for employees who handle chemotherapy drugs.

● Train all employees about the short and long-term health effects of chemotherapy drug exposures.

● Update procedures for handling hazardous drugs safely.

● Encourage employees to report work-related illnesses to hospital occupational health and safety representatives as soon as possible.

● Ensure there is employee participation on the infusion center safety committee.

● Adjust the isolation cabinet height to fit employees.

What Employees Can Do ● Wear all required personal protective equipment when handling chemotherapy drugs.

● Report any workplace health concerns to the employer.

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Health Hazard Evaluation Report 2013-0019-3205 Page iv Introduction The Health Hazard Evaluation Program received a request from a regional hospital. The employer was concerned about health symptoms (burning and itchy eyes, itchy skin, hair loss, and metallic taste in the mouth) among outpatient cancer and infusion center (referred to in this report as infusion center) employees potentially associated with chemotherapy drug exposure in the workplace. We visited the infusion center in June 2013 and shared our preliminary findings, observations, and recommendations with employer and employee representatives.

The infusion center opened in 2009 in a separate building approximately 1,500 feet from the hospital. The center employed 10 clinical and administrative staff and provided outpatient treatment to approximately 4 patients per day during the time of our visit which is the typical number of patients treated at this clinic.

Methods Our main objectives of the evaluation were to assess whether (1) the infusion center’s work surfaces were contaminated by chemotherapy drugs; (2) the cabinet used to compound chemotherapy drugs was operating as designed; (3) employee symptom reports could be related to chemotherapy drug exposure; and (4) procedures were adequate to protect employees from chemotherapy drug exposures.

Surface Wipe Samples We collected surface wipe samples for platinum-containing drugs (cisplatin, carboplatin, oxaliplatin), gemcitabine, irinotecan, cyclophosphamide, and 5-fluorouracil (Table 1). We selected these drugs on the basis of (1) frequency of use in the infusion center, (2) presence on the National Institute for Occupational Safety and Health (NIOSH) hazardous drug list, and (3) availability of a sampling and analytical method. We selected wipe sample locations based on findings from previous health hazard evaluations and other research [Connor and McDiarmid 2006; NIOSH 2012b] and where employees could touch with non-gloved hands. We evaluated these surfaces before, during, and after drug administration. For each sample, we wore a clean pair of chemotherapy protective gloves and used a new 100 square centimeter (cm2) disposable template to determine the sampling area. We wiped the area twice, once with the first texwipe, texwipe swab, or Whatman filter, and then again with a second wipe as described in Connor et al. 2010.





Compounding Aseptic Containment Isolator Cabinet and General Ventilation Evaluation We used a TSI Model 8386 VelociCalc®Plus Multi-Parameter Ventilation Meter for all ventilation measurements. We evaluated the direction of airflow between the pharmacy and the hallway, the infusion room and the hallway, and the hazardous waste storage room and the hallway to see if there was a potential for contaminated air to spread to other areas of the

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infusion center. We also evaluated the direction and velocity of airflow in the isolator cabinet used for mixing chemotherapy drugs. In addition, we reviewed a hospital consultant’s report of an isolator cabinet evaluation.

Employee Interviews, Injury/Illness Logs, and Medical Records We interviewed nine of 10 employees who worked in the infusion center. During these health interviews, we asked about work history, handling of chemotherapy drugs, acute and chronic health symptoms, personal cancer history, reproductive health history, use of personal protective equipment, and workplace health and safety training. We reviewed the Occupational Safety and Health Administration (OSHA) Form 300 Log of Work-Related Injuries and Illnesses for years 2008–2012. We reviewed employee records from medical evaluations performed by a physician contracted by the hospital’s employee health program in October 2012 to evaluate employee health concerns. The medical evaluations included physical exams, health histories, urinalyses, blood tests for liver and thyroid function, and complete blood counts, including the percentage of each type of white blood cell.

Review of Hazardous Drug Procedures We reviewed the infusion center’s standard operating procedures for handling hazardous drugs, list of hazardous drugs at the infusion center, isolator cabinet use policies, isolator cabinet inspection reports, and list of personal protective equipment required by job title.

Health Hazard Evaluation Report 2013-0019-3205 Page 2 Results and Discussion Observations During our visit, a drug distributor shipped small boxes containing chemotherapy drugs to the hospital’s main receiving area. These shipments occurred approximately 3 days a week.

The infusion center’s pharmacist picked up the drugs and transported them in a personal vehicle to the infusion center. The pharmacist unpacked the drugs in the infusion center and stored them in a locked Omnicell® cabinet in a room designed for preparing chemotherapy drug infusions. The pharmacist compounded the drugs in a compounding aseptic containment isolator cabinet designed for compounding sterile hazardous drug preparations (Figure 1). The isolator cabinet had a high efficiency particulate air (HEPA) filter air supply and exhausted 100% of the captured air to the outdoors through a second HEPA filter. Employees reported that the pass-through chamber was under negative pressure and that air flowed in from the surrounding pharmacy.

Figure 1. Compounding aseptic containment isolator cabinet. Photo by NIOSH.

All employees in the infusion center who handled chemotherapy drugs were required to wear two pairs of chemotherapy protective gloves (double gloving). We observed some employees voluntarily wearing safety glasses to prevent eye contact with the chemotherapy drug in the event of a splash. Upon patient arrival, the pharmacist verified the dose and delivered the required drug to the nurse to administer in the treatment area. After verifying the chemotherapy drug treatment with the patient’s medical record, the nurse administered the drug. This was done through a closed system with a needleless intravenous syringe or bag with tubing primed with a saline solution. The time it took to administer the chemotherapy drugs varied from minutes to hours depending on the treatment protocol. After completing the chemotherapy treatment, the nurse removed the intravenous line from the patient and disposed of all the chemotherapy drug-contaminated materials into a chemotherapy waste container. The nurse then removed both pairs of chemotherapy protective gloves, placed

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Surface Wipe Samples Appendix A, Tables A1 and A2 contain detailed surface wipe sample results. We detected platinum in 4 of the 50 surface wipe samples and gemcitabine, irinotecan, cyclophosphamide, and/or 5-fluorouracil in 18 samples. Of the detectable platinum results, levels ranged from 0.005–0.63 µg/100 cm2. We measured the highest platinum level (0.63 µg/100 cm2) inside the storage cabinet where vials were stored prior to compounding. A sample collected in the pharmacy in front of a computer touch screen used to track quantity and create vial labels contained detectable levels of all four of the other chemotherapy drugs: 1 ng/100 cm2 of irinotecan, 2 ng/100 cm2 cyclophosphamide, 50 ng/100 cm2 5-fluorouracil, and 140 ng/100 cm2 gemcitabine. The highest level of 5-fluorouracil (690 ng/cm2) was found in the sample from the isolator cabinet pass-through after 5-florouracil was used. We measured the highest level of gemcitabine (600 ng/100 cm2) in front of the pharmacist’s computer keyboard. Other locations that had detectable levels of chemotherapy drugs included the inner doorknob of the pharmacy, inside a vehicle used to transport chemotherapy drugs, the pharmacy counter left of the sink where intravenous bags were stored prior to carrying them to the infusion room, in the bin where chemotherapy drugs were stored prior to administration in the infusion room, and inside the isolator cabinet’s gloves. We also found detectable levels of chemotherapy drugs on the outside of drug vials including 430 ng/100 cm2 of 5-fluorouracil on the outside of the never opened 5-fluorouracil vial, and on the shelves where the vials were stored. The drug transport boxes did not test positive for chemotherapy drugs.

Although surface wipe samples detected the presence of platinum, likely from platinum containing chemotherapy drugs, and cyclophosphamide on some surfaces inside the infusion center, these contaminants were present in relatively low levels when compared to other NIOSH evaluations in similar environments [NIOSH 2012b,c]. The infusion center did not administer cyclophosphamide during our visit, yet it was detected in surface wipe samples.

This suggests that cyclophosphamide was stable in the environment and that housekeeping procedures were not effectively removing this chemotherapy drug. We saw similar results in a previous evaluation at an oncology clinic. In that evaluation, the surface samples for cyclophosphamide remained positive for 3 days, even after housekeeping staff cleaned the surfaces [NIOSH 2012b]. Currently no occupational exposure limits (OELs) exist for chemotherapy drugs on surfaces or in the air. However, considering the carcinogenicity of these chemotherapy drugs [IARC 2004], precautions to eliminate or minimize exposures are appropriate.

Housekeeping Although we did not observe housekeeping procedures, the employer reported that cleaning was conducted “in house” by hospital employees throughout the day as needed and after

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The infusion center managers did not give employees formal guidance on avoiding takehome contamination with chemotherapy drugs. Shoe bottoms may carry traces of drugs that can be tracked outside the infusion center. If employees follow proper procedures while working, it is unlikely they will carry the drugs home. However, items such as the totes used to transport chemotherapy drugs between the main hospital and the infusion center could become contaminated and potentially contaminate areas outside of the pharmacy and treatment stations such as personal cars.

Review of Hazardous Drug Handling Procedures and Ventilation Evaluation Reports The facility’s standard operating procedures for handling hazardous drugs provided adequate guidance to pharmacy and nursing personnel on safe techniques in preparing, administering, and disposing of hazardous drugs as well as managing chemotherapy drug spills. The standard operating procedures, however, did not apply to other hospital employees with the potential for exposure, such as shipping and receiving personnel, custodial workers, laundry workers, and waste handlers. The standard operating procedures for the pharmacist and pharmacy technicians included guidance on the use of chemotherapy gloves and gowns when handling chemotherapy drugs; however, we observed that employees did not always follow this guidance. We found no information about proper storage, routine housekeeping, or medical surveillance for employees exposed to hazardous drugs. The hazardous drug list was incomplete. It included drugs and items that are not hazardous such as plastic bags and did not contain criteria for determining whether a drug is hazardous.



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