Pennsylvania Patient Safety Advisory Hazardous Spills: The Safe Handling of Hazardous Drugs ABSTRACT incorporate national guidelines and outline policies and personnel compliance. Healthcare practitioners may underestimate the expo- sure risk associated with hazardous drugs. The risk of In 2004, the NIOSH Working Group on Hazard- exposure extends along the drugs’ entire life cycle, ous Drugs revised the 1990 ASHP hazardous drug including the manufacturing, transporting, dispens- definition to include one or more of the following ing, and administering processes. The safe handling criteria:1,2,5 of hazardous drug spills is uniquely different from ■ Carcinogenicity other healthcare spills, and exposure extends beyond ■ Teratogenicity patients and healthcare practitioners because nonclini- ■ Reproductive toxicity cal staff are often involved with the containment and disposal of spills. PA-PSRS has received more than ■ Organ toxicity at low doses 40 reports of patients and staff exposure to hazardous ■ Genotoxicity drugs. Many events involved intravenous (IV) tubing ■ Structure or toxicity similar to drugs classified as disconnections resulting in hazardous drugs leaking to the floor, the patient, hospital gowns, and linens. hazardous using the above criteria Many exposure incidents were attributed to IV port While the ASHP, OSHA, NIOSH, and ONS guide- or site leaks and involved IV spiking issues, resulting lines for the safe handling of hazardous drugs are in large hazardous spills. Risk reduction strategies readily available, the application of these guidelines include developing a hazardous drugs program; is inconsistent, resulting in increased incidence of encouraging personnel compliance in the storing, hazardous drug exposure. Research has revealed dispensing, transporting, and administering of these measurable levels of hazardous drugs in the urine of medications; managing spills; and disposing of haz- healthcare providers who are involved throughout ardous drugs in such a way that the most appropriate different stages in the drugs’ life cycles.2,5,6 The life guidelines are used to minimize exposure. (Pa Patient cycle of a hazardous drug begins at manufacture and Saf Advis 2008 Sep;5[3]:96-9.) ends at waste disposal in patient care units, outpatient facilities, office-based practices, and home care.6,7 Guidelines now include cradle-to-grave considerations for hazardous drugs because some chemotherapy Accidental patient and staff exposures during hazard- agents can be administered for noncancerous con- ous drug administration have been reported through ditions, thus increasing exposure for healthcare PA-PSRS. These exposures increase the potential for practitioners and patients and their families.6 Expo- harm to patients and staff. The most often referred sure extends to surfaces such as countertops and to U.S. guidelines for the safe preparation, dispens- floors and to the arms and hands of nurses.8 Drug ing, and administration of hazardous medications are residue inadvertently left on the outside of drug vials from the National Institute for Occupational Safety during the manufacturing process can also contribute and Health (NIOSH), American Society of Health- to hazardous drug exposures.8 Healthcare providers’ System Pharmacists (ASHP), Oncology Nursing hazardous drug exposures can occur by means of Society (ONS), and Occupational Safety and Health inhalation, dermal contact, oral intake, and injection, Administration (OSHA).1-4 There have been 42 as well as exposure to drug vaporization.5,6,8,9 Bodily reports of accidental hazardous drug events submit- fluids of patients receiving hazardous medications ted through PA-PSRS since the program’s inception are also potential sources of exposure. Some research in 2004. Two-thirds of the reported events were indicates that dermal and inhalation exposure can attributed to intravenous (IV) tubing disconnections, resulting in hazardous drugs leaking to the floor, the patient, hospital gowns, and linens. The remaining Table. Hazardous Spills Reported to reported events were attributed to IV port or site PA-PSRS leaks, IV spiking, and other issues (see Table). One- NUMBER third of reported events involved volume amounts TYPE OF OF SPILLS ranging from 7 mL to the entire contents of the medi- HAZARDOUS SPILL REPORTED PERCENTAGE (%) cation IV bag, resulting in large hazardous spills. Tubing disconnect 27 64% While there are many helpful strategies for inpatient, Intravenous port/ 5 12% outpatient, and office-based healthcare facilities to site leak apply to the safe handling of hazardous drugs, the Spiking issues 4 10% first strategy is to recognize the problem. Facilities Other 6 14% may consider developing programs for the inter- Total 42 100% disciplinary safe handling of hazardous drugs that Page 96 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Vol. 5, No. 3—September 2008 Pennsylvania Patient Safety Advisory be attributed to the act of removing bed linens, IV line connection became disconnected, chemother- decanting urine, or cleaning toilets contaminated apy meds spilled onto patient’s bed. with hazardous drugs, any of which could potentially Patient called nurse stating her sleeve was wet. Taxol expose environmental services and housekeeping staff was disconnected. Physician was notified. Approxi- as well as other nonclinical employees.10 mately 50 cc of fluid spilled. Consider these examples submitted through PA-PSRS: 5 cc of busulfan chemo spilled on floor when tubing The patient removed his IV [containing] docetaxel, [was disconnected]. Chemo spill kit used to clean up an antineoplastic agent, while in the bathroom, spill. [Environmental services] cleaned floor following spilling approximately 20 cc to 30 cc on the floor. cleanup. Physician was notified, and the IV was restarted. Patient was receiving IV chemotherapy. While Patient dislodged IV while sleeping. Approximately patient was sleeping, line became disconnected and 30 cc of Taxol® leaked onto patient’s arm and cloth- chemo infusion spilled on floor. Chemo spill kit was ing. Nurse stopped infusion, used “chemo spill kit” used to clean up. to clean patient, and disposed of clothing. Treatment Tubing disconnected, and Taxol® spilled on bed. resumed after new IV started. Patient was removed from bed and his clothes and lin- Still other accidental exposures occur when contami- ens were removed. Bed was cleaned by housekeeping. nated surfaces are touched during the preparation, While most IV equipment has been designed with administration, or disposal of hazardous drugs.6,10,11 patient safety in mind, hazardous spills continue to Oral exposure may occur from hand-to-mouth con- occur. Leaking and spills from needleless IV connec- tact.6 Crauste-Manciet et al.12 suggest that hands have tors are discussed in the following reports submitted been identified as the major route of contamination. through PA-PSRS: Other research reveals that hands, forearms, and foreheads account for 87% of cyclophosphamide Nursing staff found chemotherapy infusion tubing (i.e., an antineoplastic alkylating agent) total body wet and approximately 15 cc to 20 cc of fluid on the exposures.10,12 Drug reconstitution, transfer between floor. No cracks or defects were noted in the tubing containers, spiking and unspiking IV containers, or the medication bag. Chemo spill kit was used to priming IV tubing, and connecting or disconnect- clean area. Environmental health services cleaned ing tubing or syringes from injection ports have also entire floor. The patient remained in bed during resulted in leaking and surface contamination.5 the entire cleanup. Physician was notified. No patient injury. Other examples from reports submitted through PA- PSRS include the following: Patient presented to [emergency room]; [patient] had Patient was to receive chemo. When the nurse spiked a history of cancer and was receiving 5-FU [fluo- the bag, it began to leak. This resulted in the bag of rouracil] through port when leakage was noticed. chemo being wasted, and a new one was prepared. Nurse supervisor notified security and maintenance. The dose of chemo was administered 90 minutes Oncologist was notified. Spill was cleaned according later. Staff followed all procedures related to chemo to policy and protocol. Patient had port removed and spillage, which was contained to the medication skin cleansed. Linens and nightgown were placed in room. No harm came to the patient due to the slight red bags per policy. delay in administration of the dose. Patient with peripheral IV infusing 5-FU in forearm. When the patient arrived, the IV started beeping. Leakage noted from IV. Infusion stopped, and IV The chemotherapy bottle was found dripping onto discontinued and removed. Small contact of drug the IV pole and the floor. The spike had come out of with skin and linen only. Skin cleansed, and linens the bottle. The nurse was notified and assessed the removed per policy. Doctor notified. No injury to skin situation and reconnected the chemotherapy fluid. A noted. No patient injury noted. chemo spill kit was used to clean the area, and secu- Risk Reduction Strategies rity was alerted according to the spill kit directions. There was no apparent patient or staff injury. Although the 2004 NIOSH guidelines outline the safe handling of hazardous drugs, inconsistent use of When the nurse entered patient’s room during these strategies continues. Inpatient, outpatient, and chemo infusion, she noted that the bed linens were office-based healthcare facilities may consider develop- wet. Upon further investigation, it was noted that ing facility-specific protocols and policies to facilitate the patient’s Cytosar-U tubing had become discon- consistent approaches to the safe handling of hazard- nected and was infusing on the bed. The physician ous drugs. Consider incorporating the following was notified, and the sterile tubing was reconnected. elements into protocols and practice. Patient was showered, and area was cleaned accord- ing to chemo spill protocol. Physicians recalculated Safe Handling of Hazardous Drugs Program rate so that patient would still receive desired dose of Development Cytosar-U. Parent notified as well. No further inter- Develop a program for the interdisciplinary safe ventions required. handling of hazardous drugs that includes initial and Vol. 5, No. 3—September 2008 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Page 97 Pennsylvania Patient Safety Advisory ongoing education and competencies for all health- exposure risk. The use of pneumatic tube systems care staff. Include ongoing education for nonclinical with these drugs is not advised due to the potential personnel who are involved with hazardous spill for hazardous spills. (See the March 2008 Pennsylvania cleanup and disposal. Encourage wide availability of Patient Safety Advisory article, “Pneumatic Tubes: A policies and procedures, particularly at community- Possible Patient Safety Vacuum?” available online at based practices; one study reported that hazardous http://www.psa.state.pa.us/psa/lib/psa/advisories/ drug policies and procedures were available in hos- v5n1march_2008/mar_2008_v5_n1_article_ pitals significantly more than in community-based pneumatic_tubes.pdf.) practices.7 Consider employing the pharmacy and therapeutics committee to develop and annually Administering hazardous drugs. Keep hazardous update a list of organization-specific hazardous drugs, drug waste containers and spill kits readily available in as well as policies, procedures, and revisions, for dis- patient care areas where hazardous drugs are admin- semination to the pharmacy and appropriate patient istered. Perform all work below eye level to reduce care areas. Make material safety data sheets or drug eye and facial splash potential.1,2 Use only needleless inserts readily available, and update on an annual devices with closed fittings, syringes, infusion tubing, basis to provide drug-specific resources for healthcare pumps, and closed systems with locking connections staff if accidental hazardous exposures occur. when administering these drugs intravenously.1-3,6,9 Pharmacy staff can complete priming of IV tubing Personnel Compliance with nondrug solution before drug preparation to Storing hazardous drugs. Evaluate and monitor prevent the nursing staff from attempting to prime the current hazardous drug storage practices and tubing in the uncontrolled environment of a patient’s equipment in the pharmacy and patient care areas. room.1-3,6,9 To prevent unintended exposure from Hazardous medications require hazardous drug label leaking of residual fluid once an IV is attached, avoid warnings and safe storage in segregated areas in phar- disconnecting, removing, or unspiking the tubing.1,2,9 macy and patient care units. Use personal protective PPE is essential and includes two pairs of gloves, a equipment (PPE), including wearing chemical protec- gown, and appropriate eyewear and face shield as tive gowns and two pairs of gloves that are changed needed to avoid hand, eye, mouth, or nasal expo- after 30 minutes or whenever a tear, a puncture, or sure.1-3,9 Place a plastic-backed absorbent pad under contamination occurs.1-3,9 Spill kits must be readily the administration area to absorb leaking and prevent available wherever hazardous medications are stored. patient dermal contact.1,2 Wash hands with soap and Preparing hazardous drugs. Evaluate and moni- water after glove removal.1,2 Dispose of all PPE in tor the current work practices, equipment used, labeled yellow hazardous waste containers. and physical layout in which hazardous drugs are Managing spills and disposing of hazardous drugs. prepared. Don PPE, such as gowns and two pairs of Review the availability of spill kits in your facility gloves that are changed every 30 minutes or whenever near all potential exposure sources. Hazardous spills a tear, a puncture, or contamination occurs.1-3,9 The are considered small when their volume is less than likelihood of permeation through two pairs of gloves 5 mL or 5 gm outside the BSC; spills are considered is low, and the second pair of gloves adds protection large when volumes are greater than 5 mL.2,4,7,9 When from contamination of the healthcare providers’ managing small and large spills and disposing of haz- hands when removing gloves. Keep hazardous drug ardous drugs, wear essential PPE, including two pairs waste containers and spill kits readily available in of gloves, a gown, appropriate eyewear, and, if neces- areas where hazardous drugs are prepared.9 Maintain sary, a NIOSH-approved respirator appropriate for environmental/ventilation controls by using a phar- exposure to hazardous drugs. Also, use plastic backed macy-dedicated biological safety cabinet (BSC) with spill-control pillows or absorbent towels for larger a downward flow and a high-efficiency particulate-air spills for employee protection when managing hazard- filter. A closed system transfer device adds additional ous drug spills.1-4,9 Decontaminate all interior BSC protection. If IV tubing is attached in the BSC, care surfaces after spill cleanup of greater than 150 mL or must be taken to avoid contamination of the tub- the contents of one vial.1-4 Protect employees handling ing with the hazardous drug from the surface of the hazardous drug waste from potential exposure. When gloves or the BSC.1,2,9 Strategies for preparing hazard- handling linens or decanting urine or feces from ous drugs by pharmacy staff would include priming of patients who received hazardous drugs within the past IV tubing with nondrug solution to prevent the risk 48 hours, staff are best protected by wearing two pair of hazardous drug exposure in a patient’s room. of gloves, a disposable gown, and appropriate eye- Transporting hazardous drugs. Transport hazardous wear and face shield if splashing is possible because medications safely from the pharmacy to patient care surgical masks do not provide adequate protection areas in properly labeled containers. The precautions from splashes to the mouth, nose, and mucous for staff who handle and transport hazardous medica- membranes.1,2,4,8 Dispose of hazardous drug waste in tions from the pharmacy to patient care areas include labeled yellow hazardous waste containers; it is man- donning two pairs of gloves.1-3,9 Place medications aged differently than other medical infectious (i.e., red in clear sealable bags to facilitate verification of the bag) and noninfectious waste.1,2,4,9 Wash equipment bag’s contents without drug removal to minimize surfaces that come in contact with hazardous drugs Page 98 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Vol. 5, No. 3—September 2008 Pennsylvania Patient Safety Advisory with detergent, sodium hypochlorite solution (bleach Chapter 2, section VI. In: Occupational Safety and solution), and a neutralizer.1 Health Administration (OSHA). OSHA technical man- ual, TED 1-0.15A [online]. OSHA 1999 [2008 Feb 26]. Conclusion Available from Internet: http://www.osha.gov/dts/osta/ Practice guidelines for the safe use of hazardous otm/otm_vi/otm_vi_2.html. drugs exist, but inconsistent implementation of these 5. Polovich M. Safe handling of hazardous drugs. Online J guidelines can lead to inadvertent patient and staff Issues Nurs 2004 Sep 30 [cited 2008 Feb 13]. Available exposure. Inpatient, outpatient, and office-based from Internet: http://nursingworld.org/ healthcare facilities may consider developing facility- MainMenuCategories/ANAMarketplace/ specific protocols and policies to facilitate consistent ANAPeriodicals/OJIN/TableofContents/ approaches to the safe handling of hazardous drugs. Volume92004/Number3September30/ Risk reduction strategies include the development of HazardousDrugs.aspx. the safe handling of hazardous drugs program, which 6. Connor TH, McDiarmid MA. Preventing occupational incorporates guidelines for personnel compliance. exposures to antineoplastic drugs in health care settings. The guidelines encompass the entire drug life cycle, CA Cancer J Clin 2006 Nov-Dec;56(6):354-65. including manufacturing, transporting, dispensing and administering these medications. Consistent 7. Martin S, Larson E. Chemotherapy-handling practices managing of spills and disposing of hazardous spill of outpatient and office-based oncology nurses. Oncol Nurs Forum 2003 Jul-Aug;30(4):575-81. cleanup materials will minimize risks to patient and staff in areas where these medications are used. 8. Fransman W, Vermeulen R, Kromhout H. Occu- pational dermal exposure to cyclophosphamide in Notes Dutch hospitals: a pilot study. Ann Occup Hyg 2004 1. National Institute for Occupational Safety and Health. Apr;48(3):237-44. U.S. Department of Health and Human Services. Preventing occupational exposure to antineoplastic 9. Polovich M, Blecher CS, Glynn-Tucker EM, et al. Safe and other hazardous drugs in health care settings [alert handling of hazardous drugs. Pittsburgh (PA): Oncology online]. No. 2004-165. 2004 Sep [cited 2008 Feb 22]. Nursing Society; 2003. Available from Internet: http://www.cdc.gov/niosh/ 10. Gambrell J, Moore S. Assessing workplace compliance docs/2004-165/. with handling of antineoplastic agents. Clin J Oncol Nurs 2. Chen DF, Thompson KK. ASHP guidelines on han- 2006 Aug;10(4):473-7. dling hazardous drugs. Am J Health-Syst Pharm 2006 Jun 11. Mason HJ, Blair S, Sams C, et al. Exposure to antine- 15;63(12):1172-93. oplastic drugs in two UK hospital pharmacy units. Ann 3. Oncology Nursing Society [clinical alert online]. [cited Occup Hyg 2005 Oct;49(7):603-10. 2008 Feb 22]. Available from Internet: http://www.ons. 12. Crauste-Manciet S, Sessink PJ, Ferrari S, et al. Environ- org/publications/books/update.shtml. mental contamination with cytotoxic drugs in healthcare 4. Occupational Safety and Health Administration. using positive air pressure isolators. Ann Occup Hyg 2005 Controlling occupational exposure to hazardous risks. Oct;49(7):619-28. Vol. 5, No. 3—September 2008 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Page 99 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 5, No. 3—September 2008. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority as part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). Copyright 2008 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to https://www.papsrs.state.pa.us/ Workflow/MailingListAddition.aspx. To see other articles or issues of the Advisory, visit our Web site at http://www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the PA-PSRS program, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the PA-PSRS program or the Patient Safety Authority, see the An Independent Agency of the Commonwealth of Pennsylvania Authority’s Web site at www.psa.state.pa.us. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.