A collaborative partnership between pharmacy and nursing is an important requirement for providing high quality care to oncology patients and other patients receiving hazardous drugs. In most hospitals, the pharmacy department is responsible for compounding chemotherapy while nurses administer these medications. However, despite this interdependency, IV pharmacy personnel and nurses at the patient bedside typically have little understanding of each other’s workflow practices. Rarely do IV pharmacists and technicians have the opportunity to track finished products beyond the pharmacy and observe medication administration. Similarly, most nurses have never visited an IV room or watched the compounding process inside a clean room. Before embarking on ways to increase hazardous drug safety, nurses must understand the basics of pharmacy workflow, and pharmacy personnel must have, at minimum, an elementary appreciation for how these drugs are being administered.
Numerous sources have published information about the dangers of chemotherapy exposure to health care workers. According to the CDC’s National Institute for Occupational Safety and Health (NIOSH), a maximum recommended level of exposure has not been established1; consequently, any exposure should be considered unacceptable and must be avoided. Therefore, steps must be taken to prevent contamination at all points along the hazardous drug continuum—from the moment the cytotoxic vials are received in the facility to the moment administration is complete and requisite supplies have been disposed. The central directive of hazardous drug handling must be to keep these medications contained at all times—whether in a vial, a syringe, the IV tubing, or the bag. To fully realize this goal, a collaborating partnership between pharmacy and nursing is essential.
Published Guidelines for Hazardous Drug Handling
Beginning with ASHP’s 1985 Technical Assistance Bulletin on Handling Cytotoxic Drugs in Hospitals,2 much has been published in the pharmacy literature on safety measures for hazardous drug compounding. Determining appropriate guidelines has been an evolutionary process spanning three decades as more information has been garnered concerning the dangers of these drugs and routes of potential exposure. ASHP released its most recent guidelines for hazardous drug handling in 2006.3 In 2004, the Oncology Nursing Society (ONS) first published Safe Handling of Hazardous Drugs4 as a tool for nurses; the second edition was published in 2011.5 Although this reference is geared toward administration issues, it also draws content from ASHP, NIOSH, and numerous other sources. Pharmacy and nursing personnel must be familiar with these guidelines to ensure proper handling of hazardous medications.
Although a small percentage of nurses may compound chemotherapy—particularly those employed in private practices and those in rural areas where pharmacists and technicians are scarce—most oncology nurses are uninvolved in the compounding process. In situations where nurses must prepare chemotherapy, ONS recommends adherence to the same guidelines that are applicable to pharmacy personnel.
Safety Equipment and Processes
The type of equipment used for compounding, transporting, and administering hazardous medications—including closed system transfer devices (CSTDs) and the type of tubing utilized—impacts the likelihood of possible contamination, making it key to evaluate every option.
When employed consistently and used correctly, CSTDs decrease worker and workplace contamination by hazardous drugs. There are currently six brands of CSTDs available, and each has its strengths and weaknesses. While there is no universal benchmark for evaluating these devices, the following criteria should be taken into consideration:
All of these criteria must be taken into account simultaneously; if one device proves to be more effective than another but is also more difficult or time-consuming to employ, it will likely not be used. Devices that can be integrated into IV tubing systems will ensure compliance and reduce the possibility of the nurse forgetting to use the device.
Manufacturers only recently started to consider all of these factors when developing CSTDs, and a great deal of innovation is still required throughout the industry.
While none have been designed to replace a biological safety cabinet (BSC) for compounding, when used as intended, CSTDs provide additional protection from contamination for pharmacy personnel and nurses. For facilities that have adopted CSTDs, their use should be considered mandatory, and compliance routinely monitored.
Several other factors impact the likelihood of exposure, including the type of IV tubing employed, which kind of syringe is chosen, how the bag is spiked, and how the tubing is primed. In addition, brands of IV pumps and bags differ in design, which also can influence safety.
> Spiking the Bag
Due to the possibility of contamination, ASHP, and subsequently ONS, have recommended against nurses spiking chemotherapy bags at the patient’s bedside. Inadvertently spiking through the side of the bag is not uncommon, particularly when using brands with longer necks where the bag tends to fold over during the spiking process. Even a small puncture hole can lead to significant personnel and environmental contamination.
A safer option is to spike the bag and prime the IV tubing in the pharmacy. However, this choice involves risk. If the tubing is spiked in the BSC without the aid of a CSTD on the vial, the entire length of tubing can be contaminated with hazardous drug due to aerosolization. Most primary tubing is 6 to 8 feet long, and there is potential for part of the tubing to come into contact with the patient’s environment. Moreover, if proper PPE is not worn, a nurse could unsuspectingly touch the contaminated tubing with bare hands, spreading contamination. Secondary tubing, which connects an IV bag to a port on the primary tubing or cassette, is typically 30 to 40 inches long; using this shorter option reduces the possibility of contamination.
> Priming IV Tubing
How the tubing is primed is also a significant concern that must be addressed. Priming using the drug can cause medication to drip at the end of the tube. Consequently, for many years nurses were instructed to place a sterile gauze pad at the end of the tube to catch the drops of chemotherapy. However, this practice exposes hazardous medication and must be abjured. A better alternative is to prime tubing with a neutral solution before the bag is spiked. Once the bag has been spiked, few safety controls are available. A single roller or pinch clamp is sometimes used to prevent fluid from rapidly draining via gravity during transport, nursing verification at the bedside, and prior to being connected to the patient. However, a poorly secured clamp can come loose and result in a massive hazardous drug spill. To prevent accidents, use of a CSTD at the end of the tubing is the best option.
> IV Push Syringes
IV push syringe safety is another priority that should be considered. Standard push-on dead-heads can come loose during drug transport, resulting in contamination within the zipped plastic transport bag. While needleless connections have become the norm in the US, leakage from the syringe during connecting and disconnecting often results in droplet contamination. When this occurs, nurses again have been instructed to place an absorbent pad beneath the syringe and hold or wrap sterile gauze around the connection. As with IV tubing, use of a CSTD decreases the potential for exposure during an IV push.
> IV Pump Design
As a safety mechanism, IV pumps are set by the manufacturer to trigger an alarm when air passes through the pump’s sensor. While the size of the bubble may be significant or medically inconsequential, the infusion will not continue until the bubble has been cleared. With the exception of one manufacturer, all pumps require the nurse to break into the IV tubing with a syringe and aspirate the air, potentially removing chemotherapy along with the air bubble. Opening the system without the aid of a CSTD increases the risk of exposure.
> Post-infusion Exposure
Once the chemotherapy bag has been emptied, a certain percentage of the drug remains in the tubing. Depending on an institution’s policy, the tubing will then either be disconnected or flushed with a neutral solution. Disconnecting the tubing without flushing it first has a serious drawback: a significant volume of the drug can remain—more than 10% depending on the bag size and tubing manufacturer—resulting in the patient not receiving the full, ordered dose. In addition, not flushing the tubing increases the risk of unintended exposure.
> Other Possible Routes of Exposure
Although it may seem improbable, instances have occurred where infusions have been started without the nurse connecting the tubing to the patient, resulting in a significant hazardous drug spill—not to mention wastage of limited, expensive medications. Spills also may occur when connections are not completely tightened, which is of particular concern when using IV tubing systems that require multiple connections or extensions. Even under ideal circumstances, a patient’s peripheral IV or central venous catheter can be dislodged or pulled out completely.
Both the Infusion Nursing Society6 and the ONS7 have published standards and guidelines for securing IV catheters and implanted port Huber needles. A number of different securement methods and products help reduce the risk of dislodgement, and Luer lock tubing should be used in place of slip-tip connections. Nonetheless, oncology nurses must still regularly assess peripheral and central IV tubings and sites for leakage.
Collaborate to Safely Manage Hazardous Drugs
Putting together a comprehensive management strategy to minimize hazardous drug exposure requires a commitment from all employees who prepare, administer, and manage these medications, including pharmacy personnel, nursing, and nursing management. An optimal hazardous drug management program is one that is developed and implemented by a multidisciplinary team to ensure all departmental requirements are met and that appropriate resources are allocated. Decisions made in concert, rather than in isolation, will ensure that the safety products chosen are appropriate to meet the needs of all staff handling hazardous drugs. For example, a CSTD that is effective for pharmacy’s needs may be less than ideal for nursing, which can result in nursing not using it and thereby negating its safety benefits. Similarly, the CSTD that is the most efficient for nurses may be impractical for pharmacists to implement. Active communication and understanding of each department’s needs and workflow will result in purchasing safety products that are efficient and effective for both pharmacy and nursing.
For P&Ps to be effective, pharmacy and nursing must convene to describe and develop standard workflow practices for each department, as well as to define which drugs should be considered hazardous. Working in tandem to develop consistent practices and eliminate any procedural gray areas that could be subject to individual interpretation and thus cause safety lapses, will best guarantee success. Pharmacy and nursing policies should be consistent with each other, while still acknowledging differences in content and duties, and should be sufficiently detailed to eliminate vague areas. Without comprehensive policies, practices can vary significantly and management will have little recourse for correcting practice violations.
Develop a Spill Policy
Despite best practices, spills will occasionally occur. For this reason, policies should be developed that clearly outline who is responsible for cleaning spills in each department. Ensure that annual spill training, competency assessment, and proper safety equipment are provided for cleanup. In addition, one question that must be considered is whether patients receiving chemotherapy may leave the infusion area while their treatment is being administered. For example, if the patient is permitted to leave the infusion area while undergoing treatment and a spill occurs, how can patient and staff safety be ensured? What is the procedure for cleaning this type of spill, and who will perform the cleaning? A written P&P must clarify all of these issues as well. This is a particular concern in hospital and clinic areas with carpeting. For this reason, patients in Seattle Cancer Care Alliance Ambulatory Clinic’s 49-bay infusion department are not permitted to leave the area while chemotherapy is infusing.
In addition to implementing P&Ps, both the pharmacy and nursing departments must require mandatory hazardous drug handling education, as well as annual reviews to evaluate competency. Bad habits and workarounds can creep insidiously into daily routines, and if left unchecked, may become normal practice over time. Regular education and annual reviews assist in maintaining staff compliance over the long term.
Barriers to a Safety Culture
A hospital’s management priorities—sometimes referred to as safety culture or climate—have a profound effect on staff’s compliance with P&Ps. In facilities where P&Ps exist but are not enforced, staff may be tempted to take shortcuts or view safety requirements as optional. It is management’s responsibility to uphold the expectation that P&Ps must be adhered to, and underscore that there are consequences should P&Ps not be followed fully and consistently.
In addition, the type of oncology practice has a bearing on safety culture, with physicians’ offices historically having significantly fewer P&Ps compared with inpatient settings. This distinction is especially important to note as more treatment moves from an inpatient to an outpatient model. Regardless of whether hazardous drugs are utilized in an inpatient or outpatient setting, P&Ps must be developed and consistently followed.
Other factors can influence compliance with safety guidelines. An article published this year reported that adherence to safe handling practices were influenced by staff workload; a higher workload equated with poorer safety compliance. Difficulty accessing PPE also was identified as a significant barrier to guideline adherence. Fostering a positive safety environment, improving access to PPE, and implementing an appropriate staff-to-patient ratio are important steps toward eliminating these compliance barriers.8
Surveillance and Monitoring
Medical surveillance and monitoring—for example, annual blood or urine testing to determine staff’s exposure levels to hazardous drugs—are described by NIOSH in a 2007 publication.9 Surveillance has understandably been met with resistance, as many questions remain unanswered. For example, determining who should be tested is challenging. While it may seem obvious that pharmacists, technicians, and nurses should be tested, whether to test other staff—ie, ancillary support staff such as unit secretaries, ward clerks, nursing assistants, and housekeepers—is less transparent. If any of these staff members have worked within the proximity of a spill or in an environment where previous spills have not been thoroughly removed, they may be at risk.
Further complicating matters is the fact that many of the consequences of hazardous drug exposure are delayed (eg, reproductive problems and malignancies); hence, the validity of annual blood testing of CBCs is questionable. However, urine testing for specific marker drugs can be an excellent tool for identifying exposure, but is exceedingly costly, particularly if all staff who may be affected—including ancillary personnel—are included in testing. As there has yet to be any evidence demonstrating the benefit of performing annual blood tests on health care workers, it is likely that NIOSH will be removing medical surveillance requirements from its next hazardous drug update. Nevertheless, ongoing monitoring of staff who have been knowingly exposed remains a prudent measure; spills should be tracked, and policies should guide staff in the reporting process.
Until research renders chemotherapy obsolete, hazardous drugs will remain the most commonly utilized weapons in cancer treatment. The dangers of hazardous drugs to health care workers are apparent—there is sufficient evidence to indicate chromosomal damage in exposed employees.10 But while the risks associated with these agents cannot be eliminated, a collaborative effort—pharmacy and nursing working together to protect ourselves and our colleagues—is the best method of eliminating potential contamination.
Seth Eisenberg, RN, OCN, professional practice coordinator for infusion services at the Seattle Cancer Care Alliance Ambulatory Clinic, has been practicing in the field of oncology since 1983. His experience includes 26 years in hematopoietic stem cell transplantation at the Fred Hutchinson Cancer Research Center. Seth has published numerous articles, book chapters, and has presented nationally and internationally at nursing and pharmacy conferences.
While NIOSH is charged with ensuring safe working conditions through research, education, and training, they are not responsible for enforcement of these guidelines. For nursing personnel administering hazardous medications, worker safety requirements are exceedingly general and fail to provide the requisite level of detail. As a result, hazardous drug handling procedures are too often seen as voluntary.
In 2011, Washington state passed legislation requiring all facilities that administer hazardous drugs, including private practices and veterinary clinics, to follow the guidelines set forth by NIOSH.1 By phasing in the law over three years (the law will take effect January 1, 2014), the state Department of Labor and Industries (L&I) is allowing facilities time to develop hazardous drug handling plans, staff education, and engineering controls—the latter being the most challenging for many pharmacies, particularly those located in unfavorable locations inside hospital buildings. Enforcement of the law will be carried out by the state department of L&I, which will have authority to levy significant fines for each violation.
Prior to writing the actual text of the rule, L&I assembled a group of stakeholders that included pharmacists, nurses, and physicians, as well as organizations including ASHP, unions, and the veterinary association, in order to thoroughly grasp the needs of all affected parties. This collaboration was key in drafting a rule that satisfied the state law and also could be realistically implemented within health care facilities.
Case Examples of Accidental Hazardous Drug Exposure
Ideally, all of the remaining drug in the tubing should be flushed. This practice ensures the patient receives the full dose and reduces the exposure potential when the tubing is disconnected. Flushing the tubing can be accomplished in several ways. Historically, nurses would simply unspike the bag of chemotherapy and spike a small bag of neutral solution. However, unspiking has been strongly discouraged due to the likelihood of spraying droplets from both the end of the IV spike and the IV bag. A better option is to instill neutral solution into the upper section of tubing, although this can be challenging without tubing setups specifically designed for this purpose, or the use of a CSTD. Using a primary/secondary tubing model has the advantage of allowing the primary tubing to automatically flush the remaining chemotherapy after administration is complete.
In situations where primary tubings are employed exclusively, it is also possible to use a CSTD spike adaptor to both prime the tubing with neutral solution prior to connecting the chemotherapy, and then to connect a small bag of neutral solution to flush afterwards. However, this model does require more components and is potentially more expensive.