Pharmacy Purchasing & Products: Why is USP <800> compliance particularly important in outpatient infusion centers?
Astrid Slaughter, PhD, RPh: The fact that hazardous drug (HD) exposure can result in acute and chronic adverse health effects is well known in health care. Skin rashes, leukemia and other cancers, as well as negative effects on reproduction are possible.1 The risk level depends on the HD and the amount of exposure. Thus, every possible precaution should be taken to protect workers handling HDs.
USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings establishes standards to protect health care workers who handle HDs.2 The chapter adopts the National Institute for Occupational Safety and Health (NIOSH) list of HDs.3 Last updated in 2016, the list classifies HDs into three categories: antineoplastic drugs, non-antineoplastic drugs that meet one or more of the NIOSH criteria for an HD, and drugs that primarily pose a reproductive risk. Previous USP chapters have been fully or partially adopted by state boards of pharmacy and accreditation organizations that possess enforcing authority. The USP <800> standards will become enforceable on December 1st, so health care organizations should be working diligently to bring their facilities into compliance.
Because infusion centers typically provide chemotherapy to a high volume of patients on a daily basis, it is especially important that they do so safely and compliantly. Proper use of personal protective equipment (PPE), closed system drug-transfer devices (CSTDs), and best practices are essential to providing patients chemotherapy in a safe, compliant environment. Safe HD handling is particularly important in infusion centers because in an outpatient environment there is ample opportunity for HD residue to be inadvertently transported to another suite. Studies have illustrated that traces of chemotherapy may spread throughout the clinic. For example, wipe tests have revealed traces of chemotherapy on elevator buttons.4
PP&P: What are some commonly overlooked exposure risks during HD handling, preparation, and administration?
Slaughter: The processes for both medication preparation and medication management include opportunities for inadvertent HD exposure at several points. For example, risk exists when reconstituting drugs from a lyophilized powder, entering or spiking vials, transferring drugs to the final IV container, as well as during the cleaning process. During the administration of IV drugs, exposure is possible when priming IV lines and when connecting and disconnecting lines from injection ports. Exposure can take place through aerosolization of the drug as well as from external contamination of the medication vial. In fact, at least 15 studies demonstrate HD residue on the external surfaces of drug vials when delivered from manufacturers.5
An often overlooked HD exposure risk in many health care settings involves handling HDs in storage areas. Exposure can occur when staff is unpacking, storing, and inventorying HDs, as well as during the drug waste disposal process. Staff should don garb prior to unpacking HDs, and the unpacking process should occur in a designated area to minimize cross contamination.
USP <800> Section 5.2 provides clear direction for safe storage practices.2 While sterile and nonsterile HDs may be stored together, HDs used for nonsterile compounding should not be stored in areas designated for sterile compounding, in order to minimize traffic into the sterile compounding area. USP <800> offers further guidance regarding segregation of HDs from non-HDs: Antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage form must be stored separately from non-HDs in a manner that prevents contamination and personnel exposure. These HDs must be stored in an externally ventilated, negative-pressure room with at least 12 air changes per hour (ACPH). Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory. Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator within a negative pressure area with at least 12 ACPH.
Staff must receive comprehensive training that includes steps for safely unpacking and storing HDs as well as adhering to garbing/de-garbing policies, with the goal of avoiding transfer of HD residue from the compounding area to other parts of the health care facility.
PP&P: What is the value of conducting a gap analysis for USP <800> compliance?
Slaughter: Compiling a detailed understanding of any practice inconsistencies within the organization is a crucial first step to developing a plan to achieve full compliance with USP <800>. To accomplish this, several excellent gap analysis tools are available in the marketplace, including the following:
In addition, see Pharmacy Purchasing & Products’ April 2017 article, “Comparison of USP <800> Gap Analysis Tools,” at: www.pppmag.com/article/2021
After undertaking a gap analysis, a comprehensive USP <800> compliance plan must be developed that includes the following elements:
PP&P: What are some recommendations to help diminish staff’s risk of HD exposure?
Slaughter: A multidisciplinary approach is necessary to guarantee that all departments are sufficiently knowledgeable to make informed decisions regarding HD use. Therefore, staff engagement is key. Developing department-specific P&Ps will help to reduce exposure risks and guide staff in the adoption of safe handling practices. Key issues that must be incorporated into P&Ps include:
Effective spill management is key to reducing the risk of HD exposure. A hastily cleaned spill increases the risk of airborne HD particles and has the potential to cross contaminate other areas of the health care setting. Identifying the right spill kit and properly training staff to clean up the spill are essential. A spill kit should include all materials needed to clean up a spill, including ASTM D6978 chemotherapy-rated gloves, goggles, and a chemotherapy-rated gown.
It is important to note that patients can be unknowingly exposed to HDs. For example, a patient sent home with a continuous infusion device as part of their treatment should be aware that while these devices are prepared with patient safety in mind, HD exposure can still occur (eg, injection port issues, leaking at connections, etc). Therefore, patients should be instructed in the correct use of a spill kit, should a medication leak or spill occur at their home.
Finally, an important but costly element of risk reduction is upgrading the ventilation system to ensure USP <800> compliance. For example, although compounding areas typically vent directly outside, it is not uncommon for free-standing oncology facilities to have ventilation systems in place that do not vent to the outside—they may vent back into the room, exhaust stack height may be too low, or the air ducts might connect with other areas of the health care facility before venting to the outside.
PP&P: What steps can be taken to monitor contamination levels in the workplace?
Slaughter: Consistent monitoring of contamination levels is vital to having a clear understanding of the success of a facility’s cleaning program. Measuring contamination requires conducting wipe sampling at least every 6 months to determine the level of workplace contamination by antineoplastic agents. A variety of agents can be identified with this approach. If wipe sampling identifies HD residue, an investigation must occur to identify the cause of the contamination, and a plan should be put in place to immediately correct the problem.
A detailed evaluation is often necessary to determine how a certain area became contaminated. Were basic garbing/de-garbing procedures ignored? Did the contamination result from a spill, which might indicate that CSTDs were not used consistently? If compliance lapses are noted, all personnel entering that area should be monitored and retrained. All compounding personnel should receive adequate training regarding HD handling and should be proficient in garbing, compounding techniques, and cleaning procedures. Regular competency testing (eg, every 6 months) is critical to helping staff retain knowledge.
PP&P: What steps should be taken to establish a medical surveillance plan?
Slaughter: USP <800> and NIOSH recommend developing and implementing a medical surveillance program to monitor staff exposure to HDs. A medical surveillance program for health care workers should consist of:
Every person who comes into contact with HDs would benefit from medical surveillance.
PP&P: What is the pharmacist’s responsibility in ensuring facility-wide USP <800> compliance?
Slaughter: Doing whatever is necessary to bring the pharmacy department into USP <800> compliance falls squarely in the pharmacist’s purview. However, due to the in-depth knowledge required, a pharmacist might very well be one of facility’s central voices in ensuring USP <800> compliance throughout the health system.
Section 4 of USP <800> describes the role of a designated person who is tasked with monitoring all aspects of HD handling.2 This individual must possess the qualifications and training necessary to be tasked with the development and initiation of P&Ps. Depending on the facility’s staffing structure, a pharmacist could fill this role.
Astrid Slaughter, PhD, RPh, is the pharmacy manager at Texas Oncology Round Rock in Round Rock, Texas. She was educated at the University of Freiburg in Germany. Her professional interests include outpatient oncology and regulatory compliance.
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