Protecting employees from this potential harm is good for business, the bottom line and brand reputation. Many healthcare systems have already taken extensive steps to protect pharmacy and nursing personnel from hazardous drugs during drug preparation and administration activities. Once a hazardous drug leaves the pharmacy, however, the number of staff potentially exposed increases and the types of exposure may be difficult to control.
This article was written in collaboration with WorkingBuildings.
Becker’s Hospital Review recently spoke with two experts from WorkingBuildings about hazardous drug exposure and risk management in patient care areas. Kurt Last, Principal, and Elaine Strauss, PharmD, Pharmacy Clinical Consultant, discussed USP <800> compliance and best practices that healthcare organizations can use to limit and eliminate staff exposure to hazardous drugs.
Hazardous drugs and USP <800>
The National Institute for Occupational Safety and Health maintains a list of hazardous drugs. According to NIOSH, a drug is considered hazardous if it meets at least one of the following characteristics in humans or animals: carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity or genotoxicity.
Individuals who need hazardous drugs for disease treatment take them under informed consent. They understand the risk-benefit calculation associated with taking them. Unintentional exposure to these drugs is undesirable. “Numerous studies have proven adverse effects as a result of staff having occupational exposure to Hazardous drugs,” Dr. Strauss said. “These can include reproductive issues, skin rashes or hair loss.”
In response, the United States Pharmacopeia (USP) developed USP General Chapter <800> which focuses on handling of hazardous drugs in healthcare settings. This chapter defines processes intended to minimize exposure to hazardous drugs in healthcare organizations, with the goal of promoting safety and environmental protection for patients and workers.
USP <800> will become official on Dec. 1, 2019. Although the chapter will not be enforceable until appeals related to USP <795>, <797>, and <825> are reviewed, healthcare systems should not halt their USP <800> compliance initiatives. “Since none of the appeals impacts the facilities or engineering aspects of USP <800>, healthcare organizations should stay the course on their work. “As soon as the pending appeals are resolved, USP <800> will be going into policy, procedure, and practice,” noted Dr. Strauss.
Hazardous drug exposure isn’t limited to pharmacy and nursing units
In health systems, the primary hazardous drug exposure point is the pharmacy where the drugs are manipulated. Fortunately, pharmacies are relatively small physical spaces, the staff are typically highly trained, and well-documented procedural and engineering controls are in place to limit exposure.
Another common exposure route is in nursing units when hazardous drugs are administered or infused into patients. Most facilities have proactively implemented protocols, such as closed system engineering devices attached to the hazardous drug bags, to minimize nurses’ exposure.
“One problem is that there are many other areas of the hospital where hazardous drugs travel before they get to the pharmacy, “ Mr. Last said. “The geography of these facilities is so large and there are so many people involved that the full range of HD exposure isn’t well understood or controlled.”
In the receiving area of the hospital, warehouse or loading area employees may open boxes containing hazardous drugs. If the integrity of the packaging was compromised during shipment, those individuals could be accidentally exposed.
Health systems must also consider how to protect employees from hazardous drug exposure during everyday environmental and patient care activities like cleaning patient bathrooms, changing linens and other patient care areas. “After a hazardous drug is administered to a patient, the downstream issues are considerable. In some cases, a substantial portion of the drug will pass through the patient either unmetabolized or partially metabolized. As result, the hazardous drug ends up in the patient’s waste and body fluids,” explained Mr. Last. Most HDs are excreted from patient’s bodies within 48 hours after they have been administered, however some drugs can continue to present in patient body fluids for up to 7 days. Plans should also be developed for handling bed linens, towels and any other items from patient room that might have traces of hazardous drug contamination. Since exposure to hazardous drugs can happen in many areas of the hospital, limiting exposure requires a multifaceted approach.
“Individual healthcare programs may have other treatment plans that involve acupuncture, massage therapy and perhaps others. The risk to the staff from working with and handling those patients must also be evaluated and mitigated,” Mr. Last said.
Hazardous drug surface contamination is a reality
Surface residue from hazardous drugs is a reality in many healthcare settings. Implementing a four-step cleaning protocol is an effective way to address this issue through deactivation, decontamination, cleaning and disinfection.
In addition to surfaces in patient rooms and bathrooms, employees must clean reusable equipment like IV poles, IV pumps and hospital beds, among others. Once a health system has implemented a four-step cleaning program, it must regularly evaluate its effectiveness.
USP <800> recommends an environmental wipe sampling program. After wiping different areas, facilities look for measurable levels of hazardous drug residue. If contamination levels are found, employees are at risk of occupational exposure to hazardous drugs.
“Wipe testing should be done routinely to monitor cleaning practices. Surface hazardous drug residue is an opportunity for organizations to reevaluate work practices, retrain personnel on handling and administering hazardous drugs, and reinforce the importance of the four-step cleaning procedure,” said Dr. Strauss.
Best practices for assessing and addressing hazardous drug exposure
When it comes to addressing hazardous drug exposure, an essential first step for health organizations is to maintain a list of hazardous drugs used by the facility. This is required by USP <800>. The list should include any products that are on the current NIOSH hazardous drug list. Creating this list isn’t a onetime event.
“Each time the pharmacy team and formulary committee add a new drug to the formulary, they must evaluate whether the drug should be included on the organization’s hazardous drug list,” Dr. Strauss said. “In addition, every 12 months, health systems should conduct a complete a full review of their hazardous drug lists and exposure risks.”
In addition to creating a hazardous drug list, healthcare organizations should perform a risk assessment. This process traces all the areas where a hazardous drug and hazardous drug contaminated waste may travel after leaving the pharmacy. Hazardous drugs and hazardous drug waste are often transported on elevators, placed in medication storage rooms or even placed in environmental service areas alongside cleaning supplies. Each time a hazardous drug or waste is handed off, there is a risk of exposure.
According to Dr. Strauss, it’s important to observe and interview staff members involved in patient care activities after patients have received a hazardous drug. “Be sure to ask questions like: Are staff members wearing the right personal protection equipment while cleaning? How are employees disposing of cleaning supplies after they have cleaned a patient’s room?”
After conducting a walkthrough of the entire hazardous drug process, the next step is to perform a gap analysis. During this process, the organization reviews facility standard operating procedures (SOPs), develops new SOPs, and ensures all SOPs reflect the current guidelines for limiting hazardous drug exposure in patient care areas.
Employee education abut exposure is also essential. “We’re finding an incomplete understanding of the challenge, especially at large healthcare organizations. Downstream staff, like nursing assistants, environmental services and custodial employees haven’t been educated about this,” noted Mr. Last. In some cases, hospital administrators and physicians may not even fully recognize the severity of the problem because they don’t understand how different hazardous drugs are metabolized.
It’s the responsibility of healthcare leaders to keep team members safe, so they can do their best when taking care of patients. USP <800> recommends facilities collaborate with employee health departments to develop a medical surveillance program. Healthcare workers who regularly handle hazardous drugs should be enrolled in this type of initiative. Medical surveillance programs assess and document employee symptoms, as well as laboratory values like blood counts. The goal is to identify deviations from expected norms.
“If health systems have integrated electronic record management systems, as soon as a doctor writes a prescription for a hazardous drug, it can start a chain of alerts and a cascade of enforcement that results in better control than we see now,” explained Mr. Last.
Although USP <800> focuses on hazardous drug exposure in healthcare settings, exposure in patients’ homes is also becoming an issue as home infusions grow in popularity. Hazardous drug contamination in a home bathroom, for example, could adversely affect children or pets.
Conclusion
Healthcare systems have routinely found hazardous drugs in areas where they shouldn’t be. In response, they want to rapidly determine where hazardous drugs contamination is occurring and how to prevent it. Applying traditional biocontainment techniques to the larger health system landscape, however, usually isn’t the answer.
According to Mr. Last, “Engineering controls that work in a 2,000 square foot pharmacy aren’t going to be effective in a 700,000 square foot hospital. It’s not possible to control that large a space in the same way. Organizations must find new ways to scale hazardous drug controls so they can be used in much larger facilities. This will require thought, time and money.”
