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What to Expect with USP 800: Implementing Safe Handling Practices of Hazardous Drugs

TON - August 2019, Vol 12, No 4 - ONS
Meg Barbor, MPH

Anaheim, CA—In 2016, the US Pharmacopeia (USP) published standards for safe handling practices of hazardous drugs, aimed at minimizing the exposure risk for healthcare personnel, patients, and the workplace environment. This set of standards is commonly known as the Safe Handling of Hazardous Drugs (USP 800).

As a pharmacy-centric organization, the USP sets quality standards for medicines in the United States, and many of its standards are focused on pharmacy practice. However, it is crucial that nurses—particularly oncology nurses—also receive training on safe handling practices of hazardous drugs, according to Martha Polovich, PhD, RN, Assistant Professor of Nursing, Byrdine F. Lewis College of Nursing and Health Professions, Georgia State University, Atlanta.

In preparation for its imminent and widespread implementation, nurses will need to become compliant with USP 800 standards for hazardous drug safety in the work environment. By December 1, 2019, in any place where hazardous drugs are handled, the expectation is that these standards will be implemented, said Dr Polovich at the Oncology Nursing Society (ONS) 44th Annual Congress.

“Why am I so excited about USP 800, when in truth, it introduces a lot of complexity and problems into your workplace?” she asked. “Because in the past, organizations did not have to provide the equipment that we need to keep ourselves safe. This is the first time that there will be mandatory standards for our protection as healthcare workers, and I think that is outstanding.”

Why Standards for Hazardous Drug Handling?

The standards encompass everything that goes into ensuring a safer place in which hazardous drugs are administered to patients. They address facility and engineering controls (ie, biological safety cabinets), competency of personnel, safe work practices, proper use of personal protective equipment (PPE), and policies for hazardous drug waste segregation and disposal.

It is generally agreed upon that hazardous drug exposure at the occupational level is harmful and will potentially cause adverse outcomes, but according to Dr Polovich, people do not always “get on board” when it comes to the fact that occupational hazardous drug exposure continues to occur in the workplace, despite safe practices.

“If you work in a place where hazardous drugs are handled, you’re likely to find contamination in the environment,” Dr Polovich said. Examples include contamination on external vial surfaces or workplace surface contamination.

One of the most important issues to note when it comes to hazardous drug exposure is that organizations vary in their implementation of hazardous drug safe handling precautions. Simply put, “where you work may influence whether or not you’re exposed,” she said.

Practice Environment Affects Hazardous Drug Safety

Hazardous drug spills are positively related to handling frequency, and people with a higher workload are less likely to use PPE.

“But if you’re busy, it doesn’t mean you don’t have time to use PPE,” Dr Polovich emphasized. “It just means you have to plan to have it right there when you need it, so that you can put it on and use it.”

However, PPE tested for use with hazardous drugs is not always provided by employers in sufficient quantity, if at all.

“If your employer doesn’t provide the equipment, you have no choice,” she noted. “You cannot follow the precautions unless you’re provided the equipment.”

Organizations also vary in their resources. Several studies have shown that favorable staffing reduces the odds for hazardous drug exposure, and closed-system transfer devices (CSTDs) decrease spills. A CSTD is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations out of the system (nothing in, nothing out). However, these practices are not utilized in every institution.

Another important aspect of the work environment is the attitude toward safety. When there are fewer barriers to implementing safe handling precautions—and people have an appropriate sense of the risks associated with handling hazardous drugs—they tend to actually follow the precautions. In environments where coworkers value hazardous drug safety, the behavior of other workers in that setting can be positively influenced.

However, the opposite is also true. “If you have an influential person who does not respect [hazardous drug] safety and thinks it’s silly that you put that gown on every time you handle [hazardous drugs], they can influence the practice of other individuals in your setting,” Dr Polovich noted. “So, that’s a very important aspect of [hazardous drug] safety.”

Bottom Line: The Required Standards

According to USP 800, institutions handling hazardous drugs must maintain a facility-specific hazardous drug list and label all hazardous drugs. Every organization must also designate an individual who is responsible for oversight of compliance with the standards in the facility.

“In big organizations, this is often a safety person or a pharmacist, and in smaller organizations, it could be a nurse who is very familiar with [hazardous drugs],” Dr Polovich said.

Specific areas must be designated for receipt, unpacking, storage, and compounding of hazardous drugs, and appropriate engineering controls must be used for compounding. These controls can be externally vented through a high-efficiency particulate air filter physically separate from other preparation areas with appropriate air exchanges per hour and negative pressure to adjacent areas.

Organizations must provide the appropriate PPE (and personnel handling hazardous drugs must actually wear it). They must follow all packaging, transport, and disposal standards, and use CSTDs for administering antineoplastic hazardous drugs (although CSTDs are not required for all drug compounding). In addition, organizations must develop policies and procedures for all aspects of hazardous drug handling, and establish a hazard communication program.

Personnel must be provided with job-specific education and training (eg, training for nursing assistants on postadministration exposure). Policies must be written that define how equipment will be decontaminated in the work environment, and must also address the prevention and management of hazardous drug spills (also indicating who is responsible for cleaning them up).

USP 800 also outlines recommended standards that are cited as best practices, but are not required. According to Dr Polovich, a rule of thumb is that the word “must” used in the USP 800 guidelines refers to required standards, whereas the word “should” refers to recommended standards. Examples of recommended standards include environmental wipe sampling at baseline and every 6 months to monitor whether other precautions are decreasing contamination, and medical surveillance for healthcare workers handling hazardous drugs.

Education and Training

According to Dr Polovich, because hazardous drugs can be anywhere in a medical facility, staff should assume that most nurses will be handling them.

“But, nurses alone cannot implement these standards, nor can pharmacists alone. All interventions have to involve the entire organization, even the people who ordered the supplies, because they need to know they can’t substitute one type of glove for another if it doesn’t meet the standards. You need an interdisciplinary group to implement USP 800 standards,” she said.

Education and training are essential, but providing education does not always change behavior. If it did, no one would smoke, Dr Polovich noted. However, education is necessary, and can be provided online to streamline the process. Staff training should address labeling and communication around hazardous drugs, routes of exposure (putting emphasis on the fact that environmental contamination is the most likely source), as well as exposure opportunities and safety precautions.

“Exposure is problematic to all of us who handle [hazardous drugs]. We owe it to ourselves, our coworkers, our families, and our pets to not bring home [hazardous drug] residue on our clothes,” Dr Polovich said. “We deserve that our health is protected. Your organization has responsibilities and so do you.”

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Last modified: September 9, 2019