Prepare for Changes to Hazardous Drug Standards
Extensive new requirements issued next year
The deadline to adopt new requirements for protecting healthcare workers potentially exposed to hazardous drugs has been extended, giving employee health professionals more time to define their role in medical surveillance and other areas.
The new standards set by the U.S. Pharmacopeia — USP 800 — were originally slated for an effective date of July 1, 2018, but the deadline has been extended to Dec. 1, 2019.
“I think they discovered that people are just overwhelmed by all that this involves, so that is good news,” said Sandy Swan, RN, BSN, MS, COHN-S/CM, CEAS, CSPHP, manager of occupational health and ergonomics at BJC HealthCare in St. Louis.
Swan outlined the changes and explained her hospital’s approach at a recent webinar held by the Association of Occupational Health Professionals in Healthcare.
The USP 800 will update its 2004 guidelines and will reflect requirements and recommendations by federal agencies like OSHA and the National Institute for Occupational Safety and Health (NIOSH). Although occupational health may not have oversight of a facility’s hazardous drug policy, there is overlap of responsibilities in many areas.
“You need to make sure you are at the table,” she said. “There is a piece of this that occupational health owns. A lot [people say] is owned by pharmacy, which makes a lot of sense, but like a lot of policies within our organizations, we have a piece of them even if we don’t own the policy.”
Hazardous drug protections that may have been off the radar in many facilities now are becoming a matter of discussion and concern by healthcare workers as the revisions are discussed.
“It makes sense that people would have questions,” Swan said. “It’s an obvious question: ‘What about all the years I didn’t have this engineering control or this procedure?’”
OSHA has been recommending hazardous drug protections since 1995, but there has generally been poor compliance and a lack of a widely accepted standard, Swan said.
“I think that’s why USP 800 is pushing for more compliance and more standardization,” she said.
Outlining the Threat
Often used in oncology, hazardous drugs generally include those that threaten human health with cancer and other conditions, including genetic damage and reproductive toxicity in humans. While some of these problems may present long-term, acute effects of exposure include nausea, dizziness, and nasal sores.
The three hazardous drug categories include antineoplastic (i.e., cisplatin); non-antineoplastic (i.e., phenytoin); and reproductive hazards (i.e., oxytocin), Swan said.
Of course, lists must be kept and constantly updated as new drugs come on the market. The USP issues healthcare quality standards, but has no enforcement authority per se, she said.
“They rely on government agencies to adopt their standards and enforce them,” Swan said. “That could be state boards of pharmacy, Joint Commission, and CMS. Even though they are not regulatory, their standards are definitely adopted by others. So, it is important that everyone follows these standards.”
The new USP standard will apply to all healthcare personnel and healthcare facilities where hazardous drugs are handled or manipulated, from receipt to disposal, she noted. This includes pharmacists, pharmacy techs, nurses, and other groups.
“Nurses who administer hazardous drugs — and, of course, environmental services — are huge,” she said. “Think about who has exposure risk in your organization. We are doing so many things that are outpatient now. They are also using hazard drugs in those areas.”
It is estimated that 8 million U.S. healthcare workers potentially are exposed to hazardous drugs annually. However, they may be unaware of the risk and risk reduction measures, thinking “this is just part of my job,” she said.
Common reasons for drug exposures include lack of personal protective equipment (PPE), or failure to wear it if available. The recommended PPE for hazardous drug handling includes chemotherapy-approved gloves and nonpermeable gowns. Respirators equivalent to an N95 are recommended to prevent inhalation. Other exposures occur because some facilities may have limited use of closed-system drug transfer devices. Even with protocols in place, there is no guarantee that healthcare workers will follow them.
“It’s human nature not to always follow policies and procedures. We take shortcuts,” she said. “A lot of these consequences of exposures are long-term. They may show up 20 years later as cancer.”
Climate Change
While “safety culture” has become a common term, Swan favors “safety climate,” which she described as the employees’ perception of how important safety is in the organization.
“Does leadership really have a commitment to safety? Perception is everything, whether it’s right, wrong, or otherwise,” she said.
At some point, leadership gives way to personal responsibility. Employee health professionals have likely heard the litany of reasons and excuses why a highly trained nurse may not adequately protect herself.
“I’m a nurse, so I can say this — I’m not trying to nurse-bash,” Swan said. “We always say we don’t have time. I have safe patient-handling experts on my team and we deal with this all the time: ‘We don’t have time to use the equipment.’”
Similarly, inadequate donning and doffing of PPE may be one reason skin absorption is the most common type of exposure to hazardous drugs.
“That’s what we see more often, but of course inhalation can happen,” she said.
Exposures may occur during preparation and administration of the drugs, during spill clean-up, cleaning work surfaces and floors, and handling contaminated wastes and linens, she said.
The USP 800 calls for a risk assessment to determine potential hazardous drug exposures to workers. That means identifying workers potentially exposed based on their job duties.
“That is not an easy task,” Swan said. “I don’t feel like it is occupational health’s responsibility to identify all these people. We are in the process of rewriting our policy. We are going [to determine duties] that could be at risk as a kind of guideline for managers trying to determine who could have potential exposure. The managers in those departments are the ones who really need to know and identify their employees to protect them.”
In addition to maintaining a drug list, the updated requirements call for education, training, and medical surveillance of at-risk employees. Engineering and safety renovations may be necessary in pharmacies, she said. At BJC, pharmacies that only occasionally work with these drugs will stop doing so, funneling hazardous drug work to colleagues who perform it routinely.
“It’s an easier way than renovating each and every one of them,” she said.
The requirements also call for training and regular observance of work practices of those working with hazardous drugs. Swan recommends taking the time to walk through and observe work practices.
“I was looking at the nurses administering [drugs], and I would have to say it was sloppy,” she said. “It wasn’t because they were being defiant. I don’t think they understood the risk they were at. Regular observance of work practices is really important. We have to keep spot-checking.”
Of course, education and training is particularly important for workers who are pregnant, breast-feeding, or trying to conceive. The latter includes male healthcare workers.
“These are obviously very emotional issues,” she said. “We have a prenatal reference guide, but you have to be careful because there are federal regulations that you can’t discriminate against a pregnant employee. My feeling is that it is between that employee and their physician. They need to decide whether they need some kind of temporary reassignment, or some kind of work restriction.”
In conducting medical surveillance of employees working with hazardous drugs, look for trends that may inform prevention. The idea is to detect and eliminate underlying causes of hazards and exposures.
“We want to see if there are trends and make sure that we can get out there and target some prevention,” Swan said. “Obviously, if we catch it earlier we can minimize health effects.”
Exposure incidents warrant an evaluation of the effectiveness of engineering controls, safe work practices, PPE, and education, she said.
“If we are having people who have exposures, it points right back to one of these things — are they using the PPE, do they have the education, are they following safe work practices?” she said. “What about engineering controls? Is our ventilation system working properly? Are biosafety cabinets vented correctly?”
Post-exposure follow-up should identify the drug involved, the nature of the exposure, and whether labs or treatment is indicated for the worker.
“We’re lucky in our organization, as one of our occupational physicians has a specialty in toxicology,” Swan said. “He is well-versed and we send people to him. It hasn’t happened very often, but when it does we send them to him. It can also help alleviate some fears.”
In that regard, BJC policy is that any employee concerned about an exposure can request a physician consult.
“An employee can request a physician evaluation, even if the occupational health nurse does not feel like this has really been a huge exposure,” Swan said. “If the employee wants an evaluation, we absolutely send them — because that peace of mind is important.”
Based on the investigation, develop an action plan to prevent additional exposures and stay in confidential communication with the exposed employee.
“These employees are usually freaked out, and I would be, too,” she said. “It is important to make the time for them and send them to the right people. Make sure that you do good follow-up with them. You are going to follow these people long-term.”
The deadline to adopt new requirements for protecting healthcare workers potentially exposed to hazardous drugs has been extended, giving employee health professionals more time to define their role in medical surveillance and other areas.
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