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Hazardous drug handling is focus of coming changes to USP

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October 5, 2017

Safe-handling standards apply to all healthcare workers, from delivery to storage, administration, and disposal

As medications have grown increasingly powerful and healthcare workers have grown increasingly aware of the hazards some drugs pose, regulators and stakeholders have been looking for ways to improve safe-handling practices. While a number of guidelines and recommendations in the past have set expectations already for handling, transporting, and disposing of potentially harmful drugs, the U.S. Pharmacopeial Convention (USP) aims to make a significant improvement next year with the implementation of its ambitious contribution known as General Chapter <800>. 

The new chapter of standards, which were finalized last year, apply to all healthcare personnel who come into contact with hazardous drugs at any point, whether to store, prepare, transport, or administer them. With an implementation deadline of December 1, 2019, USP <800> aims to protect healthcare workers from drug-handling hazards that often were missed or ignored in decades past.

“The challenge is we don’t often see the results of exposure until 20–30 years down the line. That makes it much more difficult," says Charlotte Smith, RPh, MS, senior regulatory advisor at PharmEcology Services for WM Sustainability Services in Houston. "It’s not like a fire, somebody gets burned and we see it. This is a much more subtle exposure problem.”

Smith, who earned her first pharmacy degree nearly 50 years ago, says it's a bit startling to reflect on how cavalier practitioners had been in past decades with regard to handling hazardous drugs.

“It's actually very comforting and refreshing to me to see these standards being drafted and created and accepted," Smith adds. "I think it’s all to the good, especially as we get more and more very potent drugs, and we’re going to see a lot of that moving forward in drug development.”

Nothing in USP <800> should really come as a big surprise, especially not to hospitals, says Patricia Kienle, RPh, MPA, FASHP, director of accreditation and medication safety at Cardinal Health.

“Though it’s much more detailed in USP <800>, there’s been information on hazardous drugs since May 1, 2004 when the first USP <797> chapter was published,” Kienle says. “And when USP <797> was revised in 2008, there was a larger section on hazardous drugs included. So this really isn’t a surprise to hospitals.”

What could take some healthcare professionals by surprise is the chapter's scope. It covers every moment a hazardous drug is present in any healthcare facility, from receipt at the loading dock all the way through to the medicine's administration and disposal of leftovers. The standards apply, furthermore, to anyone who comes into contact with hazardous drugs at any time, including not only doctors, nurses, and pharmacists, but other less-obvious employees as well, such as loading dock personnel.

Which drugs are hazardous?

To identify which drugs qualify as hazardous, USP <800> relies on a list compiled by NIOSH that is updated about every two years. The 2016 version of the list, which runs 42 pages long, is available for download online.

“If you look at the NIOSH list, which is kind of the guide for all of this, it’s divided into three tables now," Smith says. "The [drugs in the] first table are the antineoplastics, which are the really heavy-duty cancer drugs, and those are the ones that an organization really needs to focus on initially or when they’re first doing their review. But then they also need to look at the other two tables, which have reproductive hazards or safe-handling hazards.”

Every drug on the list is considered hazardous, but proper precautions for each depend heavily upon the drug's formulation and how a healthcare worker is using the substance, the NIOSH document explains. See the table below for a breakdown of NIOSH-recommended precautions for various drug types and use cases.

Smith says the NIOSH list is an excellent starting point for anyone looking to refresh their organization's safe drug-handling practices in light of USP <800>. Healthcare workers should check the list, determine which hazardous drugs they have in their inventory, then assess how the drugs are being used.

"A classic example is estrogen, which is on the list. It’s a female hormone. It can cause some problems if exposed to pregnant women, so on and so forth. But if you’re administering a tablet, a coated tablet, and you’re not crushing it, the likelihood of being exposed is essentially slim to none. So that’s not going to be a big issue," Smith says. "If, however, as I mentioned, you’re running a compounding pharmacy where estrogen in bulk is being reformulated and people could be inhaling fumes and that type of thing, then obviously you’re going to need to do something to protect those employees. So the first thing is to look at the list, see what you’re carrying, and then evaluate how it’s being used or administered or handled in your organization, and then based on that, what level of personal protection equipment, engineering controls, administrative changes do you need to put in?"

Who's enforcing this?

While the USP standards are designed to be enforceable, USP won't do the enforcing itself. That will be up to oversight organizations, such as CMS, The Joint Commission, DNV Healthcare, and HFAP. Many of these organizations already require compliance with certain USP chapters, but it remains unclear how some of them will address the new chapter. A spokesperson for The Joint Commission said in August that an internal review of USP <800> was underway but that no decisions had been made.

That being said, Jeannell Mansur, RPh, PharmD, FASHP, FSMSO, CJCP, principal consultant for medication management and safety at Joint Commission Resources, said during a webinar last fall that she would expect The Joint Commission to handle USP <800> in much the same way as it handled earlier related chapters <797> and <795>, which are currently incorporated into the organization's Medication Compounding Certification program. Mansur said, also, that USP <800> could be adopted by state pharmacy boards and other authorities having jurisdiction, potentially giving the new standards a broad reach. Even if you think your facility won't be specifically required to abide by the provisions in USP <800>, however, you should still review the standards for the sake of promoting employee safety, Mansur said.

“For the sake of all of our colleagues who work with hazardous medication—and even other colleagues who are in areas where, even if they don’t work with hazardous medications, may incur exposure through poor practices—you really want to look at this chapter in terms of complying with it because it’s really the right thing to do," she said.

Administrators need to understand, furthermore, that OSHA has labor standards that tie into the USP standards, said Firouzan “Fred” Massoomi, PharmD, FASHP, senior director of Visante Inc. And, rather than defining best practices, the expectations set by USP <800> represent minimum practice standards, Massoomi added. 

How to prepare

Beyond reviewing the hazardous drugs identified in the NIOSH list, healthcare organizations need to conduct a risk assessment. That's new for USP <800>, says Kienle, adding that organizations shouldn’t procrastinate.

“They certainly need to do it before [the deadline], when USP <800> goes into effect. But I would recommend that they start that quickly," Kienle says. "I think it will put their mind at ease on how they are going to handle some of these other drugs that aren’t antineoplastic agents.”

Rick Schnatz, PharmD, senior manager of USP's Healthcare Quality & Safety program, notes that the staff training requirement in USP <800>—which requires that every organization designate a qualified person to develop and implement appropriate hazardous drug procedures—doesn't specify how many hours or what type of training the designated person must have. This is partly due to the fact that the standards apply to such a broad array of settings varying in size and other characteristics, Schnatz says.

“If you’ve got someone who just graduated school or just became a technician, they’ll need more training than someone who has been in this field for a number of years,” Schnatz says. “It also depends on the environment that they’re in. If they’re doing sterile, they might need more training than if they’re doing non-sterile because of complexities unto itself of making a sterile product at the end of the time you’re compounding."

No matter what level of education the designated person receives, USP <800> requires that the person refresh his or her training every 12 months, Schnatz notes. (Kienle says it's typically up to state enforcement agencies to determine precisely how many hours of training are required.)

“Particularly if people are not comfortable that they know all that they need to," Kienle says, "I would really encourage them to go to one of the courses that includes hands-on training, not just video or didactic training." 

For more on USP <800>, be sure to review the USP website.

Items to keep in mind

As you review the U.S. Pharmacopeial Convention's General Chapter <800> in an effort to improve hazardous drug handling practices, here are several points to consider:

  • Prep for spills. Employees will need to know what to do if there is a spill, what the effects of a drug are if exposed, and what PPE is needed for each job. Employers should be evaluating all the drugs their workers use to ensure they’ve got the PPE they need, whether gloves, splash guards, uniform covers, or other protective gear, said Valerie Butera, an attorney with Epstein Becker Green in Washington, D.C., last year.
  • Safety first. Make sure your process for administering drugs is as safe as possible, following best practices for protection against sharps and needlesticks, Butera advises.
  • Document training and whether it was successful. OSHA inspectors, in particular, are going to want to see that the healthcare organization trained its employees and “that your employees understood and comprehended the training,” Butera says. That includes training in a language the employee understands. A lot of companies use comprehension quizzes at the end of training to show that their employees understood what was being taught.
  • Set a minimum passing grade for the quiz. Some companies put it at 100%, Butera notes. Keep documentation of the training on hand, both of the initial orientation training and annual refresher education.
  • Train employees after problems or changes. If you see a problem, if there are changes to procedures, or if NIOSH adds new drugs to the list, put employees through training again, Butera says.
  • Scrutinize shipping of drugs to your organization. The standard notes that a package damaged in transit has the potential to contaminate whomever handles it. Whether it’s someone accepting delivery of a package at the front desk or employees in the shipping and handling areas, everyone should have some knowledge about the potential for dangers from certain drugs and how to handle them, Butera says.
  • Consider the loading dock. While hospitals likely have strong procedures already in place, one area sometimes forgotten is the loading dock, says Kurt Patton, a pharmacist and former director of accreditation services for The Joint Commission, who founded Patton Healthcare Consulting in Glendale, Arizona.
  • Review OSHA’s Hazard Communication (HAZCOM) standard. In the past few years, OSHA has been fully implementing the worldwide Globally Harmonized System (GHS) of packaging, labeling, and handling hazardous materials of all kinds, with special emphasis on training workers on the new safety data sheets and labels that bear the pertinent warnings for workers. While USP <800> is detailed in its requirements for warning labels, it isn’t as detailed as the requirements under GHS, cautions Butera. As far as OSHA inspectors go, the HAZCOM standard is more detailed, and it would be difficult for a healthcare organization to be cited under USP <800> if it made an effort to be compliant under HAZCOM, she observes.



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