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USP <800>: Effective date pushed back to 2019, but experts urge early adoption

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February 1, 2018

The U.S. Pharmacopeia Convention (USP) published standards in 2016 to protect workers who handle hazardous drugs. Those standards, contained in the chapter known as USP <800>, were slated to become fully enforceable on July 1, 2018, but USP announced in late September that it would postpone that date by 17 months, to December 1, 2019.

The delay was made “to provide a unified approach to quality compounding” by aligning USP <800> with the timeline of an earlier chapter already in force, USP <797>, the organization said in a statement announcing the postponement. The next round of revisions to USP <797>, which aims primarily to protect patients by addressing sterile preparations in pharmaceutical compounding, is expected to be published for public comment in fall 2018 with an effective date on December 1, 2019 — though organizations could have longer to implement certain sections.

The new deadline might seem like it’s a long way off, and it remains unclear exactly which authorities having jurisdiction (AHJ) will require compliance with USP <800>. But USP and others encourage healthcare organizations to adopt these standards early, especially since they’re not expected to change and they represent the culmination of more than three decades of work to protect healthcare workers and foster safe environments despite the presence and use of dangerous drugs.

Melissa A. McDiarmid, MD, MPH, DABT, professor of medicine and director of the Division of Occupational and Environmental Medicine at the University of Maryland School of Medicine in Baltimore, says the new standards reflect what safety experts from public and private entities alike have been saying for years now.

“For those who are perhaps reluctant to align their practice with the elements of USP <800> — if it makes them feel better — it’s very much aligned in many ways with the NIOSH Alert, with the OSHA guidance, with the Oncology Nursing Society guidance, with [the American Society of Health-System Pharmacists (ASHP)]’s guidance,” McDiarmid says, “so from that point of view, the affected community can see a harmonization across professional and governmental and quasi-governmental organizations, that people are in agreement about what the right thing to do is.”

Patients and workers
Sometimes acknowledging a set of standards as best practices, however, doesn’t automatically translate into broad-based support for their adoption as mandatory. That’s what happened when USP <797> was published in 2004, says Luci A. Power, MS, RPh, senior pharmacy consultant for San Francisco–based Power Enterprises. When the standards were first published, many groups and state boards of pharmacy avoided the topic. As awareness of the patient safety implications grew, though, people came around, Power says.

In 2012, at least 64 people died and another 700 were sickened by contaminated drugs from the New England Compounding Center in Framingham, Massachusetts. That story, which has continued to play out in court five years later as the center’s president and chief pharmacist have faced criminal charges, added some shock value to the public discourse over USP <797> and patient safety in sterile compounding, making it easier to convince people that subpar compounding practices pose a real and present danger to patients. Making a similar case for USP <800> will be more challenging, Power says, because it’s much more difficult to attribute the illness an individual healthcare worker experiences to his or her handling of hazardous drugs over the long term, let alone to do so in a clear and compelling manner.

“Unfortunately, in this country, we like to see body counts,” Power says.

That being said, the fallout from the New England Compounding Center tragedy could also be helping people see the interplay between patient safety and worker safety. That has “helped heighten the message and, again, harmonize it across these various stakeholder groups that have been active in the area,” McDiarmid says.

Existing expectations
Regardless of whether USP <800> enjoys widespread support from regulatory and accrediting bodies, the precepts it conveys constitute best practices that your organization should be following already, Power says. For example, OSHA requires employers to inform any workers involved with handling hazardous chemicals of the risks associated with handling those substances.

“The final rule on the OSHA Hazard Communication standard (HCS) says that drugs — except for individual oral drugs, individual, packaged, ready to use by a patient — are part of the HCS,” Power says. “And yet healthcare workers are not getting their right to know. They’re not getting their awareness training. They’re not getting their gowns and gloves. They’re not getting the understanding that they need gowns and gloves.”

In OSHA’s Controlling Occupational Exposure to Hazardous Drugs, updated in 2016, there’s an interesting discussion of recent surveys by other entities. Those surveys have found that 9%–13% of nurses and pharmacists responsible for hazardous drug preparation reported never having received hazardous drug training; most who did receive training said it had been more than a year earlier.

Respondents responsible for hazardous drug preparation reported failing to wear protective gowns 20%–36% of the time and failing to wear chemotherapy gloves 8%–10% of the time. A number of surveys between 2012 and 2015 showed that 4%–17% of employees had experienced skin or mucous membrane contact with hazardous drugs during the previous year.

“Correct work practices are essential to worker protection,” the OSHA document states. “Without appropriate compounding work practices, both workers and patients are at risk. Protective equipment and environments should be accompanied by a stringent program of work practices, including operator training and demonstrated competence, contamination reduction, and decontamination.”

Martha Polovich, PhD, RN, AOCN, assistant professor in the Byrdine F. Lewis College of Nursing and Health Professions at Georgia State University in Atlanta, says USP <800> addresses these education needs specifically.

“There has to be planned information, education, training, and competency validation for everybody who has any responsibility related to hazardous drug handling,” Polovich says, “and they need to have somebody who’s going to lead the process who’s responsible for monitoring compliance.”

One of the big reasons why some see USP <800> as controversial is because it can be expensive. “If it were free, nobody would argue,” Polovich says.

Another reason for the slow adoption, says McDiarmid, is a general lack of awareness about the evidence that clearly demonstrates the hazards these drugs pose to workers.

“I think if people are in this space … and don’t know what the outreach has been on these topics for 30 years, they’ve been Rip Van Winkle–like,” McDiarmid says. “There has just been, I think, a huge amount of focus on this in sterile compounding and, before that, in oncology pharmacy and oncology nursing.”

Enforcement
Although a spokesperson for The Joint Commission (TJC) said in August that an internal review of USP <800> was underway and that no decisions had been made on whether it will be adopted by the accrediting organization, those who have been working on USP <800> believe TJC will eventually enforce the standards, Polovich says.

“But nobody really knows for sure how that’s going to happen and when that’s going to roll out,” she adds.

While some state boards of pharmacy have adopted or will adopt USP <800> in whole or in part, others won’t, making it difficult to predict precisely which AHJs will require what from whom.

The USP website notes that the organization has no role in enforcing its standards. “Ensuring compliance with the requirements of these standards is the responsibility of regulators such as the FDA, states, and other government authorities,” USP states.

An FDA spokesperson said there are several provisions in the Federal Food, Drug, and Cosmetic Act pertaining to pharmacy compounding, but there’s no specific requirement to comply with USP <800>. “States may require compliance with both Chapters <797> and <800>,” the FDA spokesperson said in an email.

An OSHA spokesperson said in an email that the agency hasn’t adopted USP <800> as one of its standards, so the agency cannot enforce its compliance. OSHA advises employers to look to “industry standards and best practices for guidance,” the spokesperson said.

Just do it
Since USP <800> is the direction in which hazardous drug handling standards are headed, healthcare organizations should just get on board, McDiarmid says.

“This is the momentum of where things are going in safe handling, and I think that probably, again, rather than fighting it, they should begin to use that energy to try to begin to create a road map to meet it,” McDiarmid says.

Polovich recommends that each organization conduct a gap analysis then prioritize tasks. Assess whether complying with USP <800> would require construction, she says; bring in consultants; assess equipment needs; talk to workers; and make a plan.

Charlotte A. Smith, RPh, MS, senior regulatory advisor at PharmEcology Services for WM Sustainability Services, says leaders involved in hazardous drug management should go ahead and implement what USP <800> requires.

“While USP 800 is the latest significant effort to protect employees from exposure, ASHP and NIOSH have been sounding the alarm for many years now,” Smith said in an email.

“I am hopeful the delay in implementation of USP 800 will not result in a delay in employee protection,” she added.

 

USP: Quick questions and answers
Editor’s note: These questions and answers have been adapted from the U.S. Pharmacopeia Convention’s FAQ page regarding USP <800>.

When will USP <800> become official?
The organization has announced its intent to postpone the date on which USP <800> will become fully enforceable from July 1, 2018, to December 1, 2019.

Why is this delay happening?
By making USP <800> official on December 1, 2019, the organization will align this chapter with the revisions timeline for USP <797> in order to “provide a unified approach to quality compounding.”

Is USP <800> enforceable currently?
States can make their own determinations on whether to require some or all of USP <800> for the organizations under their jurisdiction. Because USP doesn’t have a hand in enforcement, the enforceability of USP <800> depends upon the legal framework in question.

Has USP <800> been updated?
Yes, “minimal editorial changes” have been made to the chapter since it was published on February 1, 2016. (These changes are listed in the “errata table” online.)

Are substantive changes coming?
No, the “official date” is the only substantive part of USP <800> that’s expected to change.
The full Q&A is available on the USP website: www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings.




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