Prepare Now for USP Standard on Handling Hazardous Drugs
No one knows exactly when healthcare facilities will be required to meet the requirements for handling hazardous drugs specified in United States Pharmacopeia (USP) chapter 800.
But now is the time to plan for compliance with the chapter, said Patricia C. Kienle, director of accreditation and medication safety for Cardinal Health Innovative Delivery Solutions.
"Don't wait for it to be official. That's going to be too late," said Kienle, who chairs the United States Pharmacopeial Convention's expert panel on compounding with hazardous drugs, which wrote chapter 800.
Ryan Forrey, associate director of pharmacy and infusion services at The Ohio State University Comprehensive Cancer Center in Columbus, likewise said there are many "work practices, administrative controls, and procedures that can be changed now that are consistent with recommendations and guidelines that are already out there" for handling hazardous drugs.
"I do think that people should . . . start to implement what we can now, and then start to formulate, also, their longer-term plans for any facility changes that may be needed," Forrey said.
He called chapter 800 "a much-needed addition to the standards that we have within pharmacy and within healthcare in general."
"I think the challenge we have in healthcare is that we have worked with these substances for so long that people have gotten desensitized to the risks of them," Forrey said. "So it's time for us as pharmacists, as healthcare workers, to really embrace the need for safety and appropriate precautions when handling hazardous drugs."
Hazardous drugs, under chapter 800, encompass all medications specified in the current National Institute for Occupational Safety and Health (NIOSH) list of antineoplastic and other hazardous drugs.
Chapter 800 applies to the handling of hazardous drugs during receipt, storage, compounding, dispensing, administration, and disposal and affects all healthcare workers who perform these activities.
USP chapter 800, like chapters 795 and 797, will be an enforceable standard. This means that state boards of pharmacy and other regulatory entities can require regulated facilities to comply with chapter 800.
"Much of what's in chapter 800 has been published for decades as guidelines and recommendations. And yet, we consistently see that healthcare practitioners don't follow those guidelines or recommendations. So I think it is truly a good thing to have it standardized [as an] enforceable chapter," Forrey said.
A draft version of chapter 800 (officially titled "Hazardous Drugs—Handling in Healthcare Settings") was released online last March. That version was revised in response to comments from stakeholders, and a second draft was released online last December.
Kienle indicated during a February 13 webinar that the earliest likely effective date for chapter 800 is August 2016. But she said implementation could be delayed, perhaps by the need for an additional round of public comments.
Kienle said the storage of hazardous drugs is likely to be the biggest compliance hurdle for healthcare providers. She recommended that healthcare facilities use the NIOSH list to determine which hazardous drugs and dosage forms of the drugs are in use and then identify where new storage space is needed.
The current draft of chapter 800 requires facilities to maintain a separate storage area for antineoplastic hazardous drugs that require manipulation other than the counting of final dosage forms. The storage area must be a negative-pressure room with 12 or more air changes per hour.
Refrigerated antineoplastic hazardous drugs must be stored in a dedicated refrigerator inside a negative-pressure room with 12 or more air changes per hour.
"I don't think it's going to be a problem as long as people have well-designed rooms in a hospital, because they can place their antineoplastic hazardous drugs in their negative-pressure room," Kienle said. "The problem is if they have built the room and it doesn't have enough space for storage in it. Because a lot of times people have undersized their negative-pressure room, thinking that all they need in there is their biological safety cabinet."
Forrey said allocating facility space is a contentious issue in healthcare settings.
He said outpatient facilities may have to decide whether to sacrifice patient care areas to accommodate the need for hazardous drug storage space.
"I think that's a difficult decision and a difficult discussion to have, especially given the growing volume of patients in the oncology setting," Forrey said.
USP chapter 797, which describes standards for the compounding of sterile products, also requires that hazardous drugs "be stored separately from other inventory." Storage of hazardous drugs in a negative-pressure room is preferred under the current version of chapter 797 but not mandated.
A United States Pharmacopeial Convention briefing document stated that revisions to chapter 797 are underway to ensure that its "facility requirements" agree with those in chapter 800.
Bona Benjamin, ASHP's director of medication-use quality improvement, said ASHP plans to update its Guidelines on Handling Hazardous Drugs after USP chapter 800 is finalized.
Under chapter 800, all compounding of hazardous drugs must be done in an appropriate ventilated device housed in a negative-pressure room that is separate from other drug preparation areas.
Chapter 800 eliminates an exemption in chapter 797 that had allowed "low volume" hazardous drug compounding to take place outside of a negative pressure area.
But chapter 800 adds a new option for the compounding of low- and medium-risk sterile preparations that contain hazardous drugs. Such work may take place within a "containment segregated compounding area" (C-SCA), defined as a separate negative-pressure room with at least 12 air changes per hour.
When compounding is performed in the C-SCA within an aseptic containment isolator, the compounded preparation may be assigned a maximum beyond-use date in accordance with USP chapter 797. Compounded sterile products prepared in a biological safety cabinet housed in the C-SCA are assigned a maximum beyond-use date of 12 hours.
These provisions supersede the requirement in chapter 797 that all hazardous drug compounding be performed inside an International Organization for Standardization class 7–compliant cleanroom equipped with a high-efficiency particulate air filtering system.
"That is just unrealistic in many outpatient infusion centers. And in private practice physician offices, it's just simply not going to happen," Forrey said of the superseded facility provision from chapter 797.
Forrey noted that his medical center operates about 150 outpatient infusion chairs and beds—a number that is growing—along with 273 inpatient cancer beds.
He said the creation of the C-SCA option in chapter 800 is "much more reasonable and achievable without major facility investments."
Benjamin said ASHP "particularly emphasized the financial and space considerations for smaller resource-constrained settings" in comments submitted during the revision process for chapter 800.
"We recommended further study of containment and handling methods to identify innovative solutions for these environments. We hope that pharmacy engineering and industrial hygiene professionals will rise to the challenge," Benjamin said. "There are hundreds of studies documenting injury and harm to healthcare workers from occupational exposure, mainly to antineoplastics. These individuals deserve a work environment that is safe."
Chapter 800 requires that packages containing hazardous drugs be opened in a neutral- or negative-pressure area. The packages may not be opened in a sterile compounding area or positive-pressure environment.
The chapter also requires the use of closed-system transfer devices for drug administration "when the dosage form allows." And chapter 800 emphasizes the appropriate use of personal protective equipment, including two pairs of powder-free, American Society for Testing and Materials–tested gloves, when administering hazardous drugs.
Double gloving is also required when disposing of hazardous drugs and personal protective equipment used during the handling of the drugs and when cleaning or decontaminating areas where hazardous drugs are used.
All antineoplastic drugs and active pharmaceutical ingredients on the NIOSH list that require manipulation other than counting final dosage forms are subject to the containment requirements of chapter 800.
Chapter 800 includes an option for facilities to perform a risk assessment for nonantineoplastic hazardous drugs and determine whether valid "alternative containment strategies" and work practices in keeping with those described in the chapter can be safely implemented.
The risk assessment must, at a minimum, consider the type of hazardous drug and its exposure risk, packaging, and manipulation. Healthcare facilities that develop their own containment strategy must adequately document that it minimizes occupational exposure to hazardous drugs.
The United States Pharmacopeial Convention is accepting written comments on the draft standards at [email protected] until May 31.
[This news story appears in the April 1, 2015, issue of AJHP.]