BETHESDA, MD 01 Feb 2016—The United States Pharmacopeial Convention (USP) today published the nation's first set of authoritative standards on the handling of hazardous drugs by healthcare personnel.
United States Pharmacopeia (USP) chapter 800, titled "Hazardous Drugs—Handling in Healthcare Settings," is part of the first supplement to The United States Pharmacopeia, 39th revision, and The National Formulary, 34th edition, a subscription product.
But unlike other content in the supplement, chapter 800 has an implementation date of July 1, 2018, nearly two years later than the norm for a new or revised USP chapter.
Chapter 800's Main Sections
The 19-page chapter has the following 18 main sections:
- Introduction and scope,
- List of hazardous drugs,
- Types of exposure,
- Responsibilities of personnel handling hazardous drugs,
- Facilities and engineering controls,
- Environmental quality and control,
- Personal protective equipment,
- Hazard communication program,
- Personnel training,
- Labeling, packaging, transport, and disposal,
- Dispensing final dosage forms,
- Deactivating, decontaminating, cleaning, and disinfecting,
- Spill control,
- Documentation and standard operating procedures, and
- Medical surveillance.
The 19-page chapter 18 main sections, a glossary, three appendices, and a list of references. One of the appendices offers examples for the design of a hazardous-drug compounding area.
In development since mid-2010 and with two drafts circulated for public comment, the chapter differs from the second circulated draft, released in December 2014, in two ways, USP said. First, certain sections have been clarified. Second, some of the mandatory requirements have been changed to recommendations.
A go-to document.
Corbin Bennett, senior director of oncology pharmacy and outpatient infusion pharmacy services at the national level for Kaiser Permanente, in early January described the forthcoming USP chapter 800 as "a single-source document for handling hazardous drugs."
USP has stated that chapter 800 builds on Occupational Safety and Health Administration (OSHA) standards, guidance in the National Institute for Occupational Safety and Health (NIOSH) Alert publication, ASHP Guidelines on Handling Hazardous Drugs, and an Oncology Nursing Society (ONS) publication.
For years, Bennett said, Kaiser has relied on the hazardous-drugs information provided by OSHA, NIOSH, ASHP, and ONS.
USPchapter 797 has a section on hazardous drugs as compounded sterile preparations, but the information "was minimal and not comprehensive," he said.
"I think [USP chapter 800] is going to help clarify a lot of questions that we have had," Bennett said, "and . . . help move us forward, especially from an employee safety perspective."
Because of requirements in the Federal Food, Drug, and Cosmetic Act, FDA uses some of USP's chapters in enforcing strength, quality, and purity standards for drug products.
But the agency has stated that it does not generally regulate the practice of healthcare professions or regulate hospitals or healthcare centers regarding their provision of care.
Nevertheless, as with USP chapter 797, "Pharmaceutical Compounding—Sterile Preparations," pharmacists should expect their state board of pharmacy to enforce chapter 800, Bennett said.
"Boards of pharmacy are already incorporating elements of the draft USP chapter 800 into state regulations," he said.
For example, in California, where Bennett works, the state board of pharmacy has proposed requiring that hazardous-drug compounding in licensed pharmacies occur only in a negative-pressure room or area.
That structural configuration was a mandatory requirement in the second proposed version of USP chapter 800 and is a mandatory requirement in the published chapter.
Patricia C. Kienle and Ryan Forrey, members of USP's 2015–20 Compounding Expert Committee, told pharmacists a year ago to plan for compliance with chapter 800.
Kaiser and Howard County General Hospital are two healthcare organizations that did just that.
Howard County General, a 266-bed hospital with an outpatient infusion center in Columbia, Maryland, is gearing up for a gap analysis, said pharmacy practice resident Amy Pham.
Pham in early January said she examined USP's second proposal for chapter 800 and compared its requirements to those of chapter 797, with which the hospital pharmacy is already compliant. Then she made charts and checklists of changes that would be necessary for the hospital to be compliant with the new chapter.
Once the finalized version of the new chapter becomes available, Pham said, she will review and revise her charts and checklists, begin the analysis, and discuss the potential changes directly with department leaders.
Maryland's pharmacy board "incorporated by reference" USP chapter 797 into the regulatory chapter on sterile pharmaceutical compounding.
"I do believe that they will endorse these changes as well," Pham said, particularly because USP chapter 800 promotes safety for all personnel in the hospital.
Susan Shermock, medication safety manager at Howard County General, said the results of the gap analysis will be important in educating the hospital and nursing administrators, who are "very pro pharmacy."
These administrators, she said, need to know about the new standards on the handling of hazardous drugs by healthcare personnel and the protection they afford the staff.
As for the hospital's gap analysis, pharmacy residency program director Adrienne Shepardson said the executive leadership views its time commitment for the project as a means to support the pharmacy.
Bennett said Kaiser already has a "national pharmacy template" that incorporates long-expected elements of USP chapter 800, such as the required use of a dedicated refrigerator in the negative-pressure room or area to store refrigerated antineoplastic hazardous drugs.
And Kaiser has a national work group, which he coleads, that is defining the criteria of a hazardous drug and developing an organizationwide list of hazardous drugs. The work group includes environmental health and safety leaders.
"Kaiser Permanente is well prepared for most of chapter 800," Bennett declared.
He credited that level of preparedness by his healthcare organization to its review of the first and second proposals for the chapter, attendance at webinars, and attention to the experts, followed by "an educated guess" on which elements would remain in the final version.
Based on that educated guess, he said, a full remodel of a pharmacy for compliance with USP chapters 797 and 800 would cost Kaiser an estimated $1.5–2.5 million if carried out now.
"For the rest of the nation and for us," Bennett said, "I believe the biggest challenge [in implementation] is identifying or procuring the capital required to update and remodel existing pharmacies."
Both proposals for the new USP chapter called for the complete physical separation of hazardous-drug manipulations from other drug-handling activities, said ASHP's Bona Benjamin, director of medication-use quality improvement. "That means hard walls and . . . dedicated different equipment."
She said construction projects and major capital equipment purchases tend to be budgeted years in advance, which is why ASHP asked for a delay in the implementation date for USP chapter 800.
ASHP had initially requested a two-year delay. But Benjamin said some members told ASHP that their facility sometimes budgeted 5–10 years in advance, hence the subsequent request for a five-year delay.
She said the ASHP Guidelines on Handling Hazardous Drugs, which originated as a technical assistance bulletin in 1985, will be revised to reflect the content of USP chapter 800.
USP's issuance of standards on hazardous-drug handling by healthcare personnel does not obviate ASHP's guidelines, Benjamin said.
"The standards are the what. . . the expectations for the processes and outcomes that are the gold standard," she said. ASHP's guidelines "are the how."
The 2018 date for implementation comes courtesy of the USP Compounding Expert Committee, which, USP said, "recognized that it may take healthcare facilities additional time to comply with the new standard."
USP said the contents of USP chapter 800 would also appear in USP Compounding Compendium.