Meeting USP Chapter 800 Head On

TOP - August 2015, Vol 8, No 3 - Conference Correspondent
Meg Barbor, MPH
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Austin, TX—A hazardous drug safety program can be established in the workplace by following certain protocols. Michael Koraleski, PharmD, outlined the proposed standards of the newest US Pharmacopeial Convention (USP) Chapter 800 (Hazardous Drugs—Handling in Health­­care Settings) at the 11th annual Hematology/Oncology Pharmacy As­­sociation conference.

Occupational Exposure in the Workplace

Eight million healthcare workers in the United States risk occupational exposure to hazardous drugs. Exposure is associated with adverse health outcomes such as acute symptoms, organ toxicity, reproductive risks, and cancer.

“The 2004 [National Institute for Occupational Safety and Health’s (NIOSH)] NIOSH Alert was the go-to guideline on how to safely manage and handle hazardous drugs,” Dr Koraleski, Patient Care Pharmacist, Nebraska Methodist Hospital, Omaha, stated. “USP works in coordination with NIOSH, and the USP Chapter 800 proposed chapter very much mimics the 2004 NIOSH document.”

How Are We Doing?

A NIOSH nursing survey published in the Journal of Occupational and Environmental Hygiene in November 2014 found the current measures of compliance to be subpar. Among other measures, it was found that 42% of respondents did not wear a nonabsorbent gown with a closed front and tight cuffs, 12% took home potentially contaminated clothing, 12% spilled or leaked an antineoplastic drug during administration, and 12% did not wear chemotherapy gloves.

Establishing a Safety Program

The objective of USP Chapter 800 is to protect personnel and the environment when hazardous drugs are handled. It applies to sterile and nonsterile compounding, and builds on Chapters 795 and 797, which are being revised and will be published in accordance with Chapter 800.

One of the underlying principles of USP Chapter 800 is the concept of the Hazard Communication Standard. “This gives employees the right to know if they’re going to be exposed to hazardous drugs, and the right to know that you as the employer are going to do everything that you can to protect them,” he explained.

To establish a hazardous drug safety program, Dr Koraleski recommends putting together a team composed of primary members such as pharmacists, nurses, and environmental services, and secondary members, including administrators and physician office managers. The team should map out the path and life cycle of hazardous drugs in a particular entity.

“The life cycle starts when we receive hazardous drugs and follow special requirements to store them, ship them, or deliver them to floors,” explained Dr Koraleski. “USP Chapter 800 is also concerned about waste disposal and management, which is a little bit different from Chapters 797 and 795. ‘Cradle to grave’ is the term I like to use.”

USP Chapter 800 Measures

Antineoplastic hazardous drugs must be stored separately from nonantineoplastic drugs; hazardous drugs cannot be opened in a positive pressure area in case there is a spill or leak. Personal protective equipment must be worn when receiving hazardous drugs and throughout their administration. “The document contains different requirements for personal protective equipment throughout the life cycle, but really there just needs to be proper demonstrated use of personal protective equipment and training documentation; this is one of the best ways we have to protect ourselves,” Dr Koraleski emphasized.

Primary engineering controls like biological safety cabinets and isolated glove boxes should be utilized and kept in a secondary room that is enclosed, filled with negative pressure air, and exhausted to the outside. Regarding supplemental controls, per USP Chapter 800, pharmacists are advised to use closed system transfer devices (CSTDs) when compounding, whereas nurses are required to use them for administration. “Currently, 39% of pharmacies are using CSTDs, and only 32% of nursing, so we need to see those numbers go up,” Dr Koraleski noted.

“Aside from the products actually being contaminated themselves, I think if we used CSTDs appropriately we could practically eliminate any exposure risk,” said Dr Koraleski. “Seven CSTDs currently exist on the market; test them out and see what your staff likes best.”

Intravenous bags must be preprimed and labeled as hazardous, spill kits should be developed or purchased, and there should be personnel available 24-7 who can manage a spill with these kits.

USP Chapter 800 requires deactivation and decontamination of the workspace; deactivation renders hazardous drugs inactive, and decontamination wipes them away. “It isn’t just about cleaning and disinfecting anymore,” Dr Koraleski explained.

Nonsterile, hazardous drugs can be stored in their final dispensing form with normal, nonhazardous drugs, but Dr Koraleski recommends segregating them. Waste should be disposed of properly. “Regarding waste management, nothing has really changed,” he added.

“Think of USP Chapter 800 as containment from cradle to grave, and really understand that it’s for the patient, the personnel, and the environment,” emphasized Dr Koraleski. “The day USP Chapter 800 is published is the day it becomes outdated; genotargeted drugs, microbot delivery of drugs, and nano­technology drugs are all hitting the market and none of them are mentioned in the proposed chapter. It is important that we keep our eyes and ears open and figure out how to handle those as well, so that we don’t fall behind.”

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Last modified: September 10, 2015