SAFE HANDLING RESOURCES: USP 800 Updates

USP 800 is the new standard of protective protocols for the safe handling of hazardous drugs from the United States Pharmacopia. It exerts more stringent safe handling recommendations for the industry, including the use of Closed System Transfer Devices. The revised General Chapter was published on February 1, 2016 in the First Supplement to USP 39–NF 34. Additionally, the Expert Committee approved a delayed official implementation date of July 1, 2018 to allow entities more than two years to implement the chapter.

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. Read more here or here.

USP 800 directly addresses the need for Closed System Transfer Devices in several sections of the document. Relevant excerpts include:

5.4 Containment Supplemental Engineering Controls

Containment supplemental engineering controls, such as CSTDs, provide adjunct controls to offer an additional level of protection during compounding or administration. Some CSTDs have been shown to limit the potential of generating aerosols during compounding. However, there is no certainty that all CSTDs will perform adequately. Until a published universal performance standard for evaluation of CSTD containment is available, users should carefully evaluate the performance claims associated with available CSTDs based on independent, peer-reviewed studies and demonstrated containment reduction.

A CSTD must not be used as a substitute for a C-PEC when compounding. CSTDs should be used when compounding HDs when the dosage form allows. CSTDs must be used when administering antineoplastic HDs when the dosage form allows. CSTDs known to be physically or chemically incompatible with a specific HD must not be used for that HD.

ENVIRONMENTAL QUALITY AND CONTROL

Environmental wipe sampling for HD surface residue should be performed routinely (e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment). Surface wipe sampling should include:

• Interior of the C-PEC and equipment contained in it
• Pass-through chambers
• Surfaces in staging or work areas near the C-PEC
• Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area)
• Areas immediately outside the HD buffer room or the C-SCA
• Patient administration areas

There are currently no studies demonstrating the effectiveness of a specific number or size of wipe samples in determining levels of HD contamination. Wipe sampling kits should be verified before use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs from various surface types found in the sampled area. There are currently no certifying agencies for vendors of wipe sample kits.

There is currently no standard for acceptable limits for HD surface contamination. Common marker HDs that can be assayed include cyclophosphamide, ifosfamide, methotrexate, fluorouracil, and platinum-containing drugs. An example of measurable contamination would be cyclophosphamide levels >1.00 ng/cm₂, which were shown in some studies to result in uptake of the drug in exposed workers. If any measurable contamination is found, the designated person must identify, document, and contain the cause of contamination. Such action may include reevaluating work practices, re-training personnel, performing thorough deactivation, decontamination, cleaning, and improving engineering controls. Repeat the wipe sampling to validate that the deactivation/decontamination and cleaning steps have been effective.

ADMINISTERING

HDs must be administered safely using protective medical devices and techniques. Examples of protective medical devices include needleless and closed systems. Examples of protective techniques include spiking or priming of IV tubing with a non-HD solution in a C-PEC and crushing tablets in a plastic pouch.

Appropriate PPE must be worn when administering HDs. After use, PPE must be removed and disposed of in a waste container approved for trace-contaminated HD waste at the site of drug administration. Equipment (such as tubing and needles) and packaging materials must be disposed of properly, such as in HD waste containers, after administration.

CSTDs must be used for administration of antineoplastic HDs when the dosage form allows. Techniques and ancillary devices that minimize the risk posed by open systems must be used when administering HDs through certain routes. Administration into certain organs or body cavities (e.g., the bladder, eye, peritoneal cavity, or chest cavity) often requires equipment for which locking connections may not be readily available or possible.

Healthcare personnel should avoid manipulating HDs such as crushing tablets or opening capsules if possible. Liquid formulations are preferred if solid oral dosage forms are not appropriate for the patient. If HD dosage forms do require manipulation such as crushing tablet(s) or opening capsule(s) for a single dose, personnel must don appropriate PPE and use a plastic pouch to contain any dust or particles generated.

SAFE HANDLING RESOURCES: USP 800 Updates

Hazardous Drugs—Handling in Healthcare Settings

Prepare Now for USP Standard on Handling Hazardous Drugs

A change is coming: Proposed USP 800

NIOSH CSTD Performance Criteria from the Federal Register

NCI Research Partners