Section 13: Compounding

Sections 1 through 12 of USP Chapter 800: Hazardous Drugs—Handling in Healthcare Settings provides the blueprint for safely getting a hazardous drug into our facilities and on to our shelves on our road to compliance. Section 13 provides us with a brief guidance on compounding considerations for hazardous drugs. The primary goal of this section is to provide guidance on compounding expectations for hazardous drugs. Without standards, legacy and or observant opinions on compounding often dominate practices which place patients at risk.

USP <800> is a broad chapter and requires the use of specific USP chapters to articulate and define expectations for compounding. It is clearly noted that entities must refer to and follow USP <795> Pharmaceutical Compounding – Non-sterile Preparations and USP <797> Pharmaceutical Compounding – Sterile Preparations for the required standard operating procedures in addition to the 18 sections outlined within USP <800>.  Not listed within USP <800>, the newly proposed chapter USP <825> Radio pharmaceuticals must be considered in its entirety for hazardous drugs when these drugs are in combination with a radio isotope. References to other chapters listed within USP <795>, USP <797>, USP <800> and USP <825> must be reviewed and implemented for full compliance.

Chapters USP <795>, USP <797>, USP <800> andUSP <825> all list specific compounding controls which include primary engineering controls (a.k.a., hoods) and secondary controls (a.k.a., rooms). With hazardous drugs the addition of a “C” to PEC and SEC refers to ‘containment’ (C-PEC; C-SEC). For hazardous drugs, containment is key to mitigating any risk of migration of hazardous drug residues to the environment and to personnel.

Historically sites have prepped the compounding surfaces for hazardous drugs with a ‘Chemo-mat’ or ‘Chemo-pad.’ These devices are often introduced onto the compounding space after cleaning and disinfection and serve to absorb any spills and sprays that may occur during compounding. USP <800> does not require the use of these pads, but the chapter does list them as a should. It is important to note that if these pads are used within the ISO 5 C-PEC they must be sterile. The introduction of non-sterile equipment into the compounding space increases the bio burden risk to the sterile compounding processes. For hazardous drugs, the pads should provide a barrier to the compounding surface of the C-PEC by the use of a plastic material such as polypropylene or polyethylene. It is inappropriate to use barrier pads not designed for compounding, such as “bed-chucks”, which are not sterile, bulky, and, may shed particulate material onto the work surface. Pads must be changed if a spill occurs and should be changed between each patient preps to minimize the risk of possible cross-contamination of products.

For hazardous drugs, the use of disposable equipment should be considered. If sites must use permanent or reusable equipment, it must be dedicated for hazardous drugs and must be appropriately cleaned between patient use or between drugs using the USP <800> 4-step cleaning procedure. Refer to the proposed USP <795> and USP <797> standards for cleaning of equipment. Equipment that often eludes cleaning programs include mortar/pestles, counting trays/spatulas, glass-ware, weighing trays, IVPB hanging hooks within the C-PEC, plug-ports/gas-ports within the C-PEC, IV-workflow equipment within C-PEC, small supply storage bins within the C-PEC, waste bins within the C-PEC, and the under-surface of repeater pumps.

This section of the chapter does mention the use of bulk containers of liquid and active primary ingredients and states they must be handled in a manner to prevent spills.  Spills can present themselves in the form of a liquid, solid (powders) or gas (through physical phase changes). Consideration should be given to the processes of manipulation that may generate a spill such as transferring powder for compounding, crushing or splitting tablets, opening capsules, opening an ampule, or using a needle/syringe to compound a sterile product. The use of a C-PEC to manipulate hazardous products must be employed to protect the healthcare worker. If there is a likely-hood spill, the use of Chemo-pad should be highly considered with the noted at-risk manipulations.

As the NEW official implementation date of December 1, 2019 for proposed USP <800> and subsequent revisions to USP <795> and USP <797> compliance allows time for sites to prepare for overall compounding compliance. The time for review of USP’s newest chapter in combination with keeping up with USP’s website for revisions to USP is now.

Don’t know where to start with a hazardous drug safety program? Visante offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact us today to get started.

References

[1] USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings

http://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare accessed 2018 September 15.

 

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