On the Road to Compliance, Sections 1 through 9 of USP Chapter 800: Hazardous Drugs—Handling in Healthcare Settings are the blueprint and engineering structures with checks and balances for quality control. They also provide direct protective measures on and an introduction to the rights of the employees. At this stage, a site is ready to test the waters for their safety program. Section 10 addresses the receiving of hazardous drugs which is the first entry point of hazardous drugs into a facility. The receiving of products process is not often a focus for a hazardous drug safety program. Receiving occurs at multiple times in multiple points of the facility, from the actual receipt at the dock from wholesalers or direct order shippments, to receipt at a point of storage for holding for additional activities.

It is important to point out that USP 800 starts out once the physical product enters the system; highlighting the fact that all activities prior to the product arriving are not addressed. Wholesalers and shipping companies do not follow USP and are held to department of transportation and shipping standards which address hazardous materials and are not specific to drugs. The designation of a drug as a hazardous material was first defined within the Resource Conservation and Recovery Act of 1976 and is based on the potential for these chemicals to cause harm to the environment. The list is outdated and does not reflect the specific current hazards. In 1990, the American Society of Health-System Pharmacists (ASHP) published their Technical Advisory Bulletin on the safe handling of hazardous drugs and gave us our first criteria to consider for defining drugs as a hazard outside of the patient. With the adoption of USP 800 deferring to NIOSH’s hazardous drug list, based on the foundation of ASHP’s TAB definitions, this concept of a ‘hazardous drug’ is new and it will take industries outside of immediate patient care to catch on to the concept. Although USP 800 calls out ‘suppliers’ to provide hazardous drugs in segregated, impervious containers; wholesalers have yet to adopt the NIOSH list for defining hazardous drugs. Thus, labeling of totes and boxes of contents as hazards is disappointingly sproradic and cannot be relied upon.

Due to the unknown handling and management of these drugs prior to entry into facilities, it must always be assumed that the products are contaminated, totes and boxes that carry the drugs are contaminated, and the potential for broken vials exist.[2] USP calls out this entry process as a critical touch point and sites must formally address this step(s) for the safety of employees. USP clearly outlines the steps to receive, inspect, handle, address breakage and spills for this process. Ideally, totes and boxes should be opened in a containment ventilated equipment residing in a space that is neutral to negative pressure to adjacent spaces.

USP clearly states that once received on site, drugs are to be delivered to the designated storage area for unpacking. Sites should define the required personal protective equipment for the process of unpacking and must at a minimum include the use of ASTM D6978 rated gloves for this process. Additional equipment may be considered such as an N-95 respirator mask and or a protective gown.

In the event of a tote/box related spill or if a vial inadvertently falls in the area of receiving, unpacking and storage, sites must have readily available a spill kit. Sites should educate all individuals in the receiving to storage processes of the formal management of spills and orientation to spill kit location(s) and their use.

Any damaged shipping containers or their contents with liquid or solid formulations of hazardous drugs must be considered a hazardous drug spill. The use of full PPE must be implemented when dealing with hazardous drug spills. It is important to note that a spill of this type is one of the most concerning since it is the most concentrated formulation of the drug(s) and gross exposure to standard PPE may exceed their potential to protect personnel depending on the drug and the quantity of the spill.

USP covers the proposed safety processes for handling damaged or suspected damaged shipping containers of hazardous drugs. If a container appears to be damaged, USP recommends notifying the supplier, not opening the container and sealing it to minimize any dispersment of materials. The damaged container should be labeled as ‘hazardous’ and should be quarantined in a room/area with neutral to negative pressure awaiting instructions for either returning the product or disposing of the product as hazardous waste onsite.

If a noticably damaged package must be opened, due to a mixture of medications within the shipping container or the spill requires a more intense intervention, staff must first use a hazardous drug kit and don PPE contents to then move the shipping container into a containment-primary engineering control unit designated for receiving or for non-sterile compounding to minimize employee and environmental exposure. The shipping container should be placed on a ‘chemopad’ and not directly on the worksurface to minimize contamination spread. The damaged container should be opened cautiously within a C-PEC and the undamaged products removed. The undamaged products must be wiped with the defined 4-step cleaning process to remove as much of the residue or suspected residue from the drug containers. As a best practice, these products that are to be retained should be placed in a zip lock baggie while stored until their use and the zip lock baggie not opened until the product is within defined primary engineering control. The damaged product and corresponding shipping container should be sealed in a manner to return to the shipper and to quarantine until such time is defined. If the shipper does not want the damaged product returned, the site must follow its defined standard operating procedures the handling of hazardous materials.

Final steps, the C-PEC used for addressing the damaged shipping container must be immediately cleaned using the site’s defined 4-step process of deactivation, decontamination, cleaning and disinfection. Disposal of all disposable materials and PPE used to address the damaged products must be considered to be ‘grossly’ contaminated and disposed of accordingly based on the institutations disposal guidelines. Sites must follow established SOPs for spill management and report it to the appropriate individual, department or agency for formal documentation.

As a thought for consideration, once the damaged shipping container is identified sites should trace the shipping container all the way to the point of entry into the facility.  Each area(s) where the shipping container was held should be properly cleaned according the the proposed USP 800 4-step process. In addition, a formal notification to the shipping company as to the spill of a hazardous material should be done and documented. It is important to note that shipping companies, wholesalers and the pharmaceutical industry are not held to USP 800 and may not have a formal program in place to appropriately manage a damaged shipping container.

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 June 2, 2018

[2] Redic KA, Fang K, Christen C, Chaffee BW. Surface contamination of hazardous drug pharmacy storage bins and pharmacy distributor shipping containers. JOPP 2017.

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