Section 11 Labeling, Packaging, Transport, and Disposal of Hazardous Drugs
As we make our way down the Road to USP 800 Compliance, we’ve seen how Sections 1 through 10 of USP Chapter 800: Hazardous Drugs—Handling in Healthcare Settingsprovide the blueprint for safely getting a hazardous drug into our facilities. Moving forward, Section 11 provides us with guidance on communication of hazardous drugs once we move it from compounding area(s) to patient administration to disposal. The primary goal of this section is to alert all personnel involved within the chain of command of the product(s) to be aware of the hazard and identify prevention of exposure procedures. During training, sites must educate personnel on the preventive measures in place, including: spill response and use of a spill kits, use of sealed impervious plastic delivery bags, use of impact-resistant and/or water-tight containers for delivery, and supplementary warning labeling.
The label represents the primary mode of communication of the contents of a compounded product. Labels can communicate patient name; drug(s) and diluents; drug dose(s); administration guidelines; date of preparation, date of expiration; compounding/verifying personnel; and supplementary information (e.g.,protect from light). Ancillary labels can be added to products to further highlight information such as “hazardous drug.” It is important that information on the label be discussed with all parties identified along the chain of custody to ensure a common understanding of terminology. For example, some ancillary labels may state ‘Chemotherapeutic’ or ‘Chemotherapy.’ Depending on who handles the product this may not convey the message such as ‘Hazardous Drug.’ Although not listed within USP <800>, the use of line-labels to assist nursing with tracing lines is an additional safety labeling feature. Sites must confirm that any labels used do not leech or impact the overall integrity of the final product(s).
Supportive packaging and containers must be defined to physically maintain the integrity of hazardous drug products during transportation. Considerations must take into account sterility and stability integrity of sterile products and stability of non-sterile products. Overall, protection of personnel who deliver the products must be considered in the event of surface contamination of products, spills, breakage and leaks from damage. The use of bubble wrap, external zip-lock baggies and/or outer containers should be considered to protect the contents. If bubble wrap and zip lock baggies are used, sites should consider these items contaminated, not be reused, and disposed of as trace hazardous waste (unless there is a spill). Outer containers can be cleaned according to the USP <800> 4-step method between deliveries and recycled for use. Standard operating procedures must be written to address the defined transport containers and supporting insulating materials. Personnel must be trained and training verified with regards to the use of transport materials packaging and processes.
The movement of hazardous drugs must be in a manner to minimize breakage and leaks. For liquid based hazardous drugs, the pneumatic tube system must not be used due to the potential impacting the overall integrity of the product, but more importantly the concern for a spill within the pneumatic tube system. Although, zip lock baggies and gasketed pneumatic tubes can be used, in the event of a spill the exposure potential to the receiving party can be unknowing at the time of receipt. Delivery outer containers with hard sides should be considered beyond zip lock baggies to help maintain the integrity of the product. Outer containers must be labeled in a manner to communicate the internal hazard. As noted, if an outer container is used it can be cleaned between uses using the USP <800> 4-step cleaning process and recycled for use. For sites transporting hazardous drugs off-site (e.g., home infusion, alternative care locations), consultation with the transportation company with supporting documents such as Safety Data Sheets of each product, storage directions, disposal directions and spill management procedures must take place. Sites must refer to state regulations surrounding the transportation of hazardous materials.
The proper disposal of pharmaceutical waste and hazardous drug waste resides under the Environmental Protection Agency’s direction with oversight by local and state agencies. States can enact exemptions and additional requirements for the management of the waste and sites must refer to state specific statutes with regards to the management of waste. Individuals who handle and package hazardous drug waste for removal must be formally trained on occupational exposure risks and minimizing contamination of the environment. Commercial waste haulers who are registered to handle hazardous drug waste may be able to assist sites with appropriate designation of waste streams (i.e., hazardous drug waste (commonly known as ‘yellow’ waste) versus EPA RCRA Hazardous Waste (sometimes denoted as ‘black’ waste). As noted, waste management for these products is regulated by local, state and federal statutes.
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.
 USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings
http://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare accessed 2018 August 13.