Hazardous Drug Handling Last-minute Checklist: Are You Ready for Chapter 800?

Monday, November 4, 2019

In August, Wolters Kluwer hosted Dr. Jeanne Sun, PharmD, JD, of USP in a webinar titled “USP Chapter <800>: What You Need to Know about Handling Hazardous Drugs.” In the session, Dr. Sun shared insights on USP’s work, the definition of hazardous drugs, the risks associated with exposure, and how and why healthcare personnel should assess risk.

The reason we felt it was important to share Dr. Sun’s expertise was the approaching deadline of December 1, 2019, for USP Chapters 795, 797, and 800 to become official. While most pharmacies, labs, warehouses, and other healthcare facilities probably have their hazardous drugs handling processes and procedures in place already, as we head into the home stretch, it is worth reviewing a few key elements of Chapter 800 to make sure you are prepared for the December deadline.

1. Automation and Identifying Hazardous Drugs

Different organizations define their containment strategies differently depending on what types of hazardous drugs they stock, dispense, and/or administer. For example, if you are only dispensing single-use tablets or capsules, you may not require additional containment precautions, compared to a facility that is compounding. Some facilities carry a wide variety of anti-neoplastic drugs or non-anti-neoplastic drugs with potential toxicity, others just a few select products with specific protocols attached to their use. Therefore, everyone is interpreting and implementing General Chapter 800 differently.

One way to streamline procedures and help reduce errors when identifying potentially hazardous drugs is to implement software in your pharmacy management system or apps to help flag and identify hazardous drugs and alert staff to key protocols and data within the workflow. USP offers an app to link individuals to its content, and Medi-Span offers an enterprise-wide solution that streamlines processes and features both USP and NIOSH content sets. Solutions like these help standardize a facility’s response to Chapter 800 guidelines and enhance safety.

2. PPE

Those who come into contact with hazardous drugs need to wear personal protective equipment (PPE) that goes above and beyond standard hospital wear. So, make sure you’re well-stocked with disposable gowns that resist permeability (even though there is no standard test for this), close in the back, and have long sleeves; eye/face protection; and respiratory protection. Stock up on chemotherapy-grade gloves, and make sure staff change them every 30 minutes.

3. Dispensing Protocols

While you don’t need a separate dispensing tray for every hazardous drug, you do need at least one dedicated hazardous drug dispensing tray that gets sterilized between every use. Of course, if you have certain hazardous products or classes that you dispense frequently, there is no rule that you can’t have a dedicated tray just for those products.

You cannot use automated counting or packaging machines when dealing with hazardous drugs. The stress the machines place on pills can sometimes release powder and cause contamination and exposure. This policy must be strictly observed.

4. Spill kits

It is not breaking news that organizations need to have spill kits available for safe clean up in the event of a spill or contamination. In the webinar, Dr. Sun advised that these be tailored to your facility, to the specific drugs you carry, and types of exposures that might occur.

There also must be sufficient, obvious signage so everyone knows exactly where the spill kits are and how to use them.

5. Documentation

Chapter 800 requires that your facility have several documents in place and accessible to staff. These include:

  • Standard Operating Procedures for handling hazardous drugs that address designated areas, receipt, storage, compounding, hand hygiene, spill control, medical surveillance or deactivation, decontamination, cleaning, and disinfection
  • Safety Data Sheets for every hazardous drug used at the facility
  • Hazardous Communications (HazCom) Program, including a written plan that describes how USP Chapter 800 will be implemented and affirms that all containers of hazardous chemicals are labeled with the appropriate warning

More than 8 million U.S. healthcare workers experience hazardous drug exposure every year, putting them at risk of carcinogenic and teratogenic effects, reproductive toxicity, organ toxicity, chemotoxicity, and other potential damage. For more information on USP Chapter 800, visit USP’s online resources. For more information on hazardous drug handling solutions, contact Wolters Kluwer.

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