Patient safety is probably a top concern across your health system. But you also need to pay attention to the safety of your staff, especially when it comes to hazardous drugs. There are many touchpoints—from the warehouse to the hospital floor—where hazardous drugs can harm your staff if they’re not handled correctly.

In fact, according to United States Pharmacopeia (USP), more than 8 million healthcare workers are exposed to hazardous drugs each year. To limit this exposure, USP created new requirements for the safe handling of hazardous drugs—called USP General Chapter 800 standards.

What are the USP 800 standards?

USP 800 is a set of new regulations on how to handle and manage hazardous drugs across your health system. They will officially go into effect on Dec. 1, 2019. The National Institute for Occupational Safety and Health defines hazardous drugs as “any drugs that can cause physical changes to the human body.” From oncology treatments to infusion therapies, drugs that can be helpful for some conditions can be hazardous to other people who may come in contact with them. That’s why it’s so important to keep the people who handle these drugs safe.

Some of the new USP 800 requirements include:

  • Wearing protective gear when administering hazardous drugs. This includes things like double gloving, head and shoe coverings and gowns.
  • Using protective medical equipment. This includes things like closed-system transfer devices, needleless equipment and plastic pouches for pill crushing.
  • Deactivating, decontaminating and disinfecting contact areas.
  • Storing, receiving and handling hazardous drugs separately from nonhazardous drugs.

Your health system needs to create its own policy for how it will meet these new regulations. Because USP is a nonprofit organization, it won’t enforce compliance. However, the Occupational Safety and Health Administration, state pharmacy boards and some state laws can. Not being compliant with the new standards can put your health system at risk of fines—and your staff at risk of health hazards.

Impact on supply chain and clinical environments

Hazardous drugs can pose a threat from the moment they are shipped to the time of their disposal. Because of this, you need to think of how USP 800 will affect both supply chain and clinical environments within your health system.

Here’s how USP 800 requirements will affect both environments:

  • Warehousing, handling, storage and distribution staff. Staff in receiving areas or distribution centers should store hazardous and non-hazardous drugs separately. They should also understand how to protect themselves from drug spills or contamination. These people are on the frontlines of handling these materials. That means they need to take every precaution listed above on protective gear and protocol.
  • Pharmacists. USP 800 also applies to your health system’s pharmacies. Pharmacists who compound, mix or prepare hazardous drugs are vulnerable. You might need to renovate your pharmacies so containment systems meet new requirements. At minimum, you should have an externally vented biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI) located in a negative pressure room with a minimum number of air changes per hour.
  • Clinicians. Anyone who administers hazardous drugs also need to assess their risk. This can help them understand the best methods of protection. These include gowns, double gloves and other personal protective gear. Because each drug has unique properties, USP 800 offers guidelines for how to safely dispose of different drugs.

Ways to prepare across the continuum of care

To make sure you’re ready for the new requirements, follow these three best practices across the continuum of care:

1. Use USP 800 compliant product formularies. Check to make sure your health system is using compliant product formularies. This includes things like:

  • Closed chemotherapy transfer devices
  • Protective equipment that meets the American Society for Testing Materials’ standards
  • Needleless equipment
  • Gloves, gowns, hoods and shoe covers
  • Cleaning and decontamination products
  • Waste disposal systems

2. Watch for engineering or construction changes. Aside from basic safety measures, you may have to make structural changes to your clinics to adapt to these new requirements. Having a third party do a clinic walk-through can help you spot necessary adjustments like these.

3. Be adamant about USP 800 education and training. Because these are complex regulations, it’s helpful to break them down into smaller pieces. Gather as much information as you can. Attend webinars and subscribe to email lists about USP 800. Make sure everyone from clinicians to supply chain staff are aware of the necessary changes.

Start assessing how prepared your health system is for these new changes. Seek out information from your national, state and local pharmacy associations if you need additional information on how to comply. Being prepared for the new USP 800 requirements from day one is crucial. You’ll help your health system avoid costly fines, and you’ll keep your staff safe when they’re on the front lines of important work.

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