Through working with clients, we’ve seen how hundreds of hospitals are approaching the challenge of complying with USP <800>. We've noticed that in every single organization, there are gaps in the compiled information. We are not being critical; there's no way that one or two or even 25 human beings can catch every detail of this massive mandate.
One of the things to remember is that you don't know what you don't know. Having a third party look at this and give it another perspective is valuable. That’s what we do with our clients.
Common gaps we’ve encountered with clients include:
- Transport hazardous drug handling guides
- How different organizations approach Assessments of Risk
- Incomplete lists of hazardous drugs
- Investigational drugs
- Designated Person
Gap 1: Hazardous drug handling instructions while in transport:
Maintaining Drug Temperature: Drug temperature must be maintained during transport if your Pharmacy has an off-site infusion center. A thermal sleeve or a thermal bag are both options mentioned in USP <800>, but most people miss it and therefore don't include it in their Standard Operating Procedures (SOPs).
Also, dispensed doses should be bagged and labeled for transport.
Gloves are required during transport unless you have an Assessment of Risk (AoR) on file that says differently.
Is there a spill kit readily available? If technicians or other delivery personnel transport the hazardous drugs with a cart, consider keeping a spill kit on that cart. Even though a spill kit will be available on the patient floor, in the infusion area, or wherever the dose is delivered, carrying a kit on the cart helps if something happens along the route.
Does your facility have a pneumatic tube system, or are you tubing Group One hazardous drugs? You should only be tubing them if you have an AoR that explains why you're allowing tubing. For example, if unit-dosed oral solids are transported in the tube within a zipper-closing bag, that could be documented in an AoR.
Here's an example of how one of our clients communicates that information to the staff for their anti-neoplastic agents.
That brings us to one of the most asked questions and misunderstood USP <800> guidelines and Gap 2: Does every drug need an AoR?
Every potentially hazardous drug must be reviewed and classified by NIOSH or a Designated Person for Safe Handling at your facility. However, this is not an AoR explicitly because an AoR allows for alternative handling or containment strategy strategies outside of the standards in NIOSH table five instructions.
But does every drug need an AoR? No.
When is an AoR not allowed? Any hazardous drug active pharmaceutical ingredient or any Group One that requires further manipulation prior to dispensing that product will need to be treated with the NIOSH table five instructions.
Any other hazardous drug that your facility allows alternative handling for can be associated with an AoR that is drug and dosage-form specific AND stipulates the following: the type of hazardous drug, meaning whether or not it's an anti-neoplastic or a non-anti-neoplastic. Alternatively, you can even state which NIOSH group it's in to cover that section.
Another aspect to consider is the dosage form.
Is it a tablet, oral solution, or pre-packaged Sub-Q injection? Is the risk of exposure from skin contact or from inhalation manipulation allowed? Would you allow crushing or splitting that dosage form? If so, you must document whether that will be allowed outside of the pharmacy. If it's inside the pharmacy, you need your own containment strategies in the AoR. If there is an alternative containment strategy for this product, you have to document that in the AoR. For example, the alternative containment strategy could be related to the PPE required, or it could be that this product can be compounded in the laminar flow hood as opposed to a biological safety cabinet (BSC) or even the requirement for a closed system transfer device (CSTD).
In the next Lunch + Learn webinar, we'll take a more detailed look into AoRs and the different approaches we're seeing.
Gap 3: An incomplete list of hazardous drugs.
We often see clients with tunnel vision focused solely on the drugs they carry on the NIOSH list. Keep in mind those patients who are already on a therapy or protocol. We’ve seen patients registered in a study that consists of hazardous drugs that a hospital may or may not stock, and therefore the hazardous drug hasn't made it to the hospital’s hazardous drug list. We’ve seen the patient continue the therapy utilizing their supply, or the hospital is forced to obtain the drug.
The bottom line is we need to keep our healthcare workers safe from these unforeseen circumstances. We suggest listing all the drugs on the NIOSH list at the very least and then considering doing your research on those new drugs when they hit the market. We know assessing these new drugs is a big undertaking, and it's most often the missed step. The last update to NIOSH was in March 2022, and more than 15 anti-neoplastic agents alone have hit the market since then.
Then there are other drugs similar in makeup to drugs on the current NIOSH list. To determine if a drug is hazardous you must consider: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, or genotoxicity. This information can sometimes be found in the manufacturer's package insert. However, sometimes with fast-tracked FDA approvals, we find that the toxicity information could be more extensive and determination may be based on similar therapeutic agents that have already been deemed as hazardous. This means you need to think outside the NIOSH box. For instance, we've had clients create additional groups for flammable drugs and monoclonal antibodies. The bottom line is: If safe handling is a concern for any drug in your facility, you should assess, document, and communicate the safety information.
What PPE is required for compounding hazardous drugs?
For sterile and non-sterile compounding, USP states that a chemotherapy gown, head, hair, and shoe covers, and two pairs of chemotherapy gloves are required. However, for sterile compounding, that outer glove needs to be sterile.
Also, USP states that two pairs of shoe covers are required when you enter the C-SEC clean room. When entering the C-SEC, the outer pair needs to be removed and placed in the trace waste bin when exiting the C-SEC.
Can gowns be re-worn on the same day if a compounder leaves the compounding area?
A: No, in general, disposable PPE must not be reused. You need to consider all PPE contaminated if worn when handling HDs.
However, if compounding Category 1 or 2 compounded sterile preparations, a gown may be reused within the same shift by the same person if the gown is maintained in a classified area or adjacent to or within the SCA in a manner that prevents contamination.
Of note, there is a new, first-to-market chemotherapy-rated gown available. The ASTM number for that gown is ASTMF 3267-22. It may be a good option for your organization.
Gap 4: Investigational Drugs
How are you protecting the staff when handling investigational drugs that have not been tested for exposure risk?
These drugs are usually left off the facility’s hazardous drug list. However, when investigational drugs are included on the list, they are often designated as Group One with full USP <800> containment strategies in place. Once they have reached the mainstream market, the group designation and handling guides can be updated to reflect new information.
Gap 5: Disposal Information
Is disposal information, including waste disposal, being communicated? Is disposal information at the point of care? That's an essential question because nurses are often handling and disposing of non-hazardous drugs. Hence, they get into a routine of what they do with waste vs. looking up and following safe handling instructions for hazardous drugs.
Some things to consider:
What will the nurse do with the bag and tubing from the completed infusion if they're working in a hazardous or a chemo infusion area? The nurses will have their typical disposal routine, but if they're working on a floor that occasionally sees this type of situation, they will need to know where to find that safe handling and disposal information.
More importantly, what about that dose that was stopped due to the patient having a reaction? That is not considered trace waste because it exceeds three percent of the dose. Will the nurse drain it down the sink as she would a standard peripheral fluid? Of course not, but you could take the guesswork out of it and provide the disposal information for that drug at the point of care.
Gap 6: Designated Person
The Designated Person will inevitably leave the organization, so how do we plan for this situation? Trust us, you want to start at something other than square one when that person moves on. At the very least, a hazardous drug committee will give you a team of people that were involved in decisions and discussions and have some knowledge of required regulations and standards. It's also a great idea to have at least one person that works alongside your Designated Person to cover any gaps.
Many hospitals we talk to at events still use a spreadsheet to document hazardous drug safety information. This was confirmed in a poll during the webinar when attendees were asked how their organization stores and maintains hazardous drug information, the majority answered that their drug safety information is stored in a spreadsheet.
If you’re using a spreadsheet, how is this document kept up to date, and how do you disseminate it to the people needing to see it at the point of care? How do we take this critical information and compress it to present it in an operational way that people can use?
A major concern when using a spreadsheet is if the Designated Person leaves the organization. Typically, the designated person owns the spreadsheet and has all the knowledge about the hazardous drug information. When they leave, a lot of intellectual property walks out the door with them.
Here’s an example of the information we typically receive when we begin working with clients to implement their online medication safety platform.
First, Sherlene Christen, our Customer Experience Specialist, studies this information and works to understand how your organization uses this document. She inevitably finds gaps and helps your organization fill them. Many hospitals find it highly beneficial to have third-party insight.
The second and most crucial component of the USP <800> safety information requirements is the communication of those standards. We asked attendees how end users access hazardous handling information in the webinar. Most said that users access the hazardous drug handling information within the Electronic Health Record (EHR), and others said they access it on the hospital’s intranet.
The event ended with two more questions from attendees:
With your interpretation of USP <797>, do you read that a base layer gown needs to be worn under a “chemo” rated gown?
A: The April 6th USP <800> webinar mentioned that an impermeable gown should go over a bunny suit before entering the C-SEC. The chemo gown must be removed - just like that secondary shoe cover -before exiting the C-SEC. Based on this, wearing a base layer gown under that chemo-rated gown would fall into the same category.
Q: Does the Designated Person have to be a pharmacist?
A: No, the Designated Person does not have to be a pharmacist. USP simply states that the designated person must thoroughly understand the USP <800> chapters - meaning they've studied that chapter and can develop and implement the procedures in that chapter. They also oversee the compliance for the facility and ensure that they're following all the laws, regulations, and standards. The Designated Person must also have full competency for the personnel and ensure environmental control of the storage and the compounding area.
In the next USP <800> Preparedness webinar, we’ll share examples of some of the different AoRs we've seen and talk through different philosophies around AoRs. Check out the events schedule and register here. Also, if you missed any of the webinars, you can watch them at your convenience here.