USP <800>. November 1, 2023. Are you panicking yet?
If you are, you are not alone. The hurry up and wait is over, and now it’s time to finish up any final updates and changes your healthcare organization needs to make before the Nov. 1, 2023 UPS <800> deadline.
On April 6, we kicked off a webinar series designed to offer you the information and support you need to ensure your organization is ready for the Joint Commission, States Board of Pharmacy or other agencies that will be evaluating your USP <800> readiness. These events create a space for conversation and community among pharmacists and healthcare leaders.
Who is Rpharmy?
Rpharmy came to be after the founders suffered a personal loss due to a medical error and vowed to do what they could to help prevent other families from going through the same tragedy. While implementing Formweb, their medication safety solution, Rpharmy began to get requests from hospitals for ways to more easily and effectively document and share hazardous drug safety information across their organization.
As is often the case, necessity is the mother of invention. Rhazdrugs was developed and is now helping many hospitals prevent dangerous exposure to hazardous drugs and also meet USP <800> safety information documentation and communication requirements.
In fact, while speaking to hospitals, we’ve seen that most underestimate how many healthcare workers are exposed to hazardous drugs each year. If you didn’t know, it’s 8 million, according to the CDC.
Also, 70% plan to take more than a year to fully comply with USP <800>.
And many (75%) are going through this arduous compliance process without a Hazardous Drugs Committee.
You don’t have to do this alone. We’re here to help.
You don’t know what you don’t know.
Conveniently, the day before our webinar on April 5, USP held a (long) meeting to provide updates to the USP <800> and USP <797> guidelines. Rharmy’s Customer Experience Specialist, Sherlene Christen, listened to all eight hours of the USP update meeting and shared the most important updates on our webinar.
Sherlene understands the challenges you’re facing having been a Certified Pharmacy Technician for 30 years, most of which were at Duke University Health System. Once a former Rpharmy client, she joined the company in 2020 and has been instrumental in implementing Formweb and Rhazdrugs into hospitals and systems across the U.S.
Let’s get to the meat…
USP <800> requires that you are up to date on all of the hazardous drug information coming out of the FDA, OSHA, EPA, NIOSH, ASHP, and many others in the alphabet soup of agencies. Not only that, but USP continues to update the guidelines in <797> and <800>. Your mind must be swimming!
Here we’ve boiled down what you need to know out of the April 5 update:
What’s the actual due date?
It turns out rumors about a six-month grace period between the official date of the enforcement of <797> and the enforcement date for <800> are NOT true. USP confirmed that once <797> becomes official on November 1, 2023, so does USP <800>.
Always a hot topic: Assessments of Risk (AoR).
Someone asked the USP: If one assessment of risk is created for a group of drugs, will that meet the standard for that group of drugs? The answer is always the same and it is always NO.
If you choose to create an AoR, it must show that the drug for each AoR was evaluated individually, including different dosage forms for the same drug.
NIOSH 2016 vs. NIOSH 2020
NIOSH 2016 is still the official list. There is still no expected release date for the NIOSH 2020 list.
Speaking of NIOSH
USP pointed out that just because it's not on the NIOSH list doesn't mean it's not harmful. A substance may be on the EPA list and needs to follow precautions as EPA regulations are enforceable as well.
Should and Must
A lot of attention was given to deciphering Should and Must language in USP <797> and <800>. You should and must pay attention to working within the regulations.
In fact, Dr. Robert Campbell from Joint Commission said that the Joint Commission will only write standards to the “must.” They are not going to hold you accountable for the “shoulds.” So when you read <800> keep an eye out for those must and shoulds.
Medical Surveillance is a Should
USP <800> recommends medical surveillance as a best practice but it is not a must.
As heard at the USP Meeting:
“Information in <800> that is not mentioned or referenced in <795> or <797> is not federally enforceable.”
This drives home the point that these are all pieces of a USP compendium. For example, since neither <795> or <797> address the administration of hazardous drugs, information in <800> surrounding administration is therefore not federally enforceable.
A caveat to this statement. You need to be aware of what your state and local regulatory agencies are enforcing.
Who’s enforcing USP <800>?
According to a poll done in the webinar, 63% of respondents said they have NOT been asked about USP <800> during inspections in the last two years.
In inspections conducted over the last two years, we’ve heard that State Boards of Pharmacy are the ones asking the questions, and Joint Commission just kind of hints around USP <800> guidelines. At this point, we’ve heard that the Ohio State Board of Pharmacy started issuing citations in August 2022. Washington and Oregon also have been inspecting using USP <800> guidelines.
However, come November 1st, it's open season on USP <800>. USP is continuing to engage regulators and keep them informed of the compendial status of the chapters; however, USP itself plays no role in enforcement.
If you want to listen to the entire webinar, it’s available here on Youtube.
And if you like what you’ve learned so far, check out the USP <800> Preparedness Lunch + Learn webinar series schedule and register for upcoming sessions today. We hope to see you soon!
