How a large health system brought all facilities into compliance with USP chapter updates ahead of the enforcement date

Pharmacy Times® USP Chapter <797>, <795 के संशोधनों के साथ अस्पताल को अप-टू-डेट लाने के लिए बदलावों को लागू करने के लिए अपने अस्पताल के प्रारंभिक प्रयासों पर नॉर्थवेल हेल्थ में अस्पताल-आधारित फार्मेसी सेवाओं के वरिष्ठ सलाहकार, मेलानी गैल्विन, PharmD, BCSCP का साक्षात्कार लिया। >And <800>, Galvin describes how early his hospital began these preparations and offers guidance to those who want to implement similar updates to align with these USP chapter revisions.

Pharmacy Times®, What has been Northwell Health’s approach to preparing for the USP update?

Melanie Galvin: So as a large health system, we knew we needed to revise Chapter <797> as well as new chapters <800> There is a need to adopt a systems standard approach to review So, in that approach, we created a task force group comprised of representatives from each of our facilities. So whether it’s the director of pharmacy or the designer, and we started having those taskforce meetings every other month.

During those meetings, we would discuss whether the chapter <797> And <800> What would be needed to proceed with the amendment of So once we understood the broad scope of changes that were going to be needed, we really started tackling them one small scale at a time, starting with facility updates and refurbishments, and then environmental monitoring, Worked on practical testing. , updating our qualification and training requirements and so on.

USP <800> Hazardous drug handling was also tackled in smaller pieces, as this was a new chapter with new requirements, some of which we were already following with oncology practice, but we decided to take that and break it down into smaller pieces. Did it too.

Pharmacy Times®, Why has Northwell Health prioritized compounding compliance before announcing the implementation date?

Melanie Galvin: Although there was no official enforcement date previously, we felt that both revisions reflect the thinking of the USP Compounding Expert Committee, and thus would indicate best practice with respect to compounding compliance. At Northwell we aim to not only meet the minimum standard requirements, but also ensure that we are adopting best practices. USP in particular <800> Although that chapter hasn’t been official, we really felt it was a best practice to protect both our employees and our patients.

Pharmacy Times®, How long has Northwell Health been preparing for these updates, and when is it expected to be evaluated?

Melanie Galvin: We began preparing for these updates in 2019 with the first revision, and it has been an ongoing process of step-by-step implementation of changes over the past 3-plus years. In those 3 years, we used an internal assessment tool to track compliance. But our next window of Joint Commission surveys as a system opens in March 2022, with our first survey being conducted in the summer.

For that survey, we chose to be surveyed on revisions, because we adopted all changes as a system, and it worked out very well for us. So we had both our internal assessment tools, and we had that secondary Joint Commission survey that showed us that we were ready for amendments and a survey on them.

Pharmacy Times®, Where does Northwell Health start its updates regarding pharmacy compounding operations at its facilities?

Melanie Galvin: As a large health system with 21 hospitals and multiple outpatient infusion centers, we knew we would need to take a very phased approach when preparing for the update. When amendments were posted in 2019, we began with an evaluation of all of our existing physical locations for compounding and began a multi-year construction project to update, renovate, build new locations, new modular trailers as needed Of. So we really started with the facility and operational component of what locations would need updates and what actual new locations would need to complete the modifications.

Pharmacy Times®, Was advance preparation helpful in the process of making necessary changes to pharmacy practice and operations?

Melanie Galvin: I think that starting early has given us the ability to take a slow and steady approach when reviewing and implementing changes and has contributed to our success in adopting these modifications. By being able to use the extended timeline to make changes, reevaluate compliance with those changes, and then move on, the process became much less daunting for our sites. Even with the peak of COVID-19 in New York, we were able to continue making progress towards compliance.

Pharmacy Times®, How does Northwell Health expect their proactive efforts to grow their system?

Melanie Galvin: I believe that our proactive efforts to adopt the amendments will not only help take the pressure off of implementing these changes over the next year, but it has also allowed us to establish a platform in our taskforce group that all things can be discussed. Through these efforts, we have created a much improved system standard approach to review the operational implementation of regulations that we can now apply to any other regulatory changes in the future.

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