How a Large Health System Brought All Facilities Into Compliance With Updates to USP Chapters <797>, <800> Before Enforcement Date


Melanie Galvin, PharmD, BCSCP, explains how Northwell Health implemented changes to bring the health system up-to-date with the revisions to USP chapters <797> and <800>.

Pharmacy Times® interviewed Melanie Galvin, PharmD, BCSCP, the senior advisor for Hospital-Based Pharmacy Services at Northwell Health, on her hospital’s preparatory efforts to implement changes to bring the hospital up-to-date with the revisions to USP chapters <797>, <795>, and <800>. Galvin explains how far in advance her hospital began these preparations and provides guidance to those looking 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 updates?

Melanie Galvin: So as a large health system, we knew that we needed to take a systems standard approach to review the revised chapter <797>, as well as the new chapter <800>. So, in that approach, we created what we called a taskforce group, with representatives from each of our facilities. So whether that was the director of pharmacy or designee, and we begin holding those taskforce meetings every other month.

During those meetings, we would discuss what the revision of chapter <797> and <800> would require moving forward. So once we had an understanding of the larger scope of changes that were going to be needed, we began to tackle them really on a smaller scale one at a time, starting with facility updates and renovations, and then working on environmental monitoring, viable testing, updating our competency and training requirements and so on.

We also tackled the USP <800> hazardous drug handling in smaller pieces as well, as that 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 into smaller pieces also.

Pharmacy Times®: What led Northwell Health to prioritize compounding compliance prior to an enforcement date being announced?

Melanie Galvin: Although there was not previously an official enforcement date, we felt that the revisions both reflected the thinking of the USP compounding expert committee, and thus would indicate best practice in regard to compounding compliance. Our goal at Northwell is not just to meet minimum standard requirements, but to ensure we're also embracing best practices as well. Especially with USP <800> on the hazardous drug handling, although that chapter hasn't been official, we truly felt that was best practice to both protect our employees and our patients.

Pharmacy Times®: How long has Northwell Health been preparing for these updates, and when are they expecting to be evaluated?

Melanie Galvin: We began preparations for these updates in 2019 with the first revision, and it's been a continual process of step-by-step implementation of changes over the last 3 plus years. Over those 3 years, we utilized an internal assessment tool to track compliance along the way. But our next window of joint commission surveys as a system opened in March of 2022, with our first survey being conducted over the summer.

For that survey, we did choose to be surveyed on the revision, as we did adopt all changes as a system, and it went extremely well for us. So we had both our internal evaluation tool, and we had that secondary joint commission survey that showed us that we were prepared for the revisions and a survey on them.

Pharmacy Times®: Where did Northwell Health start their updates around pharmacy compounding operations at their facilities?

Melanie Galvin: As a large health system with 21 hospitals and multiple outpatient infusion centers, we knew we would have to take a very stepwise approach when preparing for the updates. When the revisions were posted in 2019, we started with an evaluation of all of our current physical spaces for compounding and began a multi-year construction project of either updating, renovating, building new spaces, new modular trailers as needed. So we really started from the facility and operational component of what spaces were going to need updates and what would need actual new spaces to meet the revisions.

Pharmacy Times®: Were the advance preparations helpful to the process of making necessary changes to pharmacy practice and operations?

Melanie Galvin: I do think starting in advance gave us the ability to take a slow and steady approach when reviewing and implementing changes and did contribute to our success in adopting these revisions. Being able to utilize the extended timeline to make a change, reassess compliance to those changes and then move forward, made the process much less daunting to our sites. Even at the height of COVID-19 in New York, we were able to continue moving forward towards compliance.

Pharmacy Times®: How does Northwell Health expect their proactive efforts to serve their system going forward?

Melanie Galvin: I believe our proactive efforts in adopting the revisions will not only help to relieve the pressure of now implementing these changes over the next year, but it also allowed us to establish a forum in our taskforce group to discuss all things sterile compounding and hazardous drugs. Through these efforts, we created a much-improved system standard approach to review operational implementation of regulations that we can now apply to any other regulatory changes in the future.

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