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How a large health system brought all facilities into compliance with updates to USP chapters, before the enforcement date

Pharmacy Times® interviewed Melanie Galvin, PharmD, BCSCP, the senior advisor for Hospital-Based Pharmacy Services at Northwell Health, about her hospital’s preparation efforts to implement changes to bring the hospital up to date with the revision of USP chapters , and . Galvin explains how far ahead of time 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 was Northwell Health’s approach to preparing for the USP updates?

Melanie Galvin: As a large health system, we therefore knew that we had to take a system standard approach to the revised chapter as well as the new chapter to review. So, in that approach, we created what we called a task force group, with representatives from each of our facilities. So whether it was the director of pharmacy or designee, and we’re starting to have those task force meetings every other month.

During those meetings we would discuss what the revision of chapter and would require moving forward. Once we had an understanding of the larger scale of changes that were going to be needed, we really started tackling it on a smaller scale one at a time, starting with facility updates and renovations, then working on environmental monitoring, viability testing, updating our competency and training requirements and so on.

We also have the USP dangerous drug handling in smaller pieces because it was a new chapter with new requirements, some of which we already followed with oncology practice, but we decided to take it and break it into smaller pieces as well.

Pharmacy Times®: What led Northwell Health to prioritize composite compliance before announcing an enforcement date?

Melanie Galvin: Although there had not previously been an official enforcement date, we felt that the revisions would both reflect the thinking of the USP composite expert committee, and thus indicate best practice regarding formulation compliance. Our goal at Northwell is not only to meet minimum standard requirements, but to ensure that we also embrace best practice. Especially with USP on the handling of dangerous drugs, although that chapter was not official, we truly felt that it was the best practice to protect both our employees and our patients.

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

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

For that survey, we did choose to be interviewed about the review, as we adopted all changes as a system, and it went very 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 reviews and a survey on that.

Pharmacy Times®: Where did Northwell Health begin their updates on 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 step-by-step approach when preparing for the updates. When the revisions were posted in 2019, we began an evaluation of all of our current physical spaces for assembly and began a multi-year construction project of either updating, renovating, building new spaces, new modular trailers as needed. So we really started at the facility and operational component of what spaces are going to need updates and what are going to need actual new spaces to meet the revisions.

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

Melanie Galvin: I do think that starting up front 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 revisions. Using the extended timeline to make a change, reassess compliance with those changes, and then move forward made the process much less challenging for our sites. Even at the height of COVID-19 in New York, we were able to continue to move forward toward compliance.

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

Melanie Galvin: I believe that our proactive efforts to adopt the revisions will not only help ease the pressure to implement these changes now over the next year, but it has also allowed us to establish a forum in our task force group to discuss all things sterile compounding and dangerous substances. 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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