What to Expect From USP<800> Consulting

What to expect from USP800 consulting

This week’s BLOG post is an interview with Bryan Prince, a compounding workflow and lab design consultant exclusively with Encore Scientific. Encore Scientific has been offering USP <800> design consulting services for almost two years and we thought it would be a good time for Bryan to let those of you that have not yet begun the compliance process know what to expect from our consulting services, especially since the implementation date for USP chapter <800> of December 1, 2019 is quickly approaching.

 

Before we get started on the topic of USP <800> consulting, tell us a little bit about your journey to this point and how you became involved in compounding workflow and design consulting.
Bryan: It’s interesting at how we sometimes find ourselves in the professional roles and career path. How I got to this point was completely unintentional, but it has been a fun journey. I spent my first ten years out of college in the building industry which laid a foundation for where I am now. The decade I spent in the building industry established how to speak the same language as contractors. After 2007 when the building industry took a serious nose dive, I was lucky enough to make the transition to an engineered containment company. Our clients were all the major pharma companies and this role helped me understand the technical laboratory language and engineering principles. Along this interesting career path, I was introduced into the wonderful world of compounding pharmacy and really found a home here. My original passion was safe workflow habits for compounding technicians and my skill set has evolved into lab design since the two topics are correlated. When USP <800> was introduced in draft and then adopted by USP, it allowed me the awesome opportunity to start consulting for about three years now.

Give us the “why” behind USP <800> consulting.
Bryan: The number one question I receive from independently owned compounding pharmacies about USP <800> is, “How much is this going to cost?” When you are an entrepreneur, especially an independently owned pharmacy, cash is king and every investment is calculated, so it is understandable that pharmacy owners are concerned about the financial cost involved with USP <800> compliance. The original question about “how much is this going to cost?” is the basis for Encore Scientific’s USP <800> design consulting services and the “why” behind what we are trying to accomplish with the consulting services. I tell our clients to look at this budget building process as somewhat of a feasibility study. Will it cost $50,000 or $250,000? We don’t know until we dig into the process.

Tell us more about how the process works.
Bryan: The first step in consulting is for me to understand the business model of the compounding pharmacy. What is the average weekly or monthly script volume in hazardous versus non-hazardous for both nonsterile and sterile? Understanding the pharmacy’s business tells me how to start designing. The space allocated has to match the script volume. What that means is you cannot take 80% of your business, nonsterile HRT for example, and allocate 20% of the room space to that. You’ve painted your business into a corner you can’t grow out of. This may seem intuitive, but you would be surprised to hear that pharmacies are being advised to allocate small spaces to HD compounding when HRT is the lion share of their script volume. Don’t cap your business’s growth and productivity when that segment is driving your company’s revenue.

Who else does the pharmacy need to work with as part of the budgeting phase?
Bryan: What we have experienced and learned from years of consulting is that there can be a lot of players on the field which we will refer to as the “project team.” It’s important that everyone on the team understand the goals. One of the main goals for me is to get a local general contractor, and/or HVAC company, and/or architect, and/or mechanical engineer speaking the same language and moving the same direction. If a pharmacy proceeds with a remodel or new build-out, then more than likely a building permit for construction will have to be applied for locally. When a building permit is applied for, the process typically requires an official drawing of some sort from an architect. If a new make-up air unit is being introduced into the project, then a structural engineer will have to inspect the building to make sure it can handle the weight load, and that requires an official stamp. So, you can see these projects can require a team effort.
It’s not uncommon to be introduced to a mechanical engineer or mechanical contractor who has “done work at the local hospital” and understands the basics of what are trying to achieve with construction, but USP and negative pressure is a little bit different, and so we really need to direct their efforts accordingly. One example is helping the mechanical contractor (or HVAC contractor) understand that a negative room pressure between .01 wc and .03 wc is a touchy area, and so I help them understand why damper controls in specific areas are important for the balance of the HD room.

Construction is such a quirky animal and finding a local general contractor you trust and can rely on is super important. The general contractor is usually the point-person. My task is to clarify for them the materials of construction, so they can reach out to their distributors and get pricing. I accomplish communication with the project team via 2-dimensional drawings, 3-dimensional models, phone calls, emails, and occasionally a GoToMeeting so that everyone is speaking the same language and moving in the same direction.

Any final pieces of advice?
Bryan: As I previously stated, construction is quirky and unfortunately my role as a consultant is sometimes the “bearer of bad news” in that I reveal some of the unknown costs. The biggest example of the bad news associated with hazardous drug handling is the cost to externally ventilate the compounding room. The intent of chapter <800> is that there is no opportunity for recirculation of air from the hazardous drug room back into the air handler. The intent of the chapter is that the HD room will be fully exhausted, which requires replacing air over and over to achieve the desired number of air changes per hour as defined in the chapter. On almost every single project I’ve consulted on, replacing 100% of the air in an HD compounding room requires a dedicated make-up air unit. This means that a standard commercial package unit was not built for these intensive air change demands and the pharmacy will have to invest in a dedicated make-up air unit that solely serves the HD room.
And my last piece of advice is “time is ticking.” Entrepreneurs and pharmacy owners are super busy people that wear a lot of different hats. Finding time to deal with USP <800> isn’t necessarily the fire that is burning the brightest today, but December of 2019 is going to be here before we know it. Time is elusive, and we all grapple with managing time. The process of design-consulting and budgeting will be about a 6 to 12-week process that lays the foundation for project feasibility. It is wise to start the planning process now so design, consulting, budgeting, and construction aren’t simultaneous events that create unnecessary stress in your business.

Schedule your FREE 30-minute consultation with Bryan here, or call 800.454.2304 for more information.