Mobile compounding units, a.k.a. sterile compounding trailers

Image owned by Jerry Fahrni, Pharm.D. Taken June 28, 2018

Construction on pharmacy cleanrooms is at an all-time high in California. Every hospital I know is either renovating a sterile compounding area —  cleanroom or SCA — or building a new one. Why? Because of USP General Chapter <800>, of course. Never have I seen so little cost so much. That little 19-page document has sent shock waves throughout the pharmacy world and created more chaos than anything I’ve witnessed in my 20 plus year career. Whether or not the changes called for in the new chapter will improve patient care and worker safety remains to be seen. That’s a blog post for another time.

As pharmacies begin renovating existing sterile compounding areas, or building new ones, there may be a time when they find themselves without a suitable area to make Compounded Sterile Preparations (CSPs). Some pharmacies have the physical space and financial resources to build new sterile compounding areas without vacating their existing space. Others do not.

For those that don’t, there are few options. They can potentially get someone else to handle their CSP production while under construction, or they could give everything an immediate-use BUD. Neither is a great option, but options they are.

Enter the Mobile Sterile Compounding Unit (MSCU) built by Germfree — aka Mobile Compounding Unit (MCU), “Pharmacy Trailer”, “Rx Trailer”, “the trailer” or as the manufacturer likes to call it, “Rental Compounding Trailer”. I prefer MCU.

The MCU is basically a semi-truck trailer with a fully functional pharmacy cleanroom inside. Germfree describes it as a “turnkey rental pharmacy/cleanroom for hospital facility renovations”.  I wouldn’t go as far as to call it turnkey, but it’s close.

The Germfree MCU has three distinct work zones:

1) ISO Class 7/8 anteroom with a small area for personnel to don Personal Protective Equipment (PPE). The area has lockers for storing PPE, a hand washing sink, and a gowning bench.

2) ISO Class 7 Negative Pressure Buffer Room (HD room) with Class II, Type A Biological Safety Cabinets, storage space, and integrated refrigerator and freezer. Preparation areas are all stainless steel.

3) ISO Class 7 Positive Pressure Buffer Room (non-HD room) with Laminar Airflow Workstations, storage and integrated refrigerator and freezer. As with the HD room, preparation areas are stainless steel.

The trailer has a dedicated HVAC system for temperature and humidity control, an auxiliary generator should you require emergency power, on-board fresh water to provide for a sink, a gray water tank to collect water for disposal, data ports for computers and phones, and a host of cameras with a digital video recorder (DVR) for security.

I’ve had the opportunity in my current position to oversee the implementation of a MCU from purchase to fully-operational cleanroom. I’m a few weeks from signing off on the project. Only a bit of regulatory paperwork remains.

During my time with the MCU I’ve formed some opinions, which I present to you here.

Pros:

  • Ready-to-use, sort of. While it takes a little bit of work to get a MCU up and running, they truly are close to being a “turnkey cleanroom”.
  • ISO compliant HD and non-HD buffer rooms. Unlike an SCA, there is no limitation to what can be made in the MCU. It is fully capable of handling any type of CSP.
  • Self-contained, mostly. Once the MCU is tied to water and electricity, pharmacy personnel can work as if they were in any other pharmacy cleanroom.
  • It’s quicker and cheaper than many remodels. I don’t mean to say that MCUs are inexpensive, but I would wager that the cost is less than most major pharmacy remodels or the cost of building a completely new cleanroom.
  • The MCU is nice. Regardless of how you feel about the idea, one thing is for sure, the Germfree MCUs are nice and well-built. Honestly, the HD and non-HD buffer rooms inside the trailer are nicer than many pharmacy cleanrooms I’ve been in. Don’t take my word for it, go visit one yourself.
  • Same hoods that you find in the pharmacy. The same Germfree BZ and BBF hoods you find in pharmacy cleanrooms can be found in the MCU.
  • Lease or buy. Depending on your needs, Germfree offers both.

Cons:

  • One-year maximum use in California. This has nothing to do with Germfree but rather the state I live in. California will only give permission to use these trailers for 12 months. This seems a bit silly to me. Don’t people use trailers as permanent homes? I believe so. As mentioned above, the MCUs from Germfree are nicer than some cleanrooms I’ve been in. Meh, when in Rome…
  • Requires a “flex” or “alternate means of compliance (AMOC)” from state agencies, at least in California. It’s a bit of extra paperwork.
  • Regulatory scrutiny, again California specific. All the state agencies — OSHPD, CDPH, Board of Pharmacy — have taken an aggressive approach to these trailers, which makes getting them up and running a bit of a hassle. Be prepared to do a lot of extra paperwork, including extended policies and procedures, additional trailer-specific training and training, and so on.
  • Requires water, electricity, and internet. This is where calling the trailer self-contained becomes strained. Yes, the trailer has a fresh-water tank and a generator, but those are temporary solutions. Should you need the trailer for an extended period, you will have to find more permanent water and electricity options.
  • Gray water tank. Water used to wash hands has to go somewhere. In this case, it’s a gray water holding tank. Obviously, the tank has to be emptied when it gets full. Depending on how prolific your CSP production is, that could be more than once a week.
  • No restroom. Cross your legs or leave the trailer because there is no bathroom.
  • Customer support/service. I’m sure this will improve over time, but it’s been less than optimal.
  • Limited availability. Apparently, it takes a while to build an MCU, so if you’re in the market for one you should look into it as soon as possible.

Cool Technology in Pharmacy – Evolve Refrigeration

The Evolve line of compressor-free, medical grade refrigerators* are quite impressive. Powered by SilverCore™ Technology, they have no compressor. And because they have no compressor, they have no mechanical parts, run quiet, use less electricity, and generate less heat.

The system “absorbs heat energy from the storage cabinet using a non-toxic, non-hazardous refrigerant embedded in the walls. Heat energy is channeled up to a high-performance thermoelectric heat pump that cools the refrigerant and transfers the heat into the ambient environment“. Science!

Evolve refrigerators meet CDC vaccine storage guidelines as well as requirements for use in a clean room. In addition, the units provide alerts for temperature, door, battery, memory, loss of WiFi, and loss of power via local and remote monitoring options.

Because the refrigerators utilize solid-state technology, the company is able to squeeze more storage capacity into a unit compared to a similar sized non-solid state refrigerator. Up to 25% more storage capacity according to the company.

I’m not sure if you’re aware of how much noise refrigerators can add to a pharmacy, but it’s lot. This is especially true in the IV room where PEC’s (hoods) already make the environment less than friendly to one’s ears.

Not only does the Evolve line of refrigerators look pretty cool — no pun intended — their ability to reduce noise pollution in the pharmacy is a welcome bonus.

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* I first wrote about Evolve back in December 2015 after seeing the product at ASHP Midyear.

 

Cool Technology for pharmacy – Linked Visibility Inventory System (LVIS)

The Intelliguard® Linked Visibility Inventory System™, or LVIS for short, is an RFID-enabled anesthesia cart designed for use by anesthesiology providers in the OR. I spoke about this briefly in my last podcast.

LVIS is a free-standing cart with three drawers – one large and two small. The cart looks quite different from any of the current anesthesia carts on the market. Take a look at the image below taken at the ANESTHESIOLOGY 2016 conference for a better understanding of what I’m talking about.

Intelliguard LVIS Cart

 

LVIS utilizes RFID technology to track medications in real-time. Items placed inside the cart are labeled with RFID tags – attached by the pharmacy or pre-tagged from some third parties like PharMEDium – and placed in a drawer. Once the cart is unlocked via one or a combination of locks – RIFD reader, biometric scanner, keypad for PIN (see image below) – the user has access to any medication in any of the drawers. Each time a drawer is closed, the system scans the contents and captures data on every medication, including item, quantity, user identification and time stamp. That’s it. If you take something out, the system knows. If you place something back in the drawer, the systems knows. The user is not required to debit or credit any item or scan the drug on removal or return. That’s a win for anesthesia providers and for the pharmacy. The provider gets access to medications without interring with their workflow, and the pharmacy gets real-time inventory numbers and complete transparency for what’s being used.

LVIS Access

I like how the system was designed. There are several little things that show how much thought went into the product. For example, offering three different methods to log into the cart, or giving users the ability to configure access to each drawer individually, or offering an “in process” area to track items that have been removed but not documented as used (little green area on top of the machine), and so on. I also like how the system was designed with minimal impact on workflow in mind. Because LVIS uses RFID technology, most of what’s happening is transparent to the user, i.e. their workflow remains intact.

Not all is perfect, however. I’m not completely sold on the physical design of the system. I would like to speak to others that have seen the unit to get their feedback. The other questions I have are around integration with existing systems, especially EHRs and AIMS. That’s the elephant in the room with every small company trying to play with the big boys. Only time will tell, but I am encouraged by LVIS. I like the technology and I’m impressed with the thought that went into the product’s design.

I’m looking forward to learning more at ASHP Midyear in Las Vegas.

Couple other random images below:

 

MEPS LVIS Keypad

20161023_141315

Cool technology for pharmacy – ProteXsure Safety Capsule System

Needle sticks happen. I’ve actually stuck myself a few times during my career while compounding in the IV room. Fortunately for me, it never involved anything hazardous. Still, it was a pain. No pun intended.

Over the years a lot of attention has been given to methods for preventing needle sticks in healthcare, ranging from things like procedures, i.e. “no-recapping” to physical barriers like safety syringes. The ProteXsure Safety Capsule System falls into the latter category.

ProteXsure

medGadget: “[The ProteXsure Safety Capsule System] prevents needle stick injuries by offering an easy way to snap on a protective cap to the tip of a needle. Once a syringe is finished with, the needle is simply pushed into a slot on the side of the ProteXsure. This can be done with one hand. A cap immediately grabs onto the needle, readying the syringe for safe disposal.”

The ProteXsure Safety Capsule System gets high marks for ease of use and design. It appears to be a simple, yet elegant solution to the problem of blunting the end of a needle to prevent accidental sticks. Check the video below to see how simple the product is to use.

 

From the ProteXsure site:

  • First device to safely address recapping the Front & Back end of all dental syringes
  • Fits all size needles and gauges in most medical and healthcare settings
  • Meets all OSHA guidelines of mandated “One Hand Recapping”
  • Accepts both “Bent & Straight” needles
  • Quick and easy to use
  • Non skid gel pads adhere to any surface without leaving marks or residue
  • 100 safety capsules inside every system
  • Fully automatic (Insert needle and remove)
  • Once completely dispensed, simply dispose in a normal waste bin & replace
  • Additional downstream needle protection should original needle cap come off (capsule covers needle tip in addition to the syringe cap)

No information on cost and availability in the U.S.

Cool Technology for Pharmacy – DOSIS

Not being involved with long-term care (LTC) pharmacies much over the years, I sometimes forget that there’s technology to help with some of the day-to-day operations.

I recently came across an advertisement for a company called Manchac Technologies. The reason it caught my eye is because I had a chance to visit with Manchac several years ago when they were still in their development stage.

Manchac is a company out of Alexandria, LA that specializes in technology designed to automated blister card packaging called DOSIS. “DOSIS products are designed to enhance efficiencies in your pharmacy operations while reducing the opportunities for errors…a robotic solution that fully automates blister cards (filled, sealed, and patient-labeled)”.

Blister cards – aka punch cards, blister packs, etc. – are still prominent in nursing homes and, therefore, a huge part of LTC pharmacies. Large operations will do thousands of blister cards daily. According to information on the DOSIS site, the companies new BP198 machine is “capable of producing 40-55 filled and sealed cards per hour”.

The Cactus Smart Sink while roaming through the exhibit hall at ASHP Midyear. The Smart Sink is a pharmaceutical waste disposal container that renders its contents “unrecoverable, non-retrievable and unusable”.

Some key features of The Smart Sink include:

  • A two cartridge system, one for liquid waste and one for solid waste, including patches.
  • It runs on batteries
  • Has a small footprint, measuring only 15.5” W x 12.5″ H x 9.5” D.
  • Uses audible alarms and alert lights to notify users when cartridges are full, have expired, or when the unit has been accessed.

I thought the it was pretty cool. Obligatory video below.

Cool Technology for Pharmacy – Vestigo

Vestigo is web-based Investigational Drug Service (IDS) software made by the McCreadie Group, Inc., a privately held pharmacy software company out of Ann Arbor, Michigan. The McCredie Group is a small boutique company that builds software for niche markets like IDS.

I’ve worked in pharmacies that have an IDS, and let me just say that there’s a lot of record keeping involved and attention to detail is important. One would think that the “the drug” would be the most important thing, but that’s not really the case. Records, logs, and traceability are key.

Anyway, one of the products offered by the McCreadie Group is Vestigo. I’ve come across the product in pharmacies while traveling, but never really given it much attention. Because it’s such a niche product I couldn’t even tell you who they’re competing against.

Don’t go Googling for information on Vestigo, because you’re probably not going to find much. The company has done a pretty good job of not marketing their product and keeping relevant information off the internet. Not sure how that’s possible in this day and age, but I wasn’t able to find more than some old reference articles and press releases.

I have verified with the company that they will be at the 50th ASHP Midyear Clinical Meeting and Exhibition in New Orleans in early December. I’m interested enough in the product to drop by their booth and have a look. Until then, here’s what the McCreadie Group site has to say about Vestigo:

Vestigo increases IDS safety and compliance…

  • Protocols structured in a logical and safe manner
  • Product selection limited to drugs used for the current protocol
  • Automated checks for expired products and IRB approvals
  • Patient management functions prevent dispensing to patients not enrolled
  • Accurate, electronic drug accountability records
  • High-quality, safe labels with barcodes
  • Built-in workflow for safe practices
  • Logging and audit trails required for HIPAA and 21 CFR Part 11 compliance

…and improves IDS efficiency and reduces costs

  • Electronic protocol managementFully automated protocol billing (increases revenue and reduces the cost of generating the bill
  • Electronic inventory management including tracking patient-specific items, returns and destructions
  • Reduced paperwork and handwriting
  • Integrated dispensing with automatic label generation
  • Extensive reporting to track operations, workload and financials

So if you’re in the market for an IDS solution, you might give Vestigo a look and request a demo.

Cool Pharmacy Technology – Vaccine Smart-Fridge

The Vaccine Smart-Fridge is an interesting concept for ambulatory care. It appears to be a consignment vaccine distribution system. Reminds me of a refrigerated single-point automated dispensing cabinet (ADC).

There’s a lot to like here.

By using a consignment model, the vendor offers an ambulatory care clinic low cost, low risk access to vaccines. It also decreases the chance of something sitting in the cabinet beyond it expiration date, or going bad because the temperature is out of range. The company supplying the items has a vested interested in making sure that everything inside those refrigerators is ready for use, and that waste is kept to a minimum.

I believe that the consignment model for pharmaceuticals will only continue to grow. The largest budget item in many pharmacy is inventory, by a wide margin. Refrigerated medications seem to be the main target for consignment, but it’s possible that the model could creep into other spaces as well, especially with the introduction of biosimilars.

The system provides real-time alerts on inventory shortages and temperature. Automated temperature monitoring ensures that things stay within their appropriate temperature range. Heat is bad for lots of medications, especially vaccines. This information can be viewed from a computer or mobile device. I like that it’s proactive.

Single-item access is a great concept for an ADC. This style of distribution is frequently used for controlled substances – morphine, fentanyl, etc. It provides better security than open access trays, drawers, and bays, thus minimizing opportunity for diversion. Does it make sense for everything? No, not really, but in this case it fits.

The system provides access to real time analytics and historical dispensing data. This information could be linked to other systems for easy access to vaccination records.

Pharmaceutical refrigeration is in need of a little disruption, so when I see something like this I’m encouraged that someone is thinking about it. There’s nothing new about this technology, but it does provide a new paradigm to think about.

Cool pharmacy technology – SMART-IV

Not exactly pharmacy technology. However, SMART-IV involves integration of iv infusions with bar code scanning at the patient bedside. That’s kind of pharmacy related, in a sort of roundabout way.

Check the video below for a look at how the system works. The commentary is in Dutch, so if you don’t speak Dutch you might be in trouble. Regardless, you’ll get the basic idea anyway.

Continue reading Cool pharmacy technology – SMART-IV

FDA approves first 3D printed drug

This was all over the web yesterday, so I’m not telling you anything you don’t already know, but this is huge. 3D printing is one of those technologies that has the potential to disrupt just about every industry it touches. It’s not often that you can say that. The most recent technologies that I can think of that had that kind of impact was the explosion of smartphones and tablets, which are now ubiquitous across every industry you can imagine.

SPRITAM

Continue reading FDA approves first 3D printed drug