NIOSH puts the brakes on the CSTD vapor containment protocol

Pharmacy Practice News: “The National Institute for Occupational Safety and Health (NIOSH) held a meeting today in Cincinnati to discuss a universal closed-system drug-transfer device (CSTD) testing protocol, which is being developed… The new protocol will test both physical barrier systems, which block the intake of environmental contaminants or the unintended release of hazardous drugs into the environment; and air-cleaning systems, which clean or filter vapors to prevent the unintended release of drug or the intake of environmental contaminants… NIOSH released a draft test protocol last year to evaluate the efficacy of physical barrier–type CSTDs to see whether they prevented hazardous drugs from escaping the closed system. After hearing from the public and meeting with various stakeholders, NIOSH was asked to develop a new performance test protocol for air-cleaning CSTDs. Instead of developing a completely new protocol, NIOSH decided to develop a universal one that addressed both types of systems.

Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs”. The idea is admirable, but the testing method adopted by the protocol left some CSTD manufacturers on the outside looking in, and they let the CDC know about it. Feel free to drop by the protocol comment site for clarification.

Apparently the comments made an impact because NIOSH is going back to the drawing board to try and come up with a universal protocol to meet the testing needs for all CSTD systems. However, one has to wonder if the damage is already done. For the past several months pharmacies have been making decisions on which CSTD to use based on information in the draft vapor containment protocol. Right or wrong, that’s the truth of the matter. I have to believe that some of the companies in this space have been irreparably harmed. Only time will tell.

Someone please disrupt controlled substance storage technologies

Management of controlled substances(1) inside acute care pharmacies is a mess. It’s difficult for me to stress how utterly disappointed I am by this area of pharmacy technology.

  • The technology has been around for a long time. The controlled substance area of the pharmacy was one of the first areas to start using technology as part of routine medication distribution.
  • More pharmacies use technology to manage controlled substances than any other area of the pharmacy. It’s probably considered “best practice” to use technology in this area of the pharmacy.
  • There’s a fair amount of technology being used to deal with controlled substances: inventory management software, barcode scanning, biometrics, analytics and reports, remote access refrigeration and “vaults”.
  • It’s the worst technology in the pharmacy, hands down.

I haven’t been in a pharmacy in years that wasn’t using technology to manage these drugs. This is likely due to the amount of fear and regulation swirling around controlled substances. These drugs have the highest level of control and are more regulated than any other drug class; at least until USP <800> goes live. The paranoia around these medications is crazy. The man hours dedicated to their management is obscene.

Based on my observations, the technology is outdated, difficult to use, and has failed to improve the process in any appreciable way. It remains unclear to me what advantage these systems offer. I don’t think it would be difficult for someone to argue in favor of ditching the technology in lieu of replacing it with two people locked inside a room using pen and paper. Crud, it might even be more efficient.

Consider that in a majority of instances the inventory management system used to manage controlled substances is separate from the system used for other inventory, and almost never tied directly to the EHR. Yes, it means you have to maintain a separate database for one area within the pharmacy.

Also consider that at least one of the major players in this area cannot handle partial doses, i.e. half-tablets or increments of mL’s. That’s right, software designed to keep detailed records for controlled medications chokes on something as simple as 7.5 mL.

This is an area of the pharmacy that needs an enema. Someone out there must have a better way. If you have any ideas, please give them up.

And for the companies playing in this space, you really need to do a better job. Go sit in a pharmacy for a day or two and observe how utterly terrible these systems are to use.

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  1. The term ”controlled substance” means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of the Controlled Substances Act http://www.fda.gov/regulatoryinformation/legislation/ucm148726.htm . This includes medications like morphine, fentanyl, hydromorphone, etc.

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

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