Since In the Clean Room was released in October, Iâ€™ve received a lot of questions about i.v. room technology. The questions generally focus on a single product or a particular functionality. However, I get a surprisingly large number of people asking me â€œwhatâ€™s the best system for the i.v. roomâ€. A simple question. Unfortunately itâ€™s a question that is not easily answered.
There are several variables to consider when selecting technology for the i.v. room, as well as a number of questions that must be answered during the evaluation process.
First and foremost you must be able to articulate your endgame, i.e. what do you hope to accomplish? You would be surprised how often people I speak with are unable to answer this question. No person would make a life-altering purchase without first understanding what it is they wanted, but it happens all the time in pharmacies across the country.
Is your primary concern safety? Are you looking for improved documentation? Workflow? Do you need a lot of handholding during the implementation process? Would you like to use mobile devices such as tablets and smartphones? How much do you want to spend? Do you have labor resources to throw at the project before, during, and after implementation? These questions, and many more should be addressed before you start your search for i.v. room technology.
There are several technologies currently on the market designed to help pharmacies compound sterile products. These technologies run the gamut from simple, highly functional semi-automated systems with a small price tag to highly complex robotic systems that are much more costly. Â On the surface these systems may look similar, but each offers a slightly different approach to compounding sterile products. Several may meet your needs at the most basic level. The trick is finding the best fit, and that means doing your homework.
I highly recommend that you start by evaluating you current i.v. workflow process and addressing any workflow inefficiencies. Once that is accomplished it is important that you answer that most important of all questions, i.e. what do you hope to accomplish? As you begin to formulate your response you will realize that you have many other questions that need to be addressed, and thatâ€™s when you know youâ€™re on the right track.
Donâ€™t rush the process. Itâ€™s important that you take your time and get it right. These systems often require a significant investment in human resources, and the system you ultimately install will likely be with you for quite some time.
Good luck with your search.
5 thoughts on “Selecting technology for the i.v. room is no easy task”
How much of the desire to have IV Workflow (IVWF) solutions is an unintended consequence of USP 797?
While I have yet to see the scientific studies documenting the consequences of “pre-USP 797” IV work environments, I have seen how these regulations have significantly increased the degree of difficulty in just getting work done in the IV room. Some pharmacies have basically given up and outsourced any IV admixture work that they can. Others attempt to try to keep up with the moving target of USP 797 compliance requirements.
While USP 797 has increased the cleanliness of what is done in the IV room, has it had a negative effect on workflow, staffing, and pharmacist supervision, creating a net negative situation from a quality/safety perspective? Why are IVWF imaging solutions so desirable: presumably because you can have the pharmacist check done remotely. Is this really as good as a pharmacist “hood check”? Is the real motivator behind this so that a pharmacist does not have to “garb up” to go into the IV room? Does that make it better or just more convenient? Our patients would probably prefer better to more convenient.
I recall back to the ASHP IV Room guidelines in the early 1990’s. While they were not nearly as rigorous as USP 797 regulations, they did significantly raise the bar for pharmacy IV room operations. But, they did not negatively impact workflow in the IV room that much. Prior to these guidelines, the standard of practice for IV room didn’t go much farther than having the IV hoods in a dedicated work room. Regardless, the ASHP guidelines of the early 1990’s made sense.
Even in the early 1990’s, when IV room work processes were good, but not great, I was unaware of any scientific data from hospital studies documenting widespread pharmacy IV Room product quality issues. If USP 797 was a “new drug” trying to get on the market, would it be able to provide the scientific data to justify its “efficacy and safety”? I don’t think so.
Then, I think back about my own career in hospital pharmacy. My IV room experience began as a pharmacy intern in a hospital in Ann Arbor, Michigan in 1969. It was my job to “prepare” 50mL bottles (bags were not available then) from 150mL IV glass bottles. This was done by carefully pouring off 100mL of D5W into a graduated container; all done in a laminar air flow hood. As I recall, gloves were not an option; just clean hands. TPNs and Chemotherapy IVs were prepared similarly. The following year, I was doing a residency in the US Public Health Service, where I had the opportunity for some “IV Room Training” at the Clinical Center at the National Institutes of Health (NIH). The practices there were similar to what I experienced in Ann Arbor and to what I would experience over the next 30 years.
Fast forward to the early 1990s (ASHP IV Room Guidelines) until the mid-2000s (USP 797). Has there been a dramatically, downward trend in negative patient outcomes corresponding with the USP 797 regulatory “fixes” that have been implemented to presumably improve IV room practices? Was I part of a nationwide pharmacy conspiracy during the first 30+ years of my professional practice, using IV room processes that were having a negative impact on patient outcomes? Even back in the 1960s, I can recall infection control nurses who were always on the lookout for infection-related situations occurring in the hospitals. Did they miss seeing the problem also?
I also wonder about hospital Operating Rooms (OR). I have always thought they have done a decent job providing a very clean environment in which to perform patient surgery. Certainly, the patient is at greatest risk in this environment compared to getting a pharmacy-prepared IV admixture. Yet, I haven’t seen engineering controls implemented in the OR, like I have seen in hospital pharmacies. Should hospital pharmacies be held to a higher standard than hospital operating rooms?
Bottom line: Have the well intentioned USP 797 regulations created the opportunity for Pharmacy IVWF solutions, in the same way that they have created the new industry of vendors providing products to ensure USP 797 compliance? Strangely, this sounds similar to the military-industrial complex that continues to convince us that we need new, bigger, better weapons to combat our enemies. Certainly, any time that there is a buck to be made, someone will be there to take your order.
I’ve have also often wondered about the increased difficulty of i.v. room operations with the introduction of USP <797>. With that said, I’ve started to come around in the last couple of years. I remember working in the i.v. room in the early 2000’s. It was the wild west in there. We would make i.v.’s and give them 6 months at room temperature. Not to mention that we didn’t give a second thought about sterility. I’m not sure what the ultimate solution is, but I do know that <797> is here to stay. Ultimately we have to learn to live with it.
In regards to i.v. workflow systems. It’s difficult to say why the increased popularity. Could have something to do with <797>, but that’s been around since 2004 (finalized in 2008). It’s 2015, i.e. over a decade later and we’re just now starting to see a significant uptake in workflow systems. Based on my calculations, and implementation data from the vendors, there are between 300 and 350 systems installed throughout the U.S. That’s a tiny percentage of the total hospitals. I think we’ve only scratched the surface. I don’t believe the current crop of workflow systems are the ultimate answer, but it’s hard to imagine what the final solution will be. As I evaluate the current systems on the market my opinion on remote verification via imaging changes; and not necessarily for the better.
What you describe regarding IV Room working conditions in the early 2000’s did not need USP 797 to fix the problem. The ASHP already had reasonable guidelines in place since the early 1990’s. The problem is that no regulatory/accreditation organizations (e.g., State Boards of Pharmacy, CMS, JC) bother ed to survey against these professional guidelines. Had that happened, all IV practices would have been significantly improved withOUT turning every pharmacy IV room into a pseudo-GMP manufacturing facility (i.e., what we got with USP 797). Just another example of when the use of a sharp knife (i.e., ASHP Professional Practice Guidelines) might have solved any existing problems, instead of requiring the use of an AK47 (i.e., USP 797) and dealing with all of the collateral damage in inexperienced hands.
USP 797 brought increased focus on the pharmacy IV room. Enforced ASHP guidelines would have done the same. I still believe that is the driver behind the IVWF automation solutions that we are seeing today. I agree with you that the current solutions are a good first attempt. Now, we need to step back, reevaluate our IV room workflow processes, determine what is optimum from an quality, safety, and efficiency standpoint, and then identify how automation might improve the best practices. In the interim, we must stop using automation do automate bad practices where we just end up doing the wrong thing faster and often with new unintended consequences (e.g., the remote image verification process).
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