Tag: IV ROOM

On March 14 I posted a piece called Recommendations for technology-assisted CSP preparation.

The piece received a fair amount of traffic and some good feedback, including a comment left at my site – something that rarely happens. The comment’s author had some interesting, and valid, points. One item in particular caught my attention:

I have specific concerns with your recommendations: 1. “Must be simple to install, use. and maintain”: Even the best and more well-designed CSP production process is not a “simple” process. I’ve observed innumerable different hospitals’ CSP production processes — and there is ONE absolute truth: they are ALL different; and one nearly absolute truth: each technician makes a specific product “his or her way”. Absent a clear commitment to process standardization by a pharmacy, adding technology cannot ever be “simple”. And process change is rarely or ever “simple”.

Two thoughts on the above:

1) “Simple” is a relative and comparative term. It’s not black and white. “Simple to install” can mean many different things. Once, when I was much younger, the starter went out on my Chevy pickup. I called my grandpa for advice. He gave me instructions and told me it was a piece of cake and shouldn’t take long. Two hours later and more frustration than I care to admit, I was still crawling around under my truck with a quivering arm, busted knuckles, and no starter. Again, I called my grandpa. He showed up a while later, crawled under my truck, and with the starter in one hand, and a socket wrench in the other, proceeded to install the starter in a matter of minutes. To him is was simple. Something he’d done dozens of times. For me, having never changed a starter, it was complex and difficult. It’s all relative.

A specific iv room system may be quite difficult to install, but may be much simpler than its nearest competitor. Again, it’s relative. If I were a pharmacy director, or a pharmacy operations manager, I’d pick the easier route given similar functionality. In fact, being simple to install, use and maintain are at the top of my criteria for choosing pharmacy technology. If you can’t meet those criteria, then you had better have one heck of a system, otherwise you’ll end up on my cutting room floor. Pharmacy is a mess, adding unnecessary complexity is bad mojo.

2) I believe this is an old-school mentality. That is to say “this is how I built it, now deal with it”.* If there’s one thing the consumer industry has taught us is that people will chose the product that is simple to use, even at the loss of functionality. Vendors should always strive to make things simple to install, use, and maintain. Always. One of the biggest mistakes I see in pharmacies is failure to standardize, simplify, and minimize. People talk about “LEAN” and other similar processes but then turn right around and do the opposite.

Don’t take my word for it. Do a little research. According to a systemic review by Greenhalgh, et al. (1) technologies are more readily adopted when they (emphasis is mine):

• Have a clear, unambiguous advantage in either effectiveness or cost-effectiveness
• Are compatible with the adopter’s values, norms, and perceived needs
• Are perceived as simple to use
• Offer trialability, i.e. users can experiment on a limited basis
• Observable benefits
• When the technology can be refined and modified by the adopter to meet their specific needs
• It is relevant to the user’s work and improves task performance
• Knowledge to use the innovation can be codified and transferred easily
• Carries a low degree of uncertainty, i.e. they are perceived as having little risk.
• The technology is offered as an “augmented product” (e.g. with customization, training, and a help desk).

On the flipside, innovations are less likely to be adopted when the items above are put into a negative light, i.e. items are ambiguous, are incompatible, difficult to use, offer little to no benefit, and so on.

Do the same drivers of adoption outlined by Greenhalgh apply to pharmacy? It’s difficult to say for sure as there has been no pharmacy-specific data to suggest they do or don’t. However, I think they do. There are items in the list that will seem like common sense to some, while others will view them as nonsensical. For example, trialability is something that is rarely available to end users prior to selecting pharmacy technology. One may have the option to see the product in a live environment, which I highly recommend, but seldom does one have the ability to spend any appreciable time for a trial period. In contrast, compatibility, once seen as low priority, now tops many lists when evaluating technology purchases. I believe this is a byproduct of the increased adoption of electronic health records (EHRs), which are seen as integrated and compatible with many systems. Whether or not EHRs actually provide such integration, interoperability, and compatibility is an entirely different matter.

Usability – i.e. being simple to install, use, and maintain – has only recently landed on the radar of pharmacies interested in purchasing technology. We can thank the consumer market for that. Today’s consumer gadgets focus more on usability than true functionality. This has begun to spill over into other industries, most notably healthcare. I can recall my experience with pharmacy information systems (PhIS) during the early years of my career. They were terrible. The systems were often functionally rich and usably poor. It wasn’t until quite recently that PhIS’ become more usable. One has only to look at the introduction of EHRs, and subsequent outrage by physicians, to see why. Physicians wield a disproportionate amount of power within healthcare systems, so when they were forced to begin using EHRs with poorly designed user interfaces, the vendors heard about it. The result of all that complaining has led to significant improvements in usability. Because the PhIS is an integral part of many EHRs, pharmacists have benefited greatly. I dare say that we are nowhere near the experience seen in consumer products, but the improvements are nonetheless welcome.

Awareness of usability in pharmacy system will only continue to grow. The next generation of pharmacists and technicians have grown up with technology in their hands and it’s going to spill over into the products they chose for the pharmacy. So companies better take note. It’s time to simplify the installation and maintenance processes, standardize the user experience across your product line, and minimize complexity.

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* Akin to “Hey you kids, get off my lawn!”

(1) Greenhalgh, T., Robert, G., Macfarlane, F., Bate, P., and Kyriakidou, O. (2004). Diffusion of Innovations in Service Organizations: Systematic Review and Recommendations. The Milbank Quarterly, 82(4), 581–629.

New York Times: “The federal Medicare program and private health insurers waste nearly $3 billion every year buying cancer medicines that are thrown out because many drug makers distribute the drugs only in vials that hold too much for most patients, a group of cancer researchers has found. …  “Drug companies are quietly making billions forcing little old ladies to buy enough medicine to treat football players, and regulators have completely missed it,” said Dr. Peter B. Bach… co-author of the study.”

I read this article with great interest. While it’s true that “cancer drugs”, i.e. chemotherapy can be costly, the reasons are many and this article speaks about only a single issue that overly simplifies the problem and vilifies the manufacturers. It’s not that simple.

Before I discuss items not mentioned in the NYT article, let me give you a bit of background. As a practicing pharmacist for nearly twenty years, I’ve been involved with my fair share of sterile preparations, including chemotherapy. In the early years of my career pharmacies would frequently hold onto vials of medications that had only small amounts removed to make a patient dose. These vials with the remaining drug were affectionately called “partials”, and were often stored for later use in the refrigerator for periods of up to a week. Partials were then combined to make additional doses, thus minimizing waste. In addition, pharmacy as a whole would often utilize the “overfill” found in many medication vials to stretch inventory. As a specific example, I recall 50mcg/mL, 20mL vials of fentanyl routinely containing more than a full milliliter of overfill, i.e. more than 21mL of the solution. Sometimes, depending on the number of CSPs of a specific medication prepared, the overfill from several vials would be enough to generate another complete dose for a patient.

It’s important to understand that the two use cases described above were standard practices and were in no way meant to endanger patients or cheat anyone out of anything. At the time, they were considered strategies to minimize drug waste. Period.

Fast forward to today and neither partial vials nor overfill are routinely used. Why? Well, new regulatory requirements and standards of practice like USP <797> have made it increasingly difficult to hang onto partials secondary to beyond-use-dating, lack of stability and sterility data, and so on. In addition, insurance companies laid down the boom several years ago and mandated that pharmacies no longer use overfill because it was considered “fraudulent billing”. I’ve been in several pharmacies over the past several years where the complexity of regulatory compliance and insurance billing has made partials and overfill too risky and complex to deal with. Instead, any leftover drug is discarded, i.e. wasted. Wasting partials and overfill are now considered standard practice.

This is not to say that drug companies aren’t trying to maximize their profits. Of course they are. I’m not completely oblivious to the fact. However, as a pharmacist, I think about what healthcare would look like without the billions of dollars’ drug companies spend on research and development. It would be a sad, desperate place. Several medications brought to market during the past decade have saved countless lives.

What does it all mean? It means we have some work to do. It means that we need to find a way to extend the shelf life of partial vials, especially chemotherapy. It also means that we need to find common ground with payers that allow pharmacies to utilize the entire contents of vials. It’s not rocket science, but it’s certainly no walk in the park either.

Can you place items in the primary engineering control (PEC, aka “the hood”)? I get this question from time to time with regards to IV workflow management systems (IVWFMs). Most (all?) IVWFMs currently on the market utilize various hardware components – cameras, stands, scales, tablets, etc. – inside the hood.

Things may change in the future, but the bottom line is that there is nothing in the current USP General Chapter <797> that directly addresses the use of automation and technology inside the hood.

However, <797> does, in a general way, address the use of items inside the direct compounding area [DCA], which is where compounding equipment is typically found. Nothing found within the DCA can impact first air, and the equipment needs to be cleanable.

USP Chapter <797> states: “After proper introduction into the DCA of supply items required for and limited to the assigned operations, they are so arranged that a clear, uninterrupted path of HEPA-filtered air will bathe all critical sites at all times during the planned procedures. That is, no objects may be placed between the first air from HEPA filters and an exposed critical site.”

Further guidance may be found in Chapter <797> in a section titled Suggested Standard Operating Procedures (SOPs): “Supplies used in the DCA for the planned procedures are accumulated and then decontaminated by wiping or spraying the outer surface with sterile 70% IPA or removing the outer wrap at the edge of the DCA as the item is introduced into the aseptic work area…. All supply items are arranged in the DCA so as to reduce clutter and provide maximum efficiency and order for the flow of work… After proper introduction into the DCA of supply items required for and limited to the assigned operations, they are so arranged that a clear, uninterrupted path of HEPA-filtered air will bathe all critical sites at all times during the planned procedures.”

If the items being placed in the hoods meet both requirements, i.e. they do not obstruct HEPA-filtered air and can be properly cleaned, then there shouldn’t be an issue.

To ensure that the items are being used appropriately I recommend that users: 1) perform appropriate surface sampling to ensure sterility, and 2) perform a smoke study. Smoke studies are the only way to ensure that items in the hood are not impeding airflow. Take the time to do one for each hood where hardware is used.