I’m sure that most of you are aware, but just in case, I thought I would pass this little tidbit along.

The Compounding Expert Committee announced on November 20, 2015, that USP has approved a new General Chapter USP <800> – Hazardous Drugs—Handling in Healthcare Settings. The revised chapter will be published February 1, 2016, in the first supplement to USP 39-NF 34. USP standards typically become official 6 months after publication, but the Expert Committee approved a delayed official implementation date of July 1, 2018 to prevent any undue hardship on systems that need to make major changes.

You can get more information on General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings to be Published in USP 39–NF 34, First Supplement here.

Good luck, people.

I spent a short time observing iv preparation in two separate, distinctly different pharmacy environments in the weeks leading up to the new year.

One was a traditional iv room in a large acute care pharmacy with multiple pharmacy technicians and pharmacists putting out hundreds of compounded sterile preparations (CSPs) per day. The second was a segregated compounding area in a satellite pharmacy with one pharmacy technician and one pharmacist using a glove box to prepare STAT and first dose CSPs to critical care areas.

Neither area utilized technology for CSP preparation, instead opting for the good ole fashioned syringe pull-back method (1). In the case of the traditional iv room, I observed instances of up to twenty different CSPs with empty vials and syringes laid out awaiting pharmacist verification. In the segregated compounding area with glove box, CSPs were typically prepared one at a time or in small batches.

During my short time observing CSP preparation in the two areas I witnessed errors that would have easily been caught with the use of readily available technology.  Here are two examples:

Wrong drug selection – This may be the most common error seen in iv rooms. In this particular case, the technician used a vial of potassium phosphate (KPhos) for a CSP that called for sodium phosphate (NaPhos). The use of bar code scanning for verification during the compounding process would have prevented this error.

Calculation error resulting in an incorrect dilution – A patient-specific order called for 20 mg of hydrocortisone in a total volume of 2 mL to be placed in a syringe for iv administration. The technician started by first making a stock hydrocortisone syringe from which to draw the dose. This is a common practice. The resulting stock syringe should have contained 100 mg of hydrocortisone in 10 mL of solution, i.e. final concentration of 10 mg/mL. Instead, the technician calculated the final volume as 25 mL, resulting in a final concentration of 4 mg/mL in the stock syringe. So when the patient-specific dose of 2 mL was drawn into the syringe the final dose was only 8 mg. The pharmacist almost let it go, but something made him take a second look. It was only when he asked the technician to explain the process that the error was discovered. The use of bar code scanning for verification during the compounding process would not have prevented this error. But, the use of step-by-step instructions with intermediary step checks during the stock syringe prep, or the use of gravimetrics, would have.

The number of CSPs prepared in iv rooms daily in the United States is unknown, at least to me, but has to be somewhere in the neighborhood of a million. (2) Combine that with published literature that puts sterile compounding errors around 11%, (3) and that’s some scary stuff. With numbers like these, I wonder how many mistakes make their way to the patient?

The iv room is a busy place with a lot of dangerous medications. It’s also a place where a lot of errors occur.  With the availability of commercially available products that can easily prevent these types of errors, there’s really no excuse for continuing to use a completely manual process.

———————

(1) Syringe pull-back method is when the empty syringe used for each drug or electrolyte is left alongside the item with its plunger pulled back to the volume that was added. The pharmacist looks at the empty syringe with plunger pulled back and compares volume to the volume necessary to accurately prepare the CSP. This is common practice in many pharmacies even though it has been declared unsafe. I continue to be surprised that pharmacies use the syringe pull-back method.

(2) Using a number of 1.5 CSPs per patient, per day in acute care hospitals, and using 795,603 licensed Community Hospital beds in the United States (1999 – 2013 AHA Annual Survey, Copyright 2015 by Health Forum, LLC, an affiliate of the American Hospital Association), the number of CSPs produced per day in the United States exceeds 1 Million.

(3) Am J Hosp Pharm 1997;54:904-912

Several years ago there was a group of pharmacists taking a serious look at the long-time practice of having pharmacists review virtually all drug orders, sometimes referred to as nearly universal prospective order review (NUPOR). The argument for NUPOR is that it is needed to ensure complete, accurate orders. The argument against NUPOR is that it’s expensive, time-consuming, and unnecessary in many instances. I fall into the latter category of pharmacists, i.e. NUPOR is an antiquated practice that needs to be done away with.

There are those that argue that doing away with NUPOR is dangerous and removes the pharmacist from the medication use process. Nothing could be further from the truth. By making NUPOR a requirement you have taken pharmacists out of the healthcare discussion. NUPOR forces pharmacists to be tied to a terminal when they could be doing other things. 

The introduction of Electronic Health Records (EHRs) and Computerized Provider Order Entry (CPOE) have created a perfect opportunity to change the concept of NUPOR.

Here are some scenarios to think about:

1. Setting, a large acute care hospital with a busy Emergency Department (ED). Physicians frequently order boluses of NS, or other fluid. Does a 1L bolus of NS ordered for an adult patient in the ED really require verification by a pharmacist prior to administration? Ask yourself, as a pharmacist, what set of circumstances would cause you to reject such an order and call the physician?
2. Setting, hospital OB-GYN unit. Adult patient comes in for delivery. Physician orders 50 mg of IV meperidine x1 for pain. The patient is in good health, labs are normal, and has no allergies to the medication. Is there any reason that such an order needs verification? What would cause you to reject it and call the physician?
3. Setting, general medicine floor of a hospital. Elderly patient admitted following a minor surgical procedure. The patient is experiencing constipation secondary to the procedure and medication for pain. Physician orders a bisacodyl suppository or MOM x1 to help get things moving. Labs are ok, the patient has no allergies to the medication, and there are no significant drug interactions. Is there any reason that such an order would require a pharmacist’s blessing?

The list goes on and on. I suppose one could argue that there could be potential for a physician to blow through a catastrophic problem with the drug order that would harm the patient. Sure, that could happen. However, I would argue that a good system would allow the healthcare system to place hard stops in places where there is genuine concern or potential for a problem.

I just don’t see NUPOR as necessary in today’s healthcare environment, especially for those healthcare systems using EHRs and CPOE. Don’t agree? That’s cool. Use the comment section below to convince me I’m wrong, but make sure you have a good reason, because if you don’t, I’ll mock you in front of the other children. 

Recently a friend and colleague reached out to me looking for guidance on published studies showing positive ROI for IV room automation and technology. There’s precious little literature covering this practice are of pharmacy, much less getting into things like ROI.

Why is that? As I see it, the problem comes down to these three things:

1. Bias. Some of what is written, especially in the “throw-away journals” is sponsored content, and as a result, presents a lop-sided view to the reader. It’s still worth reading, but always with a grain of salt.
2. One-size fits all. Nope. There are too many approaches to compounded sterile product (CSP) production in pharmacies across the U.S. I’ve been in more than 20 acute care pharmacies over the past few years looking at operations, and it’s clear that we’re all doing exactly the same thing completely differently. The solution for a 200-bed community hospital may or may not be a good fit for a 600-bed level 1 trauma center, or a healthcare system with centralized IV admixture servicing several facilities. It all depends on your needs. One must look at several variables and the specific needs of the pharmacy, patient, and healthcare system. Doing anything less is a recipe for wasted time, energy, and resources.
3. Traditional literature doesn’t work. The typical literature cycle doesn’t work for pharmacy technology. Even though pharmacy automation and technology moves slowly, it still changes at a much more rapid pace than therapeutics and/or best practices. Changes in clinical approaches to the use of medication takes time, and once established typically last until something better comes along. We’re talking years here, sometimes decades. That doesn’t work for pharmacy automation and technology. Research on an IV room robot that was purchased in 2009, installed in 2010, and published about in 2015(1) is of little use to pharmacists looking for relevant information in 2016. It’s doubtful that the technology is still in a form today that could be easily compared to that presented in the article. It’s also entirely likely that the product no longer exists. An article like that offers little to those considering investing in pharmacy automation and technology, perhaps except for general interest or curiosity.

There is clearly a lack of literature on the subject, but there is also clearly no one size fits all approach. If you’re truly looking for the best way to implement automation and technology in your pharmacy, I recommend the following:

1. Go ahead and do a literature search, focusing on the “throw-aways”. I know, I just spent a page telling you this doesn’t work. You won’t find enough to make a decision, but it will, at least, give you an idea of what products are on the market.
2. Get some boots on the ground. There is no substitute for seeing the technology in action. Go visit people that are using the product. Don’t be cheap. If you’re going to drop a million dollars on a compounding robot, be willing to spend some money traveling around and looking at these things in real-world environments.
3. Take your time. This is one area where making a snap decision will cost you. Not only will you spend resources on something that might not be the best fit, you’re likely to be stuck with it for a while.
4. If you can’t do the above yourself, hire a consultant. Sounds a bit self-serving, but it’s true. Consultants will cost you upfront, but will save you several-fold the cost in the long run.

—————————————————

• Nurgat, Z., Faris, D., Mominah, M., Vibar, A., Al-Jazairi, A., Ewing, S., … Al-Jedai, A. (2015). A three-year study of a first-generation chemotherapy-compounding robot. American Journal of Health-System Pharmacy, 72(12), 1036–1045. http://doi.org/10.2146/ajhp140256

Jerry talks about his experience with Virtual Reality and where there may be some potential for use in pharmacy.

Show Notes:
Host: Jerry Fahnri, Pharm.D.

0:00 Introduction
0:28 My experience with VR
1:59 VR tiers and products
5:05 Application of VR – General
5:50 Application of VR – Healthcare
7:51 Application of VR – Pharmacy
13:01 Application of VR – Vendors

Items discussed in podcast:
Google Cardboard
Samsung Gear VR
Oculus Rift
HTC Vive
Microsoft HoloLens

Current setup:
Blue Microphones Yeti USB Microphone – Blackout Edition
Dragonpad Pop Filter
Sony MDR-V150 Headphones

Whether or not future editions of USP General Chapter <797> will include recommendations for IV room automation and technology is a great question, and one that I’ve been pondering for quite some time. I’m torn as to whether or not I think adding such recommendations to a USP General Chapter is a good idea.

On one hand, I believe that pharmacy is over-regulated as it is. The amount of time spent by pharmacy personnel adhering to and documenting compliance to regulations currently in place is staggering. New regulations are frequently added to the process, but rarely, if ever taken away.

On the other hand, pharmacies refuse to utilize game-changing automation and technology even when they know it has the potential to improve operations, improve patient safety, and decrease cost. I’ve met many pharmacy directors and operations managers over the years that operate in a state of willful blindness when it comes to adoption of technology in the pharmacy.

While I don’t support adding, even more, regulatory requirements to pharmacy practice, I’m in favor of increased use of pharmacy automation and technology, especially in the IV room. It’s a conundrum.

With that said, it may become a moot point as it is possible that recommendations addressing the use of iv room automation and technology will find their way into the next revision of USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. Recent discussions with people close to the situation lead me to believe it could happen.

Should that occur, it would likely be a good thing for pharmacy practice in the long run as it would drive adoption of CSP preparation technology. Even if the Expert Compounding Committee were to recommend adoption and not mandate it, i.e. “should” versus “shall”, the industry would surely take note. Recommendations that show up in <797> have a way of trickling down into other regulatory agencies as well as into the minds of inspectors and pharmacy directors. For example, the 2015 California Lawbook for Pharmacy(1) states that “The board shall review any formal revision to General Chapter 797 of the United States Pharmacopeia and The National Formulary (USP–NF), relating to the compounding of sterile preparations, not later than 90 days after the revision becomes official, to determine whether amendments are necessary”. Regardless of whether or not the board takes action, they are sure to take notice.

It’s too early to say whether or not the revisions to Chapter <797> will include recommendations for CSP preparation technology, but I suspect we won’t have to wait long to find out. Chapter <797> is currently up for public comment until January 31, 2016. Based on recent changes to USP General Chapter <800>, I suspect revisions to Chapter <797> will become official in a similar timeframe so that the chapters can be properly harmonized. Only time will tell.

Something worth thinking about.

———–

(1) Article 7.5, Section 4127(c)

I’ve written about the need for better integration and interoperability before. I’ve even written about the trend toward integrated systems. In January 2014, I wrote that “healthcare systems, and more specifically pharmacies, have started to understand the importance of having integrated systems.”

Here we are two years later, and to my surprise, we seem to be making great progress. There are obvious trends appearing in pharmacy.

• While walking through the Exhibit Hall at ASHP Midyear, it was clear that integration was on the minds of many – people, healthcare systems, vendors. The term “integration” was being thrown around like confetti at Mardi Gras.
• Companies like Baxter, Omnicell, and Aesynt are making a concerted effort to improve integration, each using a different approach. Baxter has a new EPIC interface, allowing DoseEdge to feed information directly into the EHR. Omnicell has made significant strides in creating a centralized database across their inventory management products for the central pharmacy. Aesynt is focusing on pulling data from several disparate sources for their data analytics tools, REINVENT and Formulary Tool Kit (FTK)
• Acquisitions continue to be on everyone’s mind. Aesynt recently became part of Omnicell, and CareFusion is part of BD. Others are possible by year’s end.
• Pharmacies want fewer disparate systems and are willing to sacrifice functionality for integration. I won’t go into specifics here, but several pharmacies that I’ve spoken with are opting for systems that are, in my opinion, missing key components, in favor of integration with their EHR or another system.

Looking over the landscape, it’s obvious that integration of systems will no longer be optional. The big boys are all in, and the little guys should take note as to not be left out in the cold.

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”.

Image of a typical “blister pack”

I wonder how that production stacks up to a pharmacy technician, in both numbers of cards per hour and error rate? Maybe it’s just me, but those numbers appear to be low compared to what a good technician could do.

The video below shows the BP198 technology from behind the scenes. The actual BP198 product appears to be contained in a cabinet about the size of a large high-speed packager, as you can see about 0:14 into the video.

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.

In this episode, Jerry talks about some of “new services” being introduced into pharmacy practice, and how these services used to be part of every community pharmacy practice.

Show Notes:
Host: Jerry Fahnri, Pharm.D.

Items discussed in podcast:
TechCrunch article: The Online Pharmacy Race Gets A New Entrant: RobinHealth
Zipdrug
PillPack
RobinHealth

Current setup:
Blue Microphones Yeti USB Microphone – Blackout Edition
Dragonpad Pop Filter
Sony MDR-V150 Headphones

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.

Clostridium difficile is a major problem in hospitals across the U.S. According to the CDC, it is estimated that C. difficile caused almost half a million infections in the U.S. in 2011, and approximately 83,000 of the patients who developed C. difficile experienced at least one recurrence and 29,000 died within 30 days of the initial diagnosis.  Staggering numbers.

C. difficile is a nasty spore-forming bacteria that produces toxins. The main clinical symptoms of C. difficile infection include watery diarrhea, fever, nausea, abdominal pain, and loss of appetite. More serious infections can result in pseudomembranous colitis, perforations of the colon, and in extreme cases sepsis.

For the reasons cited above, I found this Pharmacy OneSource article quite interesting. According to the OneSource article: “A concise communication recently published in the Infection Control & Hospital Epidemiology (ICHE) journal provides effectiveness data on a novel formulation of ethanol used for glove decontamination to prevent Clostridium difficile (spores) hand contamination during glove removal… Test solutions included the novel, sporicidal ethanol formulation (70% ethanol adjusted to pH 1.3 with hydrochloric acid), as well as, 1:10 and 1:100 dilutions of sodium hypochlorite (bleach), and 70% ethanol with no pH adjustment/additives… [the] sporicidal ethanol formulation was effective in rapidly reducing C. difficile spores by approximately two logs, with a further reduction when applied as a wipe.” This was equivalent to 1:100 dilution of bleach solution.

While there are no studies that I’m aware of linking C. difficile infection to pharmacy cleanroom practices, such a novel anti-C. difficile solution has potential wide sweeping application throughout acute care facilities as well as long-term care facilities.

The abstract for the article cited in the OneSource piece can be found here states: “Decontamination of gloves before removal could reduce the risk for contamination of hands of personnel caring for patients with Clostridium difficile infection. We demonstrated that a novel sporicidal formulation of ethanol rapidly reduced C. difficile spores on gloved hands without adverse odor, respiratory irritation, or staining of clothing.” – Infect. Control Hosp. Epidemiol. 37.03 (2015): 337-339.

Both ISMP and ASHP are working on draft recommendations for technology in the IV room. ISMP’s version is an update to their ‘Guidelines for Safe Preparation of Sterile Compounds’ that was originally published in 2013. The proposed revision is open for public comment until April 10th. ASHP is also working on new recommendations for the use of IV Workflow automation technology for the preparation of compounded sterile products (CSPs)

It feels a bit like running into a burning building to pull people out instead of taking action to prevent the building from catching fire in the first place, i.e. reactive instead of proactive. Many of us have known for years that there’s a problem in the IV room. It’s the dirty little secret of the industry. We’ve been saying that change is needed, but it has mostly fallen on deaf ears until now. What’s changed? I have an opinion, but that’s for another time.

We’ve known for decades that the IV room is not only one of the busiest areas in a pharmacy but also one of the most dangerous. IVs present higher risks than most other medications and the literature presents abundant evidence of the prevalence of pharmacy compounding errors, (1, 2, 3, 4, 5, 6, 7) which result in patient harm or death. (8,9, 10, 11) These errors not only impact patients but caregivers and healthcare facility as well. The human and financial toll are staggering.

While we may think we don’t make mistakes in the IV room, studies have shown that errors during CSP production are not uncommon. According to the frequently cited article by Flynn, Pearson, and Baker published in 1997: “A five-hospital observational study on the accuracy of preparing small and large volume injectables, chemotherapy solutions, and parenteral nutrition showed a mean error rate of 9%, meaning almost 1 in 10 products was prepared incorrectly prior to dispensing.” (7)

Many of the errors found with CSPs can be easily prevented through the use of common, currently available technologies. While adoption of technology has been slow, pharmacies are increasingly moving toward the use of these systems. Guidelines from ISMP and ASHP will certainly help speed things up.

Compliance with USP <797> Pharmaceutical Compounding—Sterile Preparations and ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products has certainly led to improved processes and safety in the IV room. Both address the need to accurate identify, measure, dilute, mix, package, and label CSPs. However neither of the guidelines is designed to drive adoption of CSP technologies to improve safety, accountability, and documentation.

The quality and safety of CSPs goes beyond sterility, potency, and stability and must include accurately identified and measured ingredients, diluents, final solutions, and containers as well as identifying, tracking, and documenting the CSP from cleanroom to patient.  Current practices do not support or encourage the use of available automation and technologies to support these activities.

Much has yet to be defined and there are currently no guidelines or governing entities to drive standardization for vendor development and design, nor is there anything to help healthcare systems make smart choices.* With that said, it appears that changes are just around the corner.

During this time, it is important to understand the following:

• Vendors must design – and users chose – systems that provide a clear advantage over manual systems in patient safety, workflow standardization, and documentation; are cost-effective; interoperable with existing systems; are simple to install, use, and maintain; and carry a high degree of certainty and reliability.
• Minimum requirements** should include interoperability with pharmacy information systems and electronic health records, control of final product label, bar code verification of all ingredients and final containers, imaging for verification and documentation, documentation of master formula records, lot numbers, expiration dating, and products used, and basic dose tracking functionality.
• While some of the products available today generate their own ISO class 5 compounding environment, these systems must function properly in cleanroom environments and comply with all USP <797> and <800> standards and recommendations.
• And finally, technologies for CSP production must be correctly selected and utilized to effectively create a safe environment for both the healthcare provider and the patients they serve. There is no one-size-fits-all approach to these systems and each healthcare system is different. Proper selection will depend on several factors.

It’s time for vendors and healthcare systems to wake up and get ready for what’s coming.

References

1. US Food and Drug Administration Website. Report: Limited FDA Survey of Compounded Drugs. Available online at: http://www.fda.gov/cder/pharmcomp/survey.htm. Accessed on January 3, 2004.
2. United States Department of Justice, Federal Bureau of Investigation Website, April 22, 2002. Available online at: http://kansascity.fbi.gov/kcmostate042202.htm. Accessed on July 6, 2002.
3. Trissel LA. “Compounding our problems–again.” Am J Health-Syst Pharm. 1 Mar. 2003: 432.
4. Selenic D, Dodson DR, Jensen B et al. “Enterobacter cloacae bloodstream infections in pediatric patients traced to a hospital pharmacy.” Am J Health-Syst Pharm. 2003; 60:1440–6.
5. Niedowski E, Bor J. State to probe Hopkins death: 2-year-old cancer patient died after receiving improper IV mixture. December 20, 2003. Baltimore Sun, Baltimore, MD.
6. Flynn, EA, Pearson, RE, Barker, KN. “Observational study of accuracy in compounding IV admixtures at five hospitals.” Am J Health-Syst Pharm. 1997 Apr 15; 54: 904–912
7. Solomon SL, Khabbaz RF, Parker RH, et al. “An outbreak of Candida parapsilosis bloodstream infections in patients receiving parenteral nutrition.” J Infect Dis 1984; 149:98–102.
8. Hughes CF, Grant AF, Leckie BD, et al. “Cardioplegia solution: A contamination crisis.” J Thorac Cardiovasc Surg 1986; 91:296–302.
9. Associated Press. Pittsburgh woman loses eye to tainted drug; 12 hurt. Baltimore Sun. November 9, 1990:3A.
10. Dugleaux G, Coutour XL, Hecquard C, et al. “Septicemia caused by contaminated parenteral nutrition pouches: The refrigerator as an unusual cause.” J Parenter Enteral Nutr 1991; 15:474–475.
11. Perrin J. “Unsafe activities of compounding pharmacists.” Am J Health-Syst Pharm 1995;52:2827–2828.

*Actually, I would argue that IN THE CLEAN ROOM: A review of technology-assisted sterile compounding systems in the US (Jerry Fahrni, Pharm.D. and Mark Neuenschwander) would be a great tool for helping pharmacies make smart choices, but most seem averse to the information.

**Minimum requirements. This is not to say that this should be the end game, but rather a place to start. Overreaching in the beginning of this process is sure to dampen development and adoption.

In this episode, Jerry talks Radio Frequency Identification (RFID) technology with Shariq Hussain, President and CEO and Jay Williams, VP of Business Development at MEPS Real-Time, Inc. MEPS Real-Time, Inc. is a market leader in RFID technologies in pharmacy.

Jerry, Shariq, and Jay discuss RFID technologies, patient safety, and the companies two main products: Intelliguard Kit and Tray Management System for managing and tracking medication trays, code trays, intubation kits, etc., and the Intelliguard Vendor Management Inventory System, which consists of RFID technologies coupled with temperature controlled storage cabinets like refrigerators.

Show Notes:
Host: Jerry Fahnri, Pharm.D.

Items discussed in podcast:
Intelliguard Kit and Tray Management System
Intelliguard Inventory Management System

MEPS Real-Time, Inc. contact information:
MEPS Real-Time, Inc.
6451 El Camino Real, Suite C
Carlsbad, CA 92009
Phone: 760.448.9500
Email: sales@mepsrealtime.com

Current setup:
Blue Microphones Yeti USB Microphone – Blackout Edition
Dragonpad Pop Filter
Sony MDR-V150 Headphones

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.

———————–

* 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.

CPhA recently sent out an alert notifying members of upcoming California State Board of Pharmacy adoption of USP <800> guidelines. You can read about it here.

California isn’t planning to adopt the entirety of USP <800>, but what they have decided to adopt will become enforceable on January 1, 2017. “The proposed California BOP regulations adopt certain requirements for engineering controls consistent with USP <800>, but the regulations do not adopt USP<800> in its entirety.  Specifically, the new regulations only apply to antineoplastic agents identified by NIOSH as hazardous.“ That’s interesting. I wish they’d just adopt the whole thing and get it over with. This is going to create a lot of confusion, especially with the proposed date of January 1, 2017. As it stands now, USP <800> isn’t supposed to be enforceable until July of 2018. Guess California has other plans.

However, it’s not all bad. Pharmacies can apply for an exemption if the meet the necessary requirements. From the alert: “… [this is] particularly concerning for compounding pharmacies because the proposed regulations have an effective date of January 1, 2017.  As explained in further detail below, pharmacies compounding hazardous drugs will not be required to comply with the USP <800> provisions on January 1, 2017 … The BOP regulations have a proposed effective date of January 1, 2017, but the BOP included a process for pharmacies to apply for a waiver from the above requirements when compliance requires physical construction or alteration and the pharmacy needs additional time beyond the implementation date to complete the upgrades.  The BOP will require that good cause be demonstrated and it is recommended that pharmacies compounding hazardous drugs develop a plan and begin implementing steps necessary to come into compliance with the above BOP requirements“. There’s always a loophole in there somewhere. So if you have to do construction or any major renovations to comply with USP <800>, you have a bit of a reprieve. Just make sure you apply for the waver.

People are going to be scrambling.

Show Notes:
Host: Jerry Fahnri, Pharm.D.

A short discussion of an article in the February 1, 2016, issue of AJHP on the implementation of BD Cato at MD Anderson hospital.

Items discussed in podcast:

• [Article discussed]: Reece, K. M. et al. “Implementation And Evaluation Of A Gravimetric I.V. Workflow Software System In An Oncology Ambulatory Care Pharmacy”. American Journal of Health-System Pharmacy 73.3 (2016): 165-173. Web. 6 Apr. 2016.
• MD Anderson
• BD Cato
• In the Clean Room: A Review of Technology-Assisted Sterile Compounding Systems in the US

Current setup:
Blue Microphones Yeti USB Microphone – Blackout Edition
Dragonpad Pop Filter
Sony MDR-V150 Headphones

A friend and colleague of mine and I were talking about pharmacy order verification and errors the other day.

Many (all?) acute care pharmacies use the number of orders entered/verified by pharmacists per unit of time as a performance metric. The theory being that the more orders you verify the busier you are and therefore the more work you do. Sounds logical. And it is. And it also isn’t. It is because more orders typically equates to a heavier patient load and/or sicker patients, which in turn results in more work. It isn’t because some orders – and the associated distribution of medications associated with those orders – are significantly more complex than others. Chemotherapy is a good example of this. The amount of work required to verify and dispense your average chemotherapy order is several orders of magnitude greater than an order for, oh I don’t know, a saline-lock.

So in theory, a pharmacist verifying more chemotherapy will certainly have lower numbers than a pharmacist verifying routine medication orders. However, when evaluating the number of orders verified over an entire year, one would expect the number of complicated orders handled per pharmacist to average out over the long haul. That’s not complicated math, just common sense.

Assuming that every pharmacist is on equal footing, and that the number of orders verified is a reasonable performance metric, what then is a reasonable number of orders to be verified per hour, per shift, or per year to be considered good, bad, or average? It’s impossible to say. One would think that the higher the number the better the productivity. Here’s the thing, during periods of high volume order verification, pharmacists make more mistakes. Not just mathematically more, i.e. 1% of 300 is more than 1% of 200, but a higher percentage of mistakes.

From a blog post at the American Pharmacist Association (APhA) website: “the number of medication errors increased with the number of orders verified per pharmacist per shift” … According to the findings, the verification of more than 400 orders per shift per pharmacist was associated with the highest risk of errors…“Once we got to the 400 mark, meaning 400 orders verified per pharmacist, [we] started to reach a higher number of errors,” said Christy Gorbach, PharmD, coauthor of the study“. The study referred to in the APhA post is this one.

So it would appear on the surface that using volume of orders verified as a performance metric is actually driving pharmacists to make more mistakes, thus leading to less productivity, not more. (1)

With the increased adoption of EHRs, the number of orders verified per pharmacist is only going to grow. EHRs have made order entry quick and easy. Physicians create lists – favorites, order sets, etc. – that allow them to simply check a box and put patients on multiple medications in a matter of seconds. This is especially true for what I refer to as “don’t-call-me” orders. Don’t-call-me orders consist of multiple PRN medications to cover everything from fever to constipation; all designed to prevent the physician from receiving a phone call at 3 o’clock in the morning, i.e. don’t call me. Most of these orders go unused and simply complicate the medication profile and medication administration record.(2) Verifying such a large number of redundant, benign orders creates alert fatigue and selective blindness which ultimately leads to something important getting missed.

All in all, the results are increased verification numbers, more work, and as it turns out, more errors. Unfortunately, I have no answer to the problem. And make no mistake, it is a problem. Orders have to get verified and released, and patients must receive their medications in a timely manner. With that said, safety must also be a top priority. Medication errors are unacceptable.

Overall, it appears that using volume of orders verified by a pharmacist as a performance metric is a bad idea. I think it’s time to slow down, pay attention, and create an environment that rewards pharmacists for the quality of their work, not for the speed at which they perform it.

———————————————————–

1. Medication errors can lead to all kinds of problems, among them wasted time.
2. All the pharmacists reading this are shaking their head and grinning because they know exactly what I’m talking about. What pharmacist hasn’t seen a post-op C-section order with 15 to 20 PRN medication orders, including half a dozen different pain meds that never get used? It happens all the time.

Show Notes:
Host: Jerry Fahnri, Pharm.D.

Jerry and Ray talk about the pharmacy IV room, specifically where we’ve been, where we’re at, and where we’re headed. Topics include workflow, the impact of USP <797> on pharmacy iv room operations, and thoughts on currently available iv workflow management system technologies.

You can learn more about Ray at his LinkedIn Profile here.

Items discussed in podcast:
Current setup:
Blue Microphones Yeti USB Microphone – Blackout Edition
Dragonpad Pop Filter
Sony MDR-V150 Headphones

There’s an interesting article in Pharmacy Practice News this month (In the IV Room, Robots Come to the Rescue). While the title of the article is a bit misleading – I think ‘rescue’ is a bit strong – it does contain quite a bit of good information.

The article discusses some of the technology being used at Brigham and Women’s Hospital (BWH) in Boston, and the University of California, San Francisco (UCSF) Mission Bay pharmacy. I’ve been in both pharmacies. BWH and UCSF both make extensive use of technology, but believe me when I say that they have very different approaches. Anyway, the article is worth a few minutes of your time.

Deep in the article, the author, Rajiv Leventhal spends a few paragraphs discussing the scope of the problem in the IV room, and some of the challenges of using robotics. Rajiv acknowledges that the iv room is a dangerous place for a host of reasons.

Regardless of the technology chosen, the need to automate IV compounding to at least some degree is hard to dispute, given the relatively high rate of errors that occur when technology is limited. In 1997, when many of the recent advances in robotics were not available, the error rate for IV compounding was 9%—or one mistake in every 11 medications coming out of the IV room.

As for the main cases [sic] of those errors, many factors have been identified, including sterility and other drug safety issues, according to a safety alert released last year by the Institute for Safe Medication Practices. The alert identified five core causes: 1) depreciating importance of the compounding and dispensing processes in pharmacy practice; 2) lack of knowledge and standardization around best practices; 3) training based on traditions handed down from one pharmacist to the next; 4) learned workplace tolerance of risk and routine practice deviations that persist; and 5) a reluctance to learn from the mistakes of others.

It seems intuitively obvious that the use of technologies like iv workflow management software, barcode scanning, gravimetrics, imaging, and even robotics can potentially decrease errors described in the article referenced above (Am J Health Syst Pharm1997;54[8]:904-912 ). However, of the causes identified in the second paragraph, only #2 can really be addressed with the use of technology alone. The rest of the items listed are symptoms of a deep-seeded problem growing in pharmacies today, and that is the failure to understand the need for our profession to provide patients with medications in the most efficient, safe, and economical way possible. Sounds ridiculous, I know, but it’s true nonetheless.

Most (all?) pharmacies I visit these days tout initiatives to improve patient care through increased ‘clinical activities’ of pharmacists, including electronic chart review, ADE follow-up, rounding with the medical team, monitoring and adjusting medications, antibiotic stewardship, and so on. However, I rarely, if ever hear directors talk about efforts to improve operations through streamlined processes, automation and technology, standardization, and heaven forbid, increased use of technicians and non-pharmacist personnel.

Examples of this can be found within open job listings at various healthcare systems. Recently I visited an acute care pharmacy with a large budget for several open ‘clinical pharmacist’s positions’ but no budget for improving operations or automating processes. In this particular case, a fraction of the money being allocated for open clinical pharmacist positions could be used to make significant improvements to the medication distribution process.

It’s an interesting dilemma for pharmacy directors. While spending tens of thousands of dollars on automation and technology to improve operations may not seem sexy, it goes without saying that a vast majority of care for a hospitalized patient involves getting the right drug at the right time. A majority of that falls to nursing staff, but the pharmacy owns a piece of the medication distribution/administration process. Nurses can’t administer medications if they’re not readily available, or wrong.

Regardless of what direction the profession wants to go, it is important that we understand that pharmacy is, at this time, tied to distribution. We must find ways to extricate ourselves from the medication distribution process first before we can begin to truly realize the benefits of pharmacists in patient care. Each time an error occurs for lack of focus, training, or sheer disinterest, the profession suffers. Preventable medication errors involving the pharmacy causes both the public and other healthcare practitioners to lose trust in our ability to get the job done. It’s difficult to recover from lack of trust. Think about it.