CPhA releases statement on USP <800> and pending California regulation

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.

JerryFahrni.com Podcast | Episode 10: Hazardous Drug Compounding

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

Short updates for the week ending March 26, 2016. I briefly touch on USP <800>, DrugCam semi-automated iv workflow management system, and the Grifols KIRO Robot

Items discussed in podcast:

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

Adoption of iv room technology

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.

JerryFahrni.com Podcast | Episode 9: RFID discussion with MEPS Real-Time

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

Recommendations for technology-assisted CSP preparation

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.

Novel formulation of ethanol for glove decontamination to prevent Clostridium difficile contamination

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.

Cost of cancer drug waste isn’t as simple as it seems

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.