USP Announces Intent to Postpone Official Date of USP Chapter <800>

In a notice posted last Friday, USP announced its intention to postpone the official date of USP Chapter <800> — Hazardous Drugs — Handling in Healthcare Settings.

According to the notice: “The intent of this postponement is to align the official date of General Chapter <800> with the official date of the next revision of General Chapter <797> Pharmaceutical Compounding — Sterile Preparations, to provide a unified approach to quality compounding. The next revision to General Chapter <797> is anticipated to be published in the Pharmacopeial Forum 44(5) September-October 2018 for a second round of public comment and is expected to become official on December 1, 2019. Sections of the revised <797> may have longer implementation dates that will allow time for adoption of the standard. ”

The original date for USP <800> to take effect was July 1, 2018.

This is good news for many as the July 1, 2018 date has created chaos in pharmacies across the country as they attempt to update their cleanrooms to become compliant. With that said, it’s a bit irresponsible for USP to wait this long to announce the postponement. Many acute care pharmacies are in the middle of lengthy and expensive cleanroom renovations.

Not to mention that many state boards of pharmacy have hung their hats on USP <800>. For example, California has already made significant changes to their regulations around hazardous drug compounding. As I’ve written previously, California made significant — and reckless — changes. Unfortunately, this postponement of USP <800> will make matters worse. It’ll be interesting to see how the California Board of Pharmacy handles the postponement.

IV workflow management systems and workarounds

A large portion of the most recent issue of the ISMP Medication Safety Alert is dedicated to IV workflow management systems (IVWFM) and errors caused by workarounds. There are a few head-scratchers in the list to be sure. There are even some that had me speculating their authenticity, i.e. too wacky to believe.

Data submitted to the ISMP National Medication Errors Reporting Program (ISMP MERP) have repeatedly shown that manual verification of intravenous (IV) admixture ingredients by pharmacy personnel who prepare solutions and pharmacists who inspect the final products is not particularly effective in detecting and correcting errors.” You can take this to the bank! Rule #1: people are people. They make mistakes and do crazy things sometimes. Rule #2: no amount of technology will eliminate rule #1.

However, as with any new technology that introduces an element of change, we want you to know about the workarounds and errors we have learned about with WFMS and why they may be happening so you can be as prepared as possible to address the when you assess or implement this technology. Some of these workarounds or errors are common to many other forms of healthcare technology.”

This is no doubt true as I’ve witnessed workarounds with pharmacy technology on many occasions.The sad truth of the matter is that no amount of technology will prevent people from finding workarounds. Just like no amount of manual processes and double checking will prevent workarounds. Unfortunately, these workarounds can lead to mistakes, which is what we are ultimately trying to prevent.

Typically, it is a combination of well-defined processes with appropriate technology that creates the safest environment. It’s also the best way to prevent workarounds. That and opening a can of whoop ass on people that don’t follow the rules; figuratively speaking, of course.

Here are some of the potential workarounds and errors identified by ISMP, many of which are similar to those seen with bar-code medication administration (BCMA):

Inability to scan the barcode — This is a common problem with any bar-code scanning process, i.e. BCMA, etc. Barcodes are far from perfect and will never be 100% scannable.

Reluctance to scan the barcode — Human nature. Go figure.

Scanning just one vial — i.e. scanning a “representative vial” when using more than one vial during CSP prep. Happens all the time.

Using a decoy for scanning or image capture — the old barcode-in-the-pocket scam.

Using the syringe pull-back method — hard to imagine that this is still going on in pharmacies across the country. It should be banned. Any facility caught using the syringe pull-back method should be fined heavily and mocked openly for their laziness.

Blurry or missing digital images — I’ve experienced this personally. Here are some images from one popular IVWFM system that were given to me. Can you tell, without any doubt, what the volumes are in these syringes? [If anyone has any sample images, I would love to see them]

Lapses in technique. “Use of WFMS touch screens can lead to touch contamination, especially when handling hazardous drugs. This and other lapses in hazardous drug handling and aseptic technique are not easily captured by the WFMS and may go unnoticed.” — No doubt a problem. Regardless of what technology you add to your process, proper technique in the hood is a must.

Interference with the scale. “ISMP has received a report about a WFMS with gravimetric technology for which the scale would not work in a laminar airflow workbench/biological safety cabinet due to vibration. Every time the pharmacy technician needed to weigh a product, he or she had to turn off the hood [what the heck!].” — not all gravimetric solutions are equal. There are at least two IVWFM systems on the market that do a great job with their gravimetrics. There is at least one that doesn’t. Any facility considering this technology should make sure to do their homework.

Has adoption of IV Workflow Management Systems in hospital pharmacies slowed?

Pharmacy Purchasing & Products (PP&P) puts out a survey each year called The State of Pharmacy Automation (SOPA). The 2017 PP&P SOPA is out and available for your reading pleasure.

The PP&P SOPA survey covers many automation, technology, and practice trends. One item that I look at each year with great interest is the reported IV workflow management system (IVWFMS) adoption rate. I’ve written about IVWFMS many times. I even went as far as to do a podcast dedicated to them back in 2015.*

While reviewing the 2017 SOPA numbers, I was surprised to see that this year’s survey shows no gain in adoption of IVWMS over last year. They appear to be stalled at approximately 19%, same as last year (see graph from PP&P 2017 SOPA below).

While informative, it’s important to take these survey results with a grain of salt. Response rates are incredibly low, for one thing. Results can also be skewed based on participants, i.e. it may not be the same pharmacies responding year over year. This makes it difficult to draw direct comparisons from one year to the next. 

Regardless, I was still surprised to see the flattened curve. I expected to see a sharp uptake. Most facilities I go into these days are using, or in the process of implementing, an IVWFMS of some kind. It’s becoming less common to find a facility not using one of these systems, especially in larger facilities where they seem to be slowly becoming best practice.  

One other item worth mentioning is my belief that last year’s survey overestimated the number of facilities using IVWFMS. So if last year was really 12-15%, perhaps this year’s result is an improvement. That’s purely speculation on my part. I have nothing concrete to back it up other than my sense of the market. Through no fault of PP&P, I feel like these surveys are a poor representation of what’s really going on in the real world.

Other takeaways from this year’s survey:

  • Larger hospitals are adopting IVWFMS faster than smaller hospitals. No surprise here. If you’re a hospital with more than 400 beds and you haven’t implemented one of these systems, you’re wrong and should be embarrassed by your lack of action. “Ninety-nine percent of the failures come from people who have the habit of making excuses.” ~ George Washington Carver. Simple as that.
  • DoseEdge by Baxter is the #1 system in use. Again, no surprise. This corresponds to what I see in the wild. Baxter has been in the game for a while. DoseEdge is definitely the first system that comes to mind when talking about IV room technology. Pharmacy Keeper by MedKeeper at #2 is a bit of a surprise. I have yet to go into a pharmacy that is using it. It’s a less functional system than say DoseEdge or BD Cato, but it’s also less expensive and easier to install, implement, and maintain. I personally believe pharmacies should be looking at systems with proven gravimetrics, but that’s just me. Pick your own poison.
  • DoseEdge by Baxter is the #1 system under consideration for new implementations. BD Cato comes in at #2 by a small margin. DoseEdge at #1 surprises me a bit. Most facilities I go into these days have BD Cato at the top of their list of possibles, and for good reason. BD Cato has a lot to offer, especially now that they are part of CareFusion. Perhaps the survey is a bit behind what I’m seeing out in the wild. Impossible to say.

That’s it. I’m not sure that the raw numbers presented in the survey are helpful, but the information in the SOPA survey goes way beyond the numbers. For instance, the SOPA may introduce pharmacies to vendors and technologies that they’ve never heard of before. I encourage everyone to read through the PP&P 2017 SOPA. Who knows, you might find something new and exciting in there. I’ve been doing this for many years, but I still get surprised from time to time. 

I can’t explain the SOPA survey results, but overall it feels to me that adoption of IVWFMS is still on the rise.

—–

*Looking back through some of my old posts — and the podcast — it’s amazing how little this landscape has changed.

[Article] Evaluation of real-time data obtained from gravimetric preparation…

I am currently reading an article on the use of gravimetrics in the preparation of hazardous CSPs published in the Journal of Clinical Pharmacy and Therapeutics.*

The article addresses data collected from a large-scale, retrospective analysis of medication errors identified during the preparation of antineoplastic drugs, aka chemotherapy. The paper looks at 759 060 doses prepared in 10 pharmacy services in five European countries (Austria, Czech Republic, Denmark, Germany, and Switzerland) between July 2011 and October 2015. While the sheer number of CSPs made over that period of time isn’t impressive, the fact that they’re all chemotherapy is. I believe this is the first article of its kind. I can’t think of another article that looks at the use of an IV workflow management system across such a large number of facilities, much less the use of gravimetrics during the compounding of sterile hazardous drugs.

The authors of the paper do a good job of: (1) addressing the use of gravimetrics versus image-assisted volumetrics, (2) covering the weaknesses of using syringes to measure small volumes (take a look at FIGURE 2 Tolerances of 1- and 5-mL syringes), and presenting a solid case for why gravimetrics is important for preparing hazardous CSPs. It also has some good images and tables, which I plan to refer to in future presentation.

In a nutshell “[e]rrors were… identified during weighing stages of preparation of chemotherapy solutions which would not otherwise have been detected by conventional visual inspection“. I find that this is the key benefit of using a system with gravimetrics, i.e. the accuracy of the dose doesn’t rely on human inspection. Overall, the gravimetric system caught errors in 7.89% of the 759 060 antineoplastic doses prepared. This percentage is consistent with other studies looking at CSP error rates.

A total of 13 831 errors for doses that deviated by more than 10% were caught by the system. That may not sound like a lot, but it can be, depending on the situation. Worse yet, 4 467 errors were off by 20% or more. Regardless of the situation, a 20% deviation in a dose is unacceptable. The significance, of course, is that a deviation this large could result in unintended toxicity or under treatment, depending on the direction of the error, i.e. 80% – 120% of the prescribed dose.

The article concludes that the “Introduction of a gravimetric preparation system for antineoplastic agents detected and prevented dosing errors which would not have been recognized with traditional methods and could have resulted in toxicity or suboptimal therapeutic outcomes for patients undergoing anticancer treatment.” I agree in principle with the sentiment, but believe that the authors overstate the significance of the gravimetric system while understating the importance of secondary checks. By stating that the system “prevented dosing errors which would not have been recognized with traditional methods” they are assuming that all errors would have made it past a pharmacist or other secondary verification method. It’s possible — maybe even likely — that some of the errors would have made their way past a secondary check, but not all. In many cases, chemotherapy preparations go through several step-checks during the compounding process. Typically, one of those step-checks is verifying the dose — volume in the syringe — prior to injecting it into the final container. Errors are often discovered at this point in the process. With that said, the author’s overzealous conclusion shouldn’t take away from the importance of gravimetrics in preparing CSPs.

Do yourself a favor and go get a copy of the article. It’s worth a few minutes of your time.

The online article is here.

A PDF copy can be downloaded here.

——

Notes:

The system used in all the pharmacies was BD Cato.

BD funded the project. While this can raise some red flags, I don’t think it’s enough to disqualify the data. Other companies, like Baxter, sponsor half of the sessions on compounding safety at ASHP Midyear. I for one am happy they do it. Support from companies like BD and Baxter go a long way in bringing important topics like compounding safety to the masses. So, focus on the use of gravimetrics, not on the company that sponsored the paper.

*Terkola R, Czejka M, Bérubé J. Evaluation of real-time data obtained from gravimetric preparation of antineoplastic agents shows medication errors with possible critical therapeutic impact: Results of a large-scale, multicentre, multinational, retrospective study. J Clin Pharm Ther. 2017;00:1–8. https://doi/org/10.1111/jcpt.12529

Time to revisit gravimetrics in the IV room 

Summary: if you’re preparing compounded sterile preparations (CSPs) in a pharmacy IV room, you should be using gravimetric analysis to determine the appropriate dose/volume.

Pharmacy practice is easy. Our job is to provide the right drug, at the right dose, to the right patient in the safest, most efficient, cost-effective manner possible. Simple.

Currently, the only method for ensuring that the correct drug is used during sterile compounding is barcode scanning. The future may hold other methods — I’ve read promising things about real-time solution concentration and drug identification using Raman spectroscopy — but for now, barcode scanning is it.

There are three basic methods for ensuring the correct dose/volume: traditional volumetrics using the pull-back method or using a pharmacist step-check process; photo-assisted volumetrics where the pharmacist views a photo of the drug drawn up in the syringe (1); and gravimetrics.(2)

Figure 1 from Terkola et al. J Clin Pharm Ther. 2017

The Volumetric method is limited by human error. In a situation where the pharmacy utilizes the pull-back method, there’s nothing to prevent a wrong dose from accidentally being injected into a bag only to have the technician pull the empty syringe back to the correct volume. The pull-back method of IV preparation is universally panned by organizations like ASHP and ISMP. Any pharmacy still using the pull-back method to prepare CSPs should be considered criminally reckless as they are endangering the lives of their patients every time they make an IV. It is unconscionable to be using the pull-back method for IV preparation in this day and age.(3)

Using either a step-check process or photo-assisted volumetrics is significantly better than the pull-back method, but not without their pitfalls. I’ve seen errors resulting from both methods where the technician pulled the wrong dose and the pharmacist verified it. It is unclear how this happens. It may result from checking bias, simple “slips”, or even laziness on the part of the pharmacist. It’s difficult to know for certain.

Gravimetric analysis utilizes the specific gravity of a solution to quantitatively determine the analyte, i.e. the drug found in the solution. In the case of an i.v. preparation, the method can be used to determine the accuracy of a dose drawn into a syringe, removed from a vial, injected into an i.v. bag, and so on. The assumption is that if you know the weight of an object – syringe, i.v. bag, a vial of medication, etc – before and after adding or removing a substance, then you know exactly how much drug was added or removed.

Gravimetrics acts as a forcing function, i.e. you can’t continue the compounding process until you have the correct weight. It’s also incredibly accurate. The only thing I’m uncertain about at this moment is how low the weight can be and still be accurate. This is important as small volumes in small syringes can be problematic.

Overall, syringes as a measuring device are accurate, but variable.(4) Tolerances for sterile graduated plastic single-use hypodermic syringes are defined by the International Organization for Standardization (ISO), specifically ISO 7886-1. ISO standards vary by syringe size and volume of fluid drawn and expelled. The commonly accepted definition for an accurate disposable syringe below 5 mL nominal capacity is +/-­ 5% when measuring volumes at or above 50% nominal volume. Accuracy increases slightly to +/- 4% when measuring volumes at or above 50% nominal volume for syringes greater than 5mL nominal capacity.

Figure 2 from Terkola et al. J Clin Pharm Ther. 2017

There are several semi-automated IV workflow management systems available today. They range from low-end, lightweight systems to high-end, feature robust systems. Pick your poison, as they say. However, I encourage anyone looking for one of these systems to give serious consideration to those that offers a fully integrated scale, i.e. gravimetrics. Doing otherwise could potentially be tragic.

Left to right: i.v.SOFT from Omnicell, BD Cato from BD, DoseEdge from Baxter. Image Source: Jerry Fahrni, Pharm.D.

—————————————

  1. The photo can be viewed before or after the drug is shot into the final container, depending on the workflow. Obviously, viewing a photo of a syringe containing drug after the CSP has been made has its limitations.
  2. The image does a good job of showing the difference between volumetric and gravimetric preparation. Source: Terkola R, Czejka M, Bérubé J. Evaluation of real-time data obtained from gravimetric preparation of antineoplastic agents shows medication errors with possible critical therapeutic impact: Results of a large-scale, multicentre, multinational, retrospective study. Journal of Clinical Pharmacy and Therapeutics. 2017. doi:10.1111/jcpt.12529.
  3. I’m of the opinion that state boards of pharmacy should begin fining pharmacies that still use the pull-back method for IV prep. Administrators should be held professionally and personally responsible for allowing the method to continue. It simply shouldn’t be allowed. It’s dangerous, reckless, and lazy.
  4. Poppe L, Savage S, Eckel S. Assessment of final product dosing accuracy when using volumetric technique in the preparation of chemotherapy. Journal of Oncology Pharmacy Practice. 2016;22(1):3-9. doi:10.1177/1078155214549489.

Compounding Today: state board of pharmacy concerns with USP <800>

Each Friday the CompoundingToday Newsletter faithfully appears in my inbox. The newsletter features commentary by Lloyd V. Allen, Jr., Ph.D., RPh, Editor-in-Chief of the International Journal of Pharmaceutical Compounding. Dr. Allen is a legend in the pharmacy compounding world for both sterile and non-sterile products. He was someone that I looked up to during my early years as a pharmacist; still do, as a matter of fact.

Long before USP <795> and <797> existed, he was preaching the gospel of proper compounding technique and the need for specialized training. Truly a visionary man ahead of his time. I hope to meet him in person someday.

So it should come as no surprise that I take seriously every thought and opinion he has. In last week’s Compounding Newsletter, Allen tackled an interesting topic with some thoughtful commentary.

From the newsletter:

Numerous state boards of pharmacy have concerns about United States Pharmacopeia (USP) Chapter <800> Hazardous Drugs-Handling in Healthcare Settings.

– The official chapter goes beyond the walls of the pharmacy and into healthcare settings, including physician offices, clinics, hospitals, treatment centers, etc. where state boards of pharmacy don’t generally have authority for enforcement.

– The requirements of <800> are very strict and extremely costly; many smaller pharmacies will no longer be able to serve their patients who depend upon compounded medications so they will simply cease compounding patient-specific medications, including some hospitals.

– There are some aspects of <800> that should be the burden of manufacturers and distributors, not pharmacies. As an example, no package should be delivered to a pharmacy contaminated with hazardous drug (HD) contents on the package surfaces that exposes pharmacy personnel upon opening. This is the responsibility of the manufacturer and distributor…

– Many of the requirements of <800> are based upon “opinion” and not necessarily upon science as demonstrated by documented, prospective studies.

It’s interesting to note that USP <800> extends into all areas where HD’s may be used, including physician offices. Where will that oversight come from? Will pharmacies be held accountable?

Dr. Allen has always been an advocate for “the little guy” and been cognizant of the balance between practical regulation and overbearing regulation. This is clear in his assessment of many areas within USP <800>. While I don’t necessarily agree with everything he says, I believe that his commitment to pharmacy practice and patient care deserve our attention. As he states, it is possible that the new regulation will simply be too much for some, resulting in the closure of compounding facilities. The greater concern, at least for me, is what impact the new requirements will have on hospital pharmacies where budgets drive change. A shift in budgetary requirements will likely mean that important projects will be postponed or canceled in favor of meeting USP <800>. The untoward consequences could be felt for years to come.(2)

Dr. Allen’s zinger about the lack of science is understandable and shared by many, but I don’t believe that prospective studies are always necessary to begin a process. For example, would you really want a 10-year pilot study showing that healthcare workers in the U.S. exposed to HDs are 10 times more likely to die of cancer than those that don’t before implementing these guidelines?(1) No, of course not. As I’ve said many times before, some fields – clean room procedure and pharmacy technology, for example – cannot be studied and scrutinized in the same manner as therapeutics. We simply can’t wait 5-10 years to change operational practices. With that said, USP <800> probably goes too far too fast in certain aspects of the regulation. Only time will tell whether the new guidelines will have the same impact as USP <797> did back when they were introduced.

Dr. Allen goes on to state: “As state boards of pharmacy have options other than accepting USP <800> in its entirety… The purpose of this document is to simply provide a resource from which state boards of pharmacy can “pick and choose” items to include for their respective state.” While this may be true, it is one area where I disagree with Allen. Giving each state the ability to “pick and choose” how to implement and use USP <800> makes things incredibly difficult. California, for example, has made a complete mess out of their new regulations. Other states will do the same, creating chaos. In Allen’s scenario, moving ten feet across a state boundary could mean following a completely different set of rules. How does that make sense? I recommend developing USP <800> to a point that everyone can live with and use it. Period.

I encourage you to read through the most recent issue of the CompoundingToday Newsletter. I also recommend that you “click subscribe” as well. The information is good and thought-provoking.

———

  • This is a fictitious example.
  • As my friend and colleague, Ray Vrabel likes to say, the clean room is “clean, but deadly”, referring to the fact that we spend all our money on regulation and virtually nothing on technology to improve safety.

Thoughts on my time with DoseEdge Pharmacy Workflow Manager 

Yesterday, I had a great opportunity to spend the day using DoseEdge in its native environment. That is to say, I staffed at a facility that was using DoseEdge in its cleanroom to prepare CSPs, including patient-specific products as well as stock bags, TPNs, etc. I’ve used DoseEdge for brief periods in the past. I’ve also spent time with the engineers that have worked on the product, product managers, sales people, marketing folks, and various other Baxter employees at conferences like ASHP midyear. But, this is only the second time that I have worked an entire  “staff pharmacist” shift using the product. And as one might imagine, using a system in its native environment can often provide a new perspective.

DoseEdge System at Boston Children’s Hospital

I’ve written about DoseEdge, and systems like it, extensively on this site over the years.  A quick search of jerryfahrni.com revealed several articles mentioning DoseEdge, dating back to 2010. I’ve also written about DoseEdge and similar products extensively elsewhere.

With over 300 installs in the U.S., DoseEdge is one of the most popular IV workflow management systems on the market and is still the most widely implemented product of its kind in the U.S. It’s a very good system, certainly in my top five. There are several things that I really like about the system, such as how it controls labels, its ability to track partial vials, and the fact that it talks. Seriously, it speaks to the user. Pretty cool.

However, there’s always room for improvement. For example, after using the system, I found that I don’t really care for the user interface (UI). I found it to be rather unintuitive and a bit clumsy. The UI is stuck somewhere between a legacy system and a modern web-based system. It’s not good. Too many clicks, things in weird places, naming conventions that simply don’t make sense in my mind, just to name a few. With that said, it’s still quite usable, and honestly, it’s likely as good as any other UI on any other product that I’ve used in the pharmacy.

The other thing that hit me yesterday was just how terrible the process of using images is to verify the accuracy of compounded products. I don’t care for it. As good as the images are – and they’re quite good in DoseEdge – there are still shadows in strange places that make reading syringe volumes difficult at times. This is especially true for small volumes. There were times yesterday when I simply made educated guesses to the exact volume and assumed that the volume was accurate, as I couldn’t quite see the exact location of the plunger. Don’t get me wrong, this is still way better than the syringe-pullback method, but image-assisted verification isn’t optimal. I would have liked to have had the gravimetric option available to me yesterday. DoseEgde offers gravimetrics, although it isn’t widely used.

So, good system, but not perfect. Better than the manual process, but room for improvement. Imaging better than pullback, but not great.

Three concepts that create a lot of confusion: stability, beyond-use date, expiration

The differences between stability, beyond-use date (BUD), and expiration for compounded sterile preparations (CSPs) causes a lot of confusion. I’m not even certain that I fully understand their roles in day to day pharmacy operations. With that said, I think the key is for everyone to at least understand and agree that the BUD of a CSP is not the same as the expiration date.

Here’s how I understand it:

Stability is based on the chemical stability of the solute in solution, i.e. ingredients alone or in combination. This is what the Handbook on Injectable Drugs is all about, i.e. loss of drug potency/activity in solution.

Expiration date is defined by the FDA and identified by the product manufacturer.  Basically, it’s the shelf-life of the drug when properly stored. The expiration date no longer applies once the manufacture’s container is opened and the drug product is transferred to another container for dispensing or repackaging. Pharmacy uses “expiration date” loosely as we are not manufacturers. Most often I see pharmacies use expiration date in place of stability, i.e. the drug is good in solution for “this long”.

Beyond-use date (BUD) is assigned by the pharmacy for a CSP and is an arbitrary date/time found in USP <797> and adopted by many boards of pharmacy. BUD is based on sterility, stability. The BUD identifies the time by which a preparation – once mixed – must be used, i.e. “hung”. Once the CSP is hung on a patient, the BUD goes out the window and no longer applies. USP <797> does not address what to do with a CSP once it is hung on a patient. So something can have a BUD of 12-Hours, but be stable much longer. Pharmacies can extend BUDs, but only after independent sterility testing performed according to USP <71>, or in some cases when appropriate literature sources are used.

In summary, the BUD is not the expiration date, nor the stability of a preparation. Nurses must hang a CSP before the BUD is reached. The CSP can continue to hang on the patient until the “Expiration Date” is reached.

I would love to hear how facilities are dealing with these three concepts. Does your facility use a BUD and expiration on CSP labels?

Compounding Resource Directory from IJPC

I received an email yesterday from the International Journal of Pharmaceutical Compounding. The email contains a link to the IJPC’s Compounders’ Resource Directory. There’s a lot of good information on the list. It’s worth a look.

Both the IJPC and CompoundingToday.com are great resources for anyone doing extemporaneous (non-sterile) or sterile compounding.

Enjoy!

NIOSH puts the brakes on the CSTD vapor containment protocol

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

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

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