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A Warning Letter; from a pharmacist to a certifier – a Warning and possible solution

A Warning Letter; from a pharmacist to a certifier – a Warning and possible solution
July 13, 2018 Seth DePasquale

A Warning Letter; from a pharmacist to a certifier – a Warning and possible solution

Compounding pharmacy as an industry has a problem. It’s multi-faceted and there isn’t just one solution. In fact, the issue is so widespread it’s going to take a lot of time, several areas of expertise involvement and a paradigm shift in thinking to course correct. The problem is that the bar has been raised, the level of expectation for what an average compounding pharmacy or hospital should know about their controlled environment has increased, and in this pharmacist’s opinion rightfully so. The FDA has made pharmacy compounding a top priority again for 2018 and most likely for the foreseeable future. Gone are the days of a semi-annual certification ending in a hand shake and a cordial, “see you in six months” salutation. At least they should be.

Why have I pinpointed cleanrooms as being an issue in particular? If you look at the FDA website, specifically where they publish Form-483s on compounding pharmacies, you’ll pick up on a trend: pharmacies lack the basic knowledge of how cleanrooms operate. What’s more is that when there is an issue in a cleanroom many don’t know the simple steps they should be taking to remediate. Also, it’s the one of the most critical aspects of many compounding operations, aside from an individual’s technique, to ensuring a patient will receive a preparation that hasn’t been contaminated. But that assurance is exactly where we’re lacking. I won’t say that every facility is a disaster waiting to happen necessarily because thankfully our engineering controls are in place. However, the goal of any industry shouldn’t be just to get by, at least that doesn’t seem like a recipe for success.

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Personally, I see certifications and inspections as a way to improve; but this sentiment isn’t shared by all. Many see both as an interruption, a necessary evil or worse: just a checkbox. There’s an opportunity for which certifiers are in an extremely unique position to help an entire industry improve: helping to educate the end users on the maintenance and certification of cleanrooms. 

One guy’s recommendations

I have a short list of recommendations based on my own experiences with what I would classify as “decent” and “excellent” experiences with companies that have come to certify my controlled environment (the latter being the goal). One of my first interactions with a technician was a very positive one. The technician took the time to explain what he tested (as he realized I was new) and when asked how to improve aspects of my report he candidly gave me his opinion. To contrast that example, a couple years later the same certification company had sent a different technician who when a problem was found made a point to be somewhat confrontational by asserting my room had been constructed improperly and needed to be fixed. Upon further investigation, that was incorrect and there wasn’t an issue with the room’s construction at all. 

The lesson here: don’t assume anything. First, we’re in a scientific, fact-based field and we (pharmacists included) should be operating as such. Assuming that clients know more than they actually do leads to lost opportunities to educate when there’s an issue; assuming they don’t know anything could end in a client not wanting to work with you again. Admittedly, it’s a fine line. Again, stick to the facts. How many times have you been in a facility and noticed particle counts in a particular location relatively higher than any other place in the cleanroom? This could be something that warrants a full investigation or something as simple as looking around and seeing if there’s a particle generating item in the vicinity. Making small, simple recommendations when obvious faults are noticed would be appreciated and looked at as going the “extra mile” for your client.

Dynamic, yet Standard Reporting

The words “dynamic conditions” for some reason seems to mean something slightly different to everyone. The intention is to demonstrate the actual in-operation conditions of the cleanroom to understand how activity influences particle counts. I’ve yet to come across a certifier who has asked what that looks like for my controlled environment. However, I have had one simulate conditions on his own and take particle counts under a few general scenarios. To date this actually seems like the best way to simulate dynamic conditions. When I witnessed this the first time I thought it was a little strange but when the reasoning was explained I was completely on board. They had a few “activities” they would perform while the particle counter was on. For example, a door would be opened and closed near the particle counter and then it would be noted how long it took for the room to recover after the activity. The last part about recovery time is a critical concept to understand. It can really demonstrate how well the room is performing in real terms. To explain the idea more completely: 3 particle counts are taken at each location. The first particle count would possibly be a “baseline” or an activity like opening a door, walking past the particle counter or dropping an object. The second, depending on the first, would either be to see if the area recovered or an activity. The third and final particle count would also be performed to see the recovery time. 

This was a definite departure from how I’ve seen anyone else perform particle counts but was in line with ISO-14644 as it talks about taking multiple particle counts at each location and averaging them. The above scenario takes it one step further and offers a real-world demonstration of how the room is performing. Obviously, taking that many particle counts is more work but the information gained is priceless.

My last recommendation has to do with reporting. No two reports are alike. What’s more is that I haven’t come across one that’s made the information very obvious to interpret. I think this could be solved using an interdisciplinary team (including pharmacists will be key) to come up with a standardized report that all companies (that are members of CETA at least) use. Honestly, a certification report has a built in limitation in that it’s just a snapshot in time; that doesn’t mean it’s completely useless though.

If you’re able to turn the report into a comparison of previous certifications, you’re also providing real value to not just the individual but the industry as a whole. The certifications and report would be transformed into a tracked and trended event. Provided the client understands what the numbers on the report mean this would encourage more testing with the goal of continuous improvement; a fairly simple concept that is often missed by healthcare professionals when it comes to sterile compounding and our controlled environments. While the compounding industry has its faults and is under a transformation of sorts with increased scrutiny, it doesn’t mean that the next several years can’t be turned into a learning experience for everyone. If the goal is system wide improvement it needs to involve all the players in the field; especially the ones with the technical knowledge.

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About the author:

Seth DePasquale is a pharmacist and co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. Seth is a 2002 graduate of Albany College of Pharmacy in Albany, NY and is a Registered Pharmacist in New York, Kentucky, Michigan, Oklahoma, Texas, West Virginia, Virginia, Alabama, Tennessee, Mississippi, Arkansas, Nebraska, Louisiana and Oregon.

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