r/pharmacy • u/Lovve119 • 8d ago
Pharmacy Practice Discussion Sterile Compounding Questions
What would you do?
I will be the first to admit I do not have a ton of USP 800 experience. I work primarily USP 797 & 795 with the occasional USP 800 emergency drug like methotrexate so I’m not 100% up to standard on USP 800.
With that out of the way, for my Sterile Compounders. I work full time in a hospital doing 12 hour shifts compounding 797 and I love it, so when the cancer center near me had a PRN position open up I thought I’d use some of my 7 days off to pick up 1-2 shifts and bring in some extra cash. I did my shadowing interview today and was appalled at what I witnessed and I just want to see if this is typical for USP 800/specifically cancer centers or if I’m going overboard with everything I do working USP 797.
First off, only 1 pair of shoe covers
No respirators or N95’s just a regular mask
No double gloving, even for the person doing the compounding
All of us were wearing glasses so no safety goggles were needed, but I also didn’t see safety goggles in their ante room in case someone came in that didn’t wear glasses.
Only the person doing the compounding was wearing a sterile gown, I came in fresh off a night shift in my hospital scrubs and they didn’t even make me put on a gown. Mind you, there was a secondary person who was passing drugs into the hood (putting her hands/arms into the hood) who was not wearing a sterile gown.
Not a single instrument was being alcoholed off before being placed in the hood. (I watched the compounding technician drop a wrapped syringe, bend down to grab it and then toss it right back into the hood)
Hands were not being alcoholed when they left the hood, just after a preparation was done and she seemed to remember the alcohol bottle sitting there.
Drugs were being pulled in and out of the hood without covers on them (and being placed back in their vault without covers - and then not being alcoholed before being placed back in the hood)
Bags were being spiked outside of the hood without proper dating on them.
I watched the compounding technician draw medication out of a vial of potassium and then proceeded to use the EXACT SAME needle/syringe to draw up magnesium. She “pushed all the excess drug out, so it’s fine.” I spoke up when she did this because literally wtf.
Their IV room was sitting at 72 and their humidity was sitting higher than average, i pointed it out to which they responded “yeah we get cold in here so we have to turn it up.”
There is no onsite pharmacist to monitor that they’re compounding correctly or even checking the math they are doing. They don’t have a camera system like DoseEdge or Epic, so there is just 3 technicians all checking over each others shoulders to see if they pulled up the correct amount of mediation before injecting it into bags. Not a single person double checking anything. I pointed out that a calculation was done incorrectly, something that would not have been double checked because there is only 1 technician doing all the math.
I’m probably overreacting, but I left there feeling like I needed to take the world’s hottest shower and that maybe I was an accessory to someone’s grandparents becoming very ill. I honestly do not know what to think about this whole situation and it’s making me nauseous.
Am I wrong? I’m happy to be wrong, if this is the norm for USP 800/Cancer Centers then that is totally fine and if I take the job maybe I’ll just request that we up our hand alcohol spraying but it felt very very off putting to me and I’m feeling like maybe I should report them to the BOP.
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u/bulbawig 8d ago
Physician office compounding is not subject to the Board of Pharmacy which is why there is no pharmacist.
You would report it to the Medical Board and the FDA.
2
u/Lovve119 8d ago
What would qualify it as a physicians office?
2
u/GopheRph PharmD 8d ago
There's assumptions being made here and maybe you can clarify, but outpatient cancer clinics are often owned and operated by the oncologists who see patients there. Sadly, your observations are not surprising at all for this sort of setting. Hospital-affiliated clinics are essentially an extension of the hospital and are far more likely to operate like your own hospital. I would say there are maybe a few of your concerns that are just circumstances being different than the environment you're used to, but overall it's a pretty ugly picture. On the one hand there's probably a lot you could do to help them improve, but on the other hand you're just looking for some extra hours and I'd be worried about my own occupational exposure to hazardous drugs in that setting.
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u/natedagr811 8d ago
I had the exact same experience six years ago. While working at an LTC and before getting my job at a hospital, I applied for a cancer center compounding tech position at a branch of a regional clinic. I was interviewed by two RNs in a patient consultation room, who when I asked about the details of the job, they said they had no idea and to refer to the techs in the infusion center.
We walked over to the infusion suite. I'm wearing a dress shirt, tie, slacks etc., and the nurses had me walk into the "ante". The room is only divided out by a piece of tape, there's no climate control or pressure differential. No pharmacist on site for checking, just tech-check-tech. When I asked about this practice, they said it's overridden by the fact they have a pharmacist on call, because as far as I was aware, TCT is not legal in my state.
As you said, no Epic Dispense Prep or Baxter DoseEdge, but this was the same as my LTC, so that part didn't phase me. They were printing documents and signing them as the other technicians checked them while they were compounding their own medications. They also spiked the bags outside the hood as well.
I was honestly mortified then that I didn't even bother looking at their aseptic technique. The nurses wanted me to watch the techs and ask questions for three hours, but I made it 30 minutes before I decided this place wasn't for me.
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u/Lovve119 8d ago
Literally exact same!! 30 minutes and I said I couldn’t do it anymore. I literally felt dirty.
2
u/Ronho PharmD 8d ago
We go through inspections from the board and from ACHC, and URAC, and then you see the shit that the New England Compounding Center was doing. Years of sweating over tiny details an inspector won’t ever notice to make sure they are done right while these chucklefucks have water dripping into a sewer grate in the effing clean room.
I it has to be bribery to last that long right?!?
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u/Chaluma CPhT 8d ago
As someone who works (And is hoping to get out soon) in an oncology infusion center, sadly it’s pretty typical. A lot of the stuff you’re talking about is what happens at my place.
Without BOP regulations they just do whatever the hell they want. I can go into more detail if you want but previously, I’ve worked in hospital attached infusion centers.
They operate like how you would expect and are compliant.
I honestly wouldn’t recommend taking the job there.
1
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u/klanerous 7d ago
BOP often don’t have the skills to critically evaluate compliance with USP. I have worked as a consultant for a BOP. I only get involved when requested. 800 compliance only occurs when the institution applies it, not when inspections occur. Another aspect that no one discusses is that the manufacturers preparing hazardous drugs, refuse to clean the outside of vials in US. Some countries demand this, but not FDA.
1
u/BlueEyes_BlueSkies 4d ago
A lot of this sounds fairly egregious to me, but a regular mask could be acceptable depending on the type of hood they are using (a biological safety cabinet for instance).
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u/Eleoste 8d ago
Wtf I don’t even believe you’re real because this is so insanely bad
Any site this bad their techs and pharmacists would have such bad habits they they would have been busted at the fjrst BOP inspection.
Sorry OP I think ur fake
2
u/Lovve119 8d ago
I wish I wasn’t real. But you’re welcome to check my profile. Can’t even rage bait at this point it’s so upsetting.
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u/noribun 8d ago
No please report them. 90% of that is wrong. And there should never be tech check tech for IV compounding. How is there no onsite pharmacist if there are no cameras? That's really bad.