Mennonite Measles in Texas

[Ken]

What is there a random person anywhere near a vaccine freezer? Unless you are a healthcare provider or clinic staff, you don't belong there and are not authorized to be anywhere near there. This story gets more outlandish with every retelling. I seriously doubt that Cleveland Clinic allows anyone without authorization anywhere near where drugs are stored. As a general rule, such facilities are "controlled areas," and unauthorized people who are found there will be asked to leave and likely escorted out.

Patient rooms are sometimes right next to the fridge or across from it. When I was in general surgery the staff was busy gossiping away about a patient (they did actually identify them…) and the clinic I worked at stored the Lupron in a common hall behind a locked door that was consistently left unlocked…
My doctor’s office back in Oregon had their vaccines stored right in the hall across from the patient rooms.

Likely there is “best practice” and what happens when you aren’t in a custom built facility.

The question here isn't whether patients can overhear conversations between medical staff in a medical clinic.

The question is whether staff at a Cleveland Clinic facility are breaking open sealed vaccine vials and mixing up their own custom "mystery cocktails" of blended vaccines in direct violation of FDA regulations. And then what? Repackaging them in empty unlabeled vials under sterile lab conditions? For the the purpose of what? Saving on a 5 cent disposable syringe?

That doesn't sound remotely plausible. And it wouldn't even match up with any patient medical records system or vaccination record which would report those two vaccines separately by lot number, NDC code, and dosage, and time, location, and site (which arm) of administration, not in combination.

[Soloist]

The question here isn't whether patients can overhear conversations between medical staff in a medical clinic.

The question is whether staff at a Cleveland Clinic facility are breaking open sealed vaccine vials and mixing up their own custom "mystery cocktails" of blended vaccines in direct violation of FDA regulations. And then what? Repackaging them in empty unlabeled vials? For the the purpose of what? Saving on a 5 cent disposable syringe?

That doesn't sound remotely plausible. And it wouldn't even match up with any patient medical records system or vaccination record which would report those two vaccines separately, not in combination.

If it was a multiuse vial, and someone was not properly educated, I could see a nurse thinking they could combined vaccines in a syringe.
There’s a reason that there’s teaching specifically on these sort of things with multiuse vials. Mostly targeted infection reduction, but knowing when you can combine the drug and then you can’t, is kind of important.
I combined some drugs, and realistically there’s protocol for when and how it’s actually done.
I could give examples of specific situations where there’s correct and then there’s the actual.
I couldn’t give you any specifics when it comes to vaccines because I don’t work in that field, but if you wanted to know, specifics about correct practice and then what’s actually done when it comes to G-tubes/g/j-tubes, I could tell you all about it.

[Ken]

The question here isn't whether patients can overhear conversations between medical staff in a medical clinic.

The question is whether staff at a Cleveland Clinic facility are breaking open sealed vaccine vials and mixing up their own custom "mystery cocktails" of blended vaccines in direct violation of FDA regulations. And then what? Repackaging them in empty unlabeled vials? For the the purpose of what? Saving on a 5 cent disposable syringe?

That doesn't sound remotely plausible. And it wouldn't even match up with any patient medical records system or vaccination record which would report those two vaccines separately, not in combination.

If it was a multiuse vial, and someone was not properly educated, I could see a nurse thinking they could combined vaccines in a syringe.
There’s a reason that there’s teaching specifically on these sort of things with multiuse vials. Mostly targeted infection reduction, but knowing when you can combine the drug and then you can’t, is kind of important.
I combined some drugs, and realistically there’s protocol for when and how it’s actually done.
I could give examples of specific situations where there’s correct and then there’s the actual.

Yes, if you were actually going to combine vaccines, you would draw two vaccines from two different vials into one syringe. Which is actually allowed for just two different vaccine combinations but not this one.

But that is not what JohnH is claiming happened here. He is claiming that the Cleveland Clinic is keeping unauthorized custom-mixed vials of blended vaccines in their clinic coolers which would be in direct violation of FDA regulations. And that they ONLY had these custom-blended vaccines available to administer to the patient, not the individual vaccine vials as they come packaged from the manufacturer. Does that sound plausible to you?

In fact, I doubt the back rooms of primary care clinics even have the sterile facilities and equipment that would be necessary to break open sealed vials and custom-mix sterile vaccines even if it were legal. That is the sort of thing that would likely require a licensed and inspected sterile lab facility at a compounding pharmacy to do properly.

[JohnH]

What is there a random person anywhere near a vaccine freezer? Unless you are a healthcare provider or clinic staff, you don't belong there and are not authorized to be anywhere near there. This story gets more outlandish with every retelling. I seriously doubt that Cleveland Clinic allows anyone without authorization anywhere near where drugs are stored. As a general rule, such facilities are "controlled areas," and unauthorized people who are found there will be asked to leave and likely escorted out.

By the way, ready-to-use drugs are kept in a refrigerator, not a freezer. Flu vaccines are not shipped to a clinic frozen. They are controlled temperature, not frozen.

I don’t know if it’s a fridge or freezer. It has a sign on it “Do not use for food!!!” It’s right by where the nurse weighs you or checks the height of children.

[Soloist]

Yes, if you were actually going to combine vaccines, you would draw two vaccines from two different vials into one syringe. Which is actually allowed for just two different vaccine combinations but not this one.

But that is not what JohnH is claiming happened here. He is claiming that the Cleveland Clinic is keeping unauthorized custom-mixed vials of blended vaccines in their clinic coolers which would be in direct violation of FDA regulations. And that they ONLY had these custom-blended vaccines available to administer to the patient, not the individual vaccine vials as they come packaged from the manufacturer. Does that sound plausible to you?

In fact, I doubt the back rooms of primary care clinics even have the sterile facilities and equipment that would be necessary to break open sealed vials and custom-mix sterile vaccines even if it were legal. That is the sort of thing that would likely require a licensed and inspected sterile lab facility at a compounding pharmacy to do properly.

After seeing how some things in our medical system work… very little would surprise me at this point…
I honestly have no idea as I said it’s not my field. Honestly, Judas would probably know more than I would. His wife worked in public health I believe.

[ken_sylvania]

What is there a random person anywhere near a vaccine freezer? Unless you are a healthcare provider or clinic staff, you don't belong there and are not authorized to be anywhere near there. This story gets more outlandish with every retelling. I seriously doubt that Cleveland Clinic allows anyone without authorization anywhere near where drugs are stored. As a general rule, such facilities are "controlled areas," and unauthorized people who are found there will be asked to leave and likely escorted out.

Patient rooms are sometimes right next to the fridge or across from it. When I was in general surgery the staff was busy gossiping away about a patient (they did actually identify them…) and the clinic I worked at stored the Lupron in a common hall behind a locked door that was consistently left unlocked…
My doctor’s office back in Oregon had their vaccines stored right in the hall across from the patient rooms.

Likely there is “best practice” and what happens when you aren’t in a custom built facility.

The question here isn't whether patients can overhear conversations between medical staff in a medical clinic.

The question is whether staff at a Cleveland Clinic facility are breaking open sealed vaccine vials and mixing up their own custom "mystery cocktails" of blended vaccines in direct violation of FDA regulations. And then what? Repackaging them in empty unlabeled vials under sterile lab conditions? For the the purpose of what? Saving on a 5 cent disposable syringe?

That doesn't sound remotely plausible. And it wouldn't even match up with any patient medical records system or vaccination record which would report those two vaccines separately by lot number, NDC code, and dosage, and time, location, and site (which arm) of administration, not in combination.

How many of those "outlandish" claims did John actually make?
Did he say that the staff at Cleveland Clinic was mixing the combo vaccine? No.
Did he say that it was blended from previously sealed vaccine vials? No.
Did he say that the blended vaccine was done in violation of FDA regulations? No.
Did he say that they were being repackaged in unlabeled vials? No.

If you wanna set up a strawman so that you can bravely demolish it, maybe you want to be a bit more discreet about it so that it doesn't look like you're just fighting a strawman.

[Ken]

How many of those "outlandish" claims did John actually make?
Did he say that the staff at Cleveland Clinic was mixing the combo vaccine? No.
Did he say that it was blended from previously sealed vaccine vials? No.
Did he say that the blended vaccine was done in violation of FDA regulations? No.
Did he say that they were being repackaged in unlabeled vials? No.

If you wanna set up a strawman so that you can bravely demolish it, maybe you want to be a bit more discreet about it so that it doesn't look like you're just fighting a strawman.

Everything he wrote is right upstream:

At the doctor's office recently one of the other patients wanted the HPV vaccine. They checked their vaccine fridge, but all they had was a combination flu plus HPV. What an utterly bizarre combination... and are we supposed to believe that the combination has received the same thorough amount of testing for effectiveness and safety that the individual seasonal flu shot and Gardasil received?

No such combination exists. It is not manufactured by any pharma company, only the individual vaccines are manufactured and distributed. Nor is it permissible to mix up such a combination.

Then he doubled down and told us WHERE this happened:

I was quite surprised as well to hear such a combination existed.

I don't think the Cleveland Clinic is off the wall.

It is possible I was hallucinating the entire appointment, but that seems unlikely.

Then he tripled-down and wrote:

I was as surprised as you are (and obviously was not going to ask questions about another patient), so I went and asked an actual medical provider, you know, a "doctor", which as far as I know neither you nor I are. He informed me there are formulations of combinations of vaccines that can be prepared sort of like a compounding pharmacy, and lots of primary-care offices stock these now. They do not have to go through any kind of normal vaccine approval process.

Administering Gardisil and a flu shot at the same time is not a novel or outlandish idea; it should not be surprising that a combination has been cooked up so it can be given in a single shot.

None of this is true. There are only two vaccine combinations that can be administered together and Gardisil/flu is not one of them. And it isn't legal to mix them at the clinic level. Nor would it be possible to do so and maintain sterility. The only thing that is legal is to draw two vaccines into the same syringe from separate vials.

[ken_sylvania]

How many of those "outlandish" claims did John actually make?
Did he say that the staff at Cleveland Clinic was mixing the combo vaccine? No.
Did he say that it was blended from previously sealed vaccine vials? No.
Did he say that the blended vaccine was done in violation of FDA regulations? No.
Did he say that they were being repackaged in unlabeled vials? No.

If you wanna set up a strawman so that you can bravely demolish it, maybe you want to be a bit more discreet about it so that it doesn't look like you're just fighting a strawman.

Everything he wrote is right upstream:

At the doctor's office recently one of the other patients wanted the HPV vaccine. They checked their vaccine fridge, but all they had was a combination flu plus HPV. What an utterly bizarre combination... and are we supposed to believe that the combination has received the same thorough amount of testing for effectiveness and safety that the individual seasonal flu shot and Gardasil received?

No such combination exists. It is not manufactured by any pharma company, only the individual vaccines are manufactured and distributed. Nor is it permissible to mix up such a combination.

Then he doubled down and told us WHERE this happened:

I was quite surprised as well to hear such a combination existed.

I don't think the Cleveland Clinic is off the wall.

It is possible I was hallucinating the entire appointment, but that seems unlikely.

Then he tripled-down and wrote:

I was as surprised as you are (and obviously was not going to ask questions about another patient), so I went and asked an actual medical provider, you know, a "doctor", which as far as I know neither you nor I are. He informed me there are formulations of combinations of vaccines that can be prepared sort of like a compounding pharmacy, and lots of primary-care offices stock these now. They do not have to go through any kind of normal vaccine approval process.

Administering Gardisil and a flu shot at the same time is not a novel or outlandish idea; it should not be surprising that a combination has been cooked up so it can be given in a single shot.

None of this is true. There are only two vaccine combinations that can be administered together and Gardisil/flu is not one of them. And it isn't legal to mix them at the clinic level. Nor would it be possible to do so and maintain sterility. The only thing that is legal is to draw two vaccines into the same syringe from separate vials.

So based on what you are quoting, JohnH never said what you pretended that he had said.

[Judas Maccabeus]

Patient rooms are sometimes right next to the fridge or across from it. When I was in general surgery the staff was busy gossiping away about a patient (they did actually identify them…) and the clinic I worked at stored the Lupron in a common hall behind a locked door that was consistently left unlocked…
My doctor’s office back in Oregon had their vaccines stored right in the hall across from the patient rooms.

Likely there is “best practice” and what happens when you aren’t in a custom built facility.

The question here isn't whether patients can overhear conversations between medical staff in a medical clinic.

The question is whether staff at a Cleveland Clinic facility are breaking open sealed vaccine vials and mixing up their own custom "mystery cocktails" of blended vaccines in direct violation of FDA regulations. And then what? Repackaging them in empty unlabeled vials under sterile lab conditions? For the the purpose of what? Saving on a 5 cent disposable syringe?

That doesn't sound remotely plausible. And it wouldn't even match up with any patient medical records system or vaccination record which would report those two vaccines separately by lot number, NDC code, and dosage, and time, location, and site (which arm) of administration, not in combination.

How many of those "outlandish" claims did John actually make?
Did he say that the staff at Cleveland Clinic was mixing the combo vaccine? No.
Did he say that it was blended from previously sealed vaccine vials? No.
Did he say that the blended vaccine was done in violation of FDA regulations? No.
Did he say that they were being repackaged in unlabeled vials? No.

If you wanna set up a strawman so that you can bravely demolish it, maybe you want to be a bit more discreet about it so that it doesn't look like you're just fighting a strawman.

By its very existence, such a combination vial would be a violation of regulations that are too numerous to count. You simply cannot have that combination unless it was created contrary to numerous regulations too numerous to count. Such a vial could not be created unless numerous entities up the chain violated all sorts of regulations. While a drug fridge in a hall might escape regulatory notice in some small rural clinics, we are talking about a major teaching hospital here, quite similar to the one I used to work in. There are both internal QC people and external inspectors checking for compliance. It is a black letter day if you are found in violation of these regulations, starting with paperwork, climbing to fines, and beyond.

It would be far simpler for our friend to admit he must have misheard, but we have seen accusations against the healthcare system nonstop. It is one of the most regulated spaces in America! People don't mix drugs together without specific protocols authorizing that mixture. Manufacturers don't just "put stuff like adjuvants into vaccines without the FDA determining they are safe. There are strict limits on what you can and cannot do on an open bench versus under a LAF hood, not to mention training and documentation requirements. If you do draw up a mixture, you cannot leave it in a fridge, such draws are for "Immediate use" only, unless it was drawn under a LAF hood.

John's stuff does not pass the smell test. It would be simpler to say, "maybe I misheard" than to keep doubling down.

[Judas Maccabeus]

Yes, if you were actually going to combine vaccines, you would draw two vaccines from two different vials into one syringe. Which is actually allowed for just two different vaccine combinations but not this one.

But that is not what JohnH is claiming happened here. He is claiming that the Cleveland Clinic is keeping unauthorized custom-mixed vials of blended vaccines in their clinic coolers which would be in direct violation of FDA regulations. And that they ONLY had these custom-blended vaccines available to administer to the patient, not the individual vaccine vials as they come packaged from the manufacturer. Does that sound plausible to you?

In fact, I doubt the back rooms of primary care clinics even have the sterile facilities and equipment that would be necessary to break open sealed vials and custom-mix sterile vaccines even if it were legal. That is the sort of thing that would likely require a licensed and inspected sterile lab facility at a compounding pharmacy to do properly.

After seeing how some things in our medical system work… very little would surprise me at this point…
I honestly have no idea as I said it’s not my field. Honestly, Judas would probably know more than I would. His wife worked in public health I believe.

She is. Got her retirement and is still a member of the "Emergency Corp." She has gotten a couple of head-shaking moments here.

Not to mention that Judas was a board-certified Nuclear Medicine Technologist for 40 years, most of that in a teaching hospital. Until the mid-90s, no one wanted to get anywhere near our radioactive drugs. Pharmacy created a whole specialty to do what we had been doing for years. I would admit they brought some needed changes into the system, but the transition was a real education. It improved the level of practice considerably. Radiopharmacy was one of my favorite areas. While I never worked with vaccines, the same general principles apply.

Retirement has been interesting, "no-notice" inspections are something I do not miss.