Remember that Las Vegas GI center and the hepatitis outbreak?

[pgg]

The anesthesiologist owner (who ordered CRNAs to reuse syringes and double-dip single dose vials, to save money) was convicted of 2nd degree murder a few months ago, and yesterday sentenced to life in prison
http://www.nbcnews.com/health/las-vegas-doctor-sentenced-hepatitis-c-outbreak-8C11461251


The five CRNAs surrendered their licenses in 2008, not sure if criminal charges were ever brought against them.
(2008 article) http://www.lasvegassun.com/blogs/news/2008/mar/05/nurses-surrender-licenses/

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[BLADEMDA]

I know places where the Physician owners (non Anesthesiologists) order their employed CRNAs to divide up the Propofol (20 ml vial) for patients in order to save money. This way the left over Propofol is used on the next patient. Some of them even do this with Versed and Fentanyl as well.

 

[pgg]

I know places where the Physician owners (non Anesthesiologists) order their employed CRNAs to divide up the Propofol (20 ml vial) for patients in order to save money. This way the left over Propofol is used on the next patient. Some of them even do this with Versed and Fentanyl as well.

That's surely safe, if they split the vials ahead of time with new syringes, and use them within 6 hours.

Billing fraud maybe, if both patients get a charge for a full vial?

 

[lord_jeebus]

Was he an anesthesiologist? I thought he was a gastroenterologist.

The stupidest part of this case was Teva having to pay $250 million to the victims because a jury thought that they should have known from the size of the vials (50 ml) that they would cause a Hep C outbreak, and thus should have refused to sell vials of that size.

 

[Idiopathic]

Was he an anesthesiologist? I thought he was a gastroenterologist.

The stupidest part of this case was Teva having to pay $250 million to the victims because a jury thought that they should have known from the size of the vials (50 ml) that they would cause a Hep C outbreak, and thus should have refused to sell vials of that size.

you are correct.

im very surprised about 2nd degree murder, honestly figured manslaughter would be more appropriate but im no legal expert

 

[pgg]

Yeah for some reason i had it stuck in my head that it was an anesthesiologist who owned the place. You're right, it was a GI.

 

[norwood]

Wow. And wow. I didn't see the Teva part in the linked articles, but sure enough, they paid $250 million. No wonder that county in Nevada got a reputation as a judicial hellhole. Clearly there are plenty of safe uses for a 50ml vial of propofol - TIVA, lengthy sedations, background infusions...

 

[Per4mer8]

It gets better. The Attorneys who represented the principle plaintiff in the Teva case contributed $40k to the re-election campaign of the presiding Judge.

They also found that the clinic wasn't sterilizing the endoscopes etc. Basically that entire clinic was dirty.

http://m.reviewjournal.com/news/crime-courts/court-prepares-hear-hepatitis-c-cases?ref=529

 

[BLADEMDA]

That's surely safe, if they split the vials ahead of time with new syringes, and use them within 6 hours.

Billing fraud maybe, if both patients get a charge for a full vial?

Part of the lawsuit was that propofol should be single patient use. It says so right on the manufacturers instructions. Dividing the propofol for multi patient use is poor form and part of the reason why Teva and the clinic got their arses handed to them.

PROPOFOL Is single patient use only.

 

[BLADEMDA]

On June 15, 2007, the FDA released a safety alert concerning reports over the past few months of cases of fever, chills, and body aches in several clusters of patients shortly after the administration of propofol. These new cases involved patients undergoing procedures in gastrointestinal suites. The FDA noted that the symptoms were similar to those reported when propofol was first introduced in the US. The postoperative infection in these early cases was attributed to lapses in aseptic technique with risk factors that included "batch" preparation of propofol syringes for use throughout the day, reuse of syringes or infusion pump lines on different patients, use of propofol syringes prepared more than 24 hours in advance, transfer of prepared syringes between operating rooms or facilities, failure to wear gloves during insertion of intravenous catheters, and failure to disinfect the stoppers of the propofol vials. It was also noted that 50-ml and 100-ml vials were used as multi-dose vials. The formulation at that time did not contain preservatives.

 

[BLADEMDA]

Recommendations and considerations by the FDA are:

Both the vial and prefilled syringe formulation must be used on only 1 patient.
Administration must commence immediately after the vial or syringe has been opened.
In general anesthesia or procedural sedation: administration from a single vial or syringe must be completed within 6 hours of opening.
In ICU sedation: propofol administered directly from a vial must be limited to only 1 patient, must commence immediately on opening the vial and must be completed within 12 hrs of opening the vial.

 

[Spinach Dip]

They also found that the clinic wasn't sterilizing the endoscopes etc.

Sometimes, there is no penalty strict enough for the crime committed.

 

[pgg]

Part of the lawsuit was that propofol should be single patient use. It says so right on the manufacturers instructions. Dividing the propofol for multi patient use is poor form and part of the reason why Teva and the clinic got their arses handed to them.

PROPOFOL Is single patient use only.

Oh, I get that the mfr says no splitting between patients. It's BS, but of course they're going to say that.

Back during the propofol shortage, we had plenty of 100 mL bottles. Our pharmacy would split one into five 20 mL syringes for us under their hood, and we'd get five cases done. Even minus the hood, it's perfectly safe to do this kind of splitting provided the bottle is entered with a new, sterile syringe each time and it all gets used within 6 hours. When the next propofol shortage hits, we'll do it again.

 

[BLADEMDA]

Although it is possible to break 50-mL and 100-mL vials of propofol, which are intended for infusions, into smaller doses for injections, the FDA strongly discouraged such practice even under sterile conditions.

“No vial of propofol is meant as a multidose vial,” stressed Arthur Simone, MD, an FDA medical officer. Splitting doses of propofol has been linked to serious, and in some cases deadly infections, FDA officials said.

Alexander Hannenberg, MD, president of the American Society of Anesthesiologists (ASA) agreed: “What may be sterile technique to you may be inconceivable to someone else.”

On Nov. 6, the FDA, the ASA and the American Society of Health-System Pharmacists (ASHP) held a joint conference call to discuss the shortages. They encouraged facilities not to hoard propofol, and urged clinicians not to jeopardize patient safety by trying to stretch vials of propofol across multiple cases.

 

[BLADEMDA]

Oh, I get that the mfr says no splitting between patients. It's BS, but of course they're going to say that.

Back during the propofol shortage, we had plenty of 100 mL bottles. Our pharmacy would split one into five 20 mL syringes for us under their hood, and we'd get five cases done. Even minus the hood, it's perfectly safe to do this kind of splitting provided the bottle is entered with a new, sterile syringe each time and it all gets used within 6 hours. When the next propofol shortage hits, we'll do it again.

Sir, many experts disagree with your statement above and would testify in court that such practice is malpractice. I don't have the Ferris doctrine in my hospital and neither did that Gi clinic in Nevada.

What you can get away with and what is considered good practice are not the same.


http://www.emlab.com/s/services/USP_797.html

USP 797 should be followed if splitting propofol is required

 

[BLADEMDA]

Dividing of Larger Propofol Vials: It is important to note that all propofol vials are single-use only and that multiple entries into the vials increase the risk of contamination. The FDA and ASA do not endorse the dividing of propofol vials except under the strict guidelines of USP-797. Therefore, ASA encourages any member who is considering dividing propofol vials to consult their hospital pharmacist prior to engaging in such activity in order to avoid potential harm to patients.

 

[norwood]

I don't know the details of what pgg's pharmacy did, but it's at least possible they were conforming to the standard you named.

I know I've seen something similar done with Dex, to make 10-ml syringes for emergence delirium. It was verboten to do it ourselves, but pharmacy was allowed to do it with their various precautions.

 

[BLADEMDA]

I don't know the details of what pgg's pharmacy did, but it's at least possible they were conforming to the standard you named.

I know I've seen something similar done with Dex, to make 10-ml syringes for emergence delirium. It was verboten to do it ourselves, but pharmacy was allowed to do it with their various precautions.

Pharmacists follow the guidelines as specified by USP 797. Anesthesia providers using single dose propofol vials on multiple patients are not following these same guidelines.

 

[BLADEMDA]

CMS has received requests to relax its policies on the use of single-dose vials for multiple patients. Shortages of critically needed drugs have prompted healthcare facilities to seek ways to make efficient use of the available drug supply.
Requestors maintain that wastage of vial contents that exceed the single-patient dose aggravates drug shortages. They question the CMS policy on deficiency citations when medications packaged in single-dose vials are reused for multiple patients. However, CMS has declined to change its policy.
CMS shares healthcare provider concerns about shortages but is equally concerned about healthcare-associated infections caused by unsafe medication preparation and injection practices, including using single-dose vials for multiple patients in the same manner as multidose vials. Such reuse of single-dose vials is not compliant with infection-control requirements and must be cited as a deficiency. "Remember," cautions a pharmacist, "your practice is held to the same USP standards even if you are ignorant of the standards."

 

[BLADEMDA]

Nevada resident and school administrator Harry Chanin would agree with this sentiment. Here is his story:
I underwent a routine colonoscopy for screening purposes in June 2006 and presented with acute hepatitis C infection 8 weeks later. I went through an ordeal of chemotherapy that luckily for me (the success rate is only 50%) suppressed the virus. I suffer lingering fatigue and chronic joint pain as a result of the treatment side effects.
The outpatient clinic where I had my colonoscopy was administered by doctors who decided to consciously cut whatever corners they could to speed things up and increase their billings. They were supplied the anesthetic propofol in 50-mL vials by drug manufacturers who knew these vials were being used for multidosing patients, but who continued selling them because their profits were higher given the lower packaging costs of bigger vials.
The Nevada outbreak was the result of systematic failure of the entire healthcare delivery system. The insurance company that directed me to the clinic never checked on the quality of the care being provided; the doctors ignored their oath; and the drug manufactures put profits over safety, consciously. The system has repeatedly failed. [Personal communication; December 4, 2012]

 

[BLADEMDA]

Please notice that using a large single dose 50 ml vial for multiple patients is specifically mentioned by the patient. If you are splitting propofol and the patient gets any kind of infection then you are wide open to a lawsuit. If "splitting" is going on then it must be performed by a pharmacist utilizing USP 797

 

[BLADEMDA]

b. Do not administer medications (or other solutions) from single-dose vials or ampules to multiple patients or combine leftover contents for later use."
Any repackaging of medications from a previously unopened single-dose container into multiple single-use items (e.g., vials or syringes) should only be performed using a laminar-flow hood by pharmacy specialist personnel in accordance with standards in U.S. Pharmacopeia General Chapter 797 (Pharmaceutical Compounding "" Sterile Preparations). It should be stressed that these conditions are not met in any clinical environment in which anesthesia professionals practice. Any use of single dose vials for multiple patients by anesthesia personnel is an extremely dangerous practice and is not permissible. Please consult the CDC, the ASA"™s "Recommendations for Infection Control for the Practice of Anesthesiology (Third Edition, 2011)", the New York State Society of Anesthesiologists' "Infection Control for Anesthesia Professionals" and other organizations for further information on safe injection practices.
Elliott Greene, MD
Department of Anesthesiology
Albany Medical Center Hospital
Albany, NY

 

[IlDestriero]

b. Do not administer medications (or other solutions) from single-dose vials or ampules to multiple patients or combine leftover contents for later use."
Any repackaging of medications from a previously unopened single-dose container into multiple single-use items (e.g., vials or syringes) should only be performed using a laminar-flow hood by pharmacy specialist personnel in accordance with standards in U.S. Pharmacopeia General Chapter 797 (Pharmaceutical Compounding "" Sterile Preparations). It should be stressed that these conditions are not met in any clinical environment in which anesthesia professionals practice. Any use of single dose vials for multiple patients by anesthesia personnel is an extremely dangerous practice and is not permissible. Please consult the CDC, the ASA"™s "Recommendations for Infection Control for the Practice of Anesthesiology (Third Edition, 2011)", the New York State Society of Anesthesiologists' "Infection Control for Anesthesia Professionals" and other organizations for further information on safe injection practices.
Elliott Greene, MD
Department of Anesthesiology
Albany Medical Center Hospital
Albany, NY

We don't split anything, and considering the size of most of my patients, we waste a shocking amount of meds every day.
Oh well. I'm not losing any sleep over it.
When the shortages come, the pharmacy does split things into syringes per their sterile protocols.