Saturday, August 14, 2010

Don't be stupid.... practice safe injection techniques

As the anesthesia community deals with the propofol shortage, many clinical options remain; obviously newer medications such as fospropofol give the unique advantages over some of the older choices.
One thing remains clear, if you have been able to continue to use propofol during these challenging times; don't practice unsafe injection techniques.
As president of our state ambulatory surgery society (GSASC.org), I have been besieged by a number of centers who fail to understand APIC guidelines and sterile injection techniques.
One of the reasons why we may have the shortage was the judgement against TEVA for millions of dollars stemming from unsafe injection practices... THis was the well known case of a Las Vegas Endoscopy center that was being unsafe.
ONE VIAL: ONE NEEDLE: ONE SYRINGE: ONE PATIENT

It is imperative to practice this technique even if it costs the center/hospital more money. There are a number of references out there regarding transmission of hepatitis from poor and unsafe practices.

DOn't let your guard down even during these times where you may feel the urge to double dip. The tempation is there; especially with the availability of propofol sometimes only in 50 ml or 100ml vials to do the unsafe thing... Please be aware of the consequences. THe federal government and state agencies are focusing on these issues and infection control. It is extremely important to find sedatives that have those properties and packaging that can be used in the appropriate clinical manner and protect your patients!

Just my take... look forward to yours.

Some resources for safe injection practices:
1. APIC; www.apic.org (association for professionals in infection control and epidemiology)
2. CDC.gov
3. Safe injection practices

Wednesday, July 28, 2010

Interesting Times...."interesting measures"...Repackaging

Interesting times ..... interesting measures....

Have you heard of compounding and/or repackaging propofol.?
Given all of the safe injection practice concerns and shortages... Is this a viable option?

The process is: The drug is drawn from the original vial via a sterile syringe and injected through a port into a sterile bab. The product is placed into a bag through a sterile tube that passes the propofol through a sterile repeater pump example calibrated to dispense the correct amount into a new, empty sterile vial.

The product is always repackaged through this sterile,closed process without ever becoming exposed to the elements.

The example: from each 100ml vial, they repackage into 20 5-ml single dose vials, allowing for 20 patient applications instead of one..
The cost is $50! for each 5 ml vial plus this company estimates the cost of 100 ml vial at $170!
That would be a total cost of $50 x 20 plust $170= $1,170.00 for the repackaging!!!!!

They claim to save you the cost of $3400 (20 x170) less the $1,170.00 for the repackaging or a total savings of $2230.0


This is the type of situation and perceived panic and alternatives which people are falling prey to during this critical time.

There are much better and safer sedation options out their and newer and better alternatives including imported propofol and Lusedra (fospropofol).

No solution is perfect.. but look at the costs and upsides of other plans. Anesthesiologists and anesthestetists tend to be perfectionists and sometimes are creatures of habit and this has us thinking outside our comfort zones.

Just my thoughts..
Stan

Friday, July 9, 2010

The Propofol Availability Conundrum

What does the lack of propofol availability mean to you as a practicing anesthesiologist?

Over the last 6-8 months, our profession has been besieged by many different forces making our job to provide our comprehensive level of high quality anesthesia services very difficult. Our focus is always to make sure our patients have the best and safest experience that is available to them for their surgical and therapeutic procedures.

In addition to numerous drug shortages, we have been engaged with having our voices heard with regards to the healthcare reform initiatives and Medicare payment policy issues.

As many of you know, over the last few months the sedative-hypnotic, propofol, a mainstay for practicing anesthesia personnel has been difficult if not impossible to attain. Numerous production interruptions and decisions by manufacturers to leave the market have severely hampered our clinical options. The American Society of Anesthesiologists has been constantly updating the anesthesia community and working closely with the FDA (Federal Drug Administration) to overcome these severe propofol shortages. Just last week Teva announced it was no longer going to produce propofol and Hospira has recalled numerous lots of its propofol. APP who markets and produces generic propofol/Diprivan and Fresenius Propoven is really the only viable option at this point. What was a very affordable and readily available drug is now not so inexpensive and not so available.

Anesthesiologists and anesthetists function in many practice settings from the operating room to the endoscopy suites and beyond. We are resourceful clinicians and have been challenged to provide the best and safest pharmaceutical options to our patients. There have been anecdotal increased utilizations of Pentothal and ketamine for use with inductions as well as the use of etomidate has been on the increase. The costs and availability of these drugs has also been altered as well. Brevital is even being used as well.

Precedex which is traditionally an ICU drug and now has an application as a MAC sedation agent (monitored anesthesia care) is an option; but the costs are fairly prohibitive compared to generic propofol and it too has characteristics that make it cumbersome to use in various clinical settings.

These drugs are not so easily available and have been universally displaced by the overwhelming use of propofol. What other options exist? Most recently in November of 2009, Eisai introduced Lusedra (fospropofol) which was approved as a sedative-hypnotic for use as MAC sedation in diagnostic and therapeutic procedures. It is a prodrug form of propofol and thus has different pharmacodynamics and pharmacokinetics. It is a viable option that provides a consistent level of propofol-like sedation with a single bolus injection.

We continue to utilize benzodiazepenes and narcotics to balance our delivery of care to our patients but there are a few alternatives that may have a role in our toolbox. Anesthesia providers take pride in the quality of the care in which they provide their patients.

We can revisit some of the older drugs which we have almost uniformly dismissed; or we have the option of learning new medications and using our clinical acumen to take our profession and the care of our patients to an even greater level.


Just my thoughts,

Stanford Plavin MD
President Ambulatory Anesthesia of Atlanta LLC
Board Vice Chair: Preventing Colorectal Cancer.org
DrP@propofolshortage.com


For more information check out the following sites:

www.preventingcolorectalcancer.org

www.fda.gov/Drugs/DrugSafety/Drugshortages/ucm207290.htm

www.ASAHQ.org