The following comments are from Daniel Van Riper, MD, an anesthesiologist for Blair County Anesthesia in Altoona, Pa., in response to "Impact of the Propofol Shortage on Anesthesiologists: Q&A With ASA President Alexander Hannenberg."
I think the ASA or APSF should consider encouraging the FDA send out a Medical Alert on the Fresenius propofol (Fresenius Kabi LTD) recently approved for use in the United States to address the national shortage of propofol now that TEVA is not going to make propofol.
Fresenius propofol does not meet the safety standards that TEVA's propofol and Baxter's propofol have. It does not contain antimicrobial preservatives (EDTA or sulfites) to reduce the risk of growing bacteria during handling, which might serve as cause for septicemia in patients. In the United States, these preservatives have been included for the past 15 years or so.
I believe propofol was not approved for extended IV sedation in the ICU until the efficacies of antimicrobial properties of EDTA were shown. I wonder whether the FDA should advise that Fresenius propofol not be used in the ICU setting.
My conversations to hospital pharmacists and propofol administrators (anesthesiologists, CRNAs and intensive care personnel) seem to indicate that few providers were aware of the function of EDTA or sulfites in propofol and even fewer have looked to check whether Fresenius propofol even had these preservatives.
Recent litigation and production issues have led to this shortage of Propofol. While Fresenius helps to address this shortage, I am concerned that providers need to be advised to handle this drug almost in an aseptic fashion and to discard any drug once opened after six hours or we will see an increased incidence of septicemia from contaminated Propofol.
The public should be advised that drug shortages have become routine, causing providers to make clinical decisions based availability of the drug that is available. When it comes to propofol, we do not choose what brand to administer or whether to use vials with volumes appropriate to that specific case. Less appropriate alternatives, like Sodium Pentothal, have been taken off the market. The public only hears through the media that harm is being done to them from drug "mistakes" in the hospital. If the public is informed of the problems we face on regular basis, the court system and juries perhaps will have to consider these problems when a less than optimal outcome arises.
One other observation is that Fresenius propofol seems to be significantly less potent (more than 10 percent) than TEVA propofol. I make this statement based on clinical observation and not scientific study. I wonder whether any other anesthesia providers agree with this observation.
I think the ASA or APSF should consider encouraging the FDA send out a Medical Alert on the Fresenius propofol (Fresenius Kabi LTD) recently approved for use in the United States to address the national shortage of propofol now that TEVA is not going to make propofol.
Fresenius propofol does not meet the safety standards that TEVA's propofol and Baxter's propofol have. It does not contain antimicrobial preservatives (EDTA or sulfites) to reduce the risk of growing bacteria during handling, which might serve as cause for septicemia in patients. In the United States, these preservatives have been included for the past 15 years or so.
I believe propofol was not approved for extended IV sedation in the ICU until the efficacies of antimicrobial properties of EDTA were shown. I wonder whether the FDA should advise that Fresenius propofol not be used in the ICU setting.
My conversations to hospital pharmacists and propofol administrators (anesthesiologists, CRNAs and intensive care personnel) seem to indicate that few providers were aware of the function of EDTA or sulfites in propofol and even fewer have looked to check whether Fresenius propofol even had these preservatives.
Recent litigation and production issues have led to this shortage of Propofol. While Fresenius helps to address this shortage, I am concerned that providers need to be advised to handle this drug almost in an aseptic fashion and to discard any drug once opened after six hours or we will see an increased incidence of septicemia from contaminated Propofol.
The public should be advised that drug shortages have become routine, causing providers to make clinical decisions based availability of the drug that is available. When it comes to propofol, we do not choose what brand to administer or whether to use vials with volumes appropriate to that specific case. Less appropriate alternatives, like Sodium Pentothal, have been taken off the market. The public only hears through the media that harm is being done to them from drug "mistakes" in the hospital. If the public is informed of the problems we face on regular basis, the court system and juries perhaps will have to consider these problems when a less than optimal outcome arises.
One other observation is that Fresenius propofol seems to be significantly less potent (more than 10 percent) than TEVA propofol. I make this statement based on clinical observation and not scientific study. I wonder whether any other anesthesia providers agree with this observation.