There was a conference call between these 3 grps FDA/AANA/ASA conference call re: propofol shortage today at
1. The FDA is aware of the shortage of Propofol and is attempting to exert whatever influence it can on companies to promote production.
2. The FDA encourages individual practitioners to maintain the best safety practices for their patients.
2. In spite of the shortage the FDA encourages individual practitioners to understand 20, 50, and 100ml vials are intended for single use.
3. The FDA is now aware of various sellers of the product charging big fees for propofol.
4. The FDA is aware of other products facing shortages but appreciates information to that effect via email on their website.
5. The FDA may have whiffed on notifying us that 2 different manufacturers of Propofol were having difficulties manufacturing/keeping up with the need after some recalls.
the recalled products from TEVA and Hospira were both contaminated with microorganisms and particulate matter.
More info can be found at the FDA website HERE
According to the FDA the three propofol manufacturers are currently
reporting the following:
· APP has Diprivan 10 mg/mL injection in 20 mL vials (NDC
63323-0269-20), 50 mL vials (NDC 63323-0269-50), 100 mL vials (NDC
63323-0269-65), 20 mL Novaplus vials (NDC 63323-0269-27), 50 mL
Novaplus vials (NDC 63323-0269-57), and 100 mL Novaplus vials (NDC
63323-0269-67) and is currently allocating to conserve supplies and is
increasing production and releasing additional propofol this week.
The firm anticipates that supplies will continue to improve over the
next several weeks.
· Hospira anticipates that the 20 mL and 100 mL vials will be
released within two weeks, and the 50 mL vials have an estimated
release date of early-December, 2009.
· Teva plans to have product available again by the end of the year.
If your hospital or practice is experiencing a drug shortage or a
problem securing any drug, please contact the FDA Drug Shortage Group
at firstname.lastname@example.org. Your report will help FDA address the
problem more quickly for all.
Further, specific information can also be found at the following links
for the American Society for Health-System Pharmacists:
Drug Shortages: http://www.ashp.org/DrugShortages/Current/
Shortage Information about Propofol: http://www.ashp.org/Import/PRACTICEA...in.aspx?id=573
Shortage Information about Thiopental: http://www.ashp.org/Import/PRACTICEA...in.aspx?id=563