November 9, 2009
Update: Propofol and Thiopental supply information and Listen to recording of ASA/FDA call from 11/06
ASA has been working in conjunction with the U.S. Food and Drug Administration (FDA) to address the current supply problems involving the anesthesia induction agents, propofol and thiopental. On November 6, 2009, ASA hosted a joint conference call with the FDA and the American Society of Health-System Pharmacists (ASHP) to provide the latest information on the situation, discuss strategies to address the shortage and to answer questions from members. To listen to a 1 hour recording of the conference call, click here.
The following link to the FDA website contains the latest information on the availability of Propofol and Thiopental. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
According to the FDA’s Director of the Division of Anesthesia, Analgesia and Rheumatology Products in the Center for Drug Evaluation and Research, some hospitals and pharmacies may experience propofol shortages through the end of November and perhaps into early December. However, the FDA’s Drug Shortage Program is working with the three major suppliers of propofol (APP, Hospira and Teva) to ensure that adequate product remains available.
The shortage of propofol is a result of overlapping recalls of the drug by manufacturers Teva and Hospira due to contamination issues.
As of November 6, 2009, FDA reports that APP has ramped up production and all vial sizes are available. In addition, they are direct shipping to hospitals rather than shipping though wholesalers to better manage their inventory. Hospira just released a new supply of 20ml and 100ml vials this week and expects to release more product as early as next week. Teva is getting its production back online but product will likely not be available until December.
The status of alternative agents is as follows:
Thiopental: Is currently unavailable due to a problem with production and product will not be available until late December or the first of the year.
Methohexital, Ketamine, and Etomidate manufacturers are still reporting adequate supply.
Fospropofol is currently being distributed to hospitals and should be available by November 16th but it is important to note that fospropofol is only indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. It is not indicated for general anesthesia.
The following strategies to address the problem were discussed during the call:
Importation of Propofol: FDA is investigating the possibility of importing propofol from foreign manufacturing facilities. The agency will first look to U.S. manufacturers with overseas operations. Before FDA considers emergency importation the agency must first conduct a compliance to ensure that the facility is an approved site that meets the strict FDA standards and that the imported product meets FDA’s product guidelines.
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.
Postponement of Elective Surgeries: To the extent possible, elective surgeries that require the use of propofol are encouraged to be postponed.
Limit hoarding or bulk ordering: Hospitals, ASCs, pharmacies and wholesalers should refrain from these practices in order to ensure that product is available to those facilities and patients who truly need the drug.
If your hospital or practice is experiencing a drug shortage or a problem securing any drug, please contact the FDA Drug Shortage Group at drugshortages@fda.hhs.gov. 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/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/GettingStarted/CurrentShortages/Bulletin.aspx?id=573
Shortage Information about Thiopental: http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/GettingStarted/CurrentShortages/Bulletin.aspx?id=563