Last week, Teva Pharmaceutical Industries announced it will stop manufacturing propofol injection, and soon after, Hospira expanded its recall of Propofol Emulsion 1% due to possible contamination. With these two major players out of the market, many healthcare providers will need to plan alternatives until the supply can be replenished.
How did the shortage begin?
According to the Food and Drug Administration, the shortage began when two of the three companies manufacturing propofol injection — Teva and Hospira — halted production and recalled vials of the drug due to a manufacturing error. The Teva recall began in July 2009, and Hospira in the fall.
Because propofol is an older drug, many manufacturers had already dropped out of the market because they were not making a profit in the drug, according to the FDA. Propofol was first approved in 1989, with other formulations appearing in 1998. As a result, with fewer manufacturers in the market, a loss of one, and especially two, major players resulted in the shortage.
What has the FDA done to address the shortage?
In March 2010, the FDA reauthorized the third propofol manufacturer, APP Pharmaceuticals, to import Fresenius Propoven 1% (1 percent propofol), approved for use in countries outside the United States and manufactured in FDA-approved facilities. APP has also increased manufacture of its propofol products. APP also issued a letter regarding special considerations for using Propoven.
The FDA, however, cannot force a company to continue to manufacture a drug that is in a shortage or require the company increase its supply, except in cases when it is the sole company supplying a medically necessary drug, according to the FDA’s website. The FDA is continuing to work with manufacturers to develop alternatives to reduce the shortage.
What is the current state of the propofol supply?
According to the FDA drug supply website, the current supply (as of May 28) is as follows:
- Teva — Specific lots continue to be recalled due to possible sterility issues. The company is withdrawing from the propofol market.
- Hospira — The company recalled specific lots due to presence of particulate matter in vials. It has released some propofol 20 mL, 50 mL and 100 mL and expects additional quantities in the coming months.
- APP — The company has increased production in response to the increased demand.
The FDA encourages providers to report drug shortages as soon as possible so the agency can quickly to prevent shortages from worsening. The agency has provided a Q&A section on its website specifically for the propofol shortage.
