Propofol Shortage and Anesthesiologists
The propofol shortage began in 2009 when two manufacturers halted distribution and recalled several lots of propofol products because of quality problems. In July, 2009, Teva Pharmaceuticals (Teva) recalled five lots of its propofol after 20 patients who received the drug had adverse reactions with flu-like symptoms. Teva discovered high levels of endotoxin, apparently linked to contaminated egg yolk used in the manufacturing process, in vials of the sedative pulled from the affected lots. In November, 2009, Teva recalled eight more lots as a precaution and in May, 2010, Teva informed the FDA it had halted all manufacturing of propofol and wouldn't resume production or distribution of the drug.
Drug shortages can have a profound effect on patient care since they limit the treatment options available to health care practitioners and patients. As well, anesthesiologists face significant potential liability exposure from the risks associated with misusing a product. Anesthesiologists should scrupulously adhere to label instructions for the use of any drug, even during a time of shortage; and, this is especially important for sterile, injectable products such as propofol. The FDA has received numerous reports of adverse events resulting from multiple entries into single-use vials of propofol to obtain multiple doses, contrary to label recommendations. This dangerous practice has resulted in life threatening illnesses due to contamination.
To read more about how the propofol shortage continues to create patient safety concerns and risks for anesthesia providers, download our anesthesia specific risk management newsletter discussing this issue in greater depth.
