The troubled and recently high-profile sedative propofol may be headed to the controlled substance list. The Drug Enforcement Administration is circulating a proposal to classify the drug, linked to singer Michael Jackson's death a year ago, as a Schedule IV substance, reports Pharmacy Practice News.
The drug has been in short supply recently, thanks to production issues at Hospira and Teva two of the major suppliers in the U.S. APP Pharma is another supplier.
Teva has decided to stop making the anesthetic, citing the complexity of its manufacture and low profit margin.
Hospira is on a propofol production comeback. Particle contamination led to a recall in March, followed by an FDA warning letter in April. That same month, the company submitted a proposal for process improvements, including installation of a finer micron filter to capture sub-visual particles. The FDA has accepted the filter change, says spokesman Daniel Rosenberg, via email. The regulator subsequently asked the company to explore additional manufacturing process enhancements, including improved filtration of the starting material.
Regarding propofol, Rosenberg says Hospira will work with the DEA and regulatory officials as they move through the classification decision. "If propofol is classified as a Schedule IV substance, Hospira will implement the required regulatory standards for the manufacture and distribution of our product to be in compliance."
The Schedule IV classification will likely cause headaches for anesthesiologists and hospitals in terms of recordkeeping and logistics. But the move also is apt to save lives, the article says, including those of the anesthesiologists and nurses who sometimes fall victim to the euphoric mood the drug produces, which can lead to abuse.
- here's the article