Propofol is back in most pharmacy cabinets now, but the situation is far from ideal. The shortage originally began because two of the three U.S. manufacturers of the drug had problems in their plants, one related to sterility and the other having to do with metal particles in the compound. The U.S. Food and Drug Administration (FDA) ultimately cleared both manufacturers to restart propofol production, but one elected not to.
Explore This IssueMay 2011
“So the supply was significantly impaired—right at the time of the worst of the economy—and it never really came back,” said Mauricio Gonzalez, MD, assistant professor of anesthesiology at Boston Medical Center. “The FDA issued an emergency dispensation that allowed us to get propofol from Europe, and a large amount of the supply is now coming from there. The problem is that all manufacturers have different preparations in terms of their inactive ingredients and the media used for suspension of the drug, and you really don’t know which brand you’ll have from week to week.”
Another drug popular for certain otolaryngology procedures recently disappeared from the market altogether. Production of tetracaine, known by the brand name Pontocaine, was discontinued in mid-2010 by its sole manufacturer, Hospira.
“This was a long-acting topical anesthetic agent that was very useful for office-based laryngeal procedures,” said Gregory Grillone, MD, associate professor and vice chair of the department of otolaryngology-head and neck surgery at Boston Medical Center. “I used topical Pontocaine for anesthetizing the surface of the larynx and the surrounding areas during procedures such as flexible endoscopy and lasering of a polyp or lesion, or for a biopsy. It was a much better topical anesthetic than the conventional varieties we are now forced to use, such as lidocaine and novocaine, which are not quite as potent or as long-lasting.”
The implications of ongoing drug shortages can be far more severe than just frustration or inconvenience. Switching from one drug to another usually means an entirely different dosage and side effect profile, which leaves the door open to medical errors. According to a survey done by the ISMP last fall, in at least six cases, patients have died because of mix-ups and dosing errors related to medication shortages. Even when the outcomes haven’t been so dire, a number of patients have experienced adverse events, ranging from respiratory problems to blood clots to hemorrhage.
“We had a very limited supply of morphine last year, which we use frequently with ENT patients,” Dr. Gonzalez said. “So we had to substitute hydromorphone, which is seven to 10 times more potent. That’s very risky when you’re not used to the dosage. Every time we have a shortage and have to change the way we practice, it’s not just forcing us to choose a drug that might be more costly or not do the job quite as well, but it’s also opening the door for accidents.”