Drug shortages have led physicians and hospitals to obtain medications from compounding pharmacies such as the New England Compounding Center-and fallout from the meningitis outbreak may further exacerbate shortages.
Drug shortages have led physicians and hospitals to obtain medications from compounding pharmacies such as the New England Compounding Center—and fallout from the meningitis outbreak may further exacerbate shortages.
Drug shortages are both an underlying cause and likely consequence of the recent fungal meningitis outbreak linked to the New England Compounding Center (NECC), a Massachusetts-based compounding pharmacy. As of Friday, November 9, 2012, the Centers for Disease Control and Prevention (CDC) reported that contaminated steroids produced by the pharmacy had been linked to 438 cases in 19 states and a total of 32 deaths.
The generic form of methylprednisolone acetate, the contaminated injectable steroid behind the infection outbreak, is in short supply. The 2 companies that make it—Teva Pharmaceuticals and Sandoz—have put it on back order with little indication of when they will resume shipments, prompting health-care providers to purchase the NECC version. There is also a brand-name version of the steroid produced by Pfizer, although it is significantly more expensive than the compounded version.
According to a report in MedPage Today from the annual meeting of the American Society of Anesthesiologists in October 2012, compounding pharmacies are a common source of medications that are unavailable or difficult to obtain due to shortages.
The FDA has also announced that the extended shutdown of Ameridose, a drug manufacturer and compounding pharmacy associated with NECC, could lead to increased shortages of other, unspecified medications for hospitals and other health care providers. Ameridose was closed on October 10, 2012, for inspection by state authorities. On October 31, 2012, Ameridose announced a voluntary recall of all of its products, although the company noted that there had been no adverse events associated with its products or evidence that they had been contaminated. The company also noted that the FDA had requested improvements in its sterility testing process.
The FDA announced that the Ameridose recall may exacerbate shortages of 6 injectable products that were already on the agency’s critical shortage list: sodium bicarbonate, succinylcholine, atropine sulfate, bupivacaine hydrochloride, lidocaine hydrochloride, and furosemide. The shortage of sodium bicarbonate has the potential to hit hospitals particularly hard, as it is used in a broad range of situations and is made by only a handful of companies. The FDA announced that it would work with other manufacturers to help alleviate the potential shortages and work to facilitate importation of backup supplies from abroad.