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Custom-mixed medicines like the steroid shots suspected in a deadly meningitis outbreak have long been a source of concern, and their use is far wider than many people realize.
These medicines are made in private and hospital "compounding pharmacies" and are used to treat everything from menopause symptoms and back pain to vision loss and cancer. Unlike manufactured drugs, these specialty products are not subject to approval by the Food and Drug Administration.
They are often drugs obtained from manufacturers that are split into smaller doses, or drug combinations mixed from ingredients sold in bulk. Any of those steps can easily lead to contamination if sterile conditions aren't maintained. For example, the fungus suspected in the current meningitis outbreak can spread in the air.
The risks from these products also may be compounded by the national shortage of many drugs. That has forced doctors to stretch supplies and seek custom-made alternatives if the first-choice treatment was not available. The steroid suspected in the current outbreak has been in short supply.
"Because of the incredible number of drugs that are out of stock or back-ordered, compounding pharmacies are working with local hospitals, clinics and physicians to fill that gap," said David Miller, executive vice president of the International Academy of Compounding Pharmacists, a trade organization.
These products have had remarkable growth. More than 7,500 compounding pharmacies operate in the U.S., up from 5,000 in 2009, Miller said. They account for a $3 billion segment of the drug market and 3 percent of all prescriptions filled.
Some say this industry needs more regulation.
"There's not a lot of oversight of compounding pharmacies" compared with drug manufacturers, said Allen Vaida, executive vice president of the Institute for Safe Medication Practices, a suburban Philadelphia advocacy group that tracks medication errors.
The outbreak of fungal meningitis has sickened at least 35 people in six states. Five of them have died. They all received steroid shots, mostly for back pain.
The FDA has said the steroid came from the New England Compounding Center, based in Framingham, Mass. The company recalled three lots of the drug last week and has said it has voluntarily suspended operations and is working with regulators to identify the source of the infection. Investigators also are looking into the antiseptic and anesthetic used during the injections.
Compounding pharmacies are supposed to supply products to meet unique patient needs, and to prepare drug products that are not available commercially, based on an individual prescription. They may cross a line if they supply a product on a large scale to a clinic or hospital without individual prescriptions, Miller and other experts said.
"They, in effect, since they do this on a large scale, have become mini-pharmaceutical companies," said William Schaffner, an infectious-disease specialist at Vanderbilt University.
That appears to be the basis for an FDA warning to the New England company and four other firms in December 2006. The FDA told them to stop compounding and distributing anesthetic creams "marketed for general distribution rather than responding to the unique medical needs of individual patients."
In May, officials reported 33 cases in seven states of a fungal eye infection stemming from products mixed in a Florida pharmacy that also prepared supplements that killed 21 elite polo horses in 2009.
In 2007, three people in Oregon died after using a compounded drug that was 10 times stronger than it was supposed to be. In 2006, the FDA sent a warning to a Maryland pharmacy for a bacteria-contaminated solution used in open-heart surgery; five patients at a Virginia hospital developed serious infections and three died.
The same steroid in the current outbreak was also tied to five cases of a different type of fungal infection in North Carolina in September 2002. Those patients also had shots from pain clinics, and one died.