A: Until other much-needed changes occur, you should only use a medication from a compounding pharmacy if no other FDA-approved product is available, say our medical advisers. Compounding pharmacies create individual, customized drugs. They can, for example, omit ingredients such as lactose or gluten for people with allergies, flavor drugs to make them easier to take, create lower doses for children, or prepare a liquid, dissolvable lozenge, or suppository for those who can't swallow a capsule.
The national meningitis outbreak, which has sickened at least 451 people and claimed the lives of 32, has heightened concern about the safety of compounding pharmacies. There are 7,500 in the U.S., plus about 8,200 associated with hospitals and other health institutions. They are mostly regulated by state pharmacy boards, whose rules vary. The Food and Drug Administration cooperates in investigations and follow-up actions, but it has limited oversight of the pharmacies, according to a recent Congressional Research Service report.
"Regulation of compounding pharmacies by state boards of pharmacy is not uniform throughout this country and it should be," says Marvin M. Lipman, M.D., chief medical adviser for Consumer Reports. "In addition, all large-scale compounding pharmacies should be under the purview of the FDA before another tragedy occurs."
The drugs implicated in the current crisis came from a single pharmacy, the New England Compounding Pharmacy, which compounded more than 17,000 doses of the potentially tainted steroids and shipped it to 76 healthcare facilities--where an estimated 14,000 patients received the injections to treat pain. By compounding so much medication, the "pharmacy was behaving more like a drug manufacturer. Instead, compounding is meant to respond to individual patient needs on a small scale," says Cynthia Reilly, B.S. Pharm, director of the practice development division of the American Society of Health-System Pharmacists.
Clinics and hospitals might purchase compounded medications when there is a shortage of a certain drug and it becomes difficult to obtain a standard version from a distributor or manufacturer. In other cases, compounders may create a less expensive version of an FDA-approved drug without having to meet the agency's strict manufacturing standards.
The major risk from compounding lies with drugs that are injected, delivered through an intravenous (IV) line, used in the eyes, or inhaled through a nebulizer. Such medications must be completely germ-free in order to prevent infection, and the meningitis tragedy demonstrates the harm that can occur if they're not.
If you are scheduled to receive an intravenous, joint or spinal injection, ask if the material was compounded and whether the compounding pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB). That advice also applies if you receive injectable eye medication or eye drops in connection with an eye operation or procedure. "In light of the current situation, health-care providers will be expecting to hear these questions much more frequently," says Reilly.
For all other medications, if your doctor prescribes a drug compounded especially for you, ask if a standard FDA-approved formulation is available and appropriate for your treatment instead. But if not, "consumers shouldn't be afraid to use a compounding pharmacy if they need a product that's not available, such as an ointment instead of a pill, and they have a prescription from their physician for it," says Allen Vaida, PharmD, executive vice-president of the Institute for Safe Medication Practices.
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