Explaining compound drugs and their ties to fungal meningitis outbreak

So what is a compound pharmacy, one of which is the focus of attention in the national outbreak of fungal meningitis?

Once upon a time, perhaps with a mortar and pestle on the window but also in the hands of the proprietor inside the store, a local pharmacist mixed medicine prescribed by the local doctor for whatever ailed the local patient.

The goal was to create a "compound" that fit the needs of that person, who might be unable to swallow a pill and required a liquid, or was allergic to the filler in most drugs or needed a slightly different dose from more common forms.

In varying degrees, this has occurred for centuries, long before global pharmaceutical companies, factory standardization of pills, bubble and sealed packaging, and the U.S. Food and Drug Administration.

Today, millions of consumers get drugs by mail order pharmacies or from local pharmacies in the shape and dosage that came from the factory. But about 1 percent to 3 percent of the 56,000 or so community pharmacists do compounding, and many provide great service. Many hospitals have pharmacists that also create compound medications.

Money and a regulatory gap gave rise to the New England Compounding Pharmacy, also known as the New England Compounding Center (NECC). Critics of the company said it acted more like a large-scale manufacturer, which would subject it to different regulation.

Then NECC shipped 17,000 supposedly sterile vials of injectable methylprednisolone acetate to clinics and hospitals around the country to treat patients for pain. Some of the vials apparently contained a fungus that caused meningitis. The company has shut down operations.

No cases have been reported in Pennsylvania, but the New Jersey Health Department reported that state's first case on Tuesday. The Centers for Disease Control and Prevention said that as of 5 p.m. on Tuesday, there were 119 cases in 10 states, with 11 deaths.

Whether it's a company or a mom-and-pop compounding pharmacy, said David Miller, who lives in Horsham and leads the International Academy of Compounding Pharmacists, the issue is: "Do you have a prescription?"

How can you have one prescription for a shipment with so many vials?

"Exactly," Miller said, mentioning one criticism of NECC. "Whether you are a manufacturer or a compounder, the differentiation is whether there is a prescription."

Regulatory jurisdiction is a problem. The FDA clearly can regulate drug manufacturers by approving medicine and inspecting factories. But as Miller's organization's website approvingly notes, "There is no such thing as an 'FDA-approved' pharmacy."

State boards, including in Pennsylvania and New Jersey, regulate pharmacies, as they do doctors, and not the FDA.

FDA officials indicate that the agency feels hamstrung by a 2002 Supreme Court decision that limited the agency's ability to regulate pharmacies, though the agency had issued a warning letter to NECC in 2006 after complaints of repackaging of a drug, inappropriate production of a cream and orders filled without prescriptions.

Miller and former FDA general counsel Sheldon Bradshaw, who represents drug manufacturers and compound pharmacies, argue that the FDA has the necessary authority but hasn't chosen to use it to stop rogue operations such as NECC.

"That isn't the traditional practice of a compounding pharmacy," Bradshaw said. "That is being a drug manufacturer."

Miller notes that only three states - Pennsylvania, Massachusetts and Georgia - don't require companies to get a license to ship drugs into their state.

"Something is wrong with that," Miller said, though he also criticized the clinics that ordered from NECC, which had no accreditation.

"Why would a clinic or hospital in Tennessee or California order from a pharmacy near Boston?" Miller asked. "Whenever you order medicine, you need to know where it comes from. When they saw that NECC was masquerading as a manufacturer, did the doctors and clinicians do the necessary due diligence?"