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Health

Report finds state oversight of compounding pharmacies lax

Food and Drug AdministrationEdward J MarkeyAmerican Medical Association

As Massachusetts closed another compounding pharmacy for unsanitary conditions, a report released Monday argued that the state boards that regulate those pharmacies are doing an inadequate job.

Released by Massachusetts Rep. Edward J. Markey, the report stems from the national fungal meningitis outbreak linked to a steroid from the New England Compounding Center that has sickened 354 people in 19 states and killed 25. In Maryland, 20 people have been sickened and one has died.

Maryland was among 34 states that the report found had "problematic" compounding practices. The state's compounding pharmacies, which make specialty drugs that aren't sold commercially, are regulated by the Board of Pharmacy.

Markey's analysis found 23 other deaths and at least 86 serious illnesses — unrelated to the current outbreak — linked to compounding pharmacies in the United States.

"This analysis makes clear that state regulators are not, or cannot, perform the same sort of safety-related oversight of compounding pharmacy practices that FDA has historically undertaken," the report said as it argued for more federal oversight of the facilities.

LaVerne G. Naesea, executive director of the Maryland Board of Pharmacy, said she could not immediately comment on the report.

The Massachusetts Department of Health said over the weekend that it had closed a second compounding pharmacy, Infusion Resource, after a state inspection found unsanitary conditions.

The industry group that represents the pharmacies said that New England Compounding was operating as a manufacturer rather than a compounder.

"Existing law gives FDA and the states the authority to oversee all pharmacies including those that compound, as well as manufacturers," the International Academy of Compound Pharmacists said in a statement. "Any pharmacy in the U.S can be inspected at any time by either the FDA or state authorities. Now we must make sure that happens. Compounding pharmacies do not fear inspections, they expect them."

The report analyzed data from state boards, FDA documents and media reports. It found that compounding pharmacies around the country made drugs with ingredients that weren't FDA-approved, mixed drugs in visibly unsanitary facilities and sold drugs without a prescription.

Only six states had records that they had taken action against compounding pharmacies for illegal or harmful activity.

As compounding pharmacies have grown to operate like large drug manufacturers, consumer groups and government officials have argued that state boards don't have the resources to properly regulate them. Most of the regulation of these facilities is in state hands.

Maryland Health Secretary Joshua M. Sharfstein argued in an article last week in the Journal of the American Medical Association that the FDA should regulate compounding pharmacies and the states should play more of a supportive enforcement role.

The FDA has tried to increase its authority over compounding pharmacies but has been thwarted by legal challenges from the industry. The regulatory agency has used its authority to issue warning letters to try to stop some bad practices, the report found.

The information found on many state board websites is limited and makes it hard for consumers to see violations by pharmacies, the report said. The boards tend to regulate using standards for traditional pharmacies, the report said.

In Maryland, the pharmacy board licenses facilities and inspects them once a year, like any other pharmacy. State law also requires the facilities to meet some of the guidelines under the U.S. Pharmacopeial Convention, a voluntary group that sets drug safety standards.

The report listed four incidents in which Maryland was confronted with tainted drugs from compounding pharmacies, according to FDA records. In 2004, 16 patients in the state got hepatitis C after getting injections of a drug used for imaging of the heart. The patients were the only ones injected with the drug from a single vial prepared at a pharmacy that delivered to three clinics, the report found.

In July 2005, the FDA sent a letter to Cape Drugs in Annapolis because its drugs contained domperidone, which had been found to cause cardiac problems and sudden death in some patients in several countries.

A month later, a Minnesota company initiated a nationwide recall of a drug used in eye surgeries because it was contaminated with bacteria that could lead to blindness. The drug was distributed to hospitals and clinics in Maryland.

In September 2005, the FDA notified hospitals of the recall of a drug made by Central Admixture Pharmacy Service in Lanham. The products were recalled because of concern they caused sterility.

andrea.walker@baltsun.com

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