Pharmacies Under Scrutiny in Meningitis Outbreak

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The death toll from the fungal meningitis outbreak is still growing, with 14 people now dead and more than 130 sick.

Now serious questions are being raised about compounding pharmacies. The industry is responsible for 3 percent of the drugs distributed in the United States.

One of those companies, the New England Compounding Center, is responsible for shipping out thousands of contaminated steroid shots to 23 states.

The shots were used by doctors to treat patients with back pain. Health experts fear that the number of cases will continue to grow because many of the victims may not know they've been infected yet.

"Our earliest estimate was in the range of two to 28 days. Based on the analysis of additional case studies, the more accurate analysis appears to be six to 42 days," James Devita, president of the Massachusetts Pharmacy Board, said.

Meanwhile, NECC has surrendered its license, and a second connected pharmacy has shut down for state and federal inspections.

"Ameridose and its partnering distributor will cease distribution of its material or anything under shared ownership. Period," Dr. Madeleine Biondolillo, director of the Mass. Bureau of Healthcare Safety, said.

Drugs dispensed by compound pharmacies are intended to be prescribed to patients with needs that can't be met by already existing medications. This has health officials wondering why thousands of generic steroid shots were shipped out across the country.

"The licensing regulations pertain to compounding pharmacies and, as I mentioned specifically, require the pharmacy to have a patient-specific prescription for every dose that is produced as a result of the compounding process," Biondolillo said.

Congress is calling for increased oversight of the custom-made pharmaceutical industry.

"Because of the current vague patchwork of federal and state oversight and regulation of these pharmacies, consumers are left at risk and often unaware of the differences between these products and others," said Rep. DeLauro, D-Conn., who sits on the House committee that sets the FDA's budget.

The Food and Drug Administration traditionally regulates compound pharmacies, monitoring the ingredients used to make the drugs and making sure that federal and state regulations are followed.

Following the deadly fungal meningitis outbreaks, however, there are new accusations that the FDA was actually aware that NECC had started compounding drugs in large quantities but failed to enforce existing regulations.

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