Published On: Wed, Oct 24th, 2012

Sterility Found Lacking at Drug Site in Outbreak

Sterility Found Lacking at Drug Site in Outbreak. The compounding pharmacy blamed for a deadly national meningitis outbreak repeatedly failed to follow standard procedures to keep its facility clean and its products sterile, Massachusetts officials said Tuesday, painting a harrowing picture of a company that flouted crucial rules as it hurried to ship drugs around the country.

Sterility Found Lacking at Drug Site in Outbreak

Sterility Found Lacking at Drug Site in Outbreak

One finding in particular stands out: the pharmacy, the New England Compounding Center, shipped some orders of the drug implicated in the outbreak without waiting for the final results of sterility testing. And while company records indicate the tests found no contamination, regulators said they were skeptical of the company’s methods.

Records suggest that the company failed to sterilize products for “even the minimum amount of time necessary to ensure sterility,” said Dr. Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department.

The findings raise questions about whether the meningitis outbreak could have been averted, or reduced in magnitude, had proper procedures been followed.

“This was preventable,” said Eric S. Kastango, president of Clinical IQ, a consulting firm that counsels compounding pharmacies. “They failed to properly sterilize this medicine that had to be sterilized. That’s huge.”

Mats used to trap dust and dirt just outside the company’s clean rooms were “visibly soiled with assorted debris,” according to a report released Tuesday by the state’s Board of Registration in Pharmacy, and hoods in the sterile compounding area were not properly cleaned. A leaking boiler next to a clean room “created an environment susceptible to contaminant growth,” Dr. Biondolillo said during a news conference at the State House here.

Investigators are also looking into “the environmental conditions surrounding the business,” she said, including a recycling center on the same property in Framingham, Mass., and owned by the same family. At the same time, the state and the Food and Drug Administration are investigating two related drug companies, Ameridose of Westborough and Alaunus Pharmaceutical of Framingham, which have many of the same owners.

All three companies list Barry Cadden, the chief pharmacist, and his brother-in-law, Gregory Conigliaro, as managers, according to company filings with the state. Mr. Conigliaro’s brother, Douglas, is also involved in the business and, through his wife, Carla, appears to be a major shareholder in the companies, according to state records.

New England Compounding has suspended operations and laid off most of its employees.

The meningitis outbreak has been tied to three lots of a steroid, methylprednisolone acetate, produced at New England Compounding that were contaminated with a fungus. In all, New England Compounding shipped more than 17,000 vials of the suspect drug, which was used mainly for spinal injections aimed at easing back and neck pain.

So far, 304 people in 17 states have contracted meningitis, and 23 have died.

Dr. Biondolillo stressed that the root cause of the outbreak has yet to be determined

Gov. Deval Patrick, speaking at the news conference here, said he had directed the state pharmacy board to “immediately start periodic, unannounced inspections of compounding pharmacies that prepare sterile and injectable medication.” There are 25 such pharmacies in Massachusetts, he said, adding that state rules governing them “have not kept pace with an industry that’s changing rapidly.” Although the F.D.A. can inspect compounding pharmacies and issue warnings, the agency says states have ultimate jurisdiction.

Mr. Patrick said that from now on, compounding pharmacies in the state would be required to submit annual reports on “production, volume and distribution of medication.” That way, he said, the state could better identify compounders that were acting more like manufacturers.

Mr. Patrick added that the state was moving to permanently revoke the licenses of New England Compounding and its three principal pharmacists, including Mr. Cadden. In a statement released after the news conference, Paul Cirel, a lawyer for New England Compounding, said the state pharmacy board had “numerous opportunities, including as recently as last summer, to make firsthand observations” of the company’s facilities and operations.

“Based on that history,” Mr. Cirel said in the statement, “it is hard to imagine that the board has not been fully apprised of both the manner and scale of the company’s operations. N.E.C.C.’s transparency in dealing with the board since inception in 1998 demonstrates its good-faith intention to operate in compliance with the requirements of its license.”

Dr. Biondolillo said there was no indication “at this moment in our investigatory process” that the pharmacy board had done anything wrong.

New England Compounding has a troubled history. It began receiving complaints less than a year after it was established in 1998. Many of the violations involved selling medicine in bulk without a prescription for an individual patient. But there were also more serious violations. For example, state health officials threatened action against the pharmacy in 2004, after the company “failed to comply with accepted standards” when mixing methylprednisolone acetate, the same steroid that has been the source of the company’s current trouble.

In 2006, the pharmacy agreed to inspections and improvement measures to avoid harsher regulatory action, and an outside investigator was brought in to ensure its practices were in compliance. A more recent complaint, made this March, about the potency of a solution used in eye surgery, remains under investigation. But none of the company’s infractions led to its having to suspend operations until now.

Mr. Kastango took issue with an inspection of New England Compounding conducted by the state last year, which found virtually no problems, according to state records released Monday. He said that inspection “seemed to be sort of a drive-by cursory thing.” The inspection report, he said, did not mention that sterility test reports had been reviewed. And it did not involve a new inventory of narcotics.

 

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