Health Department: 129 Minnesota clinics received drugs from Massachusetts pharmacy

• Injectable steroids

This photo provided by the Minnesota Department of Health shows shows vials of the injectable steroid product made by New England Compounding Center implicated in a fungal meningitis outbreak that were being shipped to the Centers for Disease Control and Prevention in Atlanta from Minneapolis. About 17,700 single-dose vials of the steroid sent to 23 states have been recalled. The outbreak involves 10 states, including Minnesota. (Minnesota Department of Health / Associated Press)

Talk about it

The Minnesota Department of Health now says 129 clinics in Minnesota received potentially tainted injectable drugs from a Massachusetts pharmacy linked to a meningitis outbreak.

The number of clinics was revised after U.S. health officials said two more drugs from the New England Compounding Center in Framingham, Mass., are being investigated. The state Health Department is contacting those clinics to make sure they are contacting their patients who were given the drugs.

Previously, health officials were focusing on contacting and evaluating patients who received injections of a steroid suspected of being contaminated. In Minnesota, that amounted to about 985 patients who received spinal injections at Twin Cities pain clinics. Almost all of those patients have been contacted.

The FDA is now advising health-care professionals to contact patients who were administered any injectable medication from the compounding center, including a drug that is used in conjunction with eye surgery, or a cardioplegic solution produced after May 21.

The department was unable to provide a list of the Minnesota clinics because it was still sorting out a rough list of purchase agreements provided by the Food and Drug Administration, said Doug Schultz, a spokesman for the Minnesota Department of Health. He said that by the time it sorts through the list, the clinics will know if they received products and will have told any patients receiving any of its drugs.

The FDA says health-care providers and clinics should inform patients who received the products of the symptoms of possible meningitis infection and tell them to contact their health-care provider immediately if they experience any of these symptoms.

Seeking the source

The number of confirmed fungal meningitis cases in Minnesota linked to tainted steroids remains at five. Nationwide the outbreak has killed at least 15 people and sickened more than 200 others in 15 states. Nearly all the victims had received steroid injections for back pain.

Federal and state investigators have been tightlipped about any problems they may have seen at the New England Compounding Center or whether they have pinpointed the source of the contamination. They did disclose last week that they found fungus in more than 50 vials from the pharmacy.

Company spokesman Andrew Paven said by e-mail that criminal investigators from the Food and Drug Administration were at the pharmacy on Tuesday. The visit was part of a broad federal and state investigation of the outbreak, FDA spokesman Steven Immergut said in an e-mail.

New England Compounding has not commented on its production process or what might have gone wrong, so outside experts can only speculate. But the betting money seems to be on dirty conditions, faulty sterilizing equipment, tainted ingredients or sloppiness on the part of employees.

The drug at the center of the investigation is made without preservative, meaning there’s no alcohol or other solution in it to kill germs such as a fungus. So it’s very important that it be made under highly sterile conditions, experts said.

Compounding pharmacies aren’t as tightly regulated as drug company plants, but they are supposed to follow certain rules: Clean the floors and other surfaces daily; monitor air in “clean rooms” where drugs are made; require employees to wear gloves and gowns; test samples from each lot.

High-volume production of the sort that went on at New England Compounding raises the chances of contamination, experts said.

Traditionally, compounding pharmacies fill special orders placed by doctors for individual patients, turning out maybe five or six vials. But many medical practices and hospitals place large orders to have the medicines on hand for their patients. That’s allowed in at least 40 states but not under Massachusetts regulations.

Last month, New England Compounding recalled three lots of steroids made since May that totaled 17,676 single-dose vials of medicine — roughly equivalent to 20 gallons.

“I don’t see it as appropriate for a community pharmacy to do a batch of something preservative-free in numbers in the thousands” of doses, said Lou Diorio, a New Jersey-based consultant to compounding pharmacies. Diorio, who has no connection to the investigation or the company, said it is harder to keep everything sterile when working with large amounts.

Whatever happened at New England Compounding, it probably wasn’t unique.

Just last year, there were at least three apparently similar incidents: At least 33 patients suffered fungal eye infections traced to products made by a compounding pharmacy in Ocala, Fla.; at least a dozen Florida patients were blinded or damaged in an outbreak linked to a compounder in Hollywood, Fla.; and the deaths of nine Alabama patients were attributed to tainted intravenous nutritional supplement provided by a compounder in Birmingham.

“These events have been happening once or twice a year for the last 15 years,” Kastango said. “We wouldn’t tolerate this if a plane crashed once or twice a year. But in health care, we’ve grown desensitized to these kinds of problems.”

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