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Sterile drugs often contaminated, pharmacists admit

As deaths continue to climb in the ongoing outbreak of fungal meningitis infections caused by contaminated pain shots, a new survey of hospital pharmacists shows that they believe it could happen again.

About 13 percent of pharmacists, pharmacy technicians and others who responded to a poll from the Institute for Safe Medication Practices said that they believed contamination had occurred in the compounded sterile drugs made by their shops last year.

Those are the same types of drugs now blamed for 45 deaths and nearly 700 infections in people who received tainted injectable steroids made by the shuttered New England Compounding Center of Framingham, Mass., according to the Centers for Disease Control and Prevention.

Only about half of staff pharmacists in the ISMP poll were confident that contamination had not occurred at their site in the past year. And nearly three-quarters of the 412 health care practitioners who responded said that contamination certainly could occur in drugs from their sites that were supposed to be sterile.

“We’ve known that this is a risk and a hazard for a long, long time,” said Mike Cohen, president of the ISMP, which monitors medication safety. “Consumers are still at risk. And they need to know.”

The fungal meningitis outbreak, which has left hundreds of people facing months or years of treatment, is among the “worst public health disasters related to medication in my lifetime,” Cohen said.

ISMP officials wanted to understand if the problems of properly managing high-risk compounded sterile preparations -- known as CSPs -- were as widespread as they thought.

It appears that the answer is yes.

The poll, which included mostly pharmacists, but also pharmacy techs, doctors and nurses, was conducted last November and December, at the height of the meningitis investigation, which was first detected in September.

It focused on how hospitals are managing CSPs, which are either made on-site by trained staff, or purchased from external compounding pharmacies, which includes companies such as NECC.

Sterile injectable drugs are particularly difficult to produce because they require mixing non-sterile drugs and other ingredients, which must be then terminally sterilized to ensure that no contamination such as bacteria, mold or fungi get into the final products.

In the case of NECC, federal inspectors found significant contamination throughout the site, including in the company’s so-called clean room.

But the new poll shows that problems may be present in other places, too. Eleven percent of the pharmacists and 29 percent of pharmacy techs in the study reported they believed there had been contamination of CSPs on site in the previous year. It’s not clear from the poll whether the contamination was detected before distribution, or whether the drugs made it to patients. Nor is it clear whether they reported the problems to hospital authorities or others.

Those are important questions, said Bona Benjamin, director of medication use quality improvement at the American Society for Health-System Pharmacists. If techs responsible for enforcing sterilization requirements under the strict USP 797 guidelines detected contamination as a result of careful testing, then it's a good sign. If the drugs were dispensed, then it's not. 

"Contamination is a well-known risk of compounding sterile products," Benjamin said. "I think the results are very interesting and I think it would bear a little bit of a deeper dive."

The poll also showed that half of the pharmacists were confident that contamination had not occurred on their watch, but that dropped to 38 percent when the pharmacy techs were asked.

Of the quarter of respondents who said that contamination could not occur in their facility, most noted that it was because high-risk CSPs were not prepared in their hospital pharmacies.

Ryan Forrey, associate pharmacy director at The Ohio State University Medical Center, said the ISMP poll underscores that hospitals should use high-risk CSPs only when they're necessary -- and that they should follow strict guidelines. 

"It highlights the need for work practices that are followed consistently and that are effective for reducing contamination," said Forrey, who is affiliated with the James Cancer Hospital and the Solove Research Institute.

The recent poll is only one more indication of the potentially serious problems involving sterile drug contamination, Cohen said. Food and Drug Administration Commissioner Margaret Hamburg faced harsh questioning by Congress in November about the agency’s handling of the fungal outbreak. In December, FDA officials recommended changing the way compounding pharmacies are regulated, in part to keep a closer eye on high-output pharmacies like NECC.

In the meantime, consumers should understand that sterile injectable drugs -- including back pain shots -- may be riskier than even the doctor acknowledges, Cohen said.

“If they’re going to get an epidural injection -- or have concerns about any injection, they should ask,” he said.

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