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% 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 that have been blamed for 45 deaths and nearly 700 infections in people who received tainted injectable steroids made by the New England Compounding Center of Framingham, Mass. This outfit has been shut down, according to the Centers for Disease Control and Prevention.
ISMP officials wanted to understand if the problems of properly managing high-risk compounded sterile preparations – known as CSPs – were as widespread as they believed it to be. Unfortunately, they were right and the answer is yes. The poll, which included mostly pharmacists, but also pharmacy technicians, doctors and nurses, was conducted last November and December. This was 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.
As we have previously reported, sterile injectable drugs are particularly difficult to produce. That’s 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% 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.
The poll also showed that half of the pharmacists were confident that contamination had not occurred on their watch, but that dropped to 38% when the pharmacy technicians 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.
As you may recall, 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.
Hopefully, Congress will pass the legislation required to give the FDA all of the authority it needs to regulate this industry. While it seems that Congress would do this, the industry’s lobbyists have done a good job over the years in defeating attempts to pass the needed legislation. Perhaps, the public having become more informed will demand action in both the House and Senate.
Sources: NBC News and Associated Press