Six central Alabama hospitals dispensed dangerous medications to patients following a careless pharmaceutical mistake. Nineteen patients received amino acid solution prepared by Meds IV, a compounding pharmacy in Birmingham. Nine of those patients died.
Due to a national shortage of manufacturer prepared solution, the pharmacy “sterilized” 80- to 100-L batches of 15% amino acid solution and added it to adult parenteral nutrient solutions for distribution to Alabama. The solution was contaminated when the pharmacy used unfiltered tap water as part of the solution. The water was contaminated with Serratia marcescens, which led to an outbreak of S. marcescens bacteremia.
The epidemic could have been far worse, but for an infection preventionist on the ball at one of the hospitals who was quick to figure out that each of five patients infected over a four-day period had been administered parenteral nutrient solutions prepared by a single pharmacy. The hospital immediately warned the pharmacy of the tainted solution. The pharmacy traced the shipments and notified facilities that had received the solution. They also stopped preparing the solution until the problem could be identified. Nine days later, Meds IV recalled all of its solutions.
Prior to this deadly mistake, Meds IV had a good reputation and no record of quality-related issues, but inexplicably, personnel at the facility admitted that they occasionally observed “excessive particulate matter” in the container after mixing sterile water and amino acid powder, and did nothing to correct it, or even investigate. There was no prefilter in place, in violation of USP chapter 797, which specifies placing a prefilter of larger-porosity membrane upstream to the sterilizing filter when using a filtration system to sterilize a solution that contains excessive particulate matter. After particulates were observed in the containers, why would the pharmacists on the job fail to act? Is it possible they were unaware of the danger?
The pharmacy workers reported changing the 0.2-µm capsule filters up to five times during a single batch filtration because the process was slowed by particulate matter. This, too, is in violation of policy. USP chapter 797 says that the dimensions of the filter must be sufficient to “permit the sterilization process to be completed rapidly, without the replacement of the filter during the process.”
The investigation also found a number of other violations, including inadequate sampling size for detection of infectious microorganisms and time delays that violate sterilization protocols.
Meds IV is closed, but is that enough? Who should be held responsible for a failure to follow procedures where 19 people got sick and 9 died? Should the pharmacists be found negligent, or is the facility itself solely at fault? You tell me.