Q&A With Brian Williamson of JCB Laboratories – by Rob Kurtz
Brian Williamson, PharmD, is president & CEO of JCB Laboratories.
Q: Can you explain the 60-minute rule for compounded medications per USP 797 and how organizations need to meet this rule?
Brian Williamson: The principle concern of the USP Sterile Compounding Committee was minimizing the risk to patients from medications drawn up from single-dose vials in ambient air or under less than ideal conditions. I’m sure that you have heard of the incidents of contamination from the misuse of single and multiple-dose vials in Las Vegas. There are studies that show microbial growth in media when simulated compounding activities occurred in ambient air environments. In the case of microbial contamination under the immediate-use conditions, one hour is nearly 100 percent guaranteed to not result in colonization or microbial population increase (i.e., not cause patient harm) based on the typical lag time of up to 4-6 hours for many microbial inoculations under ideal growth conditions.
Validating the efficacy of this practice is not easily tested at the individual patient level because the rates of failures are often low. Because of this, we need to understand that the traditional evidence-based approach cannot be the sole source of information for advancing patient safety. Many of the improvements in medicine, particularly anesthesia practices and aviation safety, were not built on evidence that certain practices reduced the frequency of errors or crashes. It relied on the widespread implementation of hundreds of small changes in procedures, equipment, training and organization that aggregated to establish a strong safety culture and amazingly effective practices. These changes made sense; were usually based on sound principles, technician theory, or experience; and addressed real-life problems, but few were subjected to controlled experiments. The one-hour timeframe was one of those small changes targeted at preventing contamination.
How do organizations meet this rule? Logistically, it has some challenges but they can be overcome with staff training and understanding why the rule is in place. Many facilities are outsourcing activities such as drawing up syringes for cases or mixing products together. Reputable compounding pharmacies are able to perform many of these activities and those that specialize in preparing sterile products should have the facilities to ensure longer shelf life dating.
Note: Thank you to Eric Kastango, who served on the USP Sterile Compounding Committee, for providing some of the information referenced in this response.
Reprinted with permission of ASC Review. Copyright ASC Communications. For the original article, please click here.