Sterile compounding: Pharmacy profession should take back control


The recent USA Today article on hospital I.V. outsourcing and the ongoing patient safety problems it creates for hospitals and the communities they serve is one more call to action for our profession. The concern is that we have not been engaged enough in demanding safety measures or proposing counter measures to outsourced I.V. compounding.

It has been 2 years since the New England Compounding Center disaster, and yet patients continue to be harmed by contaminated sterile products produced by an industry that exists in the gray zone of regulatory oversight and control.

The USA Today report highlighted the latest in a continuing succession of quality problems—this time at Specialty Compounding in Texas, which resulted in two deaths and numerous patients sickened due to contaminated products. More importantly, the report reinforced that legislative attempts at control aren’t the only solution. FDA had inspected Specialty Compounding about 5 months before the patients received the contaminated products and identified numerous and significant quality problems that were detailed in a formal FDA “483” report. Obviously, follow-up was insufficient at best. Furthermore, during inspections of 150 compounding centers, the FDA found 90% of them had safety and sanitary problems that warranted corrective action. Just in the past year, 28 warning letters have been issued.

We can’t accept these conditions. It is time for the pharmacy profession to stand together and take back control of sterile compounding.

We all know that sterile compounding is challenging. It is one of the highest risk areas of pharmacy practice, and yet it has little technology to support safe compounding. Bar code medication preparation is used in less than 10% of hospital clean rooms, and only about one-third of hospital pharmacy directors report that they are truly USP [U.S. Pharmacopeia Chapter] <797> compliant. Since most hospitals and health systems have been unable to meet increasing I.V. output demands without significant investments in facilities and personnel, it’s understandable how outsourcing would seem to be a viable option. The American Society of Health-System Pharmacists has developed comprehensive standards for outsourcing, but these are challenging to adopt, and unfortunately it comes at great cost.

Pharmacy needs to continue to build a safer medication system for our patients and staff. Fortunately, technology is catching up with our needs in the I.V. room. Workflow technologies are available that incorporate bar code scanning of the medications and diluents entering the I.V. compounding process. Bar code–enabled I.V. compounding should be the standard rather than the exception, and gravimetric dose verification must be integrated into our admixture processes to ensure accuracy of the end product.

With the recent advances in total robotic I.V. compounding technology, it is time to evaluate compounding robots. Peer-reviewed studies have shown that robotics-based I.V. automation solutions can support in-house compounding by helping pharmacists and technicians to more safely and efficiently produce I.V. medications, while reducing errors, increasing throughput, and lowering costs associated with I.V. compounding and dispensing through risk reduction. Robotics and supportive technology provide a new standard in aseptic compounding as well.

For the first time in decades, there are now tools that can help us automate our I.V. rooms, along with other areas of our pharmacy, and provide the level of safety and productivity we need to take back control of our I.V. compounding.

It is our responsibility to rise to the challenge. Accountability is something we cannot outsource.