December 28, 2020
By Bennet Ninan, PharmD
As much as sterility is important to safe compounded sterile preparations (CSPs), accuracy of prepared compounded products is also vital to prevent harmful or fatal medication errors. USP Chapters 797 and 800 provide much needed guidance on safe practices to improve the sterility of CSPs and reduce potential exposures to hazardous drugs. In order to comply with the chapters, health care leaders have poured millions of dollars into their facility’s physical environments and technologies. But it is also important for health care leaders to invest in resources to ensure the accuracy of compounded sterile products (eg, right drug, right base solution, right diluent, right concentration) during the preparation of CSPs. The ISMP Medication Safety Alert! has published many examples of harmful and fatal compounding errors due to inaccurate preparation, over the last 25 years.
Unfortunately, in many hospitals pharmacy technicians still have to use “syringe-pull back” method for pharmacists to visually verify the amounts of CSP ingredients used after the preparations had been mixed. Some EHR vendors have incorporated barcode scanning of the ingredients to verify product selection prior to mixing, through an integrated IV workflow software modules. However, these software’s usually lack imaging or gravimetrics to verify the volume of the ingredients and completed CSPs. Data submitted to ISMP’s National Medication Errors Reporting Program (ISMP MERP) have consistently shown the human-based, manual, post-production verification of CSP ingredients by pharmacy technicians and pharmacists is not reliable for detecting and correcting CSP preparation and dispensing errors. ISMP firmly believes a vital technology for facilities to ensure patient safety is IV workflow management systems. In addition to the barcode scanning capabilities offered by some EHR companies, IV workflow management systems offer imaging and/or gravimetrics to verify ingredient and finished CSP volumes. If used properly, IV workflow managers allow for a true independent double check of compounded sterile preparations. As many parenteral preparations are high-alert medications, the double check process is of great importance to these drugs and others. ISMP also believes overrides performed during the double check process whether it be compounding technology-based alerts or manual checks, should require a pharmacist to review the alerts prior to dispensing.
Although, many hospitals still do not have an IV workflow manager to protect their patients, we are confident change is on the horizon. Just as USP’s safe practices to improve the sterility of CSPs and reduce potential exposures to hazardous drugs are now required standards for facilities, we hope accuracy and CSP error prevention will also become both a leadership and regulatory mandate.
Additional recommendations can be found in the ISMP Guidelines for Safe Preparation of Compounded Sterile Preparations as well as ISMP’s Acute Care Newsletter article entitled CSP Accuracy and Error Prevention Should Be Both a Leadership and Regulatory Mandate