COMPOUNDED STERILE PREPARATION VERIFICATION

To advocate that health systems adopt automation and information technology to facilitate in-process and final verification of compounded sterile preparations (CSPs) to ensure CSP quality; further,

To advocate that, until such time as automation or technology can be implemented, independent in-process and final verification of CSPs be performed; further,

To oppose the use of the syringe pull-back method or other proxy methods of CSP verification.

Rationale

Adoption of automation and information technology for preparing and dispensing compounded sterile preparations (CSPs) is increasing but not evenly distributed among healthcare organizations. A 2017 ASHP survey showed that 64% of hospitals did not use any technology for sterile product preparation activities. Only 26.9% of health systems surveyed employed barcode verification in their IV medication preparation and verification process. The survey found that 12.8% of all health systems surveyed used drug workflow software to manage IV drug preparation, verification, and dispensing. There are many reasons for these disparate rates of adoption. Each institution has a different break-even point of investment versus return, and challenges of implementation can be daunting. Some organizations have implemented automated compounding technology only to withdraw it later. These technologies may slow the preparation and verification process; however, the enhanced safety outweighs losses in operational efficiency.

Information technology and automation, including robotics, can be used to improve the safety of CSP compounding. Although IV workflow technologies continue to be developed and improved, the majority of pharmacy departments continue to compound manually without the assistance of barcode or other technologies. Health systems have been slow to adopt IV workflow technology, with only 27% of respondents to the 2017 survey indicating their departments use barcode scanning to verify the ingredients in CSPs. If automated procedures are not employed, there are only two methods of in-process or final verification: real-time, direct, and independent visualization, or retroactive, proxy verification (e.g., the syringe pull-back method). The dangers of the syringe pull-back method have been well demonstrated, and the 2016 Institute for Safe Medication Practices (ISMP) Guidelines for Safe Preparation of Compounded Sterile Preparations discourage its use.