In response to a series of serious and fatal compounding errors, the first national ISMP summit was held in 2011. This resulted in the publication of guidelines in 2013 for the preparation of sterile preparations. This document was subsequently updated in 2016.
Recently, ISMP convened another summit, which resulted in the creation of new guidelines for sterile compounding and the safe use of sterile compounding technology that were released in May 2022. These new guidelines reflect the growing complexity and availability of the use of technology in sterile preparation compounding. Despite advances that have occurred over the years, concerns remain regarding safe compounding practices and the expansion of technology.
The purposes of the summit were to review the current state of the use of technology and automation in sterile compounding; to examine sterile compounding–related adverse events; to identify best practices that incorporate the safe use of technology and automation in sterile compounding; and to recommend best practices in sterile compounding in the absence of technology. These guidelines are meant to be used in conjunction with recommendations from the United States Pharmacopeia, the American Society of Health-System Pharmacists, and the American Society of Parenteral and Enteral Nutrition recommendations, as well as with those from regulatory agencies.
The guidelines focus on essential technology attributes, safe pharmacy processes, and safety gaps in three areas: automated compounding devices, IV workflow management systems, and IV robots. Common themes encountered in the three areas involve the ability to interface with the electronic health record; utilizing machine-readable coding; assuring calibration; defining staff training, access, and safety precautions; and clarifying emergency power failure, close-call situation, downtime, backup, updates, and maintenance procedures.
Common issues seen with automated compounding devices and IV workflow management issues include beyond-use date, lot number, and expiration date tracking; use of gravimetric checks; and handling alert overrides.
Common considerations for IV workflow management issues and IV robots include the creation or maintenance of master formulation records and electronic logs.
Examples of issues identified that involve automated compounding devices primarily include providing customizable clinical decision support that provide soft warnings, hard stops, population-specific data, incompatibilities, solution osmolarity limits, concentration and dosing units information; incorporating patient-and/or condition-based templates; and information on storage.
Workflow practices need to be established, including how new drug information is added to compounding databases. Safety gaps identified involved connecting tubing to source products; using compounded stock solutions; manually adding products to a compounded sterile product prepared using an automated compounding device; and alert overrides.
Samples of IV workflow management issues include the ability to prioritize projects; the incorporation of automatic calculations and conversions; including a guide to compounding; setting tolerance limits that trigger alerts; documenting steps involved in compounding; providing for the ability for remote verification, label printing, and workload reporting; setting minimum safety standards; identifying new products; assessing drug information needs; providing specific directions for each process step in compounding; assuring proper labeling; optimizing hardware usage and IV workflow management systems; and identifying procedural risks and gaps. Safety gaps include compounds that need multiple vials or infusion bags for preparations; tolerance limits when using gravimetric analysis; alert overrides; label swapping; and incomplete auxiliary product information.
It is important to define the role and scope of IV robots. Other issues involving IV robots include final product checking procedures and equipment certification. Safety gaps include machine-readable codes that are not readable; label swapping when the dispensing label is applied to the compounded sterile preparation manually; and incomplete auxiliary product information.
General best practices for compounding technology and sterile compounding are also discussed.
These guidelines will be updated every 2 to 3 years and serve as a valuable benchmarking tool for pharmacists on the standard of practice of sterile product compounding.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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