Sterile Compounding
Olivia C. Welter, PharmD
The now infamous RaDonda Vaught case, in which a nurse was criminally convicted of making a fatal medication error, has demonstrated that health care professionals, including pharmacists, must continue to be diligent by engaging in safe medication practices. One area of medication safety that is particularly relevant to the pharmacy profession is sterile compounding; from chemotherapy to eyedrops, pharmacy professionals play a role in preparing sterile medications for patients in all types of care settings.
In May 2022, the Institute for Safe Medication Practices (ISMP) released a new set of guidelines on sterile compounding: The ISMP Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding Technology.
“Since technology plays such an important role in capturing medication errors, these guidelines focus on specific recommendations to improve the use of I.V. workflow management systems that incorporate barcode scanning, image capturing, and/or gravimetrics, as well as automated compounding devices and robotics,” said ISMP President Rita Jew.
In 2013, ISMP released its first set of guidelines on sterile compounding practices in response to several compounding errors which ended up being fatal. These guidelines were revised in 2016 but, in the 6 years since the revision, sterile compounding technology advancements have boomed and become increasingly complex. Because of this, ISMP assembled stakeholders virtually in September 2021 for a summit on sterile compounding safety and technology. Much of the work resulted in the current set of guidelines.
More detail in the new guidelines
The 24-page guideline document highlights topics like I.V. workflow, automated compounding devices, and robotics with over 160 bullet points containing easily digestible information on ways to support safety in practice.
Safety gaps are identified throughout the guidelines, along with associated best practices that can be implemented to close those gaps. In addition, the document addresses general best practices in sterile compounding and potential points for future consideration when the guidelines are revisited.
There have been some key changes this time relative to the guidelines, which were last updated in 2016. Many points call for specific steps in ensuring technology is used in the safest way possible, compared to the previous guidelines, which didn’t always list out the steps.
One example is that the previous guidelines addressed safety related to tubing very broadly, only noting that tubing should simply be labeled and traced with each change in the source container.
The new guidelines go into much more detail and assign best practices for connecting tubing to source products, including having established policies and procedures defining required steps for setup, using code verification during set up, and having an additional person verifying and documenting that the proper steps were taken when setting up devices.
This is just one example that shows the advances made in recognizing and resolving safety gaps over the last 6 years.
How to use the guidelines
These guidelines are available to anyone who creates a free account with ISMP and accesses the PDF document through their website. From there, the document can be downloaded for easier accessibility. ISMP intends for these guidelines to be used alongside recommendations developed by the American Society of Health-System Pharmacists, the United States Pharmacopeia, and American Society of Parenteral and Enteral Nutrition.
Looking toward the future, ISMP anticipates that this set of guidelines will be updated on a regular basis every two or three years to keep pace with further advancements in technology. ■