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ISMP Releases New Guidelines on Sterile Compounding
ISMP Releases New Sterile Compounding Guidelines
By Bruce Buckley
How to drive the odds of sterile compounding errors to nearly zero through advanced technology: That’s the challenge taken on by the newly published compounding safety guidelines from the Institute for Safe Medication Practices (ISMP).
“We have sophisticated technology and automation available on the market today that can prevent or catch compounding errors and provide safe patient care. However, the adoption of this technology throughout the nation is extremely low, leaving our patients vulnerable to harm from preventable errors,” said Kevin Hansen, PharmD, MS, BCPS, BCSCP, the systemwide director of pharmacy at Cone Health in Greensboro, N.C.
“It has become inexcusable to not use some extent of compounding technology or automation in most pharmacy practice settings that perform sterile compounding,” said Dr. Hansen, who was a member of the expert panel that paerticipated in ISMP’s virtual summit last September to revise the organization’s existing compounding guidelines with a new focus on evolving technology.
Implementing sterile compounding technology has been shown to greatly reduce the risk for medication errors. A 2019 multicenter study, for example, found that the use of technology-assisted IV workflow management systems (IV-WMS) were associated with a 14-fold increase in error detection compared with nonuse of such technology (Am J Health Syst Pharm 2019;76[15]:895-901).
“The data have definitely proven that adding technology can prevent errors that we are not as good at capturing when we only have manual systems,” said Christina Michalek, BSPharm, RPh, FASHP, the director of membership and patient safety organization for ISMP, and one of the architects of the new guidelines. The 24-page document is packed with concise bullet points—more than 160 in total—all designed to boil down complex advisory information into the most essential and practicable form possible: the essential technology attributes, safe pharmacy processes, safety gaps and best practices for automated compounding devices, IV-WMS and IV robots. The guidelines also specify nearly three dozen general best practices for sterile compounding safety, and take a look at what technology vendors and designers, moving forward, can do to advance compounding safety.
One example of the latter is a recommendation to investigate the feasibility of developing a common language among technologies so that practitioners do not need to reenter data into each system.
The guidelines also stress the need for collaboration, advising use of the document “in concert” with other sources, including guidelines and recommendations from the American Society for Parenteral and Enteral Nutrition, ASHP and USP. And, indeed, representatives of those organizations showed up in force for the three-day virtual summit, along with others from the FDA, the Joint Commission, the THRIV Coalition for IV Accuracy and ECRI, ISMP’s parent organization. Also in attendance were representatives from 15 health systems and hospitals and nine leading tech vendors.
Vendors Add Value
The presence of the vendor group was one key to the summit’s success, according to Rita K. Jew, PharmD, MBA, BCPPS, FASHP, who was named the president of ISMP in January, succeeding Michael R. Cohen, RPh, MS, ScD (hon.), FASHP, who became ISMP’s president emeritus.
—Christina Michalek, BSPharm, RPh, FASHP
see GUIDELINES, page 24
continued from page 22
“The pharmacy cannot achieve what we want to achieve in optimizing safety without the help of the vendors,” Dr. Jew told Pharmacy Practice News in an interview that followed an ISMP symposium at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. Dr. Hansen and Ms. Michalek also participated in the symposium.
“In my previous experience with implementing a lot of different technologies,” Dr. Jew said, “the biggest problem was that vendors create technology but rarely think through the workflow. And even though there were a lot of safety features in place, they weren’t providing enough guidance for the pharmacy folks to implement them.”
She added: “We know that learning a new technology is always difficult. Folks tend to try to fit their old practices into the new technology, which never works. It can even make the new practice worse.”
Dr. Jew said the vendors create training programs to get people to learn how to use the software and hardware, but don’t really train on the new workflow, and “what ends up happening is that people start creating workarounds, which a lot of times bypass the technologies’ safeguards.”
Dr. Jew added that teamwork is key. “The biggest message for vendors is to collaborate with pharmacy teams to design the new workflow to maximize safety so that it can be implemented from the very beginning,” she explained. “That’s why human factor engineering is such an important focus as we implement technology.”
Although ISMP’s sterile compounding guidelines (first published in 2013 and revised in 2016) touched on IV workflow and automated compounders, they didn’t “really dive into some of the safety gaps and robotic technology out there,” Dr. Jew said. “So, the goal of the new guidelines was to focus on the safety of compounding technology, explore some of the safety gaps and come to a consensus on what the best practices should be.”
Sterile compounding technology also can help to reduce the impact of drug shortages, Cone Health’s Dr. Hansen noted. He described how his organization had used IV robotics to lessen the impact of the shortage of heparin sodium premixed bags. “Heparin is a high-alert medication with a narrow therapeutic range,” he said, “so it’s really important to have the right drug in the bag at the right concentration.” By working with its robotic technology vendor, he said, Cone Health was able to accomplish that end, and “now our robots are producing heparin infusions to meet patient needs across our health system and have had no patient care disruptions as a result of this national shortage.”
Gravimetrics Brings Accuracy to a New Level
The use of gravimetric verification also ensured drug concentration accuracy, Dr. Hansen noted. Since bringing the robotic–gravimetric approach into action, he said, “not a single report has been brought to my attention” of any differences in therapeutic effect of the robot-produced heparin compared with the conventionally manufactured premixed bags, which some organizations have reported seeing using manual preparation of heparin infusions.
“For many of these compounders who don’t think they need technology or automation,” Dr. Hansen added, “what happens when you have a shortage? Who is going to make it, and how can you make sure it’s still as sterile, safe and potent as the FDA conventionally manufactured premix? That’s where there is a strong case for using IV robotics and automation in practice settings.” At a minimum, he said, hospitals that do sterile compounding need to acquire barcode scanning technology for compounding that can “ensure that the right drug, diluent, and fluid is used for the right patient.” He further acknowledged, “It is our obligation for safe patient care to provide barcode medication preparation for compounded medications, similar to how barcoding has been adopted by nurses with barcode medication administration.”
Ms. Michalek said the response from people who took part in the summit showed that “we addressed the issues that needed to be addressed. We know that there are others out there—practitioners and organizations—that are trying to drive these safety practices and the use of better compounding systems, and all of us together are going to improve the safe care that we provide to our patients.”
—Rita K. Jew, PharmD
Dr. Hansen reported that he provides educational talks for Omnicell. He also disclosed that he is a member of the USP Compounding Expert Committee, but his statements are neither affiliated with nor endorsed by USP. Dr. Jew and Ms. Michalek reported no relevant financial disclosures.
