Ensuring Safety in the IV Process

November 2020 - Vol.17 No. 11 - Page #42

Q&A with Patricia C. Kienle, RPh, MPA, BCSCP, FASHP

Director of Accreditation and Medication Safety

Cardinal Health


Pharmacy Purchasing & Products: What are pharmacy’s intrinsic risks in utilizing a manual approach to IV preparation?

Patricia C. Kienle, RPh, MPA, BCSCP, FASHP: There are potential error points throughout every step of IV preparation when using a manual process. For example, the wrong drug, volume, dose, solution, or diluent could be used. The drugs could be mixed in the wrong order. The technique used could be incorrect. Implementing IV workflow software is necessary to prevent these types of human errors. To ensure medication safety, whatever processes can be automated should be automated.

PP&P: How can an organization identify potential errors in its IV process?

Kienle: Organizations should first look at the errors that have been reported within their own health system. This can be challenging if the errors have not been recorded, so open communication with coworkers is necessary to elucidate any errors or good catches. Secondly, review the ISMP guidelines on the safe preparation of CSPs.1 And thirdly, go to the ASHP Resource Center on sterile compounding to take advantage of the many tools offered there.2

PP&P: How should pharmacy gain buy-in from administration for adoption of IV workflow automation?

Kienle: Ensuring medication safety is the primary reason to implement IV workflow software, followed by improved efficiency. When considering implementing IV workflow software, involve the facility’s risk manager, who is often a strong supporter of pharmacy’s medication safety initiatives. Also, gain the support of others in the organization who have implemented automation to promote patient safety. It is important to emphasize that IV compounding workflow has remained unchanged since the 1960s, but now we have a significant safety improvement in IV workflow software systems. Benchmarking data can be leveraged to emphasize to administration that as a safety conscious organization, you do not want to be behind the curve in automation adoption. Data from Pharmacy Purchasing & Products’ 2020 State of Pharmacy Automation survey can be presented to illustrate that 33% of all organizations have already taken advantage of this key safety automation. Furthermore, an additional 34% of facilities currently without an IV workflow management system are considering implementing this automation.3

PP&P: What is the best approach to evaluating the different IV workflow software products on the market?

Kienle: In a normal year, without COVID, I would recommend attending the ASHP Midyear Meeting to evaluate the IV workflow products in person, but that option is off the table this year. Fortunately, the virtual ASHP Midyear Meeting will present opportunities for product evaluation. In addition, do not discount the value of networking with facilities that are currently using IV workflow management technology and if possible, visiting their locations to see the technology in action. When you plan to implement a significant piece of automation, it makes sense to gain as much exposure to it as possible. Seeing the automation in person allows you to ask questions regarding the time required for implementation and optimization of the technology. Finally, review the literature to see what the studies are reporting about the individual IV workflow software systems.

PP&P: How should an organization address any roadblocks that may be encountered?

Kienle: Be cognizant of the extra resources and space alterations that may be needed to implement IV workflow automation. In addition, consider that there may be disruption in your IV room during the implementation process. This must be accounted for in order to take proper care of patients. Moreover, consider the downstream effects on other departments. For example, materials management needs to know if new supplies will be required. Information technology may need to be involved, as changes to the drug file may be necessary. Review any impacts on procedural areas that may not be immediately evident; changes may be required to IV sets or catheters, for example.

PP&P: What education and training should be provided to staff?

Kienle: Four steps are required to ensure staff is properly trained to use the IV workflow automation:

  1. Biomedical engineering, or whichever department in your organization is responsible for new equipment, must check the system to ensure it is safe and works as intended. In some cases, the components are integrated in the primary engineering control (PEC), so they need to be part of the semiannual PEC certification. Others may include components that reside in the PEC during compounding, so those need to be inside the PEC during certification to simulate the dynamic conditions needed to meet USP <797> requirements.
  2. Implement clear policies and procedures.
  3. Provide in-service training to every staff member who will use the IV workflow software.
  4. Everyone who receives in-service training must then demonstrate competency in using the IV workflow software system.

PP&P: What are the main benefits of implementing IV workflow software?

Kienle: Medication safety—the capacity to detect errors during the preparation process prior to the medication reaching the patient—is paramount. IV workflow systems also promote standardized processes, which is critically important. These benefits are immediately realized upon implementation of the technology. Finally, as staff develop a comfort level with the new processes, the organization is likely to experience a reduction in waste and decreased medication preparation time.


  1. Institute for Safe Medication Practices (ISMP). ISMP Guidelines for Safe Preparation of Compounded Sterile Preparations; 2016. www.ismp.org/guidelines/sterile-compounding. Accessed September 16, 2020.
  2. American Society of Health System Pharmacy (ASHP). ASHP Resource Center. Sterile Compounding. www.ashp.org/Pharmacy-Practice/Resource-Centers/Sterile-Compounding. Accessed September 16, 2020.
  3. State of Pharmacy Automation Survey. IV Workflow Management. Pharm Purch Prod. 2020;17(8):50,52.

Patricia C. Kienle, RPh, MPA, BCSCP, FASHP, director of accreditation and medication safety for Cardinal Health, is a member of the USP Compounding Expert Committee, and her comments herein are her own and not official information from USP.



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