Sundheddecember 23, 2020

Pharmacies must deliver closed-loop, on-demand training for sterile compounding


Easily accessible training on best practices bolsters patient safety and industry reputation. 

According to 2020 research by Pew Trusts, between 2001 and 2019 compounding errors accounted for more than 1,500 adverse events and at least 116 deaths. Those facts highlight the importance of evidence-based policies and procedures, high quality training and validated competencies for pharmacists and technicians at any compounding facility.

To help pharmacies best ensure patient safety and demonstrate an unwavering commitment to best practices, we recently spoke with an expert panel that includes:

  • Peter Cantor, Vice President and Managing Partner at CriticalPoint, a TRC Healthcare Company
  • Annie Lambert, PharmD, BCSCP, Clinical Program Manager for Compliance Solutions, Simplifi 797
  • Shannon McGinley, Senior Product Manager, Simplifi 797

Annie Lambert: For one, it’s always a challenge to find time to meet state board requirements for continuing education (CE), especially if you have to search for or travel to settings where courses are offered. And, in some cases, there’s the added challenge of having to pay out-of-pocket for CE.

What are the consequences for failing to keep up with required training?

AL: Individual pharmacists have to attest to having undergone the proper CE to maintain their licensure; they can be cited for failing to do so. For compounding pharmacies, education is an essential component of the sterile compounding program, because their pharmacists and technicians have to demonstrate their skill sets to regulatory or accreditation bodies. But the biggest consequence is negative patient outcomes. Not having fully trained, properly qualified personnel throughout a facility puts patients at risk. And should an incident occur, the facility could wind up making headlines that threaten its long-term reputation.

What are the best ways to ensure that pharmacy staff members engage in ongoing, top-of-the-line training?

Shannon McGinley: From an end-user perspective, it’s very important to have online training modules available 24-7, so people can access training from either home or work. That value is enhanced when the training is integrated in an application you use every day and when pharmacists and technicians earn CE credits through this format, with the application automatically sending verification of completed training to ACPE (Accreditation Council for Pharmacy Education). I would add that most end-users value content that gives them the opportunity to expand their knowledge base so they can move into a more skilled role and help ensure patient safety.

Peter Cantor: Online modules also have the advantage of consistency. They’re not dependent on how a trainer’s morning went or on the quality of individual trainers; every staff member receives the same message. In the case of CriticalPoint, it is a message widely recognized as reflecting best practices – far beyond the minimum required by USP (United States Pharmacopeia). The people who develop our training are experts in the field, and our business model focuses exclusively on safe and sterile compounding of medications so you get both best practices and timely updates as USP standards change. This is what we do – and all we do.

SM: From an administrative perspective, people value the ability to quickly run reports – and, if desired, subscribe on a regular schedule to reports that offer insight into the training progress each staff member is making.

PC: Administrators also understand that this type of training is lower cost, less labor intensive, and doesn’t require your staff to be available in a certain place at a certain time, which disrupts workflow.

SM: I also think both end-users and administrators appreciate content that is creatively designed, makes clear why certain competencies are so necessary and is interactive; that type of content gives administrators confidence that their staff is fully engaged in the training. Finally, having a closed loop format is essential. That’s probably the most important differentiator for the CriticalPoint training embedded in Simplifi 797. It is all very integrated.

Can you explain in more detail what you mean by closed-loop training and why that matters?

PC: Sure. Pharmacy compounding has a number of essential competencies that ensure safety and quality, from gloved fingertip sampling through steps for cleaning the compounding area. Our training uses those competencies as the basis for our training modules—the competencies and standard operating procedures that live within the Simplifi 797 tool align with the training modules so that when new employees come on board, they will sit down in front of a CriticalPoint training program that will provide all lessons applicable to their specific competencies and SOPs.

And employees can also use the modules as a reference. Consider that people in hospitals and other compounding settings have a thousand things to do, so if you’re working the night shift and you feel a little hazy on certain cleaning procedures and there is no one there to ask, you can reference the policies and competencies to ensure you are doing things right in a tool that you likely use every day. Compare this to live learning, which tends to be one and done.

SM: Closed-loop also means that once each staff member engages in the training, they have to demonstrate their competency, and then the program’s analytics give administrators oversight of each staff’s validated skillset, and where there might be weaknesses. When we speak with customers – who know better than anyone that people are the biggest source of contamination and pose the biggest risk to patient safety and business survival – they tell us that the overall quality of their program rests on their staff training appropriately and demonstrating their skills.

Any other advantages of this approach?

PC: Well, from a regulatory standpoint, when a state board inspector wants to see how you’re training your staff, they know our training modules emerge from years of industry experience and are constantly reviewed and updated. Many, if not most state board inspectors have done CriticalPoint training.

AL: Another advantage is that this training is multi-modal. While it’s great that so much is interactive, it’s also important that some didactic foundational training in USP standards is included. Pharmacists and techs need to read, see, and process the standards – and understand why those standards exist. And that’s another important differentiator that CriticalPoint offers. Others just show you how to do the competencies, but understanding the thinking behind best practices can have a powerful effect on your people buying in to actually learning and doing the work.

SM: Also the partnership between CriticalPoint and Simplifi 797 means we don't limit the number of users; as many users as necessary can access the content. We have also created packages that support and align with varying compounding needs, such as Hazardous Drug and nonsterile compounding modules. Recently, we even linked users’ Simplifi 797 and CriticalPoint accounts to create a more seamless workflow, with fewer passwords and barriers to entry.             

PC: The bottom line is that our partnership is a best practice approach that not everyone has the experience or expertise to create. We go far beyond the USP standards because we believe that patient safety and the reputation of the organizations we serve depends on going beyond minimal compliance. We want pharmacies to feel comfortable that what they’re sending out for patient use, they would be comfortable giving to someone in their own family. The highest quality training is an investment in your employees and in patient safety. In short, it’s the right thing to do.

Simplifi 797 is an exclusive partner with CriticalPoint CE training and is the only solution that integrates USP training within the compliance software.

Simplifi 797®

Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.

Simplifi 797 provides the latest evidence-based guidance and helps navigate the complex USP Chapters 795, 797 and 800 processes to ensure inspection confidence and keep patients and staff safe.
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