Pharmacist going over manual
HealthMarch 06, 2020

USP’s designated person: Reviving the art of compounding to save lives

Pharmacists continue to play an increasingly vital role on clinical teams, working to the top of their license and helping to improve both care quality and efficiency when delivering patient care. Yet the emphasis on pharmacy’s clinical role has raised concerns that compounding – the pharmacist’s traditional role – is becoming a lost art.

That matters because in an era where there are so many different drugs and formulations – some of which are on drug shortage, require customization, or are hazardous when handled – high-quality compounding can save lives, reduce morbidity and prevent adverse events. This explains the thinking behind the U.S. Pharmacopeia (USP) defining the role of a designated person (DP) across three of its chapters focused on compounding: 795, 797 and 800.

Hospitals, health systems and community compounding pharmacies must respond. It’s not just because there is a strong regulatory imperative, with about 2/3 of states adopting the USP compounding standards wholesale, other states adopting pieces, and Joint Commission cross walking the USP standards to Joint Commission accreditation standards. It’s also that the USP standards on DPs represent a key touchstone for patient safety. In an era of intense competition, increased regulatory demands, and tight margins, the DP roles and responsibilities are an important leaping off point for best practices that can help save lives and money.

What is a designated person?

USP dedicates a few of its chapters to defining compounding standards. The latest revisions to these chapters – USP 795 (nonsterile medications), 797 (sterile medications) and 800 (hazardous drugs) – define a designated person as one or more individuals assigned to be accountable and responsible for the operation and performance of the compounding facility and personnel. That means overseeing quality assurance and control programs that establish a system of adherence to procedures, address quality problems, evaluate complaints and adverse events, and implement appropriate investigations and corrective actions. The DP also must review – and document the review of the program – at least every 12 months.

A word on certification

In response to the emergence of the DP role, a mini-industry has grown up around “certifying” designated persons. While there is usually some value in people undergoing the training needed for such certification, it’s important to understand that there is no official standard for certification – and no requirement that the DP be certified.If you decide to have your DP certified, make sure you look carefully at the syllabus being offered and that you’re satisfied there is some genuinely valuable content being offered. 

While the DP does not necessarily need to be a pharmacist or BPS approved – and the chapters don’t specify whether a system DP can suffice across multiple locations –organizations should not take the absence of a strict definition as license to take the role lightly. There is too much at stake in the DP oversight of high-quality compounding. Therefore, ensuring a person is fully qualified to play the role and that there is true accountability at each and every location is critical. To that end, any DP must have the full backing of senior leadership to drive the implementation of all compounding requirements and hold teams accountable for doing so.

Best practices for designing and implementing the DP role 

It’s also important to recognize that USP standards for the DP role describe baseline responsibilities. To get the most out of an organization’s investment in creating the DP role, there are some emerging best practices that hospitals, health systems and community compounding pharmacies can follow.

First, establishing a high-quality compounding operation must begin with a gap analysis to establish an operational baseline. As part of that, organizations can use a self-assessment tool to help them understand the degree to which they are in compliance with the USP’s compounding standards.

Next, organizations can create an action plan to close the gaps the assessment revealed. The plan could include everything from hiring the appropriate architects and engineers through purchasing the right equipment and developing standardized education and training resources for all personnel. The education piece is especially important. In many settings today, compounding training typically occurs through an experienced pharmacist mentoring a younger pharmacist, either formally or informally. That kind of oral tradition can be fine as far as it goes, but as standards and methodologies change, such an approach can also lock in old ways of doing things that are no longer relevant.

Finally, as organizations implement the plan, they will need to address the various challenges that typically arise in response to any significant process change. Implementation of the DP role is no exception and resistance can come in many forms. Perhaps the most prominent is pushback from staff members who note that no problems have ever emerged from traditional practices. Unfortunately, that claim may only be true because most organizations don’t look for the problems or don’t have an effective way to do so. Even if they do recognize a problem, many organizations have less than ideal feedback mechanisms that cannot clearly identify the root causes of patient safety events, such as infections.

That’s why a solid adverse event reporting system – one that includes pharmacy and has a strong root cause analysis component – is a powerful tool for supporting the DP’s role. If, for example, such a system identifies a problem with one particular drug or a compounding process, organizations can focus their investigations on determining whether the problem with the drug or process is a training issue, facility issue, environmental monitoring issue – or something else.

Using the DP to enhance a patient safety culture

As noted above, current USP compounding chapters have defined the DP role in response to recognition that high-quality compounding is essential to patient safety but compounding no longer has a central role in pharmacy education. The compounding chapters, with their emphasis on the DP, attempt to address these concerns.

Successfully establishing a DP depends on senior management making the role a priority and communicating that throughout the organization. The motivation for doing so goes beyond the benefits associated with high quality compounding. Establishing a DP also sends a message about an organization’s commitment to a culture of quality and patient safety. Such cultures are the key to saving both lives and dollars.

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