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.