Following the 2012 tragedy involving the New England Compounding Center (NECC) and other similar albeit smaller compounding misadventures, the public and healthcare professions pushed for improved safety of compounded drugs, primarily by seeking regulatory reform. In response, many state boards of pharmacy strengthened their compounding rules, typically by including requirements for compliance with the USP general chapters on compounding, and . The U.S. Congress also passed legislation, the Drug Quality and Security Act (DQSA) of 2013, which delineated compounding activities allowed under state law vs. compounding by “outsourcing facilities” that should comply with FDA registration, inspection, and CGMP standards.
While these regulatory reforms have focused on facilities and processes, little has changed regarding personnel. It seems to me, and to many others, that public health and safety initiatives should include additional focus on pharmacist competency in compounding activities. This leads to the question: Is compounding a specialty practice within pharmacy?
In BPS’s Five-Year Vision for Pharmacy Specialties 2013 white paper, BPS discusses possible future specialties. Generally, a specialty is envisioned to be a focused area of direct patient care associated with a PGY2 residency. A subsequent BPS survey and a BPS framework stakeholders conference in November 2014 offered general support of this vision. In addition, however, there was substantial support for consideration of certain specialties in areas of practice less associated with direct patient care, with one example being compounding.
In pondering this, it seems to me that there may be rationale and support for certification in at least two different types of specialties: 1) clinical practice specialties (i.e., what we have now, generally direct patient care specialties associated with PGY2 residencies); and 2) other specialties, which for lack of a better term, may be referred to as “technical” specialties (e.g., compounding, pharmacy informatics). The particular framework for how technical specialties fit with clinical practice specialties is not clear and will require more discussion and consensus-building. Nonetheless, I think that a strong case can be made for certain “technical” specialties in terms of advancing the profession and serving/protecting the public.
I have supported the position that compounding should be evaluated for potential recognition as a specialty, likely as a “technical” specialty. Training and experience differs from that for the current clinical practice specialties, especially related to the lack of formalized education/training programs. But because of the lack of accredited training programs, this is a scenario where board certification might be highly valuable, i.e., to recognize those pharmacists who possess the requisite knowledge to be competent regardless of their particular training.
The critical first step in the process of considering whether a focused practice area is a specialty is the conducting of a Role Delineation Study (RDS). In a June 19, 2015 press release (http://www.bpsweb.org/news/pr_061615.pdf), BPS announced plans to conduct a RDS in Sterile Compounding in the coming months. A rather aggressive timeline was developed. A call for content expert volunteers went out in August 2015, and members for the Sterile Compounding Practice Analysis Task Force were selected in early September 2015 (http://www.bpsweb.org/news/pr_091015.pdf) along with myself as a Board member. This task force met on October 2-3, 2015 and completed the rigorous RDS under the direction of an experienced psychometrician.
Sterile Compounding Task Force
The next steps include further review and refinement of the preliminary content outline by additional external subject matter experts and the task force (by late October 2015), and then a widespread validation survey to be fielded to pharmacists working in sterile compounding in November 2015. Following administration of the validation survey and subsequent data analysis, a technical report will be produced by February 2016. The BPS Board will then review the technical report, and if the Board finds that there is sufficient information showing that the focused practice area is based on specialized knowledge and that practitioners in the area perform specialized functions, BPS will issue a call for petition for the proposed specialty in 2016.
Assuming that Sterile Compounding matriculates to become recognized as a BPS Specialty, I can envision a future where there is at least one BPS-certified sterile compounding pharmacist in every hospital, home-healthcare, nuclear, and other sterile compounding pharmacy who performs and/or oversees the compounding of sterile drug preparations. This, I think, would constitute a significant step in assuring patients, healthcare practitioners, and regulators that such compounding is performed safely and accurately.
James A. Ponto, MS, RPh, BCNP
2015 BPS Board of Directors, Nuclear Specialist Member
Chief Nuclear Pharmacist, University of Iowa Hospitals & Clinics
Clinical Professor, University of Iowa College of Pharmacy