As I write this, a federal jury in Boston is hearing testimony in the criminal trial of New England Compounding Center (NECC) president Barry Cadden. The 2012 NECC tragedy, the largest and most publicized of the many cases of patient harm related to contaminated compounded sterile preparations, has been a key driver in regulatory reform. For example, many state Boards of Pharmacy have strengthened their sterile compounding rules, typically by including requirements for compliance with the USP general chapter on sterile compounding, . 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 comply with FDA registration, inspection, and CGMP standards.
Recently, The Joint Commission (TJC) has launched a Medication Compounding Certification Program (see http://jointcommission.new-media-release.com/2017_medication_compounding/ ). Although there can be a semantic argument that this is an Accreditation rather than a Certification, the point is that state and federal regulations in and of themselves may not fully address the myriad issues involved in the compounding of sterile preparations. In evaluation of this area, TJC recognized a need for a voluntary program to support health care organizations in complying with regulatory requirements. With this program, TJC joins the Pharmacy Compounding Accreditation Board (PCAB) and the National Association of Boards of Pharmacy (through its Verified Pharmacy Program ) as entities that assess compliance with USP compounding standards. Michigan is the first state to require accreditation/certification of compounding pharmacies by one of these three entities (http://www.michigan.gov/lara/0,4601,7-154-72600_72603_27529_27548-366832–,00.html ).
As stated in a previous blog (https://www.bpsweb.org/2015/10/24/is-compounding-a-specialty/ ), these regulatory reforms, and the evolving voluntary accreditation programs such as described above, have focused on facilities and processes, but little has changed regarding personnel. To address the personnel issue, BPS convened a Sterile Compounding Practice Analysis Task Force, which conducted a role delineation study in sterile compounding in October 2015. The initial content was then reviewed and refined by additional subject matter experts working with the task force, and was then subjected to a widespread validation survey in late 2015/early 2016. At its spring meeting in 2016, the BPS Board reviewed and discussed the results of the role delineation study and subsequent survey relating to sterile compounding. Finding evidence supportive for sterile compounding to move forward in consideration as a specialty, the BPS board issued a call for petition on April 15, 2016 (https://www.bpsweb.org/2016/04/15/board-of-pharmacy-specialties-issues-call-for-petition-in-sterile-compounding-pharmacy-practice/ ).
As BPS awaits receipt of a petition for sterile compounding, I remain optimistic and enthusiastic about the future role of BPS certification in sterile compounding. I firmly believe that individual pharmacist certification in sterile compounding will complement existing accreditation of sterile compounding pharmacies by recognizing competent specialists performing and/or overseeing these important activities. Together, facility accreditation and pharmacist certification will assure the public of the safety of sterile compounded preparations.
Jim Ponto, member of BPS Board of Directors