Progress on Sterile Compounding Initiatives
The 2012 New England Compounding Center tragedy shined a spotlight on problems with some sterile compounding practices, especially when greed overrides safety. Although owner Barry Cadden and Pharmacist-in-Charge Glenn Chin were acquitted of second degree murder charges, they were convicted of and are currently serving prison sentences for racketeering, mail fraud, and interstate commerce of misbranded drugs. In response to this and several other problems related to sterile compounded preparations, a number of measures have been taken, including:
- Drug Quality and Security Act of 2013, which described compounding by pharmacies and outsourcing facilities in Sections 503A and 503B, respectively.
- Centers for Medicare and Medicaid Services (CMS), which has revised Pharmaceutical Services Conditions of Participation to require compliance with current compounding standards, specifically USP <797>
- Most State Boards of Pharmacy, which have strengthened rules for sterile compounding
- Programs for independent inspection and certification of compounding facilities, such as Verified Pharmacy Program (VPP) by the National Association of Boards of Pharmacy (NABP), Pharmacy Compounding Accreditation Board (PCAB) under Accreditation Commission for Health Care (ACHC), and Medication Compounding Certification by The Joint Commission (TJC)
The United States Pharmacopeial Convention (USP) is actively at work revising standards for sterile compounding. Currently in process is a major revision of General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, with expected dissemination for public comment late summer/early fall of 2018, and anticipated official date of December 1, 2019 (http://www.usp.org/compounding/general-chapter-797). USP General Chapter <800> Hazardous Drugs –Handling in Healthcare Settings has been finalized but the official date is being delayed until December 1, 2019 to coincide with the official date for <797> (http://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare). Also under development is a new general chapter for radioactive drugs, <825> Compounding – Radiopharmaceuticals, which is expected to be disseminated for public comment early fall 2018 and anticipated official date of December 1, 2019 (http://www.usp.org/chemical-medicines/radioactive-articles).
In spite of these activities and progress in upgrading regulations, rules, standards for practice, and inspections of facilities, issues in sterile compounding persist. For example, FDA continues to investigate reports of adverse events related to compounded drugs and to issue risk alerts associated with these events (https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm570188.htm). Also, adoption of recommended testing procedures for surface contamination of hazardous drugs has been remarkably low.
The other important aspect of sterile compounding, not directly addressed above, is the training, experience, and competency of individuals who perform or supervise these tasks. Activity and progress focusing on sterile compounding personnel has been gaining momentum. In January 2018, the Pharmacy Technician Certification Board (PTCB) launched a new certification program for pharmacy technicians who are involved in compounding sterile preparations (http://www.ptcb.org/about-ptcb/news-room/news-landing/2018/01/29/ptcb-launches-new-certification-program-in-compounded-sterile-preparation#.Ws44R8-otaQ). In February 2018, the Board of Directors of BPS approved Compounded Sterile Preparations (CSP) Pharmacy as its twelfth specialty (https://www.bpsweb.org/2018/02/27/new-specialty-compounded-sterile-preparations/); the first certification examination for pharmacist practitioners in this new specialty is anticipated to be in the fall of 2019, at roughly the same time as revised USP <797>, new USP <800>, and new USP <825> become official.
Some may ask: If sterile compounding facilities are licensed and accredited, why is certification of sterile compounding personnel important?
My response is that certification of personnel is a value-added proposition. I anticipate that BPS certification of CSP Pharmacists will lead to better compliance with regulations, rules, and standards for practice and will result in fewer adverse events related to compounded sterile preparations. I base this expectation on my long experience and many interactions with other BPS certified pharmacists, who I characterize as being committed to their specialty practices. Knowledge, skills, and competency are vital to high level practice, but so is attitude. Commitment is an attitude where one strives to adopt best practices in order to achieve optimal outcomes. Commitment inherently involves pursuit of continuous learning and enhancement of skills. BPS certified pharmacists were committed initially as evidenced by their decisions to acquire training and experience in a specialty area, and then seek Board Certification. They remain committed as evidenced by their decisions to maintain and enhance knowledge and skills via participation in programs leading to re-certification. I believe that the vast majority of CSP Pharmacists have this same commitment. I eagerly look forward to the development of a certification exam in CSP Pharmacy, and I encourage pharmacists practicing in this area to work toward a goal of becoming BPS Certified in CSP Pharmacy.
James A. Ponto