The Board of Pharmacy Specialties (BPS) approved its 12th specialty certification, Compounded Sterile Preparations (CSP) Pharmacy, on February 27, 2018. The purpose of offering the BPS CSP Pharmacy certification is to ensure that pharmacists are competent to perform and oversee compounding activities.
A number of recent issues underscore the need for the BPS CSP certification, including the following:
- Increased Need for Compounded Patient-Specific Medications. In recent years, there has been an increased demand for patient-specific compounded medications. Organizations are responsible for ensuring that these compounded medications are prepared safely and effectively.
- The Impact of Drug Shortages. The significant number of drug shortages affecting the industry has led to institutions seeking outsourced CSPs; organizations must be accountable for the safety and efficacy of these medications.
- The Effects of Multiple Compounding Tragedies. The September 2012 New England Compounding Center (NECC) tragedy is one of many publicly reported disease outbreaks resulting from improperly prepared CSPs. The meningitis outbreak, which sickened over 800 and killed 76 people, was the result of NECC’s contaminated steroid injections. This incident exposed the need to create a robust process to ensure that those pharmacists working in the area of sterile compounding have the knowledge and necessary skills to ensure patient safety.
The new BPS CSP certification is a response to the increased need for patient-specific medications, the impact of drug shortages, and serious compounding errors, which underscore the need for a process to independently validate the knowledge and skills of compounding pharmacists. The ultimate goal of compounding specialization is to ensure medication safety and improve patient outcomes.
Recent State and Federal Regulations
In the past, BPS focused its attention on facility and process compliance. However, the proliferation of new regulations and guidances prompted an expanded focus. Recent increases in state and federal regulation oversight include the following:
- The Drug Quality and Security Act of 2013, which differentiated compounding into pharmacies and outsourcing facilities in Sections 503A and 503B, respectively
- State boards of pharmacy rules for sterile compounding
- The Centers for Medicare and Medicaid Services (CMS) revised its Pharmaceutical Services Conditions of Participation to require compliance with current compounding standards, specifically USP <797>
- Voluntary programs to support health care organizations in complying with regulatory requirements have been created, including independent inspection and certification of compounding facilities by the following organizations:
- The National Association of Boards of Pharmacy (NABP) Verified
Pharmacy Program (VPP)
- The Accreditation Commission for Health Care (ACHC) Pharmacy Compounding Accreditation Board (PCAB)
- The Joint Commission (TJC) Medication Compounding Certification
- The National Association of Boards of Pharmacy (NABP) Verified
However, despite these new efforts and regulations, there is still a demonstrated lack of consistent pharmacy compounding activity competency. BPS compounding certification may be a significant step in assuring patients, health care practitioners, and regulators that sterile compounding is performed safely and accurately.
Benefits of CSP Certification
BPS anticipates that certification of CSP pharmacists will lead to improved compliance with rules, regulations, and standards for practice and will result in fewer adverse events related to CSPs. Health care providers, hospitals, and other health care institutions are being held increasingly accountable for the quality of care delivered to their patients. Empowering those pharmacists interested in this compounding specialty highlights their commitment to patients’ overall safety and the quality of service provided.
Candidates for CSP Certification
Pharmacists practicing in sterile compounding should consider certification, particularly if they are typically responsible for ensuring that sterile preparations meet the clinical needs of patients, while satisfying quality, safety, and environmental control requirements in all phases of CSP preparation, storage, transportation, and administration. To be eligible to become a Board Certified Sterile Compounding Pharmacist (BCSCP), a pharmacist must:
- Graduate from a pharmacy program accredited by the Accreditation Council for Pharmacy Education (ACPE) or a program outside the US that qualifies the individual to practice in the jurisdiction
- Maintain a current, active license to practice pharmacy in the US or another jurisdiction
- Complete 4000 hours of post-licensure experience in CSP pharmacy practice (see the specifics at: www.bpsweb.org/bps-specialties/compounded-sterile-preparations-pharmacy/)
- Achieve a passing score on the CSP Specialty Certification Examination
Ideally, at least one BCSCP will be employed in every hospital, home health care environment, nuclear pharmacy, and other pharmacy areas where sterile drug preparations are compounded. The BCSCP pharmacist specialist would be accountable for the supervision, training, competency assessment, safety, and oversight of other personnel who are involved in this work. It is highly likely that BPS-certified pharmacists will be committed to their specialty practices and will remain skilled and competent throughout recertification practices.
The Certification Examination
BPS intends to offer the first examination for the CSP Pharmacy certification in the fall of 2019; the tentative start date for the initial application period is early May, 2019. A full list of BPS specialty certifications are listed in the TABLE.
Pharmacists who would like to prepare for the certification exam should study compounding information from outside organizations, state, and local professional associations and colleges of pharmacy. Candidates should seek out reputable information and accredited programs; USP Chapters <797> and <800>, FDA guidances for compounding facilities, and literature on sterile compounding and facility engineering and certification are the cornerstones of this specialty. Guidance from programs offered by ASHP, CriticalPoint, the LP3 Network, the American College of Apothecaries, the Professional Compounding Centers of America, Spectrum Pharmacy Institute, and many others may be useful when preparing.
To view the information the exam will cover, refer to the CSP Pharmacy Content Outline on the BPS web site, available at: www.bpsweb.org/wp-content/uploads/CSP_Final_Content_Outline-Public-Distribution20180517.pdf. The proportion of exam items allotted to each domain was determined through analysis and discussion of the results of the role delineation study. These domains include the following:
- Standards, Regulations, and Best Practices (20% of examination)
- Facilities, Equipment, and Environmental Control (20% of examination)
- CSPs (25% of examination)
- Patient Care (15% of examination)
- Quality Management (20% of examination)
Michigan is the first state to require accreditation/certification of compounding pharmacies by one of three entities: TJC, the NABP VPP, or the PCAB. BPS expects that other states will follow. By creating the BCSCP specialty, BPS has made it possible for qualified pharmacists to distinguish themselves as experts in sterile compounding. With this certification, pharmacists will have an opportunity to gain the respect and recognition already shared by other clinical specialties.
Dianeysis Haro Avendano, PharmD, received her Doctor of Pharmacy degree with highest honors from Nova Southeastern University in 2004. She started as a clinical pharmacist at Hialeah Hospital 13 years ago, where she later became pharmacy supervisor and clinical coordinator. Dianeysis currently practices as the clinical coordinator and sterile compounding advisor for Memorial Hospital Miramar Pharmacy Department in Florida.