The issues related to safety and quality in providing patients with Compounded Sterile Preparations has been well documented. “According to the U.S. Pharmacopeia (USP), millions of medications are compounded each year to meet the unique needs of patients,” explained BPS Executive Director, William M. Ellis, MS, RPh. “The public reports of patient illness and even deaths due to improperly prepared sterile compounded preparations only underscore the need to create a process to independently validate the knowledge and skills of those pharmacists and pharmacy technicians working in this important practice area.” Ellis added.
As healthcare providers, hospitals and other healthcare institutions are becoming increasingly accountable for the quality of the care delivered to patients, approving certifications for both pharmacists and pharmacy technicians in the Compounded Sterile Preparations Pharmacy area by both the Board of Pharmacy Specialties (BPS) and the Pharmacy Technician Certification Board (PTCB) represents the profession’s progressive commitment to developing a process to help assure safety and quality.
BPS Creates Board Certification in Compounded Sterile Preparations for Pharmacists
On February 27, 2018 BPS announced that Compounded Sterile Preparations (CSP) Pharmacy has been approved as its twelfth specialty certification. Eligible pharmacists will be able to sit for the first BPS CSP pharmacy certification examination in the fall of 2019.
BPS Board Certification in Compounded Sterile Preparations Pharmacy is a credential for pharmacists who have met the eligibility criteria and who in their unique practice are responsible for ensuring that sterile preparations meet the clinical needs of patients, satisfying quality, safety, and environmental control requirements in all phases of preparation, storage, transportation, and administration in compliance with established standards, regulations, and professional best practices.
The purpose of the BPS Board Certification in Compounded Sterile Preparations Pharmacy program is to validate a pharmacist’s advanced knowledge and experience to:
- Ensure quality patient care;
- Improve therapeutic outcomes;
- Assure safety;
- Supervise, train, and ensure competency of all personnel involved in sterile compounding.
Pharmacists who, meet all of the eligibility criteria including passing the examination will be awarded the credential titled: Board Certified Sterile Compounding Pharmacist (BCSCP).
The content outline for the BCSCP credential is as follows:
Domain 1: Standards, Regulations, and Best Practices (20% of examination)
Domain 2: Facilities, Equipment, and Environmental Control (20% of examination)
Domain 3: Compounded Sterile Preparations (25% of examination)
Domain 4: Patient Care (15% of examination)
Domain 5: Quality Management (20% of examination)
The eligibility criteria for pharmacists to sit for this examination are as follows:
- Graduation from a school or college of pharmacy accredited by the Accreditation Council for Pharmacy Education (ACPE), or program outside the U.S. that qualifies the individual to practice in that jurisdiction;
- A current, active license to practice pharmacy in the U.S. or another jurisdiction;
- 4,000 hours of post licensure experience in compounded sterile preparations pharmacy practice*; and,
- Achieving a passing score on the Compounded Sterile Preparations Specialty Certification Examination.
*The 4,000 hours of experience required may be earned in a variety of settings. ASHP-accredited residencies that include practice hours in the activities listed in the Compounded Sterile Preparations Content Outline will be accepted as practice experience on an hour-for-hour basis. As of 2019, all applicants will be required to provide an attestation for practice experience from their employer, and the required practice hours must be demonstrated during the seven years prior to the application date.
Bruce Vinson, PharmD, FASHP, Vice Chair of the BPS Compounded Sterile Preparations Pharmacy Specialty Council and Associate Director of Pharmacy at Cedars-Sinai Medical Center in Los Angeles, California, remarked that “BPS certification will give recognition and acknowledgement of pharmacists who practice unseen in a variety of settings in this practice specialty. Patient care needs pharmacists with the knowledge, skills, and abilities to safely oversee, prepare and deliver complex and oftentimes costly sterile compounded products. The BPS certification validates that the pharmacist can provide compounded sterile preparations that meet established standards.”
PTCB’s Compounded Sterile Preparation Technician™ (CSPT™) Certification Program Grants Increasing Numbers of CSPT Credentials
In December 2017, PTCB launched the Compounded Sterile Preparation Technician™ (CSPT™) Certification Program for qualified pharmacy technicians, the organization’s first advanced certification. As of December 1, 2018, more than 450 PTCB Certified Pharmacy Technicians (CPhTs) have earned their CSPT credential and hundreds more are pursuing theirs. For PTCB, the CSPT Program is an essential component of fulfilling the organization’s mission to advance medication safety.
“By meeting the rigorous standards mandated by PTCB’s certification and recertification processes, CPhTs who obtain the CSPT credential stand out as highly qualified to meet today’s expectations in sterile compounding safety,” said William Schimmel, PTCB Executive Director and CEO, “and CSPTs stay up to date in sterile compounding practices because the CSPT Program requires continuing education as part of annual recertification.”
The Program offers PTCB Certified Pharmacy Technicians (CPhTs) the opportunity to further demonstrate their commitment to medication safety, and prove they have specialized knowledge and skill in sterile compounding by meeting the program’s high standards. Employers who choose to employ CSPTs show they value the highest level of training and preparation for their technicians, and may create new career ladders for their technician employees by incorporating the CSPT Certification.
To apply to become a CSPT, a candidate must be a PTCB CPhT in good standing. In addition, CPhTs must either:
- have completed a PTCB-recognized sterile compounding education/training program and have one year of work experience in sterile compounding;
- have 3 years of work experience in sterile compounding.
Candidates must achieve a passing score on the CSPT Exam and have a qualified supervisor complete the Competency Attestation Form within the one-year Candidacy Eligibility Window.
The CSPT Exam is a two-hour, 75-question multiple choice exam. One hour and 50 minutes are allotted for answering the exam questions and 10 minutes are designated for a tutorial and post-exam survey. The exam covers hazardous and non-hazardous Compounded Sterile Products (CSPs) in the following domains:
- Medications and Components (17%)
- Facilities and Equipment (22%)
- Sterile Compounding Procedures (53%)
- Handling, Packaging, Storage, and Disposal (8%)
Fees are $50 for the CSPT Application Fee, a non-refundable one-time fee required per one-year CSPT Candidacy Window; and $149 for the CSPT Exam fee. Official score reports are typically available within 3 weeks of the exam date.
CSPT recertification is required every year, while CPhT recertification is required every 2 years. To successfully recertify, a CSPT must be a CPhT in good standing, complete 5 hours of continuing education (CE) in sterile compounding, and submit a Competency Attestation Form completed by a qualified supervisor. The 5 hours of CE in sterile compounding required for CSPT annual recertification will be counted toward the 20 CE hours required for CPhT recertification. A $20 recertification fee is due only once every 2 years (during the “off” CPhT recertification year).
Allen L. Horne, BS Pharm, RPh, an Oncology Pharmacy Specialist at Palmetto Health Richland in Columbia, SC, chaired the CSPT Exam Development Committee. He said the candidate’s successful completion of the CSPT Program ensures his or her knowledge and understanding of sterile compounding techniques and procedures. “Technicians who earn the CSPT Certification add another layer of safety in the sterile compounding area of the pharmacy.”
“With pharmacy technicians progressing to more advanced roles, I am honored to be one of the PTCB Certified Pharmacy Technicians who has received the CSPT credential,” said Tiffany Kofroth, CPhT, CSPT, Specialty Pharmacy Technician on the Continuing Pharmacy Education Team at the University of Texas MD Anderson Cancer Center in Spring, TX. “The CSPT certification advances medication safety in our pharmacy and can prepare, evaluate, and guide technicians to specialty or management roles. The program is a key to continued professional development for technicians.”
Christine Flynn, RPh, Pharmacy Manager for Allegheny Health Network Home Infusion in Meadville, PA, is leading efforts to prepare technician employees to earn the CSPT credential. “Allegheny Health Network Home Infusion is committed to providing the highest quality products to our patients,” Christine said. “As our technicians become certified through this program, we are confident that the level of expertise they employ will ensure that infusions for our patients meet the utmost level of safety and sterility. At AHNHI, we hope all our technicians will be CSPT-certified within 2 years or less.”
According to James A. Ponto, MS, RPh, BCNP, Chief Nuclear Pharmacist, University of Iowa Hospitals and Clinics and Clinical Professor, University of Iowa College of Pharmacy “In spite of efforts to upgrade 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.”
The corresponding work by both BPS and PTCB to create certifications in compounded sterile preparations is a responsible effort on behalf of the pharmacy profession to provide a solution to the patient safety and quality issues that are impacting patient care.