The Facts About High Risk Compounding
Activity Overview
Please read the following information about this continuing pharmacy education (CPE) activity before accessing the presentation using links located at the bottom of this page.
Accreditation for Pharmacists
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity provides 1 hour (0.1 CEU) of continuing pharmacy education credit (ACPE activity #0204-0000-16-453-H04-T).
Target Audience
This continuing pharmacy education series was planned to meet the needs of pharmacy technicians in a variety of settings, and it would be particularly beneficial for pharmacy technicians, supervisors, and educators who are interested in learning the basics of high risk compounding procedures.
Activity Content
Pharmacy technicians are an integral part of the sterile compounding process and are regularly responsible for preparation of compounded sterile products (CSPs). High risk compounded sterile products (CSPs) are often made from non-sterile components and require sterilization prior to administration to patients. According to USP Chapter <797> standards, additional quality assurance processes are required for compounding environments, procedures, and personnel involved in preparing high risk CSPs. Sterilization techniques and sterility testing requirements are complex procedures and require proper training and competency assessment.
Learning Objectives
After participating in this knowledge-based educational activity, participants should be able to
- Describe USP Chapter <797> standards for high risk level compounding.
- Explain the elements of the quality assurance requirements for high risk compounding including components, procedures, facility requirements, personnel requirements and qualifications.
- Differentiate between the types of sterilization methods.
- Describe quality release testing of high risk level CSPs.
Faculty
Eric S. Kastango, M.B.A., B.S.Pharm., FASHP
President/CEO
Clinical IQ, LLC
Madison, New Jersey
Eric S. Kastango, M.B.A., B.S.Pharm., FASHP, is president of Clinical IQ LLC, a health care consulting firm that assists clients who require expertise in the area of USP Chapter <797>, aseptic processing (pharmacy and pharmaceutical based), medical device manufacturing, and the implementation of extemporaneous compounding quality systems.
Mr. Kastango received his Bachelor of Science degree in pharmacy from the Massachusetts College of Pharmacy and Allied Health Sciences and his Master of Business Administration degree from the University of Phoenix. He has practiced pharmacy in a number of practice settings, including hospitals, community, and home care, in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation. He has also managed a FDA-registered cGMP manufacturing operation for Baxter Healthcare Corporation.
He has served on the USP Sterile Compounding Committee from 2005-2010 and was recently re-elected to the 2010-2015 USP Council of Experts Compounding Expert Committee. Mr. Kastango has delivered over 150 national and international presentations on a variety of pharmacy practice topics including sterile product preparation, pharmacy compounding errors, and quality systems.
Disclosure Statement
In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support and the Accreditation Council for Pharmacy Education’s Guidelines for Standards for Commercial Support, ASHP requires that all individuals involved in the development of activity content disclose their relevant financial relationships. A person has a relevant financial relationship if the individual or his or her spouse/partner has a financial relationship (e.g., employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring in the last 12 months with a commercial interest whose products or services may be discussed in the educational activity content over which the individual has control. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on presentations.
All faculty and planners for ASHP education activities are qualified and selected by ASHP and required to disclose any relevant financial relationships with commercial interests. ASHP identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity.
The following faculty and planners have no relationships pertinent to this activity.
Eric S. Kastango, M.B.A., B.S.Pharm., FASHP
Sylvia Q. Banzon, B.A., CPhT, CQIA, HACP, PMP, TFCSHP
Edna Bowser, CPhT
Rebecca B. Brewer, CPhT
Al Carter, Pharm.D., M.S.
Angela Cassano, Pharm.D., BCPS, FASHP
Donna Hamilton, MBA, B.S.Pharm.
Mary McHugh, B.S.Pharm.
Bradley Miller, CPhT, PhTR
Erin M. Ryman, B.S., CPhT
Erika L. Thomas, M.B.A., B.S.Pharm.
Rita Shane, Pharm.D., FASHP, FCSHP
Angela Triggs, B.S.Pharm.
ASHP staff has no relevant financial relationships to disclose.
Methods and Format
This activity is available in three formats:
- Web-Based CE. An online activity consisting of audio and slides (optional PDF handout with slides):
Launch Presentation - Podcast. An audio-only version of the presentation that can be downloaded to your computer or portable MP3 player (optional PDF handout with slides)
Launch Podcast - Monograph. E-publication
Launch Monograph
Participants must complete the entire activity, take the activity assessment and evaluation to receive continuing education credit. A minimum score of 70% is required on the test for credit to be awarded. A copy of the assessment test is provided as a study aid in the handout. CE credit will be reported directly to CPE Monitor. The estimated time to complete this activity is 1 hour (allow additional time to complete the assessment and evaluation).