Are You Ready?
A Promotional Theater Conducted at the ASHP 2019 Summer Meetings and Exhibition
Boston, Massachusetts
Note: While USP suspended the December 1, 2019, implementation date for USP Chapter <797> on September 23, 2019, this content is still relevant for pharmacists who want to understand and prepare for changes and improve the safety of sterile products in health systems.
Revised USP Chapter <797> Pharmaceutical Compounding—Sterile Preparations will become official (i.e., enforceable) on December 1, 2019. Despite the chapter being a standard of practice for 15 years, a 2017 survey on the state of pharmacy compounding indicated that just 37% of facilities reported that they meet or exceed all USP Chapter <797> requirements and 50% reported that they meet most requirements. To ensure safety of sterile products in health systems, pharmacy leaders must implement the revised standards and aim to achieve full compliance by the December 2019 deadline. In this activity, the faculty will provide an overview of recent changes to USP Chapter <797> and explain strategies to ensure compliance. by the December 2019 deadline. One health system’s approach to making changes will be described.
Overview of Changes to USP Chapter <797>
Patricia C. Kienle, B.S.Pharm., M.P.A, FASHP, Activity Chair
Employing Changes to USP Chapter <797>: Is Your Facility Ready?
Eric S. Kastango, B.S.Pharm., M.B.A., FASHP
Practical Approaches to Attaining Compliance with USP Chapter <797>: One Health System’s Experience
Ashley Duty, Pharm.D., M.S.
Strategies for Ensuring Compliance with USP Chapter <797>: Faculty Discussion and Audience Questions
All Faculty
In accordance with ACCME and ACPE Standards for Commercial Support, ASHP policy requires that all faculty, planners, reviewers, staff, and others in a position to control the content of this presentation disclose their financial relationships. In this activity, only the individual below has disclosed a relevant financial relationship. No other persons associated with this presentation have disclosed any relevant financial relationships.
Eric Kastango
Patricia C. Kienle
This activity was planned to meet the educational needs of pharmacy directors, assistant directors, supervisors, and other pharmacist decision makers involved with sterile compounding in hospitals, health systems, and ambulatory clinics.
This Promotional Theater, conducted at the ASHP 2019 Summer Meetings and Exhibition, is a promotional activity provided by Fresenius Kabi and is not certified for continuing education credit. The content of this Promotional Theater and opinions expressed by presenters are those of the sponsor or presenters and not of the American Society of Health-System Pharmacists.
Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP, Activity Chair
Director, Accreditation and Medication Safety
Cardinal Health Innovative Delivery Solutions
Wilkes-Barre, Pennsylvania
Patricia C. Kienle, B.S.Pharm., M.P.A, FASHP, is Director of Accreditation and Medication Safety for Cardinal Health Innovative Delivery Solutions. She received her pharmacy degree from Philadelphia College of Pharmacy and Science and a Master in Public Administration degree from Marywood University in Scranton, Pennsylvania. She completed an Executive Fellowship in Patient Safety from Virginia Commonwealth University and is Adjunct Associate Professor at Wilkes University in Wilkes-Barre, Pennsylvania.
Ms. Kienle has served on the ASHP Board of Directors and as President of the Pennsylvania Society of Health-System Pharmacists (PSHP). She is a Fellow of ASHP and has been honored with the ASHP Distinguished Leadership Award and 2018 ASHP John W. Webb Lecture Award. She has also been named PSHP Pharmacist of the Year and received the Distinguished Achievement Award in Hospital and Institutional Practice from the American Pharmaceutical Association Academy of Pharmacy Practice and Management. Ms. Kienle has served on the Pharmacotherapy Specialty Council of the Board of Pharmacy Specialties, Pennsylvania Patient Safety Authority, Hospital Professional and Technical Advisory Committee of The Joint Commission, and Board of Governors of the National Patient Safety Foundation. She is a member of the USP Compounding Expert Committee and chairs the Subcommittee on Hazardous Drugs.
Ms. Kienle is the author of Compounding Sterile Preparations: ASHP’s Visual Guide to Chapter <797> video and Companion Guide, co-author of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide, and author of The Chapter <800> Answer Book. With over 500 invited presentations and 50 publications, she has special interests in medication safety, compounding sterile preparations, accreditation, and regulatory issues.
Eric S. Kastango, B.S.Pharm., M.B.A., FASHP
President and CEO
Clinical IQ, LLC and CriticalPoint, LLC
Madison, New Jersey
Eric S. Kastango, M.B.A., B.S.Pharm., FASHP, is President and CEO of Clinical IQ LLC, a health care consulting firm and CriticalPoint, LLC, a web-based education company.
Mr. Kastango received a Bachelor of Science degree in pharmacy from the Massachusetts College of Pharmacy and Allied Health Sciences and a Master of Business Administration degree from the University of Phoenix. He completed 65 hours of training in nuclear pharmacy at Purdue University and 80 hours of didactic training for the Six Sigma-Green Belt certification that he started with BD Medical Systems. At Johns Hopkins Bloomberg School of Public Health, he is working on a Certificate in Quality, Patient Safety, and Outcomes Research.
Since 1980, Mr. Kastango has practiced pharmacy in a number of practice settings, including hospitals, community, and home care, and in a number of different of roles, including Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation. He has also managed an FDA-registered cGMP manufacturing operation for Baxter Healthcare Corporation.
Mr. Kastango served on the USP Sterile Compounding Committee from 2005-2010 and 2010-2015 USP Council of Experts, Compounding Expert Committee until April 2013. In May 2013, USP recognized Mr. Kastango and the members of Compounding Expert Committee with an Award for Outstanding Contribution to the USP Standards-Setting Process. He received a coveted ISMP Cheers Award in 2015 for his work related to sterile compounding safety. Mr. Kastango also served on the USP Hazardous Drug Expert Panel from 2010-2016, and he is actively working with NABP and state boards of pharmacy to provide training to their sterile compounding inspectors.
Mr. Kastango is an active member and Fellow of ASHP, and he served on the Expert Panel for the ASHP Research and Education Foundation in the development of the 2015 Outsourcing Sterile Products Preparation Vendor Assessment Tool and ASHP’s Insourcing Readiness Assessment Tool.
Ashley M. Duty, Pharm.D., M.S.
Clinical Pharmacy Operations Manager
Children’s Mercy
Kansas City, Missouri
Ashley Duty, Pharm.D., M.S., is Clinical Pharmacy Operations Manager at Children’s Mercy in Kansas City, Missouri. She earned a Doctor of Pharmacy degree from the Raabe College of Pharmacy at Ohio Northern University and a Master of Science in Health-System Pharmacy Administration degree from Northeast Ohio Medical University. She completed an ASHP-accredited PGY1/PGY2 Health-System Pharmacy Administration residency at the Cleveland Clinic in 2014.
At Children’s Mercy, Dr. Duty is responsible for 21 pharmacists in general medicine and hematology/oncology, as well as for USP Chapter <797> and USP Chapter <800> oversight for all sterile compounding operations. She also serves as the staffing preceptor for the accredited PGY1 and PGY2 residencies.
Dr. Duty’s professional interests include operations, medication safety, and informatics. She is also very passionate about leadership development. Within ASHP, she is a member of the Educational Steering Committee for the Section of Pharmacy Practice Managers. Previously she served as Chair and Vice Chair of the New Practitioners Forum. On the local level, Dr. Duty is Programs Chair for the Greater Kansas City Society of Health-System Pharmacists.
Dr. Duty completed the ASHP Advanced Sterile Product Preparation Certificate in 2017 and served as a planner and presenter for both the PTCB-recognized ASHP Sterile Product Preparation Certificate and the Compounded Sterile Products Certificate for Pharmacists in 2019.