ASHP Research & Education Foundation
Outsourcing Sterile Products Preparation
Vendor Assessment Tool

Expert Reviewers

Eric Kastango, B.S.Pharm., M.B.A., FASHP
President and Chief Executive Officer
Clinical IQ and Critical Point, 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 in Pharmacy degree from the Massachusetts College of Pharmacy and Allied Health Sciences and his 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. Since 1980, he has practiced pharmacy in a number of practice settings, including hospitals, community, and home care, and 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 is an active member and Fellow of the American Society of Health-System Pharmacists and has served on the ASHP's Council of Educational Affairs. He also served on the USP Sterile Compounding Committee from 2005-2010. He was recently re-elected to the 2010-2015 USP Council of Experts Compounding Expert Committee. He has been invited to speak at over 150 national and international presentations on a variety of pharmacy practice topics, including sterile product preparation, pharmacy compounding errors, and quality systems.

Mr. Kastango is author of The 2004 ASHP Discussion Guide on Sterile Preparation: Summary and Implementation of USP Chapter <797>, Sterile Product Preparation: A Multimedia Learning Tool (CD-ROM), and ASHP's web-based compliance advisor gap analysis tool for USP Chapter <797>. He is a contributing author of three chapters for the second edition of Compounding Sterile Preparations and a frequent contributor to the American Journal of Health-System Pharmacy, Pharmacy Purchasing and Products, International Journal of Pharmaceutical Compounding, and Infusion (journal of the National Home Infusion Association).

Gabrielle Cosel
Manager, Drug Safety
The Pew Charitable Trusts

As manager of the Drug Safety Project for The Pew Charitable Trusts, Gabrielle leads initiatives to protect consumers through reforms related to the safety and oversight of the US pharmaceutical supply chain. Pew’s supply chain work examines issues related to global and outsourced manufacturing, pharmacy compounding, drug shortages, FDA regulatory activity, and drug distribution system risks. Gabrielle is co-author of the Pew report, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs. Prior to joining Pew, Gabrielle worked on issues of pharmaceutical safety and appropriate prescribing for national advocacy organization Community Catalyst. Gabrielle holds an MSc in human rights from the London School of Economics (2007) and a B.A. from Yale University (2002).

Patricia C. Kienle, M.P.A., B.S.Pharm., FASHP
Director, Accreditation and Medication Safety
Cardinal Health Innovative Delivery Solutions
Laflin, Pennsylvania

Patricia Kienle is the Director of Accreditation and Medication Safety for Cardinal Health Innovative Delivery Solutions.

Ms. Kienle received her Bachelor of Pharmacy degree from the Philadelphia College of Pharmacy and Science, and Masters of Public Administration 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.

She has served on the Board of Directors of ASHP and as President of the Pennsylvania Society of Hospital Pharmacists. She is a Fellow of ASHP, was named Pharmacist of the Year by the PSHP, and received the Distinguished Achievement Award in Hospital and Institutional Practice from the American Pharmaceutical Association Academy of Pharmacy Practice and Management, and the Distinguished Leadership Award from ASHP. She has served on the Pharmacotherapy Specialty Council of the Board of Pharmaceutical Specialties, as the pharmacist member of the Hospital Professional and Technical Advisory Committee of the Joint Commission, and on the Board of Governors of the National Patient Safety Foundation. She is a current member of the USP Expert Committee on Compounding, and Chair of the Subcommittee and Expert Panel on Hazardous Drugs.

Ms. Kienle is the author of Compounding Sterile Preparations: ASHP’s Visual Guide to Chapter <797> video and Companion Guide and co-author of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide, 8th edition. She also served as editor of Understanding JCAHO Requirements for Hospital Pharmacies.

She is a frequent presenter to professional groups, with special interests in promoting medication safety, compounding sterile preparations, accreditation and regulatory issues.

Cindy Chan, Pharm.D.
Sterile Compounding Manager
Providence Infusion and Pharmacy Services
Tukwila, Washington

Cindy Chan, Pharm.D., is Sterile Compounding Manager at Providence Infusion and Pharmacy Services. Dr. Chan earned her Doctor of Pharmacy degree and Certificate in Geriatric Pharmacy at the University of Washington School of Pharmacy.

Dr. Chan has extensive experience in home infusion and long term care pharmacy. She has worked for Providence Infusion and Pharmacy services for the last 7 years and currently manages the Home Infusion and Manufacturing business lines. She has responsibility for USP Chapter <797> compliance, hazardous drug safe handling, and meeting Joint Commission Standards in their home infusion service line. Dr. Chan also recently obtained a state pharmaceutical manufacturing license for their manufacturing service line and has been successful in implementing Current Good Manufacturing Practices (CGMP).

Dr. Chan has mentored pharmacy technician and Pharm.D. students sharing her passion for high quality standards and exceptional patient care.