Oncology Pharmacy in Your Community - CAPhO

2007 | NOPS SPEAKER
CAROLYN BORNSTEIN
BScPhm, RPh, ACPR, FCSHP
BIOGRAPHY
Carolyn is a staff pharmacist at Southlake Regional Health Centre in Newmarket, Ontario. Two years ago she was project leader for the
complete review and revision of the Pharmacy Department’s policies and procedures for Compounding Sterile Preparations and Chemotherapy
with respect to USP Chapter 797, the NIOSH Alert 2004, CAPhO, ASHP and CSHP standards and guidelines. The project
included a certifi cation program for pharmacy staff on sterile IV preparation. Carolyn has presented on these topics at National and
Provincial conferences and in hospital pharmacy departments across Canada.
Carolyn graduated from the Faculty of Pharmacy, University of Toronto, completed a residency at Mount Sinai Hospital and has
worked in hospital pharmacy ever since. She is currently the President of the Canadian Society of Hospital Pharmacists and was recently
granted the CSHP Fellow designation.
SYNOPSIS
NEW STANDARDS FOR STERILE PRODUCTS- 797 AND BEYOND… Saturday, October 27th, 15:35 – 16:35
The goal of this session is to introduce pharmacists to USP Chapter , the fi rst practice standards in U.S. history for sterile
pharmacy compounding and the how they can be incorporated into the procedures for the preparation of chemotherapy.
Recommended standards using evidence-based knowledge now exists for sterile pharmacy compounding. Compliance with the
chapter’s standards will control contamination in aseptic processing of compounded sterile preparations. Everything from preparation,
labelling, dispensing, storage and delivery are addressed.
All standards are based on the microbial contamination risk levels assigned to the sterile preparations prepared in your facility. The
designations of Low risk (level 1), Medium risk (level 2) and High risk (level 3) are based on the complexity of the procedure (number
of manipulations), the sterility (or absence of) of the components, the physical facilities where preparation takes place and the
duration of storage.
Risk level will then dictate the physical layout/requirements of the sterile preparation area (including the frequency and degree of
cleaning/disinfection), garbing requirements, the training of personnel, the frequency of environmental monitoring, the aseptic
technique media-fi ll verifi cation, end-preparation evaluation testing and the beyond-use date assigned.
Critical quality assurance includes personnel education, training, evaluation and validation, environmental monitoring, process
validation/verifi cation and end-preparation testing.
But considering the risks of handling and preparing chemotherapy, can the standards of USP Chapter 797 be applied to the oncology
pharmacy? What are the unique challenges of incorporating these recommendations into this specialized area?
NOPS — Oncology Pharmacy in Your Community, October 26-28, 2007
Page 93