Prevention Guide - Safe Handling of Hazardous Drugs - Irsst

7. PLANNING THE ONCOLOGY PHARMACY
7 PLANNING THE ONCOLOGY PHARMACY
7.1 Issues and Risks
Hazardous drug preparation presents a twofold challenge, i.e., limiting microbial contamination (to protect the
patient) and limiting environmental contamination by hazardous drugs (to avoid worker exposure). This challenge
is even greater when planning the sterile preparation room, particularly with respect to the direction of the
pressure gradients, which protect both the product and the worker.
In 1995, the Ordre des pharmaciens du Québec published a standard (95.01) regarding the sterile preparation of
drugs in the pharmacy. One of the recommendations was the presence of an ISO 7 or ISO 8 room for drug
preparation, including a proper anteroom. This Quebec standard is very similar to the guidelines of the Canadian
Society of Hospital Pharmacists. In 2004, the United States Pharmacopoeia published a standard concerning
sterile preparations in the pharmacy (USP 797), specifying the procedures regarding the planning of facilities. In a
summer of 2006 prepublication version of the update of this standard, USP added a section regarding the physical
layout of pharmacies where hazardous drugs are prepared, which states that the sterile (ISO 7) preparation room
should be under negative pressure. It also discusses the values with respect to gradient pressure and air exchange
per hour, as well as other physical considerations.
In view of the growing body of knowledge and the still recent publication of the NIOSH recommendations,
discussions are taking place throughout North America with respect to the definitive characteristics of the layout
of the hazardous drug sterile preparation room and anteroom.
The Committee invited representatives from the Corporation d’hébergement du Québec (CHQ) to join us in our
work. The CHQ has agreed to develop a set of standards for the planning of oncology pharmacies and preparation
rooms following the publication of this guide. These standards will be posted on the CHQ site. Notwithstanding
this future posting, our guide proposes general recommendations regarding the planning process. In view of the
expertise of the CHQ and the standards related to the physical and mechanical aspects of the building, we will
leave it up to them to specify the design parameters regarding (among other things) pressure gradient values, air
exchange values and other technical parameters, as well as regarding the quality of materials.
The handling of hazardous drugs, particularly during preparation (i.e., reconstitution, dilution, bagging or syringe
filling, etc.) can be a major source of workplace contamination. Failure to take measures to contain these sources
(e.g. air recirculation hood) or their ineffectiveness (e.g. diffusion of contaminants outside the sterile preparation
room) may contribute to worker exposure (pharmacy and housekeeping workers).
Some drugs release particles small enough to pass through the pores of HEPA filters; some are able to evaporate
(e.g. cyclophosphamide, fluorouracil, etoposide, carmustine, cisplatin) (Turci, 2003, Kiffmeyer, 2002, Opiolka,
2000). Thus, biological safety cabinets which exhaust emissions to the outdoors (preventing their release into the
room or building) are required.
7.2 Exposed Workers
‣ Pharmacy Department workers (e.g. pharmacist, clerk, pharmacy technician)
‣ Hygiene and Sanitation Department workers (e.g. oncology pharmacy cleaner)
PREVENTION GUIDE – SAFE HANDLING OF HAZARDOUS DRUGS ASSTSAS 7-1