Prevention Guide - Safe Handling of Hazardous Drugs - Irsst

6. UNPACKING AND STORAGE
6 UNPACKING AND STORAGE
6.1 Issues and Risks
Unpacking drugs can present an exposure risk if one or more containers inside the package are broken.
The scientific literature has shown that the outside of a number of drug vials coming directly from the
manufacturer or distributor can be contaminated by detectable concentrations of antineoplastic drugs. In some
cases, the vial packing cartons are also contaminated. Thus, even when there is no breakage during shipping, the
handling of vials and bottles of hazardous drugs can be a source of exposure. Even if there is only a small amount
on each vial, repeated exposure can be significant. Some authors have hypothesized that such contamination may
partially explain the presence of antineoplastic drugs in the urine of workers (Favier, 2003).
In a collaborative pilot study conducted by the ASSTSAS, INSPQ and URPP (Unité de recherche en pratique
pharmaceutique – CHU Sainte-Justine), the level of surface contamination was assessed on 40 vials of
cyclophosphamide from two Canadian manufacturers. The results indicated the presence of contamination, but
less than that reported in a number of other studies carried out in Europe and the United States. Several factors
may contribute to the surface contamination of hazardous drug vials, including the methods of production,
packaging and labeling, the storage and distribution processes, the occurrence of incidents (e.g. breakage during
transport) and the use of protective film. The low number of vials and drugs assessed does not permit
generalization of the conclusions of this study.
Cleaning the vials helps reduce contamination at the beginning of the medication circuit. However, the scientific
literature does not specify which agent should be used to clean them. Pharmaceutical companies often use water to
clean the vials. With the assistance of the INSPQ, the Committee compared the effectiveness of three cleaning
methods, i.e., water alone, detergent and water, and premoistened towelettes (such as Wet-Ones). The use of a
detergent and water solution or premoistened towelettes proved effective in removing 100% of the contamination.
Water alone (0.5 mL) was not effective in every case. The tests were performed with cyclophosphamide.
These methods were not checked regarding drugs which are not soluble in water. To our knowledge, there is no
synthesis tool allowing the quick determination of hazardous drug solubility for decontamination purposes. This is
why gloves are always recommended when handing hazardous drug containers.
Breakage of a drug container falling off a counter or shelf may expose the workers present and contaminate the
environment via the spread of liquids, powders or aerosols or through the diffusion of vapours.
6.2 Exposed Workers
‣ Pharmacy Department workers (e.g. pharmacist, clerk, pharmacy technician)
‣ Hygiene and Sanitation Department workers
6.3 Preventive Measures
6.3.1 Unpacking and Cleaning Area RATING: ++
Set up a suitable unpacking and cleaning area limiting exposure risks for the handler.
RECOMMENDATIONS
NOTE:
The pressure gradient values, air exchange values and other technical parameters, as
well as the quality of the materials, will be specified in a document prepared by the
CHQ. The general principles are outlined here.
6.3.1.1 The unpacking area should be a separate area, preferably a separate room.
6.3.1.2 The ventilation in the unpacking area should prevent the spread of contamination to
adjacent rooms.
PREVENTION GUIDE – SAFE HANDLING OF HAZARDOUS DRUGS ASSTSAS 6-1