Prevention Guide - Safe Handling of Hazardous Drugs - Irsst

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15. MEDICAL, BIOLOGICAL AND ENVIRONMENTAL MONITORING A wide variety of hazardous drugs is handled in every pharmacy department, as well as in the care units and outpatient clinics. In the medium term, the assessment of worker exposure could be performed by identifying one or more of the most frequently used drugs and periodically measuring their concentrations in the blood or urine. Currently, however, there are no reference values in this regard. In addition, the finding of minute traces (in nanograms or picograms) must be interpreted with a great deal of caution. In theory, this type of monitoring could probably provide a more accurate picture of actual occupational exposure than environmental monitoring and confirm the effectiveness of the corrective action being taken in the workplace. The results would take into account the actual effectiveness of both the protective measures for each worker and the work techniques. However, a biological monitoring protocol has yet to be validated and this type of monitoring may present drawbacks for the workers which are not yet welldocumented. In particular, relatively little is known about the relationship between the level and duration of worker exposure and the likelihood of developing a health problem (Fransman, 2007). In addition, often not enough is known regarding how low doses of these drugs are metabolized in the body (Dranitsaris, 2005). The interpretation of the results in a group of workers may help circumvent the risk of adverse effects likely to result from analysis of a single individual and would, in all likelihood, be more reliable. Despite this, we are currently not recommending introducing this type of monitoring and these tests should only be used in a research setting. Precautionary reassignment of pregnant or nursing workers While improving preventive measures reduces exposure, the very importance of these measures and the necessity for periodic monitoring via environmental measurements and evaluation of work techniques confirm the existence of risk. Reducing contamination depends on many factors (facilities, the use of good techniques by the worker and her colleagues, protective equipment, thorough cleaning, etc.) and failures or disruptions can occur. Pregnant workers are entitled to be assigned to avoid any exposure – even accidental. Precautionary reassignment prior to conception Despite several requests in this regard, the working group is not issuing any formal recommendations in this guide regarding the reassignment of workers who are planning a pregnancy. In our opinion, such a measure will become less relevant as exposure control improves. Exclusion of workers who have been treated for cancer While it is true that the drugs used to treat a cancer can increase the risk of developing a new cancer, the level of occupational exposure is so marginal in comparison to the doses used during treatment that we do not feel it warranted to prohibit these individuals from resuming their work. However, the clinician should have the final word in this regard. Environmental monitoring Environmental monitoring allows the evaluation and measurement of chemical contamination by hazardous drugs. In view of the seriousness of the potential effects, the Act respecting Occupational Health and Safety and caution itself suggest reducing exposure as low as reasonably achievable (ALARA) (Turci, 2006). While an acceptable level has yet to be determined by occupational health and safety organizations, a scientific review of the publications in this regard should be carried out. For example, the August 15, 2006 update proposed by the United States Pharmacopoeia discusses a maximum acceptable threshold for cyclophosphamide of 1 ng/cm 2 (USP, 2006). A number of organizations recommend keeping a record of environmental measurements. The ASSTSAS Hazardous Drug Committee supports this recommendation. To this end, the Committee has requested the help of the INSPQ Toxicology Laboratory in developing a technique for detecting and measuring traces of antineoplastic agents using samples taken from work surfaces. Tests have been developed to measure three agents. They are available from the INSPQ and are based on the procedures described in Appendix 5. 15-2 ASSTSAS PREVENTION GUIDE – SAFE HANDLING OF HAZARDOUS DRUGS
15. MEDICAL, BIOLOGICAL AND ENVIRONMENTAL MONITORING An Environmental Monitoring Program should provide for the periodic verification of the level of work surface contamination in institutions. An evaluation should be performed prior to implementing the preventive measures proposed in the ASSTSAS guide and repeated once they are in place. Thereafter, an evaluation should be performed annually or at the time of major changes in the facilities (e.g. change in preparation cabinets) or practices (e.g. new preparation or administration techniques, new hygiene and sanitation protocol). The guide suggests measurement sites in the Pharmacy Department, care units and outpatient clinics. As there are currently no exposure standards (except for cyclophosphamide, for which a standard of 1 ng/cm 2 is proposed) and to help the institutions interpret their results, a compilation of the contamination values from 34 studies has been published in the INSPQ Bulletin d’information toxicologique (toxicology information newsletter) (Bussières et al., 2006). To summarize, the position of the Working Committee is as follows: Type of follow-up Medical monitoring Biological monitoring of exposure Environmental monitoring Recording of accidental exposure Precautionary reassignment of pregnant or nursing workers Precautionary reassignment prior to conception Exclusion of workers who have been treated for cancer Working Committee Position Not recommended Not recommended Strongly recommended using the tests available Mandatory, in accordance with the LATMP legislation Immediate reassignment, to avoid exposure (even accidental) No recommendation Not recommended, except on the advice of the attending physician 15.2 Exposed Workers ‣ Shipping and receiving clerks (e.g. stock-keeper, storeroom clerk) ‣ Hygiene and Sanitation Department workers ‣ Pharmacy Department workers (e.g. pharmacist, clerk, pharmacy technician) ‣ Care unit / outpatient clinic / home care workers (e.g. nurses, physicians, inhalation therapists, patient service associates) ‣ Laboratory workers (e.g. technicians performing tests on biological samples from exposed patients) PREVENTION GUIDE – SAFE HANDLING OF HAZARDOUS DRUGS ASSTSAS 15-3
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This guide has been developed by th
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Table of Contents PREAMBLE ........
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List of Tables Table 1 Medication C
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PREAMBLE In September 2004, the Uni
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1. INTRODUCTION 1.1.1 Survey Regard
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1. INTRODUCTION 1.3 Guide Structure
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2. RISKS RELATED TO THE USE OF HAZA
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Pharmacy Care Wastes Support Receiv
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3. PREVENTION OBJECTIVES AND ACTION
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4. GENERAL PREVENTIVE MEASURES 4 GE
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4. GENERAL PREVENTIVE MEASURES 4.1.
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4. GENERAL PREVENTIVE MEASURES 4.1.
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5. RECEIVING AND TRANSPORT 5.3.2 De
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6. UNPACKING AND STORAGE 6 UNPACKIN
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6. UNPACKING AND STORAGE 6.3.3 Unpa
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7. PLANNING THE ONCOLOGY PHARMACY 7
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Page 123 and 124: 16. REFERENCES 16 REFERENCES AHQ [1
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Prevention Guide - Safe Handling of Hazardous Drugs - Irsst

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