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Best Practices for the

Safe Handling
of Hazardous Drugs
About WorkSafeBC

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Best Practices for the
Safe Handling
of Hazardous Drugs
WorkSafeBC publications

Many publications are available on the WorkSafeBC website. The Occupational Health and
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Acknowledgments

WorkSafeBC thanks the many organizations who generously donated their time and knowledge to
reviewing this edition of Best Practices for the Safe Handling of Hazardous Drugs, including:
•• BC Provincial Hazardous Drugs Working Group
•• BC Provincial Hazardous Drug List Working Group
•• College of Pharmacists of BC
•• University of British Columbia
•• BC Nurses’ Union
•• College of Veterinarians of BC
•• Health Sciences Association of BC
Contents
About this book. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Part 1: Hazardous drugs in the workplace . . . . . . . . . . . . . 3
1. What are hazardous drugs? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2. Who is at risk of exposure?. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3. Why are workers at risk?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4. Routes of occupational exposure. . . . . . . . . . . . . . . . . . . . . . . 8
5. Creating an exposure control plan. . . . . . . . . . . . . . . . . . . . . 10

Part 2: Performing a risk assessment for hazardous drugs. . . 11


6. What is a risk assessment? . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7. Identifying hazardous drugs. . . . . . . . . . . . . . . . . . . . . . . . . . . 15
8. Assessing risk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
8.1 Tools for assessing risk. . . . . . . . . . . . . . . . . . . . . . . . . . 18
9. Developing and implementing control measures. . . . . . . . . 20
10. Written safe work procedures. . . . . . . . . . . . . . . . . . . . . . . 23
11. Information and communication . . . . . . . . . . . . . . . . . . . . . 24
11.1 Education and training. . . . . . . . . . . . . . . . . . . . . . . . . . . 25
11.2 Written records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Part 3: Task-specific guidelines for reducing exposure


to hazardous drugs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
12. Drug shipping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
13. Drug receiving and storage. . . . . . . . . . . . . . . . . . . . . . . . . . 30
13.1 Work area design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
13.2 Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
13.3 Guidelines for safe work practice. . . . . . . . . . . . . . . . . . 31
13.4 Personal protective equipment (PPE). . . . . . . . . . . . . . . 31
14. Drug transport. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
14.1 Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
14.2 Guidelines for safe work practice. . . . . . . . . . . . . . . . . . 32
14.3 Personal protective equipment (PPE). . . . . . . . . . . . . . . 32
15. Drug preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
15.1 Work area design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
15.2 Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
15.3 Guidelines for safe work practice. . . . . . . . . . . . . . . . . 36
15.4 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
15.5 Personal protective equipment (PPE). . . . . . . . . . . . . . . 37

Best Practices for the Safe Handling of Hazardous Drugs v


16. Drug administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
16.1 Work area design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
16.2 Drug administration equipment. . . . . . . . . . . . . . . . . . 38
16.3 Guidelines for safe work practice. . . . . . . . . . . . . . . . . 39
16.4 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
16.5 Considerations for home care . . . . . . . . . . . . . . . . . . . 40
16.6 Personal protective equipment (PPE). . . . . . . . . . . . . . . 41
17. Veterinary practice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
17.1 Work area design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
17.2 Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
17.3 Guidelines for safe work practice. . . . . . . . . . . . . . . . . 43
17.4 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
17.5 Personal protective equipment (PPE). . . . . . . . . . . . . . 44
18. Patient care. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
18.1 Work area design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
18.2 Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
18.3 Guidelines for Safe Work Practice. . . . . . . . . . . . . . . . 46
18.4 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
18.5 Personal protective equipment (PPE). . . . . . . . . . . . . . 46
19. Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
19.1 Guidelines for safe work practice. . . . . . . . . . . . . . . . . . 47
19.2 Personal protective equipment (PPE). . . . . . . . . . . . . . . 47
20. Waste disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
20.1 Work area design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
20.2 Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
20.3 Guidelines for safe work practice . . . . . . . . . . . . . . . . 49
20.4 Personal protective equipment (PPE) . . . . . . . . . . . . . 50
21. Spill response. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
21.1 Guidelines for safe work practice. . . . . . . . . . . . . . . . . . 51
21.2 Personal protective equipment (PPE). . . . . . . . . . . . . . . 51

Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Appendix 1: References and resources. . . . . . . . . . . . . . . . . . . . 55
Appendix 2: Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Appendix 3: Monitoring the workplace environment. . . . . . . . 63
Appendix 4: Personal protective equipment (PPE). . . . . . . . . . . 65
Appendix 5: Biological safety cabinets (BSCs). . . . . . . . . . . . . . 68
Appendix 6: Selection of medical equipment. . . . . . . . . . . . . . 70
Appendix 7: Cleaning agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Appendix 8: Spill kit checklist . . . . . . . . . . . . . . . . . . . . . . . . . . 73

vi Best Practices for the Safe Handling of Hazardous Drugs


About this book
This book deals with the health and safety of workers who handle
hazardous drugs. It is meant to be a starting point and a reference
guide of best practices to minimize worker exposure to hazardous
drugs in the workplace. This book has three parts:
•• Part 1 gives an overview of current knowledge on hazardous drugs
•• Part 2 describes how to perform a risk assessment
•• Part 3 gives examples of best practices for each stage of
handling hazardous drugs

The book also includes eight appendices:


•• Appendix 1: References and resources
•• Appendix 2: Glossary
•• Appendix 3: Monitoring the workplace environment
•• Appendix 4: Personal protective equipment (PPE)
•• Appendix 5: Biological safety cabinets (BSCs)
•• Appendix 6: Selection of medical equipment
•• Appendix 7: Cleaning agents
•• Appendix 8: Spill kit checklist

Who this book is intended for

This book is intended primarily for the health care industry in B.C.,
including those engaged in community or home-based care.
However, Part 3 also provides guidelines for ancillary services,
such as transportation and cleaning, and for veterinary practices.

See Chapter 2: “Who is at risk of exposure?” for a list of occupations


in which workers are at potential risk of exposure to hazardous drugs.

Terminology

Appendix 2 contains a glossary of terms frequently used when


handling hazardous drugs. When these terms appear in the text of
this book, they will be indicated with bold type. If you place your
cursor over the bold text, a pop-up box will appear with the
definition of the term.

Best Practices for the Safe Handling of Hazardous Drugs 1


Legal considerations

While the information in this book is meant to help you meet the
requirements specified in the Occupational Health and Safety
Regulation (the Regulation), it does not replace it. You will need to
refer to the Regulation to determine the exact requirements that
apply to your particular workplace.

In Canada, drug products fall under the jurisdiction of the


Food and Drugs Act and are exempt from WHMIS requirements.
However, information requirements under section 5.2 of the
Regulation still apply. Chapter 10 provides more information on
how to comply with the Regulation.

Best practices: hazardous and cytotoxic drugs

This book contains recommended best practices that apply when


handling all hazardous drugs. We use the term hazardous drugs to
indicate that occupational exposure should be controlled in the
workplace for all drugs that meet the specified criteria. Employers
should perform a risk assessment before adopting any of the
recommendations in this book.

While recommended practice is to reduce worker exposure to any


hazardous drug, exposure to cytotoxic drugs, a subset of hazardous
drugs, is specifically regulated by Part 6 of the Regulation.

Cytotoxic drugs are defined in section 6.42 of the Regulation as


drugs that “... possess a specific destructive action on certain cells
or that may be genotoxic, oncogenic, mutagenic, teratogenic, or
hazardous to cells in any way and includes most anti-cancer drugs.”

Where cytotoxic drugs are present in the workplace the employer


must ensure that the legal requirements are being met.

When you see this symbol, it indicates a specific legal


requirement from the Occupational Health and Safety
Regulation (the Regulation) when cytotoxic drugs are
present in the workplace.

2 Best Practices for the Safe Handling of Hazardous Drugs


Part 1: Hazardous drugs
in the workplace
The following chapters provide an overview of current knowledge on hazardous drugs.
This will help you understand what hazardous drugs are, why they are hazardous, and
who is at risk of exposure. Routes of occupational exposure are also covered, as well
as what kind of information should be included in an exposure control plan.
1. What are hazardous drugs?
Hazardous drugs are specific drugs with the potential to harm
workers who are exposed to them. Continual or frequent exposures
to low levels of hazardous drugs, or a single exposure to a larger
amount, can put workers at risk of negative health effects.

Refer to Appendix 1: References and Resources for a list of studies


that provide evidence on the potential health risks of occupational
exposure to hazardous drugs.

This book uses the definition of a hazardous drug that the National
Institute for Occupational Health and Safety (NIOSH) developed.
According to NIOSH’s definition, a drug is hazardous if there is
evidence of one or more of the following characteristics in humans
or animals:
•• Carcinogenicity: the ability to cause cancer
•• Teratogenicity or other developmental toxicity: the ability to
affect the development of an embryo or fetus
•• Reproductive toxicity: the ability to affect reproductive function
in adults
•• Organ toxicity at low doses: the ability to seriously affect organs
or organ systems
•• Genotoxicity: the ability to damage genetic material within cells

NIOSH determines whether drugs meet these criteria by reviewing


existing scientific evidence for each drug and then lists qualified
drugs in a periodical. Visit the NIOSH Hazardous Drugs web page
for the most recent list of hazardous drugs.

For drugs not on the NIOSH list, employers can determine whether
a drug is considered hazardous by using the following sources of
information:
•• Evidence-based research that indicates the drug meets the
criteria for a hazardous drug
•• Drug information sheets provided by the manufacturer, such as
safety data sheets
•• Product monographs in Health Canada’s Drug Product Database
•• Health warnings from government or professional groups

Best Practices for the Safe Handling of Hazardous Drugs 5


2. Who is at risk of exposure?
A wide range of people can be at risk of exposure to hazardous
drugs in their workplace, including:
•• Pharmacy workers
•• Laboratory workers
•• Nurses
•• Health care assistants
•• Cleaners, housekeeping and laundry staff
•• Physicians
•• Veterinary and animal attendant workers
•• Community health workers
•• Workers involved in drug shipping/receiving/transport services
•• Workers involved in hazardous waste services

6 Best Practices for the Safe Handling of Hazardous Drugs


3. Why are workers at risk?
In the past most hazardous drugs were antineoplastic, which refers
to drugs used to treat cancer. However, hazardous drugs are
increasingly being used to treat diseases other than cancer, such as:
•• Rheumatoid arthritis
•• Skin psoriasis
•• Multiple sclerosis
•• Some viral diseases, such as HIV
•• Hormone-dependent cancers

Hazardous drugs are increasingly being administered in non-


traditional settings—including community or home care, and
physician and veterinary practices. In these workplaces, there may
not be well-established control measures in place to minimize
occupational exposure. Part 3 touches on these workplaces and
provides practical, task-based information on working with
hazardous drugs in these environments.

With the growing potential for exposure to hazardous drugs, it is


essential that all workplaces where hazardous drugs are present
have effective measures in place to control worker exposure.

Best Practices for the Safe Handling of Hazardous Drugs 7


4. Routes of occupational exposure
Workers can be exposed to hazardous drugs in a number of ways.
The potential route of exposure depends on the form of the drug
being handled and the tasks being conducted. The table on page 9
shows the main routes of worker exposure and gives some examples
of activities where these exposures may take place. It also gives
examples of controls that may be used to minimize these routes of
exposure to workers.

Surface contamination is one of the main sources of occupational


exposure to hazardous drugs. Due to their chemical stability,
residue from hazardous drugs can persist in the workplace
and be spread far from their point of origin. Trace residue from
hazardous drugs can deposit on surfaces, such as vials and IV
bags containing hazardous drugs, work tables, and hazardous
drug transport carts. Residue can also collect on items that are
not directly used for handling hazardous drugs, such as pens,
door handles, and elevator buttons. Since surfaces throughout
the workplace may be contaminated, there is a potential risk of
exposure to others present in the workplace, including visiting
staff or patient family members. Refer to Appendix 1 for scientific
research on surface contamination.

8 Best Practices for the Safe Handling of Hazardous Drugs


Route of exposure Examples of activities Possible controls

Direct dermal •• Handling oral or topical forms of •• Wearing double


contact hazardous drugs chemotherapy-tested gloves
•• Contact with a leak or spill of •• Using a closed-system transfer
hazardous drugs device

Indirect dermal •• Handling contaminated patient •• Wearing double


contact excreta chemotherapy-tested gloves
•• Handling or touching contaminated •• Observing a precautionary
materials, such as equipment, period for handling patient
containers, work surfaces, patient excreta
laundry

Contact with eyes •• Handling liquid forms of hazardous •• Wearing eye protection or a
drugs face shield

Inhalation •• Inhaling aerosols or vapours •• Performing activities inside a


released when priming equipment biological safety cabinet
•• Inhaling particulate material •• Wearing an appropriate
released when crushing tablets or respirator
opening capsules

Percutaneous •• Preparing or administering drugs •• Using a needleless system or


exposure using a needle safety engineered medical
sharp

Ingestion •• Eating food that has been •• Ensuring all food is stored away
contaminated with hazardous from areas where hazardous
drugs drugs are handled
•• Proper hand washing

The selection of appropriate controls is discussed in Chapter 9.

Refer to Appendix 1 for additional resources that provide scientific evidence for these routes of
exposure.

Best Practices for the Safe Handling of Hazardous Drugs 9


5. Creating an exposure control plan
An exposure control plan (ECP) describes how workers will be
In the Regulation
protected from hazardous drugs in the workplace. An ECP includes
Workplaces where information on the nature of the hazard and the risk associated with
cytotoxic drugs are exposure, as well as controls that the employer will use to protect
present must have an workers.
exposure control plan
The ECP includes the following components, which are detailed in
in place. See sections
section 5.54(2) of the Regulation:
5.54(1) and 6.43 of
•• Statement of purpose and responsibilities
the Regulation.
•• Risk identification and assessment
The employer must •• Risk controls
review the exposure •• Written safe work procedures
control plan at least •• Education and training
annually and update •• Written records
if required. See •• Hygiene facilities and decontamination procedures (when
section 5.54(3) of the required)
Regulation. •• Health monitoring (when required)

The ECP should be reviewed at least annually and updated as


necessary by the employer, in consultation with the joint
In the Regulation occupational health and safety committee or the worker health and
Where cytotoxic safety representative.
drugs are present in
the workplace, the
exposure control
plan for the must be
periodically reviewed.
See section 5.54 of
the Regulation.

10 Best Practices for the Safe Handling of Hazardous Drugs


Part 2: Performing a risk
assessment for hazardous
drugs
Chapters 6 to 9 detail the three steps involved in a risk assessment: identifying
hazardous drugs, assessing risk of exposure, and implementing controls to eliminate or
minimize exposure.

Chapter 10 explains written safe work procedures and Chapter 11 outlines the
different ways that hazardous drugs are labelled and communicated, as well as
individual education and training.
6. What is a risk assessment?
A risk assessment provides a foundation for eliminating or
In the Regulation minimizing worker exposure to hazardous drugs in your workplace.
Risk assessments It involves examining the level to which workers are being exposed
must be performed to hazardous drugs and what can be done to reduce that exposure
where cytotoxic as much as practicable.
drugs are present.
A risk assessment involves performing the following three steps,
See section 5.54(2) of
which are discussed in more detail in the subsequent chapters:
the Regulation.
•• Identify hazardous drugs that are present in the workplace.
•• Assess the risks of exposure to hazardous drugs.
•• Develop and implement controls to eliminate or reduce exposure.

A risk assessment should be performed by an individual or team


who, through a combination of education, training, and experience,
are knowledgeable about the work, the hazards involved, and the
means to control the hazards.

Throughout this process, it‘s essential that front-line workers and


representatives from the joint occupational health and safety
committee of your workplace are consulted. Workers and their
representatives provide knowledge on how work is being done and
insight into potential solutions. The most effective solutions to
controlling exposure will take the needs and knowledge of the
worker into account.

Best Practices for the Safe Handling of Hazardous Drugs 13


The following diagram shows the steps to performing a risk assessment.

Health and safety


Employee Consultation
representative

Hazard identification

Risk assessment

Risk control

Evaluation of controls
Elimination (of the hazard)

Substitution

Engineering

Administration

Personal
protective
equipment

Trial and implement controls

Permission provided by WorkSafe Victoria to reproduce this diagram.

14 Best Practices for the Safe Handling of Hazardous Drugs


7. Identifying hazardous drugs
Identifying hazards is the first step toward controlling exposure to
In the Regulation hazardous drugs in your workplace. This involves creating an
A list of cytotoxic inventory of all drugs in the workplace and then determining
drugs must be whether hazardous drugs are present among them.
created if they
Create a list of hazardous drugs in your workplace
are present in the
workplace. See Once you’ve listed all the drugs that are present in your workplace,
section 6.47 of the compare them with known hazardous drugs. Visit the following
Regulation. websites to view the most recent hazardous drug lists:
•• BC Cancer Agency
•• NIOSH Hazardous Drugs

If you don’t find a drug on the list, it should be reviewed to determine


if it is hazardous, using the criteria discussed in Chapter 1.

Document hazardous drug details


Once the presence of hazardous drugs in the workplace has been
established, information needs to be gathered and reviewed for each
hazardous drug. The following table shows the potential routes of
exposure, the form of the substance, and the potential health effects.

Best Practices for the Safe Handling of Hazardous Drugs 15


Obtain and review information about hazardous drugs used

Determine the routes These may include:


of exposure. •• Inhalation of aerosols, particulates, and droplets
•• Skin or eye contact through splash of liquid
•• Ingestion through poor personal hygiene or splash of liquid
•• Injection resulting from injuries from sharps

Determine the form of This may include:


the substance. •• Liquid
•• Powder
•• Tablet
•• Creams, ointments, and lotions for topical application

Ascertain the potential These may include:


harmful effects.
•• Carcinogenic, mutagenic, or teratogenic potential
•• Alterations to normal blood cell count
•• Fetal loss in pregnant women and malfunctions in the offspring of
pregnant women
•• Abnormal pain, hair loss, nasal sores, vomiting
•• Liver damage
•• Contact dermatitis, local toxic or allergic reaction, irritation to the skin

Approval to reproduce adapted version from WorkSafe Victoria.

16 Best Practices for the Safe Handling of Hazardous Drugs


8. Assessing risk
Once the presence of hazardous drugs has been identified, the next
In the Regulation
step is to determine the level of risk. This involves determining how
A risk assessment the drugs are used in the workplace and identifying which tasks
must be performed place workers at risk of exposure.
where cytotoxic drugs
Evaluation involves analyzing the work environment, tasks and
are present. See
activities performed, and any previous incidents where workers
sections 5.54(2)(b) and
may have been exposed to hazardous drugs. This information can
6.43 of the Regulation.
be gathered by performing a walk-through survey of the workplace,
consulting with workers who are performing the tasks being
evaluated, and reviewing employer health and safety records. See
the following table for more details.

Evaluate the nature of the work involving hazardous drugs

Divide up the For example:


workplace and
determine where •• Drug preparation in the pharmacy
hazardous drugs are •• Drug administration in the ward or daycare centre
used.
•• Handling, transport, and disposal of hazardous waste on the
premises
•• Patient care after adminstration

Examine the work What to look for:


practices and
conditions. •• How substances are used in various jobs
Involve employees •• The quantities used
who are working with •• Level of potential exposure
the hazardous drugs.
•• Frequency and duration of use
•• The number of employees that may be exposed
•• Risk control measures already in place and their effectiveness

Review information What to do:


relating to incidents
or symptons of •• Review incident records.
exposure. •• Identify any problems associated with storage and transport of
hazardous drugs.
•• Determine whether employees have suffered any adverse effects.
•• Ascertain whether there have been any spills.
•• Determine if incidents have been reported and followed up.

Approval to reproduce adapted version from WorkSafe Victoria.

Best Practices for the Safe Handling of Hazardous Drugs 17


8.1 Tools for assessing risk

You can use one or all of the following assessment tools to help
you determine the level of risk posed by hazardous drugs in your
workplace:
•• Categorizing hazardous drugs
•• Environmental monitoring
•• Health monitoring

Categorizing hazardous drugs


For workplaces that use a wide variety or a large number of
hazardous drugs, it may be helpful to categorize them in terms of
the degree of risk of exposure. This may make it easier for the
employer to communicate to workers situations where they are at
high risk of exposure. This would be based on information about
the drug itself, such as the form of the drug, potential routes of
exposure, and potential health effects, as well as information on the
how the drug is used in the workplace, as determined in the risk
assessment.

Check to see if your workplace uses a hazardous drug classification


system for assessing hazardous drugs.

Categorizing hazardous drugs may help when developing safe


handling practices that are based on the risk of worker exposure
and are suitable for each stage of handling hazardous drugs.
Categorizing hazardous drugs is a tool that may be used for
assessing risk, or you may find that other means are more useful or
practicable in your workplace.

Environmental monitoring
Another tool that may be used as part of the risk assessment process
is environmental monitoring. For example, surface wipe sampling
measures surface contamination of selected sites of the work
environment by taking wipe samples and analyzing them in a
laboratory for the presence of hazardous drug contamination.
Sampling surfaces throughout the workplace can help provide a
picture of how hazardous drug contamination is spread throughout
different stages of handling. Refer to Appendix 3 for more
information on environmental monitoring.

Hazardous drug contamination throughout the workplace should


be kept as low as possible. The goal of environmental monitoring, if
it is used, is to establish baseline measurements of hazardous drug
contamination in the workplace with which future measurements
can be compared. Future measurements can be monitored for

18 Best Practices for the Safe Handling of Hazardous Drugs


reductions in contamination over a period of time or as the result of
interventions that have been implemented. These comparisons can
help determine areas where interventions were successful and set
targets for future improvements.

Health monitoring
Health monitoring is intended to prevent the development of
occupational disease in workers by detecting biomarkers in blood
or urine samples that indicate early signs of disease. For hazardous
drugs, this can be difficult in practice because the health outcomes
due to exposure are not yet fully understood.

There are also methods to detect hazardous drugs (or their


metabolites) in blood or urine. These tests should always be
interpreted with caution, as detecting signs of exposure does not
necessarily mean that disease will develop.

Health monitoring is typically used in a research setting. If health


monitoring is used in the workplace, it can help inform a risk
assessment by tracking whether worker exposure to hazardous
drugs changes over a period of time. However, health monitoring is
not a required component of an exposure control plan since these
methods are not all easily available or validated.

Best Practices for the Safe Handling of Hazardous Drugs 19


9. Developing and implementing
control measures
Once all hazardous drugs have been identified and the risks
In the Regulation
assessed, appropriate controls should be chosen that reduce the
Control measures risk of exposure to workers. Controls aim to eliminate or reduce
must be identified exposure to workers. As shown in the diagram below, one or more
where cytotoxic of these controls should be implemented in the following order:
drugs are present in (1) Elimination or substitution
the workplace and (2) Engineering controls
implemented in the (3) Administrative controls
order shown. See (4) Personal protective equipment (PPE)
section 5.5 of the
Regulation.

Most
effective

Elimination/substitution Physically remove or


replace the hazard

Engineering controls Isolate workers


from the hazard

Administrative &
work practices Change the way
workers work
controls

PPE Protect workers with


personal protective equipment

Least
effective

20 Best Practices for the Safe Handling of Hazardous Drugs


The following table provides a description and examples for each type of control.

Type of Control Description Examples

Elimination Elimination of hazardous drugs •• Removing unneeded hazardous


from the workplace is not typically drugs from the workplace
possible because these drugs may •• Having drugs delivered in a form
be the only treatment available. that is ready to administer
•• Eliminating the number of times
hazardous drugs are handled

Substitution Substitution includes using •• Using a form of hazardous drugs


a drug that is less hazardous, that has a lower risk of exposure
either because of the form it is to workers, such as tablets instead
administered in or its toxicological of IV infusions (if clinically
properties (provided it is just as appropriate)
effective at treating the patient).

Engineering Engineering controls protect •• Using an appropriate biological


controls workers by physically changing safety cabinet
the work environment to minimize •• Having negative pressure
exposure to hazardous drugs. preparation rooms or anterooms
•• Using closed-system transfer
devices

Administrative Administrative controls aim •• Regular hand washing


controls to reduce exposure in the work •• Implementing an effective
environment by changing how cleaning routine
work is carried out.
•• Protective reassignment
•• Developing and implementing
safe work procedures

PPE PPE controls exposure at the point •• Chemotherapy-tested gloves


of the individual worker. It is last in •• Chemotherapy-tested gowns
the hierarchy of controls because
•• Respirators
it requires the most activity and
is the least effective means of •• Eye and face protection
limiting worker exposure. PPE will •• Footwear and shoe covers
often have to be worn despite the
presence of other control methods.

Best Practices for the Safe Handling of Hazardous Drugs 21


Workers exposed to reproductive toxins: protective
reassignment

Some hazardous drugs may also be reproductive toxins. According


to section 6.49 of the Regulation, where reproductive toxins are
present in cytotoxic drugs, the employer must develop procedures
to reduce the risk of exposure to workers who are pregnant or who
are trying to conceive a child.

An administrative control method of achieving this is protective


reassignment. This is where the worker is assigned to alternative
tasks that reduce the risk of their exposure to hazardous drugs.
Some examples of protective reassignment include, but are not
limited to:

•• Moving the worker to a different area that does not involve


exposure to hazardous drugs
•• Assigning the worker to tasks where they won’t be exposed to
hazardous drugs
•• Reducing shift hours working in areas where hazardous drugs
are handled

22 Best Practices for the Safe Handling of Hazardous Drugs


10. Written safe work procedures
Written safe work procedures that are specific to the tasks
In the Regulation performed at the workplace are an important part of ensuring that
Safe work procedures information on minimizing exposure is communicated to workers.
must be in place Safe work procedures must be available to workers.
and posted where
Examples of safe work procedures to be developed and
cytotoxic drugs
communicated to workers include:
are present in the
•• Appropriate safe work procedures for all tasks and activities
workplace. See
involving hazardous drugs, including but not limited to, receiving,
section 6.48 of the
storage, preparation, administration, and waste handling
Regulation.
•• PPE requirements for each stage of handling and related worker
and employer responsibilities
•• Requirements for proper hygiene, including proper hand washing
and the prohibition of eating, drinking, smoking, applying
cosmetics, and storing food where hazardous drugs are present
•• Procedures for documenting acute exposures and reporting
suspected exposures
•• Procedures for emergency spills, including medical treatment
and personnel decontamination for acute exposures and proper
cleanup
•• Procedures for hazardous drug waste disposal

Best Practices for the Safe Handling of Hazardous Drugs 23


11. Information and communication
[Picture:
In the Regulation
In Canada,Sample
drug productsHazardous Drugs
fall under the jurisdiction of the Warning
Food Labe
and Drugs Act and are exempt from WHMIS requirements.
Where cytotoxic However, information requirements under section 5.2 of the
drugs are present Regulation still apply. These requirements include communicating
in the workplace, information about hazardous drugs to workers via:
information must •• Labels, signs, and lists
be communicated •• Education and training
•• Written records
CAUTION CHEMOTHERAPY
to workers in the
Authorized Personnel Only
form of labels, signs,
Labels, signs, and lists
lists, education and
training, and written If workers are exposed to hazardous drugs, this information must
records. See sections be communicated to workers, including those who may not be
6.45, 6.46, 6.47, proficient in English. This may be done by:
6.50, and 6.52 of the •• Ensuring all hazardous drugs are labelled to identify them as
Regulation. hazardous
•• Posting warning signs to workers in areas where hazardous drugs
e: Sample Hazardous Drugs Warning Labels and Signs]
are present
•• Maintaining a list of all hazardous drugs present in the workplace

CAUTION CHEMOTHERAPY
Authorized Personnel Only

24 Best Practices for the Safe Handling of Hazardous Drugs


11.1 Education and training

Training is an essential component of reducing exposure to


hazardous drugs in occupational settings. It is the employer’s
responsibility to ensure that workers are informed about the
exposure control plan for their workplace.

All workers who are potentially exposed to hazardous drugs must


receive education on known health risks, including any potential
reproductive hazards and, where appropriate, training on:
•• Relevant techniques and procedures for safe handling
•• Proper use of relevant equipment and materials
•• Spill and waste disposal procedures
•• Procedures for reporting known exposures and suspected health
effects

11.2 Written records

All components of an exposure control plan for hazardous drugs


should be documented, including periodic reviews. Maintaining
records is useful for demonstrating compliance with the Regulation.

Best Practices for the Safe Handling of Hazardous Drugs 25


Part 3: Task-specific
guidelines for reducing
exposure to hazardous
drugs
The following chapters provide information for making changes in the workplace at
each stage of handling hazardous drugs. The practices that your workplace chooses to
adopt should be based on the findings of the risk assessment, with the goal of
minimizing worker exposure to hazardous drugs.
12. Drug shipping
Containers or packages of hazardous drugs can potentially be a
source of exposure to workers involved in shipping hazardous drugs
to facilities where they are prepared or administered. This is because
it’s possible there may already be surface contamination on the
outside of the packaging from the manufacturing stage. Shipments
may also be damaged during transport resulting in leaks or spills.

Potential activities that could result in exposure include:


•• Surface contamination on the exterior of shipping packaging
•• Leaks or spills during transport

Refer to Appendix 1 for references regarding surface contamination.

Guidelines for safe work practice


Drug suppliers and shipping companies handling hazardous drugs
should ensure that there are appropriate procedures in place to
protect their workers from exposure to hazardous drugs.

Best practices for purchasing and shipping of hazardous drugs


include:
•• Sealing hazardous drugs in plastic bags or shrink wrap during
transport
•• Ensuring there are warning labels on the outside of shipping or
transport containers containing hazardous drugs
•• Using packages and packaging methods that will minimize
breakage

Personal protective equipment (PPE)


In the Regulation
PPE must be consistent with the worker’s potential exposure and
PPE that is consistent may include:
with the ECP must be •• Chemotherapy-tested gloves
used where cytotoxic •• A chemotherapy-tested gown
drugs are present.
See section 6.55 of Refer to Appendix 4 for further details on PPE.
the Regulation.

Best Practices for the Safe Handling of Hazardous Drugs 29


13. Drug receiving and storage
Surface contamination of containers and packaging is a potential
source of exposure for workers as they unpack and store incoming
shipments of hazardous drugs. Facilities should communicate with
the drug suppliers to identify hazardous drugs during shipping and
reduce exposure for the workers transporting and receiving the drugs.

Potential activities that could result in exposure include:


•• Handling incoming shipments of hazardous drugs that may
have surface contamination
•• Opening packages containing hazardous drugs, which could
result in the generation of particulates or aerosol
•• Handling individual containers or bags of hazardous drugs that
may have surface contamination
•• Handling damaged packaging that has resulted in a leak or
spill

Incoming shipments may also be damaged or broken, in which


case proper spill procedures need to be taken (refer to Chapter 21).

13.1 Work area design

Hazardous drugs may be received in a receiving bay or in a


designated room or area of a pharmacy before being stored in a
storage area. In order to minimize exposure, areas where hazardous
drugs are received or stored should be built and organized to
minimize exposure.

Receiving and storage areas should:


•• Be in a designated area, preferably separated from the rest of the
facility
•• Have negative pressure with respect to surrounding rooms

30 Best Practices for the Safe Handling of Hazardous Drugs


13.2 Equipment

Equipment used in receiving and storage areas should, where


possible, be designed to minimize potential exposure to hazardous
drugs. Examples include:
•• Storage shelves with fall guards, such as lipped edges or barriers
•• Containers with lids for storage and transport of hazardous drugs
•• Equipment that can accommodate special storage requirements,
such as a refrigerator for drugs that require cooler temperatures

13.3 Guidelines for safe work practice

Best practices to eliminate and minimize the risk to hazardous drugs


during receiving and storage include:
•• Having incoming shipments checked for damage before any
container is opened
•• Implementing a procedure to clean containers before they are
moved to storage, such as wiping the exterior with a single-use
disposable absorbent pad and a detergent and water solution
•• Limiting access to the storage area and using signs to indicate
restricted entry to authorized personnel only
•• Storing hazardous drugs inside their original packaging (for
example, resealable bags or shrink wrap)
•• Ensuring storage containers are not overfilled

13.4 Personal protective equipment (PPE)


In the Regulation
PPE must be consistent with the worker’s potential exposure and
PPE that is consistent may include:
with the ECP must be •• Chemotherapy-tested gloves
used where cytotoxic •• A chemotherapy-tested gown
drugs are present. •• An approved and fit-tested respirator, if handling damaged
See section 6.55 of packages containing hazardous drugs
the Regulation.
Refer to Appendix 4 for further details on PPE.

Best Practices for the Safe Handling of Hazardous Drugs 31


14. Drug transport
Workers who transport hazardous drugs throughout a facility may
be exposed if they come into contact with hazardous drug surface
contamination or a hazardous drug leak or spill.

Potential activities that could result in exposure include:


•• Handling containers or packages with hazardous drug surface
contamination
•• Handling containers or packages when there has been a leak
or a spill

14.1 Equipment

The equipment used for transporting hazardous drugs throughout a


facility should be designed to minimize exposure to workers
handling hazardous drug products. This includes:
•• Equipment that reduces spills, such as carts with lipped edges
and closed, hard-sided transport boxes
•• Using equipment that is easy to clean

14.2 Guidelines for safe work practice

Best practices for transporting hazardous drugs include:


•• Using resealable clear plastic bags to place hazardous drug
products in before transport
•• Using closed, hard-sided boxes to be used for transport
throughout the facility
•• Implementing procedures for safe handling of products during
transport

In the Regulation 14.3 Personal protective equipment (PPE)


PPE that is consistent
PPE must be consistent with the worker’s potential exposure and
with the ECP must be
may include:
used where cytotoxic
•• Double chemotherapy-tested gloves
drugs are present.
•• A chemotherapy-tested gown
See section 6.55 of
the Regulation. Refer to Appendix 4 for more details on PPE.

32 Best Practices for the Safe Handling of Hazardous Drugs


15. Drug preparation
A preparation room is where drugs are prepared, compounded, and
verified before they are administered to patients. Workers may
work directly with hazardous drugs. Care must be taken to minimize
exposure during handling and to limit the spread of hazardous drug
contamination.

Potential activities that could result in exposure include:


•• Compounding, diluting, or altering hazardous drug medications
•• Priming administration equipment, which can generate aerosol
or particulate contamination
•• Handling, crushing, or opening oral medications
•• Handling hazardous drugs while verifying before they leave the
pharmacy, as packaging may have surface contamination

15.1 Work area design

Preparation rooms can be sterile or non-sterile, depending on the


conditions that are required for the task being performed. A sterile
preparation room (which may also be called a clean room) should
not be used for compounding non-sterile preparations.

Refer to the following resources for detailed information on clean


room specifications:
•• NAPRA “Model Standards for Pharmacy Compounding of
Hazardous Sterile Products”
•• USP Chapter <797> “Pharmaceutical Compounding - Sterile
Preparations”
•• USP Chapter <800> “Hazardous Drugs - Handling in Healthcare
Settings”

Sterile preparation rooms should:


•• Be an ISO Class 7 environment, if the room contains a biological
safety cabinet for sterile preparations
•• Exhaust all air through at least one high efficiency particulate air
(HEPA) filter before being exhausted externally from the building
•• Have an ISO Class 7 anteroom through which personnel enter,
with interlocking doors that cannot be opened at the same time
•• Use pass-through hatches for the transfer of preparations out of
the room

Best Practices for the Safe Handling of Hazardous Drugs 33


•• Have a viewing window and an intercom system so workers can
communicate with workers outside the room
•• Have furniture and equipment made of materials that are easily
cleaned and decontaminated, such as stainless steel

Non-sterile preparation rooms are where hazardous drugs can be


prepared in non-sterile conditions, such as splitting or crushing oral
medications, repackaging medications into dosettes, preparing oral
solutions, or preparing topical creams.

Non-sterile preparation rooms should:


•• Be kept under negative pressure with respect to surrounding rooms
•• Be a separate room that is dedicated for non-sterile hazardous
drug preparations
•• Exhaust all air externally
•• Use furniture and equipment made of materials that are easily
cleaned and decontaminated, such as stainless steel

15.2 Equipment

The equipment used during the preparation of hazardous drugs


should be selected based on their effectiveness at reducing worker
exposure to hazardous drugs.

Biological safety cabinets


In the Regulation
A biological safety cabinet (BSC) is a ventilated containment
Where preparation cabinet that is designed to provide personnel, product, and
activities involving environmental protection.
cytotoxic drugs take
place at the facility,
Not all BSCs are appropriate for use with hazardous drugs. BSCs
an approved BSC
that are used for preparing hazardous drugs should:
must be provided and
•• Be exhausted to the outside atmosphere to prevent recirculation
used. See section
into the preparation room
6.53(1)(a)(b) of the
•• Have exhaust and ventilation systems that operate continuously
Regulation.
to ensure that no contaminants escape from the biological safety
cabinet into the workplace

BSCs are divided into three classes (Class I, Class II, and Class III)
that are each designed to meet different needs depending on their
intended use. In workplaces where both sterile and non-sterile
preparations take place, it is best practice to have a separate BSC
dedicated for each purpose.

Refer to Appendix 5 for additional information on the selection of


an appropriate BSC.

34 Best Practices for the Safe Handling of Hazardous Drugs


Performance testing of BSCs
In the Regulation
Performance testing of the preparation room equipment should
Where a BSC is used, take place regularly.
it must be equipped
with a continuous All BSCs used for hazardous drugs should be equipped with a
airflow monitoring continuous airflow monitoring device to ensure adequate airflow
device where and performance of the BSC before it is used to prepare hazardous
cytotoxic drugs are drugs. Workers who use the BSC should regularly document the
present. See section readings on the monitoring device and be able to recognize when
6.53(1)(c) of the the readings indicate a malfunctioning BSC, as well as appropriate
Regulation. procedures to follow if this occurs. Safe work procedures must be
developed to ensure worker protection when a BSC is turned off.

BSCs must be regularly tested and certified to ensure that they are
performing properly following the manufacturer’s specifications
and the requirements of the Regulation.

Closed-system transfer devices


Closed-system transfer devices (CSTDs) are designed to contain
hazardous drugs and minimize potential exposure when transferring
hazardous drugs between containers or pieces of equipment.

It is important to note that a CSTD is not a substitute for compounding


preparations inside a BSC. When a CSTD is used during the
preparation of hazardous drugs, it should always be inside a BSC.

Several studies have demonstrated that the use of a CSTD in


addition to a BSC reduces surface contamination of hazardous
drugs in the workplace. Strong consideration should be made to
using a CSTD for transferring hazardous drugs between containers
whenever practicable.

Additional equipment
Many different types of equipment and supplies are used in the
preparation of hazardous drugs. Further examples include:
•• Fittings that prevent accidental disconnection, such as luer lock
In the Regulation
fittings
Locking fittings which •• Appropriate needleless systems or safety engineered needles
cannot accidentally that reduce the risk of workers getting a percutaneous exposure
disconnect must be •• Filtered venting devices, such as chemotherapy dispensing pins
must be used where and chemotherapy vents, which can minimize the accidental
cytotoxic drugs release of hazardous drugs when reconstituting or withdrawing
are present. See from a vial
section 6.54 of the
Regulation. Refer to Appendix 6 for information on medical equipment that
may be appropriate for use with hazardous drugs.

Best Practices for the Safe Handling of Hazardous Drugs 35


In the Regulation
15.3 Guidelines for safe work practice

Safety engineered Best practices for the preparation of hazardous drugs include:
needles or needleless •• Obtaining hazardous drugs from the supplier in a form that is
systems must be ready to administer
used when caring •• Using safety-engineered needles that do not produce spray
for or treating a when activated
person. This applies •• Using CSTDs
to all hazardous •• Using disposable plastic syringes
drugs, including •• Using an approved BSC for preparations of hazardous drugs
cytotoxic drugs. See (where possible, the BSC should be designated for either sterile
section 6.36 of the or non-sterile compounding)
Regulation. •• Planning tasks to avoid unnecessary leaving and re-entering the
preparation room
•• Limiting access to the preparation room to workers trained to
work in the room (such as pharmacy and housekeeping staff)
•• Limiting equipment and materials in a BSC to those required to
prepare one dose for one patient, to avoid overcrowding and
mixing up drugs
•• Implementing procedures for priming equipment with a
hazardous drug solution in a BSC (see the next chapter for
priming with a non-hazardous drug solution)
•• Implementing procedures to have all alterations of hazardous
drug tablets or capsules (such as cutting, splitting, and crushing)
inside an approved BSC
•• Not using automated unit-dose packaging machines or
automated counting machines with tablet or capsule forms of
hazardous drugs
•• Implementing procedures to reduce contamination of containers
and IV bags after they leave the BSC, such as cleaning with a
soap-moistened towel and placing the product in a clear
resealable bag

15.4 Cleaning

The preparation room should also be cleaned regularly as part of


regular housekeeping and throughout the work day. This includes:
•• Regular cleaning of the interior of the BSC
•• Cleaning and decontaminating of the preparation room, from
cleanest areas to the most contaminated (for example, from the
walls and then inwards to the BSC)
•• Cleaning, disinfecting, and decontaminating the entire interior of
the cabinet after a non-sterile preparation (this should be done
before a sterile preparation can be performed in the same BSC)

36 Best Practices for the Safe Handling of Hazardous Drugs


Refer to Appendix 7 for more information on the selection of
cleaning agents.

In the Regulation 15.5 Personal protective equipment (PPE)

PPE that is consistent PPE must be consistent with the worker’s potential exposure and
with the ECP must be may include:
used where cytotoxic •• Chemotherapy-tested gloves
drugs are present. •• A chemotherapy-tested gown
See section 6.55 of •• Shoe covers
the Regulation. •• Eye and face protection
•• An approved and fit-tested respirator

Refer to Appendix 4 for more details on PPE.

Best Practices for the Safe Handling of Hazardous Drugs 37


16. Drug administration
Administration of hazardous drugs can take many forms, such as IV
therapy, inhalation therapy, surgical procedures, injections, oral,
and topical medications.

Potential activities that could result in exposure include:


•• Using administration equipment that may leak or spill, such as
IV equipment
•• Cutting or crushing tablets at the point of administration
•• Directly handling medications, such as oral or topical treatments
•• Removing air or priming equipment such as syringes
•• Exposure to blood or body fluids during the precautionary
period

16.1 Work area design

Hazardous drugs are administered in treatment areas in a number


of different settings. The design of treatment areas should reflect
the findings of the risk assessment.

Treatment areas where hazardous drugs are administered:


•• Should be kept under neutral or negative air pressure to the
surrounding rooms, where possible
•• Should use surfaces that are easy to clean, such as stainless steel,
where possible
•• Should keep any rest areas for workers or visitors isolated from
any administration areas

16.2 Drug administration equipment


In the Regulation
The selection of appropriate equipment for the administration of
All activities involving
hazardous drugs can help minimize the risk of exposure to workers.
the administration
of medication to All activities involving the administration of medication to a person
a person must be must be done with safety-engineered medical sharps or a
done using a safety needleless system, where clinically appropriate.
engineered medical
sharp or a needleless
Equipment used for the administration of hazardous drugs includes:
system. See section
•• Closed-system transfer devices (CSTDs) designed for the
6.36 of the Regulation.
administration of hazardous drugs
•• Safety-engineered needles

38 Best Practices for the Safe Handling of Hazardous Drugs


•• Filtered venting devices, such as chemotherapy-dispensing pins
and chemotherapy vents
•• Administration equipment, such as IV pumps and CADD pumps

Refer to Appendix 6 for information on how to select medical


equipment that is appropriate for use with hazardous drugs.

16.3 Guidelines for safe work practice

Best practices for the administration of hazardous drugs include:


In the Regulation •• Avoiding priming IVs with a hazardous drug solution at the point
All priming of of administration (this should be done as part of the preparation
administration sets step in an approved BSC)
with a cytotoxic drug •• Avoiding altering oral medications, such as crushing or cutting, at
must be performed the point of administration (this should be done as part of the
in an approved BSC. preparation step in an approved BSC)
See section 6.53 of •• Where possible, avoiding contact with oral medications during
the Regulation administration by using medication cups, unit-dose packaging
from the manufacturer, or having patients administer their own
medication
•• If priming of administration sets cannot be done as part of the
preparation step, implementing procedures so that priming is
performed with compatible dilutant and the drug is added afterwards
•• Using CSTDs for administration activities, including withdrawing
and injecting hazardous drugs from syringes and IV systems
•• Using disposable, absorbent pads to be placed under the patient
where administration is occurring
•• Using bandages that can be applied over an area where a topical
medication has been applied to avoid spreading contamination
to clothing or bedsheets
•• Limiting access to administration areas (this is extremely important
for some administration forms, particularly aerosolization therapy,
and only the patient should be in the room where treatment is
taking place)
•• Implementing procedures for proper disposal of administration
equipment, such as flushing IV tubing with a dilutant before
disconnecting or discarding tubing immediately after use as
hazardous waste

16.4 Cleaning

There should be regular cleaning of administration areas. The


administration area should have a set of cleaning equipment
dedicated for that area.

Best Practices for the Safe Handling of Hazardous Drugs 39


Work areas, such as trays, carts, tabletops, chairs, and beds where
hazardous drugs are administered, should be cleaned daily.

Refer to Appendix 7 for more information on the selection of


cleaning agents.

16.5 Considerations for home care

Administering hazardous drugs in home care settings poses


additional challenges because there is less ability to change the
physical work environment.

Where possible, an initial assessment of the home should be done


to determine that there are appropriate facilities for the activities
that will take place in the home. This may include:
•• Running water to allow for hand washing
•• A properly functioning toilet
•• Windows that can be opened to provide ventilation

The guidelines for safe work practice in administration settings


discussed in the previous sections may also be applied in the home
care setting, where relevant. Additional best practices for
administration in the home include:
•• As much as possible, avoiding any alteration of hazardous drugs
in the home (activities such as cutting or crushing oral
medications and dissolving powders into solution should be
done by pharmacy staff in a BSC)
•• Providing the patient with instructions on:
–– How to use administration equipment, such as electronic
diffusion devices
–– Safe handling precautions for bodily fluids during the
precautionary period for their treatment, including
recommendations for the equipment and PPE required
–– How to safely dispose of hazardous drug waste and
contaminated medical sharps

The precautionary period is the period of time that a patient


excretes hazardous drugs after their treatment. For most treatment
protocols this is 48 hours but may be up to seven days. Refer to
the treatment protocol to determine the precautionary period for
each patient.

40 Best Practices for the Safe Handling of Hazardous Drugs


In the Regulation 16.6 Personal protective equipment (PPE)

PPE that is consistent PPE must be consistent with the worker’s potential exposure and
with the ECP must be may include:
used where cytotoxic •• Chemotherapy-tested gloves
drugs are present. •• A chemotherapy-tested gown
See section 6.55 of •• Face and eye protection
the Regulation.
Refer to Appendix 4 for more details on PPE.

Best Practices for the Safe Handling of Hazardous Drugs 41


17. Veterinary practice
Hazardous drugs are increasingly being used to treat animals,
In the Regulation ranging from cats and dogs to horses. Regardless of whether the
To reduce exposure, animal is being treated at a clinic or in the community (for example,
appropriate a barn), there should be a risk assessment to determine appropriate
treatment controls controls for reducing worker exposure to hazardous drugs.
resulting from a risk
assessment must Potential activities that could result in exposure include:
be applied where •• Administering hazardous drugs to animal patients
cytotoxic drugs are •• Holding the animal during treatment
present. See sections •• Cleaning the treatment area, cages, or kennels
5.55 and 6.43 of the
Regulation.

17.1 Work area design

In order to minimize exposure, veterinary settings where hazardous


drugs are administered should have appropriate controls reflecting
the results of the risk assessment. This may include:
•• Having a preparation room as described in Chapter 15 if any
preparation activities take place at the facility
•• Having a separate storage area for hazardous drugs, away from
other drugs and from animal or worker food and drink
•• Having one room dedicated for the administration of hazardous
drugs
•• Having cages, kennels, or stalls dedicated for animals that are
receiving or have recently received chemotherapy

42 Best Practices for the Safe Handling of Hazardous Drugs


In the Regulation
17.2 Equipment

Where preparation Appropriate equipment for using hazardous drugs in veterinary


activities involving practice may include:
cytotoxic drugs take •• An approved BSC, if any preparation activities take place at the
place at the facility, an facility.
approved BSC must •• Safety-engineered sharps or needleless systems for the
be provided and used. administration of hazardous drugs. Although not a regulatory
See section 6.53 of requirement in veterinary practice, these reduce the risk of
the Regulation. exposure to workers.
•• Equipment dedicated for use with animals receiving hazardous
Where a BSC is used,
drugs.
it must be equipped
with a continuous Refer to Appendix 6 for information on how to select equipment
airflow monitoring that is appropriate for use with hazardous drugs.
device where
cytotoxic drugs are 17.3 Guidelines for safe work practice
present. See section
6.53(1)(c) of the
Best practices for the use of hazardous drugs in veterinary settings
Regulation.
include:
•• Where possible, purchasing hazardous drugs in a form that is ready
to administer, to avoid preparation activities at the practice facility
•• Where possible, referring animals to specialized treatment centres
•• Identifying animals who have received hazardous drugs, such as
by placing signs on cages or kennels
•• Prohibiting the use of pressure washers to clean cages, kennels,
and stalls of animals being treated with hazardous drugs to
minimize the spread of aerosolized contamination
•• Supplying disposable towels for cleaning cages, kennels, and
animals, where practicable

Animals who have received hazardous drugs should also be cared


for with safe handling precautions after their treatment (see Chapter
18, “Patient Care”).

17.4 Cleaning

Cleaning and decontamination of the veterinary practice facility


should take place regularly to reduce contamination with hazardous
drug residues. This includes:
•• Regular cleaning of animal excreta
•• Regular cleaning and decontamination of the treatment area
•• Gently hosing down cages and kennels to avoid producing
aerosolized contamination

Best Practices for the Safe Handling of Hazardous Drugs 43


In the Regulation
17.5 Personal protective equipment (PPE)

PPE that is consistent PPE must be consistent with the worker’s potential exposure and
with the ECP must be may include:
used where cytotoxic •• Chemotherapy-tested gloves
drugs are present. •• A chemotherapy-tested gown
See section 6.55 of •• Face and eye protection
the Regulation. •• An approved and fit-tested respirator

Refer to Appendix 4 for more details on PPE.

44 Best Practices for the Safe Handling of Hazardous Drugs


18. Patient care
Providing personal care for patients receiving hazardous drugs
requires additional precautions. Body fluids have been shown to
contain hazardous drugs for a set amount of time known as the
precautionary period, which is the period of time that safe handling
precautions are required when caring for the patient.

Potential activities that could result in exposure include:


•• Handling patient bodily fluids from a patient who has received
hazardous drugs
•• Bathing the patient
•• Handling contaminated bedding or laundry
•• Assisting with toileting, especially flushing toilets
•• Cleaning the patient’s room, washroom, or home

18.1 Work area design

The design of the patient care area must reflect the results of a risk
assessment to reduce exposure to hazardous drugs.

In general, care areas where patients are receiving or have received


hazardous drugs should:
•• Be isolated from other patient care areas, where possible
•• Have dedicated washroom facilities for patients who have
received hazardous drugs
•• Have appropriate laundry services

18.2 Equipment

Equipment used for caring for patients within the precautionary


period includes:
•• Bed pans that are disposable, when possible
•• Carts and trays that are easy to clean and dedicated for use with
patients who have received hazardous drugs

Refer to Appendix 6 for information on how to select medical


equipment that is appropriate for use with hazardous drugs.

Best Practices for the Safe Handling of Hazardous Drugs 45


18.3 Guidelines for safe work practice
In the Regulation
Best practices for the care of patients receiving or who have
Employers must have received hazardous drugs include:
procedures for the •• Implementing safe handling procedures for handling body fluids
disposal of body of patients within the precautionary period, such as covering
fluids from patients toilets and double flushing
who have been treated •• Implementing safe handling procedures for handling laundry
with cytotoxic drugs. from patients within the precautionary period, such as avoiding
See sections 6.48 and shaking, folding the bedding so any contamination is trapped in
6.57 of the Regulation. the centre, and placing laundry in a plastic bag
•• Where possible, discarding laundry or bedding that is heavily
contaminated by body fluids, or alternatively washing separately
once before being added to other facility laundry
•• On top of regular charting requirements, documenting the length
of the precautionary period for the patient as per the treatment
protocol
•• Ensuring workers review patient history before providing care

When patients are being cared for after treatment at home, either
by a health care worker or their family, they should be provided
with the instructions described in Chapter 15.

18.4 Cleaning

Patient care areas should be cleaned and decontaminated regularly.


This includes:
•• Cleaning washrooms of patients receiving hazardous drugs regularly
•• Cleaning up spills of patient body fluids immediately

In the Regulation 18.5 Personal protective equipment (PPE)

PPE that is consistent PPE must be consistent with the worker’s potential exposure and
with the ECP must be may include:
used where cytotoxic •• Chemotherapy-tested gloves
drugs are present. •• A chemotherapy-tested gown, if there is a risk of splashing of
See section 6.55 of body fluids
the Regulation. •• Face and eye protection, if there is a risk of splashing of body fluids
•• An approved and fit-tested respirator, if there is a risk of inhaling
aerosols or particulates

Refer to Appendix 4 for more details on PPE.

46 Best Practices for the Safe Handling of Hazardous Drugs


19. Cleaning
Many workplaces may have contract workers who are responsible
for the majority of cleaning activities. If this is the case, it is
essential that there is coordination with the contracting company to
develop procedures to minimize hazardous drug contamination
throughout the workplace.

Potential activities that could result in exposure include:


•• Contact with hazardous drug surface contamination
•• Contact with body fluids or waste
•• Splashing of cleaning solutions used to clean hazardous drugs

19.1 Guidelines for safe work practice

Best practices for cleaning activities in areas with hazardous drug


contamination include:
•• Providing training on hazardous drugs for workers, including
potential routes of exposure and how to minimize exposure for
themselves
•• Using cleaning supplies designated for areas known to have
potentially high hazardous drug contamination, such as
pharmacies
•• Changing routine cleaning practices to minimize hazardous drug
contamination

Refer to Appendix 7 for information on how to select appropriate


cleaning agents for use with hazardous drugs.

In the Regulation 19.2 Personal protective equipment (PPE)


PPE that is consistent
PPE must be consistent with the worker’s potential exposure and
with the ECP must be
may include:
used where cytotoxic
•• Chemotherapy-tested gloves
drugs are present.
•• A chemotherapy-tested gown
See section 6.55 of
•• Face and eye protection,
the Regulation.
•• An approved and fit-tested respirator

Refer to Appendix 4 for more details on PPE.

Best Practices for the Safe Handling of Hazardous Drugs 47


20. Waste disposal
Hazardous drug waste is a potential source of exposure to
In the Regulation hazardous drugs. The employer should develop safe work
The employer must procedures for safely disposing of hazardous drug waste.
develop safe work Hazardous drug waste may include:
procedures for •• Hazardous drugs that are to be disposed of
handling cytotoxic •• Disposable equipment used to administer hazardous drugs, such
drug waste. See as syringes, needles, or IV tubing
sections 6.48 •• Disposable PPE used for protection against exposure to
and 6.57 of the hazardous drugs
Regulation. •• Bodily fluids, such as vomit, stool, urine, and sweat, from
patients who have recently received hazardous drugs
•• Disposable materials contaminated with body fluids from
patients who are within the precautionary period

Potential activities that could result in exposure include:


•• Disposing of hazardous drug-related waste, if it is contaminated
or leaking
•• Handling hazardous drug waste containers, which may have
surface contamination

20.1 Work area design

If hazardous drug waste is stored at the workplace before it is taken


to be disposed of, it should be stored with appropriate precautions,
as determined by the risk assessment. This includes:
•• Storing hazardous drug waste in a cool, locked, and ventilated
area until it is transported out of the facility
•• Isolating the storage area for hazardous drug waste from other
areas of the workplace as much as possible
•• Storing in a manner to prevent leaks and spills, such as by having
shelves with lipped edges
•• Using materials that are easy to clean, such as stainless steel

48 Best Practices for the Safe Handling of Hazardous Drugs


In the Regulation
20.2 Equipment

A hazardous drug Hazardous drug waste should be collected in a hazardous drug


waste container or waste container.
bag must be provided
where cytotoxic A hazardous drug waste container:
drugs are present. •• Must be leak-proof and puncture resistant
See section 6.57 of •• Must be designated for use with hazardous drugs
the Regulation. •• Should be easily identifiable as designated for hazardous drugs,
such as by using a uniform colour throughout the workplace

A bag used for disposal of soft materials (for example, laundry,


gloves, or gowns) contaminated with hazardous drugs:
•• Should be leak-proof
•• Should be made of thick, leak-proof plastic
•• Should be easily identifiable
•• Must be appropriately labelled with a hazardous drug warning

All areas where there is potential for hazardous drug waste should
have a hazardous drug waste container. These areas can be
determined as part of a risk assessment.

Hazardous drug waste containers and bags should also be provided


to patients and animal owners who are receiving hazardous drugs
or being cared for at home.

20.3 Guidelines for safe work practice

Best practices for disposal of hazardous drug waste include:


•• Coordinating of hazardous drug communication with external
waste-collection companies to reduce worker exposure
•• Sending hazardous drug waste for disposal by a certified
hazardous waste organization and in accordance with local
regulations
•• Having hazardous drug waste containers collected and
transported throughout a facility only by workers trained to do so
•• Arranging for the collection of hazardous drug waste containers
from patients homes
•• Implementing procedures to reduce leaks from hazardous waste
containers, such as by placing contaminated items in double
For information on plastic bags before placing in a hazardous drug waste container
hazardous waste
disposal in B.C., visit
Refer to CSA Standard Z317.10-09 Handling of Waste Materials in
www.hazwastebc.com.
Health Care Facilities and Veterinary Health Care Facilities for
more information on hazardous drug waste.

Best Practices for the Safe Handling of Hazardous Drugs 49


In the Regulation
20.4 Personal protective equipment (PPE)

PPE that is consistent PPE must be consistent with the worker’s potential exposure and
with the ECP must be may include:
used where cytotoxic •• Chemotherapy-tested gloves
drugs are present. •• A chemotherapy-tested gown
See section 6.55 of •• Face and eye protection, if there is a risk of splashing
the Regulation. •• An approved and fit-tested respirator if there is a risk of inhaling
aerosols or particulate

Refer to Appendix 4 for more details on PPE.

50 Best Practices for the Safe Handling of Hazardous Drugs


21. Spill response
Employers must develop emergency procedures that address spills
In the Regulation of hazardous drugs. Signs detailing spill response procedures
Employers must should be posted in all relevant areas of the workplace.
develop emergency
procedures for spills Potential activities that could result in exposure include:
of cytotoxic drugs. •• Contact with a leak or spill
See section 6.58(1) of •• Inhalation of aerosols, vapours, or particulates released as the
the Regulation. result of a spill
•• Contact with contaminated cleaning supplies

In the Regulation
21.1 Guidelines for safe work practice

Spill kits must be Best practices for hazardous drug spill response include:
provided where •• Supplying a spill kit in all areas where hazardous drugs are
cytotoxic drugs handled
are present. See •• Placing personnel decontamination kits in all areas where
section 6.58(2) of the hazardous drugs are handled
Regulation. •• Providing home care workers who are administering hazardous
drugs with the tools they might need to safely clean up a spill
•• Providing regular training on emergency spill procedures
•• Allowing only workers trained and authorized to clean spills to do so
•• Training workers not authorized to clean a large spill on how to
notify other workers and block off an area
•• Ensuring all spill cleanup supplies are discarded as hazardous waste

Refer to Appendix 8 for an example of what should be included in a


spill kit.

In the Regulation
21.2 Personal protective equipment (PPE)

PPE that is consistent PPE must be consistent with the worker’s potential exposure and
with the ECP must be may include:
used where cytotoxic •• Chemotherapy-tested gloves
drugs are present. •• A chemotherapy-tested gown
See section 6.55 of •• Face and eye protection, if there is a risk of splashing
the Regulation. •• An approved and fit-tested respirator, if there is a risk of inhaling
aerosols or particulate

Refer to Appendix 4 for more details on PPE.

Best Practices for the Safe Handling of Hazardous Drugs 51


Appendices
Appendix 1: References and resources
Health effects of occupational exposure
Connor, T.H, Lawson, C.C, Polovich, M, McDiarmid, M.A.
Reproductive health risks associated with occupational exposures
to antineoplastic drugs in health care settings — A review of the
evidence. J Occup Environ Med 56 (2014):901-910.

Fransman, W., Kager, H., Meijster, T., Heederick, D., Kromhout, H.,
Portengen, L., Blaauboer, BJ. Leukemia from dermal exposure to
cyclophosphamide among nurses in the netherlands: Quantitative
assessment of the risk. Ann Occup Hyg (2014): 1-12. doi:10.1093/
annhyg/met077.

Hemminki K, Kyyrönen P, Lindbohm M-L. Spontaneous abortions


and malformations in the offspring of nurses exposed to anesthetic
gases, cytostatic drugs, and other potential hazards in hospitals,
based on registered information of outcome. J Epidemol
Community Health 39 (1985): 141-147.

Hon, C., Teschke, K., Shen, H., Demers, PA., Venners, S.


Antineoplastic drug contamination in the urine of Canadian
healthcare workers. Int Arch Occup Environ Health (2015) DOI
10.1007/s00420-015-1026-1.

Ratner, PA., Spinelli, JJ., Beking, K., Lorenzi, M., Chow, Y., Teschke,
K., Le, ND., Gallagher, RP., Dimich-Ward, H. Cancer incidence and
adverse pregnancy outcome in registered nurses potentially
exposed to antineoplastic drugs. BMC Nurs 9:15 (2010).

Selevan SG, Lindbohm ML, Hornung RW, Hemminki K. A study of


occupational exposure to antineoplastic drugs and fetal loss in
nurses. N Engl J Med 313 (1985): 1173–78.

Sessink PJM, Cerna M, Rossner P, Pastorkova A, Bavarova H,


Frankova K, Anzion RB, Bos RP. Urinary cyclophosphamide
excretion and chromosomal aberrations in peripheral blood
lymphocytes after occupational exposure to antineoplastic agents.
Mutat Res 309.2 (1994): 193-199.

Stücker I, Caliiard J-F, Collin R, Gout M, Poyen D, Hémon, D. Risk


of spontaneous abortion among nurses handling antineoplastic
drugs. Scand J Work Environ Health 16 (1990): 102–107.

Best Practices for the Safe Handling of Hazardous Drugs 55


Valanis B, Vollmer WM, Steele P. Occupational exposure to
antineoplastic agents: Self-reported miscarriages and stillbirths among
nurses and pharmacists. J Occup Environ Med 41 (1999): 632–638.

Routes of occupational exposure


Connor T.H. Permeability of nitrile rubber, latex, polyurethane, and
neoprene gloves to 18 antineoplastic drugs. Am J Health Syst
Pharm 56.23 (1999): 2450-2453.

Connor T.H, DeBord, D.G, Pretty, J.R, Oliver, M.S, Roth, T.S, Lees,
P.S.J, Krieg, E.F. Evaluation of antineoplastic drug exposure of
health care workers at three university-based US cancer centers.
American C Occ Env Med 52.10 (2010):1019-1027.

Connor T.H, Shults, M, Fraser, M. Determination of the vaporization


of solutions of mutagenic antineoplastic agents at 23 and 37˚C
using a desiccators technique. Mutat Res 470 (2000): 85-92.

Odraska, P., Mazaurova, E., Dolezalova, L., Blaha, L. In vitro evaluation


of the permeation of cytotoxic drugs through reconstructed human
epidermis and oral epithelium. Klin Onkol 24.3 (2011): 195-202.

Turci R, Minoia C, Sottani C, Coghi R, Severi P, Castriotta C, et al.


Occupational exposure to antineoplastic drugs in seven Italian
hospitals: The effect of quality assurance and adherence to
guidelines. J Oncol Pharm Pract. 17.4 (2011): 320-332.

Surface contamination
Connor T.H., Sessink P.J., Harrison B.R., Pretty J.R., Peters B.G.,
Alfaro R.M., Bilos A., Beckmann G., Bing M.R., Anderson L.M.,
Dechristoforo R. Surface contamination of chemotherapy drug vials
and evaluation of new vial-cleaning techniques: results of three
studies. Am J Health Syst Pharm 62.5 (2005):475-84.

Hedmer M, Tinnerberg H, Axmon A, Joensson BAG. Environmental


and biological monitoring of antineoplastic drugs in four
workplaces in a Swedish hospital. Int Arch Occup Environ Health
81.7 (2008): 899–911.

Hon, C., Teschke, K., Chu, W., Demers, P., & Venners, S.
Antineoplastic drug contamination of surfaces throughout the
hospital medication system in canadian hospitals. J Occ Env Hyg
10.7 (2013): 374-383 DOI: 10:1080/15459624.2013.789743.

56 Best Practices for the Safe Handling of Hazardous Drugs


Hon, C., Venners, S., Demers, P., Chua, P., Astrakianakis, G., Chu,
W., Ensom, R., & Teschke, K. Healthcare workers and antineoplastic
drugs: Identifying the determinants of exposure and current
challenges to reducing exposure. (2012). Focus on Tomorrow.

Closed-system transfer devices


Sessink PJM, Trahan J and Coyne JW. Reduction in surface
contamination with cyclophosphamide in 30 hospital pharmacies
following implementation of a closed-system drug transfer device.
Hosp Pharm 48 (2013):204-212.

Yoshida J, Tei G, Mochizuki C, Masu Y, Koda S and Kumagai S. Use


of a closed system device to reduce occupational contamination
and exposure to antineoplastic drugs in the hospital work
environment. Ann Occup Hyg 53 (2009):153-160.

Cleaning and decontamination


Barzan, C. Towards the Reduction of Occupational Exposure to
Cytotoxic Drugs, 2010. Thesis dissertation.

Lamerie, T.Q, Nussbaumer, S, Décaudin, B, Fleury-Souverain, S,


Goossens, J.F, Bonnabry, P, Odou, P. Evaluation of decontamination
efficacy of cleaning solutions on stainless steel and glass surfaces
contaminated by 10 antineoplastic agents. Ann Occup Hyg 57.4
(2013):456-469. DOI: 10.1093/annhyg/mes087.

Best practice resources

These resources were reviewed to develop the best practices


throughout this book.

American Society of Health System Pharmacists (ASHP). 2004.


Guidelines on Handling Hazardous Drugs.

Association paritaire pour la santé et la sécurité du travail du


secteur affaires socials (ASSTSAS) [Joint Sector-based Association
for Health and Occupational Safety for the Social Sector]. 2007.
Prevention Guide: Safe Handling of Hazardous Drugs.

BC Cancer Agency (BCCA). 2012. Safe Handling of Hazardous


Drugs- Module 1.

Canadian Association of Pharmacy in Oncology (CAPhO). 2009.


Standards of Practice for Oncology Practice in Canada.

Best Practices for the Safe Handling of Hazardous Drugs 57


Chaffee, B, Armitstead, J, Benjamin, B, Cotugno, M, Forrey, R,
Hintzen, B, Pfeiffenberger, T, & Stevenson, J. Guidelines for the
safe handling of hazardous drugs: Consensus recommendations.
Am J Health-Syst Pharm 67 (2010): 1254-1546.

International Society of Oncology Pharmacy Practitioners (ISOPP).


2007. Standards of Practice – Safe Handling of Cytotoxics.

National Institute for Occupational Safety and Health (NIOSH). 2014.


NIOSH List of Antineoplastic and Other Hazardous Drugs in
Healthcare Settings, 2014. Centers for Disease Control and
Prevention.

National Institute for Occupational Safety and Health (NIOSH).


2010. Safe Handling of Hazardous Drugs for Veterinary Workers.
Workplace Solutions.

National Institute for Occupational Safety and Health (NIOSH).


2004. Preventing Occupational Exposures to Antineoplastics and
Other Hazardous Drugs in Health Care Settings. NIOSH Alert.

Occupational Health and Safety Administration (OSHA). 1999.


Technical Manual Section VI Chapter 2– Controlling Occupational
Exposure to Hazardous Drugs.

WorkSafe Victoria. 2013. Handling cytotoxic drugs in the


workplace: Handling health and safety risks associated with
handling cytotoxic drugs in the healthcare industry.

In-text resources

These are additional resources that are mentioned throughout the


book.

ASTM D6978 – 05(2013). American Society for Testing and


Materials: Standard Practice for Assessment of Resistance of
Medical Gloves to Permeation by Chemotherapy Gloves.

Canadian Biosafety Standards and Guidelines (CBSG) First Edition:


http://canadianbiosafetystandards.collaboration.gc.ca/cbsg-nldcb/
index-eng.php.

Canadian Pharmacists Association (CPhA): Compendium of


Pharmaceuticals and Specialties (CPS).

Canadian Standards Association (CSA): Z317.10-09 Handling of


Waste Materials in Health Care Facilities and Veterinary Health
Care Facilities.

58 Best Practices for the Safe Handling of Hazardous Drugs


NIOSH: Hazardous Drugs webpage http://www/cdc/gov/niosh/
docket/archive/docket233.html.

NIOSH: Antineoplastic and Hazardous Drugs List http://www.cdc.


gov/niosh/topics/hazdrug/#a.

Health Canada: Drug Product Database http://www.hc-sc.gc.ca/


dhp-mps/prodpharma/databasdon/index-eng.php.

National Association of Pharmacy Regulatory Authorities (NAPRA):


Model Standards for Pharmacy Compounding of Hazardous Sterile
Products.

United States Pharmacopeia (USP): Chapter <795> Pharmaceutical


Compounding – Nonsterile Preparations.

United States Pharmacopeia (USP): Chapter <797> Pharmaceutical


Compounding – Sterile Preparations.

United States Pharmacopeia (USP): Chapter <800> Hazardous


Drugs – Handling in Healthcare Settings (Draft).

WorkSafeBC: Breathe Safer: How to Use Respirators Safely and


Start a Respirator Program http://www.worksafebc.com/
publications/high_resolution_publications/assets/pdf/bk75.pdf.

WorkSafeBC: How to Implement a Formal Occupational Health


and Safety Program http://www.worksafebc.com/publications/
health_and_safety/by_topic/assets/pdf/howtoimplement_ohs.pdf.

Best Practices for the Safe Handling of Hazardous Drugs 59


Appendix 2: Glossary
Administrative Methods that reduce exposure to a hazardous substance by changing work
controls procedures and the organization of the workplace.

Antineoplastic An agent that acts to prevent, inhibit, or prevent the development of a


neoplasm (a tumour), and which is most often used in the treatment of
cancer.

Biological safety A ventilated containment cabinet that provides an ISO Class 5 environment
cabinet (BSC) for compounding products.

Biomarkers Measureable, biological signs that indicate exposure to a substance or


development of a disease. For example, this could be a metabolite of a
chemical or a predicted change in normal body functioning.

Chemical A cartridge that can be added to an elastomeric respirator that is designed


cartridge to trap gases or vapours from the air a worker breathes. These cartridges
contain chemical compounds that react with specific contaminants so they
are removed from the air and must be replaced following a specific
schedule outlined by the manufacturer.

Chemotherapy Gloves that are designed specifically for handling hazardous drugs. They
gloves should be tested and approved according to the American Society for
Testing and Materials (ASTM) standard for permeability to hazardous drugs.

Clean room A preparation room where sterile drugs are prepared. It is “clean” because
it controls the level of contamination by using ventilation and air flow to
remove non-sterile air.

Closed-system A device that completely contains a substance it is carrying, by preventing


transfer device leaks, airborne particulates, and vapours from escaping.
(CSTD)

Controls Methods of protecting against hazards. In the case of hazardous drugs,


they remove or minimize the risk of exposure to workers.

Cytotoxic drugs Drugs that act to treat disease by killing cells. They are a subset of
hazardous drugs and are specifically covered under the Regulation.
See the “About this Book” section for a detailed definition.

Engineering Methods of minimizing exposure by physically changing the work


controls environment to contain the source of exposure.

60 Best Practices for the Safe Handling of Hazardous Drugs


Environmental The use of analytic techniques to measure contamination of an
monitoring environment over a period of time. In the case of hazardous drugs, this is
useful for identifying areas with higher amounts of contamination and
determining whether current or introduced controls are effective at
reducing the levels of hazardous drugs in the work environment.

Exposure A requirement in the Regulation that details how the workplace will
control plan minimize exposure to hazardous drugs. Employers must develop and
implement an exposure control plan if their workers may be exposed to
cytotoxic drugs.

Food and Canadian federal legislation that regulates the use of cosmetics, drugs, and
Drugs Act food. Substances under this act are not required to provide supplier labels
and SDSs as described in WHMIS.

Genotoxic A substance that can damage the genetic material of cells, which causes
mutations to arise.

Hazardous As defined by NIOSH, a group of drugs that have know carcinogenicity,


drugs teratogenicity, reproductive toxicity, organ toxicity, or genotoxicity in
humans or animals (or a new drug that mimics an existing drug with one of
these characteristics). Examples include drugs used for treatment of
cancer, hormone treatments, and diluted forms of these drugs used to
treat a range of illnesses.

Hazardous A container that is designated to be used only for hazardous waste. These
waste container must be clearly labelled as meant for hazardous waste and are generally a
different colour than other waste containers in the workplace so that they
can be easily identified.

High efficiency A specialized filter that traps particulate matter. They are used to filter air
particulate air that is entering a biological safety cabinet as well as air that is exhausted
(HEPA) externally. They may also be used in local ventilation systems for specific
rooms in a workplace.

ISO Class 7 A measure of air quality using the ISO classification system, which is based
on how much particulate is present per cubic metre of air. The classes go
from what is considered the “dirtiest” air (ISO Class 9) to what is the
“cleanest” air (ISO Class 1).

Luer lock A fitting for medical instruments that is designed to prevent leaking.

Mutagenic A substance that causes mutations to occur in the genetic material of cells.

Oncogenic Describes a substance that has the ability to cause a (malignant) cancer.

Best Practices for the Safe Handling of Hazardous Drugs 61


Percutaneous A cut or puncture that breaks through the skin.

Personal protective A method of reducing occupational exposure to hazardous substances that


equipment (PPE) involves the worker wearing or using specialized clothing or equipment.

Permeability The ability of a substance to pass through a barrier.

Precautionary The amount of time after the administration of hazardous drugs when
period patient bodily fluids should be treated as hazardous and handled with safe
handling precautions. The exact time period is determined by the
treatment protocol for the drugs being administered, but most often it is
48 hours.

Priming Running of fluid through tubing to remove air.

Protective Placing a worker in a role that is different than what he or she normally
reassignment performs in order to reduce exposure to reproductive toxins.

Risk assessment The process of examining the workplace in order to understand where
workers are exposed to a hazard. It is the foundation of an exposure
control plan.

Safety-engineered A medical sharp with a built-in safety feature or mechanism that eliminates
medical sharp or minimizes the risk of accidental parenteral contact while or after the
sharp is used (for example, using a retracting mechanism or blunt tip).

Substitution A control measure used to minimize a hazard by replacing a substance or


process with one that is less hazardous.

Surface Refers to residues of hazardous drugs that are deposited on a surface.


contamination

Surface wipe A method of quantifying hazardous drug surface contamination by


sampling collecting hazardous drug residues on a wipe.

62 Best Practices for the Safe Handling of Hazardous Drugs


Appendix 3:
Monitoring the workplace environment
Environmental monitoring, when used, should be carried out:
•• Before implementing controls
•• After any changes (for example, new equipment, new drugs, or
same drugs in a different format) that could affect hazardous
drug contamination
•• After a major exposure event, such as a large spill
•• Periodically in areas of concern

Environmental monitoring should also include the following:


•• Compare with records of past environmental measurements
(suggested time period is at least five years, but longer may be
useful for research purposes).
•• Involve workers by asking for suggestions on where sampling
should take place and informing them of the results of any
monitoring activities.

Best Practices for the Safe Handling of Hazardous Drugs 63


Site of handling Suggested sampling areas

Receiving/unpacking areas •• Unpacking table


•• Floors
•• Exterior of drug containers

Storage areas •• Work table


•• Storage shelves
•• Cart

Preparation areas •• Cabinet work surface


•• Floor near cabinet
•• Technician’s chair
•• Product verification counter
•• Exterior of drug bags

Treatment areas •• Door handle


•• Counter used for priming/preparing equipment
•• Arms of chairs
•• Floor near administration area
•• Hazardous drug waste containers

Other areas •• Patient waiting room


•• Equipment storage areas

Recommended sampling sites for an environmental monitoring program for hazardous drugs,
adapted from ASSTSAS Prevention Guide – Safe Handling of Hazardous Drugs. Refer to this
guide for more information on implementing an environmental monitoring program.

64 Best Practices for the Safe Handling of Hazardous Drugs


Appendix 4:
Personal protective equipment (PPE)
The specific PPE that is required for each task in the workplace is
In the Regulation
determined by a risk assessment. Workers should refer to the safe
PPE that is consistent work procedures at their workplace for determining what types of
with the ECP must be PPE they are required to wear when handling hazardous drugs.
used where cytotoxic
It is the employer’s responsibility to provide appropriate PPE and
drugs are present.
training on its correct use and disposal. Workers are responsible for
This may include:
wearing supplied PPE when it is needed.
•• Gloves designed
for use with If the PPE is disposable, such as chemotherapy gloves and
cytotoxic drugs chemotherapy gowns, then once it’s been used for hazardous drugs
•• Gowns that are it must be discarded as hazardous drug waste.
moisture resistant
Chemotherapy-tested gloves
with long sleeves
and tight-fitted Chemotherapy-tested gloves must be worn whenever hazardous
cuffs drugs or potentially contaminated objects are handled.
•• Respirators
•• Face and eye Chemotherapy gloves should meet the requirements of ASTM
protection Standard 6978-05 Standard Practice for Assessment of Resistance
of Medical Gloves to Permeation by Chemotherapy Gloves.
See section
6.55(2)(a) to (d)
Chemotherapy-tested gloves should:
Also, see sections
•• Not be powdered, as the powder can be contaminated and then
8.40 and 8.41 of the
fall off the gloves during removal and contribute to
Regulation for the
contamination
requirements around
•• Be compatible with cleaning and decontaminating agents used in
the use of respirators.
the workplace
•• Be latex free (acceptable alternatives include neoprene, nitrile,
and polyurethane)
•• Be able to maintain their resistance to permeation by hazardous
drugs when disinfected with alcohol

When following best practices for the use of gloves during handling
of hazardous drugs, workers should:
•• Wear double gloves when the risk for dermal contamination with
hazardous drugs is high (this is determined as part of your
workplace risk assessment)

Best Practices for the Safe Handling of Hazardous Drugs 65


•• Follow steps to avoid contamination when putting on gloves and
during removal, including washing hands before and after
wearing gloves
•• Change gloves after 30 minutes of continuous compounding or if
they have been contaminated or compromised
•• Remove outer gloves before taking them out of a biological
safety cabinet

Chemotherapy-tested gowns
Chemotherapy-tested gowns used for handling hazardous drugs
must be worn when there is risk of bodily contact with hazardous
drugs or contaminated patient body fluids and waste during the
precautionary period.

Gowns should:
•• Be identified by the manufacturer as gowns for handling
hazardous drugs
•• Be moisture resistant with long sleeves and tight-fitting cuffs
•• Have a closed front that covers the worker from shoulders to
knees and fastens in the back
•• Be disposable

When following best practice for the use of chemotherapy gowns


with hazardous drugs, workers should:
•• Change the gown every 3.5 hours or immediately when
contaminated or compromised
•• Wash hands immediately after removing a gown

Chemotherapy gowns should meet the requirements of ASTM


Standard F739-99a Standard Test Method for Resistance of
Protective Clothing Materials to Permeation by Liquids or Gases
under Conditions of Continuous Contact or a comparable standard.

Respirators
An approved and fit-tested respirator must be worn when there is a
risk of exposure to airborne particulates, aerosols, or vapours from
hazardous drugs.

The respirator selected must provide protection from particulates as


well as gases or vapours that can be generated from solid or liquid
forms of hazardous drugs, depending on the activity. This could
include a half-or full-face air-purifying respirator that has a
particulate filter (such as P100) and a chemical cartridge that
removes vapour contaminants from air as it is inhaled.

66 Best Practices for the Safe Handling of Hazardous Drugs


The choice of respirator must be made as part of the risk assessment
based on the potential exposure to airborne particulates, aerosols, or
vapours from hazardous drugs for each task in the workplace. Fit
tests must also be carried out before a respirator is issued to a
worker. The worker must perform a seal check before each use.

Refer to the WorkSafeBC publication Breathe Safer: How to


Use Respirators Safely and Start a Respirator Program for more
information on how to select an appropriate respirator.

Face and eye protection


Face protection, such as full or partial face shields and goggles,
should be worn when there is a risk of splashing, which may occur
when handling liquid forms of hazardous drugs or contaminated
body fluids and waste.

When following best practice for wearing face protection for


hazardous drugs, workers should:
•• Wear full face shields
•• Use disposable face protection whenever practicable
•• Clean non-disposable face protection immediately after use

Footwear and shoe covers


Workers must ensure their footwear is in a condition to provide
protection against exposure to hazardous drugs, such as by wearing
closed shoes that are made of a material that prevents liquids from
soaking through. Refer to section 8.22 of the Regulation for more
information on the requirements for footwear.

Shoe covers are part of sterile preparation procedures but also help
reduce exposure by preventing contamination being spread to other
areas of the workplace on workers’ shoes.

Best practices for footwear and shoe covers include, but are not
limited to:
•• Having a dedicated set of footwear that is only used in the
preparation area
•• Having all workers wear shoe covers when entering a sterile
preparation room
•• Removing shoe covers with gloved hands and disposing as
hazardous waste upon exiting the preparation room
•• Wearing shoe covers when cleaning up spills or broken
containers on the floor

Best Practices for the Safe Handling of Hazardous Drugs 67


Appendix 5:
Biological safety cabinets (BSCs)
A biological safety cabinet (BSC) should be used for all preparation
In the Regulation activities with hazardous drugs. The information in this appendix
Where preparation outlines which BSCs are appropriate for use with hazardous drugs.
activities involving
cytotoxic drugs take For more information on BSCs, refer to the Canadian Biosafety
place at the facility, an Standards and Guidelines, First Edition.
approved BSC must
be provided and used.
See section 6.53 of Class I BSCs
the Regulation. A Class I BSC provides environmental and personnel protection,
but does not provide sterile conditions for the product. The
Where a BSC is used,
Regulation states that a Class I BSC is not acceptable for use with
it must be equipped
cytotoxic drugs, however it may be permitted if it is designed to be
with a continuous
total exhaust. Depending on whether non-sterile activities are
airflow monitoring
carried out in the workplace, the use of Class I BSCs with
device where
hazardous drugs may need to be evaluated with a WorkSafeBC
cytotoxic drugs are
occupational hygiene officer.
present. See section
6.53(1)(c) of the Class II BSCs
Regulation.
Class II Type A BSCs recirculate HEPA-filtered air back into the
preparation room and, because of this, do not meet the ventilation
requirements under the Regulation. Since HEPA filters only protect
against particulate contamination and not gases or vapours, this
recirculated air must be considered a potential risk for workers in
the preparation room to be exposed to hazardous drugs. For this
reason, Class II Type A1 and Type A2 BSCs should not be used for
In the Regulation the preparation of hazardous drugs.
Type A1 and A2
Class II Type B BSCs do not recirculate HEPA-filtered air into the
cabinets must not
preparation room and should be used for ventilation and
be used for the
containment control for preparations of hazardous drugs. However,
preparation of
it is best practice to use a Class II Type B2 BSC, since they
cytotoxic drugs. A
externally exhaust all air that passes through the cabinet.
minimum Class II Type
B must be used when Class III BSCs and isolators
preparing cytotoxic Class III BSCs and isolators could potentially provide additional
drugs. See section protection against exposure because they are completely enclosed
6.53 of the Regulation. and air tight. Unlike other classes of BSCs, they have a glass barrier
between the worker and the preparation. When being used for

68 Best Practices for the Safe Handling of Hazardous Drugs


containment, they are kept at negative air pressure to the
surrounding room. Preparations enter and exit the BSC via pass-
through hatches with interlocking doors, and workers reach
preparations inside the cabinet by placing their hands inside built-
in glove assembly fixtures.

Class III BSCs and isolators are not typically used for hazardous drug
preparation. Any Class III BSC or isolator used for hazardous drug
preparations must meet the operational requirements for BSCs as
described in the Regulation. Refer to section 30.12 of the Regulation.

Class Recirculated Permitted for Cytotoxic Recommended Best Practice


of BSC air Drugs under the Regulation for Hazardous Drugs

Class I Can be total No No


exhaust or
partial exhaust

Class II 70% into BSC, No No


Type A 30% into
preparation
room

Class II 30% into Yes No


Type B1 the BSC

Class 0% Yes Yes


II Type
B2

Class III 0% Yes No

A comparison of the BSC classes and their uses according to the Regulation and recommended by
best practice.

Best Practices for the Safe Handling of Hazardous Drugs 69


Appendix 6:
Selection of medical equipment
Not all equipment is suitable for use with hazardous drugs.

Where applicable, equipment that is selected for use with


hazardous drugs should:
•• Be approved for use with hazardous drugs by the manufacturer
•• Eliminate or minimize the release of hazardous drugs in the form
of liquids, solids, or vapours as much as reasonably possible
•• Clearly indicate any functions where the equipment is not a
closed system, if it is marketed as a closed-system transfer
device
•• Be supported by evidence that demonstrates the effectiveness of
the equipment at reducing environmental contamination in
occupational settings

Employers should periodically review the equipment and supplies


used for hazardous drugs for their effectiveness at reducing
exposure.

70 Best Practices for the Safe Handling of Hazardous Drugs


Appendix 7: Cleaning agents
Effective cleaning and decontamination is a key part of reducing
hazardous drug surface contamination. Hazardous drug
contamination has been detected on surfaces even after cleaning
using conventional methods and cleaning products. Hazardous
drug contamination may accumulate in porous materials.

No single cleaning agent can be used in all situations. The


effectiveness of a cleaning or decontaminating agent depends on
the chemical and physical properties of the drug, as well as the
surface that is being cleaned.

Workplaces should have multiple cleaning and decontaminating


supplies that are effective on different drugs, or at least different
types of drugs based on their chemical and physical properties.

When selecting cleaning and decontamination supplies,


workplaces should consider:
•• Current research on the effectiveness of different procedures
and agents on the types of hazardous drugs being used in the
workplace
•• Surfaces (e.g., stainless steel BSC) that may have specific
cleaning requirements outlined by the manufacturer
•• The characteristics of the surfaces that will be cleaned and
decontaminated, such as porosity and texture
•• The ease of use, such as having pre-packaged wipes soaked in
solution
•• The potential for hazardous by-products from cleaning and
decontamination products, or products that are hazardous
themselves

Best Practices for the Safe Handling of Hazardous Drugs 71


The table below compares some of the cleaning and decontaminating agents commonly used
on surfaces that may have hazardous drug contamination.

Deactivating Decontaminating Disinfecting Cleaning


agent agent agent agent

Mode of Breaks down Physically removes Surface Removes


action hazardous drugs hazardous drugs disinfection organic and
inorganic
material

Examples Hypochlorite Laboratory-grade Ethyl alcohol, Chlorhexidine


(household bleach) detergents 70% isopropyl
alcohol

Benefits •• Highly effective at •• Relatively safer •• Commonly •• Commonly


deactivating than bleach used in used in
several commonly •• Convenience routine routine
used hazardous disinfection cleaning
•• Use of different
drugs procedures procedures
solvents can
improve
efficiency against
different drugs

Challenges •• Can produce •• May be •• Do not directly act on


hazardous by- less effective hazardous drugs
products when •• Can leave residues that trap
•• Known to corrode contamination microbes or hazardous drugs
stainless steel (this is unknown and spread them around
can be minimized •• Higher •• Should not be used as the sole
by following with a concentrations agent for removing hazardous
neutralizing agent) may leave drug contamination
•• Can cause skin, residues that can
eye, and respiratory trap hazardous
irritation drugs

72 Best Practices for the Safe Handling of Hazardous Drugs


Appendix 8: Spill kit checklist
Spill kits should be available wherever hazardous drugs are
In the Regulation
handled. Best practices for the contents of a spill kit include:
Spill kits must be
present where
……
Laminated, written instructions

cytotoxic drugs are ……


Warning signs and plastic “caution” tape to alert other staff to
the hazard and to isolate the spill area
used in the workplace.
See section 6.58(2) of Personal protective equipment (PPE):
the Regulation.
……
Chemotherapy-tested gown
……
Two pairs of chemotherapy-tested gloves
……
Disposable eye goggles or face shield
……
Shoe covers
……
N95 or better respirator mask

……
Disposable scoop and scraper
……
An absorbent spill pad for small volumes of liquid
……
A spill pillow capable of absorbing very large volumes of liquid
(if not practical to fit inside the spill kit, this may be located
separately and retrieved when required)
……
Two large plastic waste disposal bags
……
Concentrated alkaline detergent solution
……
Bottled water, of the correct volume for diluting the detergent
……
Clearly labelled hazardous waste container
……
Information on reporting the spill and potential worker exposure

Best Practices for the Safe Handling of Hazardous Drugs 73


WorkSafeBC offices

Visit our website at worksafebc.com.

Abbotsford North Vancouver


2774 Trethewey Street V2T 3R1 400 – 224 Esplanade Ave. W. V7M
Phone 604.276.3100 1A4
1.800.292.2219 Phone 604.276.3100
Fax 604.556.2077 1.888.875.6999
Burnaby Fax 604.232.1558

450 – 6450 Roberts Street V5G 4E1 Prince George


Phone 604.276.3100 1066 Vancouver Street V2L 5M4
1.888.621.7233 Phone 250.561.3700
Fax 604.232.5950 1.800.663.6623
Coquitlam Fax 250.561.3710

104 – 3020 Lincoln Avenue V3B 6B4 Surrey


Phone 604.276.3100 100 – 5500 152 Street V3S 5J9
1.888.967.5377 Phone 604.276.3100
Fax 604.232.1946 1.888.621.7233
Courtenay Fax 604.232.7077

801 30th Street V9N 8G6 Terrace


Phone 250.334.8765 4450 Lakelse Avenue V8G 1P2
1.800.663.7921 Phone 250.615.6605
Fax 250.334.8757 1.800.663.3871
Kamloops Fax 250.615.6633

321 Battle Street V2C 6P1 Victoria


Phone 250.371.6003 4514 Chatterton Way V8X 5H2
1.800.663.3935 Phone 250.881.3418
Fax 250.371.6031 1.800.663.7593
Kelowna Fax 250.881.3482

110 – 2045 Enterprise Way V1Y 9T5 Head Office / Richmond


Phone 250.717.4313 Prevention Information Line:
1.888.922.4466 Phone 604.276.3100
Fax 250.717.4380 1.888.621.7233 (621.SAFE)
Nanaimo Administration:
4980 Wills Road V9T 6C6 6951 Westminster Highway
Phone 250.751.8040 Phone 604.273.2266
1.800.663.7382 Mailing Address:
Fax 250.751.8046 PO Box 5350 Stn Terminal
Nelson Vancouver BC V6B 5L5

524 Kootenay Street V1L 6B4 After hours


Phone 250.352.2824 health & safety emergency
1.800.663.4962 604.273.7711
Fax 250.352.1816 1.866.922.4357 (WCB.HELP)
R13/09
11/15
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