Hazardous Drugs - Pharmacy Services - LMPS

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Lower Mainland Pharmacy Services

Page 1 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

TABLE OF CONTENTS
BACKGROUND
PURPOSE
DEFINITIONS
POLICY
Hazardous Drug List and Hazardous Drug Groups
Education
Personal Protective Equipment
Medication Preparation by Pharmacy Services
Order Processing
Dispensing
Dispensing
Labelling Patient Specific Medications
Patient’s Own Medication
Pass Medications
Outpatient Medications
Access via Automated Dispensing Cabinets
Re-packaging
Hazardous Drug Warning Auxiliary Labels
Signage
Receiving
Storage
Transport
Transport Within a Facility
Transport Between Facilities
Protective Reassignment
Record Keeping
Handling Records
Exposure Records
Education and Training Records
Spill Management
Hazardous Drug Spill Kit
Hazardous Drug Spill Response
Managing Hazardous Drug Exposures
Waste Management
Cleaning
Laundry Management
REFERENCES
APPENDICES
Appendix A: Hazardous Drug Handling Precautions – Pharmacy Staff
Lower Mainland Pharmacy Services

Page 2 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

Date Comments / Changes


17 Feb 2022 Revisions include:
 Documentation on Handling Record clarified to include preparation of all Group
1 hazardous drugs whether they are prepared in the BSC or not
 Appendix A – as above
27 May 2022 Revision includes:
 Statement 1.43: Pharmacy staff shall decontaminate and clean all work surfaces
and re-usable equipment (previous statement included deactivation which is not
required)
08 Nov 2022 Revisions include:
 Statement 1.13: Dispense oral liquids in multi-dose containers with a self-sealing
bottle adapter inserted in the bottle opening to minimize contamination and
spillage in patient care areas, where feasible (previous statement did not include
“where feasible”). Note that a Safe Work Procedure has been established for
removal of an oral liquid dose from a multi-dose container in the patient care
area.
 Statement 1.43.1: Reference to “two-step hazardous drug wipe procedure”
replaced with “wiping down twice with disposable wipes”

BACKGROUND

Hazardous drugs are drugs that pose a potential health risk to workers who may be exposed to them
during receipt, transport, preparation, administration, or disposal. These drugs require special handling
because of their potential to cause toxicity.

PURPOSE

 To outline safe handling precautions for Pharmacy Services staff that minimize hazardous drug
exposure to staff and the work environment
 To outline standard labeling, packaging, and dispensing processes that minimize exposure to
hazardous drugs by nursing staff

DEFINITIONS

B.C. Provincial Hazardous Drug List is a list of hazardous drugs in the province of B.C., categorized
into Group 1 and 2. The B.C. Provincial Pharmacy Hazardous Drug Review Committee evaluates the
NIOSH list and amends the B.C. Provincial Hazardous Drug List as necessary.

Biological Safety Cabinet (BSC) is a type of primary engineering control that is a ventilated cabinet
for compounded sterile preparation, personnel, product, and environmental protection having an open
front with inward airflow for personnel protection, downward (or vertical) high-efficiency particulate air
(HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhausted air for
environmental protection. These primary engineering controls are typically located in negative pressure
clean rooms for preparation of hazardous drugs. (Source: Sterile Compounding – Cleaning and
Disinfection of the Controlled Work Area – LMPS)
Lower Mainland Pharmacy Services

Page 3 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

Chemotherapy approved is personal protective equipment that has undergone testing according to
standard methods against permeation to hazardous drugs and deemed acceptable for use with
hazardous drugs.

Cleaning Removal of dirt, dust and other substances that may host microorganisms. (Adapted from
NAPRA Nov 2016 Model standards for pharmacy compounding of hazardous sterile preparations)

Closed System Drug Transfer Device is a drug transfer device that mechanically prevents the
transfer of environmental contaminants into the system and the escape of the hazardous drug or
vapour outside of the system.

Deactivation is the treatment of a hazardous drug to create a less hazardous agent, for example by
chemical deactivation. (Adapted from NAPRA Nov 2016 Model standards for pharmacy compounding
of hazardous sterile preparations)

Decontamination is the transfer of a hazardous drug contaminant from a fixed surface (e.g., counter,
bag of solution) to a disposable surface (e.g., wipe, cloth). (Adapted from NAPRA Nov 2016 Model
standards for pharmacy compounding of hazardous sterile preparations)

Disinfection is treatment that eliminates most of the pathogens present on an object or surface.
(Adapted from NAPRA Nov 2016 Model standards for pharmacy compounding of hazardous sterile
preparations)

Exposure (Occupational) is potentially harmful contact with a hazardous drug that results during the
performance of a worker’s job duties. Exposure routes may include absorption, percutaneous /
permucosal contact, inhalation, or ingestion.

Hazardous Drug is a drug that


 Is accompanied by prescribing information that specifies special handling information
(Manufacturer Special Handling Information - MSHI) to protect workers handling the drug, OR
 exhibits one or more of the following toxicity criteria in humans, animal models, or in vitro
systems:
o Carcinogenicity
Lower Mainland Pharmacy Services

Page 4 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

o Developmental toxicity (including teratogenicity)


o Reproductive toxicity
o Genotoxicity
o Organ toxicity at low doses or
o Structure and toxicity profile that mimics existing drugs determined hazardous by
exhibiting any one of the previous five toxicity types
unless the drug also exhibits a molecular property that may limit the potential for adverse health effects
in health care worker exposure to the drug

Hazardous Drug – Group 1


 Drugs accompanied by manufacturer’s special handling information (MSHI); and/or
 Drugs which meet the National Institute for Occupational Safety and Health (NIOSH) definition
of a hazardous drug and are classified by the National Toxicology Program (NTP) as “known to
be a human carcinogen,” and/or classified by the International Agency for Research on Cancer
(IARC) as “carcinogenic” or “probably carcinogenic”
 Many of these drugs are cytotoxic and the majority are hazardous to employees who are
actively trying to conceive, who are pregnant or may become pregnant, and who are breast
feeding, because the drugs may be excreted in breast milk.
 Not all drugs in Group 1 are antineoplastic drugs.

Hazardous Drug – Group 2


 Drugs that meet the NIOSH definition of a hazardous drug but are not drugs which have MSHI
and are not classified by the NTP as “known to be a human carcinogen,” and/or classified by the
IARC as “carcinogenic” or “probably carcinogenic.”
 These drugs exhibit one or more of the types of toxicity described in the NIOSH definition of
hazardous drug.
 Some of these drugs may present an occupational hazard to employees who are actively trying
to conceive, who are pregnant or may become pregnant, and who are breast feeding, because
they may be present in breast milk.

Multi Unit Dose (MUD) is an automated drug distribution system where the patient’s medications for a
specific medication administration time are contained within one or more packages.
Lower Mainland Pharmacy Services

Page 5 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

MUD Strip is a number of unit dose or multi unit dose packages connected by perforations, intended
for a specific patient

Protective Eye Wear is eye wear that prevents exposure of the eyes and may be disposable or
reusable. Eye protection can be provided by wearing:
 Properly fitted safety goggles
 Transparent full-face splash shield
 Full-facepiece elastomeric respirator or powered air purifying respirator
NOTE: Prescription glasses, safety glasses, and medical mask (with an attached visor) are NOT
acceptable for splash protection. Medical masks with attached visors are intended for droplet
precautions, they do not prevent splashes from coming overtop of the shield or prevent liquid running
down the face into the eyes.

Respirator provides respiratory protection and is required when there is a risk of inhalation exposure
and local exhaust ventilation (e.g. BSC) is not feasible. Suitable respiratory PPE for hazardous drugs
include:

 N95 filtering facepiece respirator - disposable respirators that do not require maintenance
 Elastomeric half-facepiece respirators - reusable respirators that offer filter cartridge options
to protect against different types of inhalation hazards
 Elastomeric full-facepiece respirators - reusable respirators that offer filter cartridge options
to protect against different types of inhalation hazards. Full-facepiece respirators offer a higher
protection factor than N95 and half-facepiece respirators. They also include a built-in faceshield
for face protection
 Powered air-purifying respirators (PAPRs) - battery-powered respirators that supply filtered
air into the user’s breathing zone via tubing and a hood

Risk assessment is the overall process of taking identified hazards and performing an analysis and
evaluation of its risks.

Safe work procedures is a written work procedure for a hazardous task that incorporates ways to
eliminate or minimize risks to workers from these hazards in a list of actions.

Self-sealing bottle adapter is a self-sealing closure that is placed in the bottle opening to help prevent
evaporation, spills, and contamination. The closure is easily penetrated by an oral syringe and reseals
when the syringe is removed. Bottle caps can still be secured with the adapter in place.

POLICY
Hazardous Drug List and Hazardous Drug Groups

1.1 The BC Provincial Hazardous Drug List must be made available to all staff working in areas
where hazardous drugs are present.
Lower Mainland Pharmacy Services

Page 6 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

1.2 The hazardous drug group for products compounded by Pharmacy Services, containing a drug
on the BC Provincial Hazardous Drug List shall be determined by the hazard group of the
ingredients.

1.3 Newly available drugs shall be evaluated for hazardous drug criteria by the Lower Mainland
Pharmacy Services (LMPS) Medication Safety Team and added to LMPS pharmacy information
systems, as an interim determination, if they are deemed hazardous.
1.3.1 The interim determination is forwarded to the BC Provincial Pharmacy Hazardous Drug
Review Committee (PPHDRC) for final endorsement and approval.

Education
1.4 Pharmacy Coordinators shall ensure that pharmacy staff, who may be at risk of occupational
exposure to hazardous drugs, have completed all required education and training, as follows:
1.4.1 Applicable online education modules are completed every 3 years
 Refer to the Learning Hub integrated Course Catalogue Registration System
(CCRS) for the Hazardous Drug Safety for Pharmacy Staff modules:
o Awareness
o Compounding
o Receiving, unpacking and transport
o Pharmacy spill responder
1.4.2 Participation in a mock drill for those who complete the Pharmacy Spill Responder online
education module, is performed annually:
 Must occur within six months of completing the online education module, then
annually (e.g. site may conduct a mock drill twice yearly)
 Is completed in the presence of a supervisor or delegate
 Can be conducted by spilling a small amount of water and cleaning the spill
following the posted procedures (steps outlined in Appendix N of the Hazardous
Drug Exposure Control Program)
 Participation may be achieved in a group setting through observation and
discussion rather than each individual cleaning a separate mock-spill

1.4.3 Applicable site-specific training is competed once only. See Hazardous Drug - Training
Checklist – LMPS – (sample template)

1.5 Online education, mock drills, and site-specific training records are retained for at least 3 years
from the date that the training occurred. See Hazardous Drug - Training Checklist – LMPS
(sample template)

Personal Protective Equipment

1.6 Personal protective equipment shall meet applicable standards and shall be properly used by
Pharmacy staff, as indicated in the Hazardous Drug Exposure Control Program.
Lower Mainland Pharmacy Services

Page 7 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

1.7 Pharmacy staff shall use personal protective equipment for activities, as indicated in the
Hazardous Drug Exposure Control Program; Appendix B: Control Matrix

Medication Preparation (by Pharmacy Services)


See Appendix A: Hazardous Drug Handling Precautions – Pharmacy Staff

1.8 The following activities shall be performed by Pharmacy staff in a biological safety cabinet
(BSC)
 Preparation of sterile hazardous drugs
 Preparation of non-sterile hazardous drugs, likely to result in particle generation, e.g.:
o compounding
o opening capsules
o crushing or splitting tablets
o handling tablets or capsules with evidence of powder residue

1.8.1 Exception: Preparation of a hazardous drug, which is likely to result in particle


generation, may be performed by Pharmacy staff outside a BSC, adhering to the
following limits and conditions:
 BSC is not available
 A risk assessment is performed by Pharmacy Services in consultation with
Occupational Health and Safety
 A provincial safe work procedure for Pharmacy Services is established
 The work is performed:
o In a designated area of pharmacy away from general circulation in a ventilated
area
o Wearing appropriate personal protective equipment, as per the Hazardous Drug
Exposure Control Program; Appendix B: Control Matrix
o Using dedicated hazardous drug equipment

1.9 Where implemented, closed system drug transfer devices shall be used in the preparation of all
compatible Group 1 hazardous drugs.
1.9.1 Closed system drug transfer devices are recommended in the preparation of Group 2
hazardous drugs.
1.9.2 When used, the closed system drug transfer device must be used along with other
control methods and required PPE.

1.10 Non-sterile activities performed by Pharmacy staff that do not result in particle generation may
be performed outside the BSC.
1.10.1 Examples of activities not likely to result in particle generation include:
 Unit dose packaging (whole tablets)
 Pouring oral liquids
 Inserting bottle adapters

1.10.2 Such activities outside the BSC shall be performed:


Lower Mainland Pharmacy Services

Page 8 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

 In a designated area of pharmacy away from general circulation in a ventilated area


 Wearing appropriate personal protective equipment, as per the Hazardous Drug
Exposure Control Program; Appendix B: Control Matrix
 Using dedicated hazardous drug equipment

1.11 When uncertain whether an activity will result in particle generation, a risk assessment shall be
completed by Pharmacy Services in consultation with Occupational Health and Safety.

Order Processing

1.12 Pharmacy Services shall include standard warnings on all medication administration record
(MAR) entries and standard label comments on patient specific medication labels, where
indicated, to alert health care providers:
 Hazardous Drug Group 1 or Hazardous Drug Group 2
1.12.1 At sites using computer systems that are not capable of including standard label
comments (e.g. those used for both inpatients and outpatients), Pharmacy Services shall
ensure that hazardous drug warning auxiliary labels are affixed to patient specific
medication to identify hazardous drugs.

Dispensing
See Appendix A: Hazardous Drug Handling Precautions – Pharmacy Staff

1.13 Hazardous drugs dispensed by Pharmacy Services shall be provided in a ready-to-administer


format as stipulated below, so that further manipulation in the patient care area is minimized:

Table 1: Ready-to-Administer Format

Hazardous Ready-to-Administer Format Comments


Drug
Injectable Compounded sterile product Pharmacy Services may spike infusion bags with
infusion bag adaptor or infusion line and prime IV
lines in the BSC, where the service is already
established
Oral solids Unit dose package Including partial tabs so that splitting tabs in patient
care areas is not required
Oral liquids1 Unit dose package Where the service is already established
OR
Multi-dose format Dispense with a self-sealing bottle adapter inserted
in the bottle opening where feasible, to minimize
contamination and spillage in patient care areas
Aerosolized Primed in BSC prior to dispensing See safe work procedures for sites c no BSC
nasal spray

1
Supply oral liquids when warranted to minimize crushing tablets or opening capsules in patient care
areas.
Lower Mainland Pharmacy Services

Page 9 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

1.13.1 Exception: Select hazardous drugs that are not in ready-to-administer format may be
dispensed or provided where a risk assessment for nursing has been completed and a
Health Authority approved safe work procedure has been established for preparation in
patient care areas.

1.13.2 Situations that warrant preparation of a hazardous drug in patient care areas may
include, but are not limited to:
 Medication is required in patient care area in response to an urgent need
 Medication in ready-to-administer format has a short beyond use date (BUD)

Labelling Patient Specific Medications

1.14 Patient specific medications dispensed from Pharmacy Services shall be labelled appropriately,
with standard label comments embedded within the patient specific label.
1.14.1 At sites using computer systems that are not capable of including standard label
comments (e.g. those used for both inpatients and outpatients), Pharmacy Services shall
ensure that hazardous drug warning auxiliary labels are affixed to patient specific
medication to identify hazardous drugs.

Patient’s Own Medications


See Health Authority decision support tools for standard processes in handling patient’s own
medications

1.15 Patient’s own supply of hazardous drugs shall be used only when no other alternative sources
are available.

1.16 Patient’s own supply of hazardous drugs shall not be further manipulated (e.g. re-packaged).

1.17 Patient’s own supply of hazardous drugs shall be placed in a zip lock bag and labeled with
standard label comments embedded within the patient specific label.
1.17.1 At sites using computer systems that are not capable of including standard label
comments (e.g. those used for both inpatients and outpatients), Pharmacy Services shall
ensure that hazardous drug warning auxiliary labels are affixed to patient specific
medication to identify hazardous drugs.

Pass Medications

1.18 Hazardous drugs prepared by Pharmacy Services for patients on a pass shall be labelled as per
current site-specific practice.

Outpatient Medications

1.19 Hazardous drugs dispensed for outpatients shall be labelled as per current site-specific practice.
Access via Automated Dispensing Cabinets
Lower Mainland Pharmacy Services

Page 10 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

1.20 Pharmacy Services shall ensure that a standard electronic alert appears when staff access
hazardous drugs via the automated dispensing cabinet:
Hazardous Drug – Group 1 or Hazardous drug – Group 2

Re- Packaging
See Appendix A: Hazardous Drug Handling Precautions – Pharmacy Staff

1.21 Oral Group 1 hazardous drugs must not be packaged in automated counting and packaging
machines.

1.22 Oral Group 2 hazardous drugs may be packaged in automated counting and packaging
machines, if the machines are in a ventilated area.
1.22.1 Automated counting and packaging machines are cleaned by wet wiping with
appropriate cleaning and decontamination agents and by HEPA vacuuming, as per an
established schedule.

1.23 The following warnings shall be included on the labels of all re-packaged hazardous drugs:
 Hazardous Drug Group 1 / Hazardous Drug Group 2
OR
 Hazardous Group 1 / Hazardous Group 2 (where there are character limitations)

1.24 In the multi unit dose (MUD) medication system (e.g. long term care), oral hazardous drugs shall
be packaged separately from other medications:
1.24.1 Group 1 hazardous drugs shall be provided as a single unit dose package separate
from the multi unit dose (MUD) strip.
1.24.2 Group 2 hazardous drugs shall be provided as a single unit dose package contained
within the multi unit dose (MUD) strip

Hazardous Drug Warning – Auxiliary Labels


See Appendix A: Hazardous Drug Handling Precautions – Pharmacy Staff

1.25 Pharmacy Services shall ensure that hazardous drug warning auxiliary labels are in place to
identify hazardous drugs, including the following:
Within Pharmacy Services:
 Storage bins, drawers, and shelving areas, unless stored in a segregated area with
appropriate signage
 Dedicated equipment used to compound or handle hazardous drugs
 Sealed plastic bag used to transport hazardous drugs within the facility
 Transport containers if used to transport hazardous drugs within the facility

Patient Care Areas (when medication is stored outside automated dispensing cabinet):
 Storage bins, drawers, and shelving areas
 Overwrap on infusion bags from manufacturer
 Outer containers of stock medications (e.g. outer package containing amps)
Lower Mainland Pharmacy Services

Page 11 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

Night Medication Storage Areas (outside automated dispensing cabinets)


 As above for patient care areas

1.26 It is not required to apply hazardous drug warning auxiliary labels to the following:
 individual dosage forms (e.g. amps, vials) contained within packages such as medication
containers, storage bins, or zip lock bags
 unit dose packages or strips
 multi unit dose (MUD) packages or strips

Signage

1.27 Warning signs, which are clearly visible and clearly state the identified hazards, shall be posted
in all areas where hazardous drugs are received, stored, and prepared. Examples:

CAUTION CAUTION
Hazardous Drug
Storage Hazardous Drug
Known or Suspected Preparation Area
Carcinogen Authorized
Authorized Personnel Only
Personnel Only

Receiving
See Appendix A: Hazardous Drug Handling Precautions – Pharmacy Staff

1.28 Standard processes shall be adhered to when receiving hazardous drug, as outlined in Table 2:
Receiving Hazardous Drugs.
1.28.1 Inspect outer containers to check for damage before handling
Lower Mainland Pharmacy Services

Page 12 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

Table 2: Receiving Hazardous Drugs

Received in undamaged state Received in damaged or potentially damaged


state
Wear 2 pairs of chemotherapy approved gloves Wear 2 pairs of chemotherapy approved gloves

Unpack product in receiving area Seal the container in an impervious container

Decontaminate outer surface of product with a Contact the supplier


disposable wipe
Where approved, return to the supplier in an impervious
Discard outer pair of gloves in hazardous waste sealed container
container OR
Dispose in a cytotoxic container, adhering to Hazardous
Store product in hazardous drug storage area Drug Spill Cleanup procedures as outlined in the
Hazardous Drug Exposure Control Program – Appendix N
Decontaminate the receiving area work surface OR
with disposable wipes Follow instructions below:

Discard decontamination wipes and gloves in a Don full PPE including protective eye wear, face shield,
hazardous waste container and chemical cartridge respirator
(e.g. elastomeric half face mask respirator with a face-
Discard packaging material and shipping shield and safety goggles or a full face-piece respirator)
container in regular waste containers; do not re-
use for other purposes Place a plastic backed mat on the work surface of the
BSC

Unpack the container in the BSC and remove any usable


items

Decontaminate the outside of these items with a


disposable wipe

Discard the damaged items in a cytotoxic waste container

If a spill has occurred inside the container, box or outside


bag, then all packaging materials and shipping container
are discarded in a cytotoxic waste container

Discard mat and cleaning disposables as cytotoxic waste

Clean the BSC as indicated in Table 2: Biological Safety


Cabinet (BSC) Cleaning Processes (non-sterile
hazardous drugs) and purge for 15 minutes
Source: NAPRA. (Jun 2018) Guidance Document for Pharmacy Compounding of Non-sterile Preparations — Companion to
the Model Standards for Pharmacy Compounding of Non-sterile Preparations; page 46
Lower Mainland Pharmacy Services

Page 13 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

Storage

1.29 Hazardous drugs shall be stored in a manner that maintains protection of the employees and
surrounding environment, adhering to the requirements outlined in Appendix A: Hazardous Drug
Handling Precautions – Pharmacy Staff

1.30 Hazardous drug spill kits shall be available in or near the hazardous drug storage area

Transport (Within a Facility or Between Facilities)

1.31 Hazardous drugs shall be packaged and transported in a manner that maintains protection of
the product, employees and surrounding environment, as indicated in Appendix A: Hazardous
Drug Handling Precautions – Pharmacy Staff

Protective Reassignment

1.32 Pharmacy staff who regularly compound reproductive risk hazardous drugs shall have the option
to request protective reassignment if they are pregnant, breastfeeding, or intending to conceive,
as per processes outlined in Hazardous Drug Exposure Control Program – Protective
Reassignment:
1.32.1 The Pharmacy staff member presents a request for temporary reassignment in writing to
the Pharmacy Coordinator
1.32.2 Requests are evaluated by the Coordinator in conjunction with Human Resources,
Disability Management, and/or Occupational Health and Safety, where applicable
1.32.3 Based on the above evaluation, a recommendation for protective reassignment may be
requested from the staff member’s physician
See Hazardous Drug - Staff Temporary Reassignment Request Form – LMPS to be completed
by the physician

1.33 When protective reassignment has been approved:


1.33.1 Duties for pregnant staff shall be reassigned for the duration of the pregnancy
1.33.2 Duties for staff who are breastfeeding or actively trying to conceive shall be reassigned
for up to 6 months, at which time the staff request shall be re-evaluated and extended if
appropriate.

Record Keeping
See Appendix A: Hazardous Drug Handling Precautions – Pharmacy Staff

Handling Records

1.34 Pharmacy staff, who prepare Group 1 hazardous drugs, shall document each drug prepared on
a record that indicates:
 Date the drug was prepared
 Name of the drugs prepared
 Number of times the drug was prepared on the indicated date
Lower Mainland Pharmacy Services

Page 14 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

See Hazardous Drug - Handling Record – LMPS (sample template)

1.35 Handling Records shall be retained in the department for one year.
1.35.1 After one year, the Handling Records shall be forwarded (electronically where possible)
to Occupational Health and Safety where the documents shall be filed for the duration of
employment plus 10 years.

Exposure Records

1.36 All hazardous drug exposures shall be reported to the Workplace Health Call Centre (1-866-
922-9464).
1.36.1 Examples of hazardous drug exposures may include splash to eyes, exposure to
unprotected skin, needlestick injury, etc
1.36.2 Exposure records shall be maintained for the duration of employment plus ten years

Education and Training Records

1.37 Online education, mock drills, and site specific training shall be retained for at least 3 years from
the date that the training occurred.
 See Hazardous Drug - Training Checklist – LMPS (sample template)
 Note: Records of participation in online education modules may be available via Health
Authority specific reports.

Spill Management

Hazardous Drug Spill Kit

1.38 Clearly labelled spill kits, containing all materials and equipment necessary to clean a spill, shall
be available in or near areas where hazardous drugs are received, stored, prepared, or
transported.

1.39 Copies of spill management procedures shall be posted in all such areas.

Hazardous Drug Spill Response

1.40 Spills occurring when Pharmacy staff is handling hazardous drugs shall be cleaned up
immediately by Pharmacy staff trained in safe handling of hazardous drugs, following
procedures as outlined in the Hazardous Drug Exposure Control Program – Appendix N:
Hazardous Drug Spill Cleanup Procedures – Pharmacy.
 Procedure A: Spills inside the BSC
 Procedure B: Spills outside the BSC (up to 1 litre)
 Procedure C: Spills outside the BSC and greater than the spill kit capacity and department
capability
1.40.1 Spills occurring when Nursing staff are handling hazardous drugs shall be dealt with by
personnel from the area where the spill occurred.
Lower Mainland Pharmacy Services

Page 15 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

Managing Hazardous Drug Exposures


Examples of hazardous drug exposures may include splash to eyes, exposure to unprotected skin,
needlestick injury, etc

1.41 An employee that has been exposed to hazardous drugs shall:


1.41.1 Remove contaminated PPE and place in a hazardous waste container
1.41.2 Treat direct skin or eye contact as per Hazardous Drug Exposure Control Program –
Managing Hazardous Drug Exposures
1.41.3 Inform the supervisor (or have a co-worker inform supervisor) immediately
1.41.4 Seek first aid, where necessary
1.41.5 Call the Provincial Workplace Health Call Centre (1 866 922 9464) to report the exposure
as soon as possible

Waste Management

1.42 Group 1 and Group 2 hazardous drug waste shall be disposed properly, as indicated in
Appendix A: Hazardous Drug Handling Precautions – Pharmacy Staff

Cleaning

1.43 Pharmacy staff shall decontaminate and clean all work surfaces and re-usable equipment.
1.43.1 Clean rigid containers used for transport once daily:
 using detergent and water or by wiping down twice with disposable wipes
 wear 1 pair of gloves and discard gloves and wipes in hazardous waste
1.43.2 Adhere to established processes for cleaning the BSC as outlined in policy Sterile
Compounding – Cleaning and Disinfection of the Controlled Work Area – LMPS)
1.43.3 After using the BSC for bacillus Calmette-Guérin (BCG) or non-sterile hazardous drug
compounding, refer to Table 3 for specific cleaning processes:

Table 3: Biological Safety Cabinet (BSC) Cleaning Processes


BSC used for Cleaning Routine Special Instructions BSC
Purge Time
(after use)
Hazardous drug As per policy Sterile Compounding – Cleaning and Disinfection of the None
Controlled Work Area – LMPS
sterile compounding
Hazardous drug Clean all interior surfaces As per policy Sterile 15 min
(as per process at start and end of each Compounding –
non-sterile workday) Cleaning and
compounding Disinfection of the
Controlled Work Area –
LMPS
BCG Clean work surfaces tuberculocidal 15 min
(as per process between batches) disinfectant 1 (for
specified contact time)
Lower Mainland Pharmacy Services

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POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

1
Accel Intervention Wipes® are tuberculocidal and therefore suitable for use after BCG compounding,
where available. Refer to manufacturer information for alternatives to Accel®.

Laundry Management
See Appendix A: Hazardous Drug Handling Precautions – Pharmacy Staff

1.44 Hospital provided scrubs worn during compounding hazardous drugs shall be handled as
outlined in Appendix A: Hazardous Drug Handling Precautions – Pharmacy Staff

REFERENCES

BC Cancer. (Sep 2021) Safe Handling of Hazardous Drugs – Module 1. Retrieved from
http://www.bccancer.bc.ca/pharmacy-
site/Documents/Safe%20Handling/2%20%20Module%201_Safe%20Handling%20of%20Hazardous%2
0Drugs.pdf

B.C. College of Pharmacists. (24 Mar 2017) Guest post: hazardous drugs – what’s your occupation
exposure. Retrieved from https://www.bcpharmacists.org/readlinks/guest-post-hazardous-drugs-whats-
your-risk-occupational-exposure

Hazardous Drug Exposure Control Program – to minimize occupational exposure to hazardous drugs.
Version 3.0. Originally created: April 2014; Reviewed/revised: Nov 2021. Retrieved from
https://your.healthbc.org/sites/hazardousdrugsafety/_layouts/15/start.aspx#/

National Association of Pharmacy Regulatory Authorities (NAPRA). (Jun 2018) Guidance Document
for Pharmacy Compounding of Non-sterile Preparations — Companion to the Model Standards for
Pharmacy Compounding of Non-sterile Preparations. Retrieved from
https://napra.ca/sites/default/files/documents/Mdl_Stnds_Pharmacy_Compounding_Nonsterile_Prepara
tions_Guidance_June2018_FINAL.pdf

National Association of Pharmacy Regulatory Authorities (NAPRA) (Nov 2016) Model standards for
pharmacy compounding of hazardous sterile preparations. Retrieved from
https://napra.ca/sites/default/files/2017-
09/Mdl_Stnds_Pharmacy_Compounding_Hazardous_Sterile_Preparations_Nov2016_Revised_b.pdf

National Institute for Occupational Safety and Health (NIOSH). (Sep 2004) NIOSH Alert: Preventing
Occupational Exposures to Antineoplastics and Other Hazardous Drugs in Healthcare Setting.
Retrieved from http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf

National Institute for Occupational Safety and Health (NIOSH). (2020) NIOSH List of Hazardous Drugs
in Healthcare Settings, 2020. Retrieved from
https://www.cdc.gov/niosh/docket/review/docket233c/pdfs/DRAFT-NIOSH-Hazardous-Drugs-List-
2020.pdf
Lower Mainland Pharmacy Services

Page 17 of 20

POLICY TITLE
HAZARDOUS DRUGS – PHARMACY SERVICES - LMPS
AUTHORIZATION DATE APPROVED DATE(S) REVISED
Executive Director, Lower Mainland Pharmacy Services 11 Jan 2022 17 Feb 2022
27 May 2022
08 Nov 2022

WorkSafe BC. (2015) Best practices for the safe handling of hazardous drugs. Retrieved from
https://www.worksafebc.com/en/resources/health-safety/books-guides/best-practices-safe-handling-
hazardous-drugs?lang=en

WorkSafeBC. (17May2006) Occupational Health and Safety Regulation, Part 6: Substance Specific
Requirements; Section 6.49 Reproductive toxins. Retrieved from
https://www.worksafebc.com/en/law-policy/occupational-health-safety/searchable-ohs-regulation/ohs-
regulation/part-06-substance-specific-requirements#SectionNumber:6.49
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APPENDIX A
HAZARDOUS DRUG HANDLING PRECAUTIONS – PHARMACY STAFF
HAZARDOUS GROUP 1 GROUP 2
DRUG GROUP
MEDICATION BSC for manipulating sterile preparations
PREPARATION BSC for non-sterile activities likely to cause particle generation (e.g. compounding, opening caps,
crushing or splitting tabs)
If BSC is not available, a risk assessment must be competed and safe work procedures must be
established for preparation by Pharmacy staff outside BSC.
Activities where there is no particle generation may be performed:
 In a dedicated area of Pharmacy, away from general circulation in a ventilated area
 Wearing appropriate PPE
 Using designated hazardous drug equipment
ORDER Include standard warnings on medication administration record (MAR) and patient specific labels
PROCESSING Hazardous Drug Group 1 OR Hazardous Drug Group 2
MAR and Patient
Medication Label
DISPENSING Dispense injectables as compounded sterile products
 Dispense in a Dispense oral tabs and caps in unit dose packaging, including partial tabs
ready-to- Dispense oral liquids as unit dose or multi-dose packaging, as per current system
administer format  When supplied in multi-dose format, dispense oral liquids with a self-sealing bottle adapter inserted in
the bottle opening to minimize contamination and spillage in patient care areas
 Dispense liquid form when warranted to minimize crushing tablets or opening capsules in patient care
areas
Select hazardous drugs that are not in ready-to-administer format may be dispensed or provided where
a risk assessment has been completed and a Health Authority safe work procedure has been
established for preparation in patient care areas. Refer to Health Authority safe work procedures for
nursing.

RE-PACKAGING  Tabs and caps must not be packaged in  Tabs and caps may be packaged in automated
automated counting and packaging machines counting and packaging machines, if the
 Wear 2 pairs chemotherapy approved gloves machines are in a ventilated area.
 see Hazardous Drug Exposure Control  Clean automated counting and packaging
Program Appendix B: Control Matrix for machines by wet wiping with appropriate
additional PPE to be used with specified cleaning and decontamination agents and by
dosage forms HEPA vacuuming, as per an established
schedule
 Wear 2 pairs chemotherapy approved gloves
 See Hazardous Drug Exposure Control Program
Appendix B: Control Matrix for additional PPE to
be used with specified dosage forms
In multi unit dose (MUD) system, package as a In multi unit dose (MUD) system, package
single unit dose package provided separately from separately as a single unit dose package
the MUD strip contained within the MUD strip

HAZARDOUS
DRUG WARNING –
AUXILIARY LABEL
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APPENDIX A
HAZARDOUS DRUG HANDLING PRECAUTIONS – PHARMACY STAFF
HAZARDOUS GROUP 1 GROUP 2
DRUG GROUP
 Storage bins, drawers and shelving areas (Pharmacy and patient care areas)
 Outer containers or packaging of stock medications in patient care areas when stored outside ADCs
 Outer containers or packaging of stock medications in night medication storage areas outside ADCs
 Equipment used to compound or handle hazardous drugs
 Outer sealed clear plastic bags used for transporting hazardous drugs within the facility
 Transport containers if used for transporting hazardous drugs within the facility

RECEIVING  Wear 2 pairs chemotherapy approved gloves


 Unpack undamaged shipments in receiving area
 Refer to Table 1: Receiving Hazardous Drugs for receiving damaged or potentially damaged packages

STORAGE  Store away from any space designated for food storage, food consumption, application of cosmetics,
changing or clothing storage
 Store in bins labelled with hazardous drug warning auxiliary label
 Ensure shelves used for storage have barriers to prevent drug containers from falling and breaking
 Do not store non-sterile hazardous drugs in sterile compounding areas
 Hazardous drug spill kits must be available in or near the hazardous drug storage area
Recommendations for storage of drugs not in final  All dosage forms may be stored with non-
dosage form (e.g. medication requires further hazardous drug inventory in bins labelled with
manipulation before administration). hazardous drug warning auxiliary label
 Store separately from non-hazardous drugs  Refrigerated items may be stored in the fridge
in an externally ventilated negative pressure with non-hazardous drug inventory in bins
room with at least 12 air changes per hour, labelled with hazardous drug warning auxiliary
with the posted hazardous drug warning label
sign
 Refrigerated drugs are stored separately
from non-hazardous drugs in an externally
ventilated negative pressure room with at
least 12 air changes per hour, with the
posted hazardous drug warning sign

Final dosage forms (no further manipulation


required before administration):
 Store with non-hazardous drug inventory in
bins labelled with hazardous drug warning
auxiliary label
TRANSPORT All hazardous drugs:
(within a facility)  Place in an outer sealed clear plastic bag for transport, clearly labelled with a hazardous drug warning
auxiliary label and wear 2 pairs chemotherapy approved gloves
 Gloves are not required if transporting via secondary container

Hazardous drugs in liquid consistency:


 Ensure infusion bags, syringes, etc are securely capped and sealed
 Recommend to transport in a rigid transport container which can be easily cleaned and is clearly
labelled with a hazardous drug warning auxiliary label
 Transport on a cart if appropriate to further reduce risk of accidental spills
 Ensure a hazardous drug spill kit accompanies transport or is readily available (e.g. in the patient care
area)
 Do not place hazardous drugs in liquid consistency in a pneumatic tube

TRANSPORT Must be packaged and transported in a manner to prevent unintended release of the package contents:
(between facilities)  Ensure infusion bags, syringes, etc are securely capped and sealed
 Place in a leak proof primary inner package inside a rigid secondary container
 Ensure packaging contains sufficient absorbent material to absorb the contents in the event of a spill
 Clearly label the outer container with a hazardous drug warning auxiliary label

RECORD KEEPING Document preparation on Handling Record Documentation not required


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APPENDIX A
HAZARDOUS DRUG HANDLING PRECAUTIONS – PHARMACY STAFF
HAZARDOUS GROUP 1 GROUP 2
DRUG GROUP
SPILL Follow same protocol for Group 1 and Group 2 spills (see Hazardous Drug Exposure Control Program)
MANAGEMENT
EXPOSURE Follow same protocol for Group 1 and Group 2
Call the Provincial Workplace Health Call Centre (1 888 922 9464) to report exposure as soon as
Examples of possible
exposure to
hazardous drugs
include splash to
eyes, exposure to
unprotected skin,
needlestick injury,
etc.

WASTE  Discard drug in cytotoxic waste container  Discard drug in pharmaceutical waste container
MANAGEMENT  Discard sharps in cytotoxic sharps container OR cytotoxic waste container
 Discard other waste in cytotoxic waste container  Discard sharps in regular sharps container
 Discard other waste in regular garbage
LAUNDRY Place hospital provided scrubs into a hazardous Place hospital provided scrubs into a regular
MANAGEMENT labeled laundry bag laundry bag

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