188-Safe handling and waste management of hazardous drugs

Background

This document provides guidelines for the safe handling and waste management of hazardous drugs based on current evidence and best practice. All personnel required to transport, reconstitute or administer hazardous drugs or handle anything potentially contaminated with the unchanged drug or active metabolites should consult their local institutional policy and procedure, state legislation and work, health and safety (WHS) guidelines to ensure they comply with requirements.

Note: In general, these guidelines do not apply to safe handling of monoclonal antibodies. For more information on safe handling of monoclonal antibodies, refer to that section below.

Safe handling of monoclonal antibodies in the cancer care setting

The following recommendations have been adapted from the Clinical Oncology Society of Australia (COSA) and Cancer Pharmacists Group (CPG) position statement 2013^r and the Australian Consensus Guidelines 2014.^r They apply to currently marketed monoclonal antibodies (MABs) except MABs conjugated to a cytotoxic agent, fusion protein or a radioisotope. These conjugated MABs are considered hazardous and should be prepared and administered following accepted cytotoxic safe handling precautions and regulations related to the handling of cytotoxics and radiopharmaceuticals.

Dermal absorption of MABs across intact skin during dose preparation or administration is unlikely due to their high molecular weight; however, the use of gloves and effective hand hygiene are recommended to minimise risks of contamination and infection.
A respirator mask (P2/N95) and protective eyewear should be worn during dose preparation but are not mandated during the administration of MABs. However, they may be considered during the administration of intravenous formulations where dis/connecting administration lines may present a risk of aerosolisation.
The use of gowns and/or coveralls are not warranted for either dose preparation or administration of MABs.
Disposal of waste products, including waste and/or bodily fluids of patients, should be in accordance with the disposal of clinical biohazardous waste, i.e. not as cytotoxic waste, unless conjugated with a cytotoxic agent.

Safe handling of reproductive hazardous drugs

Healthcare workers (both male and female) who are actively trying to conceive and females who are pregnant, breastfeeding or may become pregnant should use full PPE when handling these drugs. Due to their dosage formulation, intact drugs (such as coated tablets or capsules) may not pose the same degree of occupational exposure risk as compounded injectable drugs. The National Institute for Occupational Safety and Health (NIOSH) recommends single gloving for handling and administration for these intact formulations. However, if these formulations are manipulated (crushed, dissolved etc.), they may pose a higher risk, and full PPE is recommended.^r All other healthcare workers handling these medications should use precautions as set out by their organisations' policies and procedures.

Safe handling of drugs with unknown hazardous classification

For the handling of drugs that have been classified as unknown risk and have not been categorised by NIOSH,^r eviQ recommends at minimum universal precautions be used. eviQ will not include the ongoing safe handling information in protocols containing these drugs; individual institution policies or guidelines should always be followed.

Hazardous drugs

Definition

Drugs are considered hazardous if they exhibit one or more of the following six characteristics in humans or animals:^r

carcinogenicity, or the ability to cause cancer; a carcinogen
genotoxicity, or the ability to cause a change or mutation in genetic material; a mutagen
teratogenicity or other developmental toxicity, or the ability to cause foetal malformation or defects in foetal development; a teratogen
reproductive toxicity or fertility impairment
serious organ toxicity or adverse health effects at low doses
the structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the five previous criteria.

Hazardous drugs may include cytotoxic, antiviral, antibiotics, immunomodifiers, biological and molecular targeted drugs.

The adverse effects of exposure to hazardous drugs can be categorised as biologic or health effects, acute or chronic. The most frequently reported biologic effects of occupational exposure to hazardous drugs include genetic damage, chromosomal aberrations, DNA damage and urinary mutagenicity. Health-related effects of hazardous drug exposure include reproductive effects and an increase in cancer occurrence.^r

Identification of hazardous drugs

All cytotoxic materials are universally identified by a purple symbol representing a cell in the late phase of division known as telophase.

Hazardous drugs that have the potential to transmit infection should be suitably labelled as per institutional policy and state or territory legislation.

Refer to the eviQ Hazardous drugs table for more information regarding hazardous drugs.

Exposure to hazardous drugs

Exposure to hazardous drugs can occur through:^r

skin absorption
mucosal absorption
inhalation of drug aerosols, dust, powder or droplets
ingestion of contaminated food or drink or other hand-to-mouth contact
needle stick or sharps injuries.

Whilst undertaking:^r

drug preparation
drug administration
handling of patient waste
handling of drug waste products
drug and patient transport
cleaning up spills
contact with equipment/surfaces in areas where hazardous drugs may be used or administered
contact with contaminated linen from patients who have received hazardous drugs.

Personnel likely to be involved in these activities include:^r

pharmacists
nurses
cleaning, maintenance and waste disposal staff
medical officers
paramedics
laboratory staff
hospital assistants and wardspersons
carers.

Minimising exposure to hazardous drugs

Storage

The Society of Hospital Pharmacists of Australia (SHPA) recommends that cytotoxic drugs should be stored in separate, clearly marked storage areas, including refrigerated areas.^r NIOSH recommend that hazardous drugs are stored separately from other drugs in closed containers that minimise the risk of breakage.^r

Packaging

Prepared hazardous drugs should be packaged:

in a sealed leak-proof container with the outer bag heat sealed where possible
in a container offering protection from light if required
in a manner that will protect the drug container from breakage and contain any leakage if breakage occurs in transit
and labelled 'do not cut or crush' in the case of oral drugs^r
and labelled with an appropriate label or sticker identifying the hazard, i.e. cytotoxic or biohazard.^r ^r

Personal protective equipment (PPE)

When used appropriately, personal protective equipment (PPE) is an effective way to prevent exposure to hazardous drugs. The Oncology Nursing Society (ONS) defines PPE as chemotherapy tested gloves, gowns made of materials tested for use with chemotherapy, respirators (respiratory protective equipment) and face shields or goggles.^r

PPE should be worn during any activity which has the potential to cause exposure to hazardous drugs and related waste products. These activities include the reconstitution, administration and disposal of hazardous drugs and handling waste contaminated or potentially contaminated with hazardous drugs, including body waste products. A detailed discussion of PPE can be found in the personal protective equipment section below.

Transportation

Containers used to transport hazardous drugs should be robust, hard-walled, securely closed and labelled with appropriate warnings. A spill kit should always accompany hazardous drugs during transportation, and personnel required to transport hazardous drugs should be aware of the risks involved and be able to contain a spill if it occurs.^r ^r

Waste management

Hazardous drug waste, including contaminated waste and related equipment, should be sealed in appropriate secondary packaging to contain any leaks and disposed of into the appropriate hazardous waste bin. Cytotoxic waste should be segregated and double bagged (the first bag being sealable) and discarded into specifically labelled cytotoxic waste containers with a sealable lid as per relevant legislation. Other hazardous waste should be discarded as per relevant legislation.^r Patients having treatment at home or receiving anti-cancer therapy may require approved containers for disposal of cytotoxic drugs and related waste.^r ^r ^r These measures ensure that hazardous drug waste is handled separately from other waste and the individuals (environmental services) handling the waste are protected from exposure.^r