Hazardous drugs table

Hazardous drug: a drug that exhibits one or more of the following six characteristics in humans and/or animals^r:

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

Antineoplastic (anti-cancer): an agent used to control or kill cancer cells; includes cytotoxic, hormonal, immune-system-modifying (immunomodifier), some antiviral, biological and molecular targeted therapies.

Biohazard: an infectious agent or hazardous biological material that presents a risk to the health of humans or the environment.

Carcinogenicity: ability or tendency to induce cancer.

Cytotoxic: an agent capable of disrupting the growth and function of both healthy and diseased cells and can be carcinogenic, genotoxic, mutagenic, teratogenic or hazardous to cells in any way. Commonly used in referring to antineoplastic drugs that selectively damage or destroy dividing cells.

Developmental toxicity: toxicity resulting in adverse effects induced during pregnancy, or as a result of parental exposure, that can be manifested at any point in the life span of the organism.

Genotoxicity: toxicity resulting in heritable (passed on to progeny/offspring) changes in the genetic material in germ cells, namely spermatocytes or oocytes via chemical interaction with DNA and/or non-DNA targets. Genotoxins include substances that are mutagenic; substances that induce transmissible changes in DNA structure involving a single gene or a group of genes.

Immunomodifier: an agent that interacts in some way with the immune system either to stimulate it to recognise and attack cancer cells or to inhibit the production of abnormal immune system cells or molecules present as a result of cancer.

Reproductive toxicity: any effect of agents that would interfere with reproductive ability or capacity (fertility), including effects on lactation.

Targeted therapies: agents that block the growth and spread of cancer by interfering with specific molecules involved in tumour growth and progression.

Teratogenicity: ability to disturb the development of an embryo or foetus. Teratogens can halt a pregnancy or produce a congenital malformation (birth defect).

The following recommendations have been adapted from the COSA 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 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.

• All currently available MABs have a low risk of internalisation at occupational exposure levels.
• 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 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 aerolisation.
• 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 waste, i.e. not as cytotoxic waste.

Note: NIOSH includes pertuzumab as a hazardous drug due to a black box warning about embryo-foetal death and birth defects in the US product information. This warning is not in the Australian product information and was not deemed necessary when reviewed by the Therapeutics Goods Administration (TGA).^r For this reason, pertuzumab has not been classified as a hazardous drug below.

These tables are based on the NIOSH^r, IARC^r and product information^r recommendations and only include drugs used in the treatment of cancer. It is intended as a guide and should not be construed as complete representation of all hazardous drugs used in health care settings.

Some drugs defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation (e.g. intact medications such as coated tablets or capsules that are administered to patients without modifying the formulation). However, they may pose a risk if solid drug formulations are altered outside a ventilated cabinet (e.g. If tablets are crushed or dissolved, or if capsules are pierced or opened). The dust from uncoated tablets may present a risk of exposure by skin contact and/or inhalation when the tablets are counted.^r

Reproductive hazardous drugs have a potential to be an occupational hazard to those healthcare workers (both male and female) who are actively trying to conceive and females who are pregnant, breastfeeding or may become pregnant. These healthcare workers should use precautions when handling these drugs.^r 

Occupational Health and Safety and Worker Compensation authorities^rr, as well as various Professional Practice Standards^rr, uniformly mandate the use of personal protective equipment (PPE) by healthcare workers who handle hazardous drugs. While the tables below separate antineoplastic drugs into the categories ‘cytotoxic’ and ‘non-cytotoxic’ there is no intention to imply that hazardous drug handling recommendations should not be applied, including the use of PPE, in either case. Due to the existence of minimal data regarding occupational risk involved in administering many agents, eviQ recommends PPE be employed unless local institutional guidelines exist that specifically address occupational risk minimisation for individual agents.

The following tables list common antineoplastic agents classified as hazardous or reproductive hazardous.

Hazardous cytotoxic antineoplastics

NIOSH recommends full PPE when handling and administering these drugs^r.

Hazardous non-cytotoxic antineoplastics

For parental and oral liquid formulations NIOSH recommends full PPE when handling and administering. Intact drugs (such as coated tablets or capsules) may not pose the same degree of occupational exposure risk as compounded injectable drugs due to their dosage formulation. For these intact formulations NIOSH recommends single gloving for handling and administration. However, if these formulations are manipulated (crushed, dissolved etc.) they may pose a higher risk and full PPE is recommended. Healthcare workers (both male and female) who are actively trying to conceive and females who are pregnant, breastfeeding or may become pregnant should use PPE when handling all formulations of these drugs.^r

* For parenteral and oral liquid formulations of these drugs NIOSH recommends PPE when handling and administering.

** Olaparib is not classified as cytotoxic however has cytotoxic inducing effects so is considered hazardous.^r 

^ NIOSH groups these agents in Group 1 i.e. recommending double gloving and a protective gown during administration. The risk of occupational exposure from prefilled syringes is difficult to quantify and no guidance provided in the literature. Whilst we have chosen to predominantly adopt the NIOSH 2016 definitions of hazardous medicines, we propose that for the administration of prefilled syringes, a more pragmatic approach may be taken permitting these agents to be administered, similarly to intact formulations.

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. Intact drugs (such as coated tablets or capsules or prefilled syringes) may not pose the same degree of occupational exposure risk as compounded injectable drugs due to their dosage formulation. For these intact formulations NIOSH recommends single gloving for handling and administration. 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 universal precautions.

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