Written by David Skinner
30 Sep 2021

What is Cytotoxic Waste?

Knowledge of the difference between healthcare waste streams is vital for compliant segregation and disposal processes. That goes for cytotoxic and cytostatic wastes as well. Cytotoxic drugs are considered hazardous substances and should be handled, stored, and treated as such. Cytotoxic and cytostatic medicines must be handled and disposed of properly, not only to protect employees and patients in healthcare settings, but the general public and the environment as well.

Regulations can often be confusing. While cytotoxic waste is considered a hazardous waste, it is also a type of clinical waste because it poses a chemical hazard, as well as pharmaceutically active agents, according to the Health Technical Memorandum 07-01: Safe Management of Healthcare Waste, published by the Department of Health.

According to guidelines of the Department of Health, one of the key principles in healthcare waste management is to handle clinical waste as if it is hazardous waste. Cytotoxic waste or cytostatic medicine is defined per the standards as “any medicinal product that possesses any one, or more, of the following hazardous properties: toxic, carcinogenic, toxic for reproduction, or mutagenic."


TOPICS WE WILL COVER:

1 / What are Cytostatic Medicines?

2 / Regulations Regarding Risk Assessments in the Workplace

3 / Storage and Labelling of Cytotoxic Waste

4 / Disposal of Cytotoxic Waste

5 / Sharpsmart Supports Compliance of Cytotoxic Waste



What are Cytostatic Medicines?
 

In many scenarios, the terms cytotoxic and cytostatic are often used interchangeably. However, cytostatic medicines and/or drugs inhibit cellular growth and division, while cytotoxic medicines or drugs are literally toxic to cells. Cytotoxic drugs are also known as antineoplastics. Their basic definition defines them as a group of medicines that contain certain chemicals that are toxic to cellular structures, primarily in the prevention of growth or replication. Such drugs are commonly used to treat a number of cancers or other medical conditions such as multiple sclerosis or rheumatoid arthritis.

Such drugs are not able to target a specific area of the body and have the potential to produce not only side effects to the patient undergoing treatment, but to others who may become exposed to the medicines. Settings where cytotoxic drugs are used can include hospitals, hospices, a care home, and even veterinary clinics.

A cytostatic or cytotoxic medicine for waste classification purposes contains hazardous properties of any one or more of the following:

  • Carcinogenic - has the potential to cause cancer
  • Mutagenic - capable of inducing genetic mutation
  • Acutely toxic - may cause adverse effects from a single exposure or within a short time frame
  • Toxic for reproduction - has the potential to inhibit sexual function, fertility, and reproductive organs
     

As cytotoxic drugs are commonly used in the treatment of cancer, any facility that uses them has a duty of care to train employees to be aware of the hazards associated with cytotoxic drugs. Such individuals must always take precautions with handling.

Guidance regarding substances that are hazardous to health are found in a publication titled “Control of Substances Hazardous to Health”. Control measures, prevention to exposure, monitoring in the workplace, and training standards are outlined in the book. A list of types of cytotoxic and cytostatic drugs can be found in the Health Technical Memorandum 07-01. Some examples of non-chemotherapy cytotoxic and/or cytostatic drugs include:

  • Anastrozole
  • Dutasteride
  • Finasteride
  • Letrozole
  • Progesterone containing products
  • Tamoxifen
     

Chemotherapy drugs specifically designed for the treatment of cancers include but are not limited to:

  • Aldesleukin
  • Bleomycin
  • Carboplatin
  • Dactinomycin
  • Doxorubicin
  • Hydroxycarbamide
  • Rituximab
     

Waste segregation for safety and to ensure proper disposal is important. Suitable colour-coded packaging and labelling must maintain standards that are compliant with healthcare waste management processes. This ensures waste is properly handled, transported, and disposed of safely.

It is the producer's duty of care to classify and describe waste. Failure to do so not only increases the risk of penalties and fines, but the risk of unauthorised and inappropriate disposal that can prove harmful to people and the environment.



Regulations Regarding Risk Assessments in the Workplace
 

Regulations regarding safety are found under the Control of Substances Hazardous to Health (COSHH). Employers are responsible for performing risk assessments in such cases. A number of issues are to be taken under consideration, including those found under Regulation 6, Section 2:

  • The hazardous properties of the substance;
  • Information on health effects provided by the supplier, including information contained in any relevant safety data sheet;
  • The level, type and duration of exposure
     

Risk assessments are to be reviewed on a regular basis. So too are processes involving storage and labelling of cytotoxic and cytostatic wastes.



Storage and Labelling of Cytotoxic Waste


Cytotoxic and cytostatic medicines are to be packaged in yellow and purple-coloured waste bags. If the properties of any medicine are difficult or cannot be determined, err on the side of caution and classify that waste as cytotoxic and cytostatic.

Cytotoxic and cytostatic medicines (in their original packaging) can be disposed of in purple-lidded and rigid yellow containers. One is typically labeled for solids and another for liquids. This is also applicable to cytostatic and/or cytotoxic waste medicines that are not in their original packaging.

Sharps waste that has been medicinally contaminated with cytostatic or cytotoxic medicines should also be segregated and disposed of in a purple-lidded sharps receptacle and properly disposed of at an authorised incinerator.

Containers must be labelled accurately and clearly identify the type of waste contained within. In addition, containers are to be tagged and labelled in a way that identifies the producer of that waste, which is often required by disposal sites.

Carriage regulations require that classification and identification, packaging, marketing, labelling, and documentation are all the responsibility of the consignor or the generator of medical waste. Relevant labelling, such as hazard warning diamonds as applicable, must be appropriate to the class of dangerous goods prior to transportation.



Disposal of Cytotoxic Waste


Every facility that produces cytotoxic waste is required to have procedures in place for its safe disposal. It is not just the cytotoxic waste or component itself that must be dealt with properly, per the Health and Safety Executive, but it’s important for employees to be aware that excretions from a treated patient may also contain “unchanged cytotoxic drugs or active metabolites".

Cytotoxic and cytostatic waste, clearly identified by purple bags or containers, indicates the treatment process and disposal through incineration in an appropriately permitted or licensed facility.

According to the Health Technical Memorandum, Sections 9.26 and 9.27 define specific treatments and disposal requirements for cytotoxic and cytostatic waste. Any waste that is contaminated with a cytostatic and/or cytotoxic substance should only be disposed of in a suitably authorised facility, which in most cases includes incineration facilities. Sharps receptacles that contain sharps that have been contaminated with cytostatic and/or cytotoxic products are to be disposed of in suitably authorised facilities that specifically accepts cytotoxic and cytostatic waste.



Sharpsmart Supports Compliance of Cytotoxic Waste


Sharpsmart understands and acknowledges that successful waste segregation is effective when all staff are properly trained and have proper equipment, including appropriate colour-coded and labelled waste receptacles. Such containers and bins must be properly positioned to meet work practice requirements. For additional information regarding services, products, and cytotoxic waste management and disposal processes, contact Sharpsmart today.

 

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David Skinner

David Skinner

Vice President

With over 18 years experience in healthcare and a genuine passion for reinventing the medical waste model of our era to achieve higher infection control standards, David is a walking almanac or, as we call him, the "skinnerpedia" of clinical knowledge.