Requirements for cytotoxic and cytostatic waste containers
Joanna Ford and Pete Phillips
Version 3, January 13 2014
Cytotoxic or cytostatic (CT/CS) medicinal waste is produced in reconstitution centres (usually pharmacy departments) and also in small amounts in clinical settings. The waste product can be in original medication containers as well as residue within medical equipment such as tubing and syringes. CS/CT waste is defined as waste that is toxic, carinogenic, or toxic for reproduction or mutagenic. The Department of Health (DH) have recently produced guidance on the disposal of all health care waste, including medicines. The guidance HTM-07-01 is entitled 'Safe Management of Healthcare waste' (Department of Health 2013). It is an updated version of guidance initially published in 2006. The focus of the report presented here is to summarise the requirements of CT/CS waste containers.
The 2006 Department of Health Guidance was produced in the light of changes in legislation. One of the most relevant pieces legislation that has led to this new guidance is 'The Hazardous waste regulations (England and Wales) 2005'. The labelling and packaging of waste is subject to the 'Transport of Dangerous Goods' legislation (communication with the Department for Transport). Other relevant legislation includes regulations relating to the final disposal of waste (please refer to the Environmental Agency web-site for more information).
Key recommendations from guidance document
The guidance which the Department of Health has produced is not mandatory but if it is not adhered to, alternative methods of complying with legislation must be put in place. The main purpose of the recommendations surrounding CT/CS waste is to segregate CT/CS medicines (considered hazardous) from all other medicines (generally considered not to be hazardous). The single most important requirement is that CT/CS waste containers are visually distinct from all other waste containers and a colour coded system is recommended (purple is suggested).
Appropriate packing group and package requirements
Hazardous chemicals are assigned to a packing group (PGI, II or III) and there are package regulations which correspond to each group. The packing group for cytotoxic waste is PGII which is considered 'medium danger'.
Containers used for the disposal of hazardous waste are regulated by the European Commission [UNECfE] and companies producing disposal containers must adhere to these regulations. Packaging must be 'type approved' for a particular packaging group and should bear appropriate marks to identify this. Each type of waste has packing instructions which will stipulate the type of containers required and the quantity limits. Cytotoxic/cytostatic waste should be segregated from all other medicines at the point of production. They recommend that the containers available for the disposal of cytotoxic/cytostatic waste are defined by the colour purple (for example, a yellow sharps box with a purple lid). Different types of waste should be disposed of in different containers as shown in the following table:
Type of waste (example)
Other package requirements for surplus CT/CS waste
Under the new guidance, waste from cytotoxic and cytostatic medicines are grouped together and segregated from all other medicines. These two types of waste have the following EWC codes:
18.01.08 - Cytotoxic and cytostatic medicines
18.01.09 - Medicines other that 18.01.08
They are also assigned different UN numbers to those used previously. In the past most clinical waste came under UN3291 but this has changed for CT/CS waste to :
UN1851 (for liquids),
UN3249 (for solids) or
UN3248 (for liquid, flammable)
In addition they are also assigned the following:
Hazard class 6.1 (i.e. toxic, substances)
Shipping name - Medicine, liquid (or solid), toxic, N.O.S
A consignment note must accompany any hazardous waste when it leaves the site of production to be disposed of. These forms include details of the medicines being disposed alongside the appropriate EWC codes and hazard class.
Recent regulatory changes and related guidance in the area of health care waste management have lead to the recommendations that all cytotoxic and cytostatic waste is separated from all other medicinal waste at the point of production. This is to be achieved by the use of colour coded waste containers (purple recommended for CT/CS waste).
Appropriate containers with purple lids and/or labels for CT/CS waste are available from a number of manufacturers in the UK. Some of these containers are available on the most recent Welsh NHS purchase contract and uptake across the Welsh NHS has been reasonable (personal communication with member of 'UK Safe disposal of clinical waste' group).