|Title:||Clinical and Related Waste Management Ė Pharmaceutical Wastes|
|Document ID:||Operational Directive OD 0260/09|
|Date of issue:||Wednesday, 30 December 2009|
|Status:||NO LONGER APPLICABLE|
|Description:||The OD provides the minimum requirements for the management of the pharmaceutical waste stream generated by WA Health Facilities. This OD must be implemented within the context of the Clinical and Related Waste Policy 2009 and each Clinical and Related Waste OD where appropriate.|
|Applicable to:||All Clinical services|
|Period of effect:||from 30 December 2009 to 30 December 2015|
|Review date:||30 December 2015|
|Authorised by:||Dr Peter Flett, Director General, Department of Health, 30-Dec-2009|
|Print version:||View print version|
Clinical and Related Waste Management Ė Pharmaceutical Wastes
Compliance with this Operational Directive is mandatory.
Implementation of this Operational Directive must be within the context of the Clinical and Related Waste Policy 2009 and each Clinical and Related Waste Management Operational Directive where appropriate.
This Operational Directive describes the minimum requirements to be adhered by WA Health to ensure clinical and related waste is segregated, stored, transported and disposed of in a manner that minimises the risk of public exposure to potentially contaminated material and minimises environmental impact .
It applies to healthcare that is provided both within a facility and through healthcare at home programs. WA Health and home service providers are responsible for the waste generated from the provision of healthcare from the point of generation to final disposal.
This Operational Directive applies to Clinical Waste in the Related Waste category, which includes the pharmaceutical and chemical waste streams. Specific requirements for the management of cytotoxic wastes are detailed in Operational Circular OP 1961/05 (Safe handling of cytotoxic drugs).
1. Related Waste
Definition: waste which is contaminated with cytotoxic drugs, chemicals or pharmaceuticals and can be further categorised into:
Some chemical wastes may also be classed as hazardous substances and/or dangerous goods. For chemical wastes which are also hazardous substances, information on disposal requirements is available from Worksafe (Department of Commerce) and for chemical wastes which are also dangerous goods information on storage, transport and disposal is available from Resources Safety (Department of Mines and Petroleum).
Generally, disposal of chemical wastes into the sewage system is unacceptable due to the risk of explosion, generation of toxic gases and disruption of biodegradation processes. Where it is technically and economically feasible, the reclamation and recycling of chemical wastes should be supported.
Particular attention should be given to the disposal of chemical wastes containing significant concentrations of heavy metals including mercury and mercury amalgam.
Excludes pharmaceutical drugs and their metabolic by-products excreted by patients undergoing therapy, uncontaminated packaging material including empty pill bottles and strip packages, used syringes and intravenous giving sets (unless contaminated with cytotoxic drugs), simple intravenous solutions such as saline or glucose without added drugs. Used syringes and intravenous giving sets may be classed as Clinical waste – sharps and therefore need to be disposed of accordingly.
Pharmaceutical waste includes any drug which is included in the “Poisons Schedules” (Appendix A of the Poisons Act 1964) and also includes other medicines such as simple analgesics and vitamins available from both pharmacies and general retail outlets.
Schedule 8 (drugs of addiction) medicines have special restrictions on their handling and their destruction may only be performed by certain persons as described in Poisons Regulation 44A. There are also legislated requirements for documentation of the destruction of Schedule 8 medicines.
Pharmaceutical substances do not readily break down and can remain biologically active for years, except when incinerated at a high temperature.
Disposal of pharmaceutical waste at landfill sites may result in medicines being available for both misuse and abuse by consumers, including children.
Where disposal methods other than high temperature incineration have been used, contamination of wastewater with pharmaceuticals in levels exceeding predicted no-effect concentrations has been documented. Leaching of pharmaceutical substances from landfill has also occurred.
Potential environmental risks associated with the inappropriate disposal of pharmaceutical wastes, including cytotoxic and radioactive wastes, include direct toxicity, hormonal disorders and mutations.
Expired pharmaceuticals or substandard pharmaceuticals should never be collected for the purpose of donation for humanitarian relief. Refer to the Australian Guidelines for Drug Donations to Developing Countries (endorsed by the Australian Pharmaceutical Advisory Council –
Under the Poisons Regulations 1965, any scheduled poison (most drugs and many chemicals) must not be disposed of in any place or manner likely to constitute a risk to the public.
2. Waste Management Policy and Plan requirements
The WA Health Waste Management Policy shall address the components specific to this waste stream that are not provided in the General Requirements Operational Directive OD 0258/09.
2.2 Education and Training
Refer to General Requirements Operational Directive OD 0258/09.
2.3 Waste Segregation and Handling
Management of pharmaceutical and chemical waste must be such that access by unauthorised persons is precluded during handling, interim transport, storage at collection points and transportation to a site for final disposal.
2.4 Clinical Waste Labelling
The containers used for collection of pharmaceutical and cytotoxic wastes should comply with Australian Standard 3816:1998:
Table 1 Cytotoxic Waste Labelling
Table 2 Waste Labelling
2.5 Clinical Waste Containment
Non-PVC plastic liners should be used for containers which will be incinerated.
2.6 Transport and Storage within the Health Care Facility
Pharmaceutical waste awaiting disposal must be stored in such a manner that access by unauthorised persons is prohibited in the same way as would be required when the pharmaceuticals were “in use”. For example, Schedule 8 drugs awaiting destruction must be stored in a safe or in a locked cupboard on a hospital ward that is staffed continuously.
Returned medicines awaiting collection for incineration must be stored securely but in an area separated from “in use” pharmaceutical stock.
All pharmaceutical and cytotoxic waste must be stored in a way to prevent contamination of food and to preclude access by unauthorised persons.
3. Treatment and Disposal Options
Incineration is the only method for disposal of both pharmaceutical waste and cytotoxic waste. Incineration must occur at an authorised controlled waste facility in
For cytotoxic waste, the incineration temperature in the secondary burning chamber should be 1100 degrees Celsius with a minimum residence time for the emission gases of 1.0 second. Refer to Operational Circular OP 1961/05 “Safe Handling of Cytotoxic Drugs”.
For chemical waste, the relevant Material Safety Data Sheet (MSDS) should provide details of suitable disposal methods.
4. Emergency Procedures
Organisations involved with the storage, removal, transport or disposal of waste must have a detailed Emergency Procedures plan on how to manage accidental or deliberate spillages. Staff within these organisations should be educated in relation to the contents of the plan, and their responsibilities within the plan.
Dr Peter Flett
This circular last updated: Wednesday, 30 December 2009 at 4:47pm