Disposal of Schedule 8 medicines

Case scenario

The son of a regular customer comes into your Queensland pharmacy to tell you his father has passed away from cancer. He asks what he should do with his father’s leftover medicines, which include oxycodone tablets. You advise him that he can return the medicines to the pharmacy as part of the national Return Unwanted Medicines (RUM) project. Later that day, he returns with a bag full of medicines, advising you that there are no needles or glass ampoules in the bag.

Introduction

Medicines, if disposed of unsafely, have the potential to both cause damage to the environment and pose a risk to public safety.¹ The National Return and Disposal of Unwanted Medicines project (RUM project) enables customers to return medicines that are no longer required, have expired or are damaged, to any community pharmacy for disposal.¹

This is a free service for customers, available only at community pharmacies. It was established to ensure all medicines are disposed of safely, reducing the risk of accidental childhood poisoning, medication misuse or confusion, and environmental damage.¹

Schedule 8 medicines, however, due to their risk of harm and diversion, can only be placed in the RUM bin (following local legislation requirements) once they have been rendered unusable and unrecognisable by an authorised person.¹

It is the pharmacist’s responsibility to ensure Schedule 8 medicines are disposed of in a manner which does not present a risk to public health or safety and is legislatively compliant.

This article discusses the processes of Schedule 8 medicine disposal and provides a summary of the recording and storage requirements; however, pharmacists must refer to their current local state or territory legislation and requirements to ensure they are compliant with these.

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Schedule 8 medicine disposal

Considerations

The process for the disposal of Schedule 8 medicines is subject to not only local legislation relating to the management of medicines and poisons, but also environmental protection and waste management regulations. Medicines can take many years to degrade and therefore can persist in the environment for considerable amounts of time.² Medicines are not suitable for landfill and should not be disposed of down the sink, in the toilet or be permitted to enter the waterways by any means.¹

In 2016 pharmaceutical opioids, the majority of which are Schedule 8 medicines, were involved in more opioid deaths and opioid poisonings than heroin.¹⁵ This statistic shows the importance of safely and securely disposing of Schedule 8 medicines. Due to the high risk of diversion, Schedule 8 medicines must be removed from their original packaging and be rendered unrecognisable and unusable (i.e. destroyed) prior to disposal.^2,4–12,14

Specialised high-temperature incineration by an approved waste management contractor is the only safe and accepted method of medicine disposal.² Medicines disposed of via the RUM project are subject to incineration.¹

Prior to collection by the wholesaler for disposal and incineration, community pharmacies must store medicines for disposal securely in a pharmaceutical waste bin that meets the Australian Standard AS3816:2018 Management of Clinical and Related Waste. Please note however there are specific requirements for storage of Schedule 8 medicines awaiting destruction and for Schedule 8 medicine waste (once the medicines are destroyed and awaiting collection for disposal) – explained further below. 

This standard outlines the requirements for pharmaceutical waste bins in Australia.³ RUM bins are an example of a pharmaceutical waste bin that meets this standard.

All pharmaceutical waste bins must be safely stored in an area of the pharmacy e.g. in the dispensary, under the direct supervision of the pharmacist and must not be able to be accessed by the public.⁴

Destruction recommendations

Several states and territories have provided fact sheets and guidance on the preferred ways to destroy Schedule 8 medicines prior to disposal. Purpose-made disposal kits provide an alternative to physically destroying (e.g. crushing) the Schedule 8 medicine. These kits contain a chemical neutralising agent (absorbent), which denatures the Schedule 8 medicine and then suspends it in a gel, making it difficult to retrieve.^2,7

These kits are particularly helpful in destroying Schedule 8 medicines manufactured in a tamper-resistant formulation e.g. Oxycontin, Jurnista.⁷

Alternative absorbent agents that can be used to prevent retrieval of waste, once the medicine has been rendered unusable, include kitty litter or sawdust (see Table 1 for examples of when this may be used).⁷ Table 1 outlines suggested methods for destroying different forms of Schedule 8 medicines, to be considered alongside local jurisdictional requirements (e.g. use of pharmaceutical waste bins, use of absorbents/disposal kits and storage of Schedule 8 medicine waste). 

Table 1 – Suggested methods for destroying different forms of schedule 8 medicines

References: WA Health², NSW Government Health⁶, Queensland Health⁷, NT Health¹⁰

In Queensland, an option for organisations with large commercial quantities of Schedule 8 medicines for disposal is to contract an authorised waste management company for high-temperature incineration. This allows the large quantities of Schedule 8 medicines to be sent for disposal, without first destroying them.⁷

In these instances, the Schedule 8 medicines must be stored in the approved Schedule 8 safe and accounted for in the register until collection. There must also be accompanying documentation to evidence the change in the chain of custody.⁷ Please refer to local guidelines for further information on whether disposal via this pathway is allowable.

Summary of storage and recording requirements

All Schedule 8 medicines awaiting destruction must continue to be securely stored in the approved Schedule 8 safe, separated from other medicines, and clearly identified as awaiting destruction and be accounted for in the Schedule 8 register.

Once destroyed and rendered unusable, the storage requirements for Schedule 8 waste while awaiting disposal varies between jurisdictions. For example, in Tasmania and Western Australia, once rendered unusable and unidentified (i.e. destroyed) Schedule 8 medicine waste must continue to be stored in an approved Schedule 8 safe before being placed in the pharmaceutical waste bin on the day of bin collection (Tasmania) or immediately prior to bin collection (Western Australia).^2,8 Whereas in Queensland, the waste does not need to be stored in the safe, and can be stored in the RUM bin until it is collected.⁷ Please refer to local and current jurisdictional requirements.

Complete records of the disposal of Schedule 8 medicines must be maintained. The process must be recorded in the Schedule 8 register and be signed by both the person authorised to dispose of the Schedule 8 and the authorised witness (see Table 2) following local requirements.^2,4–11

Table 2 – Authorised witnesses for destruction of Schedule 8 medicines by pharmacists

Who can destroy Schedule 8 medicines? 

Only people authorised by legislation can destroy and dispose of Schedule 8 medicines and dispose of them in an approved manner. Destruction and disposal of Schedule 8 medicines by a pharmacist must be witnessed by an approved person.^{2,4-7,10,11,16-1}

The authority as to who can destroy, and witness the destruction of, Schedule 8 medicines differs slightly across each state and territory.

It is detailed in state and territory legislation with a summary shown in Table 2 – from legislation information available in July 2023.

Resources

Pharmacists can refer to the Poisons Standard for further information on the scheduling of medicines.¹⁹

The RUM project provides a useful summary for pharmacists on the disposal of medicines and what can and cannot be included in the program.¹

Each state and territory’s legislation details the current regulatory requirements for the disposal of S8 medicines, and pharmacists should refer to and regularly review their local legislation to ensure their process is compliant. Pharmacists must also meet the requirements under disposal in Standard 10: safe and secure handling of therapeutic goods of the updated Professional Practice Standards Version 6 available from www.psa.org.au/practice-support-industry/pps/ when disposing of medicines.

Knowledge to practice 

The collection and safe disposal of unwanted medicines forms part of the Australian National Medicines Policy and is an important public health issue.¹³ Accumulation of unwanted medicines stored in the home increases the risk of accidental poisoning or misuse and security issues such as theft or diversion. Pharmacists should educate customers on the safe disposal of medicines at every opportunity and include this information when providing medicine information and advice.

When receiving medicines back from patients for disposal, it is important that pharmacists identify any Schedule 8 medicines and ensure they are appropriately processed and disposed of according to current local state or territory requirements.

Pharmacists must also ensure the original packaging with the pharmacy label attached is disposed of securely according to their confidential waste processes and not disposed of in the general waste.

Conclusion

Pharmacists, one of the most accessible healthcare professionals, have a role to play in promoting the safe disposal of medicines, thereby reducing the risk of environmental damage, public harm and theft. Promoting this service is an important harm-minimisation strategy.

It is essential that all pharmacists are familiar with their local legislation and best practice guidelines for the correct process for disposal of all medicines, including Schedule 8 medicines. 

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Key points 

• Schedule 8 medicines must be destroyed and disposed of according to legislative, environmental and health regulations.
• Local legislation dictates who can destroy or witness the destruction of Schedule 8 medicines, and this differs in each state and territory.
• The destruction and disposal of Schedule 8 medicines must be recorded in the Schedule 8 register, according to local jurisdiction requirements.
• Pharmacists should regularly review their process for disposing of medicines to ensure it is legislatively compliant.

References

1. Department of Health and Aged Care. Return of Unwanted Medicines Project. 2023. At: health.gov.au/our-work/return-unwanted-medicines-project. 2023
2. Government of Western Australia, Department of Health. Disposal of medicines. At:  health.wa.gov.au/Articles/A_E/Disposal-of-medicines
3. Australian Standards Committee, AS3816. 2018 Australian Standard Management of clinical and related wastes. 2018. At: https://ablis.business.gov.au/service/tas/australian-standard-as-3816-management-of-clinical-and-related-wastes/38023#:~:text=This%20standard%20sets%20out%20requirements,or%20human%20health%20and%20safety.
4. Return Unwanted Medicines. Pharmacists: About Return Unwanted Medicines. At: https://returnmed.com.au/pharmacists/
5. VicTAG (Victorian therapeutics Advisory Group). Victorian Framework for handling and disposal of Pharmaceutical Waste. 2020. At: victag.org.au/Framework__Appendices_FINAL_formatted.pdf
6. NSW Government. Guide to Poisons and Therapeutic Goods Legislation for Pharmacists. At: health.nsw.gov.au/pharmaceutical/Documents/guide-pharmacists.pdf
7. Queensland Health. Disposal and destruction of diversion-risk medicine waste. Medicines and Poisons Act 2019 – Factsheet July 2022. At: health.qld.gov.au/__data/assets/pdf_file/0022/1113097/fs-disposal-destruction-medicine-waste.pdf.
8. Tasmanian Government – Department of Health. Disposal of Narcotic Substances Fact Sheet. At: health.tas.gov.au/publications/disposal-narcotic-substances-fact-sheet#:~:text=How%20narcotic%20substances%20(Schedule%208,a%20community%20pharmacy%20for%20disposal
9. Pharmacy Regulation Authority SA (PRASA). Guidelines for the operation of pharmacy premises by pharmacy services providers. 2018. At: https://pharmacyauthority.sa.gov.au/downloads/PharmacyGuidelinesSouthAustralia.pdf
10. Department of Health, Northern Territory Government. Medicines and Poisons Information Sheet. 2022. At: https://health.nt.gov.au/__data/assets/pdf_file/0010/1099630/s8-destruction-information-sheet.pdf.
11. ACT Government Legislation. Medicines, Poisons and Therapeutic Goods Regulation 2008. Republication No 45 Effective October 2022. At: legislation.act.gov.au
12. Victoria Department of Health. Managing Schedule 8 poisons. At: health.vic.gov.au/publications/managing-schedule-8-poisons
13. Department of Health and Aged Care. National Medicines Policy 2022. At:: health.gov.au/sites/default/files/2022-12/national-medicines-policy.pdf.
14. NSW Government Policy Directive. Medication Handling. 2022. At: health.nsw.gov.au/14pds/ActivePDSDocuments/PD2022_032.pdf
15. Australian Institute of Health and Welfare. Opioid harm in Australia and comparisons between Australia and Canada. Canberra: AIHW. 2018. At: aihw.gov.au/getmedia/605a6cf8-6e53-488e-ac6e-925e9086df33/aihw-hse-210.pdf.aspx?inline=true
16. Tasmania Department of Health. Poisons Regulations 2018. At: legislation.tas.gov.au
17. South Australia Government. Controlled Substances (Poisons) Regulations 2011. At: legislation.sa.gov.au/__legislation/lz/c/r/controlled%20substances%20(poisons)%20regulations%202011/current/2011.140.auth.pdf
18. NSW Health. Frequently asked questions – Schedule 8 (S8) medicines. 2023. At: www.health.nsw.gov.au/pharmaceutical/pharmacists/Pages/faq-schedule-8-medicines.aspx#bookmark1
19. Australian Government. Poisons Standard October 2022. At: www.legislation.gov.au/Details/F2022L01257
20. Queensland Government. Medicines and Poisons (Medicines) Regulation 2021. At: legislation.qld.gov.au/view/html/asmade/sl-2021-0140

Our author

Elke Smith (she/her) BPharm, MHithMgt is an experienced pharmacist who specialises in quality management, legislative compliance and clinical governance.

Our reviewer

Morna Falkland (she/her) BPharm