Management of Schedule 8 medicines

Schedule 8 (S8) medicines are strictly regulated to prevent harm and protect public health. When used appropriately, these medicines can improve patient health, function, and quality of life. However, many are associated with a risk of physical or psychological dependence and may cause serious harm if misused.

S8 medicines are also known as drugs of addiction, drugs of dependence, or controlled drugs.

The following information outlines the legal requirements for the possession, procurement, prescribing, supply, storage, record keeping, loss or theft, and destruction of S8 substances in all settings (excluding wholesalers).

Additional requirements apply to the management of S8 in public health facilities. These are outlined in the policy directive PD2022_032 Medication Handling.

On this page

1. List of Schedule 8 medicines
2. Who is authorised to handle Schedule 8 medicines
3. Ordering and receipting of Schedule 8 medicines
4. Storage and access to Schedule 8 medicines
5. Drug registers
6. Prescribing and supplying Schedule 8 medicines
7. Record-keeping requirements for Schedule 8 medicines
8. Loss or theft of Schedule 8 medicines
9. Destruction of Schedule 8 medicines
10. Compliance and inspections

List of Schedule 8 medicines

The most common S8 medicines are listed at Schedule 8 (S8) medicines, with a complete list available in The Poisons Standard (SUSMP) .

Who is authorised to handle Schedule 8 medicines?

Any person issued with a S8 medicine from a valid prescription, or their agent or carer, is allowed to have the medicine as long as it's used as prescribed and for the intended medical purpose.

Ahpra registered health practitioners who are required to possess a S8 medicine for the purpose of their profession, for example, medical practitioners, nurse practitioners, dentists, pharmacists in charge of a pharmacy, etc.

Possession is not permitted by health practitioners who have their authority to prescribe or handle S8 medicines withdrawn under the Poisons and Therapeutic Goods Act 1966 (NSW), or if stated under conditions listed on their registration on Ahpra. See Withdrawn Schedule 8 drug authorities under the Poisons and Therapeutic Goods Regulation for more information.

Roles and responsibilities for S8 medicines

The responsibility for ensuring compliance with S8 storage, access, and record-keeping requirements is:

• in public hospitals, as stated in the policy directive PD2022_032 Medication Handling.
• in residential care facilities, the Director of Nursing (DON) or facility manager.
• in other settings, the person who is authorised to prescribe, supply, or administer a S8 medicine for the purpose of:
• their profession, or
• activity authorised under a licence, or an authority as issued under the Poisons and Therapeutic Goods Act 1966 (NSW).

Ordering and receipting of Schedule 8 medicines

Ordering

S8 medicines must be ordered and signed by an authorised person.

Orders may be made by telephone, email, or fax. A written order must be received by the supplier within 7 days of supply; otherwise, the event must be reported to Pharmaceutical Services via email to MOH-PharmaceuticalServices@health.nsw.gov.au.

Delivery and receipt

When a S8 medicine is delivered, an authorised person must sign and date the receipt. The supplier must be informed in writing within 24 hours that the medicine has been received.

The person who receives the medicine must immediately place it in the S8 safe and record the transaction in the drug register. Please note that on a ward, residential care facility, or managed correctional centre, this record must be made in the presence of a witness.

If a courier (or similar carrier) delivers a S8 medicine, the supplier must keep written proof of the consignment. On delivery, the courier must get a signed receipt and return it to the supplier.

Storage and access to Schedule 8 medicines

Storage

S8 medicines must be stored:

• in a locked safe, cupboard, drawer, or other secure receptacle that is securely attached to the premises
• separately from other goods (except cash or documents)
• in their original packaging, or the packaging as received from the supplier.

In a pharmacy, S8 medicines must be stored in a steel safe that meets the specified requirements and is fixed to the building. Specific requirements for safes are listed in Division 2 Storage of the Poisons and Therapeutic Goods Regulation 2008.

If refrigeration is required:

• S8 medicines must be stored in a locked refrigerator or a refrigerator located within a locked room
• the refrigerator must be securely attached to the premises and kept locked when not in immediate use
• only other medicines that are listed in Schedules 2, 3, 4, or 8 of the Poisons List, or other therapeutic goods, may be kept in the refrigerator. The refrigerator must not be used to store food or unrelated items.

More information is available at Storage of a Schedule 8 medicine (drug of addiction) requiring refrigeration.

Access to S8 medicines

• Access to S8 medicines is restricted to authorised personnel only.
• Any safe, cupboard, drawer, refrigerator (or room where the refrigerator is kept), or other receptacle, must be kept securely locked when not in immediate use.
• Keys, codes, or combinations must be:
• held only by authorised staff as defined under Who is authorised to handle Schedule 8 medicines
• not shared with unauthorised people (e.g., non-prescribers or non-pharmacists)
• secured when no authorised person is present, e.g., locked in a separate safe overnight, with a process in place to ensure access by authorised staff the next day.

Drug registers

A drug register must be used to record all transactions involving S8 medicines, including manufacture, receipt, supply, dispensing, administration, and destruction. The following requirements apply:

• each brand and strength of a S8 medicine must have its own dedicated page in the register
• all transactions must be recorded in the drug register on the same day they occur
• drug registers must be kept on the premises where the S8 medicines are stored.

Format of a drug register

Drug registers are available in both print and electronic formats.

The drug register may be:

• a bound book form whose pages are consecutively numbered
• an approved electronic format
• another form approved by the Secretary, NSW Health.

Electronic drug registers must comply with NSW Health's standards, which include requirements for system security, user authentication, and data integrity.

Subsidiary drug registers

Community pharmacies participating in the NSW Opioid Treatment Program (OTP) are recommended to use a subsidiary drug register to record the dosing of S8 medicines, such as methadone and buprenorphine.

These registers act as supplementary records to the primary S8 drug register and are essential for accurate and compliant medicine management.

Further information can be found in the NSW Opioid Treatment Program community pharmacy dosing point protocol.

Drug register entries

Each entry must be made on the day or at the time of the transaction and must include:

• date of the transaction (receipt, supply, administration, destruction)
• the quantity of the medicine
• the name and address of the person involved in the transaction*
• signatures of the person making the entry, and where required, a witness

If the medicine is supplied on prescription, the entry must also include:

• the prescription reference number
• the name of the prescriber.

*The name and address of the person involved in the transaction are commonly that of:

• a patient, issued the medicine on prescription or administered the medicine on a prescriber's direction
• an animal, including the species of animal and the name and address of the animal's owner
• a wholesaler, who is supplying the medicine to the pharmacy or prescriber's practice
• a prescriber, if a medicine is being issued as an urgent-use medicine, or a S8 destruction is required.

For drug register entries in public health facilities, refer to PD2022_032 Medication Handling.

Only an authorised person is permitted to make final entries in a drug register. For electronic drug registers, this must be someone who has been assigned a unique access credential.

Inventory and reporting requirements

• An inventory of each S8 medicine must be conducted and recorded in the drug register twice a year, in March and September.
• If an authorised person takes control of a practice for one month or more, they must complete a stock check regardless of the time of year.
• A loss or destruction of part or all of a drug register must be reported to Pharmaceutical Services, see Notifying the loss or destruction of a drug register.

Witnessing requirements

Certain transactions in the drug register require the presence of an independent witness. These include:

• public health facilities, as outlined in the policy directive PD2022_032 Medication Handling
• a ward, residential care facility and managed correctional centres
• the destruction of S8 medicines. See Destruction of Schedule 8 medicines for more information.

Ordering drug registers

Drug registers in a bound book form can be ordered from the state government printing contractor, Finsbury Green by emailing nswhealth@finsbury.com.au or calling the helpdesk on 1800 515 222 (available Monday to Friday, 8am – 5:30pm). Registers available for purchase are:

• Ward Register of Drugs of Addiction NH612005 - Form H22
• Register of Drugs of Addiction NH612000 - Form H21.

Drug registers may also be purchased from some pharmaceutical wholesalers and the Pharmaceutical Society of Australia.

Subsidiary drug registers for the dosing of methadone, Subutex, and Suboxone (note: each medicine has its own) are available from the NSW Pharmacy Guild on (02) 9467 7100.

Prescribing and supplying Schedule 8 medicines

For information on who can prescribe and supply S8 medicines, types of prescriptions or orders for S8 medicines, and what to include on a prescription, see Supply of prescription medicines.

For safe prescribing principles, see Safe prescribing of high-risk medicines.

Record-keeping requirements for Schedule 8 medicines

Drug registers must be retained for a minimum of two years from the date of the last entry.

Dispensed prescriptions for S8 medicines must be kept for two years at the pharmacy premises where the prescriptions were dispensed.

Dispensed paper S8 prescriptions must be stored separately from other prescriptions, except those for certain barbiturates and anabolic/androgenic steroidal agents.

Dispensed S8 electronic prescription records must be stored in a way that allows the pharmacist on duty to access and retrieve them promptly when needed.

All records must be stored so they are retrievable upon request by a Pharmaceutical Services authorised officer or NSW police officer.

Loss or theft of Schedule 8 medicines

Any loss or theft of S8 medicines must be reported to Pharmaceutical Services via the online form, Notifying for loss or theft of medicines.

Destruction of Schedule 8 medicines

General principles

• S8 medicines must be destroyed in a way that they cannot be recovered or identified.
• Destruction must be carried out in a way that poses no risk to people and causes no harm to the environment.
• Destruction is generally performed by a pharmacist in the presence of a witness (see details below).
• An inspector from the NSW Ministry of Health, or an on-duty NSW Police officer, may destroy S8 medicines. The destruction must be recorded in the S8 drug register in a similar manner to that stated below, but the entry does not need to be witnessed.

Community pharmacies

• Unwanted S8 medicines may be destroyed by a pharmacist who practises at a community pharmacy in the presence of an independent witness.
• For details on acceptable witnesses and details on how to destroy the S8 substances, see Destruction of Schedule 8 medicines at community pharmacies.

Public health facilities

For information on the destruction of S8 medicines in a public health facility, refer to the Policy Directive PD2022_032 Medication Handling.

Residential care facilities

Residential care facilities that are classified as nursing homes under the Public Health Act 1991 must refer to Policy Directive PD2022_032 Medication Handling. For all other residential care facilities:

• unwanted S8 medicines may be destroyed by a community pharmacist who supplies these medicines to the facility or its residents
• destruction must occur on the premises of the facility
• the destruction must be in the presence of, and witnessed by, the Director of Nursing (DON) or the residential care facility manager
• the destruction must be recorded in the register and include:
• the date of destruction
• the pharmacist's name and professional registration number
• signatures of both the pharmacist and the witness.

Private health facilities

• Unwanted S8 medicines may be destroyed by a community pharmacist who has supplied medicines to the facility or its patients.
• Destruction must occur on the premises of the facility.
• The destruction must be in the presence of and witnessed by the Director of Nursing (DON).
• The destruction must be recorded in the register and include:
• the date of destruction
• the pharmacist's name and professional registration number
• signatures of both the pharmacist and the DON.

Private medical practices

• Unwanted S8 medicines may be destroyed by a pharmacist working in any community pharmacy (not necessarily the original supplier of the medicines).
• A pharmacist is not obliged to destroy medicines on request.
• The destruction may occur either at the pharmacy or on the premises where the practitioner practices. The pharmacist cannot take possession of the medicines or enter them into the pharmacy's drug register.
• The pharmacist must record the destruction in the practitioner’s drug register and include the:
• date
• practitioner’s name, and
• pharmacist’s name and professional registration number.
• The practitioner must witness the destruction, and both the pharmacist and the practitioner must include their signatures for each entry.

Compliance and inspections

Facilities may be subject to inspections by NSW Health to ensure compliance with activities such as storage, record-keeping, and the issue of prescriptions. Non-compliance may result in compliance and enforcement activities.