Schedule 8 and 9 Therapeutic Drugs

Any queries should be directed to Dr Paul Sou animalethics@unsw.edu.au

What are Schedule 8 and 9 drugs?

Schedule 8 (S8) and 9 (S9) drugs are respectively known as Drugs of Addiction and Prohibited Substances, as per the Poisons Standard (the Standard for the Uniform Scheduling of Medicines and Poisons).

S8 drugs such as buprenorphine, ketamine and fentanyl are commonly used for anaesthesia and analgesia in animal research. At times, S9 drugs such as amphetamine, muscimol, morphine, cocaine and cannabidiol are used in animal research, especially in fields such as psychology and pharmacology.

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How do I know if my drugs are S8 or S9?

A list of commonly used S8 drugs can be found here. For a full list of drugs and their classification, refer to the Poisons Standard.

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Legislation

Regulation of S8 and S9 drugs is set out in the Poisons and Therapeutic Goods Act 1966 and the Poisons and Therapeutic Goods Regulation 2008. For an excerpt, click here.

The possession of S8 and S9 drugs must be accompanied by a valid Authority issued from the NSW Ministry of Health. All conditions of the Authority are to be adhered to including but not limited to: a valid associated animal research ethics protocol, not exceeding the maximum stipulated quantities, procuring drugs only from authorised suppliers as stated in the application form, and handling, storage, destruction and recording of the receipt and disposition of each drug in accordance with the Poisons and Therapeutic Goods Regulation 2008.

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Application Process

The Chief Investigator of an animal research project using S8 or S9 drugs is to obtain authority from the NSW Ministry of Health (hereafter known as NSW Health) for such use. Animal Ethics Online has been adapted to facilitate this process.

1.       Chief Investigator submits an animal ethics application via Animal Ethics Online

2.       Answers from Animal Ethics Online will auto-generate onto the NSW Health application form

3.       A cover letter to NSW Health will also be auto-generated by Animal Ethics Online

4.       These documents will be sent to the Chief Investigator for sign-off, after which it is returned to RECS to be submitted to NSW Health on behalf of the Chief Investigator

Please note that the Authorised Head of School for Drugs of Addiction will continue to have responsibility for the drug store and dispensing of the drugs.

RECS will oversee the application process and monitor compliance by requiring that compliance reports be submitted by 30 April and 31 October each year.

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Drug Register

A separate drug register must be kept for each safe where S8 and S9 drugs are held (registers available from RECS by contacting animalethics@unsw.edu.au).

On the day that an S8 or S9 drug is received, used, or disposed of (the latter only permitted in the presence of a police officer), the following details are to be recorded in the register:

  1. Date;
  2. Name and address company that the drug was received from e.g. Provet, 3/14 Anella Ave, Castle Hill, NSW 2154;
  3. Name of person who administered or used the drug;
  4. Quantity of drug received, administered or used;
  5. Animal species and ID;
  6. UNSW ACEC approval number;
  7. Name of Authorised Person listed on NSW Health Authority under which drugs are used;
  8. Signature by the person by whom it is made

Registers must be kept for at least 2 years after the last entry.

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Inventory

An accurate inventory of all S8 and S9 drugs must be made:

  1. Each March and September
  2. if a person assumes control for a period of one month or more

RECS will send each Chief Investigator a pre-filled "Drugs of Addiction or Prohibited Substances Compliance Report" each March and September to complete.

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Training

All personnel involved with S8 or S9 drugs are to complete the UNSW Schedule 8 and 9 Therapeutic Drugs course.

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Pentobarbitone Sodium

Pentobarbitone Sodium (Lethabarb) is predominantly used for the euthanasia/humane killing of animals used in research and teaching approved by the ACEC. As a Schedule 4(D) therapeutic drug, pentobarbitone sodium is to be stored in accordance with Clause 73 of the Poisons and Therapeutic Goods Regulation 2008, and a register of its use is to be maintained in accordance with Clauses 111 & 112 of the Poisons and Therapeutic Goods Regulation 2008.

Disposal of Pentobarbitone Sodium is to be in accordance with the UNSW "HS321 Laboratory Hazardous Waste Disposal Guideline".

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Disposal

S8 and S9 drugs may only be destroyed and/or disposed of by or under the direct personal supervision of a police officer, and in accordance with the UNSW "HS321 Laboratory Hazardous Waste Disposal Guideline". Eastern Beaches Local Area Command can be contacted for a police officer to come on campus to witness the destruction and/or disposal of such drugs.

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