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.
Schedule 4 Appendix D (S4D) substances are restricted, however not considered drugs of addiction. A commonly used S4D drug for research purposes is Pentobarbitone Sodium (Lethabarb).
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/disposal and recording of the receipt and disposition of each drug in accordance with the Poisons and Therapeutic Goods Regulation 2008.
S4D drugs are restricted substances and therefore require handling, storage, recording and disposal in accordance with the Poisons and Therapeutic Goods Regulation 2008.
According to the Poisons and Therapeutic Goods Regulation 2008 (NSW), section 101:
(2) The following persons are authorised to have possession of (but not to supply) drugs of addiction:
(a) a person in charge of a laboratory used for the purpose of analysis, research or instruction, who is, or who belongs to a class of persons who are, authorised for the time being by the Director-General for the purposes of this clause,
(b) an analyst,
(c) a person acting under the direct personal supervision of a person referred to in paragraph (a) or (b).
In line with the UNSW Animal Research Ethics Procedure, the use of Schedule 8 and 9 substances for animal research at UNSW, including their storage and security arrangements, reflects the requirements of the Poisons and Therapeutic Goods Regulation 2008 (NSW). Authorised persons as issued by NSW Health are responsible for the storage, dispensing and use, monitoring and security of the substances and may delegate some of the tasks to a drug custodian. Authorised persons as issued by NSW Health may delegate some of the tasks to drug custodians.
A drug custodian must:
- Have attended the S8/9 training course
- Be listed on:
- The ACEC approved application (for animal research projects); and
- S8/9 cover letter to the NSW Ministry of Health.
At UNSW, all S4D, S8 and S9 substances must be ordered through the Jaggaer Chemical Inventory Management (CIM) software. If the drug is not listed in Jaggaer, contact RECS (email@example.com) to have it included in the purchase list.
The Chief Investigator of a 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 for research projects involving animals.
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.
For all other projects that require an authority from NSW Health (for example for analysis purposes) please contact RECS to facilitate the application process.
In accordance with the Poisons and Therapeutic Goods Regulation 2008, Clause 73, Storage of S8/S9 drugs involves;
1) A person who is in possession of any drug of addiction must keep the drug:
a) in his or her possession stored apart from all other goods (other than cash or documents) in a separate room, safe, cupboard or other receptacle securely attached to a part of the premises and kept securely locked when not in immediate use, or
b) stored in any other manner approved by the Director-General for the particular person or class of persons to which the person belongs.
2) A person who is an authorised practitioner or a person referred to in clause 101 (1) (g) is taken to comply with subclause (1) (a) if he or she keeps any drug of addiction (for use in an emergency only) in a bag that is in a room, or in a vehicle, kept locked when not occupied by the person.
A separate drug register must be kept for each safe where S8 and S9 drugs are held (registers available from RECS by contacting firstname.lastname@example.org).
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:
- Name and address company that the drug was received from e.g. Provet, 3/14 Anella Ave, Castle Hill, NSW 2154;
- Name of person who administered or used the drug;
- Quantity of drug received, administered or used;
- Animal species and ID;
- UNSW ACEC approval number;
- Name of Authorised Person listed on NSW Health Authority under which drugs are used;
- Signature by the person by whom it is made
Registers must be kept for at least 2 years after the last entry.
An accurate inventory of all S8 and S9 drugs must be made:
- Each March and September
- 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.
All personnel involved with S4D, S8 or S9 drugs are to complete the UNSW Poisons and Therapeutic Substances (S4D, S8, S9) Course.
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 65 and 73 of the Poisons and Therapeutic Goods Regulation 2008, and a register of its use is to be maintained in accordance with Clause 65 of the Poisons and Therapeutic Goods Regulation 2008.
At UNSW the 'authorised person' for Pentobarbitone Sodium are those persons listed on the approved UNSW ACEC application who are responsible for the euthanasia of animals for research or teaching purposes. This includes personnel listed under section B7 or whose role in the study specifies that they are responsible for euthanasia.
Further information on the acquisition, storage, record keeping and disposal requirements for preparations of injectable Pentobarbitone Sodium can be found here.
A downloadable copy of the summary is available here.
S4D, 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". This process is organised by contacting the RECS Office (email@example.com) who will organise with Eastern Beaches Local Area Command for a police officer to come on campus to witness the destruction and/or disposal of such drugs.