The use of restricted drugs and the conduct of restricted acts of veterinary science in animal research
Animal Research Review Panel Policy 14
Revised 27 February 2014
1. Use of schedule 2, 3 or 4 (S2, S3 or S4) drugs:
A scientifically qualified person in charge of a laboratory or department, or a person acting under the direct personal supervision of such a person, is authorised to possess and use any Schedule 2, 3 or 4 substance that is required for the conduct of medical or scientific research or instruction or the conduct of quality control or analysis. (Poisons and Therapeutic Goods Regulation 2008 clause 129 and Appendix C clause 19). The use of these substances in animal research must also be approved by the establishment’s Animal Ethics Committee (AEC) in the course of approving an application to carry out a research project, and they must be used strictly in accord with the approved project.
The authority to possess and use S2, S3 and S4 substances is given to the “scientifically qualified person in charge of the laboratory or department”, who is therefore responsible for the restricted substances and must directly and personally supervise any other researchers using these substances.
2. Use of pentobarbitone sodium for injection (S4) for the humane destruction of animals in the field:
Use of pentobarbitone sodium by scientifically qualified persons conducting wildlife research in the field under an Animal Research Authority issued on the recommendation of an Animal Ethics Committee under the Animal Research Act 1985 (NSW), is authorised under the Poisons and Therapeutic Goods Regulation 2008, for the purpose of the person’s profession or employment, in the humane destruction of animals in a field setting where a veterinary practitioner is not available and other forms of animal destruction are not practicable.
This authority under the Poisons and Therapeutic Goods Regulation 2008 is subject to the following conditions:
- Each person so authorised must hold appropriate scientific qualifications for conducting wildlife research in the field under an Animal Research Authority issued on the recommendation of an Animal Ethics Committee under the Animal Research Act 1985 (NSW).
- Each person so authorised must have received appropriate training and assessment of his/her competency and have a demonstrated need to have access to pentobarbitone sodium for injection in order to carry out his/her official duties.
- Pentobarbitone sodium for injection must be stored and recorded in accordance with the provisions of clauses 65 (1) - (6) inclusive of the Poisons and Therapeutic Goods Regulation 2008, except that if the authorised person is working in the field, pentobarbitone sodium for injection may alternatively be stored in an opaque closed bag or container that is in his or her immediate personal possession, or that is in a room or vehicle which is kept securely locked and vacant when not occupied by the authorised person.
- The stocks of pentobarbitone sodium for injection obtained and kept by each person so authorised must be kept to the minimum which is considered likely to be required.
- The pentobarbitone sodium so obtained must not be re-supplied to any other person.
The bodies of animals that have been humanely destroyed with pentobarbitone sodium in the field may pose a risk of poisoning to other animals if they are eaten. Animal Ethics Committees which approve the use of pentobarbitone sodium for the humane destruction of animals in the field must ensure that the research protocol describes an appropriate method of disposing of the bodies so that the risk of scavenging by other animals is minimised.
3. Possession and use of schedule 8 (S8) drugs of addiction:
Persons authorised to have possession of (but not to supply) drugs of addiction include: A person in charge of a laboratory used for the purpose of analysis, research or instruction, who is, or belongs to a class of persons who are, authorised for the time being by the Director-General of NSW Ministry of Health, or a person acting under the direct personal supervision of that person (Poisons and Therapeutic Goods Regulation 2008 clause 101). The use of these substances in animal research must also be approved by the AEC and use must be in strict accord with the approved project.
The NSW Ministry of Health Pharmaceutical Services Unit provides guidance for scientists with appropriate qualifications who wish to apply to use S8 substances. The following website provides background advice, a checklist and an application form. It is strongly recommended that investigators wishing to use these substances for the purpose of animal research should first consult the website: http://www0.health.nsw.gov.au/resources/publichealth/pharmaceutical/apdp_pdf.asp
4. Restricted acts of veterinary science
Researchers who are not veterinary practitioners may conduct restricted acts of veterinary science and not be veterinary practitioners only if they have approval to do so from an Animal Ethics Committee and are in compliance with their Animal Research Authority issued for the approved project. (See Veterinary Practice Act 2003 sections 7 and 9; Veterinary Practice Regulation 2013 clauses 4 and 5(b) )
The contribution of Ms Leanne Wilkinson and Dr Mike Fleming (Office of Environment and Heritage) and Ms Monique Reyes (Pharmaceutical Services Unit, NSW Ministry of Health) to the revision of this policy is gratefully acknowledged.
Authority to obtain possession of pentobarbitone sodium for the humane destruction of animals in a field setting: