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Acts of veterinary science and the use of restricted drugs

Policy

1. A person may conduct, as part of their animal research, acts of veterinary science as defined under the Veterinary Practice Act 2003 and not be a practising veterinarian (as defined under that act) only if they have authority to do so under the Animal Research Act 1985 and only within the terms of that authority.

2. A person may obtain and possess restricted substances (Schedule 4 - 'S4' drugs) for use in their profession or employment, under exemptions in the Poisons and Therapeutic Goods Regulation 2002 Section 61;

"A scientifically qualified person in charge of a laboratory or department, being a person who is engaged in medical or scientific research or instruction, or in quality control or analysis".

3. A person may obtain and possess prescribed restricted substances (as listed in Appendix D of the Regulation) including pentobarbitone sodium, for use in their profession or employment, under exemptions in the Poisons and Therapeutic Goods Regulation Regulation 2002, Clause 61, provided the person is;

"A scientifically qualified person in charge of a laboratory or department, being a person who is engaged in medical or scientific research or instruction, or in quality control or analysis";

or "a person acting under the direct personal supervision of a person referred to" (above)

(Poisons and Therapeutic Goods Regulation 2002 Clause 61 (e) and (f).

4. Possession of drugs of addiction (Schedule 8 'S8' drugs) requires written authorisation from the Director-General of NSW Health (Clause 101 of the Regulation).

Explanatory Notes

1. Researchers who are not registered veterinary surgeons may conduct acts of veterinary science, provided they have approval to do so from an Animal Ethics Committee (AEC) and are in compliance with the Animal Research Act, the Regulation and their AEC approval.

2. Note that the authority under point two is given to' the scientifically qualified person in charge of the laboratory or department', who is therefore legally responsible for the restricted substance and must personally supervise any other researchers using these substances. The use of such drugs must also be approved by the AEC and be used in accordance with that approval.

3. A researcher may therefore use sodium pentobarbitone to euthanase animals as part of an approved AEC protocol, under supervision by the head of the department or laboratory.

Use of this drug under field conditions is a grey area and researchers should be aware of the potential legal implications.

4. Researchers wishing to use S8 drugs must apply in writing to the:-

Chief Pharmacist
Pharmaceutical Services Branch
NSW Health
PO Box 103
GLADESVILLE NSW 1675

For any questions, contact the Duty Pharmicist:
Phone: (02) 9879 3214
Fax: (02) 9859 5165

The application must show that the drug will be used for the purpose of scientific research, instruction, analysis or study.

If approved, the researcher must then ensure that the drug is stored in a secure manner and that a register of use is maintained.

v. Registered veterinary surgeons may only supply both S4 and S8 drugs for animals under their care.

vi. Approved researchers may obtain supplies of sodium pentobarbitone from commercial veterinary medical wholesalers by providing a written statement to the effect that they are exempted under Clause 61 of the Poisons and Therapeutic Goods Regulation 2002.

vii. Ethics committees may issue approval to researchers to use restricted drugs, including pentobarbitone sodium for euthanasia, having assessed the competency of the applicant, the methods and dosages to be used, the justification for the drug's use, and the details of how the drugs will be stored.

Extracts of relevant legislation

Veterinary Practice Act 2003

Definitions of "veterinary science"

"includes any branch of the science or art of veterinary medicine or of veterinary surgery and, without limiting the generality of the foregoing, includes the following:

(a) the examination of or attendance on any animal for the purpose of diagnosing the physiological or pathological condition of the animal,

(b) the giving of any anaesthetic to, or the performance of any operation on, any animal,

(d) without limiting the generality of paragraph (b):

(i) the carrying out of any artificial breeding procedure involving surgery, and

(ii) the de-antlering of deer,

(e) the doing of any act that is prescribed by the regulations as forming part of the practice of veterinary science.

Section 5

"Certain accredited or authorised persons may do restricted acts of veterinary science in certain circumstances:

The following classes of persons and circumstances are prescribed for the purposes of section 9 (2) (e) of the Act:

(a) persons, or persons of the class of persons, who are accredited by the Board to carry out a specified restricted act of veterinary science and who are acting as permitted by, and in accordance with, that accreditation,

(b) persons who hold an authority to carry out animal research under section 25 of the Animal Research Act 1985 and who are acting as permitted by, and in accordance with, that authority

Animal Research Act 1985

Section 3 definition of animal research

"animal research means any procedure, test, experiment, inquiry, investigation or study in connection with which an animal is used and, without limiting the generality of the foregoing, includes any procedure, test experiment, inquiry, investigation or study in the course of which

a) an animal is subjected to:

1. Surgical, medical, physiological, biological, chemical or physical treatment;

2. Abnormal conditions of heat, cold, light, dark, confinement, noise, isolation or overcrowding;

3. Abnormal dietary conditions; or

4. Electric shock or radiation treatment; or

b) Any material or substance is extracted from or derived from the body of an animal, but does not include any procedures, test, experiment, inquiry, investigation or study which is carried out in the course of:

c) the administration of veterinary treatment to an animal for the purpose of protecting the welfare of the animal; or

d) the conduct of normal husbandry operations;"

Poisons and Therapeutic Goods Act 1966

Section 16 (1)

"A person shall not have in his or her possession or attempt to obtain possession of a prescribed substance unless:

d) he is a person authorised in writing by the Director-General to obtain possession of the prescribed restricted substance for the purposes of his profession or employment and obtains, or attempts to obtain, as the case may be, possession of the prescribed restricted substance in accordance with any conditions subject to which he is so authorised,

e) the person in licensed or otherwise authorised by the regulations to obtain possession of the substance for the purposes of his or her profession or employment".

Section 24 (2c)

"Regulations shall be made under this Division making provision for or with respect to:

c) authorising persons in charge of laboratories for the purpose of research or instruction, and such other persons as to the Minister may seem proper to be in possession of any drug of addiction for the purposes of their professions or employments, subject to such conditions and restrictions as may be prescribed;"

Poisons and Therapeutic Goods Regulation 2002

Clause 61

"for the purposes of section 16 (I) (e) of the Act, the following persons are authorised to obtain possession of prescribed restricted substances for the purposes of their profession or employment.

e) a scientifically qualified person in charge of a laboratory or department, being a person who is engaged in medical or scientific research or instruction, or in quality control analysis"; or

f) a person acting under the direct personal supervision of a person referred to in e)."

Clause 64

(1) An authorised person who uses pentobarbitone sodium for the destruction of animals must ensure that the requirements of this clause are complied with

(2) pentobarbitone sodium must be kept separately from all other goods in a safe, cupboard or other receptacle:

a) that is securely attached to a part of the premises; and

b) that is kept securely locked when not in immediate use.

(3) an authorised person must keep a separate register of all pentobarbitone sodium that is obtained or used by an authorised person.

(4) on the day on which an authorised person obtains or uses any pentobarbitone sodium, the authorised person must enter in the register such of the following details as are relevant to the transaction:

a) the quantity that was obtained or used;

b) the name and address of the person from whom it was obtained;

c) the number and species of animals for which it was used;

d) the total quantity held by the authorised person after the entry is made.

(5) each entry must be dated and signed by the authorised person.

(6) In this clause, "authorised person" means:

a) a person nominated by the council of a local government areas; or

b) an officer of an animal welfare organisation nominated by the organisation, being in either case a person who is authorised under section 16 (1) (d) of the Act to obtain possession of pentobarbitone sodium for the humane destruction of animals.

Clause 101

Possession of drugs of addiction by medical practitioners, dentists, veterinary surgeons, hospital pharmacists

(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, being a person who is approved for the time being by the Director-General for the purposes of this clause,

(b) an analyst,

(3) This clause authorises a person referred to in subclause (1) or (2) to have possession of, or to supply, drugs of addiction for the purpose only of the lawful practice of the person's profession or occupation.

Animal Research Review Panel Policy 14