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Storage and Use of Drugs of Addiction Used in Research Procedure

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Section 1 - Purpose

(1) To detail the actions and responsibilities required for obtaining, possession and use of Schedule 8 Drugs - Drugs of Addiction and / or Prohibited Drugs which are used at Macquarie University for research, analysis or instruction.

Scope

(2) This Procedure requires actions by the following:

  1. Head of Animal Facilities;
  2. Head of Laboratory Facilities in which in-vitro and or invertebrate animal in-vivo work, using Drugs of Addiction and / or Prohibited Drugs, is performed;
  3. Manager, Workplace Health and Safety;
  4. Authorised Individuals – i.e. an individual University staff member / researcher who has written authority from the Pharmaceutical Services Unit, NSW Ministry of Health to obtain, possess and use substances listed in Schedule 8 of the NSW Poisons List and commonly called Drugs of Addiction (also known Schedule 8 Drugs - Drugs of Addiction) for research, analysis or instruction. More specifically this authority is issued under clause 170 of the Regulation for the purpose as defined in clause 101 (2)(a). The Authority places conditions on the obtaining, possession and use of Drugs of Addiction according to clause 171 (1);
  5. in the case of Prohibited Drugs, Pharmaceutical Services issues an authority under Section 10(1)(a) of the Drug Misuse and Trafficking Act 1985 with conditions imposed under Section 41(b) of the Drug Misuse and Trafficking Act 1985;
  6. in the case of Prohibited Plants, Pharmaceutical Services issues an authority under Section 23(4)(b) of the Drug Misuse and Trafficking Act 1985. In each case, conditions may be imposed on an authority by the Director-General (Pharmaceutical Services) under Section 41(b) of the Drug Misuse and Trafficking Act 1985;
  7. Supervised Individuals – i.e. individual University staff members / researchers or postgraduate students working under direct supervision of an ‘Authorised Individual’ and approved as a researcher on an Animal Research Authority or other research instrument appropriate to and described in an Authority to obtain, possess and use the drug of addiction; and
  8. other - Macquarie staff or postgraduate students.
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Section 2 - Policy

(3) Nil.

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Section 3 - Procedures

Responsibilities and Required Actions

(4) The steps and / or actions that must be undertaken for obtaining, possessing and use of Drugs of Addiction include:

  1. maintain authority;
  2. training;
  3. supervision
  4. storage, inventory and stock-take;
  5. issuing of substances / Drugs of Addiction / Prohibited Drugs / Prohibited Plants (cultivation of a Prohibited Plant can also be authorised);
  6. maintain drugs register;
  7. disposal; and
  8. loss or theft.

Head of Animal Facilities / Head of Laboratory Facilities

(5) Confirm and file copies of each Authorised Individual’s Authority before allowing an Authorized Individual to use Drugs of Addiction within animal facilities.

(6) Ensure a health and safety risk assessment is conducted for any new Drugs of Addiction not so assessed.

Manager, Workplace Health and Safety

(7) Facilitate the health and safety risk assessment for any Drug of Addiction / Prohibited Drug / Prohibited Plant that has not had such an assessment.

(8) Assist in the training of Supervised Individuals to ensure these individuals comply with drug and chemical safety regulation of the Work Health and Safety Act 2011 (NSW).

Authorised Individuals

Authority

(9) Maintain a current Authority and ensure any changes are, as soon as practicable, relayed back to Pharmaceutical Services, NSW Health.

(10) Provide a copy of the Authority to the relevant Head of Animal Facilities and / or Head of Laboratory Facilities before taking any Drug of Addiction / Prohibited Drug / Prohibited Plant into the relevant facility.

(11) Comply with all the requirements of the Authority.

Training

(12) Ensure the required training for Supervised Individuals is provided and undertaken.

(13) Such training must include as a minimum:

  1. induction training on the law and regulation governing the use of Drugs of Addiction in NSW, working knowledge of the University’s Alcohol and Drug Policy including this Procedure, and the use of Drugs of Addiction in animals and / or in vitro systems; and
  2. a risk analysis of the use of Drugs of Addiction.

Supervision

(14) Ensure that any individual required to work with any Drug of Addiction / Prohibited Drug / Prohibited Plant under supervision of an ‘Authorised Individual’ is approved as a researcher on an Animal Research Authority or other research instrument appropriate to and described in the Authority to obtain, possess and use the Drug of Addiction / Prohibited Drug / Prohibited Plant.

(15) Actively supervise Supervised Individuals to ensure they comply with all requirements for control of the Drug of Addiction / Prohibited Drug / Prohibited Plant.         

Storage and Inventory and Stock-take

(16) Ensure that Drugs of Addiction are stored and secured in accordance with requirements under the Regulation currently in force.

(17) Ensure a periodic inventory stock-take of Drugs of Addiction held under Authority (refer clauses 73 and 118). 

Issuing

(18) Issue any Drug of Addiction / Prohibited Drug / Prohibited Plant only in accordance with the Authority issued in the name of the Authorised Individual requesting them and only for the Animal Research Authority or authorised research instrument nominated within the Authority and in full compliance with the specific clauses detailed within the Authority.

(19) Issue any Drug of Addiction / Prohibited Drug / Prohibited Plant only in the physical presence of another Authorised Individual. 

(20) Note: it is a University requirement that two (2) people be present during the issuing of Drugs of Addiction, therefore if another Authorised Individual is unavailable, an appropriately trained Supervised Individual is acceptable.

(21) Record the specific quantity of drug issued in the Drugs of Addiction register and ensures the record is noted by both individuals, with signature above printed name and MQ staff / student identity number of both individuals.

Maintain a Drug Register

(22) Develop and maintain a drug register specifically for any Drug of Addiction / Prohibited Drug / Prohibited Plant in accordance with the requirements of the Regulation (refer clauses 111 112, 176 and 177).

(23) Lost or stolen drug register must, as soon as possible, be reported in writing to the Director-General, NSW Health, detailing the loss or theft and of the circumstances of the loss or destruction. Refer to the NSW Health Pharmaceutical Services website for further details.

(24) Make an accurate inventory of any Drug of Addiction / Prohibited Drug / Prohibited Plant held at the premises concerned and enter, in a new drug register, the particulars of the drugs so held (refer clause 119).

Disposal

(25) Dispose of any Drug of Addiction / Prohibited Drug / Prohibited Plant only by or under the direct personal supervision of a police officer or an inspector or under the direct personal supervision of another Authorised Individual (refer to clause 125).  Such Authority is issued under Part 8, clause 170 of the Regulation.

Loss or Theft

(26) Notify the Director-General, NSW Health if a Drug of Addiction / Prohibited Drug / Prohibited Plant is lost or stolen from the Authorised Individual’s stock (refer clause 124) by completing and submitting an electronic form.

(27) Report the loss or theft to University Security for reporting to the Police.

Supervised Individuals

(28) Undertake the required training as instructed by the Authorised Individual before working with Drugs of Addiction.

(29) Undertake a health and safety risk assessment for the Drugs of Addiction being used.

(30) Be included on the relevant Animal Research Authorit or relevant research instrument to the appropriate Authority to obtain, possess, and use the Drug of Addiction / Prohibited Drug / Prohibited Plant.

(31) Comply with all instructions given by your supervising Authorised Individual and with relevant legislative requirements.

(32) Request Drugs of Addiction / Prohibited Drugs / Prohibited Plants from an Authorised Individual and ensure that two (2) Authorised Individuals are present, or one Authorised Individual and another Supervised Individual are both present when collecting the Drug of Addiction / Prohibited Drug / Prohibited Plant from the safe.

(33) Report any suspected or actual loss or theft of a drug of addiction to an Authorised Individual as soon as possible.

(34) Report any suspected or actual loss or destruction of a drug register to an Authorised Individual as soon as possible.

Other

(35) Consult the relevant Head of Animal Facilities and / or Head of in-vitro / invertebrate in-vivo Laboratory Facilities for University requirements relating to obtaining, possession, use and disposal of Drug of Addiction / Prohibited Drug / Prohibited Plant.

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Section 4 - Guidelines

(36) Nil.

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Section 5 - Definitions

(37) Commonly defined terms are located in the University Glossary. The following definitions apply for the purpose of this Procedure:

  1. Regulation means the Poisons and Therapeutic Goods Regulation 2008 with particular reference to clauses as identified in the Authority issued to Authorised Individuals.
  2. Act means the Drug Misuse and Trafficking Act 1985.
  3. Authority means documentary evidence from the Pharmaceutical Services, NSW Health that authority has been granted to an individual University staff member / researcher to obtain, possess and use Drugs of Addiction / Prohibited Drugs / Prohibited Plants for the purpose of research, analysis or instruction.
  4. Drugs of Addiction means substances appearing in Schedule 8 of the NSW Poisons List under the Poisons and Therapeutic Goods Act 1966.
  5. Prohibited Drugs means substances appearing in Schedule 1 of the Drug Misuse and Trafficking Act 1985.
  6. Prohibited Plants means plants appearing in Schedule 1 of the Drug Misuse and Trafficking Act 1985.