Storage and Use of Drugs of Addiction used in Research

Storage and Use of Drugs of Addiction used in Research

SUMMARY

The Storage and Use of Drugs of Addiction used in Research Procedure establishes the actions and responsibilities required for obtaining, possession   and use of drugs of addiction (Schedule 8 drugs) and/or prohibited drugs which   are used at Macquarie University for research, analysis or instruction.

PROCEDURE

Purpose

To detail the actions and responsibilities required for obtaining, possession and use of drugs of addiction (Schedule 8 drugs) and/or prohibited drugs which are used at Macquarie University for research, analysis or instruction.

Procedure

This procedure requires actions by the following:
  • Head of Animal   Facilities
  • 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
  • Manager,   Health and Safety
  • 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 S8 drugs) 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).
  • 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 Act
  • 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.
  • 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..
  • Other - Macquarie staff or postgraduate   students
The steps and/or actions that must be undertaken for obtaining, possessing and use of drugs of addiction includes:
  • Maintain Authority
  • Training
  • Supervision
  • Storage, Inventory and Stock-take
  • Issuing of substances / drugs of addiction/prohibited   drug/prohibited plant (cultivation of a prohibited plant can also be   authorised)
  • Maintain Drugs Register
  • Disposal
  • Loss or theft

DEFINITIONS
Regulation: The Poisons   and Therapeutic Goods Regulation 2008 NSW with   particular reference to clauses as identified in the Authority issued to   Authorised Individuals.

Act: Drug Misuse and   Trafficking Act 1985 (NSW)

Authority: 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.

Drugs of Addiction: Substances appearing   in Schedule 8 of the NSW Poisons List.

Prohibited drugs: Substances   appearing in Schedule 1 of the Drug   Misuse and Trafficking Act 1985.

Prohibited Plants: Plants appearing in Schedule 1 of the Drug   Misuse and Trafficking Act 1985.
Head of Animal Facilities   / Head of Laboratory Facilities

Confirm and file copies of each Authorised   Individual’s Authority before allowing an Authorized Individual to use drugs   of addiction within animal facilities.

Ensure a Health and Safety risk assessment is   conducted for any new drugs of addiction not so assessed.

Manager, Health and   Safety

Facilitate the Health and Safety risk assessment for any drug of   addiction/prohibited drug/prohibited plant that has not had such an   assessment.

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

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.

Comply with all the requirements of the Authority.

Training
Ensure the required training for Supervised Individuals is provided   and undertaken.

Such training must include as a minimum:
  • 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
  • a risk analysis of the use of drugs of addiction.

Supervision
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.

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
Ensure that drugs   of addiction are stored and secured in accordance with requirements under the   Regulation currently in force.

Ensure a   periodic inventory stock-take of drugs of addiction held under Authority (refer clauses 73 and 118).

Issuing
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 ARA or   authorized research instrument nominated within the Authority and in full   compliance with the specific clauses detailed within the Authority.

Issue any drug   of addiction/prohibited drug/prohibited plant only in the physical presence   of another Authorised Individual.  Note: It is a University   requirement that two people be present during the issuing of drugs of   addiction, therefore if another Authorised Individual is unavailable, an   appropriately trained Supervised Individual is acceptable.

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
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).

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.  An electronic form is available at http://www0.health.nsw.gov.au/resources/publichealth/pharmaceutical/loststolen_pdf.asp

Make an accurate inventory of any drug of   addiction/prohibited drug/prohibited plan   held at the premises concerned and enter, in a new drug register, the   particulars of the drugs so held (refer clause 119).

Disposal
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, Regulation 170.

Loss or Theft
Notify the   Director-General, NSW Health if a drug of addiction/prohibited   drug/prohibited plant is lost or stolen from the Authorised Individuals’   stock (refer clause 124) by   completing and submittingan electronic form.

Report the loss or theft to University security for reporting to the Police.

Supervised Individuals

Undertake the required training as instructed by the Authorised   Individual before working with drugs of addiction.

Undertake a Health and Safety risk assessment for the drugs of   addiction being used.

Be included on the relevant ARA or relevant research instrument to the   appropriate Authority to obtain, possess, and use the drug of   addiction/prohibited drug/prohibited plant.

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

Request drugs of addiction/prohibited drugs/prohibited plants from an   Authorised Individual and ensure that two 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.

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

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

Other

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.

Procedure Information

Contact OfficerManager Health and Safety
Date Approved13 June 2014
Approval AuthorityVice-President, University Services and Strategy, and Deputy Vice-Chancellor (Research)
Date of Commencement13 June 2014
Amendment History

9 August 2019 - Updated Approval Authority from Director, Human Resources to Vice-President, University Services and Strategy, and Deputy Vice-Chancellor (Research) in accordance with responsibilities per Delegations of Authority Register.

Date for Next ReviewJune 2017
Related Documents

Alcohol and Drug Policy
Poisons and Therapeutic Goods Act 1966 (NSW)
Poisons and Therapeutic Goods Regulation 2008 (NSW)
NSW Health, Pharmaceutical Services / Application
NSW Poisons List

Drug Misuse and Trafficking Act 1985 (NSW)
KeywordsSchedule 8 Drugs, drugs, Animal Facilities, In-vitro, invertebrate in-vivo Facility, Addiction, Prohibited Drug, Prohibited Plant.
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