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Guideline: Schedule medicines and poisons guideline

Purpose

A guideline into the use of Scheduled Medicines and Poisons in the University.

Guideline

Scheduled Medicines and Poisons

  1. In conducting scientific research hazardous materials and processes may be employed. The use of such materials is controlled through relevant Acts and Regulations. Legislation for Scheduled Medicines and Poisons include the Work Health and Safety Regulation 2011; Medicines, Poisons and Therapeutic Goods Act and Regulation 2008 and Poisons Standard 2012.

See: Chemical Management Policy

See: Chemical Management Procedure

  1. Medicines (drugs) and Poisons requirements cover the labelling, supply and consumer access to poisonous chemicals, whether for human consumption or industrial processes. Medicines and common Poisons are assigned into a Schedule according to their hazardous nature and degree of control required. The Schedules are determined by the National Drugs and Poisons Schedule Committee and are published in the Poison Standard 2012 (incorporating the Standard for Uniform Scheduling of Drugs and Poisons (SUSDP)).
  2. The Schedules are:

Schedule

Regulated Substance title

Property of Poison

Material Availability

1

(Not currently in use)

2

Pharmacy Medicine

Drugs (medicinal poisons for therapeutic use)

Pharmacy retail

3

Pharmacist Only Medicine

Drugs of higher potency

Restricted pharmacy retail

4

Prescription only Medicine

Prescription drugs

Medical/dental/veterinary prescription

At ANU this should be under the control of a veterinarian, medical officer, scientifically qualified person.

5

Low Harm Poison

Domestic poisons

General retail

6

Moderate Harm Poison

Industrial and Agricultural poisons

Restricted retail

7

Dangerous Poison

Special poisons

Restricted wholesale

At ANU this must be under the control of a scientifically qualified person.

8

Controlled Medicine

Drugs of Addiction

Restricted medical/dental/vet prescription

At ANU, contact the OHS Branch for advice

9

Prohibited Substance

Prohibited substances or Appendix C substances

Restricted wholesale

At ANU, contact the OHS Branch for advice

  1. The relationship between the different schedules is shown below:

image

  1. The Schedule number for a chemical can be found in its Safety Data Sheet (previously known as MSDS), or on the label (e.g. S4). Some general exemption for certain materials exist and these can be found in Appendix A, B and G of the Poison Standard 2012.

See: http://sails.anu.edu.au/chemwatch3 for Safety Data Sheets.

Authorisation

  1. Medicines, Poisons and Therapeutic Goods Regulation (section 695) authorises dealings with a dangerous poison (Schedule 7) without a license when:
  • The dealing is being done by a scientifically qualified person (doctor, dentist, pharmacist, veterinary surgeon or a person with a doctorate in a form of scientific studies, AND
  • That person is at a recognised research institution (ANU is a ‘Recognised Research Institution’ under the Act [s20 (5)(b)]), AND
  • The dealings is for approved medical or scientific research at the institution, or is for instruction at the institution, or is for quality control or analysis, BUT
  • The dealings must not involve administration for human use.
  1. If Schedule 7 poisons are used by non-scientific qualified persons e.g. School of Art, Facilities and Services then a license is required specific for that poison and its intended purpose.
  2. A license is required for Scheduled 8, Scheduled 9, Appendix C Substances. The license has to be specific for each medicine or substance, respectively. Further advice is available from the OHS Branch or ACT Health.

See: Legislation application to the University

See: ACT Health for licence information

See: Appendix C Substances

  1. Before acquiring a license for Sch 8, 9 and App C substances ANU conditions in item 14 must be met.
  2. A list of license holders (e.g. those able to order these scheduled poisons) should be kept by Area management.

See: ANU on-line risk assessment system

  1. A license can be obtained by using the application form found in the ACT Health Website. Further advice is available from the OHS Branch or ACT Health.
  2. Authorised dealings with a Regulated Substance may include but may be limited in a license to:
  • Manufacture
  • Obtain
  • Possess
  • Administer/ Use as specified in the Risk Assessment and/or Chemical handling protocol
  • Discard
  • Issues a purchase order
  1. A Licence Holder is usually the Research Group Leader or Head of Workshop, and must have knowledge, experience and training related to the dealing. The Licence Holder (or an authorised person), needs to consider any dealings (uses of the substance) and restrictions, registers (see below) and must report any losses.

ANU approval

  1. In addition to authorisation by the regulator ANU approval is also required. ANU approval requires:
  1. Scheduled drugs used in animal experiments may require vet approval. In this case contact your vet officer.

Purchasing

  1. A written and signed purchase order (including electronic forms) is the only method to purchase regulated substances. No credit cards, phone orders etc. are to be used.
  2. The issuer’s authority (licence number) is required to obtain licensed regulated substances.

Registers

  1. A regulated substance register is in addition to the chemical inventory register maintained for hazardous substances and dangerous goods. The register must:
  • Have an individual page related to a single form, container and strength of the controlled medicine, dangerous poison, prohibited substance or Appendix C substance.
  • Have entries signed off (see example registers below). For controlled Medicines a witness is required, who must also sign.
  • Be stored in a predetermined storage location on premises.
  • Be kept for 2-years after last entry.
  • Reconcile quantities used when the container is empty or to be disposed of.

See: University chemical inventory system.

An example regulated substance register is available. An example controlled medicine register (requiring a witness) is also available.

  1. All registers and stock should be regularly maintained and inspected.
  2. Any loss/theft must be reported as soon as it is discovered.
  3. ACT Health may conduct audits against the requirements for regulated substances.

Labelling

  1. A decanted regulated substance must be labelled with the following as a minimum:
  • the product identifier; and
  • hazard pictograms or
  • hazard statements.

See: Hazardous substances label template for decanted substances.

See: Labelling of hazardous substances.

Storage

  1. The regulated substances must be stored under the correct environmental conditions, especially temperature.
  2. Controlled medicines, prohibited substances, appendix C substances, must be stored in a:
  • Medicines cabinet, safe, strong room or vault, meeting Schedule 5 requirements of the Regulations.
  • Securely locked when not in immediate use.
  • Personal custody of the key or a secret combination code.
  1. Scheduled 7 substances must have restricted access e.g. a locked cabinet / dangerous goods cabinet or locked laboratory door when users are not present.

Disposal

  1. An ACT Medicines and Poisons Inspector must witness the disposal of Controlled Medicines (Sch 8) and Prohibited Substances (Sch 9).
  2. The disposal of a Dangerous Poison (Sch 7) is to be witnessed by the Hazardous Waste Safety Officer (as long as they are not supervised by, or the supervisor of, the person doing the disposal, in which case the head technical officer or other safety officer may be substituted as the witness).

Information

Printable version (PDF)
Title Schedule medicines and poisons
Document Type Guideline
Document Number ANUP_003802
Version 5
Purpose A guideline on the use of scheduled medicines and poisons in the University including storing and labelling.
Audience Staff
Category Administrative
Topic/ SubTopic Health, Safety & Environment - Occupational Health & Safety
 
Effective Date 23 May 2013
Review Date 26 May 2016
 
Responsible Officer Director, Human Resources
Approved By: Director, Human Resources
Contact Area Human Resources Division
Authority Work Health & Safety Act 2011