WHS-PRO-011 Drugs and Poisons Procedure

Intent

James Cook University (JCU) uses regulated poisons (drugs and poisons) and S7 (restricted) and high-risk poisons (S8 and S9) for non-therapeutic purposes for research, teaching and analysis.

JCU recognizes its obligation to manage regulated poisons in accordance with the:

• Medicines and Poisons Act 2019
• Medicines and Poisons (Medicines) Regulation 2021
• Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021
• The Poisons Standard (Current edition), also known as The Standard for the Uniform scheduling of Medicines and Poisons (SUSMP)

JCU is committed to correct procedures in relation to scheduled drugs and poisons including:

• Establishing genuine need for teaching, research or analysis
• Correct procurement, usage, record keeping, storage and disposal of regulated poisons

The purpose of this procedure is to detail the processes by which regulated poisons (drugs and poisons) are to be procured, stored, used and disposed of.

Scope

This procedure applies to all JCU employees, students, visitors, volunteers and contractors in all JCU workplaces.

JCU Controlled Entities, JCU Brisbane and JCU Singapore are not covered by this procedure.  JCU Controlled Entities use drugs and poisons under a different context of therapeutic use.

The following should be taken into account when reviewing this Procedure;

The University does not:

• Use drugs and poisons for therapeutic use;
• Manufacture or compound drugs or poisons to be administered to people or animals;
• On sell drugs or poisons;
• Produce prescriptions for supply to the public;
• Fill prescriptions.

The University uses regulated poisons for teaching and research including:

• Animal procedures and maintenance of stock;
• Analysis and laboratory procedures;
• Novel research studies as identified;
• Under the context of:
  • Royal Flying Doctor Service (RFDS) first aid kits.  These kits are administered under the RFDS system.
  • Stock first aid kits on marine vessels where required.

Definitions

Table of Contents

1 Procedure

2 General Approval & Substance Management Plan Process

3 Acquisition

4 Approval Process

5 Possession

6 Storage

7 Supply of Regulated Poisons

8 Applying the Regulated Poison

9 Disposal

10 Training & Competency

11 Transport

12 Delivery

13 Labelling

14 Schedule 4 - Treated as High-Risk

15 Reference Material Exemption

16 Loss of, or Exposure to, Regulated Poison

17 Central Register, High-Risk Poisons Register & Annual Audits

1 Procedure

JCU is authorised by Queensland Health to use regulated poisons including high-risk poisons for genuine teaching and research.  The requirements of this procedure must be adhered to for substances to be procured, stored, used and disposed of correctly.

2 General Approval & Substance Management Plan Process

JCU has in place a general approval issued by Queensland Health that allows procurement, use, storage and disposal of regulated poisons for genuine teaching, research and analysis.

JCU is authorised to obtain Schedules 2, 3, 4, 7 (restricted), 8 and 9 substances for genuine teaching, research and analysis.

The usage of substances is highlighted in Table 1 below.

TABLE 1: SCHEDULES AND USE

All purchases of regulated poisons must occur through the JCU My Requisition system. Refer to Section 4 Acquisition for more details.

Drugs Officers are selected to assist the university to review the purchase, storage, use and disposal of regulated poisons.  A central register of all current storage and responsible persons that use regulated poisons is kept by the WHS Unit.  Refer to Section 17 Central Register, High-Risk Poisons Register & Annual Audits.

Users of substances are required to meet their obligations for purchase, storage, use and disposal.

3 Acquisition

The acquisition of a regulated poison must be conducted through the JCU My Requisition system.  The application must include a completed copy of Approval to Purchase Regulated and High-Risk Poisons form.

The application requires:

• Details of the genuine teaching, research or analysis needs. Substances may have a broad range of use and the application should state this.
• Storage location of the substances:
  • Secure for S2, S3 and S4 substances.
  • In a drug safe for S7 (restricted), S8 and S9 substances.
    • List of staff with access to the storage.
• Controlled drug register details for S7 (restricted), and high-risk poisons (S8 and S9).
• Name of staff who will have access to the substance.
• Approval by a direct supervisor.
• First time purchase of S7 (restricted) and high-risk poisons (S8 or S9 substances) requires approval by a Director/Dean of the organisational unit.
• Fit and Proper person questions to be answered by the applicant.  This section must be completed.
  • If yes is indicated for any of the questions, further review will be required by the WHS Unit and Drugs Officer before the order is approved or rejected.

Use the Account codes listed on the form to have the request assigned to the Drugs Officers.  All requirements for the regulated poison must be adhered with and all regulated poisons must be purchased on a purchase order.  Purchase orders will be prepared by the JCU Procurement team after the Drugs Officer has approved the purchase.  The Drugs Officer will forward a copy of the approved Approval to Purchase form to the WHS Biological, Radiation and Chemicals Safety Advisor.

Where a substance was obtained prior to the current legislative framework, or in a manner that does not include a purchase, the Approval to Purchase form must still be completed, however the document should be forwarded to both the Drugs Officer and the WHS Biological, Radiation & Chemicals Safety Advisor via email.  The acquisition will be added to the central register for recording.

4 Approval Process

The approval of a regulated poison requires the applicant to demonstrate a genuine need for teaching, research or analysis. Acquisition of regulated and high risk poisons will not be approved for therapeutic use.

Examples of a genuine need include:

• Antibiotics required for a microbiological practical.
• Maintaining stocks for animal research or teaching needs such as ketamine for anesthetising animals.

Substances required for a research project. The Drugs Officer on receiving an order in the My Requisition system will review the form “Approval to Purchase regulated and High-Risk Poisons”.  All required sections are to be completed on the form.

Where the order is for a new instance of regulated poison use, the Drugs Officer will arrange a discussion with the person ordering the substance to confirm controls are in place.

Where the order is for a new instance of a high-risk poison (example S8 Ketamine) the approval to purchase form is to be signed by a representative of management from the college or business unit.  Once approved a copy of the acquisition form for both first time and ongoing orders are to be sent through to the WHS Biological, Radiation & Chemicals Safety Advisor.

The WHS Biological, Radiation & Chemicals Safety Advisor will add/review against the central register of regulated poisons. This is to record the storage location and person as a contact for auditing.  This register is available through a closed teams group managed by the WHS Unit.

5 Possession

Possession of S2, S3, S4, S7 restricted, S8 and S9 is only permitted by staff or post graduate students that have purchased the substance through the acquisition and approval process or are obtaining from a central storage (such as antibiotics within a research laboratory).

The substance must only be used for teaching, research or analysis as indicated during the acquisition process.

The person possessing the substance must ensure all requirements have been met.

Undergraduates must be supervised and cannot be in possession of a schedule substance.

6 Storage

Regulated poisons other than high-risk poisons (i.e. S2, S3, and S4) must be stored securely.  This may include a card access laboratory, locked drawer or lock box. Only authorised users are to have access to the secure storage.

S7 (restricted), and high-risk poisons (S8 and S9) must be stored in a drug safe in a secure area.  When being transported, the poison must be stored in a secure area of the vehicle.

At the storage location a list of staff with access to the safe is to be kept and made available during the annual audit process.

Substances must be stored in a manner so as to avoid contamination (such as the original container).

7 Supply of Regulated Poisons

Supply of regulated poisons must only occur for genuine teaching or research applications.

When supplying regulated poisons, the following processes must be observed:

• Transfer between storage locations is allowed provided records are maintained in the controlled drug registers and staff have approval to acquire/possess the substance.
• Supply from a central storage point for a genuine teaching or research need must be recorded in the controlled drug registers. For example:
  • Antibiotics used in microbiology practical classes or research laboratories.
  • Ketamine supplied at point of use for anesthetizing a research or teaching animal.
  • Lethabarb (pentobarbitone sodium) supplied from storage to euthanise an animal.

JCU does not supply poisons to members of the public or to separate businesses.  Queensland Health approval only covers use by JCU staff and students.

8 Applying the Regulated Poison

A person applying a regulated poison must do so:

• In accordance with the label/supplier directions; or
• Otherwise in a way that does not cause, or is not likely to cause, a health risk.

Where the substance is being applied in a novel way, such as adding to a fish tank or aerosolizing, then a risk assessment must be produced by the user.  If the use of the substance involves animal or human subjects, ethics approvals must be in place.

9 Disposal

Regulated poisons (other than high-risk poisons) can be disposed of by the user.  The method of disposal must not pose risk to persons or the environment.

Disposal of S7 (restricted), and high-risk poisons (S8 or S9) can only be conducted by Drugs Officers or the WHS Biological, Radiation & Chemicals Safety Advisor.

These substances will either be disposed of by:

• Engaging a registered waste company for larger quantities.
• Small amounts could be wasted (such as mixing with animal bedding) and then adding to an appropriate waste stream such as clinical waste.

Records in the controlled drug register must be updated to reflect disposal of the substance.

10 Training & Competency

Training and competency can be demonstrated by:

• Qualifications and experience, for example:
  • Registered Veterinary Surgeon
  • Degree qualified researcher with laboratory experience
  • Animal technician or researcher trained in the application of substances to research animals
• Postgraduate student trained by supervisor in the techniques being applied.
• Undergraduate students are to be supervised when using regulated poisons.

11 Transport

Transport of regulated poisons must only be conducted by members of staff, or research students that have approval for the substance (such as the student who has completed the acquisition process).  Undergraduate students are not permitted to transport regulated poisons.

During transport the substance must be secured when not being used/supervised, such as in a locked vehicle.  If a regulated poison is being sent to another location, the parcel must be sent as a registered parcel with a courier.

12 Delivery

Orders of regulated poisons must be sent directly to the person who made the order. The parcel may be received at administration desks and the receiver then notified.

13 Labelling

If the substance is decanted, a compliant label must be applied to the decanted container, unless the decanted substance is used immediately and the container cleaned of the residue, such as a measuring flask.

14 Schedule 4 - Treated as High-Risk

There are schedule 4 substances (regulated poisons) that JCU may choose to apply higher controls to. This will occur at the time of purchase, or retrospectively if required. Any S4 substances determined to require additional controls are required to be listed on the central register with a notation that that particular S4 has increased controls in place.

For example, Lethabarb (pentobarbitone sodium) is treated as a high-risk poison as it has potential to be diverted for suicide. The increased control will be:

• Upgraded storage requirement.
• Requirement to have a controlled drug register in place.
• Auditing of the stock annually by the Drugs Officer.

15 Reference Material Exemption

Reference standards are exempt if the following applies:

• Applying or using reference material containing 1 gram or less of a regulated poison at an analytical or chemical laboratory.
• Applying or using reference material containing 0.5 grams or less of a regulated poison in a portable testing device.
• Reference material means a substance used to calibrate analytical equipment, or validate an analytical measurement process, that has been manufactured by an accredited laboratory in compliance with:
  • AS ISO/IEC 17025:2018 (General requirements for the competence of testing and calibration laboratories); and
  • AS ISO/IEC 17034:2018 (General requirements for the competence of reference material producers).

16 Loss of, or Exposure to, Regulated Poison

JCU must notify the regulator (verbally or in writing) if either of the following occurs:

• An amount of a restricted S7 poison or high-risk poison (S8 or S9) cannot be accounted for; or
• A release of a restricted S7 poison or high-risk poison (S8 or S9) possessed under the authority causes, or is likely to cause, someone to obtain medical treatment.

The user of the substance must notify the JCU WHS Unit as soon as possible.

The notification to the Queensland Health will be placed by the WHS Unit. The user must provide detail, as requested, during the investigation.

17 Central Register, High-Risk Poisons Register & Annual Audits

The WHS Unit maintains a central register of the current regulated poisons that are obtained, stored and used at the University. The register is populated by the Drugs Officers by providing approved “Approval to Purchase Regulated and High-Risk Poisons” forms.

The central register consists of information about the regulated or high risk poisons, including:

• Campus location
• Building number
• Room number
• Person responsible
• Staff or research student responsible for storage
• Schedules of substances held

The central register provides detail to allow central tracking of users and substances to allow annual audits to take place.

Users at the storage location maintain the controlled drugs register and must have the information required for high-risk poisons register for S7 (restricted), S8 and S9 substances.  A controlled drug register fulfils this purpose.

The controlled drug register must be reconciled at least monthly for S7 (restricted) and high-risk (S8 and S9) poisons.

Related policy instruments

Work Health and Safety Policy

Schedules/Appendices

Appendix 1 - Procedures for Purchasing of all Schedules of Drugs/Poisons

Appendix 2 – Procedures for Transport, Storage, Use and Disposal of all Schedules of Drugs/Poisons

WHS-PRO-FORM-011a Request for Acting Authorised Officer – JCU Drugs Officer

WHS-PRO-FORM-011b Approval to Purchase Regulated and High-Risk Poisons

Related Documents and Legislation

Medicines and Poisons Act (Qld) 2019

Medicines and Poisons (Medicines) Regulation (Qld) 2021

Medicines and Poisons (Poisons and Prohibited Substances) Regulation (Qld) 2021

The Poisons Standard, also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)

Administration

NOTE:  Printed copies of this procedure are uncontrolled, and currency can only be assured at the time of printing.

Approval Details

Revision History