Policy WHS-PRO-011 Drugs and Poisons Procedure

WHS-PRO-011 Drugs and Poisons Procedure


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Intent

James Cook University (JCU) recognises its obligation to manage drugs and poisons in accordance with the Health Act 1937 (Qld) and the Health (Drugs and Poisons) Regulation 1996 (Qld).

Unauthorised access, storage, use or disposal of drugs and poisons could result in harm to a person from JCU held materials, illegal on-selling of restricted or controlled drugs, and Regulatory action.

The scheduling of drugs and poisons should be in accordance with the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), available from the Australian Government, Department of Health Therapeutic Goods Administration website.   The safety data sheet (SDS) for a drug or poison should state if that drug or poison is assigned to a particular schedule.

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

  • Maintain an accurate inventory of drugs and poisons, and the location stored at the university and university external facilities;
  • Maintain accurate use logs to account for schedule 4, 7, 8 and 9 drugs and poisons at each site of use;
  • Ensure that scheduled drugs and poisons are (appropriately / securely) stored and have appropriate security arrangements for the applicable schedule;
  • Provide requirements for the disposal of scheduled drugs and poisons.

Scope

This Procedure applies to all JCU employees, students, visitors, volunteers and contractors in all JCU workplaces conducting:

  • Research;
  • Teaching;
  • Study;
  • Professions endorsed by the Health Act 1937 (Qld)the Health (Drugs and Poisons) Regulation 1996 (Qld).

JCU Controlled Entities are required to meet the obligations of the Queensland Health Act 1937 and the Health (Drugs and Poisons) Regulation 1996(Qld).  JCU Controlled Entities are not required to specifically follow this Procedure.

This Procedure has been written in the context that:

  • JCU does not manufacture or compound drugs or poisons to be administered to people or animals.  These products are for teaching purposes only;
  • Teaching laboratories typically substitute placebo / replacement props instead of actual scheduled drugs and poisons;
  • Administration of scheduled drugs or poisons to humans only occurs in dental teaching facilities;
  • Practicals may occur where animals are anesthetised;
  • Practicals may occur where drugs and poisons are analysed, manufactured or compounded and then disposed of;
  • Drugs and poisons are used during research projects;
  • Drugs and poisons may be prescribed and administered to animals;
  • JCU does not fill prescriptions for human or animal therapeutic use;
  • JCU does not manufacture drugs or poisons for therapeutic purposes.
  • The JCU pharmacy is for teaching purposes, and drugs or poisons are not actually dispensed from this location;
  • JCU does not on-sell scheduled drugs or poisons;
  • S4, S7, S8, and S9 drugs and poisons should not be purchased on credit card unless being purchased for an urgent therapeutic use;
  • JCU Controlled Entities may conduct the above activities, and will need to ensure appropriate procedures and controls are in place.  JCU does not directly control compliance for the Entities;
  • JCU does not dispense or sell drugs or poisons to people under the age of 16;
  • Administration of scheduled drugs and poisons to humans primarily occurs at locations other than JCU teaching facilities, such as at Queensland Health facilities;
  • JCU has Royal Flying Doctor Kits based at some remote locations;
  • Purchase, use and storage of carcinogens are not included within this Procedure.
  • JCU does have vessels that have first aid kits containing scheduled drugs and poisons.

Definitions

Authorised Officer Delegated the Vice Chancellor’s Authority

An Authorised Officer delegated by the Vice Chancellor’s Authority under sections 179A and 265A of the Health (Drugs and Poisons) Regulation 1996 (Qld).  These persons have the authority to obtain, possess and give S2 and S3 poisons and S4 restricted drugs.

This role is also used by JCU to coordinate the approval of the purchasing of S2, S3, S4, S7, S8, and S9 drugs and poisons.

JCU has also elected these personnel to coordinate the annual audits of the S4, and S8 drugs within their Division.

Chief Executive Officer

This is the Chief Executive Officer of Queensland Health or their delegate

Controlled drug

An article or substance prescribed under a regulation to be a controlled drug.

Drug

Without limiting the ordinary meaning of the term, means any article used for or in the composition or preparation of medicine for internal or external consumption or use by humans, and includes disinfectants, germicides, antiseptics, pesticides, detergents, preservatives, deodorants, anaesthetics, tobacco, narcotics, soaps, cosmetics, dusting powders, essences, unguents, and all other toilet articles, and also includes goods for therapeutic use within the meaning of the Therapeutic Goods Act 1989 (Cth), and an article or substance declared under a regulation to be a drug.

Drug Officer

Person approved by Qld Health to obtain S7, S8, and S9 drugs and poisons, and provide the drugs and poisons to personnel that have an approval from Qld Health to store and use the particular drug or poison.  A list of JCU Drugs Officers  is maintained by the WHS Unit.

Endorsed Professional

Professional endorsed under the Health (Drugs and Poisons) Regulation 1996 (Qld). Includes registered Dentists, Doctors, Pharmacists, and Veterinary Surgeons.

James Cook University (JCU)

James Cook University is a public university and is the second oldest university in Queensland, Australia.  JCU is a teaching and research institution.  The university’s main campuses are located in the tropical cities of Cairns, Singapore and Townsville.

Label

Means a label, tag, brand, mark, or statement in writing, whether or not containing any pictorial or other descriptive matter.

Personal supervision

By a person (the supervisor) of another person, includes supervision using any technology that allows reasonably contemporaneous and continuous communication between the persons, and allows reasonably contemporaneous and continuous observation by the supervisor of actions taken by the other person.  For example videoconferencing.

Pharmacist

Means a person registered under the Health Practitioner Regulation National Law to practice in the pharmacy profession, other than as a student.  The university’s fields of research include marine sciences, biodiversity, sustainable management of tropical ecosystems, genetics and genomics, tropical health care, and tourism.

Poison

Means every substance or article prescribed as such.

Prescription

Prescription for a poison or drug for the purposes of therapeutic use prepared by an Endorsed Professional.

Restricted drug

Means every substance or article prescribed as such.

Sale

Includes barter, and also includes offering or attempting to sell, or receiving for sale, or having in possession for sale, or exposing for sale, or sending, forwarding, or delivering for sale, or causing or suffering or permitting or allowing to be sold or offered or exposed for sale, but, refers only to sale for consumption or use by humans, and also, so far as relates to any poison, or to any restricted drug, or to any controlled drug, or to any biological preparation includes supplying, exchanging, lending, or giving away, and whether for consumption or use by humans or for any other purpose whatsoever, and also includes, in relation to any article for use by humans, permitting or allowing such use as a means of advertisement.

Schedule 1 (S1)*

Schedule not currently in use.

Schedule 2 (S2)*

Pharmacy Medicine.

Schedule 3 (S3)*

Pharmacist Only Medicine.

Schedule 4 (S4)*

Prescription Only Medicine OR Prescription Animal Remedy.

Schedule 5 (S5)*

Caution (available to the public).

Schedule 6 (S6)*

Poison (available to the public).

Schedule 7 (S7)*

Dangerous Poison.

Schedule 8 (S8)*

Controlled Drug.

Schedule 9 (S9)*

Prohibited Substance.

Scheduling

The scheduling of drugs and poisons is in accordance with the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).  A copy of the current schedule can be obtained at: https://www.tga.gov.au/publication/poisons-standard-susmp.  The safety data sheet (SDS) for a drug or poison should state if that drug or poison is assigned to a particular schedule.

Student

A person who has been admitted to the University and has enrolled for a course or a subject and whose enrolment for that course or subject has not lapsed or been cancelled.

Transaction

As defined under Part 2, Section 6 of the Health Drugs and Poisons Regulation 1996 (Qld) means an event by which:

  1. A controlled drug,   restricted drug or a poison comes into or goes out of a person’s possession;   or
  2. The composition,   form or strength of, or way of packing, a controlled or restricted drug or a   poison is changed.

Examples of transactions:

  • Obtaining and   keeping samples of chemical starting materials used in manufacturing a   controlled or restricted drug or a poison
  • Obtaining and   keeping samples of finished products of a manufactured controlled or   restricted drug or a poison
  • Manufacturing,   packing and repacking a controlled or restricted drug or a poison
  • Moving a controlled   or restricted drug or a poison from one place to another (with or without a   change of ownership)

Veterinary Surgeon

Means a Veterinary Surgeon within the meaning of the Veterinary Surgeons Act 1936 (Qld).

Visitor

Includes students, staff, or public that may not be studying, researching or enrolled at JCU however are participating in JCU related activities or at JCU owned or controlled properties.

Table of Contents

1      Duty, Obligations and Responsibilities

1.1       Vice Chancellor

1.2       Director of Operations/ College Managers/ Directors/ Managers/ Head Academic

1.3       Authorised Officer Delegated the Vice Chancellor’s Authority

1.4       Drugs Officer (S7, S8, & S9) (see Appendix 1, Table 1)

1.5       Professionals Endorsed under the Health (Drugs and Poisons) Regulation 1996 (Qld), and Authorised by JCU to provide Scripts or Sign Purchase Orders

1.6       Employees / Students

1.7       Visiting Researchers / Students

2      Requirements Applying To All Schedules of Drugs and Poisons

2.1       Acquisition

2.2       Packaging

2.3       Transport

2.4       Storage

2.5       Use

2.6       Central Reporting of S4, S7, S8 & S9

3      Royal Flying Doctor Medical Kit (Remote Location)

4      Scheduled Substances in Vessel First Aid Kits

5      Authorised Officer Delegated the Vice Chancellor’s Authority

6      Procedures for Purchasing of all Schedules of Drugs / Poisons

7      Procedures for Transport, Storage, Use and Disposal of all Schedules of Drugs / Poisons

Procedure

1. Duty, Obligations and Responsibilities

1.1 Vice Chancellor

  • To carry out the Vice-Chancellor’s endorsement in line with the requirements of the Health (Drugs and Poisons) Regulation 1996 (Qld);
  • To ensure management obligations are being met within the University.

1.2 Director of Operations/ College Managers/ Directors/ Managers/ Head Academic

  • To ensure management obligations are being met within the university;
  • To ensure the requirements of this Procedure are being met;
  • Ensure that the WHS Unit is provided a consolidated list annually of S4, S7, S8, & S9 substances that are being obtained, stored, used and disposed of;
  • Provide training to staff in regard to their obligations and duties for drugs and poisons, specifically on:
  • Purchasing requirements relevant to a person’s role;
  • Storage and accounting for drugs and poisons relevant to a person’s role;
  • Use of the drug or poison relevant to the person’s role;
  • Disposal of the drug or poison relevant to the person’s role;
  • Ensure that all scheduled drugs and poisons are purchased through the correct process.

1.3 Authorised Officer Delegated the Vice Chancellor’s Authority

  • Organise at a minimum 12 monthly audits of the S4 and S8 scheduled drugs and poisons stocks within their Division;
  • Pursuant to the table for “Purchasing of all Scheduled Drugs and Poisons” and when these conditions have been met, provide authorisation in My Requisition System to purchase S2, S3, S4 drugs and poisons;
  • As required and when conditions have been met provide approval within the “My Requisition System” for the purchase S7, S8, S9 to occur.

1.4 Drugs Officer (S7, S8, & S9) (see Appendix 1, Table 1)

  • As required and when conditions have been met provide authorisation in the My Requisition System for purchase orders to obtain S7, S8, S9 drugs and poisons if requirements of this Procedure have been met.

1.5 Professionals Endorsed under the Health (Drugs and Poisons) Regulation 1996 (Qld), and Authorised by JCU to provide Scripts or Sign Purchase Orders

  • As required, write scripts for therapeutic use;
  • As required, sign purchase orders to obtain scheduled drugs and poisons where the requirements of the Procedure have been met.

1.6 Employees / Students

  • To comply with this Procedure;
  • To attend training as directed;
  • To follow instructions.

1.7 Visiting Researchers / Students

Visiting researchers or students that will purchase, store, use and dispose of scheduled drugs and poisons must also comply with this Procedure.

2. Requirements Applying To All Schedules of Drugs and Poisons

2.1 Acquisition

  • The requirements in Appendix 1 of this Procedure are to be applied for any purchase of scheduled drugs and poisons;
  • When entering a requisition use the appropriate user code for the schedule of drug or poison.  In the free field text field provide a description of the schedule of drug or poison and the intended use;
  • Attach a completed copy of the form “Approval to Purchase S2, S3, S4, S7, S8, and S9 substances”;
  • Depending on the schedule of drug or poison the approval will go to:
    • The Divisional Authorised Officers listed as having the Vice Chancellor’s Delegation to approve and obtain S4 substances (example antibiotics) ;
    • The Divisional Drugs Officer for the approval of S7 S8 and S9 substances.  In practice the Authorised Officers should obtain this approval;
  • The order leaving JCU in some instances may require the following from the supplier;
    • Copy of the Vice Chancellor’s Delegation of Authority from Procurement for S4;
    • Copy of a Divisional Drugs Officer approval, or signature on the Purchase Order for S7, S8 and S9;
    • Signature of a person; Endorsed under the Health (Drugs and Poisons) Regulation 1996 (Qld) (example Registered Veterinary Surgeon);
    • Copy of an individual’s Qld Health Approval for a particular substance;
  • Prescriptions are to be completed in line with the requirements of the Health (Drugs and Poisons) Regulation 1996 (Qld);
  • For therapeutic use on JCU animals, a prescription for a drug or poison shall be completed by a registered veterinary surgeon;
  • Urgent purchases during business hours should be placed using the usual procedure, with the exception that JCU Procurement Office should be contacted to explain that the order is urgent at which point they can expedite the order;
  • Urgent purchases out of business hours should occur with a company where JCU has an account and an invoice obtained.  As a last resort a JCU credit card can be used but purchasing and approving management must be informed of this action.  Place a My Requisition order on the first business day after the purchase;
  • When one of the Authorised Officers Delegated the Vice Chancellor’s Authority is on leave, a person can be nominated to formally act in their role:
    • Complete the form “Request to Appoint Acting “JCU Authorised Officer Delegated the Vice Chancellor’s Authority”;
    • As part of this process Procurement is informed to change the delegation pool for 8436 S4;
    • This does not apply to the Drugs Officer approval from Qld Health which is not transferable from person to person.  This person relieving cannot approve 8473 S7, S8 and S9;
  • A supplier will ask for an End User Declaration to be completed when purchasing substances listed in schedule 6 and apparatus listed in section 8B of the Drugs Misuse Regulation 1987.

2.2 Packaging

  • The requirements in Appendix 2 of this Procedure are to be applied for any packaging of scheduled drugs and poisons;
  • A package containing therapeutic goods or other drugs shall bear on or attached to it, a label on which shall be written:
    • Trade name, description of the therapeutic goods, or other drugs contained in the package;
    • The name and business address of the manufacturer;
    • Net weight or number or true measure or, volume of the contents;
    • Therapeutic goods “Batch no”;
    • Expiry date where applicable.
  • In the case of a package containing a therapeutic substance (except a specified S3 or S4) the precise dose and frequency;
  • A person shall not pack therapeutic goods or other drugs for sale in a package that has previously been used where that package is made wholly or partly of paper, cardboard or similar absorbent material;
  • A person must not change, cover, deface or remove a brand, declaration, label, mark or statement that is required by the legislation to be fixed to, or shown on, the container of a poison;
  • A person must not possess or sell a cracked or damaged package containing a poison;
  • If the substance is repacked and is not intended to be administered to a patient or consumer, and is not intended for therapeutic use than labelling requirements of the WHS20 Hazardous Chemicals Standard can be applied.

2.3 Transport

  • The requirements in Appendix 2 of this Procedure are to be applied for any transport of scheduled drugs and poisons;
  • Transfer between internal JCU storage locations can occur provided the appropriately endorsed personnel approve the transaction, the relevant permits and approvals are in place for the proposed storage and use, and the transfer is recorded in the drug register where relevant;
  • Transport of drugs and poisons by undergraduate students is not allowed.

2.4 Storage

  • The requirements in Appendix 2 of this Procedure are to be applied for any storage of scheduled drugs and poisons;
  • Food and drink containers must not be used to hold a poison;
  • Do not wash containers that have held or are commonly used for poisons, in a receptacle used to soak/wash/treat containers that are commonly used to hold human or animal food or drink;
  • Lethabarb storage and use as for S8 drugs.

2.5 Use

  • The requirements in Appendix 2 of this Procedure are to be applied for any use of scheduled drugs and poisions;
  • Use of drugs and poisons must be consistent with the Health Act 1937 (Qld) the Health (Drugs and Poisons) Regulation 1996 (Qld);
  • Where a drug or poison will be used in a manner that is not consistent with the intended therapeutic use, a risk assessment will need to be completed on this method of use;
  • A person must not place arsenic or strychnine, or a substance or chemical compound containing arsenic or strychnine, on or in the body, or a part of the body, of a cadaver for embalming the body or part of the body;
  • Animal drugs and poisons are not to be administered to humans.

2.6 Central Reporting of S4, S7, S8 & S9

  • The WHS Unit is to be notified annually by each relevant Division of the University of the following in regard to S4, S7, S8, & S9 substances:
    • Campus, building number, room number;
    • Person responsible for the item;
    • Indication if the person has the substance;
      • under endorsement by the Health (Drugs and Poisons Regulation 1996 (QLD); or
      • through a Qld Health approval to obtain, store and use the substance.
        • If under an approval from Qld Health, provide a copy of the current approval to obtain, use and store to the JCU WHS Unit.
  • The list of items is to be provided as requested;
  • Audits are then conducted by both the:
    • WHS Unit;
    • Divisional Drugs Officer/ JCU Authorised Officer Delegated the Vice Chancellor’s Authority;
  • A report of findings and corrective actions is prepared by the WHS Unit.

3. Royal Flying Doctor Medical Kit (Remote Location)

As listed on the Royal Flying Doctor Service website (https://www.flyingdoctor.org.au/wa/our-services/medical-chests/ ) only authorised, registered custodians are permitted to manage medical chests. These custodians are obliged to meet certain conditions, which include the following:

  • A medical chest must be kept locked at all times when not in use, with the keys only accessible to the approved person;
  • The contents of a medical chest must be checked regularly for expired items and general completeness;
  • Highlighted prescription drugs are only to be used under RFDS doctor’s instruction;
  • Keeping a record of the RFDS doctor’s consultation numbers in a drug register is essential for re-ordering prescription medication;
  • The appropriate registration number should be clearly marked on the chest;
  • The responsible custodian should advise the RFDS when someone else takes over care and control of the chest;
  • There are items that require refrigeration if the chest is unable to be kept in a cool location;
  • Medical chests are registered to a location and must not be moved without the permission of the RFDS;
  • A list of the locations of the kits must be maintained by the relevant Division.

4. Scheduled Substances in Vessel First Aid Kits

The Queensland Government controls the issue and use of scheduled drugs and poisons.  However, a Master of a ship is required to carry certain quantiles of restricted and controlled medicines:

  • The recommended types of medicines are based upon the scale of your vessel and whether you act under the navigation Act 2012 or Maritime Safety (Domestic Commercial Vessel) National law Act 2012.  Determine the class;
  • Review the requirements of the National Standard for Commercial Vessels Annex H (Part C, Section 7) or Annex 3: Quantification Addendum of the International Medical Guide for Ships to know your requirements for medicines and poisons on board your ship;
  • Purchase under this scheme can only occur from a pharmacy that is approve to sell controlled and /or restricted medicines to ships masters by Queensland Health;
  • Use the My Requisition system for the purchase with the following:
    • Purchase under use code:______
      • This code will send the order for approval to Operations Manager, Research Infrastructure;
    • In the comments section identify the scheduled drug and the type of first aid kit required for the vessel;
    • A purchase order will be generated by Procurement.  Suppliers (eg pharmacist) may ask that the Ship Master directly signs a printed purchase order;
    • The substance is to be placed within the first aid kit;

5. Authorised Officer Delegated the Vice Chancellor’s Authority

  • The Health Drugs and Poisons Regulation 1996 (Qld) provides the “as of right” for the University to use S2, S3 and S4 substances for genuine teaching and research.  Provided the use of the substance is approved by staff that are delegated the Vice Chancellor’s authority to obtain the substances.  Staff that have been delegated the authority are referred to as “JCU Authorised Officer Delegated the Vice Chancellor’s Authority”;
  • The Vice-Chancellor’s instrument listing the JCU Authorised Officer delegated the Vice Chancellor’s Authority is maintained by the WHS Unit;
  • Staff can be nominated to act as JCU Authorised Officer Delegated the Vice Chancellor’s Authority.  This must be conducted by use of the form “Request to Appoint Acting “JCU Authorised Officer Delegated the Vice Chancellor’s Authority” Health (Drugs and Poisons) Regulation 1996 (Qld):
    • This authority only applies to the purchase of S2, S3 and S4 substances.  This is not a Qld Health Drugs Officer approval

6. Procedures for Purchasing of all Schedules of Drugs / Poisons

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

7 Procedures for Transport, Storage, Use and Disposal of all Schedules of Drugs / Poisons

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

Related policy instruments

Queensland Health Medicines and Poisons

Health Act 1937

Health (Drugs and Poisons) Regulation 1996

Drugs Misuse Act 1986

Drugs Misuse Regulation 1987

Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)

Controlled Drugs destruction form (https://www.health.qld.gov.au/__data/assets/pdf_file/0022/443614/drug-destruction-fm.pdf)

Application for an approval to use scheduled substances for non-therapeutic purposes at a university – HDPRs18 – Approv App Form Non-Therap Uni v1 https://www.health.qld.gov.au/system-governance/licences/medicines-poisons/approvals-authorities

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 S2, S3, S4, S7, S8 & S9 Substances

Administration

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

Approval Details

Policy Sponsor

Deputy Vice-Chancellor, Division of Services and Resources

Version no

20-1

Date for next Major Review

23/04/2023

Revision History

Version

Approval date

Implementation date

Details

Author

20-1

23/04/2020

07/05/2020

Major Review – additions regarding system for purchasing Schedule Drugs for vessel first aid kits; Schedule 4 Drugs “as of right” changes; Approval to Purchase S2,S3,S4,S7,S8 & S9 Drugs now included in procedure.  Nomenclature changes HSE Unit to WHS, Name change from HSE-PRO-004.  Original tables added as Appendices due to web page requirements.  Updated Procedure Sponsor in alignment with other WHS Procedures.

WHS Biological, Radiation and Chemicals Safety Advisor

1.0

23/10/2015

23/10/2015

Procedure established

WHS Biological, Radiation and Chemicals Safety Advisor

Keywords

Drugs & Poisons, Drugs and Poisons, Drugs, Poisons, Antibiotics, Lab Safety, Lab, Laboratory, WHS, scheduled drugs,