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Reporting medicines matters to the chief executive

Online approved forms have been developed to assist with meeting reporting and notification requirements under the Medicines and Poisons Act 2019 (MPA) and the Medicines and Poisons (Medicines) Regulation 2021 (MPMR).

The MPMR Chapter 8, Part 5 requires people dealing with medicines to report particular matters to the chief executive in a range of circumstances (e.g. when the lost or theft of an S8 medicine is suspected  or when prescriptions or purchase orders are suspected to be unlawful e.g. false or fraudulent) as per the following:

The following matters also require a notice to be given to the chief executive in the approved form:

If the circumstances you wish to report do not fit under any of the above requirements, e.g. reporting lost or stolen prescription stationery, please complete the General report (Medicines) form noting the circumstances must relate to the Medicines and Poisons Act 2019 (MPA) and/or MPMR.

Notices to the chief executive

Electronic copies of forms (i.e. forms to be downloaded and completed) are available if required by emailing MedicinesCompliance@health.qld.gov.au.

Compliance, monitoring and enforcement

Compliance, monitoring and enforcement (PDF 552 kB) outlines Queensland Health’s regulatory approach under the MPA and MPMR including the compliance and enforcement pyramid, a summary of enforcement options and offences under the legislation, the Monitored Medicines Monitoring Strategy and information about administrative action.

Related forms

Reporting lost or stolen medicines (s226 MPMR)

Approved persons employed by Hospital and Health Services (HHS) are required to report suspected loss or theft of medicines under s226 of the MPMR to the Chief Executive of the relevant HHS in accordance with local procedures.

If the Chief Executive deems the suspected loss or theft a system matter, the form listed here must be completed.

Contact your local Director of Pharmacy for more information if required.

For locations other than HHSs, report suspected loss or theft of medicines using the appropriate forms.

If you require assistance in completing this form, contact Medicines Compliance at MedicinesCompliance@health.qld.gov.au.

Approved form

Reporting lost or stolen medicines - s226 MPMR

Relevant legislation - Section 226 (MPMR): Reporting lost or stolen medicines

  1. This section applies to each of the following persons in the following circumstances (each an incident)—
    1. a person, in the course of acting as an approved person, reasonably suspects an S8 medicine has been lost or stolen;
    2. a person, in the course of acting as an approved person, reasonably suspects pentobarbital has been lost or stolen;
    3. a pharmacist, in the course of practising the pharmacist’s profession, reasonably suspects pseudoephedrine has been lost or stolen;
    4. a person, dealing with a diversion-risk medicine under a general approval, reasonably suspects the medicine has been lost or stolen.
  2. As soon as practicable, but no later than the end of the next business day, after the incident, the person must—
    1. give notice about the incident to the chief executive in the approved form; and
    2. notify the police service about the incident.

    Maximum penalty—40 penalty units.

    1. Subsection (2) does not apply if—
    2. (a) the medicine is lost or stolen from an RFDS medicine chest kept by the Royal Flying Doctor Service of Australia; and
    3. (b) a report about the incident is given to the senior medical officer of the Royal Flying Doctor Service of Australia.

Notification of loss or theft (wholesaler) (s231)

Approved form

Notification of loss or theft (wholesaler) - s231 MPMR

Example of use

Section 231 of the MPMR requires a person who is authorised to supply medicines by wholesale or a person who is a wholesale representative (each the wholesaler) to report the loss or theft of a diversion-risk medicine that was in the possession of the wholesaler before the loss or theft. This includes manufacturers, wholesale suppliers, wholesale representatives and pharmacists.

This report must be made to:

  1. the police service.
  2. the chief executive in the approved form

Relevant legislation – Section 231 (MPMR): Notification of loss or theft (wholesaler)

  1. This section applies to a person (each the wholesaler) who—
    1. is authorised to supply medicines by wholesale; or
    2. is a wholesale representative.
  2. The wholesaler must report the loss or theft of a diversion-risk
  • medicine that was in the possession of the wholesaler
  • immediately before the loss or theft.

Maximum penalty—40 penalty units.

  1. The report must be made as soon as practicable, but no later than the end of the next business day, after the loss or theft—
  • to the police service; and
  • to the chief executive in the approved form.

Maximum penalty—40 penalty units.

Reporting failure to give written prescription (s227 MPMR)

Approved form

Reporting failure to give written prescription - s227 MPMR

Example of use

Failure to send the paper prescription to the person after sending a digital copy of a paper prescription for a diversion-risk medicine.

Relevant legislation – Section 227 (MPMR): Reporting failure to give written prescription

  1. This section applies if—
    1. a prescriber fails to comply with a relevant provision relating to a prescription for a medicine; and
    2. a person dispenses, gives or administers the medicine on the prescription; and
    3. the person is not aware of a reasonable excuse for the prescriber’s failure to comply.
  2. The person must give notice about the prescriber’s failure to comply with the relevant provision—
    1. if the person is employed by the same entity as the prescriber—to the relevant manager of the prescriber as soon as practicable;
    2. otherwise—to the chief executive in the approved form within 48 hours after the end of the period for compliance mentioned in subsection

Maximum penalty—20 penalty units.

  1. Subsection (4) applies if—
    1. the person notifies the relevant manager of the prescriber of the prescriber’s failure to comply; and
    2. the prescriber does not rectify the failure within 48 hours after the notification.
  2. The relevant manager must give notice about the failure to the chief executive in the approved form as soon as practicable.

Maximum penalty—20 penalty units.

  1. In this section

    relevant manager of a prescriber means a person who is responsible for managing the prescriber’s compliance with a relevant provision.

    relevant provision means section 84(4), 92(3) or (4), or 100(2) or (3).

Reporting and preventing use of unlawful document (s228 MPMR)

Approved form

Reporting and preventing use of unlawful document - s228 MPMR

Example of use

Fraudulent script or purchase order for a diversion-risk medicine identified before supply.

Relevant legislation – Section 228 (MPMR): Reporting and preventing use of unlawful document

  1. This section applies if a person who is authorised to deal with a medicine receives any of the following documents—
    1. a purchase order for stock of a medicine;
    2. a prescription for dispensing a medicine;
    3. a prescription for giving a treatment dose of a medicine.
  2. If the person reasonably believes the document has been unlawfully obtained or made, the person must take the following action—
    1. record the name and address of whoever gave the person the document;
    2. notify the police service as soon as practicable;
    3. if the document is for a diversion-risk medicine—give notice to the chief executive in the approved form as soon as practicable;
    4. for a hard copy of a purchase order—keep the purchase order or a copy of the order;
    5. for a purchase order given electronically—process the purchase order in the system in which it is kept to prevent stock of the medicine being supplied;
    6. for a paper prescription—keep the prescription or a copy of the prescription;
    7. for an electronic prescription—process the prescription in the system in which it is kept to prevent the medicine being dispensed or given.

    Maximum penalty—60 penalty units.

  3. The person is required to comply with subsection (2) only to the extent it is safe for the person to comply.

Reporting supply on false prescription or purchase order for diversion-risk medicine (s230 MPMR)

Approved form

Reporting supply on false prescription or purchase order for diversion-risk medicine - s230 MPMR

Example of use

Fraudulent script or purchase order identified after supply of a diversion-risk medicine.

Relevant legislation – Section 230 (MPMR): Reporting supply on false prescription or purchase order for diversion-risk medicine

  1. This section applies if, after supplying a diversion-risk medicine on a prescription or purchase order, the supplier of the medicine reasonably suspects any of the following incidents has happened—
    1. false information, material to the prescription or purchase order, was given to the person who prescribed the medicine or gave the purchase order;
    2. the prescription or purchase order was changed by a person other than—
      1. for a prescription—the prescriber of the prescription or the dispenser of the medicine for the prescription; or
      2. the prescription or purchase order was false in any material particular.
    3. (ii) for a purchase order—the person who gave the purchase order;
    4. The supplier must give notice about the incident to the chief executive in the approved form and to the police service no later than 24 hours after becoming aware of the incident.

      Maximum penalty—60 penalty units.

In this section—

supplier, in relation to a medicine, means a person who is authorised to supply the medicine.

Giving chief executive information about particular diversion-risk medicines (s233 MPMR)

Approved form

Giving chief executive information about particular diversion-risk medicines - s233 MPMR

Example of use

Person seeking excessive diversion-risk medicine that is not a monitored medicine.

Relevant legislation – Section 233 (MPMR): Giving chief executive information about particular diversion-risk medicines

  1. This section applies if—
    1. a person seeks a supply of a diversion-risk medicine from a pharmacist, other than a medicine that is also a monitored medicine; and
    2. the pharmacist reasonably suspects the amount of the medicine sought exceeds the amount or frequency of doses that the person could reasonably be seeking for the therapeutic treatment of the person or the person’s animal.
  2. The pharmacist must give notice to the chief executive in the approved form unless the pharmacist has a reasonable excuse.

Maximum penalty—40 penalty units.

Supplier to notify chief executive if no receipt provided (s69 MPMR)

Approved form

Supplier to notify chief executive if no receipt provided - s69 MPMR

Example of use

A supplier has not received a notice of receipt from a buyer within 5 business days after the date of delivery of stock of an S8 medicine.

Relevant legislation – Section 69 (MPMR): Supplier to notify chief executive if no receipt provided

  1. This section applies if a supplier has not received from a buyer a notice of receipt mentioned in section 53 within 5 business days after the date of delivery of stock of a medicine.
  2. The supplier must give a notice to the chief executive in the approved form about the buyer’s failure to confirm receipt.

Reporting system breaches for monitored medicines (s192 MPMR)

Approved form

Reporting system breaches for monitored medicines - s192 MPMR

Example of use

Virus software enters an electronic prescription management system to create false prescription.

Relevant legislation – Section 192 (MPMR): Reporting system breaches for monitored medicines

  1. This section applies if the system manager, or a system administrator, of an entity’s electronic prescription management system becomes aware of an incident in which the system may have been unlawfully accessed or otherwise unlawfully used to obtain a monitored medicine.

    Example of an incident— virus software enters an electronic prescription management system to create false prescriptions

  2. Within 5 business days after becoming aware of the incident, the system manager or system administrator must give notice to the chief executive about the incident in the approved form, unless the manager or administrator has a reasonable excuse.

Maximum penalty—80 penalty units.

Reporting lost, stolen or destroyed register (s218 MPMR)

Approved form

Reporting lost, stolen or destroyed medicine register - s218 MPMR

Example of use

A paper register or an electronic register for an S8 safe or approved store has been lost, stolen or destroyed.

Relevant legislation – Section 218 (MPMR): Reporting lost, stolen or destroyed register

  1. This section applies if a medicine register for an S8 safe or approved store is lost, stolen or destroyed (each an incident).
  2. A manager of the safe or store must give notice about the incident to the chief executive in the approved form as soon as practicable, but no later than the end of the next business day, after the incident.

Notification about events (s35 MPMR)

Approved form

Notice of intention to attend an event (MPMR-35)

This form is managed by Healthcare Approvals and Regulation Unit (HARU). If you require assistance with completing this form, contact HARU at HARU@health.qld.gov.au.

Example of use

Holders of general approvals (emergency first aid) must notify the chief executive when proposing to attend an event to provide emergency first aid services.

Relevant legislation – Section 35 (MPMR): Notification about events

  1. The holder of a general approval (emergency first aid) must give notice to the chief executive if a registered nurse, first aid provider or paramedic intends to attend an event under the approval.
  2. The notice must be given in the approved form no less than 2 business days before the event happens.

Reporting medicines usage

Approved form

Medicines usage report - MPA-70MUR

This form is managed by Healthcare Approvals and Regulation Unit (HARU). If you require assistance with completing this form, contact HARU at HARU@health.qld.gov.au.

Example of use

Periodical reporting of medicines usage where required as a condition of a substance authority.

Relevant legislation

Under section 70 of the MPA, a substance authority is subject to any additional condition decided by the chief executive. Further, section 71 of the MPA requires that a person to whom a substance authority applies must comply with the conditions of the authority unless the person has a reasonable excuse.

Certain substance authorities granted under the MPMR are subject to the additional condition that the holder must periodically report medicines usage to the chief executive of Queensland Health in the approved form — this form must be used to notify the chief executive for this purpose.

Notification of particular changes affecting authority (s42 MPMR)

Approved form

Notification of particular changes affecting authority (s42 MPMR)

This form is managed by Healthcare Approvals and Regulation Unit (HARU). If you require assistance with completing this form, contact HARU at HARU@health.qld.gov.au.

Relevant legislation – Section 42 (MPMR): Notification of particular changes affecting authority

  1. The holder of a substance authority must give notice to the chief executive in the approved form if any of the following changes are proposed by the holder—
    1. a change to an authorised place stated in the authority;
    2. a change to a relevant person stated in the authority;
    3. if the substance authority is a manufacturing licence—a change to the person who is appointed to supervise manufacturing under the licence;
    4. another change to the holder’s circumstances that substantially affects the holder’s ability to comply with a condition of the authority.

    Example for paragraph (d)—

    a fire at an authorised place stated in a wholesale licence damages stock of medicines and the security system at the place

  2. The notice must be given as soon as practicable, but no later than 5 business days, after the change of circumstances happens

Stopping dealing (s43 MPMR)

Approved forms

Notice of intention to stop dealing - MPMR-43

This form is managed by Healthcare Approvals and Regulation Unit (HARU). If you require assistance with completing this form, contact HARU at HARU@health.qld.gov.au.

Example of use

Holders of substance authorities must notify the chief executive if they propose to stop carrying out a dealing with a medicine under their substance authority.

Relevant legislation – Section 43 (MPMR): Stopping dealing

  1. This section applies if a holder of a substance authority proposes to stop carrying out a dealing with a medicine under the substance authority.
  2. The holder must give the chief executive a notice in the approved form stating the following information—
    1. the day the dealing is proposed to stop;
    2. the amount of medicine that is likely to be unused on the day mentioned in paragraph (a), if any;
    3. how the holder proposes to deal with any unused medicine.

Notification when starting treatment of a patient on Opioid Treatment Program – Admission (s31 MPMR)

Holders of prescribing approvals authorising treatment under the Queensland Opioid Treatment Program (QOTP) must ensure notice is given to the chief executive if they start treating a patient under the QOTP. A completed Queensland Opioid Treatment Program (QOTP) – Admission form is to be given to the chief executive as soon as practicable, but no later than the end of the next business day after the treatments starts.

This form is not available online or electronically. Please contact Healthcare Approvals and Regulation Unit (HARU) at QOTP@health.qld.gov.au if you require assistance or a copy of this form.

Notification when stopping treatment of patient on Opioid Treatment Program – Discharge (s31 MPMR)

Holders of prescribing approvals authorising treatment under the Queensland Opioid Treatment Program (QOTP) must ensure notice is given to the chief executive if they stop treating a patient under the QOTP. A completed “Queensland Opioid Treatment Program (QOTP) – Discharge form” is to be given to the chief executive as soon as practicable, but no later than 3 business days, after the treatment stops.

This form is not available online or electronically. Please contact Healthcare Approvals and Regulation Unit (HARU) at QOTP@health.qld.gov.au if you require assistance or a copy of this form.

Relevant legislation – Section 31 (MPMR): Notification when starting and stopping treatment

  1. If the holder of a prescribing approval starts treating a patient under an opioid treatment program, the holder must ensure notice is given to the chief executive in the approved form.
  2. The notice must be given to the chief executive as soon as practicable, but no later than the end of the next business day, after the treatment starts.
  3. If the holder stops treating the patient, the holder must ensure notice is given to the chief executive in the approved form as soon as practicable, but no later than 3 business days, after the treatment stops.
Last updated: 13 October 2021