Monitored Medicines Monitoring Strategy

Risk-based, education-first approach

Queensland Health is committed to a risk-based, education-first approach to monitoring and enforcement of monitored medicines offences under the Medicines and Poisons Act 2019 (MPA) and the Medicines and Poisons (Medicines) Regulation 2021 (MPMR).

Education and advice

The legislative framework promotes compliance and enables effective enforcement through regulatory action.

A phased approach to monitoring and enforcement of monitored medicines offences will be implemented with a focus on education and guidance,

Visit Real-time prescription monitoring of monitored medicines to learn how to:

• register and use QScript (the monitored medicines database)
• access best practice eLearning modules designed to improve clinical practice on the prescribing and dispensing of monitored medicines

If education and assistance for non-compliance is not effective, we may issue a compliance notice.

Administrative action

If non-compliance continues, regulatory action may need to be escalated. This can mean taking administrative action such as changing a condition of an authority, suspending an authority for a stated period or indefinitely or cancelling a substance authority.

Prosecution

Prosecution of offences will only be considered as a final action where compliance is not being achieved and there is a continuing risk to the public.

Actions of significant risk

The initial focus of monitoring and enforcement of monitored medicines offences is on education and voluntary compliance, but actions of significant risk will always be investigated.

We will consider progressing to more serious regulatory intervention, e.g. giving show cause notices or taking immediate administrative action, faster if we identify high risk activities.

Key monitoring strategies

The key monitoring strategies that will be implemented will be the:

1. Not Look Up (NLU) Strategy
2. Monitored Medicines Standard (MMS) Strategy
3. Self-Prescribe (SP) Strategy
4. Amfetamine and Methylphenidates (AM) Strategy

Not Look Up (NLU) Strategy

The Not Look Up (NLU) Strategy provides compliance guidance for health practitioners dealing with s41 of the MPA.

Before prescribing, dispensing or giving a treatment dose of a monitored medicine for a person, practitioners must check the monitored medicines database (QScript) to see whether information recorded in the database shows that the person has previously been prescribed, dispensed or given any monitored medicine.

General statement - education approach

The NLU proactive strategy will be implemented from 1 January 2023.

The NLU strategy focuses on education and warning letters over directed compliance and other regulatory action.

Letters include information about:

• how to register for QScript (if relevant)
• how to access training
• a practitioner’s obligations under the legislation.

General statement - reasonable excuse

Section 41(3)(b) of the MPA says that if a practitioner has a reasonable excuse for not checking QScript, they do not commit an offence.

Practitioners are encouraged to document their reasons for not looking up QScript so that this information can be provided to Queensland Health if requested. If they are unable to access QScript for technical reasons, they should document attempts to access QScript.

We will assess this information and determine the appropriate level of action required, if any, using a consistent approach.

Not being a registered user of QScript is not considered a reasonable excuse.

Monitored Medicines Standard (MMS) Strategy

The Monitored Medicines Standard (MMS) Strategy provides compliance guidance for health practitioners regarding s93 MPMR and s126 MPMR.

Prescribing monitored medicines

Section 93 of the MPMR states a prescriber must prescribe a monitored medicine, whether orally or by written prescription, in accordance with the departmental standard called Monitored medicines (the Monitored Medicines Standard (MMS)).

Section 126 of the MPMR states ‘a dispenser must dispense a monitored medicine in accordance with the departmental standard called Monitored medicines MMS.

Part 1 of the MMS applies if a prescriber prescribes a monitored medicine for dispensing or giving a treatment dose for a patient, such as if a prescriber directs a person orally or in writing to:

• dispense a monitored medicine for the treatment of a person
• give a treatment dose of a monitored medicine for the treatment of a person.

Part 2 of the MMS applies if a dispenser dispenses a monitored medicine for a patient irrespective of whether the prescription for the monitored medicine:

• was an oral or written prescription
• was prescribed in Queensland or another jurisdiction.

General statement - education approach

The MMS describes six high-risk clinical scenarios for patients and identifies minimum requirements that health practitioners must comply with when a high-risk clinical scenario has been identified. They are as follows:

• Scenario A: Patient currently registered on the Queensland Opioid Treatment Program
• Scenario B: Patient previously registered on the Queensland Opioid Treatment Program
• Scenario C: Patient receiving monitored medicines from multiple prescribers
• Scenario D: Increased patient overdose risk - daily opioids of 100mg OME or greater
• Scenario E: Increased patient overdose risk - opioid and benzodiazepine/z-drug combination
• Scenario F: Patient receiving an opioid or benzodiazepine/z-drug for the first time in 90 days.

The MMS companion document provides general guidance and compliance guidance to assist health practitioners to comply with the departmental standard.

Routine monitoring of compliance with the MMS is currently on hold as the focus is on encouraging health practitioners to register and use QScript.

Once QScript and the MMS become standard practice, further education will not be required and a warning letter or compliance notice may be given prior to consideration of administrative action. Deliberate or repeated non-compliance with the MMS, despite education and warning, will be indicators for regulatory action.

Self-prescribe (SP) Strategy

The Self-prescribe (SP) Strategy provides compliance guidance for health practitioners regarding s40 MPA.

Section 40 of the MPA includes a specific offence for self-prescribing high-risk medicines.

The definition of high-risk medicines in the MPMR includes all S8 medicines and the following S4 medicines:

• benzodiazepines
• codeine
• gabapentin
• pregabalin
• quetiapine
• tramadol
• zolpidem
• zopiclone.

From 1 January 2023, prescribers who are identified as self-prescribing a high-risk S8 or S4 medicine may be given a warning letter in the first instance prior to consideration of further regulatory action.

Where high-risk matters are identified, (e.g. repeated self-prescribing of concern or other indicators of non-compliance with the MPA) other regulatory action may be taken.

Amfetamine and Methylphenidates (AM) Strategy

The Amfetamine and Methylphenidates (AM) Strategy provides compliance guidance for health practitioners dealing with amfetamines or methylphenidates.

Under the MPMR, a prescribing approval is not required to treat a patient with amfetamines or methylphenidates if:

• You are a medical practitioner prescribing the medicine for the treatment of a relevant condition:
  • narcolepsy - of a patient of any age
  • brain damage, or attention deficit disorder (ADD), of a child patient who is at least 4 years (Schedule 6, Part 1, Division 5 MPMR).
• You are a paediatrician prescribing the medicine for the treatment of a relevant child condition:
  • brain damage, or ADD, of a child patient (from Schedule 6, Part 2, Division 15 MPMR).
• You are a psychiatrist prescribing the medicine, within the maximum dosage, for treatment of a relevant adult condition:
  • ADD of an adult patient (from Schedule 6, Part 2, Division 16 MPMR).
• You are a psychiatrist prescribing the medicine for treatment of a relevant child condition:
• brain damage, or ADD, of a child patient (Schedule 6, Part 2, Division 16 MPMR).

Maximum dosage of a medicine is:

• dexamfetamine - a dose of the medicine that does not exceed 40mg a day
• lisdexamfetamine - a dose of the medicine that does not exceed 70mg a day
• methylphenidate - a dose of the medicine that does not exceed 80mg a day (Schedule 6, Part 2, Division 16 MPMR).

Patient class treatment approvals are no longer required for psychiatrists to prescribe amfetamines or methylphenidates within maximum dosage levels specified in Schedule 6, Part 2, Division 16 of the MPMR for ADD of an adult patient.

A medical practitioner (who is not a psychiatrist) cannot prescribe amfetamines or methylphenidates to a patient over the age of eighteen (18) years without a prescribing approval, unless the patient has narcolepsy (a relevant condition).

The Amfetamines and Methylphenidates Strategy will adopt an education-first approach to practitioners who are identified as prescribing amfetamines and/or methylphenidates without the appropriate prescribing approval

Review

These monitoring strategies will be reviewed 12 months.