Controlled Medicines

The Health Protection Service (HPS) has a critical role in promoting the safe and effective use of controlled medicines in the ACT.

What are Controlled Medicines?

Controlled medicines are listed under Schedule 8 of the Commonwealth Poisons Standard. Examples of these medicines include morphine, oxycodone, dexamfetamine and alprazolam. The ACT adopts the Poisons Standard under the Medicines, Poisons and Therapeutic Goods Act 2008.

The Medicines, Poisons and Therapeutic Goods Regulation 2008 (MPTG Regulation) establishes the regulatory framework for prescribing and supplying controlled medicines in the ACT.

This Framework gives the ACT a unique opportunity to be a leader in reducing harm associated with the abuse, misuse and diversion of these medicines.

ACT Real Time Prescription Monitoring

DAPIS Online Remote Access (DORA) is a web based real time prescription monitoring system that will provide prescribers and pharmacists secure access to clinical information for their patients relating to controlled medicines.

ACT DORA will be made available to pharmacists and prescribers from March 2019.

A prescriber or pharmacist will be able to look up information in DORA for any ACT patient that presents to them. Information displayed will include patient details as well as their controlled medicine dispensing history and any ACT prescriber approvals that are in place for them.

DORA is an extension of the Drugs and Poisons Information System (DAPIS), which is used by the ACT Health Protection Service (HPS) as its prescription monitoring system.

Why use DORA?

Australia has a growing national problem with the misuse and abuse of pharmaceuticals. The number of harms including deaths from prescription medicines has increased and is now higher than illegal drugs.

DORA is intended to be a clinical support tool for prescribers and pharmacists, to enable them to better identify and manage patients who may be exhibiting signs of drug dependency or drug seeking behaviours, such as ‘doctor shopping’.

DORA is being introduced to improve the safety of ACT patients by giving prescribers and pharmacists valuable information before they write or dispense a prescription for a controlled medicine.

DORA is not intended to disadvantage patients where there is a legitimate clinical need for a medicine and where a prescriber is authorised to prescribe a controlled medicine for a person.

How can a pharmacist or prescriber access DORA?

Any prescriber of controlled medicines and pharmacists may apply to access DORA to support ACT patient care. Prescribers include doctors, dentists and some nurse practitioners.

Using DORA is not mandatory, however ACT Health urges all eligible prescribers and pharmacists to use DORA as a new part of their clinical practice, with the aim of minimising harms associated with the use and misuse of controlled medicines.

From March 2019, prescribers and pharmacists will be able to apply to register for DORA via the DORA registration website. Applicants will also need to provide a range of verification documents to the HPS to complete their registration. This will include a copy of their AHPRA certificate, 100 points of ID and their organisation or practice’s Public Key Infrastructure (PKI) certificate.

Further details will be provided to prescribers and pharmacists about the registration process when DORA becomes available from March 2019.

Security of patient records in DORA

The ACT Government is committed to ensuring the security of patient information within DORA. DORA has undergone rigorous security testing and complies with the ACT Government Protective Security Policy Framework and the ICT Security Policy.

A record in DORA is a health record and is protected by law under the Health Records (Access and Privacy) Act 1997. The Medicines, Poisons and Therapeutic Goods Act 2008 also outlines acceptable use provisions and offences related to this information. Strict penalties apply for any person found to be inappropriately accessing or using DORA information.

Real time reporting from pharmacies

Most of the information in DORA will be displayed in real time, immediately after a prescription is dispensed from a pharmacy in the ACT.

All ACT community pharmacies are currently able to report dispensing information to DORA via their dispensing software. Dispensing information from hospital pharmacies will still appear in DORA, however there may be a time lag in the information being viewable.

All ACT pharmacies are required to report information for all controlled medicine dispensing events to ACT Health at least each week, in accordance with the Medicines, Poisons and Therapeutic Goods Act 2008.

Visit the real time reporting page for further information.

How can I find out more about DORA?

Detailed information about DORA for consumers and health professionals is being developed and will be provided when DORA becomes available from March 2019.

Detailed training packages will be made available for prescribers and pharmacists when DORA is introduced.

Applying for Chief Health Officer Approval

Prescribers must have approval from the Chief Health Officer (CHO) to prescribe controlled medicine for a drug-dependent patient or for ongoing treatment of more than two months in the ACT.

Prescribers can now apply for approval to prescribe a controlled medicine electronically using a Smartform. This Smartform allows prescribers to apply to the HPS for a controlled medicine approval directly via their practice management software or online.

Prescribers wishing to use the Smartform can access the form via their practice software if they use Best Practice Premier®, Genie Solutions® or Medical Director®.

For further information please refer to the Smartform Quick Start Guides for each of the following practice software systems:

Prescribers who do not use any of the above practice management systems are still able to apply online using the Smartform via a HealthLink portal. Please contact the HPS on 02 5124 9208 or pss@act.gov.au if you wish to start using the HealthLink portal.

For those prescribers who still wish to submit applications by fax, they can submit the Application for approval to prescribe a controlled medicine to HPS.

The HPS can process an application within one to two working days providing further information is not required in support of the application.

Prescribers should tick the URGENT box on the application if an urgent approval is required. The HPS can consider urgent applications within one working day.

Controlled Medicines Prescribing Standards

The ACT Controlled Medicines Prescribing Standards support a flexible approach to the prescription of controlled medicines.

The Standards allow you to seek approval to prescribe a therapeutic class of controlled medicine(s) for patients. You can do this through a category approval system (Category Approval) or you can seek approval to prescribe by drug, form and strength (Approval by Drug).

Opioid Maintenance Treatment

Only endorsed prescribers may commence a patient on opioid maintenance treatment or prescribe for more than 5 stable patients at the same time.

Non-endorsed prescribers can only prescribe methadone, buprenorphine or buprenorphine/naloxone for up to 5 drug dependent patients.

Category 3 of the ACT Controlled Medicines Prescribing Standards states conditions and criteria for prescribing methadone, buprenorphine or buprenorphine/naloxone under an approval. You are also required to prescribe these drugs in line with the National Guidelines for Medication Assisted Treatment of Opioid Dependence. Prescribers should also endeavour to comply with the Opioid Maintenance Treatment in the ACT: Local Policies and Procedures wherever possible.

If you would like to become an endorsed prescriber to treat drug dependency in the ACT, you are required to undertake ACT Health training. These requirements are outlined in the Medicines, Poisons and Therapeutic Goods (Guidelines for treatment of opioid dependency) Approval. Please submit an Application for Endorsement to Treat Drug Dependency to us.

Pharmacies

Community pharmacies in the ACT must be licensed to dispense methadone, buprenorphine or buprenorphine/naloxone for treatment of drug dependency. Pharmacists can apply to HPS to obtain an Opioid Dependency Treatment Centre Licence. You can apply for this by submitting an Application for Opioid Dependency Treatment Centre Licence (Pharmacist).

You must also dispense methadone, buprenorphine or buprenorphine/naloxone in line with the National Guidelines for Medication Assisted Treatment of Opioid Dependence. You should also comply with the Opioid Maintenance Treatment in the ACT: Local Policies and Procedures wherever possible.

All pharmacists dispensing treatment must successfully complete training for the safe administration and dispensing of opioid maintenance treatment. These requirements are outlined in the Medicines, Poisons and Therapeutic Goods (Guidelines for treatment of opioid dependency) Approval.

You can access local contacts and program related information from the Alcohol and Drug Services webpage.

Medicines, Poisons and Therapeutic Goods (MPTG) Regulation

Definition of Drug Dependent Person

*The MPTG Regulation defines a drug dependent person, in relation to a controlled medicine as being a person with a condition:

(a) who, as a result of the administration of the medicine or substance, demonstrates, in relation to the person’s use of the medicine or substance—

(i) impaired control; or

(ii) drug-seeking behaviour that suggests impaired control; and

(b) who, as a result of the cessation of the administration of the medicine or substance, is likely to experience symptoms of mental or physical distress or disorder.

Medicines Advisory Committee

The Medicines Advisory Committee (MAC) is a statutory body established under the Medicines, Poisons and Therapeutic Goods Act 2008 to provide expert advice to the CHO on complex clinical matters involving the prescribing and supply of medicines in the ACT. Specifically, the MAC provides advice to the CHO on applications for approval to prescribe controlled medicines, and applications for endorsement to treat drug dependency. The MAC may also consider applications for review of an unfavorable CHO decision on controlled medicine issues.

Under Chapters 13 and 15 of the Medicines, Poisons and Therapeutic Goods Regulation 2008, the MAC is responsible for reviewing and providing recommendations to the CHO as described by the following table. 

Considered Matter

MAC Recommendation to CHO

Referred applications for Approval to Prescribe a Controlled Medicine.

Either:

  1. Approve the application in same terms applied for;
  2. Approve the application in terms different from those applied for; or
  3. Refuse the application.

Applications for review of an unfavourable CHO decision about a controlled medicine approval.

Either:

  1. Confirm a previous CHO decision; or
  2. Revoke a previous CHO decision and recommend a substitute decision.

Applications for review of a CHO decision to refuse an endorsement to treat drug-dependency.

Either:

  1. Confirm a previous CHO decision; or
  2. Revoke a previous CHO decision and approve the application as recommended by the MAC.

Guidelines for the CHO decisions on applications to prescribe a controlled medicine.

Either:

  1. Accept a MAC draft Guideline; or
  2. Modify a previous Guideline; or
  3. Revoke a previous Guideline.

Membership

In accordance with the MPTG Regulation, the MAC consists of seven members including: a psychiatrist, pharmacist, general practitioner, consumer representative, doctor with experience in pain or addiction medicine, and nominee of the ACT Branch of the Australian Medical Association (AMA). The current membership of the MAC is as follows:

Member

Role

Specialty

Term of Appointment

Dr Rashmi Sharma

Chair

General Practice

DI2017-23 - until 8 March 2020

Dr Antonio Di Dio

Member

General Practice

DI2017-23 - until 8 March 2020

Dr Peter Norrie

Member

Psychiatry

NI2017-111 – until 8 March 2020

Ms Amanda Galbraith

Member

Pharmacy

Dl2018-26 – until 21 February 2021

Dr Romil Jain

Member

Pain Medicine and
Intensive Care Medicines

 
 

Member

Consumer Representation

 

Dr Marianne Bookallil

Member

General Practice and
Public Health Medicine

NI2017-112 – until 8 March 2020

Subject to agreement by the Minister for Health or Chief Health Officer, sub-committees of the MAC may be established to assist the Committee in their role in providing expert advice about controlled medicines public health impact of controlled medicines i.e. the Medicinal Cannabis Medical Advisory Panel and the Medicinal Cannabis Advisory Group.

The Health Protection Service provides all Secretariat services for the MAC and can be contacted on the details below. Prescribers wishing to apply to the MAC for a review of an unfavourable decision on a controlled medicines approval or endorsement to treat drug-dependency, or for any other matter, may do so by forwarding correspondence to the below address.

Medicines Advisory Committee
C/-Health Protection Service
Locked Bag 5005
WESTON CREEK ACT 2611

Ph: (02) 5124 9208

Email: hps@act.gov.au   

Real time reporting from pharmacies

All ACT pharmacies are required to report information for all controlled medicine dispensing events to ACT Health at least each week, in accordance with the Medicines, Poisons and Therapeutic Goods Act 2008.

All pharmacies currently submit this information electronically to ACT Health each week via a web portal.

ACT Health is working with the Australian Government to establish real time reporting for ACT pharmacies via the National Data Exchange (NDE), which forms part of the national Real Time Prescription Monitoring (RTPM) system.

The ACT is working to achieve real time reporting via the NDE by March 2019, in time for the rollout of ACT DORA. This means that dispensing information in DORA will be viewable for health professionals in real time, immediately after a prescription is dispensed.

This also means that ACT community pharmacies will no longer be required to submit weekly controlled medicines dispensing reports to ACT Health.

All ACT community pharmacies are currently able to report information indirectly to the NDE via their dispensing software.

ACT Health will provide further details to pharmacies in the coming months to confirm whether they are reporting via the NDE and when they can cease submitting manual electronic reports.

The ACT is the first Australian jurisdiction to integrate with the NDE. The ACT plans to adopt full national RTPM functionality in the future after the initial ACT DORA rollout.

Page last updated on: 7 Feb 2019