Prescribing drugs of dependence

• Doctors are now expected – and in some states and territories required – to check real time monitoring systems before prescribing drugs of dependence.
• In all states and territories except Queensland, doctors usually also need a state/territory authority to prescribe a drug of dependence to non-drug-dependent patients for more than two months, or to prescribe to drug-dependent patients at all.
• The authority required from your state or territory health department to prescribe drugs of dependence is additional to the authority required from the PBS.

‘Drugs of dependence’ refers to a group of drugs with properties that make them addictive and create a high potential for misuse. Broadly, drugs of dependence include opioids, sedatives, steroids and stimulants. Most are classed under Schedule 8 of the Standard for the Uniform Scheduling of Medicines and Poisons (Poisons Standard) and often referred to as S8s, or controlled medicines. When prescribed and used appropriately they can help to meet a patient’s therapeutic needs. However, these medicines present unique challenges for doctors and patients.

Doctors are only permitted to prescribe these drugs in line with restrictions that have been developed to promote their safe and proper use. It is important to understand and comply with your legal obligations when prescribing drugs of dependence. Failing to do so can lead to patient harm, and to legal and professional penalties.

In most jurisdictions a ‘drug-dependent person’ is defined in legislation. There are some differences in the definitions, but generally a ‘drug-dependent person’ is someone who:

• exhibits impaired control or drug-seeking behaviour
• is likely to experience withdrawal symptoms of a mental and/or physical nature as a result of cessation of the medication
• has consumed medications contrary to, or in excess of, prescribed instructions.

You need to determine if your patient is drug-dependent or not before you prescribe opioids for them. This will involve undertaking a comprehensive medical history and assessment of the patient. You will also need to confirm the information from other sources if the patient is not known to you.

All states and territories have real time prescription monitoring (RTPM) to help alert prescribers to patients who may be at risk of over-supply or who engage in doctor shopping.

The medications monitored vary between jurisdictions but generally include drugs of dependence and some others associated with multi-drug toxicity or at risk of overdose or misuse.

It is best practice to check the RTPM system every time before prescribing a monitored medication. In Victoria, Queensland, South Australia, Tasmania and the Northern Territory, it is mandatory to check before prescribing. If you do not check, you may be fined. Limited exemptions apply.  In other states, use is voluntary, but prescribers are ‘strongly encouraged’ to check

Seeing a green, amber or red notification in your practice software is not the same as checking the RTPM system. To check, you must click on the notification which will take you to the RTPM so you can see your patient’s history. The system tracks when you check a patient.

Doctors can prescribe to a patient with an alert in the system, but need to consider whether it is clinically appropriate to do so, given the risk of potential harm, and document their reasoning. It is also important to check if you need an additional authority.

You can use RTPM to help you understand your patient’s situation or as an aid to having a conversation with your patient about alternatives, reduction or cessation of their medication.

You are required by law to obtain approval from your relevant state or territory health authority before prescribing a drug of dependence in certain circumstances. Depending on the state or territory, this is referred to as an ‘authority’, ‘approval’ or ‘permit’.

Generally, in states and territories except Queensland, approval is required to prescribe drugs of dependence if the patient is deemed to be drug dependent.

If the patient is deemed to not be drug dependent, depending on your state or territory, approval may also be required, for example when prescribing for more than two months (including prescribing by previous doctors) or if dosage exceeds certain levels.

If considering prescribing for anyone under the age of 18 years, contact your state/territory authority.

In Queensland, approval is required to prescribe to a patient on a ‘methadone program’ or to prescribe amphetamine, methylphenidate and some other restricted medicines.

For more information see the state- and territory-specific information on our Prescribing safely hub.

Exceptions

There are exceptions to these requirements, where the risks of prescribing these drugs in specific circumstances are significantly reduced, for example prescribing Schedule 8 medicines to hospital inpatients.

The exceptions are different in each state and territory, so make sure you check your state or territory health website.

Approval process

The approval process generally involves completing an application form and forwarding it to the relevant state or territory authority.

The application form usually requests clinical information about the patient’s condition. In some cases, this requires a specialist report, for example, from an addiction medicine specialist.

Can there only be one authority?

Only one doctor in a practice needs to hold a valid authority for a patient. If another doctor in that practice sees the patient and chooses to prescribe, they must check the details of the authority (to determine if it is current). They cannot prescribe more than the authority indicates. It is wise to endorse the prescription, for example ‘deputy to Dr X the authority holder’.

Only one authority is issued at a time per patient. If you take over the care of a patient who is on a drug of dependence from a previous prescriber with an authority, the previous prescriber must cancel that authority before a new one can be issued to you.

The Pharmaceutical Benefits Scheme (PBS) is a government scheme that provides many medicines at a subsidised price. Some PBS medicines are classed as ‘Authority required’ and doctors need approval from Services Australia or the Department of Veterans’ Affairs (DVA) before prescribing these medicines. Others are classed as ‘Authority required (STREAMLINED)’ which do not require prior approval from Services Australia or the DVA but do require the recording of a streamlined authority code that is appropriate for the specific indication.

The PBS authority is additional to, and different from, the authority, approval or permit required to prescribe a drug of dependence by your state or territory health authority.

You can apply for a PBS authority on the Services Australia PBS authorities website, by mailing a form or by calling 1800 888 333. For DVA authorities, contact the DVA Authority Freecall service on 1800 552 580.

When a PBS authority application is for a drug of dependence (other than dexamphetamine sulfate), the following guidelines apply:

1. The maximum quantity authorised is generally for one months therapy (for example, one weeks therapy with three repeats).

2. Where supply for a longer period is warranted, quantities are usually for up to three months therapy.

3. Telephone approvals are limited to one months therapy.

If you are prescribing a repeat of this drug, you should state the interval of repeat, and ensure that it matches the authority granted from your state or territory health authority.

More information about PBS authorities can be found on the PBS website.

All prescriptions for Schedule 8 medications must contain:

• name and address of the prescriber and the patient
• description of the medication
• quantity of the medication in words and numbers
• precise directions for use
• number of repeats and intervals at which they may be dispensed
• signature of the prescriber.

States and territories differ as to what additional information is required and how it is presented so check your local requirements.

Electronic prescriptions 

You may prescribe drugs of dependence using electronic prescriptions if you are using conformant prescribing software. You can check this with your prescribing software vendor or the Australian Digital Health Agency’s Electronic Prescribing Conformance Register.

• Take a relevant history, including any treatment already tried, and examine the patient.
• Determine whether you believe there is a clinical need to prescribe the drug.
• Check your state/territory real time prescription monitoring service to see the patient’s prescription history.
• Consider any alternative strategies that could be implemented.
• Contact the patient’s usual/previous treating doctor to find out why it was originally prescribed.
• Check if there is an authority in place with your state or territory authority.

Avant factsheet: Identifying doctor shoppers

National prescribing service: NPS MedicineWise: Opioids, chronic pain and the bigger picture

Our suite of Insights & Resources has articles, eLearning courses, videos and webinars under the topic ‘Prescribing’.

For medico-legal advice, please contact us here, or call 1800 128 268, 24/7 in emergencies.