Medicines and Poisons Regulation (MPR) has prepared information to help prescribers understand the key legislative requirements associated with prescribing drugs of dependence.
Not all legislative requirements are referred to – only those that may be relevant to the majority of general practitioners.
For full details, see the Drugs, Poisons and Controlled Substances Act 1981 and the Drugs, Poisons and Controlled Substances Regulations 2017. Documents dealing with other key legislative requirements may be found under ‘Medicines and Poisons Regulation legislation’.
Drug dependency – clinical advice
Although this document includes references to treatment strategies and options, it relates primarily to legislative issues associated with prescribing drugs of dependence for a drug-dependent person. Clinical advice relating to the treatment of a drug-dependent person (including other treatment options) should be sought from authoritative sources.
To obtain clinical advice from specialist consultants, registered health practitioners (only) may phone the Drug and Alcohol Clinical Advisory Service (DACAS) on 1800 812 804 (at any time).
For 24-hour confidential drug and alcohol counselling, and treatment information, patients, family members and health practitioners may phone Direct Line – 1800 888 236.
Drug-dependent person – what does it mean
Although the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) lists criteria to assist medical practitioners to diagnose the condition, the Drugs, Poisons and Controlled Substances Act 1981 does not define the term ‘drug-dependent person’. It refers instead to when a practitioner has reason to believe that a patient is a drug-dependent person.
Examples of circumstances that might (or should) be a reason to believe that a patient is a drug-dependent person, especially when multiple circumstances apply, are when the person:
- has admitted current misuse or abuse of pharmaceutical medicines and/or illicit drugs
- has engaged in prescription-shopping and/or obtaining prescription medicines from illicit sources
- shows physical signs of intravenous drug use
- has forged prescriptions or obtained drugs of dependence by false representation
- has had multiple unsanctioned dose escalations of prescribed medicines
- is being treated with opioid-replacement therapy for opioid dependence.
Drugs of dependence
The term 'drug of dependence' is used to describe Schedule 8 medicines plus some Schedule 4 and Schedule 3 medicines that are subject to misuse and trafficking. Schedule 4 medicines in this category include benzodiazepines, phentermine (Duromine), pseudoephedrine, testosterone and other anabolic steroids.
Before prescribing a drug of dependence, a medical practitioner must take all reasonable steps to ensure that a therapeutic need exists and to confirm the identity of the patient. Issuing a prescription merely because another prescriber has done so is unlikely to satisfy these requirements.
Drug-dependent person – treatment
It is an offence to prescribe a drug of dependence merely to support the drug dependence of a person.
Treatment of a drug-dependent person should involve meaningful objectives and appropriate strategies to reduce the risks associated with providing drugs of dependence to a drug-dependent person. Such strategies typically include limiting a patient’s access so that drugs of dependence are prescribed by a single practitioner and supplied, in a controlled manner, by a single pharmacy. A collegiate approach between prescriber and pharmacist is often an important component of sound treatment of a drug-dependent person.
Unless a prescriber holds a current Schedule 8 treatment permit to treat a drug-dependent person, they must notify MPR if there is reason to believe that a patient is a drug-dependent person and the patient seeks a drug of dependence or the medical practitioner intends to prescribe a drug of dependence.
Schedule 8 treatment permits
Where there is reason to believe that a patient is a drug-dependent person, a medical practitioner must obtain a permit before prescribing a Schedule 8 medicine, unless a specific exception applies.
There are additional requirements for Schedule 8 treatment permits where a patient is not believed to be a drug-dependent person (see 'Patient Schedule 8 Treatment Permits').
Drug dependence – notification
A prescriber must notify MPR if there is reason to believe that a patient is a drug-dependent person and the patient seeks a drug of dependence or the medical practitioner intends to prescribe a drug of dependence.
This notification is a legislative requirement, which provides information to MPR. Notification enables MPR officers to assist prescribers who might seek advice or apply for a permit to treat a person, or to intervene to address concurrent prescribing, when it is identified.
The notification also informs MPR when a medical practitioner intends to treat a drug-dependent person with a drug of dependence, in which case the corresponding box must be ticked.
A medical practitioner or a nurse practitioner must also make a notification when they are aware that a prisoner is to be released from custody, and they have prescribed methadone or buprenorphine for opioid dependence to that prisoner –
(a) prior to that prisoner’s release from custody; or
(b) for a period not exceeding 7 days after that prisoner’s release from custody.
The gazettal notice for this is available from here.
Opioid dependence – treatment
Methadone and buprenorphine (Suboxone, Subutex) are the Schedule 8 medicines that have been registered in Australia for opioid-replacement therapy (ORT).
To address the inherent risks associated with the vulnerability of the patients and the potential toxicity of the medicines (especially methadone), most Schedule 8 treatment permits to prescribe ORT are issued only to medical practitioners who have completed the training and assessment required to become an ‘approved prescriber’.
However, an exception now enables general practitioners who are not approved prescribers to obtain a Schedule 8 treatment permit to prescribe Suboxone (only) for up to five patients (see ‘Suboxone prescribing by general practitioners’).
For more information, see the following passage and Pharmacotherapy.
Suboxone prescribing by general practitioners
Whereas Subutex contains buprenorphine as the only active ingredient, Suboxone also contains naloxone, which was added to the formulation to deter injection of the medicine.
In recognition of the lesser risk of diversion of Suboxone and the less complicated pharmacokinetics of Suboxone use, any medical practitioner (after first obtaining a Schedule 8 treatment permit in relation to each patient) may prescribe Suboxone (sublingual films) for up to five patients without completing the training or assessment required to prescribe methadone or Subutex.
To ensure that prescribing of Suboxone is safe, appropriate and consistent with current policy and guidelines, medical practitioners who are not approved ORT prescribers should seek advice from an approved prescriber (or DACAS) before prescribing to a patient. Guides (in document and video format) are also available, see Pharmacotherapy.
Obtaining information for patients under treatment
In addition to its Prescription Shopper Information Service (PSIS), Medicare Australia can provide a patient’s treating medical practitioner with detailed information about that patient’s consulting and prescription history with other medical practitioners. Obtaining such information requires the consent of the patient, but might be essential to the safe management of the patient.