Different schedules and legal requirements
Examples of Schedule 4 and Schedule 8 medicines can be found in the section titled ‘Scheduled Medicines’. A full list of Schedule 4 and Schedule 8 poisons can be found in the Poisons Standard.
Schedule 8 medicines
Schedule 8 medicines have the strictest legislative controls of commonly available medicines. A permit might be required to prescribe Schedule 8 medicines.
Methadone (Physeptone®), nabiximols (Sativex®), amphetamine, dexamphetamine, lisdexamfetamine, methylamphetamine and methylphenidate (Ritalin®) are Schedule 8 medicines that most medical practitioners must not prescribe without first obtaining a permit.
Schedule 4 medicines
Schedule 4 medicines include other medicines for which prescriptions are usually required.
Drugs of dependence
The term ‘drugs of dependence’ is used to describe Schedule 8 medicines plus some Schedule 4 and Schedule 3 medicines that are subject to misuse and trafficking. For this reason there are stricter controls around their availability.
The Schedule 4 medicines in this category include all benzodiazepines that are not in Schedule 8, phentermine (Duromine®), pseudoephedrine, testosterone and other anabolic steroids.
Schedule 4 medicines with special restrictions
Retinoids (acitretin, bexarotene and etretinate plus isotretinoin and tretinoin for oral use), ovulatory stimulants (clomiphene, cyclofenil), prostaglandins (dinoprost, dinoprostone) plus thalidomide and thalidomide-like substances (lenalidomide, pomalidomide) are Schedule 4 medicines with which treatment may only be initiated by a medical practitioner with the appropriate qualifications and expertise and who holds a warrant to prescribe the medicine, in which case each prescription must be endorsed with that practitioner’s warrant number.
A medical practitioner who does not hold the appropriate warrant, may only prescribe one of these medicines when acting in accordance with the direction of the warrant holder who usually treats the patient, in which case the prescription must be endorsed with the warrant holder’s name and warrant number.
Over-the-counter medicines (Schedule 2 and 3 medicines)
Schedule 2 and 3 medicines must only be supplied (in an open shop) by pharmacists. Medical practitioners may use or supply Schedule 2 and 3 medicines in a similar manner to Schedule 4 medicines.
Victorian legislation is not to be confused with the PBS
The Drugs, Poisons and Controlled Substances Act 1981 and Regulations govern the lawfulness of prescribing and supplying medicines containing scheduled medicines in Victoria.
The Pharmaceutical Benefits Scheme (PBS) is operated by Medicare Australia to subsidise the cost of listed medicines, including Authority Prescriptions for increased quantities of PBS listed medicines. Whether a medicine is prescribed under the PBS, on a PBS Authority Prescription, subsidised by another agency (e.g. WorkCover) or prescribed on a ‘private’ prescription has no bearing on whether it is lawful to prescribe or supply the medicine. Failure to comply with the legislation renders a person liable to prosecution.
Note: Medical practitioners are not obliged to prescribe the maximum PBS quantity of a medicine, especially when a smaller quantity can address an immediate need whilst minimising the potential risks associated with drug-seeking behaviour.
Medical practitioners must not prescribe a Schedule 4 or Schedule 8 medicine merely because a person requests a prescription or because another prescriber has done so.
Before prescribing, a medical practitioner must take all reasonable steps to ensure a therapeutic need exists. Issuing a prescription, merely because another prescriber has done so, is unlikely to satisfy this requirement.
Before prescribing a drug of dependence, a medical practitioner must also take all reasonable steps to confirm the identity of the patient.
Medical practitioners who issue prescriptions are personally responsible for ensuring that the prescribing is safe, appropriate and lawful. They should ensure they are aware of the active ingredient/s and effects of prescribed medicines - especially when issuing a prescription for an unfamiliar medicine.
Examples of unlawful prescribing
Medical practitioners must not prescribe any Schedule 4 or Schedule 8 medicines for the purpose of self-administration (regardless of whether the treatment was initiated by another practitioner).
A medical practitioner must not prescribe a Schedule 4 or Schedule 8 medicine other than for the medical treatment of a patient under his/her care. Accordingly, it is not lawful to prescribe:
- testosterone or other anabolic steroids for bodybuilding purposes or to enhance sporting performance
- stimulants merely to enhance or prolong wakefulness in long distance drivers
- drugs of dependence merely to support the drug dependency of a person
- for persons who are not under the practitioner’s care, e.g. a person who has not consulted the medical practitioner and whose therapeutic need and/or identity cannot be confirmed or established.
Prescriptions for Schedule 4 and Schedule 8 medicines must:
- contain details of the prescriber (including name, address and contact phone number)
- contain the patient’s name and address
- identify the medicine unambiguously
- show the quantity and number of repeats (in words and figures for Schedule 8 medicines)
- be signed and dated by the prescriber
- contain precise directions for use (except where complex directions are provided separately in writing - or if administration is to be carried out by a registered health practitioner).
Computer-generated prescriptions must:
- comply with the published criteria for computer-generated prescriptions
- not be manually amended; if an error is made, the prescription must be destroyed and reprinted
- contain specified elements in the prescriber’s handwriting for Schedule 8 and Schedule 4 drugs of dependence.
Permits and notifications for Schedule 8 medicines
The legislation aims to minimise concurrent prescribing of Schedule 8 medicines by requiring principal prescribers to obtain treatment permits and/or submit notifications in relation to specific patients.
Requirements for Schedule 8 treatment permits and notifications can vary according to the circumstances of the patient or the qualifications of the medical practitioner. Medical practitioners are strongly advised to familiarise themselves with requirements for Schedule 8 treatment permits before prescribing a Schedule 8 medicine.
Prescribing opioid-replacement therapy (ORT)
Most medical practitioners wishing to prescribe methadone, buprenorphine (Subutex®) or buprenorphine in combination with naloxone (Suboxone®) to treat opioid-dependent patients, are required to undertake relevant training and assessment to gain approval from the department as ORT prescribers.
However, in recognition of the greater safety associated with the use of Suboxone® film, any medical practitioner may prescribe Suboxone® for up to 5 patients without undergoing the training or assessment to become an approved ORT prescriber.
Medical practitioners who are not approved ORT prescribers should seek advice from an approved prescriber (preferably in the same practice or through the Drug and Alcohol Clinical Advisory Service (DACAS) before prescribing to a patient. Brief guides, in document and video format, are also available on the DPR website.
General practitioner checklist: Schedule 8 permits
The following checklist has been prepared to assist general practitioners to decide whether a permit should be applied for or obtained. A copy of the checklist can be downloaded at the bottom of this page.
Start with question 1 and continue until you can answer ‘yes’ in Figure 1.
General practitioner checklist - further information
‘Inherited’ patients (including transient and occasional patients)
A medical practitioner who is not initiating treatment and considers it necessary to prescribe a Schedule 8 medicine (other than where a permit must be obtained before prescribing) must immediately apply for a permit if there is reason to believe that his/her prescription will contribute to a patient being treated for a continuous period greater than 8 weeks - including the preceding period of treatment (by any prescriber/s).
To avoid delaying treatment for a genuine patient, a medical practitioner is authorised to continue treating the patient until the outcome of his/her permit application has been determined but he/she must submit a permit application immediately – even if there is no intention to prescribe on subsequent occasions.
- This provision is intended to prevent drug-seeking patients (with or without genuine documentation) from obtaining multiple prescriptions from a clinic on the pretext that their regular treating practitioner is interstate, overseas or otherwise unavailable.
- An explanation or documentation, which indicates that a prescription is required to provide ongoing treatment for a chronic condition, should be sufficient to alert a general practitioner to the need to apply for a permit – especially when patients are seeking prescriptions for higher doses of Schedule 8 medicines.
- The National Prescribing Service recommendation, that daily doses should not exceed 100mg in morphine equivalence (for example, 60 mg of oxycodone) without specialist advice, could serve as a guide to what might be considered a higher dose.
The requirement to obtain a permit before prescribing methadone does not apply when treating a patient under the care of a palliative care service; or a patient at an oncology clinic or a pain clinic at a hospital.
The requirement to obtain a permit before prescribing amphetamines or methylphenidate does not apply where a paediatrician or psychiatrist is prescribing for a person with attention deficit disorder. However a permit (or notification) is still required to treat a drug-dependent person or to provide treatment with any of these medicines for more than 8 weeks – unless another exception applies.
General exceptions – prisons, residential aged care services, hospital inpatients
In circumstances where a person is confined and not personally managing his/her medicines, the risk of concurrent prescribing is significantly reduced. Accordingly, a permit is not required to prescribe Schedule 8 medicines for prisoners being treated in a prison, residents being treated in a residential aged care service and patients receiving inpatient treatment in a hospital (not including day procedure centres). A notification of treatment of a drug-dependent person would still be required, where applicable.
For information about suspected drug-seeking patients, contact Medicare Australia’s Prescription Shopper Information Service.
To obtain clinical advice from specialist consultants, registered health practitioners (only) may phone the DACAS at any time.
For 24-hour confidential drug and alcohol counselling and advice about available treatment facilities, patients, family or health practitioners may phone DirectLine.
For information relating to prescribing under the Pharmaceutical Benefits Scheme (PBS), refer to the Medicare Australia website or contact Medicare Australia.