Things medical practitioners need to know
Key prescribing requirements in Victoria 2015.1
This document has been prepared by Drugs and Poisons Regulation (DPR) to assist medical practitioners to understand key legislative requirements associated with writing prescriptions. It also refers to legislative requirements, which are detailed in similar documents (see page 4) on the DPR website (at For simplicity of reading, this document does not refer to all legislative requirements; merely those that are relevant to the majority of medical practitioners, especially general practitioners. For full details, reference should be made to the Drugs Poisons and Controlled Substances Act 1981 and Regulations 2006 (at
Drugs that require prescriptions
Note: The following lists are not exhaustive and show only some brand names (in brackets). There are other Schedule 4 and Schedule 8 poisons and there may be lesser-known brand names of the listed drugs.
Schedule 8 poisons (labelledControlled Drug) have stricter legislative controls than other commonly available drugs, including but not limited to morphine (Kapanol®, MS-Contin®), pethidine, oxycodone (OxyContin®, OxyNorm®, Endone®), buprenorphine (Subutex®, Suboxone®, Norspan®), fentanyl (Durogesic®) and hydromorphone (Jurnista®) plus two benzodiazepines, alprazolam (Kalma®, Alprax®) and flunitrazepam (Hypnodorm®). A permit might be required to prescribe Schedule 8 poisons (see page 3)
Methadone (Physeptone®), nabiximols (Sativex®), amphetamine, dexamphetamine, lisdexamfetamine, methylamphetamine, methylphenidate (Ritalin®) and sodium oxybate are Schedule 8 poisons that most medical practitioners must not prescribe without first obtaining a permit.
Schedule 4 poisons (labelled Prescription Only Medicine) include other drugs for which prescriptions are usually required, e.g. diuretics, oral contraceptives, antibiotics, compound analgesics (e.g. Panadeine Forte®), pseudoephedrine and many others.
The term “drugs of dependence” is used to describe drugs found in Schedule 8 plus some drugs that are found in Schedule 4 that are subject to misuse and trafficking. The Schedule 4 poisons in this category include all benzodiazepines that are not in Schedule 8, propoxyphene (Digesic®), phentermine (Duromine®), testosterone and other anabolic steroids.
Not to be confused with the Pharmaceutical Benefits Scheme
The Drugs Poisons and Controlled Substances Act and Regulations govern the legality of prescribing and supplying medicines containing scheduled poisons in Victoria. Failure to comply with the legislation renders a person liable to prosecution.
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 medications. Note:
  • 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.
  • Medical practitioners are not obliged to prescribe the maximum PBS quantity of a medicine or any repeats – especially when a smaller quantity can address an immediate need whilst minimising the potential risks associated with drug-seeking behaviour.
Writing prescriptions
Medical practitioners are not authorised to prescribe a Schedule 4 or Schedule 8 poison merely because a person requests a prescription.
Before prescribing, a medical practitioner must take all reasonable steps to ensure a therapeutic need exists and, before prescribing a drug of dependence, must takeall reasonable steps to confirm the identity of the patient. Issuing a prescription, merely because another prescriber has done so, is unlikely to satisfy these requirements.
Medical practitioners who issue prescriptions are personally responsible for ensuring that the prescribed medicine is safe, appropriate and lawful. They should, therefore, ensure they are aware of the active ingredient/s and effects of prescribed medicines - especially when multiple brand names exist for many drugs – and by wary when issuing a prescription for an unfamiliar medicine.
Examples of unlawful prescribing
A medical practitioner must not prescribe a Schedule 4 or Schedule 8 poison - other than for the medical treatment of a patient under his/her care. Accordingly, it is not lawful to prescribe:
  • anabolic steroids for bodybuilding purposes or to enhance sporting performance
  • stimulants merely to enhance or prolong wakefulness in long distance drivers and others
  • drugs of dependence merely to support the drug dependency of a person
  • for persons who are not under his/her care, e.g. a person who has not consulted the medical practitioner and whose therapeutic need and/or identity cannot be confirmed.
Prescriptions for Schedule 4 and Schedule 8 poisons:
  • Must contain full details of the prescriber (including address andphone number)
  • Must contain the patient’s name and address
  • Must identify the medication unambiguously
  • Must show the quantity and number of repeats (in words and figures forSchedule 8 poisons)
  • Must be signed and dated by the prescriber
  • Must contain precise directions for use (except where complex directions are provided separately in writing - or if administration is to be carried out by a doctor or nurse).
Computer-generated prescriptions:
  • Must meet specified criteria; for full details, refer to the “Approved by the Secretary” section on the DPR website (
  • Must not be manually amended; if an error is made, the prescription must be destroyed and reprinted.
  • Must contain specified elements in the prescriber’s handwriting for Schedule 8 and Schedule 4 drugs of dependence (see page 1 of this document for the definition of drugs of dependence).
Permits and notifications for Schedule 8 poisons
The legislation aims to minimise concurrent prescribing of Schedule 8 poisons 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 poison.
Please refer to the DPR website (at and the document “Schedule 8 treatment permits” for details of requirements and exceptions.
Permit application forms and notification forms may be submitted online or downloaded from the DPR website (at
Checklist for general practitioners
The final two pages of this document have been designed to be used as a general practitioner checklist for Schedule 8 treatment permits.
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.
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 (at

Schedule 4 poisons with special restrictions

Retinoids (e.g. acitretin, oral isotretinoin), ovulatory stimulants (clomiphene, cyclofenil), prostaglandins (e.g. dinoprost) plus thalidomide and lenalidomide are Schedule 4 poisons 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 drug, in which case each prescription must be endorsed with the warrant number.
A medical practitioner without a warrant may only prescribe one of these drugs 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.

Miscellaneous

Over-the-counter medicines
Schedule 2 and 3 poisons (labelled Pharmacy Medicine or Pharmacist Only Medicine respectively) must only be supplied (in an open shop) by pharmacists. Medical practitioners may use or supply Schedule 2 and 3 poisons in a similar manner to Schedule 4 poisons.
Prescribing for self-administration prohibited
Medical practitioners are not permitted to prescribe any Schedule 4 or Schedule 8 poisons for the purpose of self-administration (regardless of whether the treatment was initiated by another practitioner).
Other documents on the DPR website
The DPR website ( contains the following documents (and others), to assist medical practitioners in understanding various aspects of their legislative requirements:
  • “Schedule 8 treatment permits”(including general and specific exceptions)
  • “General practitioner checklist: Schedule 8 treatment permits”
  • “Stimulants to treat ADHD or narcolepsy” (including permit and notification requirements)
  • “Drug seeking patients: obtaining information” (from both DPR and Medicare Australia)
  • “Treating a drug-dependent person” (prescribing drugs of dependence or opioid-replacement therapy)
  • “Scams by drug seeking patients” (examples of previously noted scams)
  • “Managing drugs in general practice clinics” (including storage and recording requirements)
  • “Software to be used by health practitioners” (including computer-generated prescriptions)
Key contacts
  • To seek legislative advice on the Drugs Poisons and Controlled Substances Act & Regulations, or information about Schedule 8 permits for the treatment of individual patients, contact DPR via Email (), fax (1300 360 830) or, for urgent advice, phone 1300 364 545 (Monday to Friday during office hours).
  • For information about suspected drug-seeking patients, contact Medicare Australia’s Prescription Shopper Information Service 1800 631 181 orthe DPR Help Line - 1300 364 545 (option 1). Please refer to the document “Obtaining information relating to drug-seeking patients” for more details.
  • To obtain clinical advice from specialist consultants, registered health practitioners (only) may phone the DACAS at any time on 1800 812 804
  • For 24-hour confidential drug and alcohol counselling and advice about available treatment facilities, patients, family or health practitioners may phone Direct Line - 1800 888 236
  • For information relating to prescribing under the Pharmaceutical Benefits Scheme (PBS), refer to the Medicare Australia website (at or contact Medicare Australia on 132 290 (General) or 1800 888 333 (Authorities).

For further information

Department of Health & Human Services (DHHS)
Drugs and Poisons Regulation
GPO Box 4057
Melbourne 3001
Tel: 1300 364 545
Fax: 1300 360 830
Email:
Web:

General practitioner checklist: Schedule 8 treatment permits

Start with question 1 - continue until you can answer ‘yes’ - and you will have your answer with no need to proceed to the following question.





See the following page for details of general exceptions and specialist exceptions plus an indication of where to locate additional 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 poison (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.
Note:
  • 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 poisons.
  • The National Prescribing Service recommendation, that daily doses should not exceed 100mg in morphine equivalence (e.g. 60 mg of oxycodone) without specialist advice, could serve as a guide to what might be considered a higher dose.

Specialist exceptions

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.
Note: A permit (or notification) is still required to treat a drug-dependent person or to provide treatment with any of these drugs 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 medications, the risk of concurrent prescribing is significantly reduced. Accordingly, a permit is not required to prescribe Schedule 8 poisons 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.
Note: The checklist does not cover every situation to which Schedule 8 treatment permits might relate. See the DPR website (at for more information dealing with other legislative requirements for with prescribing drugs of dependence and treating drug-dependent persons.
To receive this publication in an accessible format contact Drugs and Poisons Regulation on 1300 364 545. Authorised and published by the Victorian Government, 1 Treasury Place, Melbourne.
July 2015