Legal requirements for the prescription and supply of drugs of dependence
Regulation aims to minimise the induction of drug dependence, abuse or diversion of prescribed drugs for non-medical purposes through the granting and revocation of authorities to prescribe drugs of dependence.
Prescribing of drugs of dependence?
A prescriber must not (unless an emergency exists) prescribe or supply a drug of dependence in the following situations:1
- having not first examined the patient or animal and determined that it is clinically necessary
- for self- treatment
- for the treatment of their spouse or other family member unless authorised by the Minister
- for the purpose maintaining or treating drug dependence unless authorised by the Minister
Prescriptions for drugs of dependence are valid for a maximum period of six months from the date of prescribing.2
What to include on prescriptions?
Prescriptions must include3:
- prescriber name, address, telephone number and signature
- date on which the prescription is written
- patients full name and address
- patient’s date of birth
- the quantity to be supplied in words and numerals
- in the case of veterinary prescriptions to treat an animal; the species of animal, name if applicable, and the name and address of the owner of the animal
In addition to the above, Medication Assisted Treatment for Opioid Dependence (MATOD) prescriptions should also include the:
- dose in milligrams, and for methadone, millilitres as well to minimise error,
- doses to be administered under supervision
- number of take away doses that may be provided each week
- expiry date of the prescription. This date is the date after which no more drug can be supplied and should coincide with the date that the patient is to be reviewed
- name of the pharmacy that can dispense the prescription
What is an authority?
An authority4 is a legal document granted by the Minister allowing prescribers to treat a particular patient with specified drugs of dependence; it is not intended to provide clinical endorsement of the treatment being prescribed, this is the responsibility of the prescriber.
An authority issued under section 18A of the Act stipulates the conditions under which prescribing of a drug of dependence must occur, including dosage and quantity. It is not the same as an authority issued by Medicare Australia that issues its authorities for the subsidy of medications under the Pharmaceutical Benefits Scheme (PBS). Please refer to the PBS information line for more information on 1800 020 613.
When do I need an authority?4
It is an offence to prescribe or supply (including administering from the prescribers’ own supply), drugs of dependence for a patient for regular treatment exceeding two months without authority from the Minister.4
Treatment provided by other prescribers must be considered when calculating the two-month period.
Veterinary surgeons are not required to hold authorities to treat animal patients.
How do I get an authority?
Applications must be made to the Minister via the Drugs of Dependence Unit. Applications are to be made in writing only and signed by the applying prescriber.4
See below for a list of forms to apply or renew your authority.
Can I prescribe a drug of dependence for the purpose of treating drug dependence?
Treating drug dependence, be it illicit, licit or iatrogenic dependence, requires an authority from the Minister in the first instance; it is an offence to prescribe for this purpose without an authority for any period.4
A person is drug dependent if he or she has acquired, as a result of the repeated administration of prescription drugs or controlled drugs, an overpowering desire for the continued administration of any such drugs and is likely to suffer mental or physical distress or disorder upon cessation of the administration of the drug; or has consumed prescribed drugs in a manner that presents a risk to that person’s health.
What is drug diversion?
Drug diversion is a term used to describe a significant and growing problem which involves the sale or supply of prescription drugs to persons to whom they are not prescribed. Prescription opioid drugs have significant “street value” and may be sold on the black market for illicit recreational use; they may also be traded for other drugs.
Are there circumstances in which I am exempt from requiring an authority?5
Yes. An authority is not required when prescribing or supplying a drug of dependence in the following circumstances:
- a patient aged 70 years or more and the drug involved is not pethidine
- a patient whose life expectancy is less than 12 months if the drug is not pethidine and the prescriber has informed the Minister of the patient’s name, address, date of birth and the nature of the condition for which the drug is prescribed. In these cases, the prescriber must endorse the prescription either “Notified Palliative Care Patient” or “NPCP”
- an inpatient in a hospital or correctional institution where the duration of treatment with a drug of dependence does not exceed 14 days
- a patient discharged from a hospital following an inpatient stay and the duration of treatment after discharge does not exceed 14 days
What are the legal ramifications if I do not obtain an authority or do not prescribe in accordance with an authority?
The prescription and supply of drugs of dependence are regulated to minimise harms associated with their use. There is growing evidence to suggest that prescription drug abuse is a significant public health issue with over 25% of deaths now linked to prescribed opioid drugs.6
The Drugs of Dependence Unit seeks the co-operation of prescribers when administering legislation and aims to work with prescribers to promote quality use of medicines principles.
In cases where this cannot be achieved, legislation determines penalties that may apply including Prohibition Orders that effectively remove the ability to handle certain drugs, notification to the Australian Health Practitioner Regulation Agency (AHPRA), fines and imprisonment.
S18A application for authority forms
- non-MATOD authority application form
- Medication Assisted Treatment for Opioid Dependence (MATOD) authority application form
1 Controlled Substances (Poisons) Regulations 2011 (SA) , r37
2 Controlled Substances (Poisons) Regulations 2011 (SA) , r35 7B
3 Controlled Substances (Poisons) Regulations 2011 (SA) , r35
4 Controlled Substances Act 1984 (SA), 18A
5 Controlled Substances (Poisons) Regulations 2011 (SA) , r22
6 Coroners Reports, Notifications to the Drugs of Dependence Unit SA, 2006-2012.