Schedule 8 Medicines
Prescribing Code
Pharmaceutical Services Branch
Version: C20121121AG-3
Citation
Department of Health, (2014), Schedule 8 Medicines Prescribing Code, Pharmaceutical Services
Branch, Public Health and Clinical Services Division, Department of Health, Perth, Western Australia
___________________________________________________________________________________
Contents
Forward ....................................................................................................................................... 1
Access ........................................................................................................................................ 1
Definitions .................................................................................................................................. 2
1. Requirements for the prescribing of Schedule 8 medicines .............................................. 4
Diagnosis.................................................................................................................................. 4
Authorisation for the prescribing of Schedule 8 medicines ....................................................... 4
1.1
High risk criteria ......................................................................................................... 4
1.2
Low risk criteria .......................................................................................................... 5
1.3
Application for authorisation to prescribe Schedule 8 medicines ............................... 5
2. Consultant support ................................................................................................................ 6
2.1
Initial support .............................................................................................................. 6
2.2
Support on renewal .................................................................................................... 6
2.3
Hospital discharge ...................................................................................................... 6
3. Consultant status ................................................................................................................... 7
3.1 Pain................................................................................................................................. 7
3.2 Addiction medicine specialists ........................................................................................ 7
3.3 Prescribing flunitrazepam ............................................................................................... 7
3.4 Prescribing alprazolam ................................................................................................... 8
4. Terminal illness ...................................................................................................................... 8
5. Opioid contracts and limited dispensing ............................................................................. 8
6. Prescribing Schedule 8 benzodiapines ............................................................................... 8
6.1 Prescribing flunitrazepam .............................................................................................. 8
6.2 Prescribing alprazolam (effective 1 February 2014)....................................................... 9
7. General regulatory matters ................................................................................................... 9
8. Resources............................................................................................................................. 10
9. Contacts................................................................................................................................ 11
10. Sending applications ......................................................................................................... 11
Appendix 1: Schedule 8 Quick reference guide to low and high risk criteria ..................... 12
Forward
Schedule 8 medicines (drugs of addiction) are regulated by the Poisons Act 1964 and the
Poisons Regulations 1965 (state legislation). The information in this document relates to
the Western Australian (WA) legislation.
Schedule 8 (S8) medicines are defined by the Poisons Act 1964 as:
“Substances which should be available for use but require restriction of manufacture, supply,
distribution, possession and use to reduce abuse, misuse and physical or psychological
dependence”.
In Western Australia, S8 medicines include:

opioids

stimulants (methylphenidate and dexamphetamine)

benzodiazepines (flunitrazepam and alprazolam).
The prescribing, storage and dispensing of S8 medicines are subject to a greater level of control
than that of Schedule 4 medicines. The Poisons Act 1964 and the Poisons Regulations 1965
stipulate the legal requirements for the prescribing of S8 medicines.
This Code does not apply to:

off label use

unregistered products

stimulant medicines (please refer to the Stimulant Prescribing Code)

buprenorphine or methadone prescribed as part of the Community Program for Opioid
Pharmacotherapy (CPOP).
The Stimulant Prescribing Code and further information on the CPOP may be found at the
Pharmaceutical Services Branch website at www.health.wa.gov.au/pharmacy
Access
This document can be made available in alternative formats on request for a person with a
disability.
1
Definitions
The following terms are defined for the purposes of this Code:
“Application” means an “Application for authorisation to prescribe a Schedule 8 medicine”
form.
“CEO” means the Chief Executive Officer of the Department of Health or the delegate of the
Chief Executive Officer of the Department of Health.
“the Code” means the Schedule 8 Medicines Prescribing Code
“Consultant” means a medical practitioner registered with the Australian Health Practitioner
Regulation Agency (AHPRA) with specialty qualifications and recognised as a consultant by the
Department of Health for the purpose of this Code.
“CPOP” means the Community Program for Opioid Pharmacotherapy administered by the
Department of Health.
“Diagnosis” means a medical condition, which has been determined by a practitioner as the
cause for the signs and symptoms presented.
“Doctor-shopper” means a patient who has obtained prescriptions for S8 medicines from
three or more doctors from different practices over a three-month period.
“the Department” means the Department of Health, Western Australia.
“ICD-10” means the International Statistical Classification of Diseases and Related Health
Problems 10th Revision.
“Immediate release (IR)” means the formulation is rapidly absorbed and quickly effective but
requires repeated doses.
“Morphine equivalents (MEqD)” means the equianalgesic morphine dose in mg per day.
“Off-label use” means an indication not approved by the Australian Register of Therapeutic
Goods (ARTG)
“Opioid” refers to both natural and synthetic drugs whose effects are mediated by specific
receptors in the central and peripheral nervous system commonly used for pain.
“Parenteral” means delivery of medicines by the intravenous, intramuscular, subcutaneous,
or intrathecal route.
“Practitioner” refers to a medical practitioner or nurse practitioner registered with the
Australian Health Practitioner Regulation Agency.
“Prior written authorisation” means that the practitioner must obtain written authorisation from
the CEO to prescribe before he/she is permitted to prescribe this medicine to the patient.
2
“PRN” (Pro re nata) means when necessary.
“Registered drug addict (RDA)” means a person who has been notified and registered in
accordance with the Drugs of Addiction Notification Regulations 1980.
“Schedule 8 (S8) medicine” as specified by the Standard for the Uniform Scheduling of
Medicines and Poisons (SUSMP), including:

alprazolam

codeine (when not combined with any other medicine)

buprenorphine

fentanyl

flunitrazepam

hydromorphone

methadone

morphine

oxycodone

pethidine
 tapentadol
or
 salts of any of these substances and any preparation or admixture containing any of
these substances, or the salts of any of these substances.
“Substance misuse”

History of substance abuse including:
o substance abuse within the previous five years
o being a registered drug addict
o being a current participant in the CPOP.

History of the diversion of S8 medicines within the previous five years.
“Sustained release (SR)” means the drug is released over several hours to maintain a
constant plasma concentration of the drug.
“Terminal illness” means an illness giving rise to a life expectancy of 12 months or less.
3
1. Requirements for the prescribing of Schedule 8 medicines
Diagnosis
Before prescribing S8 medicines in the treatment of pain, a relevant diagnosis is to be made.
A useful aid is the ICD -10. The diagnosis must be included on the application.
Authorisation for the prescribing of Schedule 8 medicines
Prior written authorisation from the CEO is required for practitioners to prescribe a S8 medicine
in accordance with the Poisons Regulations 1965 for:

a patient whose details correspond with a registered drug addict
 a period longer than 60 days (or for more than 60 days in any 12-month period)
or
 flunitrazepam.
When practitioners intend to prescribe a S8 medicine in these circumstances, an application to
the CEO must be made for authorisation.
1.1
High risk criteria
Authorisation requires consultant support (refer to section 2) where:

a patient is less than 18 years of age

a patient whose details correspond to those of a RDA

a patient is identified as a doctor shopper

a patient has a history of substance misuse

the total combined daily dose of S8 medicines is greater than 90 MEqD (excluding
terminal illness)

the treatment is with immediate release (IR) preparations at a total combined daily dose
greater than 45 MEqD (excluding terminal illness)

the treatment is with a combined immediate release/sustained release (IR/SR) regimen
where the IR form constitutes more than 50% of the total combined daily dose (excluding
terminal illness)
 the treatment is with a parenteral form of S8 medicine (excluding terminal illness)
or
 as requested by the CEO.
The Department reserves the right to request a second opinion or review by a multidisciplinary
pain service at its discretion to assist in determining an appropriate treatment management
plan.
4
1.2
Low risk criteria
Streamlined S8 authorisations will be provided (without the requirement for consultant support)
where:

the patient is aged 18 years or over

the patient is not a RDA

the patient is not identified as a doctor shopper

the patient has no history of substance misuse

the form of medication is not parenteral (excluding terminal illness)

the total combined daily dose of S8 medicines is less than or equal to 90 MEqD
(excluding terminal illness)

no more than 50% of the total combined daily dose of up to 90 MEqD is in the form of an
immediate release (IR) preparation (excluding terminal illness)
or
 the total combined daily dose of IR preparations prescribed alone is less than or equal to
45 MEqD (excluding terminal illness).
1.3
Application for authorisation to prescribe Schedule 8 medicines
An application for authorisation is required to be completed when a practitioner wishes to
prescribe a S8 medicine as set out in the Code.
A new application will be required to be completed when:

a patient’s treatment within the high risk criteria has changed

the patient moves from ‘low risk’ into ‘high risk’

there is a change in drug

there is a change in drug form

there is a change in drug dose

there is a change in the patient’s name details

the previous authorisation has expired
 the authorised practitioner changes practice address
or
 the patient moves to a different medical practice.
5
2. Consultant support
Practitioners are required to provide consultant support for any patient who meets one or more
of the criteria in the list of high risk criteria (refer to Appendix 1: S8 Quick reference guide to
low and high risk criteria for the full list of criteria).
Consultant support should provide details of the:

patient’s diagnosis and need for ongoing treatment with S8 medicines

drug, dose and frequency of administration of the S8 medicine(s) required

length of time that a consultant will support an application. If no shorter length of time is
specified, the Department will accept the most recent consultant’s support for a
maximum of three years.
Where a patient is a RDA, identified doctor shopper or has a history of substance misuse
evidence must be provided to show these issues have been addressed.
Authorisations will not be issued where patients fail to attend scheduled consultant
appointments. It is the responsibility of the practitioner and the patient to ensure ongoing
consultant review if required.
2.1
Initial support
Consultant support is required before authorisation for all patients who fit the high risk criteria
unless otherwise determined by the CEO.
2.2
Support on renewal
Consultant support is required for renewal of authorisation for treatment with S8 medicines for
all patients with high risk criteria and as determined by the CEO.
2.3
Hospital discharge
A hospital discharge summary dated no more than three months prior to the application date,
plus evidence of referral to a consultant will be considered with applications to prescribe for
patients who satisfy any high risk criteria and who have recently been released from hospital.
The discharge summary and evidence of referral must accompany the application form.
6
3. Consultant status
3.1 Pain
The following specialists are recognised as being able to provide consultant support for high risk
applications provided that the speciality is relevant to the diagnosis under treatment:

anaesthetist

endocrinologist

gastroenterologist

neurologist

oncologist

pain medicine specialist

palliative care specialist

physician

rheumatologist

surgeon

other specialists as approved by the CEO.
3.2 Addiction medicine specialists
Practitioners who are a Fellow of the Australasian Chapter of Addiction Medicine (FAChAM) will
be recognised as consultants for the management of Schedule 8 treatment for pain for patients
who are registered drug addicts and patients with a recent history of substance abuse, diversion
or doctor shopping, provided:

S8 treatment is prescribed for pain not for addiction

the patient is reviewed within 12 months by a multidisciplinary pain clinic or a specialist
appropriate for the pain diagnosis.
All other applications will be treated in accordance with Departmental policy.
3.3 Prescribing flunitrazepam
For the purposes of this policy the following specialties are recognised as being able to provide
consultant support for the prescribing of flunitrazepam:

psychiatrist

sleep medicine physician

neurologist.
7
3.4 Prescribing alprazolam
For the purposes of this policy the following specialties are recognised as being able to provide
consultant support for the prescribing of alprazolam:

psychiatrist

other specialists as approved by the CEO.
4. Terminal illness
If a patient during the course of treatment becomes terminally ill (i.e. has a life expectancy of
less than 12 months) then a practitioner is required to notify the Department accordingly by
completing an application. A specific drug and dose will be authorised where indicated on the
application. Where S8 medicines are being titrated, then the name of the drug together with
‘PRN’ should be indicated on the application to enable flexibility in treatment.
Palliative care practitioners from the same practice or team can apply for a group authorisation
to allow all prescribers in the group to prescribe for a patient who is terminally ill.
Applications for terminal illness are considered low risk unless the patient:

is less than 18 years of age

is a RDA
 is identified as a doctor shopper
or
 has a history of substance misuse.
In these instances the patient will be considered in the high risk category and consultant support
will be required.
5. Opioid contracts and limited dispensing
An opioid contract should be used in all cases where an S8 is prescribed.
Written opioid contracts between patient and prescriber are used routinely by specialist pain
clinics and represent best practice, as the contract clearly sets out the patient’s and prescriber’s
responsibilities. They also serve to document informed consent.
In certain circumstances, patients may be required to have a limited amount of their medication
dispensed at a time and this may be conditioned as a requirement of the authorisation. This is
to assist in reducing the likelihood of a patient requesting additional prescriptions due to
medication being used up ahead of time before the next prescription is due.
6. Prescribing Schedule 8 benzodiazepines
6.1 Prescribing flunitrazepam
In accordance with the Poisons Regulations 1965, prior written authorisation from the CEO is
required by practitioners wishing to prescribe flunitrazepam for each individual patient. This
8
unique authorisation number must be hand written by the prescriber on the prescription prior to
presentation at a pharmacy. If there is no authorisation number the pharmacist must refuse to
dispense and will be required to contact the practitioner.
An authorisation will only be issued if the application is accompanied by written support from an
appropriate consultant i.e. psychiatrist, sleep medicine physician or neurologist
(see section 3.3).
6.2 Prescribing alprazolam (effective 1 February 2014)
Written authorisation from the CEO is required by practitioners wishing to prescribe alprazolam
for each individual patient for a period greater than 60 days. This authorisation number does not
need to appear on the prescription. Consultant support is not required for applications if
prescribing is for approved indications and in dosages within the normal therapeutic range.
Practitioners wishing to prescribe alprazolam for a RDA for any period of time will require prior
authorisation and appropriate consultant support (see section 3.4).
7. General regulatory matters

The CEO may revoke or cancel an authorisation issued to a practitioner.

A practitioner who has completed an application or who has received a written
authorisation from the CEO may request in writing that their application or authorisation
be cancelled.

Practitioners should notify the CEO in writing if replacement prescriptions are required for
lost, stolen or otherwise inaccessible medication.

Pharmacists are required to be familiar with the practitioner’s handwriting or must verify
with the practitioner that the prescription is valid. Repeat prescriptions must be retained
at the pharmacy.

Practitioners are required to specify intervals between prescription repeats when writing
prescriptions for S8 medicines including directions for use. Prescriptions are valid for six
months from the date that they are written.

To prescribe S8 medicines for clinical research, an application will require submission of
a copy of the research proposal with approval from an Ethics Committee constituted in
accordance with the Guidelines issued by the National Health and Medical Research
Council (NHMRC)

An application to prescribe a S8 medicine when high risk criteria are met must be
forwarded to the CEO by the practitioner for further consideration.
The application must be accompanied by any relevant consultant reports available or as
requested.
9
8. Resources
The following resources are available from www.health.wa.gov.au/S8

Application to prescribe a schedule 8 medicine

Treatment contract for the use of an opioid medicine

Morphine equivalent dose conversion calculator

Notification of addiction to drugs

S8 Quick reference guide to low and high risk criteria
The Poisons Act 1964, Poisons Regulations 1965 and Drugs of Addiction Notification
Regulations 1980 are available from the State Law Publisher at www.slp.wa.gov.au
The ICD-10 is available at www.who.int/classifications/icd/en/
10
9. Contacts
Pharmaceutical Services Branch
PO Box 8172 Perth Business Centre WA 6849
Tel: (08) 9222 4424 (Monday – Friday 8.30am to 4.30pm)
Fax: (08) 9222 2463
10. Sending applications
Applications may be submitted by:
Mail: Pharmaceutical Services Branch
PO Box 8172 Perth Business Centre WA 6849
Facsimile: (08) 9222 2463
11
Appendix 1: S8 Quick reference guide to low and high risk criteria
If any high risk criteria are ticked, consultant support must accompany an, “Application for
authorisation to prescribe a Schedule 8 medicine” form.
Criterion
Low risk criteria
High risk criteria
(no consultant support required) (consultant support required)
Patient age
 18 years or over
 Less than 18 years
Patient is an RDA1
 No
 Yes
Dose*
 Total combined daily dose less
than or equal to 90 MEqD2
 Total combined daily dose
greater than 90 MEqD2
Form of medication*
 Not parenteral
 Parenteral
IR3 formulations only*
 Total daily dose less than or
equal to 45 MEqD2
 Total daily dose greater than
45 MEqD2
Combined SR4 and
IR3 formulations*
 Total combined daily dose
 Total combined daily dose
3
where the IR form constitutes
where the IR3 form is greater
up to 50% of a IR3/SR4 regimen
than 50% of a IR3/SR4
regimen
Patient identified
doctor-shopper5
 No
 Yes
History of substance
abuse
 No
 Yes
History of diversion or
misuse of Schedule 8
medicines
 No
 Yes
*excluding terminal illness
1RDA:
Registered drug addict
2MEqD:
3IR:
Equianalgesic morphine dose per day
Immediate release formulation
4SR:
Sustained release formulation
5Doctor-shopper:
A patient who has obtained Schedule 8 prescriptions from three or more
doctors from different practices over a three month period.
12