Opioid Prescribing Legislation and Regulation

There have been many concerns expressed, by coroners as well as others, about the inappropriate prescribing of drugs capable inducing dependence, particularly benzodiazepines and opioids. These highlight the need for doctors to be aware of and understand the requirements imposed on them by the respective state/territory laws.

This article first appeared in GP Update in 2014 and has been updated to reflect changes in legislation.

The purpose of this article is to demonstrate common themes and pitfalls across the various State/Territory regulatory requirements.

Drug Scheduling

A Therapeutic Goods Administration committee¹ categorises drugs into one of eight schedules as part of the Poisons Standard (SUSMP)^2,3, which is amended several times per year. They then pass these recommendations over to each State/Territory to incorporate into their legislation.

Schedule 8 [S8] controlled drugs are considered to have a high potential for abuse and addiction. They include a broad range of drugs – e.g. amphetamines, barbiturates, opioids, and benzodiazepines (flunitrazepam and alprazolam are S8 drugs) – although not all of the drugs in these classes are Schedule 8 drugs.

This article does not discuss S8 stimulant regulation (e.g. dexamphetamine and methylphenidate), nor cannabinoids, which are subject to differing requirements.

Commonwealth requirements

To prescribe under the Pharmaceutical Benefits Scheme (PBS), a doctor may need to obtain federal government authority from Medicare Australia to satisfy certain conditions. Commonwealth PBS authority is different to and does not address state/territory legislative and regulatory requirements, which are separate (and generally more restrictive).

State/territory requirements⁴

The definitions, terms, relevant drugs and requirements vary between states/territories (see the table below).

In general terms, before prescribing you need to consider:

1. Is the patient drug dependent?
   
   If a patient presents and requires the prescription of S8 drugs and your assessment is that the patient is drug dependent (or equivalent term used), then you will need to consider the additional and stringent requirements about obtaining an Authority (or equivalent) before you prescribe. Note that in some states (QLD, VIC, TAS), drug addicted patients seeking S4 drugs of dependency (particularly benzodiazepines) may also require consideration.
   
   
2. Does the patient need to be reported as drug dependent to the authorities?
   
   Some jurisdictions (NT, TAS , VIC, WA,) separately require that a drug dependent patient be reported under certain conditions. 
   
   
3. Does the length of anticipated treatment of a non-drug dependent patient with S8 drugs require approval?
   
   If the patient is not deemed to be drug dependent, then there are strict time limits (generally 2 months, 60 days or 8 weeks) in some jurisdictions (ACT, NSW, NT, SA, Vic, Tas) that S8 drugs can be prescribed before approval is required. This includes the time other doctors have been prescribing Schedule 8 medications for the ongoing period of S8 use.

In NSW an Authority is required for only a very limited list of S8 drugs if the patient is not drug dependent. In WA, some patients being treated with S8 opioids for pain do not require authority, but need to be on a treatment contract at 30 days.


In NT and TAS, out of state prescribers are not able to prescribe S8 drugs.

Given the complex and varying requirements, if you deal with S8 prescribing, it is imperative that you familiarise yourself with the relevant regulations.

References

1. National Drugs and Poisons Scheduling Committee
2. Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
Poisons Standard February 2017 (SUSMP No 16)
3. Due to the disparity of terms and definitions between the various jurisdictions, the following abbreviations have been used (the table uses the specific legislative terms):
4. Drug addicted/dependent/seeking patients are collectively referred to in this article as “drug dependent” patients
5. Authority/Permit /Approval are collectively referred to in this article as an “approval”

 State and Territory Opioid Prescribing Legislation and Requirements

Contacts:

ACT
Health Protection Service
Post: Locked Bag 5005, Weston Creek ACT 2611
Phone: (02) 6205 0998
Fax: (02) 6205 0997
Email: hps@act.gov.au   

NSW
Pharmaceutical Services
Post: Locked Mail Bag 961 North Sydney NSW 2059
Phone: (02) 9391 9944
Fax: (02) 9424 5860
Email: pharmserv@doh.health.nsw.gov.au

NT
Medicines and Poisons Control
Post: PO Box 40596 Casuarina NT 0811
Phone: (08) 8922 7341           
Fax: (08) 8922 7200          
Email: poisonscontrol@nt.gov.au

Qld
Medicines Regulation & Quality Queensland
Post: Locked Bag No. 21 Fortitude Valley BC QLD 4006         
Phone: (07) 3328 9890 
Fax: (07) 3328 9821
Email: MRQ@health.qld.gov.au

SA
Drugs of Dependence Unit
Post: PO Box 6, Rundle Mall, Adelaide South Australia 5000
Phone: 1300 652 584             
Fax: 1300 658 447
Email: HealthDrugsofDependenceUnit@sa.gov.au   

Tas
Pharmaceutical Services Branch
Post: Department of Health and Human Services (PSB) GPO Box 125 Hobart Tas 7001
Phone: (03) 6166 2064 (Chief Pharmacist 03 6166 0400)             
Fax: (03) 6233 3904
Email: pharm.services@dhhs.tas.gov.au                 

Vic
Drugs and Poisons Regulation
Post: (DPR) GPO Box 4541 Melbourne Victoria, 3001  
Phone: 1300 364 545 
Fax: 1300 360 830
Email: dpcs@dhhs.vic.gov.au                  

WA
Medicines and Poisons Regulation Branch
Post: PO Box 8172, Perth Business Centre, WA 6849
Phone: (08) 9222 6883
Email   poisons@health.wa.gov.au