Safe prescribing of high-risk medicines

High-risk medicines listed here are medicines that are subject to stricter regulation to reduce harm and protect public health. When used appropriately, these medicines can improve patient health, function, and quality of life. However, many are associated with a risk of physical or psychological dependence and may cause serious harm if misused.

High-risk medicines include:

Schedule 8 medicines (S8) such as:

opioids - including but not limited to buprenorphine, codeine, fentanyl, hydromorphone, methadone, morphine, oxycodone, pethidine, tapentadol, tramadol
benzodiazepines - alprazolam, flunitrazepam
psychostimulants - dexamfetamine, lisdexamfetamine, methylphenidate
ketamine, cannabis medicines containing nabiximol, dronabinol, tetrahydrocannabinol (THC)

Schedule 4 Appendix D medicines (S4D) such as:

benzodiazepines – e.g., bromazepam, clobazam, clonazepam, diazepam, lorazepam, midazolam, nitrazepam, oxazepam, temazepam
zolpidem, zopiclone, pregabalin, quetiapine, peptides

Schedule 4 Appendix B medicines (S4B), including anabolic and androgenic steroidal agents

Additional legal requirements apply to high-risk medicines

High-risk medicines listed on the monitored medicines list are recorded in SafeScript NSW, the Real-Time Prescription Monitoring (RTPM) system for NSW. SafeScript NSW provides real-time information about a patient’s prescription history for monitored medicines and supports clinical decision-making and patient safety.

Health practitioners need to be aware of the additional regulatory requirements that apply to S8 medicines. These include:

Prescriptions must meet the requirements listed at What is required on a prescription.
In some cases, a NSW Health approval is required to prescribe or supply these medicines, see NSW requirements for approval to prescribe or supply Schedule 8 medicines for more information. Applications for approval can be made via SafeScript NSW or by submitting an application form.
All transactions for all S8 medicines must be recorded in a drug register. This includes procurement, supply, administration, and destruction.
Any loss or theft of S8 or S4D medicines must be reported to Pharmaceutical Services. To make a report and view recent notifications, see Notifying the loss or theft of medicines.

Key points for prescribing and supplying high-risk medicines

Confirm patient identity and any specialist referral correspondence presented by the patient.
Review the patient's medicine history:

Check SafeScript NSW for prescribing and dispensing information.
For new patients seeking continuation therapy, contact the patient’s previous prescriber and/or dispensing pharmacy to confirm treatment.
You may access the patient’s PBS medicine history by contacting the Prescription Shopping Information Service on 1800 631 181 (available 24 hours, 7 days).
Be aware that some high-risk medicines may be obtained through non-prescribed sources, which can increase the risk of harm.
If you have any concerns about the patient’s treatment, consider referring them to a specialist. You may also seek advice and support from the Drug and Alcohol Specialist Advisory Service (DASAS), a free 24/7 specialist phone advisory service.

Ensure the medicine prescribed:

aligns with therapeutic guidelines and practice standards,
is clinically appropriate and safe for that patient,
is for a dose and route of administration that are appropriate for the patient, and
the quantity is appropriate and adequate for the required treatment period or until the patient’s next visit.

For opioids: Calculate the oMEDD (Oral Morphine Equivalent Daily Dose) before prescribing to ensure safe dosing, compare opioid potency, guide dose adjustments, and support clinical decisions. Opioid calculators and supporting documents are available on Australian and New Zealand College of Anaesthetists.
Consider naloxone for patients who use opioids. See Take Home Naloxone Program for more information.
Refer to the RACGP Drugs of dependence: Responding to requests for guidance to requests by patients.
Help prevent prescription forgeries, reduce the risk of diversion, illicit use, and harm by:

keeping prescription stationery secure and inaccessible to the public
storing electronic prescribing passwords safely and updating them regularly
assisting pharmacists to verify prescriptions when requested
reporting lost, stolen, or forged prescriptions and stationery.

Opioid medicine risks

Opioid medicines can be very effective for managing pain, but they carry significant risks if not used correctly. Key risks include:

developing physical or psychological dependence and addiction, even when taken as prescribed,
overdose which can be life threatening,
side effects and drug interactions that may increase risk of serious harm,
obtaining or sharing these medicines through unofficial channels which can be unsafe and illegal.

Fentanyl misuse in NSW

Fentanyl is one of the strongest opioids available in Australia. Because the margin between therapeutic dose and toxic dose is very small, fentanyl carries all the associated opioid risks listed above, and misuse can be particularly dangerous.

Fentanyl patches have a high illicit value and are subject to trafficking. In Australia, the main source of fentanyl patches used illicitly is obtained from prescriptions. To reduce harm and lower the risk of hospitalisations and deaths, the Therapeutic Goods Administration (TGA) implemented restrictions on when fentanyl should be used.

When prescribing or dispensing prescriptions for fentanyl patches, follow the above guidance in Key points for prescribing and supplying high-risk medicines.

Information for patients and consumers on fentanyl is available on healthdirect: Fentanyl and Taking opioid medicines safely.