​​​​​​​​​​​​​​​​ ​​On this page​​

1. ​​ Key changes from 5 November​
   
2. Prescribing and supplying scheduled medicines for continuous use is limited to one month​
3. Drug registers: stocktake required every 3 months
4. New mandatory Standards
   
5. Urgent use medicines from pharmacies ​​restricted to registered products only
6. Changes for dental therapists, oral health therapists and dental hygienists​​​
7. Other changes
8. New offences and p​enalties
9. Terminology and definitions
10. More information​

​​​Key changes​ from 5 November​

Schedule 4D medicine prescriptions will now be valid for 12 months

This is an increase from the previous period of 6 mon​ths. Schedule 4D medicines include those that are anabolic-androgenic steroidal medicines.​

Restrictions on Schedule 8 medicines

Dentists can only issue a prescription supply, or administer a Schedule 8 medicine that is listed in the Dental Schedule of the Pharmaceutical Benefits Scheme​​, unless the medicine is for a patient in a public health entity or private health facility. 

Self-prescribing of Schedule 8 and Schedule 4D medicines is no longer permitted

Dentists cannot self-prescribe Schedule 8 and Schedule 4D medicines or obtain them via wholesale for self-administration.

Only unexplained losses of Schedule 8 and Schedule 4D medicines to be reported

Dentists must now report only unexplained losses of these medicines to Pharmaceutical Services​. However, all losses of Schedule 8 medicines must be recorded in the drug register.

Note: explained losses include residual volume left in the syringe or needle hub, a witnessed and unrecoverable spill etc.

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Prescribing and supplying scheduled medicines for continuous use is limited to one month​

Dentists can only prescribe or supply a scheduled medicine to a patient for a total period of up to one month of continuous therapeutic use. This one-month period includes any previous prescriptions or supplies of the medicine provided by the dentist in previous visits.

Note: under previous legislation this only applied when prescribing a scheduled medicine.

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Drug registers: stocktake required every 3 months​

Dentists must now record the balance of Schedule 8 medicine in a drug register at least once every 3 months.

For private and public hospitals, the stocktake requirement remains 6-monthly and may be conducted in any month (it is no longer limited to March and September).

In private practice an authorised practitioner is responsible for keeping a compliant drug register on the practice premises where Schedule 8 medicines are kept. Please ensure you are aware of any obligations you may have.

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New mandatory Standards

From 5 November, all health practitioners must comply with following:

• ​Medicines Storage Standards - for the safe and secure storage of Schedule 4D and Schedule 8​ medicines.
• Electronic Drug Register Standards - for the requirements on the use of electronic drug registers to record transactions of Schedule 8 medicines.
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Urgent use medicines from pharmacies restricted to registered products only​

Dentists can only request to obtain registered Schedule 4 and 8 medicines for emergency or urgent use from a pharmacy. Unregistered products are no longer permitted to be supplied as urgent use medicines.

The registered medicine isn’t restricted to those listed on the PBS Prescriber Bag​ orders.

Dentists must provide a written and signed order for the pharmacist to supply the registered medicine. A record of the request for this supply must be kept for two years.

If a dentist needs medicines for non-urgent use, you can continue to obtain these from a wholesaler.

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Changes for dental therapists, oral health therapists and dental hygienists

Dental therapists, oral health therapists and dental hygienists can:

• ​obtain supplies of a Schedule 2, 3 or 4 medicine that is a synthetic local anaesthetic
• administer a Schedule 2 or Schedule 3 medicine, or a Schedule 4 synthetic local anaesthetic medicine to a patient as part of their professional practice, and when acting under the direction of a dentist
  
• administer a Schedule 4 or Schedule 8 medicine to a patient under the direction of a dentist, as part of their professional practice​
  
• obtain and administer adrenaline for the treatment of anaphylaxis.

Dental therapists and oral health therapists can obtain supplies tetracycline and triamcinolone for use in preparation for the treatment of dental pulp.

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Other changes​

Removal of requirement to endorse prescription with “For Dental Treatment Only”

Prescriptions issued by dentists are no longer required to be endorsed with the words “For Dental Treatment Only”. Dentists must still exercise their clinical judgment and only prescribe within their scope of practice. ​

Restrictions to medicine samples

Samples of Schedule 4D and Schedule 8 medicines are no longer permitted. Dentists must issue a written order when receiving samples for other scheduled medicines.

Compliance with policies and procedures is mandatory in some settings

Dentists working in public health entities must continue to comply with the NSW Ministry of Health Policy Directive on Medicines Handling.

Dentists working in private health facilities and managed correctional centres must comply with the facility or centre’s medicines policies and procedures.

Labelling requirements are listed in Appendix L of the Poisons Standard

The labelling of scheduled substances is no longer listed in the Regulation. Scheduled substances must be labelled as per the requirements of the Poisons Standard.

A pharmacist will no longer retain the repeat paper prescription for a Schedule 8 or Schedule 4 Appendix D medicine on the pharmacy premises.

Repeats can be given back to the patient to be dispensed at their pharmacy of choice.

Prescription​​ changes

Handwritten prescriptions must be legible for the prescription to be valid.

Dentists no longer need to underline high or unusual doses on a prescription.​

​New restrictions on the supply of nitrous oxide 

To help reduce harms associated with the misuse of nitrous oxide, new restrictions will apply to its supply for non-therapeutic purposes. These measures are intended to support the safe and responsible supply of nitrous oxide and limit access where there is a risk of misuse.

More information is available at Nitrous Oxide Regulations​.

​New offences and increased penalties​

The Act and Regulation set out penalties for offences associated with unauthorised activities.

Penalties are classified in 5 tiers​​​ and differ for individuals and corporations. They range from 20 to 400 penalty units for individuals and 100 to 2000 penalty units for corporations.

More information can be found in the offences and penalties section of the Act and the Regulation. Further information on compliance notices and penalties will also be available at a later date.

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​New terminology and definitions​

• ​Schedule 8 substance or medicine replaces Drug of addiction
  
• Schedule 4 substance or medicine replaces Restricted substance
  
• Schedule 4D substance or medicine replaces Prescribed restricted substance, Schedule 4 Appendix D
• Nominated Schedule 4 substance or medicine replaces Certain restricted substance
• ​Schedule 4D substance that is an anabolic-androgenic steroidal substance replaces Special restricted substance, Schedule 4 Appendix B
  

Further definitions and terminology can be found at key definitions and terminology​.​​

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