Medicine approvals

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1. When is approval required
   
2. Exemptions - when approval is not required
3. Who can apply for approval
4. Considerations for prescribers
   
5. How to apply for approval​
   
6. More information​​
   

​For information about the ​​legislative requirements to prescribe, supply or administer medicines under the NSW Opioid Treatment Program (OTP) see the Opioid Treatment Program​ webpage.

​​​​​​​​​​​​​​​​​When is approval required

NSW Health approval under the Medicines, Poisons and Therapeutic Goods Act 2022​ (NSW) ​is required to prescribe, supply, or administer certain medicines. Some exemptions apply.​

Note: This approval is not the same as a PBS authority which allows access to a medicine at a subsidised cost.

A medical practitioner, nurse practitioner, or registered nurse with an endorsement (designated registered nurse prescriber) requires NSW Health approval to prescribe, supply or administer the following restricted Schedule 8 medicines: ​

• any Schedule 8​ medicine to a person with substance dependence​
• a Schedule 8​ psychostimulant medicine (dexamfetamine, methylphenidate, lisdexamfetamine)
• the opioids morphine, oxycodone, fentanyl, or hydromorphone when used individually or in combination, in a total daily ​dose exceeding 100mg oMEDD* (oral Morphine Equivalent Daily Dose).
• the following medicines when known to have been used continuously, individually or in combination, for more than 3 months:
  
• Schedule 8 medicines in a formulation for injection or intranasal use
• alprazolam
  
• flunitrazepam
• ​methadone (excluding when used under the NSW Opioid Treatment Program)

• psilocybine for treatment-resistant depression. Further restrictions apply; for more information refer to Psilocybine and MDMA.
  
• MDMA (N,α-dimethyl-3,4-(methylenedioxy)phenylethylamine)​ for the treatment of post-traumatic stress disorder. Further restrictions apply; for more information refer to Psilocybine and MDMA.

Approval requirements also apply to some Schedule 4 (prescription-only) medicines. See nominated Schedule 4 medicines for more information.

*Note: oMEDD is the total daily dose of any opioid(s) converted into an equivalent dose of oral morphine. There are calculators available that may be used to calculate the oMEDD, such as Faculty of Pain Management (FPM) ANZCA opioid calculator​​.

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​​​Exemptions - when approval is not required​

Approval from NSW Health is not required under the circumstances listed below. The only exception is for psilocybine or MDMA, for which approval is always required.

Providing palliative treatment of a patient

When providing palliative treatment to a patient who:​

• has an incurable, progressive, far advanced disease or medical condition, and
• has a limited life expectancy, with death expected within the next 2 years due to the disease or medical condition.

Replacing or c​overing another practitioner temporarily

When prescribing, supplying or administering these medicines on behalf of another practitioner who holds approval and is temporarily unavailable, and the replacing or covering prescriber:

• provides continuation treatment only, and
• practises at the same practice or premises as the original practitioner, or is nominated by the original practitioner to provide the medicine(s) to their patient(s).​

The prescriber is an exempt medical practitioner

When the prescriber is registered with the Australian Health Practitioner Regulation Agency (Ahpra)​ in one of the following specialties or specialty fields of practice:

• medical oncology
• paediatric medical oncology
• palliative medicine
  
• paediatric palliative medicine
• radiation oncology
  
• gynaecological oncology.

Treating patients in hospital

When treating a patient who is admitted to, or receiving emergency treatment in, a public or private hospital.

Continuing treatment in correctional centres

When treating a person who enters custody in a correctional centre and requires continuation of treatment with a medicine they were receiving immediately prior to entering custody.

Providing up to 3 days urgent pain relief

When prescribing, supplying, or administering a medicine for urgent pain relief and the treatment does not exceed 3 consecutive days. This applies to all setting and all patients including those with substance dependence.

​When the medicine is a psychostimulant (dexa​mfetamine, lisdexamfetamine, or methylphenidate) and the prescriber is one of the below listed specialists

When prescribing, supplying, or administering a psychostimulant medicine to a patient who is not considered to have a substance dependence, and you are an ​​Ahpra registered medical practitioner with specialist registration or specialty field of practice in:​

• paediatrics and child health
  
• psychiatry
• neurology
• respiratory and sleep medicine
  

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​​Who can apply for approval

All medical practitioners, nurse practitioners and nurses with an endorsement (designated registered nurse prescribers) ​​are required to apply for approval to prescribe, supply, or administer these medicines, unless approval is not required as listed above. ​​

Please note that designated registered nurse prescribers cannot prescribe, supply, administer, or issue a direction to supply or administer unregistered scheduled medicines.

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Considerations for prescribers

Prescribers must prescribe, supply, or administer these medicines within their scope of practice and should:

• ​​​Refer to Safe prescribing of high-risk medicines for prescribing key points when prescribing these medicines.
• Review information on SafeScript NSW when making informed clinical decisions related to prescribing, supplying, or administering high-risk monitored medicines.
• Follow current published and approved Product Information (PI), recommendations from the relevant professional body (such as RANZCP, RACP, RACGP, ACRRM etc.), best practice guidelines, and current evidence-based medicine standards.​
  
• Ensure treatment is in accordance with a management plan, which considers all available treatment options, including non-pharmacological strategies.
  

​Nurse practitioners and nurses with an endorsement prescribing for children under the age of 16 years

Before a nurse practitioner or nurse with an endorsement (designated registered nurse prescriber)​ applies for approval to treat a child under 16 years with a Schedule 8 medicine, they must ensure they understand and comply with their legal obligations.

• ​Under the Children and Young Persons (Care and Protection) Act 1998 (NSW)​​​​, only a medical practitioner may apply for exemption to carry out special medical treatment on a child under the age of 16 years. Special medical treatment includes “any medical treatment that involves the administration of a Schedule 8 substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022 (NSW)​ over a period or periods totalling more than 10 days in any period of 30 days."
  
• This means that a nurse practitioner or registered nurse with an endorsement is not authorised to administer Schedule 8 medicines to children under 16 years of age, for more than 10 days in any 30-day period.
• ​Any approval issued under the Medicines, Poisons and Therapeutic Goods Act 2022 is subject to legal and professional obligations under other NSW laws or Commonwealth laws. When applying for a medicine approval, you are confirming that you understand your responsibilities and legal obligations.
  

​How to apply for approval

Applications for approval can generally ​be made by a prescriber via ​Safescript NSW​.​, however submissions via the applicable PDF form are accepted for manual processing​. Applying online allows prescribers to receive quicker responses, with approvals issued in real-time in some cases.

For applications under the current legislation please refer to webpage Applicat​ion forms for approval to prescribe or supply.

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