Psychostimulant changes
The PDL Professional Officers would like to bring to the attention of NSW pharmacists some recent regulatory changes regarding the requirements to prescribe the Schedule 8 psychostimulant medicines dexamfetamine, lisdexamfetamine and methylphenidate.
As NSW pharmacists are aware, an authority/approval from the NSW Ministry of Health is required to prescribe or supply dexamfetamine, lisdexamfetamine or methylphenidate. Pharmacists cannot dispense a prescription for a psychostimulant medicine unless the prescription shows an authority/approval number issued by NSW Health, regardless of which state or territory a prescription is issued in. Please note that NSW Health is updating the terminology currently used from ‘authority’ to ‘approval’. In SafeScript NSW an approval is a reference to an authority issued under the Poisons and Therapeutic Goods Act 1966.
From 13 November 2023 psychiatrists, paediatricians and neurologists are authorised to prescribe or supply a Schedule 8 psychostimulant medicine under a class authority issued by NSW Health. These prescribers are required to include the class authority number ‘CA2023’ on prescriptions issued for a Schedule 8 psychostimulant medicine. The class authority applies when prescribing:
- to a patient who is not drug dependent, and
- for the treatment of attention deficit hyperactivity disorder (ADHD), and up to a maximum daily dose of:
- dexamfetamine 50mg
- lisdexamfetamine 70mg
- methylphenidate 108mg
To prescribe for non-ADHD indications or to drug-dependent patients, or for higher doses for ADHD, these specialists will need to apply for an individual authority/approval, and the prescription will show an authority/approval number with the prefix ‘A’.
General practitioners and other registered medical practitioners are required to apply for individual patient authority/approval to prescribe a psychostimulant medicine to a patient for any indication. In most cases these applications will only be approved where the applicant has the ongoing support and recommendation from a relevant treating specialist medical practitioner.
A prescription for dexamfetamine, lisdexamfetamine or methylphenidate can be lawfully dispensed when it is endorsed with one of the following reference numbers:
- CA2023 (i.e. class authority issued for psychiatrists, paediatricians and neurologists for the treatment of ADHD)
- CNS ******* (i.e. unique number for prescriber)
- S28c ******* (i.e. unique number for prescriber)
- AU ****** (i.e. unique number for prescriber specific for each patient)
- A******* (i.e. unique number for prescriber or unique number specific for each patient)
Note: Current prescriptions endorsed with reference numbers ‘CNS’ or ‘S28c’ are valid for dispensing until 30 June 2024, unless expired.
Pharmacists should also note that applications for an authority/approval to prescribe or supply a psychostimulant medicine can now be submitted via SafeScript NSW. This allows prescribers to monitor their application progress online and to receive real-time approval in many cases. Prescribers will be notified immediately if:
- an approval is required;
- the application is automatically approved; and
- the application needs to be reviewed by NSW Health.
Requirements for the destruction of Schedule 8 medicines
As of 29 September 2023, the Poisons and Therapeutic Goods Regulation 2008 allows a pharmacist who practises at a community pharmacy to destroy a drug of addiction (Schedule 8 medicine) at the pharmacy in the presence of an *independent witness.
A pharmacist who destroys a Schedule 8 medicine must record the following in the drug register kept at the pharmacy:
a. the date of destruction
b. the name and quantity of the medicine destroyed
c. the pharmacist’s name, registration number and signature
d. the independent witness’ name, registration number and signature
*independent witness means a medical practitioner, nurse practitioner or pharmacist who:
a. is not employed or otherwise engaged to provide professional services at the pharmacy;
b. is not a family member of the pharmacist; and
c. if the independent witness is a pharmacist—does not have a financial interest, within the meaning of the Health Practitioner Regulation National Law (NSW), Schedule 5F, in the pharmacy.
Guidance on how to destroy Schedule 8 medicines is available on the Pharmacy Council of NSW website, and this includes the definition of a family member as referenced above.
The PDL Professional Officers remind pharmacists that if you supply any medicine to an aged care facility or its residents, you may go to the facility and destroy the unwanted Schedule 8 drugs on the premises in the presence of the Director of Nursing. These medicines should not be removed from the facility premises.
Exposure Draft Medicines, Poisons and Therapeutic Goods Regulation
NSW Health is seeking your feedback on the Exposure Draft Medicines, Poisons and Therapeutic Goods Regulation (Draft Regulation) and its Regulatory Impact Statement.
The Medicines, Poisons and Therapeutic Goods Act 2022 launch (the Act) was passed in Parliament in November 2022. On commencement, the Act will replace the current Poisons and Therapeutic Goods Act 1966 (PTGA) which is the primary legislative framework governing the control of medicines, poisons and therapeutic goods in NSW.
Together, the Act and Draft Regulation set out who can manufacture, supply by wholesale, obtain, supply, prescribe, use and administer these substances. The Draft Regulation also sets out specific obligations about prescription requirements, on-the-spot fines, fees, when an approval or authority from the Health Secretary is required, labelling, disposal and destruction of these substances. The Act and the Draft Regulation seek to ensure that the framework regulating medicines, poisons and therapeutic goods is contemporary, robust, safe and efficient.
The PDL Professional Officers encourage pharmacists to review the Draft Regulation and consider making a submission before the consultation closes on 22 December 2023.
For immediate advice and incident support, call PDL on 1300 854 838 to speak with one of our Professional Officers. We are here to support our pharmacist members 24/7.
