Prescribing unregistered Schedule 8 medicines
Unregistered medicines are not assessed for quality, safety or efficacy by the Therapeutic Goods Administration (TGA). To prescribe an unregistered medicine in Australia, the prescriber must obtain an approval to supply an unregistered good issued under the Commonwealth’s Therapeutic Goods Act 1989 by the TGA (Commonwealth Approval), under one of:
- Special Access Scheme, or
- Authorised Prescriber Scheme, or
- Clinical Trial Schemes.
Under the NSW Poisons and Therapeutic Goods Act 1966, an authority (NSW authority) is required to prescribe and supply an unregistered Schedule 8 medicine (S8):
- to a drug dependent person*
- that is a compounded medicine, or
- for a clinical trial.
* A drug dependent person means a person who has acquired, as a result of repeated administration of any of the following drugs, an overpowering desire for the continued administration of a drug of addiction (Schedule 8), or a prohibited drug within the meaning of the Drug Misuse and Trafficking Act 1985 (including but not limited to heroin, methylamphetamine or cocaine). A person treated under the Opioid Treatment Program is a drug dependent person.
The medical practitioner must write the NSW authority number on a prescription for an unregistered compounded S8 medicine (not to be confused with a ‘PBS authority number’ issued by the Commonwealth for subsidy under the Pharmaceutical Benefits Scheme). All the other requirements for an S8 prescription apply, such as adequate directions for use, handwritten, quantity in words and figures and repeat intervals, and required records (see Guide to Poisons and Therapeutic Goods Legislation for Medical, Nurse and Midwife Practitioners and Dentists).
The applicant medical practitioner would be expected to be a specialist in the management of patients with the disease being treated with the medicine. The application must include the rationale for the treatment and the available scientific evidence to support this treatment of choice.
Prescribers holding an existing general NSW authority for S8 psychostimulants such as dexamfetamine, do not need additional authority to prescribe them as compounded preparations.
Dispensing unregistered Schedule 8 medicines
A pharmacist can compound or dispense an unregistered S8 medicine only on receipt of a hard copy original written prescription (or a duplicate copy of a Pharmaceutical Benefits Scheme Hospital Medication Chart prescription, at a pharmacy contracted to supply to the hospital and named on the prescription, in accordance with Commonwealth and NSW requirements for the PBS HMC).
The prescription for a compounded S8 medicine must bear the NSW authority number issued to and written by the prescriber (which has the format "AUXXXXXXX" where X is a numeral).
Emergency phoned/faxed/emailed prescriptions are not permitted. However hospital pharmacies may supply for inpatients on a copy of a medication chart order.
The unregistered S8 medicine supplied to a patient by a pharmacist or medical practitioner must have a dispensing label with the usual details as for any dispensed medicine (see Guide to Poisons and Therapeutic Goods Legislation for Pharmacists).
The requirements as for all S8 prescriptions apply, e.g. the pharmacist must verify the prescriber, report any apparently forged or fraudulently altered prescriptions, and retain the dispensed prescription, separately. All transactions must be recorded in a drug register and loss or theft reported.
Wholesale supply of pharmacy-compounded medicines is not permitted.
Unregistered S8 medicines must be stored separately and securely, as for all S8 drugs. A Schedule 8 medicine requiring refrigeration may be stored in a refrigerator.
The Secretary, NSW Ministry of Health has issued an Order which is published on Page 3708 of the NSW Government Gazette No 117 of 16 December 2016, exempting the following substances from the requirement to obtain authority to prescribe or supply an unregistered Schedule 8 medicine:
- Schedule 8 substances manufactured by a person under a contract between the person and a public or private hospital, or other public institution and:
- that are manufactured to a formulation specified by the relevant hospital/public institution for use by a patient of that hospital/institution (or if it is a public hospital, a patient of another NSW public hospital); and
- there is no substantially similar listed or registered medicine; and
- the person manufactures them in Australia at premises for which he (or she) holds a medicine manufacturing licence under the Therapeutic Goods Act 1989; and
- the person notifies the Commonwealth Secretary of Health each quarter of the details of the substance/s manufactured and the relevant hospital/institution. (See Therapeutic Goods Regulation 1990)
- Schedule 8 substances compounded by a pharmacist in a public hospital pharmacy for the treatment of a patient of a public hospital.
- Schedule 8 substances compounded by a pharmacist at a dispensary in a facility licensed under the Private Health Facilities Act 2007 for the treatment of a patient who is receiving:
- chemotherapy (parenteral cytotoxic agent/s), or
- emergency services or treatments relating to the care of patients injured in accidents, or suffering from medical or other emergencies, through provision of reception, resuscitation, medical and surgical treatment and use of life support systems,
- neonatal services (treatment to a baby under the age of 28 days),
- medical services for the purpose of palliative care,
- surgical procedures performed on patients who are administered general, epidural or major regional anaesthetic or sedation resulting in more than conscious sedation, other than a surgical procedure carried out by a dentist.
- Cocaine compounded by a pharmacist for treatment via topical application of a patient in a facility licensed under the Private Health Facilities Act 2007.
For further information please contact the Chief Pharmacist Unit on (02) 9391 9944 or MOH-PharmaceuticalServices@health.nsw.gov.au