Schedule 4 Appendix D drugs - Prescribed restricted substances

Appendix D of the Poisons and Therapeutic Goods Regulation 2008 (Regulation) lists Schedule 4 substances (prescription-only medicines) that have common therapeutic uses, but are also liable to abuse, misuse and diversion, warranting more stringent controls on possession and supply. These substances are referred to under the Regulation as prescribed restricted substances, and are also more commonly referred to as Schedule 4 Appendix D (S4D) medicines.

Refer to List of substances in Appendix D of the Poisons and Therapeutic Goods Regulation 2008.

Possession of a S4D medicine is prohibited unless authorised, such as in the lawful practice of a person’s profession as a medical practitioner, pharmacist, dentist or veterinary practitioner. A person for whom the S4D medicine has been lawfully prescribed or supplied, or their carer, may also be in possession of the medicine. A licensed wholesaler may possess and supply S4D medicines to authorised entities in accordance with the conditions attached to the licence. A carrier may also be in possession of a S4D medicine for the purpose of delivering it to the addressee.

Appendix D of the Regulation (NSW Appendix D) is not the same as Appendix D of the National Poisons Standard (National Appendix D), noting:

• NSW does not automatically adopt the National Appendix D
• To date, NSW has included all entries in section 5 of the National Appendix D in the NSW Appendix D
• NSW Appendix D is independently compiled in NSW, irrespective of the substance’s inclusion in the National Appendix D
• NSW Appendix D includes substances considered to be high risk warranting more stringent controls, and includes substances other than those in the National Appendix D
• NSW adopts the Schedules of the National Poisons Standard, however Appendix D of the National Poisons Standard is not included in the Schedules

Storage

Medicines in Appendix D of the Regulation in a hospital ward or nursing home must be stored apart from all other goods (other than drugs of addiction) in a separate room, safe, cupboard or other receptacle securely attached to a part of the premises and kept securely locked when not in immediate use.

For further information on storage of refrigerated S4D medicines in NSW public health facilities see section 5.4.4 of the NSW PD2022_032 Medication Handling.

Prescribers

Prescribing S4D medicines is the same as prescribing any other Schedule 4 medicine. Care should be taken to monitor for overuse or misuse. Of note is that the prescription will only be valid for six months, rather than twelve months.

Record keeping

There are specific record keeping requirements under the Regulation, however most of these details are regularly being recorded and kept in prescribing software.

An authorised practitioner who prescribes a S4D medicine must make a record of the following particulars:

1. the name, strength and quantity of the substance prescribed and the date on which it was prescribed
2. if the substance is intended for the treatment of a person, the name and address of the person to be treated
3. if the substance is intended for the treatment of an animal, the species of animal and the name and address of the animal’s owner
4. the maximum number of times the substance may be supplied on the prescription
5. in the case of a prescription for a special restricted substance (some barbiturates and anabolic and androgenic steroidal agents), the intervals at which the substance may be supplied on the prescription
6. the directions for use, as shown on the prescription

The record must be kept at the surgery, hospital or office of the prescriber.

Disclosure by patient

Prescribers should note that patients who ask to be prescribed or supplied a S4D medicine must disclose the quantity of that and any other S4D medicine with which they have been prescribed or supplied, within the last two months. Prescribers should ask patients about such previous supplies and note the response in their records.

Community pharmacists

There are more stringent requirements on dispensing S4D medicines on prescription, and supply without a prescription, than other Schedule 4 medicines. A subset of S4D medicines are subject to further requirements on dispensing. These medicines are listed in Appendix B of the Regulation and are known as S4B medicines or 'special restricted substances'.

Prescription validity

A prescription for a S4D medicine is valid to be dispensed only up to six months from the date it is written and it cannot be dispensed once it is out-of-date. For example, if a patient presents a prescription for tramadol on 17 April 2020, and the prescription is dated 16 October 2019 (more than six months old), then the pharmacist cannot dispense the prescription as it is out-of-date.

Forged or fraudulently obtained prescriptions

Immediately on being requested to supply a S4D medicine on a paper prescription that appears to have been forged or fraudulently obtained, or if the prescription appears to have been altered otherwise than by the authorised practitioner by whom it was issued, a pharmacist must retain the prescription and report the request to a police officer.

Lost or stolen S4D medicines

The loss or theft of S4D medicines must be reported to the NSW Ministry of Health. See the NSW Health webpage on Notifying the loss or theft of drugs under Poisons and Therapeutic Goods legislation.

Doctors bag orders

A pharmacist may supply an authorised practitioner with any Schedule 4, including a S4D, medicine for emergency use, but only on a written order signed and dated by the authorised practitioner.

Emergency supply on the direction of an authorised practitioner

A pharmacist may supply a patient with a Schedule 4, including a S4D, medicine if an authorised practitioner directs the supply either face-to-face, by telephone, by email or by fax. The authorised practitioner must then make out a prescription immediately and send it within 24 hours of giving the direction to the pharmacist. If the pharmacist does not receive this prescription within seven days, a report must be made to the NSW Ministry of Health by emailing MOH-Pharmaceuticalservices@health.nsw.gov.au.

Emergency supply without the direction of an authorised practitioner

There is no provision under the Regulation to supply an S4D medicine to a patient without a prescription. The patient will need to obtain a valid prescription by an authorised prescriber.

Special restricted substances (S4B medicines)

Special restricted substances are S4D substances that are also listed in Appendix B and are commonly referred to as S4B medicines. They include some barbiturates and anabolic and androgenic steroidal agents. S4B medicines have more stringent dispensing requirements than other S4D medicines. For details see Schedule 4 Appendix B drugs - Special restricted substances.

Lost or stolen S4D medicines

A person authorised to be in possession of a S4D medicine (for example medical practitioner, pharmacist, dentist, nurse, nurse practitioner, ambulance officer, veterinary practitioner, pharmaceutical wholesaler) must report the loss or theft of a S4D medicine to the NSW Ministry of Health. See the NSW Health webpage on Notifying the loss or theft of drugs under Poisons and Therapeutic Goods legislation.

List of substances in Appendix D of the Poisons and Therapeutic Goods Regulation 2008

Anabolic and androgenic steroidal agents, barbiturates and benzodiazepines that are not listed individually are included in their classes. Salts, derivatives, preparations and admixtures of the substances listed are controlled in the same way as the substances themselves.

Generic name

References

1. when included in Schedule 4 of the Poisons List*
2. included in Schedule 4 of the Poisons List*, except when referred to elsewhere in this Appendix
3. except when referred to elsewhere in this Appendix
4. except when included in Schedule 6 of the Poisons List*
5. including those separately specified in Schedule 4
6. except when included in Schedule 5 of the Poisons List

*For information on the NSW Poisons List see Legislation.