This article applies to organisations that supply or administer monitored drugs.
Controlled Substances (Poisons) (Miscellaneous) Amendment Regulations 2024 (SA)
On 18 July 2024, the Controlled Substances (Poisons) (Miscellaneous) Amendment Regulations 2024 (SA) (the Amending Regulations) were released and came into operation on the same day. The Amending Regulations insert a range of amendments into the Controlled Substances (Poisons) Regulations 2011 (SA) (the Regulations) including new requirements for the supply or administration of monitored drugs
Monitored drugs
Currently, the Regulations require prescribers giving a prescription for the supply of a monitored drug for human use to take all reasonable steps to check relevant information held in the monitored drugs database, known as ScriptCheckSA. The Amending Regulations extend these requirements to the supply and administration of monitored drugs.
Under the new Part 4A of the Regulations, a registered health practitioner acting in the ordinary course of their profession must not supply or administer monitored drugs to a person unless the practitioner has taken all reasonable steps to check the relevant information held in the monitored drugs database relating to the person.
In addition, a registered health practitioner acting in the ordinary course of their profession must not instruct or otherwise cause another person to supply or administer a monitored drug unless the practitioner has taken all reasonable steps to check relevant information held in the monitored drugs database relating to the person.
Failure to comply with the above requirements carries a maximum penalty of $5,000.
Practitioners can access ScriptCheckSA here.
Exemptions
New Regulation 35C(3) sets out the following circumstances where the above new requirements do not apply:
- where a registered health practitioner (being a prescriber) gives a prescription for a monitored drug; or
- where a monitored drug is to be dispensed on prescription; or
- where a monitored drug (not being dextromoramide or pethidine) is to be supplied or administered to a person aged 70 years or more; or
- where a monitored drug (not being dextromoramide or pethidine) is to be supplied or administered to a person and the registered health practitioner principally responsible for treatment of the person:
- reasonably believes the person’s life expectancy to be less than 12 months; and
- has informed the Minister of that belief along with the person’s name, address and date of birth; or
- where a monitored drug is to be supplied or administered to a person who is receiving treatment in a hospital or a correctional institution and the duration of treatment of the person with the drug while the person is in the hospital or correctional institution does not exceed 14 days; or
- where a monitored drug is to be supplied or administered to a person who is being discharged from a hospital following treatment in the hospital and the duration of treatment of the person with the drug after discharge does not exceed 14 days; or
- to a registered health practitioner supplying or administering a monitored drug on the lawful instruction of another person; or
- to a registered health practitioner who, on the lawful instruction of another person, instructs or otherwise causes another registered health practitioner to supply or administer a monitored drug; or
- to a person registered under the Health Practitioner Regulation National Law to practice in the paramedicine profession as a paramedic who is acting in the ordinary course of that profession.•
The Amending Regulations also introduced the following new exemption for the original requirement for prescribers giving a prescription for the supply of a monitored drug for human use to take all reasonable steps to check relevant information held in the monitored drugs database:
- the prescription is a medication chart prescription; and
- the provisions of the Commonwealth Regulations applying to the giving of a medication chart prescription for a pharmaceutical benefit are complied with in relation to the giving of the prescription for the drug (whether or not the drug is a pharmaceutical benefit).
Conclusion
Organisations should ensure that relevant staff are made aware of the new requirements, and exemptions to the requirements. If appropriate, organisations should update their prescribing and drug supply procedures.