This article applies to prescribers of controlled substances.
Controlled Substances (Poisons) (Miscellaneous) Variation Regulations 2021 (SA)
Please be advised that the Controlled Substances (Poisons) (Miscellaneous) Variation Regulations 2021 (SA) (the Variation Regulations) commences on 1 April 2022 and will amend the Controlled Substances (Poisons) Regulations 2011 (SA) (the Regulations) to clarify the way a prescription or dispensing record of monitored drugs is to be transmitted, as well as provide a new obligation to check the monitored medicines database prior to prescribing or dispensing a monitored medicine.
How a prescription is to be given
Regulation 33 of the Regulations will be amended to make it a requirement that all electronic prescriptions of monitored medicines are to be transmitted to a data source entity at, or immediately following, the creation of the record. This will replace the previous obligation to transmit the record to the Chief Executive so that it is received by the 7th day of the month following the month in which the drug was dispensed. Records of the dispensing of monitored drugs must now also be transmitted to a data source entity, in accordance with amendments made to regulation 35A.
If a prescriber or dispenser is unable to transmit the record to a data source entity, the record must be transmitted to the Chief Executive so that it is received:
- if the prescription is prepared on a day falling within the first 14 days of a month—the 21st day of that month; or
- if the prescription is prepared on any other day—the 7th day of the month following the month in which the prescription was prepared; or
- in any case, such later day as the Chief Executive may, on application, authorise.
Similarly, written prescriptions for monitored drugs, under the amended regulation 34, if kept in an electronic form, must also be transmitted to a data source entity at, or immediately after, the creation of the record. If unable to do so, the prescriber must transmit the record to the Chief Executive in accordance with the above listed timeframes.
Data source entity means any of the following:
- eRx Script Exchange Pty Ltd;
- MediSecure Pty Ltd;
- Medication Knowledge Pty Ltd;
- a prescription exchange service operating in an Australian jurisdiction.
Monitored drugs – special provisions
In accordance with the new regulation 34A, there will be an obligation to take all reasonable steps to check the monitored drugs database for relevant information relating to the person for whom the drug is being prescribed. Failure to do so may result in a maximum penalty of $5,000.
There is also an obligation for the dispensing pharmacist or practitioner to check the database when dispensing a monitored drug. Failure to check the database may result in a maximum penalty of $5,000.
These obligations do not apply when the drug (not being dextromoramide or pethidine) is for use by a person 70 years or older, or is for use by a person whose life expectancy is reasonably believed by the primary responsible registered health practitioner to be less than 12 months and the Minister has been made aware of the patient’s name, address, date of birth and nature of the patient’s condition and the prescription has been endorsed either “Notified Palliative Care Patient” or “NPCP”.
Further, the obligations do not apply when the drug has been prescribed to a person in a hospital or correctional institution and the treatment duration with the drug is not more than 14 days, or the patient has been discharged from a hospital following treatment and treatment with the drug after discharge is not more than 14 days.
Please click here to access the full Variation Regulations.
For further information please contact the Law Compliance team:
Phone: 1300 862 667