New standards for the use of electronic drug registers in a range of settings including hospitals, licensed health facilities, community pharmacies, residential aged care facilities, medical/dental/veterinary practices and research organisations, are now in place.
Persons at these facilities authorised to be in possession of Schedule 8 drugs may keep an electronic drug register (instead of a drug register in the form of a book), where the use of the electronic drug register complies with standards described in:
These standards are in addition to requirements set out in the Poisons and Therapeutic Goods Regulation 2008 (the 'Regulation'). Obligations under the Regulation must be met except where expressly stated otherwise in the relevant Framework. For example, everyone authorised to possess Schedule 8 (S8) drugs must:
Proposed electronic drug register systems that do not comply with the standards may alternatively be approved by the Ministry of Health on a case by case basis. For further information contact the Pharmaceutical Services Unit by email at MOH-PharmaceuticalServices@health.nsw.gov.au.
The standards have been developed to ensure the security, accountability and use of electronic drug registers is appropriate.
The standards describe requirements for:
While there are separate standards for a drug register requiring a single signature and a drug register requiring dual signatures, an electronic drug register system may be configured for both single and dual signatures (such as at a hospital for use at the pharmacy and the wards/clinics).
An electronic drug register may be integrated within an automated drug cabinet, where the drug cabinet meets requirements in the Regulation for storage of Schedule 8 drugs.
A licensed pharmaceutical wholesaler may use an electronic drug register, which should be self-assessed against the Standards specified in the TG 217/1 Framework for use of an Electronic Drug Register Requiring Single Signature by a Licensed Wholesaler. For an electronic drug register to be valid to record the movement of Schedule 8 medicines held by a licensed wholesaler in NSW, the Standards for Use of an Electronic Drug Register Requiring Single Signature by a Licensed Wholesaler outlined in TG217/1 must be complied with.
An Authority under the Poisons and Therapeutic Goods Regulation 2008 has been issued until 31 December 2025 to approve the keeping of a drug register other than in the form of a book, where the use of the electronic drug register complies with the Standards for Use of an Electronic Drug Register Requiring Single Signature by a Licensed Wholesaler outlined in TG217/1.
Electronic drug register systems that were previously individually approved by the Secretary, NSW Health prior to the new Framework for use of an Electronic Drug Register Requiring Single Signature by a Licensed Wholesaler may continue to be used but must be self-assessed against the aforementioned framework.