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: 

  • keep a drug register of the type specified for the place 
  • make entries in it for all transactions including all the required details 
  • conduct an inventory of each S8 drug and record its balance on hand in the register every March and September and at more frequent intervals as required for the type of place, and immediately on assuming control of the drugs for one month or a lesser period as required 
  • immediately report the loss or destruction of a register to the Secretary, NSW Health

An Information Bulletin has been issued providing more information on use of electronic drug registers in public health facilities.  

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 Chief Pharmacist Unit by email at MOH-PharmaceuticalServices@health.nsw.gov.au.

The standards 

The standards have been developed to ensure the security, accountability and use of electronic drug registers is appropriate. 

The standards describe requirements for: 

  • the electronic drug register system 
  • the person who authorises the operation of the system in the facility 
  • the person responsible for use of the electronic drug register at the facility 
  • an authorised person who may possess, supply or administer Schedule 8 drugs and must make entries in the electronic drug register 
  • an eligible witness who countersigns entries made by an authorised person (relevant to the dual signature electronic drug register) 
  • each user of the electronic drug register.

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.

What does this mean for electronic drug registers implemented before the new standards?

The single signature frameworks replace  TG213/1 Electronic Drug Register for Pharmacy and the dual signature framework replaces TG210/1 Criteria for Electronic Drug Records (for opioid treatment program clinics). Existing systems that comply with the requirements described in these guides will continue to be legally recognised until 31 January 2023. Persons responsible for these systems should self-assess for conformance with the new standards and ensure they are compliant from 1 February 2023. 

Where an electronic drug register system has been individually approved for use by the Secretary, NSW Health, unless otherwise specified, these approvals remain in place until 31 January 2023. Persons responsible for these systems should self-assess for conformance with the new standards and ensure they are compliant from 1 February 2023, or, where an individual approval is in place, by the end date of that approval.

Framework and Standards for use of electronic drug registers by licensed wholesalers

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 May 2024 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.
Current as at: Thursday 4 November 2021
Contact page owner: Pharmaceutical Services