Electronic drug registers

​Persons authorised to be in possession of Schedule 8 (S8) medicines may keep an electronic drug register instead of the required 'drug register in the form of a book', provided this electronic drug register meets the following standards:​

• ​For hospital wards, residential care facilities and managed correctional centres
• ​​ Framework for Use of an Electronic Drug Register Requiring Dual Signatures, 
• For community pharmacies, medical, dental, veterinary practices and research organisations
• ​ Framework for Use of an Electronic Drug Register Requiring Single Signature, 
• For licensed wholesalers* 
• ​​Framework for use of an Electronic Drug Register Requiring Single Signature by a Licensed Wholesaler.​

These standards must be complied with and apply in addition to requirements for the management of S8 medicines that are set out in the Poisons and Therapeutic Goods Regulation 2008. All obligations under this law must be met unless expressly stated otherwise in the relevant Framework. 

*​The electronic drug register framework for licensed wholesalers was introduced in 2021. Electronic drug register systems that were individually approved by the Secretary, NSW Health before 2021 may continue to be used provided they have been self-assessed for compliance with the current framework.

The electronic drug register standards

The standards have been developed to ensure the security, accountability and appropriate use of electronic drug registers. They outline requirements for:

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

While separate standards exist for drug registers requiring single signature and those requiring dual signatures, an electronic drug register system may be configured to support both in settings, for example in a hospital for use at the pharmacy (single signature) and the wards/clinics (dual signature).

An electronic drug register may be integrated with an automated drug cabinet, provided the drug cabinet meets all the legal requirements for storage of Schedule 8 medicines​​.

​Legal instruments authorising these standards

The following legal instruments have been issued to authorise electronic drug registers:

• ​For hospital wards, residential care facilities and managed correctional centres - Authority​
  
• ​For wholesalers - Authority​​​
• For all other settings, such as community pharmacies, medical, de​ntal, veterinary practices and research organisations - Authority

Key drug register obligations 

Everyone authorised ​to possess S8 medicines​ must:

• keep a drug register of the type specified for the setting 
  
• record entries in the register for all transactions, including all the required details
• conduct an inventory of each S8 drug and record the 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 medicines for one month or a lesser period as required
• immediately report the loss or destruction of a register​ to the Secretary, NSW Health.

Electronic drug register systems that do not comply with the standards may 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.​

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