Opening the gates for generics - E-prescribing requirements implemented in Australia

The Australian Pharmaceutical Benefits Scheme (PBS) provides for and regulates government subsidies for the supply of certain medicines. A requirement to receive subsidised medicine under the PBS is that the medicine must have been prescribed by an approved medical professional in accordance with the regulations. Prior to 31 October 2019, doctors were free to prescribe PBS medicines by referring either to the brand name, or the Active Pharmaceutical Ingredient (API).

In Australia, most doctors have chosen to prescribe by brand name, for example, a study in 2010 found that only 19.5% of prescriptions issued by GPs in Australia were issued with reference to the API.

With the introduction of new prescribing regulations on 31 October 2019, doctors are now required generally to prescribe with reference to the API and not the brand name.


Electronic prescribing (E-Prescribing) was introduced in Australia in 2019 as an alternative to conventional paper-based prescriptions. It was identified in the 2018-2019 Federal budget as a priority to improve efficiency, compliance, safety and data collection and forms a key part of the National Digital Health Strategy, which aims to provide paper-free medication management by 2022. The E-Prescribing initiative also included a commitment to implement API prescribing.

The API prescribing initiative has the stated aims of increasing understanding of APIs, increasing the uptake of generic and biosimilar medicines and contributing to the long-term economic sustainability of the PBS system. Digital API prescribing is hoped to reduce medication errors, improve safety and reduce costs.

E-Prescribing Regulation Amendments

The National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019 entered into force on 31 October 2019. It is made under the National Health Act 1953 and amends the National Health (Pharmaceutical Benefits) Regulations 2017.

The new E-prescribing requirements contained in the amendment make a subtle, but significant difference to the way in which PBS medicines are provided. Under the new regulations, a health practitioner issuing an electronic prescription for a PBS medicine must identify the medicine by reference to the API, rather than the brand name (e.g. identifying the API "rosuvastatin" rather than the specific brand "Crestor"). Where clinically necessary, the prescribing doctor may also include the brand name, provided it is listed on the PBS, after the API on the prescription form.

Additionally, from 31 October 2019 prescription software must not default to identifying a medicine by brand name.

Handwritten prescriptions (including paper medication charts used in hospitals and residential care facilities), prescriptions for medicines containing four or more APIs and certain medicines specified by the Secretary of the Department of Health are exempt and only need to include sufficient information to identify the medicine.

A 12 month transition period, until 1 November 2020, has been put in place to allow the necessary updates to be made to prescribing software.

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