Legal Insights

Active ingredient prescribing rules rolled out

By Steven Tang & Andrew Theodosi

• 17 June 2021 • 2 min read

As of 1 February 2021, it became mandatory for prescribers to prescribe most medicines by their respective active ingredient.* Under the new requirements, prescribers are still able to include a brand choice and disallow brand substitution, but active ingredients will always appear first on prescriptions. There are reports of teething problems as prescribers, patients and pharmacists get use to the new requirements. The Department of Health is allowing a grace period to 31 July 2021 for claims to be paid on non-conforming prescriptions.

Background to the changes

In the 2018-19 budget, the Australian Government announced the implementation of active ingredient prescribing as part of the development and implementation of electronic prescribing.

The Government’s stated reasons for introducing active ingredient prescribing include:

  • recognition that consumers’ ability to identify the active ingredient present in their medicine is important to pharmaceutical safety and that confusion surrounding the active ingredients in medicines poses a significant risk to consumers with many only knowing their medicines by brand name
  • a concern that patients may mistakenly take multiple doses if they are prescribed two different brands of medicine containing the same active ingredient
  • the risk being perceived to be substantially increased for patients who regularly use a number of medicines, such as the elderly or chronically ill.

The changes were also expected to promote the uptake of generic and biosimilar medicines, reducing out-of-pocket expenses for patients.

Active ingredient prescribing

Active ingredient prescribing requires prescribers to include the active ingredient name(s) when preparing prescriptions of Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS (RPBS) medicines.

While prescribers remain able to write in a brand name and require non-substitution, the active ingredient of a prescribed medicine must be recorded as the primary prescription detail.

To further entrench the change, prescribers are no longer able to set prescribing software to automatically include a brand name on prescriptions. Consequently, any brand recommendation or requirement will need to be manually added by the prescriber.

Prescriptions that do not follow active ingredient prescribing guidelines will not be permitted to be dispensed as PBS prescriptions (and consequently PBS claims will not be approved for such prescriptions).

In this regard, it has been reported by NPS MedicineWise that the Department of Health has agreed to the Pharmacy Guild’s request to provide a six-month grace period for pharmacies in processing non-compliant prescriptions when processing PBS claims.

For more information about the roll out of active ingredient prescribing, refer to the Department’s commentary.

*There are exceptions for hand written prescriptions; paper-based residential medication charts; computer generated ‘free-text’ prescriptions; prescriptions for medicines with four or more active ingredients; prescriptions for medicines on the Excluded List prepared by the Australian Commission for Quality and safety in Healthcare; and Non-PBS prescriptions (though similar principles would be expected to be applied to these prescriptions).

To read more articles from this edition of The Prescription, please click here.

By Steven Tang & Andrew Theodosi

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