Active Ingredient Prescribing

Active ingredient prescribing is an initiative to support the uptake of generic and biosimilar medicines and improve the health literacy of consumers and prescribers around the active ingredient in medicines. 

In October 2019 the National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019, and the Veterans’ Affairs Pharmaceutical Benefits Schemes (Electronic Prescriptions and Active Ingredient Prescribing) Amendment Instrument 2019 mandated active ingredient prescribing.

Active ingredient prescribing will increase consumer health literacy around their medicines; improve safe and quality use of medicines with consistent and standardised descriptions of medicines; and promote the uptake of generic and biosimilar medicines as described in the Australian Government’s 2018-19 Budget.

Implementation and principles

From 1 February 2021 most prescriptions for supply under the PBS and the RPBS must describe the medicine by active ingredient name to be eligible for subsidy.

Prescribing using the active ingredient name is safe in the majority of prescribing situations where available brands are therapeutically equivalent. The brand name should be included after the active ingredient on prescriptions where clinically necessary. A set of principles determine the limited, but clinically important exceptions to this approach; particularly important for some high-risk medicines and/or for high-risk consumers. The principles of active ingredient prescribing extend to all prescriptions, including private prescriptions.

Four documents have been developed to support clinicians with active ingredient prescribing:

2020
Fact sheet or brochure

2020
Guide, user guide or guidelines

2021
Guide, user guide or guidelines

2021
Guide, user guide or guidelines

The LMBC  and the LEMI should be used as appendices 1 and 2 to the Active ingredient prescribing User guide for Australian prescribers. The lists describe active ingredient by the International Non-proprietary Name (INN)[1] and are reviewed at regular intervals. Tall Man lettering is applied consistent with the Commission's National Tall Man Lettering List[2]. Please contact medsafety@safetyandquality.gov.au for previous iterations of the LMBC and the LEMI. 

The Commission review and curate the LMBC and the LEMI according to the principles in the user guide and in consultation with the Australian Government Department of Health, the Therapeutic Goods Administration (TGA), the Department of Veterans’ Affairs (DVA) and the Medical Software Industry Association (MSIA). The Commission is advised by medication safety experts forming the Active ingredient prescribing advisory group (AIPAG). The recommendations and actions from AIPAG are recorded in the Active ingredient prescribing issues register. 

2021
Publication, report or update

To raise issues for the AIPAG's consideration, send full details of the medicine, the reasons for addition/exclusion from the LMBC or LEMI to medsafety@safetyandquality.gov.au

References

[1] International Nonproprietary Names Programme and Classification of Medical Products. Available from https://www.who.int/teams/health-product-and-policy-standards/inn [Accessed 17 December 2020]

[2] Australian Commission on Safety and Quality in Health Care. National Tall Man Lettering List. Sydney: ACSQHC; 2020. Available from https://www.safetyandquality.gov.au/publications-and-resources/resource-library/national-tall-man-lettering-list [Accessed 17 December 2020]