Active ingredient prescribing: what health professionals need to know about new regulations from 1 February

Health professionals are reminded of changes coming into effect from Monday 1 February 2021 bringing mandatory active ingredient listings on medicines, with some exceptions.

NPS MedicineWise medical adviser and GP Dr Jill Thistlethwaite says the changes will not affect clinical decision making or consumer choice, but will help consumers to understand more about the medicines they are taking.

“These changes help support greater consistency in the way people see their medicines information, and can lead to safer and more appropriate use of medicines,” she says.

From 1 February 2021, inclusion of the active ingredient is mandatory for all Pharmaceutical Benefits Scheme (PBS) and Repatriation Schedule of Pharmaceutical Benefits (RPBS) prescriptions with a small number of exceptions, such as for vaccines, hand-written prescriptions and prescriptions with four or more active ingredients.

To support pharmacies, and ensure consumers have continued access to PBS and RPBS subsidised medicines during the transition, the Department has agreed to provide a six-month grace period for pharmacy, ceasing 31 July 2021. Within this period, if a pharmacy receives a prescription that does not meet active ingredient prescribing requirements the pharmacist should contact the prescriber and request the prescription be re-issued. If the prescriber is unable to issue a compliant prescription for any reason, the pharmacy may supply and claim for the medicine as normal under the PBS or RPBS without penalty. From 1 August 2021, new prescriptions that do not meet active ingredient prescribing requirements cannot be dispensed as PBS prescriptions and will need to be reissued in alignment with active ingredient prescribing requirements, or dispensed as private prescriptions.

The initiative supports conversations between consumers, prescribers and pharmacists about options for generic and biosimilar medicines that contain the same active ingredients (and are often cheaper).

The NPS MedicineWise fact sheets for prescribers and for pharmacists, as well as further background information and links to other resources, are available at www.nps.org.au/active-ingredient-prescribing.